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spk01: Good morning, ladies and gentlemen. My name is Mark, and I will be your operator today. Welcome to the Knight Therapeutics second quarter 2023 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 statements, 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, further 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 info at nightstx.com or via phone at 514-484-4483. I would like to remind everyone that this call is being recorded today, November the 9th, 2023. And I would now like to turn the meeting over to your host for today's call, Samira Sagir. Please go ahead, Ms. Sagir.
spk03: Thank you, Mark. Good morning, everyone, and welcome to Knight Therapeutics' third quarter 2023 conference call. I'm joined on today's call with Amal Khoury, our Chief Business Officer, and Arvind Ujjana, our Chief Financial Officer. I'm pleased to announce that Knight achieved record results for the nine months ended September 30th, 2023. We delivered revenues of over $254 million and adjusted EBITDA of over $48 million. a growth of 20% and 19%, respectively, over the same period last year. Moving on to an update of our product portfolio. We received the regulatory approval for Venduvia in Brazil, as well as the pricing approval from CMED, the regulatory body that establishes maximum prices allowed for drugs sold in Brazil. As a result, we expect to launch Venduvia in Brazil in the second quarter of 2024. I'm extremely proud of our team's achievements in getting the product approval faster than our expectations using the rare disease regulatory pathway available in Brazil, as well as getting optimal pricing much faster than expected. In addition, we advanced our product pipeline with the regulatory approval, regulatory submissions of Fosamatinib, also marketed as Tevalis in the U.S. in Colombia and Mexico, and Pemigatinib, marketed as Pemizirin, U.S. and Europe, in Brazil. With these submissions, we now have three innovative products awaiting regulatory approval in multiple territories. More specifically, Tepacitamab or Renjuvi in Argentina, Colombia, and Mexico, Fosnamatinib in Colombia and Mexico, and Pemigatinib in Brazil, Argentina, Colombia, and Mexico. In addition, we have four branded generic products pending regulatory approval in Colombia. As we're continuing to build our pipeline during the second quarter of 2023, we strengthened our oncology and hematology portfolio with the in-licensing of a branded generic product for Brazil. I will now turn the call over to Arvind to provide an update on our financial results.
spk07: Thank you, Samira. When speaking of our financial results, I will refer to EBITDA and adjusted EBITDA, which are non-IFRS smart measures, as well as adjusted EBITDA per share, which is a non-IFRS ratio. NICE defines EBITDA as operating income or loss, excluding amortization and impairment of non-current assets, depreciation, purchase price accounting adjustments, and the impact of accounting under hyperinflation, but to include costs related to leases. Adjusted EBITDA excludes acquisition costs and non-recurring expenses. NIGHT defines adjusted EBITDA per share as adjusted EBITDA over the number of common shares outstanding at the end of the respective period. Furthermore, my discussion on the operating results will refer to figures that exclude hyperinflation. In the third quarter of 2023, we delivered revenues of over $81 million, representing an increase of more than $12 million, or 18%, and on a constant currency basis by more than $8 million, or 11%, versus prior year. This growth is driven by our oncology and hematology disease portfolio, which delivered over $31 million of revenues, an increase of approximately $5 million, or 19%, compared to the same period last year. Our key promoted brands, including Lendvima, Fossor, Palbosil and Akinzeo contributed approximately $7 million of incremental revenues. This increase was offset by a reduction in sales of approximately $2 million on certain Maxu and Brandon generic products due to the life cycle and the entrance of new competitors. As for our infectious diseases portfolio, our revenues were $29.2 million, a growth of approximately $2 million or 7% compared to the same period last year. This growth is driven by our key promoted products, including Cresemba and higher demand of Improvido, partially offset by the purchasing patterns for certain products. With respect to our other specialty portfolio, During the quarter, revenues were $21.1 million, an increase of $5.5 million, or 36% compared to the same period last year. The increase is primarily driven by the transition