Knight Therapeutics Inc.

Thank you, Sergio. Good morning, everyone, and welcome to Knight Therapeutics Second Quarter 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'm excited to announce that for the first half of 2025, we achieved a record high adjusted revenues of CAD 197 million, driven by our innovative promoted product portfolio, which delivered organic growth of 15% on a constant currency basis.

Our adjusted EBITDA for the 6 months of 2025 was CAD 27.6 million. In addition to driving strong results, we continue to execute on the business development front.

With the Paladin and Sumitomo transactions, we added over 50 products to our portfolio, including five pipeline and early launch assets, which will further accelerate the growth trajectory of our Canadian business. We also continue to strengthen our relationships and partnerships.

Earlier this year, we expanded our agreement with Helsinn and relaunched ONICIT in Brazil and Mexico. In addition, earlier this week, we announced that we added two innovative pipeline products in oncology, retifanlimab and axatilimab for LatAm from Incyte.

Moving to the pipeline. We continue to advance our portfolio with the regulatory submissions of MINJUVI for follicular lymphoma in Brazil as well as CREXONT in Canada and Mexico.

In addition, we obtained the approval of Pemazyre in Argentina and Rembre or dasatinib in Chile. Now talking about our NCIB.

Knight completed the NCIB launched in July 2024. And during the 12-month -- during that 12-month period, we purchased 2 million shares at an average price of CAD 5.48 for an aggregate consideration of CAD 11 million.

Finally, we have secured a $50 million revolving credit facility with National Bank. We have launched a syndication process to increase the size of the facility to up to $100 million with an additional accordion of $50 million.

This facility will ensure that we remain well positioned to continue to transact and execute on our mission to acquire, in-license, develop and commercialize pharmaceutical products in Canada and Latin America. I'll now turn the call over to Arvind to cover our results.

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 or loss, excluding amortization and impairment of noncurrent assets, depreciation, the impact of accounting under hyperinflation, acquisition and transaction costs, inventory step-up expense and other nonrecurring 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 non-GAAP measures. Financial results at constant currency obtained by translating the prior period results at the average foreign exchange rates in effect during the period, except for Argentina, where we only exclude hyperinflation.

Furthermore, my discussion on the operating results will refer to figures that exclude hyperinflation unless otherwise indicated. For the second quarter of 2025, we delivered revenues of CAD 108.5 million, representing an increase of CAD 14 million or 15% compared to the same quarter last year.

On a constant currency basis, revenues increased by approximately CAD 19 million or 21%. This increase was driven by the growth of our key promoted products, which grew by CAD 13.5 million or 20% as well as incremental revenues of over CAD 2 million from the Paladin and Sumitomo transactions transaction as well as buying patterns of certain products.

Moving on to revenues by therapeutic area. The oncology/hematology portfolio delivered CAD 35.5 million in Q2 '25.

Excluding the termination of a nonstrategic distribution agreement in Colombia, the portfolio increased by approximately CAD 2.1 million on a constant currency basis compared to the same period last year. This growth was primarily driven by AKYNZEO, the launch of MINJUVI and the addition of ORGOVYX and ONICIT, which was offset by a decline in our mature and branded generic products due to the life cycle.

Our infectious disease portfolio delivered CAD 45 million, an increase of CAD 7.5 million or 20%. On a constant currency basis, the portfolio grew by CAD 9.5 million or 26% compared to the same period last year.

The increase was due to the growth of Cresemba, additional AmBisome deliveries to the Ministry of Health in Brazil, offset by purchasing patterns of certain products. Turning to our other specialty therapeutics areas.

The portfolio generated approximately CAD 28 million in revenues, an increase of CAD 7 million or 34%. On a constant currency basis, the portfolio grew by CAD 8 million or 42% compared to the same period last year.

The increase was mainly driven by the launch of IMVEXXY and BIJUVA, the additions of Paladin and the Sumitomo products as well as purchasing patterns of certain customers. Now moving on to gross margin.

