Knight Therapeutics Inc.

Good morning, ladies and gentlemen. My name is Sylvie, and I will be your conference operator today. Welcome to Knight Therapeutics' fourth quarter 2024 results conference call. Before turning the call over to Samara Zakir, President and CEO of Knight, listeners are reminded that portions of today's discussion may, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the company and its subsidiaries, may ultimately prove to be incorrect. The company and its subsidiaries may ultimately prove to be incorrect The company disclaims any intentions or obligations to update or revise any forward-looking statements, whether a result of new information, future events, except as required by law. We would also like to remind you that questions during today's call will be taken from analysts only. Should there be any further questions, please contact Knight's Investor Relations Department via email to ir at knighttx.com or via phone at 514-484-4483. I would like to remind everyone that this call is being recorded today, March 20th, 2025. And now I would like to turn the meeting over to your host, Samara Zakir. Please go ahead.

Thank you, Sylvie. Good morning, everyone, and welcome to Knight Therapeutics' fourth quarter and year-end 2024 conference call. I'm joined on today's call with Amal Khoury, our Chief Business Officer, and Arvind Uchana, our Chief Financial Officer. I am proud to announce that we have delivered 11 years of consecutive record high revenues since the inception of Knight. In 2024, we delivered revenues of over $365 million and adjusted EBITDA of approximately $58 million. Our growth was driven by our key promoted products, which account for 75% of our total revenues. The promoted portfolio grew by 16% over the prior year period and has delivered a three-year CAGR of more than 30%. While delivering on excellent results, we made significant progress in expanding our pipeline with five new products. We have expanded our neurology portfolio with the licensing of Crexant from Amnil and Journey PM from Collegium for all of our territories. In addition, we have strengthened our partnership with Halcyon with the addition of Onisit for certain LATAM countries. With respect to our branded generic portfolio, we added two branded generic molecules in oncology and hematology for select LATAM countries. To date, we have a pipeline of 18 products, including recent launches, which is expected to generate peak sales of over $150 million. In addition, we further advanced our pipeline with regulatory submissions of Calgary in Canada and Tavalise in Brazil and Argentina. With these submissions, we now have four innovative products, namely Calgary, Tavalise, Minjuvi, and Pemezir, awaiting regulatory approval in multiple territories. In addition, we have five branded generic products pending regulatory approval in multiple countries. We not only executed on regulatory submissions, we also obtained several regulatory approvals, namely Minjuvi and Tavalise in Mexico, and Journey PM in Canada, and Pemezir in both Mexico and Brazil. In addition to the regulatory process, we launched two products in Canada, Bijuva and Invexi. The latter competes in a growing market valued at over $110 million in 2024. Outside of Canada, we launched Minjuvi in Brazil. Moving to our NCIB, during 2024, we purchased approximately 1.6 million common shares for $9 million. In the first quarter of 2025, we purchased approximately 600,000 common shares for $3.3 million. I will now turn the call over to Arvind to provide a financial update on our financial update.

