HLS Therapeutics Inc. (TSX:HLS)
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May 1, 2026, 3:59 PM EST
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Earnings Call: Q3 2022

Nov 10, 2022

Operator

Good morning, and welcome to the Q3 fiscal 2022 financial results conference call for HLS Therapeutics. On this morning's call, we have Gilbert Godin, Chief Executive Officer, and Tim Hendrickson, Chief Financial Officer. At this time, all participants are in listen-only mode. Following management's presentation, we'll conduct a question-and-answer session during which analysts are invited to ask questions. To ask a question, please press star one on your touch-tone phone to register. Should you require any assistance during the call, please press star zero. Earlier this morning, HLS issued a news release announcing its financial results for the 3- and 9-month period ending September thirtieth, 2022. This news release, along with the company's MD&A and financial statements, will be available on HLS's website and on SEDAR.

Please note that slides accompanying today's call can be viewed via the website, a link of which is available in the company's earnings press release and at its website on the Events page. Certain matters discussed in today's conference call or answers that may be given to questions could constitute forward-looking statements. Actual results could differ materially from those anticipated. Risk factors that could affect results are detailed in the company's annual information form, which have been filed on SEDAR at www.sedar.com. During this conference call, HLS will refer to adjusted EBITDA. Adjusted EBITDA does not have any standardized meaning prescribed by IFRS. Adjusted EBITDA is defined in the company's press release and annual filings that are available on SEDAR and on the company's website. Please note that all financial information provided in US dollars unless otherwise specified.

I would now like to turn the meeting over to Mr. Godin. Please go ahead, sir.

Gilbert Godin
CEO, HLS Therapeutics

Great. Good morning, everyone, and thank you for joining us. On our call today, I will start off with a review of recent highlights. Tim will follow with a more detailed look at our financial results, and then we will hold a Q&A session. The third quarter product revenue in Canada grew 11% versus the same quarter last year and grew 15% on a constant currency basis, which reflects the growing contribution from Vascepa while our core products continue to drive solid and reliable levels of Adjusted EBITDA and cash flow from operations at $6 million and $4.2 million, respectively. The total Q3 revenue was $15.7 million, which would otherwise be up year-over-year by 7% to $16.1 million in constant currency.

The key highlights in the quarter were the signing of product listing agreements in Ontario and Saskatchewan, which are reflected here in the first slide, bringing public market reimbursement coverage for Vascepa to approximately 70% of Canadians on public plans, while at the same time, more than 95% of Canadians on private health plans who are in label have reimbursement coverage for the product. This newly reached level of public and private access, sales force expansion, and medical society endorsement are the catalysts that are now combining to drive prescription growth higher for Vascepa. The next slide shows the progression in total prescriptions, and we have extended that reporting to the most recent time period that we could put our hands on. In this case, October 28.

As the rate of growth remained constantly, essentially constant through the third quarter, we're now, and I will say finally, attending to an expected upward trend of late. Most observers, us included, had expected a rapid onset from the Ontario agreement that was signed at the end of July. However, the precise timing of how these things unfold is hard to predict. While the summer months proved to be seasonally quiet, we're very encouraged by the greater level of prescription activity seen at quarter end, which continued through October. The table on the right-hand side of the slide provides detail of this positive trend. We see that, for the four-week period ended October 28, compared to the prior four-week period ended September 30, new prescriptions and total prescriptions in Quebec rose 20% and 10%, respectively.

As the slide indicates, our public access agreement with Quebec was signed at the end of May 2022. The table also shows that for the four-week period ended October 28th, compared to the prior four-week period, new prescriptions and total prescriptions in Ontario rose 12% and 5%, respectively. Keep in mind that Quebec has had a three-month head start on Ontario in terms of public access, and we are confident that similar growth trends lie ahead for Ontario. With 40% of the population, Ontario alone has been responsible for more than 50% of all Vascepa prescriptions since launch, and the traction we're now beginning to see here should be material in its effect. As mentioned on our last call, after the inception of public reimbursement, we observed Quebec claim processing delays of 5-6 weeks.

