Knight Therapeutics Inc. ($GUD)

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 Sakhia, 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 e-mail to [email protected] or via phone at (514) 484-4483. I would like to remind everyone that this call is being recorded today, March 19, 2026. And I would like to turn the meeting over to your host for today's call, Samira Sakhia. Please go ahead.

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 Khouri, our Chief Business Officer; and Arvind Utchanah, our Chief Financial Officer. I am proud to announce that we have delivered 12 years of consecutive record high revenue 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 4 growth products: XCOPRI, ORGOVYX, MYFEMBREE and ENVARSUS. 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 the revenue and profitability within the next 2 to 3 years. We also expanded our partnerships with Helsinn adding ONICIT and with Incyte adding Niktimvo and ZYNYZ for Latin America. In addition, we further advanced our pipeline with the regulatory submissions of TAVALISSE in Argentina, CREXONT 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 Niktimvo in Brazil. We now have multiple innovative products, namely CREXONT, Qelbree, TAVALISSE, MINJUVI and Niktimvo awaiting regulatory approval in our territories. In addition, we obtained several regulatory approvals across multiple territories namely Wynzora in Canada, MINJUVI for follicular lymphoma in Brazil and for second-line DLBCL in Argentina. PEMAZYRE in Brazil and Mexico and Bapocil, our generic to -- in Colombia. Furthermore, to our regulatory approvals, we had multiple launches throughout the year, namely JORNAY PM, MYFEMBREE, ORGOVYX and XCOPRI in Canada, MINJUVI in Argentina and Mexico, PEMAZYRE in Brazil and Mexico as well as ONICIT 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 3 launches with IMVEXXY and BIJUVA in Canada as well as MINJUVI 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.

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 SEDAR 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 Ambisome MOH contract and the performance of the products we acquired in Canada. Specifically, ORGOVYX, MYFEMBREE and XCOPRI performed better than expected as they were less impacted by promotional 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 ORGOVYX and ONICIT, the growth of MINJUVI and AKYNZEO as well as the launch of PEMAZYRE. This growth was partly offset by declines in our mature and branded generics due to the life cycle as well as the termination of a nonstrategic 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 are now separating the previously disclosed other specialty segment into 2 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 patterns of certain customers and the launch of JORNAY PM. 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 IMVEXXY 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 Paladin 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 year as a result of the infrastructure and spend required to support the larger portfolio of 50 products and 10 launches across our territories. Our G&A 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 vesting 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 $0.74, an increase of $0.16 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 operations of $69 million, driven by our record adjusted EBITDA of $73 million. Our disciplined 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 1.5x at the end of Q3 2025 to under 1x at the end of Q4 2025. I will now turn the call over to Amal.

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 8 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 Helsinn and Incyte, 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.

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 from the actual -- differ the actual results may vary materially. We expect to generate nearly between $490 million to $510 million and adjusted EBITDA of approximately 15% of revenues. Our revenues are expected to grow due to our recent and new launches and the full year effects of the Paladin and Sumitomo transactions. As a result, we anticipate an increase in our operating expenses. With 13 launches over the past 2 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 the 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 twofold increase in our business within 5 years. This concludes our formal remarks. I would now like to open up the call for questions.

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 e-mail to [email protected] or via phone at (514) 484-4484 (sic) [ (514) 484-4483 ], once again, (514) 484-4483. [Operator Instructions] And our first question will be from Andre Uddin at Research Capital.

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

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 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 MINJUVI in Brazil, in 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, XCOPRI, MYFEMBREE and ORGOVYX, 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 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 and the disruption in the commercial activities really did not slow down the adoption of these products. It also really helped that, especially in the case of ORGOVYX and XCOPRI, having reimbursement really completed by our teams by the end of June really helps continue the acceleration of these products.

That's great. 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?

Sure. This is Amal. 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 all of our -- in terms of pipeline and all of our current therapeutic areas. And when it comes to acquisitions of products with 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.

Next question will be from David Martin at Bloom Burton.

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?

We have -- 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. That, that we've really moved on from integration to execution. We're going to continue to monitor brand performance. If we see that we can -- 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, was the effect of buying patterns stocking up or destocking, was that all net positive in Q4, and we should expect to swing back in Q1? Or was it neutral? Some products were stocked up or some were stocked down?

At the end of the day, it was pretty neutral because it really depends on country with certain brands. And so it varied between country to country. I'm going to 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.

Okay. Great. And last question. The press release mentioned that Anvisa accepted the refiling for TAVALISSE in Brazil -- sorry, the appeal. Does that mean you now have approval or they just accepted it to review it? And if the second, when is approval expected?

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.

Next question will be from Michael Freeman at Raymond James.

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.

So what I can kind of talk to is generally, when you have products at launch, it takes 3 to 5 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, we -- the earliest of the launches were -- the third year that's happening is MINJUVI, DLBCL, IMVEXXY and BIJUVA. 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.

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

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.

And last, and 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 Ambisome or other assets?

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

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

It's about $32.5 million in total, of which $6.7 million has already shipped in Q4 '25.

[Operator Instructions] Next question will be from Sahil Dhingra at RBC Capital Markets.

This is Sahil for Doug Miehm. My first question is regarding the Paladin and Sumitomo portfolio performance. Can you speak to the performance of these assets? And how are they 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?

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 2 together, it was about $80 million portfolio. That included 4 growth assets, 3 really early launch ones, MYFEMBREE, ORGOVYX and XCOPRI. 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 are -- we overperformed in Q4, and we are a much higher guidance number for 2026 is because these launch brands as well as the Knight's original portfolio are performing better than our expectations. So if I take XCOPRI, MYFEMBREE and ORGOVYX, 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 are 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.

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 like how should we think about gross margin trajectory into [ 2023 ], especially with the full integration of Paladin and Sumitomo?

So there's gross margin is impacted by a couple of things. Part actually was a little bit of product mix. But generally, given the higher weighting of the Canadian business, there is a -- we're seeing a couple of points shift into -- in gross margins. 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 of points higher than we have been historically.

Okay. 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?

So the integration has really -- it's almost done. Like it is -- we're really -- the last bits are really more system related. So if you look at Q4, that's really our run rate of spend that we should expect for next year. So the savings, we've 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 -- like OpEx in total will remain at the levels that you saw in Q4, there will be a shift that we had higher G&A mostly because of a catch-up on stock-based comp expense going forward, that's going to be -- like G&A will be proportionately 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.

Next question will be from David Martin at Bloom Burton.

Same question or a similar question for Qelbree in Canada as TAVALISSE in Brazil. When in '26, do you expect to refile? And how long would it take after that for approval?

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

Okay. Yes. 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 6 noncore products that you returned and so the $60 million will decrease in '26? Or are those 6 from another area?

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.

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. I mean it's -- that's -- 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 deals accelerate and decelerate for different reasons. So kind of it's hard to say exactly 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.

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

Thank you, everyone, and thank you for your confidence in the Knight team and for joining our Q4 and year-end 2025 conference 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 do ask that you please disconnect your lines.