Thank you, Samira. When speaking of our financial results, I will refer to adjusted EBITDA and financial results at constant currency, which are non-IFRS measures, as well as adjusted EBITDA per share, which is a non-IFRS ratio. Knight defines adjusted EBITDA as operating income or loss, excluding amortization and impairment of non-current assets, depreciation, the impact of accounting under hyperinflation, acquisition costs, and non-recovering expenses, but to include costs related to leases. We define adjusted EBITDA per share as adjusted EBITDA over the number of common shares outstanding at the end of the respective period. In addition, revenues and financial results at constant currency are also a non-GAAP measure. Financial results at constant currency are obtained by translating the prior period results at the average foreign exchange rates in effect during the current period, except for Argentina where we only exclude hyperinflation. Furthermore, my discussion on the operating results, we refer to figures that exclude hyperinflation unless otherwise indicated. For the fourth quarter of 2024, we delivered revenues of over $94 million, representing an increase of $6 million, or 6% versus prior year. In 2024, as Samira mentioned, we delivered record high revenues of over $365 million, representing an increase of $22 million, or 6%. On a constant currency basis, revenues increased by approximately $29 million or 9% versus prior year, driven by growth across all of our therapeutic areas. In 2024, our oncology and hematology disease portfolio delivered approximately $137.6 million, a growth of $15 million or 12% compared to last year. This increase was driven by the continued growth of our key promoted brands, which contributed approximately $24 million of incremental revenues, mainly coming from Lendvima, Akinzeo, 12thora, as well as the launch of Minjuvin Brazil. This growth was partially offset by a decline in our mature and branded generic products due to their lifecycle and the market entrance of new competitors, as well as the impact of LATAM currencies depreciation. Our infectious diseases portfolio delivered approximately $149 million, an increase of $8.5 million or 6% compared to the same period last year. The increase was driven by the growth of our key promoted products, including Ambisome and Crescemba, partly offset by a decrease in U.S. demand for Improvido. As a reminder, under our sales contract with the Ministry of Health in Brazil, or MOH, in 2024, we delivered $24.8 million of Ambisome compared to $25.2 million in 2023. In January 2025, we have signed a new contract for Ambisome with the MOH and we expect to deliver approximately $22.4 million in 2025. Turning to our other specialty therapeutic area, the portfolio generated $79 million in revenues, remaining relatively unchanged compared to last year. Now moving on to gross margin. We reported $44.3 million, or a gross margin of 47% of revenues, in the fourth quarter of 2024 compared to $42.4 million or 48% of revenues in the same period last year. For the year ended December 31, 2024, we reported $173 million or a gross margin of 47% of revenues compared to $166 million or 48% of revenues last year. The decrease in gross margin as a percentage of revenues was due to product mix. I will now turn to our operating expenses. Our operating expenses excluding amortization and impairment of non-current assets for the fourth quarter was $31.2 million, remaining relatively unchanged compared to the same period last year. For 2024, our operating expenses excluding amortization and impairment of non-current assets were $119.3 million, an increase of $10.8 million, or 10% compared to last year. The increase in operating expenses was driven by an increase in marketing and medical initiatives behind the launches of Minjuvi, Invexi, Bijuva, and pre-launch activities for GNA-PM in Canada. In addition, our R&D costs increased driven by product development activities in connection with our pipeline, as well as regulatory submission fees. Lastly, our GNA costs increased due to our structure and higher compensation expenses. As a reminder, all costs related to development activities have been expensed, which typically include regulatory submission, analytical method transfers, stability studies, and bioequivalent studies. Moving on to adjusted EBITDA. For the fourth quarter of 2024, we reported $15 million, an increase of $2.9 million, or 24% compared to the same period last year. For 2024, we reported $57.8 million, a decrease of $2 million or 4% compared to last year. Our adjusted EBITDA per share was 58 cents, remaining relatively unchanged compared to 2023. I will now cover our financial assets, which are valued at $134 million at the end of 2024. During the year, we recorded a total net loss of $2.8 million on our financial assets, driven by the revaluations of our strategic fund investment, offset by the change in the value of our synergy shares. In 2024, our synergy shares were revalued at $8.3 million compared to nil in the prior year. With respect to our strategic fund investment, we have recorded a net loss of $11.4 million, driven by mark-to-market adjustments. As a reminder, our funds continue to be a source of cash. In 2024, we collected $14.7 million, including $5.8 million, for certain contingent milestones which were not previously recorded on the balance sheet. Moving on to our cash flows. During 2024, Knight generated cash inflows from operations of $36 million, including a net working capital increase of $20 million. Investment in net working capital was driven by an increase in our accounts receivable, due to both higher revenues and timing of collection, as well as investments in our inventory due to timing of purchases and new product launches. I will now turn the call over to Amal to provide more details on our business development activities.