This appears to be the steady state at which we can expect the processing time to remain. In Ontario, we're currently observing a claims processing time of about two weeks. While these timelines may have a variability in the early stages, they result from administrative processes that could become more fluid over time. Another sign of recent strength for Vascepa is that October shipments of the product increased 18% over September and 40% over the average monthly volume in the third quarter. Shipment volume to wholesale is a leading indicator of future prescription reports. Wholesale purchases typically replenish the retail sales, and hence we anticipate an increase in TRX growth as those get reported within a couple of weeks. We believe this recent strength in script activity is being driven by public access agreements signed over the past several months and normalized detailing.

Regarding the remaining provinces that have yet to sign a PLA, we are experiencing delays due to their request to include terms that are not part of the LOI signed with the pCPA and are not included in the other PLA agreements. We continue to work towards a solution with those individual provinces. Finally, on this slide, Q3 saw strong continued growth in other key metrics related to Vascepa. The number of prescriptions year-over-year was up 89%, while the number of physicians prescribing Vascepa was up 105%, and the number of patients having used the product was up 96% year-over-year. Ontario's listing did not produce as rapid an onset as expected, but it is now producing a gratifying uptake.

While sequential prescription growth in Q3 did not quite reach the 30% we looked for, in the month of October, we are seeing signs of activity more in line with that growth level. There are plenty of statistics involved in measuring the progress of a new product introduction, and one benchmark is to consider the question. How have we performed in relation to our competitive set? On this next slide, the September data shows that Vascepa's growth is far exceeding that of statins, and it should, as well as PCSK9 for every time period, whether it's on a month basis, a quarter, or for the last 12-month versus the same period last year. I will concede that comparisons are usually imperfect and that at this stage of its evolution, Vascepa should be outpacing its comps by a notable margin.

If only that, the data leaves little doubt as to direction and the relative magnitude of the differences in growth rates, which is 2x to 5x greater for Vascepa, depending on the time period. Another key catalyst for Vascepa is our larger combined sales force. Our third quarter call activity reached new highs in the quarter, with more than 80% of those interactions being in person. We are calling now on more than 10,000 physicians, and with nearly 90% of the target physicians having been reached at least once, raising the frequency of contact with these physicians is a top priority to increase the prospect that they will engage patients on the medication. Here's an important point to realize.

HLS has interacted with 2,200 to 2,500 specialists for more than 2.5 Years since launch, and Pfizer's team has done so with 7,500 GPs for just about a year through lockdowns as they began their GP outreach last fall. Therefore, because specialists have been called upon more than GPs, the percentage of specialists prescribing Vascepa in proportion is about four times greater than it is for GPs. Over time, as general practitioners reaches similar levels we have achieved for specialists, we believe that we will see a similar rate of adoption for Vascepa by GPs to the benefit of course, many more Canadians who are at risk for cardiovascular disease. Our next slide shows the evolution of physician groups and their relative level of prescribing volumes for Vascepa.

The specialists that are cardiologists and endocrinologists essentially denoted here in blue and dark gray in particular were key opinion leaders and early adopters of Vascepa. The adoption of statins over the last 20 years has shown that over time, general practitioners will become the greatest source of prescription volume for Vascepa, an estimated 80%. The green line shows that this transition is already underway as they are now the highest and the fastest-growing prescribing group in absolute numbers. Even though the average frequency of reach for GPs is still well below that of specialists. During the third quarter, GPs accounted for 43% of new prescription and 33% of total prescriptions.

These are early indicators of the positive impact being realized from the expansion of our commercial footprints with our partner, Pfizer, and GP engagement will accelerate further now that key public reimbursement agreements are in place. Finally, looking at our last slide, just this past weekend in the late breaking session of the American Heart Association conference, the investigators of the RESPECT-EPA trial, which is an independent trial funded by the Japan Heart Foundation, showed that using 1.8 grams per day of purified EPA provided event reduction results consistent with the substantial body of evidence from the REDUCE-IT and the JELIS trials. It showed that highly purified prescription EPA plus statin significantly reduces the risk of cardiovascular events in high and very high risk statin-treated patients.