We reported CAD 49 million or a gross margin of 46% of adjusted revenue in Q2 '25 compared to CAD 45 million or 48% of adjusted revenue in the same period last year. The decrease in the gross margin percent was mainly explained by the product mix as well as severance costs related to the closures of Knight's HIV and respiratory facility in Argentina.

All the key products produced in that manufacturing facility were transferred to certain contract manufacturers. I will now turn to our operating expenses, excluding amortization.

For the second quarter, our operating expenses were CAD 38.4 million, an increase of CAD 8 million or 27% compared to the same period last year. Excluding the acquisition costs related to the Paladin transaction, our operating expenses increased by approximately CAD 5 million or 15%.

The increase in operating expenses was driven by prelaunch and launch investments behind the launch of MINJUVI in Mexico, Jornay PM in Canada, an increase in activities behind our key promoted products, incremental costs related to the Paladin infrastructure as well as an increase in share-based compensation following periodic reassessment of vesting targets. Moving on to adjusted EBITDA.

For the second quarter of 2025, we reported CAD 15.5 million of adjusted EBITDA or CAD 0.16 per share, which is relatively unchanged compared to the same period last year. I will now cover our financial assets, which are valued at CAD 103 million as of June 30, 2025.

In the second quarter, we settled the synergy loan receivable in exchange for CAD 13.8 million in cash and CAD 1.1 million in warrants. In addition, subsequent to the quarter, we collected CAD 3.8 million to settle Knight last strategic loan receivable with a life science company.

As of today, Knight has collected all of its strategic loan receivable. Now moving on to our funds and equities.

In the second quarter, we recorded a net loss of CAD 5.7 million, mainly driven by the mark-to-market revaluations of our strategic fund investments, partly offset by the change in value of certain equities. As a reminder, our funds continue to be a source of cash.

We received net proceeds of CAD 5 million in 2025 and CAD 44 million since 2020. Moving on to our cash position and cash flows.

At the end of Q2, our net debt position was CAD 6.5 million. We held CAD 97.7 million in debt and CAD 91.2 million in cash and marketable securities.

During the quarter, we generated cash inflows from operations of CAD 20 million, driven by our operating results as well as a decrease of CAD 13 million in working capital as a result of collections in our accounts receivable. In terms of our investing activities, we deployed CAD 131 million in the Paladin and Sumitomo transaction and received CAD 15.8 million from our strategic loans and funds.

A portion of the Paladin acquisition was financed by the withdrawal of CAD 60 million from the revolving credit facility with National Bank. In addition, as announced previously, we had withdrawn $35 million from our Citi working capital line of credit.

That amount was repaid in full during the quarter. I will now turn the call over to Amal.

Thank you, Arvind. 2025 continues to be a very productive year for our business development team.

This week, we announced that we expanded our existing relationship with Incyte and added exclusive LatAm rights to retifanlimab, which is sold at ZYNYZ in the U.S. and Europe and axatilimab, which is sold as Niktimvo in the U.S.

Retifanlimab is approved in the U.S. and Europe for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma or MCC, which is a rare and aggressive type of skin cancer.

Based on epidemiological data from two Brazilian registries, there are an estimated 550 to 1,250 new cases of MCC each year across Brazil, Mexico, Colombia and Argentina. Retifanlimab is also approved by the FDA in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal or SCAC.

In addition, the FDA approved retifanlimab as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy. While epidemiological data for SCAC in LatAm is limited, there are an estimated 2,700 to 4,000 new cases of SCAC each year in Brazil, Mexico, Colombia and Argentina.

The second product, axatilimab is approved in the U.S. for the treatment of chronic graft- versus-host disease or cGVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms.

cGVHD is a serious complication of allogeneic stem cell transplantation in which the donor's immune cells attack the recipient's tissues, potentially affecting multiple organs such as the skin, liver, lungs and gastrointestinal tract. There are approximately 1,400 to 1,800 reported allogeneic transplants in Brazil every year.