Thank you, Arvind, and good morning, everyone. In the last 15 months, we grew our portfolio by adding five new products. In January 2024, we unlicensed Crexant for Canada and Latin America. Crexalt is a novel oral formulation of carbidopa-levodopa extended release capsules designed for the treatment of Parkinson's disease. Knight expects to submit Crexalt in Canada and certain LATAM countries in 2025. According to IQVIA, the carbidopa-levodopa market is valued at $50 million in Canada and $120 million in Brazil. The controlled release segment is valued at around $15 million in each of Canada and Brazil. In May 2024, we announced an exclusive supply and distribution agreement for Journey PM for Canada and Latin America. Journey PM is an innovative extended release formulation of methylphenidase, a highly differentiated treatment option for ADHD. In November 2024, Journey PM was approved by Health Canada and is expected to be launched in the second half of 2025. According to IQVIA, the Canadian ADHD market totals approximately $1.25 billion, of which the methylphenidate segment represents $500 million and has been growing at over 14% CAGR over the last four years. In addition, during 2024, we enlicensed two branded generic molecules in oncology and hematology for certain territories in LATAM. Furthermore, in the first quarter of 2025, we announced the addition of Onisit from Helsin for Mexico, Brazil, and certain other LATAM countries. Onisit is used for the prevention of chemotherapy-induced nausea and vomiting and the prevention of post-operative nausea and vomiting. Onisit is sold in Canada as Aloxi, which was part of our original agreement with Halcyon. Finally, in addition to expanding our pipeline, as announced last week, we entered into an agreement with Endo to acquire all of the assets of Paladin. In 2024, Paladin generated revenues of $70 million, excluding products that they had stopped commercializing or are in the process of discontinuing. The Paladin portfolio mainly consists of mature, primarily owned assets, as well as promoted licensed products. As a reminder, the purchase price for this transaction is $100 million, plus an additional $20 million of inventory, all payable in cash at closing. In addition to the upfront and inventory, Knight may pay future contingent payments of up to $15 million upon achievement of certain sales milestones. These recent deals illustrate our focused approach to building on the strong platform and capabilities that we have, specifically in oncology and neurology, as well as our strategy to build a balanced portfolio that includes innovative, growing, promoted products, mature cash flow generating products, as well as branded generics. I will now turn the call back to Samira.

Thank you, Amal. Now on to our financial outlook for fiscal 2025. I would like to remind everyone that this guidance includes the assumption that we will close the Paladin transaction in the middle of 2025 and also assumes that there is no material adjustment due to hyperinflation accounting in Argentina. In addition, our guidance is based on a number of assumptions which are described in our press release. Should any of these assumptions differ, the financial outlook and actual results may vary materially. We expect to generate revenues between $390 million to $405 million and adjusted EBITDA of approximately 13% of revenues. The decrease in our adjusted EBITDA as a percent of revenues compared to 2024 is driven by investments behind new product launches, such as Journey PM in Canada and Minjuvi in Mexico, as well as advancing our pipeline of 18 products through development, submission, and pre-launch across our territories. Our team has been extremely successful in executing our Pan-American ex-US strategy and has built a profitable business with a unique platform and a strong foundation from where to continue growing over the long term. Looking ahead, we are very excited that we can deliver to our stakeholders with the launches of Minjuvi in Mexico, GRN-APM in Canada, and additional pipeline products. In addition, we expect to close the Paladin transaction in the middle of the year. This synergistic transaction adds critical mass and significantly increases the size of our Canadian business and adds a portfolio of stable cash flow generating products that will help fund our growth in Canada and Latin America. We remain well-positioned to continue to execute on our mission to acquire and license, develop, and commercialize pharmaceutical products in Latin America and Canada. This concludes our remarks. I'd like to open up the call for questions. Sylvie?

Thank you. Before we begin, may I please remind you, questions during today's call will be taken from analysts only. Should there be any further questions, please contact Knight's Investor Relations Department via email to ir at knighttx.com or via phone at 514-484-4483. Thank you. And if you would like to ask a question, please press star followed by the number one on your telephone keypad. If you're using a speakerphone, you will need to lift the handset first before pressing any keys. And if you would like to withdraw from the question queue, please press star followed by two. Please go ahead and press star one now if you have any questions. First, we will hear from Michael Freeman at Raymond James. Please go ahead.

