3/19/2026

speaker
Unknown
Unidentified Speaker

Thank you. Thank you.

speaker
Sylvie
Operator

Good morning, ladies and gentlemen. My name is Sylvie, and I will be your operator today. Welcome to Knight Therapeutics' fourth quarter and year-end 2025 results conference call. Before turning the call over to Samira Sakia, 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 disclaims any intention or obligation 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, 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 19th, 2026. And I would like to turn the meeting over to your host for today's call, Samira Sakia. Please go ahead.

speaker
Samira Sakia
President and CEO

Thank you, Sylvie. Good morning, everyone, and welcome to Knight Therapeutics' fourth quarter and year-end 2025 conference call. I'm joined on today's call with Amal Khoury, our Chief Business Officer, and Arvind Ujjana, our Chief Financial Officer. I am proud to announce that we have delivered 12 years of consecutive record high revenues since the inception of Knight. In 2025, we delivered record revenues of $452 million, record adjusted EBITDA of $73 million, and record cash flow from operations of $69 million. Our 2025 revenues grew by $87 million, or 24%, compared to the prior year. This increase was driven by our key promoted products, which delivered growth of 12% on a constant currency basis, as well as the incremental revenues from the Paladin and Sumitomo portfolios, which included four growth products, Xcopri, Orgovex, Mifembre, and Envarsis. The sales of these products grew by 68% in the second half of 2025 compared to the first half of the year according to IQVIA. While delivering record results, we strengthened our Canadian infrastructure and portfolio with the addition of multiple mature cash flow generating products, as well as early launch and pipeline products. This positions our Canadian business to be one of Knight's largest contributors to their revenue and profitability within the next two to three years. We also expanded our partnerships with Ahelson, adding Onesit, with and with INSIGHT adding nictinfo and Zainis for Latin America. In addition, we further advanced our pipeline with the regulatory submissions of TAVALIS in Argentina, Crexant in Canada, Mexico, Chile, and Argentina, and Peru, and the supplemental indication of Minjuvi for follicular lymphoma in Brazil, Mexico, and Argentina, and as announced earlier this year, the submission of nictinfo in Brazil. We now have multiple innovative products, namely Crexant, Calgary, Tavalese, Minjuvi, and Nictimbo awaiting regulatory approval in our territories. In addition, we obtained several regulatory approvals across multiple territories, namely Winsor in Canada, Minjuvi for follicular lymphoma in Brazil, and for second-line DLD-CL in Argentina. Pemezir in Brazil and Mexico and Bopocell are generic to in Colombia. Furthermore, to our regulatory approvals, we had multiple launches throughout the year, namely Journey PM, MyFembre, Orgovix, and Xcopri in Canada, Minjuvi in Argentina and Mexico, Hemazir in Brazil and Mexico, as well as Onisit in Brazil and Mexico. As we have been saying, Knight has built a great pipeline of assets. While we continue to grow the portfolio that we acquired, In 2019, we are now executing and growing our pipeline. In 2024, we had three launches with Invexi and Bejuba in Canada, as well as Ninjuvi for second line DLBCL in Brazil. In 2025, we had 10 launches across Canada and Latin America. And as we look forward to 2026, we expect to have at least another 10 launches across our territories. Before I turn the call over to Arvind to cover our financial results, I'll provide an update on our NCIB. During 2025, we purchased 1.1 million shares for $6.4 million. In the first quarter of 2026, we purchased an additional 1.2 million common shares for $7.3 million. Over to you, Arvind.