The expansion of this existing relationship with Incyte and earlier this year with Helsinn reflect our ability to deliver in-market success from regulatory submissions to approvals to commercial execution. In addition, the Paladin and Sumitomo transactions illustrate our ability to build a balanced portfolio that includes both innovative, growing promoted products as well as profitable, mature cash flow generating products.

I will now turn over the call back to Samira.

Thank you, Amal. Now on to our financial outlook for fiscal 2025.

I would like to remind everyone that the guidance provided earlier this year included the close of the Paladin acquisition in mid-2025 and also assume 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 the actual results may vary materially. We are increasing our outlook for fiscal 2025 and expect to generate revenues between CAD 410 million to CAD 420 million, up from CAD 390 million to CAD 405 million.

We expect our EBITDA to remain at approximately 13% of revenues. The change in our revenue outlook is driven by better performance in the first half of the year and the incremental revenues from the Sumitomo transaction.

Looking ahead, we are very excited with what we can deliver to our stakeholders with our recent and upcoming launches as well as our pipeline products. In addition, the Paladin and Sumitomo transactions mark a pivotal step in accelerating our growth and strengthening our position in the Canadian market.

With our expanded portfolio, increased operational scale and capital flexibility, we remain well positioned to drive long-term value and deliver on our mission to acquire, in-license, develop and commercialize pharmaceutical products for Canada and Latin America. Thank you for your support and confidence in the Knight team.

This concludes our formal remarks. I would now like to open the call for questions.

Back to you, Sergio.

Congratulations on this quarter and all the business development and launch activity you've been doing recently. It looks like it's been a busy year.

My first question, it looked like there was a significant order from the Brazilian MOH this quarter. I wonder if you could describe whether you expect more orders from the MOH during the rest of the year if this completed the contract that was contemplated for 2025.

And then in addition, I wonder if you could tell us about when a potential 2026 contract would be negotiated.

That's a great question. We did see a bigger purchase than we originally expected.

As for can they buy more in the rest of the year, as of today, we don't really have a commitment from them to purchase. Yes, they are allowed to purchase more, but we haven't seen it yet.

They may purchase more, but it will be a small amount, probably maximum in the 4 to 6 range. As for next year's contract, we expect to have more information later in the fall.

Okay. All right.

And now I wonder if you could give us an update on your integration of Paladin. We saw a few transaction costs here, also saw that R&D increase as a result of some Paladin-related activity.

I wonder, yes, if you could provide us that update. And then if you could give us your expectation of what R&D levels might be for the rest of the year.

So what you see in the G&A is really the transaction costs, not really integration costs. And that's really legal bank fees and kind of other advisory fees that we had in the process.

And for the year -- for kind of the 6 months, that was in the CAD 4-ish million range. As it comes to R&D or G&A or sales and marketing, it's kind of spread throughout the various OpEx lines.

When it comes to transition, our teams have run really fast through it and are continuing to rise through it because as we've talked about before, part of the kind of the return thesis is bringing OpEx under control. As we -- as it's in our MD&A, to date, we have restructured the organization by about 25% of the headcount.

We do expect a little bit more. And as we said in the Sumitomo call, it will not be as high as we originally expected because there will be in connection with JORNAY, in connection with the brands that we just brought on with Sumitomo, a few more positions, and those gaps will be filled by the Paladin.

Congratulations on the quarter. The business development activity seems to have really stepped up recently.

I'm wondering, have opportunities become more attractive and what has changed to make them more attractive? Or is this because the company completed the integration and streamlining of Biotoscana and that position them better to increase the BD?

So David, what I'm going to say is we have been extremely productive over the last 5 years. If I was to probably go back and pull the transcript this time last year, everybody said we've been more productive than we had been in the previous year.

And as Amal has always said, there is ebbs and flows, but the -- we have been executing since 2020, 2021 on transactions. We will continue.

