Earnings Transcript for KHTRF - Q1 Fiscal Year 2024

Operator: Good morning, ladies and gentlemen. My name is Liz and I will be your operator today. Welcome to Knight Therapeutics First Quarter 2024 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 email to info@knighttx.com or via phone at (514) 484-4483. I would like to remind everyone that this call is being recorded today, May 9, 2024. And I would now like to turn the meeting over to your host for today's call, Samira Sakhia. Please go ahead, Ms. Sakhia.

Samira Sakhia: Thank you, Liz. Good morning, everyone, and welcome to Knight Therapeutics first quarter 2024 conference call. On today's call, I am joined by Amal Khouri, our Chief Business Officer; and Arvind Utchanah, our Chief Financial Officer. I'm pleased to report that in Q1 2024, we delivered revenues of over $85 million, a growth of $3 million or 4% over the same period last year including 13% or $7.1 million growth from our promoted portfolio. In addition, during the first quarter, we launched three products in two different territories, Imvexxy and Bijuva in Canada, and Minjuvi in Brazil. Beyond delivering growth across our promoted portfolio, we have advanced our pipeline with the regulatory submission in Brazil for fostamatinib, which we licensed from Rigel and the approval of Karfib, our branded generic of carfilzomib in Colombia. At the end of Q1, we had nine products, including JORNAY PM, under regulatory review in various countries across our region. In parallel to advancing our products towards regulatory approval and launch, we are continuing to strengthen our pipeline and to add to our portfolio through business development. This year, so far, we have added two products for Canada and LATAM. IPX203, a novel formulation of carbidopa, levodopa for Parkinson's disease. And as you saw this morning, we have added JORNAY PM, a novel formulation of methylphenidate for ADHD. With these two products and Qelbree, we have added -- which we added at the end of 2023, we are well on our way to building a strong neurology portfolio, allowing us to leverage our existing Exelon infrastructure. I will now turn the call over to Arvind to provide an update on our financial results.

Arvind Utchanah: Thank you, Samira. When speaking of our financial results, I will refer to EBITDA and adjusted EBITDA, which are non-IFRS measures, as well as adjusted EBITDA per share, which is a non-IFRS ratio. Knight defines EBITDA as operating income or loss, excluding amortization and impairment of non-current assets, depreciation, purchase price accounting adjustment and the impact of accounting under hyperinflation but to include costs related to leases. Adjusted EBITDA excludes acquisition costs and non-recurring expenses. Knight defines adjusted EBITDA per share as EBITDA over the number of common shares outstanding at the end of the respective periods. Furthermore, my discussion on the operating results will refer to figures that exclude hyperinflation. For the first quarter of 2024, we delivered revenues over $85 million, an increase of $3 million or 4% versus prior year. Our infectious disease portfolio contributed to $38 million of revenues, an increase of $7 million or 23% compared to the same period last year. This was driven by our key promoted products including AmBisome and Cresemba, partly offset by the timing of demand for certain products, including Impavido. During this quarter, we sold a total of $9.2 million of AmBisome under our sales contract with the Ministry of Health or MoH in Brazil, an incremental $6.8 million compared to the MoH sales in the same period last year. During 2024, we expect to deliver approximately $18.9 million to MoH, including the $9.2 million overly delivered in Q1 2024. Now moving to our oncology and hematology disease portfolio. We generated $30.8 million in the quarter, a growth of approximately $2 million or 6% compared to the same period last year. Our key promoted brands, including Lenvima, Trelstar, Akynzeo, Palbocil, and the launch of Minjuvi contributed approximately $5 million of incremental revenues. This increase was offset by a decline of approximately $3 million in the sales of our mature and branded generic products due to the lifecycle. Turning to our other specialty portfolio, during the quarter, the portfolio generated $17 million in revenues, a decrease of $6 million or 26% compared to the same period last year. The decrease is mainly due to advanced purchases of Exelon in the first quarter of 2023, driven by the transition of commercial activities from Novartis to Knight, as well as the purchasing patterns of certain customers. Now, moving on to gross margin. In the first quarter of 2024, we reported a gross margin of $40.7 million or 47% of revenues, compared to $41.4 million or 50% of revenues versus Q1 last year. The decrease in gross margin as a percentage of revenues was due to product mix. I will now turn to our operating expenses, excluding amortization. Our operating expenses were approximately $27.5 million in Q1 2024, an increase of $3.8 million or 16% compared to the same period last year. The increase was driven by higher marketing spend for the launches of Imvexxy, Bijuva and Minjuvi, an increase in our G&A costs due to our structure and higher compensation expenses as well as developments for our pipeline products. Moving on to adjusted EBITDA. For the first quarter of 2024, we reported $13.6 million of adjusted EBITDA, a decrease of $4.6 million or 25% compared to the same period last year, driven by the investment in our product launches and pipeline. Our adjusted EBITDA per share was $0.13 for the quarter. I will now cover the unrealized losses on our financial assets, which are not reflected in our adjusted EBITDA. In Q1 2024, we reported a net loss of approximately $16 million driven by the unrealized losses on the valuation of certain private investments of our strategic funds. Finally, on to our cash flows. During Q1 2024, Knight generated cash inflows from operations of $30.8 million, driven by our operating results as well as a decrease in working capital. Our working capital decreased by $15.5 million due to an increase in our accounts payable and a decrease in our trade receivable and inventory levels compared to December 31, 2023. Our accounts payable, excluding all investment activities increased by $9.4 million due to the purchases of inventory of our key promoted products. We expect to set all those payables in the second quarter of this year. I will now turn the call over to Amal to provide more details on our product pipeline.