of commercial operations of Exelon from Novartis to Knight. More specifically, in Q3 2022, NICE recorded lower revenues of Exelon due to the advance customer purchases of $3 million in Brazil and Colombia in Q222. The remainder of the variance is explained by the change in accounting treatment of Exelon from net profit transferred to revenues with related cost of sales, as well as timing of purchases from certain customers. Now, moving on to gross margin. The reported $42.1 million or a gross margin of 52% of revenues in the third quarter of 2023 compared to $33.8 million or 49% of revenues in the same period last year. The increase in gross margin as a percentage of revenue is driven by the change in the product mix. I will now turn to our operating expenses. For the third quarter of 2023, Our operating expenses were approximately $39 million. Excluding the impairment of intangible assets recorded in Q3 2022, the operating expenses increased by $2.2 million, which is mainly due to an increase in compensation costs related to NITE's long-term incentive plan, higher spending on professional and consulting fees, and expansion in our product development and medical initiatives. Moving on to adjusted EBITDA. For the third quarter of 2023, we reported $15.5 million of adjusted EBITDA, an increase of $6.5 million or 72% compared to the same period last year. In addition, Knight's adjusted EBITDA per share was 15 cents, an increase of 7 cents per share or 88% over the same period last year. With respect to gains or losses on our financial assets, which are not reflected in our adjusted EBITDA, in the third quarter of 2023, we recorded $5.6 million of net unrealized gain on financial assets measured at fair value through profit or loss. This gain is made up of an unrealized gain of $12.9 million driven by the increase in the fair value of our Marks.8 warrants and the conversion of our strategic 60P loan into sales. offset by a loss of $7.3 million due to the decrease in the share prices of the publicly traded equities of our strategic fund investments. Moving on to our cash flows. During the third quarter of 2023, Knight generated cash inflows from operations of $15.2 million, including a net working capital investment of $7.2 million. The increase in the working capital is mainly due to an increase in inventory related to our key promoted products and the settlement of the corresponding accounts payable offset by a decrease in accounts receivable. I will now turn the call back to Samira for concluding remarks.
spk03: Before discussing our 2023 guidance, I'd like to provide an update on our NCIB. During the third quarter of 2023, we purchased approximately 2.2 million common shares for $9.8 million which represents an average purchase price of $4.55. Subsequent to the quarter, we purchased an additional 676,000 common shares for $3.1 million. Now on to our financial outlook for fiscal 2023. I'd like to remind everyone that this guidance is provided on a non-GAAP basis due to the difficulty in predicting Argentinian inflation rates. Once again, we have raised our financial guidance on revenue and adjusted EBITDA. We now expect to generate revenues between $325 million to $335 million, an increase of $15 million on the lower end and $5 million on the upper end of the range. Our adjusted EBITDA is now expected to be approximately 18% of revenues. The increase in financial outlook is primarily due to the improvement of the last time currencies against the Canadian dollar and an additional ambisome order we received from the from the Ministry of Health of Brazil for $4.9 million, which we expect to deliver in Q4 of 23. The guidance is also based on a number of assumptions which are described in our press release. Should any of the assumptions differ, the financial outlook and the actual results may vary materially. Considering the recent volatility in certain of our currencies, we will continue to monitor and revise foreign exchange assumptions, which may materially impact our results and forecasts. We remain on track to deliver record results in 2023 while continuing to advance our product portfolio and build our pipeline for long-term growth. Furthermore, we ended the quarter with $153 million in cash, cash equivalents, and marketable securities. This positions us well to continue to execute on our mission to build a leading Pan American ex-US specialty pharmaceutical company by bringing innovative products and generic branded products to our market. Thank you for your support and confidence in the Knight team. This concludes our formal remarks. I'd like to open up the call for questions. Over to you, Mark.