And as you see, -- we are -- yes, we've used up our cash, but we have begun a process to continue to have financial flexibility. We ended the quarter with CAD 90 million of cash.

We are expanding our debt facility that could give us anywhere between an additional CAD 70 million and CAD 150 million so that we can continue to execute.

Okay. Great.

Second question, with Paladin and the new drug launches that you've got queued up, that should be good for top line growth and gross margin expansion moving forward. But in the near term, you've got drug launch costs and the Paladin overhead.

How do you expect these moving parts to affect the EBITDA margin in 2026 versus the 13% you're forecasting for this year?

We'll guide to 2026 later in -- in early '26. But yes, Paladin will have a better margin, but it is relatively small when you compare it to the entire business.

What I do expect is as we move through the next couple of years, and I'm talking about '26, '27, '28, we will see step-ups, small increases over the next couple of years and then really a relatively bigger increase as the products that are launching start to become real large contributors.

Okay. And just one last quick question.

Are there plans for any further share buybacks?

So as you know, over the last few years, we've invested over CAD 250 million in our stock. We continue to believe that Knight is of good value.

We're going to continue to evaluate. And if we think that there is an opportunity, we will be relaunching the NCIB.

This is Sahil for Doug. I have 2 questions.

One is on the Sumitomo portfolio. Can you remind us of what's the current run rate for top line for that portfolio?

And what growth are you anticipating in 2026? And second question I have is on -- is business development related.

So after the Paladin acquisition that you've closed now, do you -- should we expect more acquisitions in Canada given that you have a larger commercial footprint?

Sure. So I'll take the first one, and then I'll turn the second one over to Amal.

So when we had this call -- when we announced Sumitomo, we had said that the portfolio had approximately CAD 11 million in sales for the last year. We expected that number to be the same for this year.

We didn't -- and so really, we have a half year impact of that CAD 11 million in 2025. We didn't really guide to the growth of those specific products.

What I can tell you is in the case of ORGOVYX, ORGOVYX is an antagonist in a market -- in a large market. There is one other antagonist in the market today, which is Firmagon.

That's an injection. There is an advantage of ORGOVYX, which is an oral.

And the injection is not listed -- does not have public reimbursement in Alberta and BC, and it does approximately sales of about CAD 8 million in Canada. So if you can kind of project out, this was a product that was just launched.

ORGOVYX does have reimbursement is going -- it has passed through pCPA. It has reimbursement.

We have today signed up Ontario, Quebec, BC, a couple of the smaller provinces, and we expect to get rest of Canada over the next year. Actually, I should talk about MYFEMBREE, sorry.

MYFEMBREE is also an early launch product. It has a couple of different competitors.

ORILISSA, which is really kind of another oral does about CAD 9 million of sales, mostly private and it was launched in 2018. There is more to this market through LHR agonist for women.

But if you kind of look at ORILISSA, it does about CAD 9 million of sales. MYFEMBREE was just launched about a year ago.

We expect that product to continue to grow. And what's great about these two products is they are a great fit in the case of ORGOVYX with TRELSTAR and in the case of MYFEMBREE with IMVEXXY and BIJUVA.

So we already have reps in the field. For these physicians, we will be expanding the teams slightly, and that's why I'm saying that there will be team additions to have better reach in places that we don't have today.

Sahil, this is Amal. I'll take your second question.

From a BD perspective, I think your question was with the Paladin transaction, does that change? Or what does that mean for further acquisitions?

Well, the answer is really simple. As we've been saying, this is really what you guys have been seeing over the last year and the last 5 years is a continuing execution of our strategy.

So -- and nothing will change there. We will continue to look for both acquisitions, whether it's specific products or portfolios of products or companies as well as in-licensing additional products for our pipeline.

So none of that will change. We have the capacity to execute, and we'll continue to execute as we have been.

Thank you, Sergio. Once again, thank you for the confidence in the Knight team for joining our Q2 '25 conference call.

Have a great morning.