Amal Khouri: Thank you, Arvind. Earlier this morning, we announced an exclusive supply and distribution agreement on JORNAY PM for Canada and Latin America. JORNAY PM is a highly innovative and differentiated product, and is the first and only evening dose methylphenidate product that is commercially available in the United States to treat Attention-Deficit Hyperactivity Disorder or ADHD, in patients six years of age and older. JORNAY PM is an extended release formulation of methylphenidate, a stimulus medication used for the treatment of ADHD. JORNAY PM's formulation consists of micro beads for the delayed release layer and an extended release layer. The first layer delays the release of the active ingredients until the next morning, while the extended release layer controls the release of the active ingredients from the early morning and throughout the entire day. This unique formulation provides a pharmacokinetic profile that allows a dose-dependent duration of effect and control of ADHD symptoms from the time the patient wakes up until they go to bed. JORNAY PM was studied in two randomized, double-blind, placebo-controlled Phase 3 clinical trials. Both studies met their primary and key secondary end points, demonstrating a statistically significant and a clinically meaningful improvement in ADHD symptoms during the early morning and a late afternoon or evening. JORNAY PM was submitted in Canada for regulatory approval in November 2023. Following the in-licensing of Qelbree, a non-stimulant medication for ADHD as well as IPX203, a novel extended release formulation of carbidopa, levodopa for Parkinson's disease, JORNAY PM represents the third neurology asset that we in-licensed in the last six months. These deals illustrate our focused execution and building our pipeline in a disciplined way that leverages our infrastructure, and they demonstrate our positioning as a partner of choice with deep capabilities in our key therapeutic areas. We will continue to execute on our strategy of leveraging our unique platform to in-license and acquire innovative products from Canada and Latin America. I will now turn the call back to Samira for concluding remarks.

Samira Sakhia: Thank you, Amal, and congratulations to you and your team on closing JORNAY PM and adding another neurology assets. Now on to our financial outlook for fiscal 2024. I would like to remind everyone that this guidance is provided on a non-GAAP basis due to difficulty in predicting Argentinian inflation rates. We are reconfirming our outlook for fiscal 2024 and expect to generate revenues between $335 million to $350 million and adjusted EBITDA of approximately 17% of revenues. This guidance is based on a number of assumptions, which are described in our press release, including foreign currency exchange rates remaining at the same level as 2023 with the exception of Argentina. Considering the volatility of LATAM currencies, we will continue to monitor and revise our foreign exchange assumptions, which may materially impact our results and forecast. Should any of the other assumptions differ, the financial outlook and the actual results may vary materially. We have a profitable and cash flow generating business and with approximately $182 million in cash, cash equivalents, and marketable securities at the end of the quarter, we remain well-positioned to continue to execute on our strategy to in-license and acquire innovative and branded generic pharmaceuticals, as well as develop our own branded generic product portfolio. Looking ahead, we remain committed to continuing to build a leading Pan-American ex-U.S. specialty pharmaceutical company. Over the last several months, we've announced three product submissions in multiple territories, two product approvals, three product launches, and we have added three pipeline assets from three new partners. We have a pipeline of 18 products that are expected to generate over $150 million in revenue, and should they achieve our estimated peak sales. This demonstrates not only our commitment, but also our ability to execute on our strategy. This concludes our formal remarks. I would now like to turn the call for questions. Over to you, Liz.