Importantly, as shown on the slide, and I'm talking here to the top left, the study showed a 21.5% reduction in the primary endpoint measuring cardiovascular risk at the p-value of 0.054. Top right achieved a statistically significant 26.6% reduction in the secondary endpoint of reduction of events related to coronary artery disease with the low p-value of 0.03. In addition, on the bottom chart, for those patients that attained target EPA level in their bloodstream, it yielded a statistically significant 27.5% reduction in the primary endpoint, here again with p-value of 0.02. That is probably the most important element to retain. Getting patients to the right level of EPA in their blood was significantly associated with 27.5% reduction of cardiac events.

It's also worth mentioning that this study was an open label and as such, contained no mineral oil placebo and hence there's no question that all the benefit is coming from the EPA. This trial results confirms the clinical significance and the important unmet medical needs supporting our peak year sales estimate for Vascepa, particularly now that the key reimbursement catalyst is in place for most of the country. Looking now at other products in our portfolio, Clozaril continues to generate steady and reliable financial results. The broader market remains stable but flattish, with muted growth dynamics as mental health settings of care face resourcing issues and continue to gradually recover from the impact of the pandemic had on access to treatment for existing patients and on new patient enrollment.

As of the third quarter, the total clozapine market grew 1.5% year to date and 1.8% year-over-year, while our sales grew 3% year-over-year. We think that clozapine usage pattern will continue to normalize and trend up towards historical growth rates of 2%-4% as new patient access to the treatment continues to improve. We continue to maintain our leading market share and are working to consolidate our franchise and even further expand it with the ongoing deployment of CSAN Pronto. Our installed base of CSAN Pronto increased 15% in the third quarter, and we now have 93 devices deployed. Number of tests performed was up 18% in the quarter and more than 12,000 tests have been performed on more than 1,200 patients since we launched the product.

We expect that the number of devices deployed will continue at a similar pace in the coming quarters. The launch of MyCare, our therapeutic drug monitoring diagnostic technology or TDM, is making good progress. The groundwork laid in prior quarters to introduce MyCare to lab specialists and clinicians has led to the successful completion of the first client lab certification, which is in their jargon, called a validation against a reference standard. The template for this validation can now be applied at a larger scale to help accelerate those mandatory lab certification processes. MyCare enables precise measuring of anti-psychotic drug levels in a patient's blood to assess efficacy or adherence to treatment in mental health patients. It's a growing topic of interest in the field of psychiatry, and it was a focus in nine national conferences and workshops to which we participated in the recent month.

MyCare's TDM technology fits very well into this emerging team. We're aiming to have a couple more sites clinically enabled with access to clozapine testing by year-end. With that, I will turn it over to Tim for a closer look at our third quarter numbers. Tim?

Tim Hendrickson
CFO, HLS Therapeutics

Thank you, Gilbert, and good morning, everyone. I will start with revenues and product sales. Overall, Q3 revenues were $15.7 million. 4% year-over-year, 7% in constant currency. While the Canadian dollar has fared better than many other currencies against a strengthening US dollar, we still saw a 3.5% year-over-year erosion and a 2.5% sequential quarter-over-quarter decline in the Canadian dollar this quarter, and could see even more erosion in Q4 if current trends persist. Our product sales in Canada were up 15% in Canadian dollar terms, driven by the growth of Vascepa net sales that were up 48% year-over-year in Canadian dollar terms.

As Gilbert illustrated in his section, with public reimbursement agreements now in place covering nearly 70% of publicly insured Canadians, and with the increase in activities we saw near quarter end and into October, we expect that the sequential and annual growth rates for Vascepa will accelerate in coming quarters. Clozaril sales in Canada were up 3% in the quarter, again, delivering reliable results that contribute meaningfully to Adjusted EBITDA. In the US market, Clozaril net sales in Q3 were down by $0.6 million, reflecting a one-time benefit in Q3 2021 from the successful resolution of a state rebate matter. Current year US Clozaril results benefited from favorable gross to net trends and from pricing changes that offset modest volume erosion.