speaker
Arvind Ujjana
Chief Financial Officer

Thank you, Samira. When speaking of our financial results, I will refer to certain non-IFRS measures, including adjusted revenues, adjusted EBITDA per share, adjusted gross margin, and constant currency results. Refer to our press release and MD&A and CEDAR filings for their definitions. For the fourth quarter of 2025, we delivered record revenues of $133.2 million, and record adjusted EBITDA of $24.4 million, a respective increase of $39.1 million, or 42%, and $9.5 million, or 63%, compared to the same period last year. In Q4, we exceeded our expectations on revenues, driven by an early shipment of the 2026 AMBISOM MWage contract and the performance of the products we acquired in Canada. Specifically, Orgovix, MyFembray, and Xcopri performed better than expected as they were less impacted by promotion disruption due to their uniquely differentiated profiles that address clear unmet medical needs. We also exceeded our expectation on adjusted EBITDA due to the higher revenues as well as lower spending because of the integration of our acquisitions, which resulted in delays in the execution of certain selling, marketing, and medical initiatives. In 2025, as Samira mentioned, we delivered record revenues of over $452 million, an increase of $87 million, or 24%. The increase was due to the addition of the Paladin and Sumitomo portfolios, which contributed $56.5 million of incremental revenues, as well as our key promoted products that grew by $32.5 million, or 12% on a constant currency basis. Moving on to revenues by therapeutic area. In 2025, our oncology and hematology disease portfolio delivered $147.5 million, a growth of $10 million, or 7% compared to last year. The revenues from our key promoted products increased by $14.5 million, or 20% on a constant currency basis, mainly driven by the addition of Orgovix and Oneset, the growth of Minjuvi and Akinzeo, as well as the launch of Pemazir. This growth was partly offset by declines in our mature and branded generics due to the lifecycle, as well as the termination of a non-strategic distribution agreement in Colombia. Our infectious disease portfolio delivered $161 million, an increase of over $12 million, or 8%, compared to last year. The increase was primarily due to the growth of Cresemba and Ambisome, partly offset by purchasing patterns of certain customers. Given the size and growth of our neurology portfolio, we're now separating the previously disclosed other specialty segment into two distinct segments. One is neurology and the second is other specialty. The neurology portfolio includes products in ADHD, Parkinson's, Alzheimer's, epilepsy, pain, and other products in CNS. Our newly defined neurology portfolio delivered $85.5 million, an increase of $32 million, or 61% compared to last year. The Paladin and Sumitomo portfolio contributed $28 million of incremental revenues, and the remaining variance was driven by purchasing patents of certain customers and the launch of JourneyPM. Turning to our other specialty therapeutic area, The portfolio generated $58.2 million in revenues, an increase of over $32 million or 129% compared to last year. On a constant currency basis, the portfolio grew by $32 million or 125% compared to last year. The Paladin and Sumitomo portfolios contributed $24.3 million of incremental revenues. The rest of the variance was driven by growth of Imbexi and Bijuva, as well as purchasing patterns of certain customers. Now, moving on to gross margin. The adjusted gross margin as a percentage of adjusted revenues increased to 51% in Q4 2025 from 47% in Q4 2024. Our adjusted gross margin as a percentage of adjusted revenues was 48% in 2025 compared to 47% in 2024. The increase in our annual adjusted gross margin was mainly driven by the Pallid and Sumitomo portfolios in Canada, which contributed to a higher adjusted gross margin. I will now turn to our operating expenses, excluding amortization. In 2025, our sales and marketing and R&D expenses were $97.9 million, an increase of $22.6 million, or 30% compared to the prior, as a result of the infrastructure and spend required to support the larger portfolio of 50 products and 10 launches across our territories. Our GAIN expenses in 2025 were $55.3 million, an increase of $11.3 million, or 26% compared to last year. The increase was driven by the acquisition and transaction costs of $4.6 million related to the Paladin transaction, as well as additional share-based compensation expense, mainly as a result of period of reassessment of achieving investing target. Moving on to adjusted EBITDA. For 2025, we reported a record $73 million of adjusted EBITDA, an increase of $15 million, or 26%, compared to last year. The increase was mainly driven by higher adjusted gross margin, partly offset by higher operating expenses. Our adjusted EBITDA per share was 74 cents, an increase of 16 cents, or 28%, compared to 2024. I will now cover our financial assets, which are valued at $98 million at the end of 2025. During the year, we recorded a net loss of $6.4 million, driven by the mark-to-market revaluations of our strategic fund investments. As a reminder, our funds continue to be a source of cash. During 2025, we received net proceeds from distributions of $8 million, and since 2020, $47 million. Moving on to our cash position and cash flows. At the end of 2025, we held $95 million in cash and marketable securities and $68 million in debt. In 2025, we generated record cash flow from operation of $69 million, driven by our record adjusted EBITDA of $73 million. Our discipline, financial management approach, and focus on sustainable growth have delivered results. We improved our cash position from net debt of $1 million at the end of Q3 2025 to net cash of $27 million at the end of 2025. In fact, as of today, we have already repaid half of the principal of the revolving credit facility that was withdrawn to finance the Paladin transaction. Our debt to adjusted EBITDA leverage ratio significantly improved from over 1.45x at the end of Q3 2025 to under 1x at the end of Q4 2025. I will now turn the call over to Amal.