Operator: Thank you. And 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 info@knighttx.com or via phone at (514) 484-4483. [Operator Instructions]/ And your first question comes from the line of Andre Uddin from Research Capital. Please go ahead.

Andre Uddin: Good morning, everyone. You reported some nice Q1 revenues. Was that primarily due to CPI of Argentina dropping and also the Argentinian peso doing better relative to Q4, just looking at Q1 to Q4? And -- or was that because some products did very well this quarter? Thanks.

Samira Sakhia: So I’m going to start, and then I'll ask Arvind to conclude on this. This is -- so if you look at our revenues, over 50% of our revenues actually come from Brazil and Argentina is a much smaller part of our business. The growth is really coming from our promoted products. If you look at our oncology portfolio, we see a bit of a decline. We see an increase in our infectious diseases portfolio. And a lot of this is really buying patterns Q1. Like if I look at Q4 versus Q1, there is seasonality that has come back into the business, which is normal kind of post-COVID. So it is a lighter quarter in certain categories. We had a bit of -- we had a big shipment out to the Ministry of Health also in the quarter. That contract is $18.9 million, and we shipped almost half of it this quarter. Arvind?

Arvind Utchanah: Yes. Andre, I think to answer the point on FX, I would say between the two quarters, Q4 and Q1, the FX was very stable. Argentina, there were some changes, obviously, but that did not really impact our results as we reported.

Andre Uddin: That's great. And just if I look at portfolio, your pipeline portfolio, given your new in-licensing agreement today, what would you say are your top three new product launches that are coming up in the next, say, 6 months to 12 months? And if you could prioritize on top three that would be great. Thanks.

Samira Sakhia: So the big launch that -- the couple of big launches are right now are Minjuvi and Imvexxy. Minjuvi's launched in Brazil, and it will really pick, year one launch is always a light year, and then it starts to pick up. In the case of Minjuvi, we only launched Brazil and other territories will start coming online, next year or the year after. We also have fostamatinib in our portfolio. Behind that, we've got Qelbree, we've got JORNAY, we've got IPX. All of these products are going to be very meaningful. And I'm not going to really comment on the branded generics because some of them can also be meaningful. And each one of these adds up.

Operator: Thank you. And your next question comes from the line of Rahul Sarugaser from Raymond James.

Rahul Sarugaser: Good morning, Samira, Arvind, thanks so much for taking our questions and back on this morning's announcement at the JORNAY PM. So given that you haven't had a lot into that particular drug, can you perhaps give us a sense for the sales trajectory market and where do you expect that market share that is currently in genders? We'd be able to replicate that in your market.

Samira Sakhia: I'm really sorry Rahul, but I'm going to ask you -- I'm not sure if you're on a speaker, but we’re having a really hard time hearing you.

Rahul Sarugaser: Is that any better?

Samira Sakhia: Much better.

Rahul Sarugaser: Okay. Sorry about that. So I will try to remember my question. First I said good morning, thank you. So congratulations on the JORNAY PM. I guess, given that we haven't had a chance to dig into the drug yet, could you perhaps give us a sense for the sales and market penetration in this current market? And how you expect to replicate that in your LATAM and Canadian market?

Samira Sakhia: So JORNAY -- so we got the rights for JORNAY for Canada and Latin America. The biggest market potential for this product right now in our base case assumptions are in Canada. In Canada, the ADHD market is approximately $1 billion and methylphenidate is just over $400 million and growing at 15% CAGR over the last four years. The other thing that we saw in this market, the last launch that happened in this market, pre-reimbursement that product was doing about $30 million. So we're really -- we're not going to have -- we don't -- we are not forecasting coverage in Canada. We are also being conservative on our label at this point. So it may not reach that number, but we are excited about this product. The market in Mexico, which is the second market that we are forecasting, is not as big as in Canada, but growing rapidly, and we expect to take a significant share there as well.

Rahul Sarugaser: Great. That's really helpful. And sorry, I meant to also ask, I assume this fits within the current guidance of $120 million and approximately off the peak what proportion contribution do you expect the new drug to contribute?

Samira Sakhia: So we updated as of this morning, and we're guiding to just over $150 million. And this will be -- we're not giving kind of how much of a proportion that this is going to be.