Hey, good morning, Samira, Amal, Arvind. Congratulations on finishing another strong year. I know we had a call on this last week, but I'll start with a question on Paladin. I'm wondering how your acquisition of Paladin might adjust your business development approach in Canada And also, how do you feel about the balance sheet pro forma this transaction? Thanks.

Good morning, Michael. This is Amal. I'll start with your first question. The acquisition doesn't really change our business development approach. It's actually very much in line with our business development approach, which, as a reminder, is really three-pronged, right? We look to acquire products with existing sales that will bring in profitability to help fund the second growth vertical, which is in licensing innovative products and then bringing on brand generics. So this acquisition really is very much in line with that. The bulk of the portfolio is products with existing sales, existing profitability that will help fund a lot of the launches and future growth that we have across all of our countries. The portfolio also has a couple of growth assets, so it really hits, it's well within our business development approach and we will continue going forward with the same. If you look back at the deals that we have done in the last few years, the majority of the deals are licensing deals, so really bringing in growth assets and these products don't really, these types of deals, I should say, don't really require the type of upfront and purchase prices that go with this type of acquisition. And I think as we said, as Samira said on the call last week, in terms of capacity, again, we have a very strong business that with this deal is even stronger in terms of profitability and cash flow generation. And we still have a lot of capacity on the debt side if we needed to add anything. behind the current business, but also if we were to do another acquisition that would require additional funding, that acquisition would be coming with EBITDA and profitability. So we're not concerned about capacity to do more deals. So no change.

Thanks very much, Amal. Now I'll ask a question, just asking for an update on the situation with Linvima and Latam with a generic competitor launched. I'm wondering if you could describe the impact you're seeing on sales, how you're seeing that generic received in the market, what the effect is on pricing and any legal action that you and your partners might be taking.

Hi, so the... Let me be generic was introduced kind of in the second half of last year. We have, we know that it's on the market. Some of our, uh, I would say, you know, we had a small amount of sales that were in the public market. We are seeing that as a slowdown in Brazil, but generally the product continues to sell well and. the legal pursuit will continue, but we don't expect that to have a positive, even at the end of the day, if we get a positive outcome, we don't really believe that we think that it'll have no impact on the market.

Okay, that's very helpful. I'm just going to shoehorn one more in here. Really positive news on the new MOH contract in Brazil for Amazon. I wonder, is there opportunity to I recognize this is the single drug that you sell into the MOH. Is there an opportunity to secure further contracts with that organization?

Actually, that's one of the things that I'm actually really proud of, of our Brazilian team. We're not only selling Ambosone, but we have been able to introduce Crisemba because of this relationship. And over the last year, we've seen some expansion of their purchasing of Carsemba as well.

Fantastic.

Okay. I'll hand the call over. Thank you.

Thank you. Next question will be from Justin Keywood at Stifel. Please go ahead.

Good morning. Thanks for taking my call. Just on the 18 products that are in the early launch phase mentioned in the outlook, how should we look at that as far as contributing to financials in 2025, 2026 and beyond?

So of the 18 products that are in the pipeline, three of them are in early launch today. So that's Minjuvi, Bijuva and Imbexi. And Minjuvi is going to be launched in Mexico in this queue. We're also adding Journey PM that launches in Canada later this year. And we're expecting to launch Tavalise in Mexico and Brazil next year. So they're all stepping up. And then the rest kind of come on between, and it's NRMDNA, kind of the launch dates that we expect for the rest of them. And they all step up over time. So the $150 million or at least $150 million is their peak potential.

So that's combined $150 million. I assume that's Canadian dollars. Yes. Thank you. Of the 15 to be launched, is that in the next couple of years or are some of these still very early stage assets in trials or regulatory review?