Royalty revenues were $2.5 million in Q3, up $0.3 million or 14% from Q3 last year, including an initial amount for royalties on the fourth product in the portfolio that was first approved in Japan in Q1, in Europe in Q2, and in the US early in Q3 2022. Year to date, royalty revenue has grown 8% to $7.5 million. Looking forward, we expect revenues from Clozaril and royalties to remain overall stable with the potential for some modest growth, while the primary growth driver will continue to be Vascepa. All else being equal for Q4 2022, this would translate into sequential consolidated revenue growth in the mid to high single digit percentage range before any currency effects. Operating expenses in Q3 increased 19% from Q3 2021.

The increase in cost of product sales was driven by the year-over-year increase in Vascepa sales, while the increase in other operating expenses was led by increased selling and marketing costs for Vascepa, as well as initial introductory spending related to MyCare. The increase in the selling and marketing activities for Vascepa includes the primary care sales force expansion begun in fall 2021, as well as a return to increased market activities following removal of public health restrictions earlier in the year. Medical, regulatory, and patient support costs and general and administrative costs have increased modestly year-over-year. Adjusted EBITDA in Q3 was $6 million compared to $6.9 million in Q3 2021. The change was due primarily to the increased selling and marketing expense and increased cost of product sales related to the growth in sales of Vascepa.

Even in a quarter like Q3, where we saw noticeably higher sales and marketing activities for Vascepa, we continued to generate solid Adjusted EBITDA results. This level of Vascepa selling and marketing support is approaching full levels with most of the expansion and return to field activities that will be in place in Q4. Not to mention a higher level of spending activity in the fourth quarter due to a number of significant and very relevant medical conferences that take place this quarter and that have had or will have significant Vascepa presence. In Q3, we generated cash from operations of $4.2 million, up from $3.6 million in Q3 last year. Year- to- date, cash from operations is $13.4 million compared to $12.5 million in the same period last year.

Cash and cash equivalents were $21.3 million at September 30, 2022, compared to $21.2 million at year end. The European approval of the fourth product in the royalty portfolio at the end of June was a positive development that brought us closer to the start of royalties on global sales of this product. That approval also triggered a $10 million regulatory approval milestone payment that was made in Q3. When the portfolio of royalty interest was purchased in 2020, a $10 million increase in the revolver facility was put in place to support that milestone payment. In Q3, borrowing on that revolver facility was used to fund the milestone payment as originally contemplated. There are no further regulatory or pre-commercially milestones for any of the royalty interests.

On September 30, we updated our credit agreement and senior secured term loan with our existing syndicate of lenders. The updates extend the maturity of the loan by one year, reduce the required amortization by an estimated annual $7.5 million per year, and include other changes that increase our financial flexibility. Total borrowing and unused borrowing capacity remain unchanged. Also, the interest rate swap in place since October 2019 that covers a majority of the debt outstanding, remains in place through August 15, 2023, which provides rate stability in the changing near term rate environment.

With solid fundamentals in place, increasingly diversified revenue, sustained Adjusted EBITDA, and reliable cash from operations, we have continued to deleverage the business from $185 million of debt at the company's inception down to total borrowing of $99.8 million at the end of Q3, including the amount remaining from the amount borrowed for the regulatory approval milestone payment for the fourth royalty interest. In addition to the cash balance, positive cash from operations, and $25 million of revolver facility that remains undrawn, HLS is able to request incremental loans up to a maximum of $70 million to support growth opportunities.