Rahul Sarugaser: Okay. Fair enough. Sorry for missing that. Thank you very much. And then one last quick question. Just looking at the BGx portion of the portfolio, we see a little dip this last quarter. Is that seasonal? How should we be thinking about BGx for the remainder of the year?

Samira Sakhia: So we expect BGx -- our BGx portfolio to decline from last year to this year. In Q1, there is two factors. One is the regular decline because of pricing that we expected, because of competitors. The second is there is a bit of seasonality in Q1.

Rahul Sarugaser: Great. That's very helpful. Thanks so much for taking the questions. I'll get back into queue.

Samira Sakhia: Thank you.

Operator: [Operator Instructions]. The next question comes from of Scott McAuley from Paradigm Capital. Please go ahead.

Scott McAuley: Hi, good morning, everyone. Thanks for taking the questions. First, just on the new agreement, this may be kind of obvious, but just wanting to confirm, you're saying you have the license in Canada and Latin America. So for Latin America, that includes essentially all the countries that you currently have operations in?

Samira Sakhia: Yes, it does.

Scott McAuley: Excellent. Congratulations on that. And then second, on the cash flow, again, kind of noting that significant increase year-over-year and the change in working capital, how -- like moving forward, is that kind of a one-time change? Is that something that could be sustained in the coming quarters as you adjust kind of the receivables, expenditures and inventory? Or is that something that would go back down for the rest of the year.

Arvind Utchanah: Okay. So typically, we have a high cash to EBITDA conversion ratio. That's as a reminder. So in the quarter, there was an improvement in the cash flow from operations because we had an increase in our payables of about $9 million. That is really driven by the timing of payments. So that $9 million, we will be paying this in Q2, and that will lead to a decrease in an investment in working capital in Q2. So you should expect lumpiness between the quarters based on purchasing of inventory. But overall, cash flow from operations will remain positive. And you should expect to see a high cash to EBITDA conversion ratio.

Scott McAuley: That's great. I think my other questions have already been answered, so congrats on the quarter and thanks for taking the questions.

Samira Sakhia: Thank you.

Operator: Thank you. And your next question comes from the line of Doug Miehm from RBC Capital Markets.

Doug Miehm: Yes. Good morning. A little bit more detail on JORNAY. Could you walk us through half of the product is in the U.S. since it was launched. And what expectations might be for it. And then the other question I have back to JORNAY's, can you give us a bit of detail on the financial position of company that developed in?

Amal Khouri: Sure. This is Amal. So on the financial performance of the product, as you know, Ironshore is a private company, so they haven't really disclosed their -- the sales expectations for the product, but we have access to some U.S. market data, and I'm sure you guys do as well. So you can see there that the product is doing pretty well. I think initially, they launched during COVID. So that's really impacted the launch, just like it impacted all launches during that time period. But then you see an acceleration post-COVID and they've had a change as well within Ironshore in terms of management and kind of how they're running the company and the product, I mean you really see that on the results of the product. So the product is doing well in the U.S. And again, you might be to look at market data and you can compare it to other launches, it is still performing pretty well. And part your -- second part of your question, I mean, part of our diligence, we usually diligence, not just the product but the partner as well. And we're -- we don't have any concerns. We're quite comfortable with situation of the company. And again, the product is doing well. So we don't have any concerns going forward.

Doug Miehm: Okay. Fantastic. And then perhaps for Samira, has there been any updates on political situation in various countries in South America and how it may impact the company over the next year or two?

Samira Sakhia: So for it's business as usual. What we see, I mean I read our note this morning, there's probably going to be a union strike in Buenos Aires. We had one earlier. But the political landscape is stable. There's really nothing, also like if I take kind of our big major markets, Argentina is stable. He has almost 50% approval rating. Brazil is doing fine. We're monitoring in -- also in Colombia. The issue there is not really political stability, but healthcare reforms that they are looking to put into place. So far, they have not been able to get Congress approval and things are stalled, and we continue to monitor.

Operator: Thank you. [Operator Instructions]. There are no further questions at this time. We will now close the question-and-answer session. And I would now like to hand the meeting back over to Samira Sakhia for closing remarks. Please go ahead, Ms. Sakhia.

Samira Sakhia: Thank you. Once again, thank you for your confidence in the Knight team and for joining our Q1 2024 conference call. Have a great morning.

Operator: Ladies and gentlemen, this concludes today's conference call. You may now disconnect.