speaker
Amal Khoury
Chief Business Officer

Thank you, Arvind. Last year was a very productive year on the licensing and acquisition front as we further demonstrated our ability to execute on our portfolio growth strategy. In 2025, we deployed over $140 million of capital and grew our portfolio by adding over 50 products, including eight pipeline and launch assets. In addition to increasing the scale of our Canadian operations, the Paladin and Sumitomo transactions brought in both growth products as well as a portfolio of profitable, mature products that generate a healthy cash flow to help fund our launches across our territories. In addition, as Samira mentioned, we expanded our existing relationships with HealthIn and Insight, which speaks to Knight's position as a partner of choice recognized by our partners for our ability to deliver in-market success. Finally, we continue to grow our branded generic portfolio with the addition of one molecule in oncology and hematology for Brazil. These recent deals illustrate our focused approach to building on the strong platform and capabilities that we have. In the past year, we significantly expanded our product portfolio, increased our operational scale, improved our diversification, and changed our growth trajectory. I will turn the call back to Samira.

speaker
Samira Sakia
President and CEO

Thank you, Amal. Now on to our financial outlook for fiscal 2026. I would like to remind everyone that the guidance provided 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 actual results may vary materially. We expect to generate nearly between $490 to $510 million, an adjusted EBITDA of approximately 15% of revenues. Our revenues are expected to grow due to our recent and new launches and the fuller effect of the Paladin and Sumitomo transactions. As a result, we anticipate an increase in our operating expenses. With 13 launches over the past two years and an additional 10 launches planned for 2026, bringing the total to more than 20 new product introductions. We will continue to invest behind our brands and pipeline to maintain sustainable long-term growth. Our team has been extremely successful in executing on our strategy to acquire, in-license, develop, and commercialize pharmaceutical products for Canada and Latin America. In 2025, we delivered record results. We also made a difference in the lives of over 250,000 patients across our territories. This is a result of our execution of our strategy, which we will continue into 2026, as we expect to deliver nearly $500 million of revenues, which represents a two-fold increase in our business within five years. This concludes our formal remarks. I would now like to open up the call for questions.

speaker
Sylvie
Operator

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 514-484-4484. Once again, 514-484-4483. If you would like to ask a question, please press star followed by one on your telephone keypad. And if you're using a speakerphone, please lift the handset before pressing any keys. And if you would like to withdraw your question, simply press star, then two. Thank you. And our first question will be from Andre Uden at Research Capital. Please go ahead, Andre.

speaker
Andre Uden
Analyst, Research Capital

Thank you, operator. Hi, Samira, Arvind, and Amal. Nice quarter and year. You've launched some decent new in-license products recently with significant opportunity. Can you please elaborate on how some of those launches are actually going and if you think you'll add to your sales force?