As part of our Q3 earnings release, we also announced the approval of our renewal of the normal course issuer bid as the most recent NCIB expired earlier this week on November 8. Under the terms of the new NCIB, which will come into effect on November 14, we are permitted to acquire up to 5% of our issued and outstanding common shares over the ensuing twelve-month period. This equates to just over 1.6 million shares. In the six months through October 2022, we spent CAD 1 million purchasing shares for cancellation under the previous NCIB. While there is no guarantee we will continue to be active on the buyback going forward, we view this as a very appropriate use of capital in the current circumstances.

Finally, yesterday, the board of directors declared that the subsequent quarterly dividend of CAD 0.05 per outstanding common share is to be paid on March 15, 2023 to shareholders of record as of January 31, 2023. With that, I'll pass it back to Gilbert for his closing comments.

Gilbert Godin
CEO, HLS Therapeutics

Thank you, Tim. We're entering a powerful stage in the commercialization of Vascepa with public reimbursement done in place for 70% of the market. We continue to work closely with our partner, Pfizer, to maximize our outreach effort to the physician community. Sales execution is a key focus right now, and increasing the frequency of interaction with physician is the next big driver for adoption. We look forward to reporting to you on our progress in the coming quarters. That concludes my prepared remark. At this point, I will ask the operator to please provide instructions for asking questions. Thank you.

Operator

Thank you. Ladies and gentlemen, we will now begin the question- and- answer session. Should you have a question, please press star followed by one on your touch tone phone. You'll hear a three-tone prompt acknowledging your request. If you'd like to withdraw your request, please press star followed by two. If you're using a speaker phone, please lift your handset before pressing any keys. Your first question comes from Rahul Sarugaser from Raymond James. Your line's open.

Rahul Sarugaser
Managing Director of Equity Research, Raymond James

Good morning, Gilbert. Good morning, Tim. Thank you so much for taking our questions. It looks like, post the end of the quarter, there's been some sort of an inflection on Vascepa shipments and prescriptions. I guess I wanted to sort of understand a little more clearly in terms of, you know, those two variables being leading indicators for revenue. You identified almost 40% in shipments, around 11%, for prescriptions. How should we be thinking about one versus the other as a predictor for revenue and what that lag would be to the consequent revenue?

Gilbert Godin
CEO, HLS Therapeutics

Thank you. Good morning, Rahul. Thank you for your question. You know, as we're getting close and at those critical moment, we are literally scrutinizing every piece of data trends, changes in pattern, that we can put our hands on because, you know, we're trying to evaluate the direction and the efficiencies of the things we're doing. I would say, in that order, you know, we're working to get doctors to prescribe or to amend their prescription. Therefore, the direct read of this would be new prescriptions and total prescriptions, which translates subsequently in, let's call it volume at retail, what would get dispensed in all the pharmacies across Canada. When those get dispensed, of course, they get replenished. Those are replenished by wholesalers.

We go one level up and the wholesalers order products from us, and this was what we call shipments or ex-factory sales. Those things happened in a cascade of events, and sometimes those wholesaler activities are instructed by the demand at the pharmacy level, and they're trying to lead it a little bit because if the demand is increasing, well, their inventories and those of pharmacies need to increase as well. That's the usefulness of us communicating the data for October. We saw a change in trend in terms of shipment in October and even nascent in September. We do attribute that to the cascade of events that I just described.

Since TRXs and new scripts are reported always with a lag of a couple, sometimes three weeks, we're treating them as lead indicators, and we're expecting to see somewhat of a correlated trend in the prescription starting to happen and punch through in October and hopefully persisting November, December. Pointing really to the combined effect of the things of which we talked abundantly, which is, you know, opening up the market with public reimbursement, full steam detailing now, and finally getting closer with a very broad segment of those new prescribers, those general practitioners, getting closer by the day to the threshold where, you know, they got all the information they need and they will hopefully try the product and adopt the product.

Rahul Sarugaser
Managing Director of Equity Research, Raymond James

Terrific. That's very helpful for our modeling purposes. A follow-up would be, it's an interesting divergence that you identified in terms of GPs now sort of becoming the bulk of the prescribers. Given this, we're looking at the timeline, this is relatively well correlated with Pfizer's team starting to commercialize the asset. How should we be thinking about the divergence of those curves? Should we be seeing specialists somewhat flattening out and GPs being exponential? How should we be thinking about the relative growth between those two major groups?