spk01: 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 info at knighttx.com. or via phone at 514-484-4483. With that said, if you wish to ask a question, please dial star 1 on your telephone keypads now to enter the queue. Once your name is announced, you can ask your question. If you find your question is answered or it's your turn to speak, you can dial star 2 to cancel. So once again, that's star 1 to ask a question or star 2 if you need to cancel. Our first question comes from the line of Andre Udin of Research Capital. Please go ahead. Your line is open.
spk02: Good morning, everyone. Samira, we're just looking at Brazil. Can you please discuss the market potential of Minjuvi and Pemezir? I'm not sure if I got those pronunciations right. Thanks.
spk03: Sure. So let me start first with Minjuvi. What I can tell you, we don't really provide guidance or revenue by product, but what I can tell you is Minjuvi is doing about $100 million U.S. today, just a couple in the U.S., $100 million in U.S., $100 million. So let's say around $130 million Canadian. They're just a couple of years into the launch. Given that, and if you know, like, our Our markets are about 5%, like the LATAM market is about 5%. We are launching at optimal price. This is where, and the brand is, whether it's in the US or the market, there is a lot of interest in this category. It is a medically necessary product. And this is to help you kind of come up to the number. In the case of Pemizir, it's an even more rare disease. The second thing is that it's really genetically based. Given that, we expect that to be a much smaller product. We are working with our specialists in the market to see where and how the testing will work.
spk02: That's great. Thanks. That's useful. Looking ahead, I know you haven't provided guidance yet for 2024, but where would you say your growth is primarily going to come from in 2024?
spk03: It's coming from a whole bunch of different places. So we have in our oncology portfolio, I look at products like Linvima, Akinzeo, TrailStar. They all continue to grow. We will be launching Minjuvi, which is coming earlier than we originally expected. We are launching Invexi also in Canada next year. And all of those products are going to continue to provide growth. We also have Cresemba in our infectious disease portfolio, which is continuing to grow in all of our markets. And we're going to continue to build a pipeline and advance the pipeline that we have.
spk02: And so in terms of growth, would you say that would be single-digit growth or is it going to be double-digit growth? Can you provide that color a little bit?
spk03: Thanks. Not yet. We'll be providing guidance kind of earlier in the next year when we announce Q4. Okay.
spk02: That's great. Thank you, Simran.
spk03: Thank you.
spk00: Thank you. Our next question comes from the line of Dave Martin at Bloomberg. Please go ahead. Your line is open.
spk04: Hi, this is Garish on behalf of Dave. Congrats on the great quarter and increased guidance. We do have a few questions. The first one surrounding the oncology hematology portfolio. Has the full impact of the generic competition launched launch been felt in the third quarter? And if it's not fully in this quarter, how much erosion do you anticipate going forward?
spk03: Sorry, just to clarify, if you're talking about generic competition on our own EGXs, on our own branded generics, that competition has been delayed because the The Colombian agency has been behind in their approvals. So it hasn't fully impacted in Q3. We do expect to, what we are seeing from the agency with some changes and updates to their regulations that they're going to start approving faster now. We do expect it to come next year. That being said, like I said earlier to Andre, Trelstar, Lendima, Akinzeo are continuing to show great growth.
spk04: Okay, thank you. And one last question. In the assumptions for your revised guidance, you mentioned discontinuations of certain distribution agreements. Does this refer to agreements that have already been discontinued or agreements you expect to be discontinued going forward? And if it's allowed, can you provide your comments?
spk03: Sure. No, this is really the impact of the Gilead termination that we had last year, and that's fully impacted. Like this third quarter, if you look at kind of the discontinuation impact, it's immaterial. So that's already all washed out of our results.
spk04: Thank you very much, Samir.
spk01: Thank you. Just as a reminder to participants, if you do wish to ask a question, please dial star 1 now. Our next question comes from the line of Doug Myham of RBC Capital Markets. Please go ahead. Your line is open.
spk05: Good morning. First question just has to do with Exelon. We did see an almost $6 million increase in the quarter, but that was more because of the switch. to you holding the revenues, but what I'm curious about are the unit sales trends. Are they starting to drop because of the increased competition on the generic side yet? Just curious about the unit trends.