speaker
Samira Sakia
President and CEO

So from a commercial footprint and infrastructure, what I can say is for the products that we have today and that we have launched, we have the teams in place that we need. For these products, we don't expect to add more people more teams in the field. As you know, we are launching more products. Like I said earlier in the call, we expect at least 10 launches through 2026. This will have some additional infrastructure, but not to the level that we saw in 2025, especially when I think of the Canadian infrastructure or Mexico, where we have been having to build because these organizations were much smaller at the beginning of 2025. As for the launches, they are all on track or exceeding expectations. So if I look at Minjuji in Brazil and Mexico and Argentina that launched between 24 and 25, both performing really up to our expectations. If we look at PEMI, also performing to expectations. If I look at the Canadian products, especially the ones that we just brought on, Excopri, Mifembre, and Orgovix, these are actually exceeding our original expectations. And a lot of that is because as part of transition, we were expecting a little bit of disruption due to the commercial, like the change in commercial activity going from one company to the other. But these products really are unique. They address an unmet medical need. And the kind of the switch in the disruption in the commercial activities really did not slow down the adoption of these products. It also really helps that, especially in the case of Orgovix and Xcopri, having reimbursement really completed by our teams by the end of June really helps continue the acceleration of these products.

speaker
Andre Uden
Analyst, Research Capital

That's great. Thanks, Amir. And just if you could just elaborate a little bit on business development. Have you seen prices go up or down in the past year? And what are you currently seeing? And what are you currently targeting in terms of countries and therapeutic areas? Thanks.

speaker
Amal Khoury
Chief Business Officer

Sure. This is Amir. So in terms of what we're targeting, it's still the same in terms of whether it's geographies or therapeutic area or type of product. So we are looking across our markets. We're looking to build in terms of pipeline in all of our current therapeutic areas. And when it comes to acquisitions of products, mature products with existing sales, we're TA agnostic in that sense. So we're really continuing, again, to look at the same types of opportunities across all of our products. In terms of valuations, I think it's really, it does vary, I think, depending on what's happening in the market, but also the type of assets and the expectations. So we continue to be financially disciplined when it comes to all of the deals that we're looking at.

speaker
Andre Uden
Analyst, Research Capital

All right. Thanks, Amal.

speaker
Sylvie
Operator

Thank you. Next question will be from David Martin at Bloombergton. Please go ahead, David.

speaker
David Martin
Analyst, Bloombergton

Good morning and congratulations on the year and the quarter. You've been really conservative with your guidance in the past. Would you say there's a similar level of conservatism built into your 2026 guidance?

speaker
Samira Sakia
President and CEO

What we try to be is cautiously optimistic. We remain cautiously optimistic. As I said, the reasons we were cautious when it came to the Canadian portfolio was really about the disruption of the commercial activities. And I think our teams were also, I'm going to say on their end, the teams were optimistic as to how much they could get done while they're still integrating. We've really moved on from integration to execution. We're going to continue to monitor brand performance. If we see that we start to perform better, we're going to update our guidance accordingly. This is the beginning of the year. The teams are just starting really to get out there all of the sales meetings across all of our countries have been had as We see how we line up We will adjust if we've been too cautious Okay Second question for several of your therapeutic areas buying patterns were mentioned and I'm wondering if

speaker
David Martin
Analyst, Bloombergton

was the effect of buying patterns stocking up or destocking, was that all net positive in Q4 and we should expect a swing back in Q1, or was it neutral? You know, some products were stocked up or some were stocked down.

speaker
Samira Sakia
President and CEO

At the end of the day, it was pretty neutral because it really depends on countries. with certain brands, and so it varied between country to country. I'm gonna say there's maybe a little bit of seasonality in the Canadian business in advance of the Christmas holidays, but not, at the end of the day, I think it netted out.

speaker
David Martin
Analyst, Bloombergton

Okay, great, and last question. The press release mentioned that Anvisa accepted the refiling for Tavalis in Brazil. Sorry, the appeal. Does that mean you now have approval or they just accepted it to review it? And if the second one is approval expected?

speaker
Samira Sakia
President and CEO

That's a great question. It is the second, so they reversed the denial. And they're continuing to review, and we expect to hear later this year.

speaker
David Martin
Analyst, Bloombergton

Okay, great. Thanks.