Gilbert Godin
CEO, HLS Therapeutics

Yes. I'll juggle a few numbers here again. You know, that's just the foundational element. As we said on the call, we have you know, about 2,500 specialists that are prescribing in percentage terms. The percent of those 2,500 that are prescribing is about four times greater than the percentage of the 7,500 GPs that are prescribing. That's because we got a head start, right? We started calling on specialists right from the get-go before we got reimbursement. They're KOLs. They're the ones that are leading the adoption of the product.

If you look at it from kind of a mathematical standpoint, and this is only, I would say, to create an image here, if those prescribers that are three times more numerous than the GPs start to trend towards the rate of prescription, it creates a, you know, a magnitude of prescriptions that will actually be this kind of elusive breakpoint in the curve, you know, where the curve gets steeper. That's because we finally reached those thresholds and the volume prescribers with, you know, a message that has been satisfying to them and compelling. This is really what lies ahead and that we've been pursuing.

I think I've commented in the past that, you know, 2 years of pandemic probably got us to lose in aggregate maybe a year. We could have been there a year earlier had we been acting in free-flowing fashion, but it wasn't the case. You know, this inflection point that we've been pursuing will be coming from the combination of those elements. Calling more on those doctors, satisfying their quest for information and understanding of who should get the product. Since this is on a target that is 3 x broader than the initial one we developed, it should provoke that kind of acceleration.

Rahul Sarugaser
Managing Director of Equity Research, Raymond James

Perfect. That's really helpful. If you'll indulge just one quick last question. We've been asked by several clients around about the NCIB and the relative, you know, the relative purchases that the company is making, compared to being steady in its dividend. Can you maybe give us a little bit more color in terms of your perspective on the balance between the NCIB and the dividend and how, you know, given where the stock is right now, you know, the relative opportunity to be able to capture more of the value in the company? That'll be it from today.

Gilbert Godin
CEO, HLS Therapeutics

Yes. I will talk in general terms because you know, the dividend is always a prerogative of the board meeting quarterly and deciding on paying a dividend. The dividend and the NCIB are communicating vessels. I think they're often commented upon as two ways of returning capital to shareholders. The situation that we have is regulated by the number of things. The capital that we can and wish to return to shareholder is sometimes constrained or will fluctuate over time, especially as we continue to grow and increase our cash flow.

I would say that what you've seen during the course of the last six months, what Tim alluded to here, and how many shares we bought back and the value of those, was first predicated on the fact that, you know, we think our stock is grossly undervalued, and therefore, we're investing in ourselves with some of the capital that we can devote to that. We've continued to pay the dividend in the meanwhile, because, you know, as far as we're concerned, they are, you know, two different ways of accomplishing something that is somewhat similar for our shareholders. You know, longer term, you know, the situation of the company may change in terms of our ability to return more capital to the shareholders.

That's something that we often engage with with our shareholders, and there's a variety of views and opinion out there. We think that you know, progressively over time, that kind of leeway could augment, and it will give us the choice to do certain things in greater or lesser level.

Rahul Sarugaser
Managing Director of Equity Research, Raymond James

Okay, great. That's all for me today. Thank you again for taking our questions.

Gilbert Godin
CEO, HLS Therapeutics

Thank you, Rahul.

Operator

Your next question comes from Noel Atkinson from Clarus Securities. Your line is open.

George Anghelache
Institutional Equity Trader, Clarus Securities

Good morning, guys. This is George dialing in on behalf of Noel here. Just a few questions. With regards to the recently approved olipudase alfa drug in your royalty portfolio, could you please talk a little bit about the next steps and potential timelines for the commercialization of the product? Can you also refresh our memory on the expected relative revenue contribution per year for the drug?