spk03: Sure, that's a great question. We're actually seeing the objective when it comes to Exelon was really to maintain flattish and whether it's in dollars or units, we are retaining our share and the unit volumes are straight.
spk05: Okay. That's really good to hear. Do you expect that to change, though, Samira, based on any change in the competitive environment?
spk03: Well, yes and no, in the sense that as As there are more competitors in the market, there is more share of voice on this one molecule. So here we may start to lose share, but actually gain volume and really maintain the brand. And that is really what each of our teams are working towards.
spk05: Ambizome, another warder. Can you give us an idea as to why? Because I know that you indicated that we're not likely to see that again. But what's happening in that market that has the government continue to come back to you?
spk03: Sure. So one of the reasons, this really started with hard work on our team's part. The competitor product has been on backorder and has remained on backorder. We have continued to strengthen our relation with the Ministry of Health. What they are seeing from our team is a quality product and reliable supply. And as long as we continue to deliver on that, I believe that we can extend their replenishment. We'll see what happens when the competitor returns back in supply.
spk05: Excellent. Thanks very much.
spk01: Thank you. And there seems to be no further questions in the queue at this time. So I'll hand the floor back to our speakers for the closing comments. Actually, just as I've said that, there has come forward one further question. That's from the line of Justin Ewood at Stiefel. Please go ahead, your line.
spk06: Good morning. Thanks for fitting me in. So just on the financial assets, there's a few movements in the quarter. You had the repayment from Lashka 8 and then also a marked market adjustment. Just wondering if you could explain the mark-to-market adjustment and then also the state of the remaining financial assets and if there's any near-term further expected liquidity events.
spk03: I'm going to clarify a couple of things there. On the financial assets, there's three different things that are happening. The Moksha 8 loan has not been fully repaid. It will be repaid in Q4. Moksha was recently announced that Moksha has been acquired, so our loan will be repaid. And because we own warrants, we had warrants of that company, we recognize a gain on the warrants because we had to mark them to market. And all of the loan and the warrants will be both paid out, we expect, in Q4. The second thing that we had is we converted our loan to synergy, to equity, and that actually had a gain all there. That was about a couple million dollars. The rest is a write-down of our financial assets, is really coming from the public securities held in our funds. And those, as we've seen in the capital markets and the biotech index, there's been a significant downturn on those investments, and we continue to mark to market. So we have about $100 and some million of financial assets, and we mark them to market. And that's really been the history for the last almost 10 years in Knight, where that's initial fund investments and the markups and markdowns that we've seen.
spk06: Thank you. And is there another expected liquidity event aside from Oshka A?
spk03: Not really. At the end of this quarter in the loans, at the end of this year, we will only have Synergy left. Synergy is a loan that is expected to be paid back during 24, but we may, depending on how their results are doing, we may continue to extend that out a little bit longer. And as you know with the funds, on the funds we have about $11 million that is pending capital calls, but over the last few years, the funds have been cash flow positive and cash generating rather than a net outflow.
spk06: Understood. Just a question of clarification. The 60 pharma loan, was that repaid or does that still remain outstanding?
spk03: That was converted to equity.
spk06: At the same value? I believe it was $6 million U.S. around there?
spk03: So we had written down, given the financial situation of 60P, we had written that loan down to almost zero. So it's actually a gain of $2 million in the quarter.
spk06: Thank you for taking my questions.
spk00: Thank you. Thank you.
spk01: Once again, if there are any final questions, please dial star 1 on your telephone keypads now. Okay, there seems to be no further questions at this time, so I'll hand the floor back to our speakers for the closing comments. Thank you, Mark.
spk03: Once again, thank you for the confidence in the night team and for joining our Q3 23 call. Have a great morning.
spk00: This now concludes the conference. Thank you all very much for attending. You may now disconnect your lines.
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