speaker
Sylvie
Operator

Thank you. Next question will be from Michael Freeman at Raymond James. Please go ahead, Michael.

speaker
Michael Freeman
Analyst, Raymond James

Hey, good morning, team, and congratulations on a great year. I wonder, talking about the slate of launches you have planned for 2026 and have been investing behind and plan to continue investing behind, I wonder if you could give your sense of when EBITDA will begin to lift materially, just balancing the investments you're making and the incremental top line that these new launches will be bringing in.

speaker
Samira Sakia
President and CEO

What I can kind of talk to you is generally when you have products that launch, it takes three to five years for them to reach peak sales. And it is kind of in that period that you start to see EBITDA contribution. So we're very early in most of our launches, as you can tell. The earliest of the launches were the third year that's happening is Ninjuvi DLBCL. Invexi and Bejuva. So these are the products that are going to start to come online and be a little bit more positive on the bottom line this year versus the last couple of years. But we have a lot of launches happening and we're going to start to see kind of pick up a couple of years from now.

speaker
Michael Freeman
Analyst, Raymond James

Okay, that's very helpful. I noticed that for some Canadian assets that you just described as non-core, you've returned the commercial rights for some of these assets. Could you describe some of the rationale for this return of rights?

speaker
Samira Sakia
President and CEO

Sure. So as you can imagine, when there is mergers and acquisition happening, there is a cleanup, a bit of portfolio. And that's really the case here. And as you can tell, it was part of the negotiations. We did receive a payment, or we will be receiving a payment from the partner, and a portion of that will be returned to Endo as part of a reduction of the purchase price.

speaker
Michael Freeman
Analyst, Raymond James

Okay. All right. Thank you. And, Lassen, I apologize if I missed this in the prepared remarks. I joined the call a little late. But I wonder if you could comment on the status of negotiations with the Brazilian Ministry of Health. Will there be orders in 2026 for Ambosom or other assets?

speaker
Samira Sakia
President and CEO

Actually, we did sign. We signed at near the end of the Q, at the end of Q4. And we actually already shipped in Q4 2025 almost $7 million under the 2026 contract.

speaker
Michael Freeman
Analyst, Raymond James

Okay. And are you able to provide details on the total estimated size of the 2026 contract?

speaker
Samira Sakia
President and CEO

It's about $32.5 million in total of which 6.7 has already shipped in Q4 2025.

speaker
Michael Freeman
Analyst, Raymond James

All right. That's great news. Okay. I'll pass it on. Thanks so much.

speaker
Sylvie
Operator

Thank you. I would like this time to remind analysts to please press star 1 should they have any questions. Thank you. Next question will be from Sahil Dhingra at RBC Capital Markets. Please go ahead, Sahil.

speaker
Sahil Dhingra
Analyst, RBC Capital Markets

Hi, good morning. This is Sahil for Dagmin. Thank you for taking the questions. My first question is regarding the Paladin and Sumitomo portfolio performance. Can you speak to the performance of these assets and how are the tracking versus your expectation at the time of acquisition? And looking ahead, how are you thinking about the revenue and EBITDA contribution from these in 2026?

speaker
Samira Sakia
President and CEO

So the Paladin and Sumitomo portfolio, if you kind of look at what we announced, was part of that, like if you look at the two together, it was about $80 million portfolio. That included four growth assets, three really early launch ones, MyFembrae, OrgoVix, and ExcoBrate. If I take those kind of out, the base portfolio is about $60 million, and that's really tracking to our expectations, depending on the individual product, maybe one is higher, maybe one is lower, but generally tracking. And that is a portfolio that's going to continue to be stable to slightly declining over time. When I look at the growth assets, this is where part of the reasons we overperformed in Q4 and we are a much higher guidance number for 2026 is because these launch brands, as well as the Knight original portfolio, are performing better than our expectations. So if I take Xcopri, Mifembre, and Orgovix, our expectation was that the disruption in commercial activities would have impacted the growth trajectory in the first few months, which really did not happen. And so we are excited about these products. This is why we're stretching our guidance a bit more than our original expectations. And if they continue to overperform, as I mentioned earlier on the call, we will be increasing our guidance.