Tim Hendrickson
CFO, HLS Therapeutics

Good morning. Thanks for the question. The good news is that the commercialization has started. The entity that commercializes that product has announced that the first sales were in fact reported in Q3 of this year. That has started. As you know, with the royalty interests, we have a passive royalty interest. We're not actively involved in the day-to-day commercialization, so we can't really comment too much further on what their plans might be for that. That is the start. The nature of the product is such that it is a very you know well-defined well-described finite number of patients who should be and eagerly anticipating the arrival of that product now that it's on the market.

We would generally assume that it will be a fairly quick uptake for that product. Beyond that's not something that we would have much more to share on that.

Gilbert Godin
CEO, HLS Therapeutics

Yeah. When we announced the acquisition of that basket, just a piece of complementary information here for memory. We did say that, you know, on average for the next 10 years, that there would be some revenues coming from those. There will be ebb and flows and, you know, the olipudase alfa was part of that evaluation. What you will see over the next few years coming from olipudase alfa for some part could be momentarily incremental and could be subsequently complementary or making up for royalties that are slowly trending downwards. I think that that's the gist of it. Not to expect anything that would be disproportionate or highly visible.

It's gonna blend in the stream of royalties that we've seen and over time will be consistent with the investment thesis we shared when we did the transaction.

George Anghelache
Institutional Equity Trader, Clarus Securities

Okay, got it. That's helpful. Thanks, guys. Moving on Vascepa. Do you see the potential for it to be added to BC and Alberta public formularies before the end of the year, or are those likely to be 2023 events?

Gilbert Godin
CEO, HLS Therapeutics

We would love to. We're actively involved in trying to get there. I can't get into specific details as that process and what has been delaying it is ongoing. I guess all I can say is that one of their asks was unexpected, not part of the terms agreed to in the LOI, and not market, since we've not encountered that kind of request with the jurisdiction with whom we have signed that do represent any percent of population. It's something that you know is really at the heart of the discussions taking place. We're working to make it happen. That's what I can tell you. Of course, it takes two to tango, so we'll see where that migrates.

George Anghelache
Institutional Equity Trader, Clarus Securities

Understood. Just one last question for me here. What are the milestones and timeline now for getting Trinomia approved in Canada and launched in the market?

Gilbert Godin
CEO, HLS Therapeutics

Okay. Trinomia to get approved will require a refiling, and that refiling will incorporate some of the results that came from the very study that Health Canada had raised in their Complete Response Letter to us. They wanted to see the results and certain aspects of that investigation be translated in relation to their questions. We are at the present time discussing with the developer of the drug so that refiling can be prepared and eventually filed. We'll keep you apprised. Right now, we don't have a precise timing other than saying that we'd like to make that filing as soon as possible, since it involves an external party. We're not in a position to make a definite statement on that. That's the intent. That's the plan.

I would say that, you know, we're talking of a time horizon that could be 6-9 months for that filing to take place. We will see if we can do it more rapidly, and we'll certainly keep the investment community informed if it does happen in a different timeframe.

George Anghelache
Institutional Equity Trader, Clarus Securities

Got it. Great. That's it for me. Thanks for taking our questions.

Gilbert Godin
CEO, HLS Therapeutics

You're welcome.

Operator

Ladies and gentlemen, as a reminder, should you have a question, please press star followed by one. Your next question comes from Justin Keywood from Stifel. Your line is open.

Justin Keywood
Managing Director of Institutional Research, Stifel

Good morning. Thanks for taking my call. I had a question on the revenue conversion of Vascepa. Obviously, the data trends continue to show pretty well, and I'm just wondering when we'll start to see this in the actual financial results, because if we look over the past, call it four quarters, the overall business has been, you know, kind of in the 1%-2% year-on-year growth range. Obviously, Vascepa is a smaller part of that, but when will Vascepa revenues start to contributing to a higher growth trend overall? Thank you.

Gilbert Godin
CEO, HLS Therapeutics

Hi, Justin. Thanks for the question. I think we shared that we are expecting to see, you know, a higher rate of growth starting now driven by the growth in Vascepa.