They go from launching as early as 26, like I mentioned, to as late as 2030.

Okay, so some real early assets within that. And just as the Paladin starts to contribute, I realize there's a number of sales reps already in Canada. How should we look at that transition? I guess a platform in Canada, like how much additional revenue could that support? Will you need to have some additional hire for some new launches or how should we be looking at that?

So as I said in our call last week, one of the things is our Canadian business today is about, the Knight Canadian business today is about 60 people. quarter of them actually are in global function so it really leaves about 45 we do have a lot of open positions as we prepare for the launch of journey p.m. this year Calgary early next year and we're going to look to optimize our structure between the two companies and as I said also in last week's call the 70 million that we're really providing for the business that is Paladin, we expect that to stay flattish over the next couple of years. The Paladin acquisition is majority non-promoted legacy assets.

Okay, thank you. And then just finally, on the 130 million of financial assets, are there any liquidity events in the near term to anticipate?

One of the things that we have seen with the investment funds is that they are a source of cash. We only have capital calls of about $5 million left on that, and we do expect them to be cash flow generating. Our loans are going to be – they're also starting to pay back as well. Nothing material, though.

Okay. Thank you for taking my questions.

Thank you. Next question will be from Doug Meham at RBC Capital Markets. Please go ahead.

Good morning, Samira. I'm all. A couple questions with respect to the business over the longer term. When you think about the mix of Canadian versus rest of world slash South America, Would you expect it to remain in the 20% to 25% level for Canada post the Paladin deal, or is it just going to be based on opportunities and execution pricing of those opportunities?

Good morning, Dr. Zamal. It's really the latter. So, again, our approach and our goal is really to grow our business across Canada. um all of the countries that we that we have whether it's acquiring products or portfolios with existing sales or uh growth assets and we're going to be looking at doing that across our markets and it's really going to be we're going to continue to do you know with the same level of discipline of looking opportunity by opportunity to see what makes the most sense to to grow our business across the board

Right, but is there a chance that based on the opportunities in Canada, we could see something in the range of 35 to 50% over the next year or two, based on potential acquisitions, or should we not think about it that way?

What I would say, Doug, we're going to be opportunistic when it comes to asset acquisitions, so whether they're in Canada or somewhere else. That being said, if I look at our portfolio in Canada with the Paladin acquisition, with Journey PM, with Calgary, with Croissant launching, Canada is going to start with the powder business today where we will be getting to kind of that 20-ish percentage. But as these products grow, it will rise as a percentage without us doing any more transactions in Canada.

Okay, perfect. And then just to wrap up, when you Think about all these launches over the next, let's just say two years. When you think about the expense that is typically required to launch products, number one, these are likely going to be profitable until the third year is my guess, but maybe second year. You can correct me there. But can you sort of frame how large those investments are that you're spending on all these drugs over the next while?

So you're right. You don't really hit profitability until the third year where you're closer to break even than really profitability. You're seeing that in our – as to the level of spend, you're really seeing that in our guidance, right? where you see even with the pallet and acquisition, our EBITDA is declining and it's declining in the range of about eight to $10 million because of that investment that we're making. And we expect that over the next couple of years, this year, next year, then these brands start to feed into that top line and profitability as we launch more.

Perfect. Okay. So the next several years should have some good growth and then accelerating profitability as well. Okay. Thank you. Absolutely.

Thank you. Next question will be from David Martin at Bloom Burton. Please go ahead.

Good morning. This is a follow-up to Doug's question. So the SG&A, the sales and marketing expenses is going to increase in 25 based on the guidance you've given for revenues and EBITDA margin. Beyond 25, will you see stabilization of operating expenses or will they continue to grow? Once you've built out Your infrastructure, will it need to grow in line with the revenue growth as the new products launch, or will you reach a point of stability by the end of 2025?

The infrastructure is probably going to be right-sized. There still will be more A&P that will be brand-specific, given the launches that are there, but that's not going to be a significant increase.