speaker
Sahil Dhingra
Analyst, RBC Capital Markets

Thank you. That is very helpful, Samira. And then I have a question on gross margin. So gross margins were ahead of versus what we were looking for, so 51%. And how should we think about gross margin trajectory into 2026, especially with the full integration of Paladin and Sumitomo?

speaker
Samira Sakia
President and CEO

So there's a gross margin is impacted by a couple of things. Partially was a little bit of products, like product mix, but generally given the higher weighting of the Canadian business, there is a, we're seeing a couple points shift into in gross margin. So if you look at kind of last year, we were at 48%. With the higher proportion of the Canadian business, we will be coming up a couple, we will remain a couple points higher than we have been historically.

speaker
Sahil Dhingra
Analyst, RBC Capital Markets

Okay, thank you. And then my last question is, With regard to the Paladin integration, can you quantify the annualized run rate cost savings from that integration? And should we broadly expect that the savings will be reinvested into marketing and promotional activities as you launch new products?

speaker
Samira Sakia
President and CEO

So the integration has really, it's almost done. Like it is, like we're really, the last bits are really more system related. So if you look at Q4, That's really our run rates of spend that we should expect for next year. So the savings, we moved extremely rapidly to restructure the organization to the most effective structure that we wanted. So over 30% of the headcount has already been reduced. You're seeing the kind of the levels that we should have. If you kind of break the OPEX in total remain at the levels that you saw in Q4, there will be a shift that we had higher GNA mostly because of a catch up on stock based comp expense going forward. That's going to be less like a GNA will be proportionally less, but selling marketing and R&D will be higher because of the promotion activities that we need to have behind our 20-plus launches that we're going to be managing in 2026. Great.

speaker
Sahil Dhingra
Analyst, RBC Capital Markets

Thank you so much for taking the questions.

speaker
Sylvie
Operator

Thank you. Next question will be from David Martin at Bloomberg. Please go ahead, David.

speaker
David Martin
Analyst, Bloombergton

Thanks again. Same question or similar question for Calgary in Canada as Tavelisa in Brazil. When in 26 do you expect to refile and how long would it take after that for approval?

speaker
Samira Sakia
President and CEO

We expect to refile later this year and we expect approval by the end of the year. Okay.

speaker
David Martin
Analyst, Bloombergton

Yeah, okay, another question. You mentioned the $80 million from Paladin and Sumitomo, and if you take out the growth assets, the $60 million. Is part of that $60 million the six non-core products that you returned, and so the $60 million will decrease in 26, or are those six from another area?

speaker
Samira Sakia
President and CEO

They are. They are in that 60. They will phase out over this year, but it was already, there's other smaller products that are going to continue on. So kind of that 60-ish range is fine for 2026.

speaker
David Martin
Analyst, Bloombergton

Okay, good. And then lastly, for Amal, What's the outlook for M&A this year? Do you think it will again be a primary growth driver for 26? Yes.

speaker
Amal Khoury
Chief Business Officer

I mean, if you look at the history of our activity, I think you can expect the same going forward. But as you know, when it comes to BD in general, including M&A, There are a lot of, there are, you know, deals accelerate and decelerate for different reasons. So kind of it's hard to say exactly, you know, how many deals will be executed in a particular year. But I think in terms of overall, if you average out the history that we've had in terms of number of transactions, we're not expecting any changes going forward.

speaker
David Martin
Analyst, Bloombergton

Okay, great. That's it for me.

speaker
Sylvie
Operator

Thank you. And at this time, we have no other questions registered. I would like to turn the call back over to Samira.

speaker
Samira Sakia
President and CEO

Thank you, everyone. And thank you for your confidence in the NITE team and for joining our Q4 and URAN 2025 conference call. Have a great morning.

speaker
Sylvie
Operator

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 do ask that you please disconnect your lines.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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