There are a number of things that go into going from that, you know, the TRX growth to the net sales growth. One of them obviously is we've now introduced some publicly reimbursed patients into the mix. We will see that affecting the mix of businesses that goes forward. As that's adjusting, we'll see that affect the growth in the net sales. It is a very exciting time, and we are expecting to see that ramp up in the uptake. That will happen first in the prescriptions and then see that migrating down to the net sales growth. You know, just to reiterate, that kinda works out for Q4.

We're expecting to see, you know, sequential growth in the mid- to high-single-digit. That will be a meaningful step forward on our consolidated total revenues. You know, there's also always some timing differences between when you see the prescription growth and the trade shipments and purchases. They do match each other over time. That is one of the things that we'll be working and looking at very closely over the coming months.

Justin Keywood
Managing Director of Institutional Research, Stifel

Thank you. That's helpful context. Just to clarify, was that sequential mid- to high- single- digits for Q4? Would that be the overall business or just-

Gilbert Godin
CEO, HLS Therapeutics

That's right.

Justin Keywood
Managing Director of Institutional Research, Stifel

Okay. It was mid to high- single- digits?

Gilbert Godin
CEO, HLS Therapeutics

That's right.

Justin Keywood
Managing Director of Institutional Research, Stifel

Okay, great. My other question, I may have missed it in the opening remarks, related to the public access in Alberta, British Columbia. I'm missing another province, but if you could just provide some additional context on the delay there and when we might see a resolution in adding Vascepa to the formulary. Thank you.

Gilbert Godin
CEO, HLS Therapeutics

Okay. Well, I'll draw a very simple parallel. You know, with provinces like Quebec and Ontario, after we signed the LOI, we moved to the agreement. The agreement was pretty straightforward and consistent with everything that was expected. In the case of BC and Alberta, we encountered something unexpected that was not part of the LOI. We've just decided to engage on that specific aspect because we don't think it's material, we don't think it was part of the LOI, and therefore, you know, we've made our point and are trying to resolve that situation.

Justin Keywood
Managing Director of Institutional Research, Stifel

Is it the same issue with the provinces, or are they individual, I guess items, for each of the provinces?

Gilbert Godin
CEO, HLS Therapeutics

I would say it's a similar nature, and I would say not financial. It's more kind of a term related.

Justin Keywood
Managing Director of Institutional Research, Stifel

Okay. Any idea when we may see a resolution to that?

Gilbert Godin
CEO, HLS Therapeutics

I'd love it to be ASAP. We are on the receiving end of anything. We turn it around in minutes. I think that you know, we can't forecast the speed at which this may get resolved. You know, we are all in. We would have loved this to be a thing of the past. I think that's probably a general statement that most manufacturers relate to. You know, what I've alluded to in the script earlier is that you know, there's a resourcing challenge happening. I think you know, for all of us Canadians on the call here, we all relate to what we hear is happening in the healthcare system, shortage of staff, shortage of resources, financial pressures.

I think it has some repercussions that go beyond the sole delivery of care. You know, matters such as the one we have here. We experienced it firsthand when the negotiations with the pCPA were delayed by 9 months and then took another year. All of that, I think, is a bit symptomatic of the strained healthcare system and you know, why things that would normally you know, take a certain amount of time can take a longer time. I'm not blaming anyone here. I'm just saying that the context has been conducive to you know, fairly protracted discussions.

Justin Keywood
Managing Director of Institutional Research, Stifel

Understood. Thank you for taking my questions.

Gilbert Godin
CEO, HLS Therapeutics

You're welcome, Justin.

Operator

There are no further questions. I turn the call back over to Mr. Godin for closing remarks.

Gilbert Godin
CEO, HLS Therapeutics

All right. Well, all I have I'm left to say here is, first, thank you, operator. Thank you for all of you that participated in today's call. We look forward to speaking again with you in the near future. Thank you. Goodbye.

Operator

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you disconnect your lines.

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