And as you roll from one launch product to the next launch product, you'll be able to redeploy the investment to the new products and ease off on the ones that were previously launched?

So what I would say, like, I'll give you an example. In the case of Journey PM, we're launching that this year. We're going to have a lot of investment behind it this year. We're going to have a lot of investment behind it next year. And we're going to expand that same team as we add Calgary. Going into 26, there's not going to be that much more incremental, but there will be continued investment. But we're going to be launching IPX at the same time. That's going to require more money. But hopefully by the time I'm getting into 27, the investments behind Invexi and Bujuva will start to come off. as we are investing in IPX. And that's because by that time, Invexi and Bejuva have been promoted for three plus years. And that's how we're really cycling. You do need investment and promotion, significant investment and promotion for those first three years, and then you can start pulling back.

And what about in Latin America? I know you're building out in Mexico, but is there build-out in other countries in anticipation of launches, or are you right-sized there?

Majority of our territories are right-sized when it comes to hematology and oncology. They're right-sized on neurology, but more on the Alzheimer's, and the Alzheimer's team can support Crexant. As we look to invest in ADHD, we may have some expansion of our teams.

Okay, great. Thank you. That's it.

Thank you. Once again, ladies and gentlemen, if you have any questions, please press star followed by one. Next, we will hear from Tanya Armstrong at Canaccord Genuity. Please go ahead.

Good morning. Just a couple questions for me. So congrats on re-signing that Brazil MOH contract, and just wondering if you can speak to the quarterly impact of that 22.4 million in revenue. Should we expect it all to come early in the year, back half of the year?

Hi, Tanya. I think we're going to start with, from what I have from the Brazilian team, we're going to start in this queue. I'm not really sure if it's actually even already shipped or not. We're a couple weeks left in the queue. And probably be done by Q3. But it's really unpredictable with the MOH. Okay.

Okay, that's fair. And then just definitely for me with Journey PM launching this year, could you give us an idea of peak sales expected for that drug?

Sure. So we haven't really guided on the product itself. What, as Amal said in her comments, the methylphenidate market is over half a billion dollars and growing at a rate of 14% CAGR. The one thing that I would give you as an example is FroQuest, which was the last launch in this category prior to getting public reimbursement. had sales of $30 million. The one thing I would note there, we don't expect to get to that number because FoQuest was for people over six years. Journey PM is indicated for children, so six to 12. But what you need to know and what we have from the U.S. market is 85% of the Journey PM sales are pediatrics.

That's good insight. And maybe on the $150 million in potential peak sales that you outlined in the MDMA, could you give us a sense of how much of that is attributable to products that are in the early launch phase or expected to launch in the near term? So I guess Minjuvi, Suva, Infecti, Jarnay, PM, and Sotheby's.

I would say more than half is coming from the near-term launches. Perfect. Okay.

Okay. That's all for me. Thank you, Tina. Thank you.

Next question will be from Andre Uden at Research Capital. Please go ahead. Please go ahead, Andre.

Hi, everyone. I realize I usually don't discuss gross. Sure.

Can you hear me? Yes.

Hello? Hello?

Hi, Andre.

Good morning, everyone. I just realized I usually don't discuss gross margins, but if we look at your 18 pipeline products, can you hear me now? I realize you usually don't discuss gross margins, but if you look at your 18 pipeline products, so basically you have 150 million of peak sales in your pipeline products.

Do you expect that to move the needle on your gross margins? Any color there would be appreciated.

We don't really guide to gross margins, but we don't really expect... the margins really to change. They may grow over time, but not that significantly.

That's appreciated. Thanks. That's all for me.

Thank you. And at this time, we have no other questions registered, so I would like to turn the conference back over to Samara Sakaia. Please go ahead.

Thank you, Sylvie. Thank you for joining Knight's Q4 and URAN 2024 call. Once again, thank you for your confidence in the Knight team and for joining our call. Have a great morning.

Thank you. 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.