Good m orning, ladies and gentlemen. My name is Kate, and I will be your operator today. Welcome to Knight Therapeutics, Inc., Exelon acquisition. Before turning the call over to Jonathan Ross Goodman, CEO of Knight, listeners are reminded that portion 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 514-678-8930. I would like to remind everyone that this call is being recorded today, April 23rd, 2021, and would now like to turn the meeting over to your host for today's call, Jonathan Ross Goodman. Please go ahead, Mr. Goodman. Good morning, welcome to Knight Therapeutics' conference call. I am joined on today's call with Samira Sakhia, our President and Chief Operating Officer, Amal Khouri, our Chief Business Development Officer, Arvind Utchanah, our Chief Financial Officer, and Jeff Martens, our VP Commercial. We've agreed to acquire Canadian and Latin American rights to Exelon from Novartis to strengthen our existing footprint. While good things may come to those who wait, it wasn't the case this time. Waiting isn't in our DNA, waiting for a good deal, for the right deal is most definitely. It was the sheer tenacity of Samira, Amal, and Knight's entire business development team that made this happen. I will now turn the call over to Samira and Amal, who will walk through this transaction. Thank you, Jonathan, and good morning, everyone. As we have mentioned many times, including on our last conference call, we have been focused on building our portfolio in order to leverage the great Pan-American ex-U.S. platform, which we now have following the acquisition of Grupo Biotoscana. One of Knight's growth strategies is the acquisition of mature or underpromoted products from Big Pharma. The acquisition of Exelon for LATAM and Canada is a great example of execution of that strategy. Exelon is a well-established innovative brand that is prescribed for the symptomatic treatment of mild to moderate dementia associated with Alzheimer's. Exelon's indication falls into one of our priority therapeutics areas, more specifically CNS. In addition, this acquisition will be immediately accretive to both our top line and our bottom line. I will turn the c all over to Amal, who will provide more details on the product and the transaction. Thank you, Samira, and good morning, everyone. As we announced earlier today, we have entered into a definitive agreement to acquire the exclusive rights to manufacture, market, and sell Exelon in Canada and Latin America, as well as an exclusive license to use the intellectual property and the trademarks associated with the product within Canada and Latin America. This acquisition leverages our Pan-American ex-U.S. platform and further validates our rest-of-world strategy. Exelon will be the first product that Knight will be selling across our entire territory. Exelon is a prescription rivastigmine product that was first approved in 1997 and is currently registered and commercialized in approximately 90 countries. As Samira mentioned, Exelon is indicated for the symptomatic treatment of mild to moderately severe dementia in people with Alzheimer's disease. In 2020, Exelon had annual revenues of approximately $47 million in Canada and Latin America. About two-thirds of those revenues were generated in Brazil and Colombia. At closing, Knight will pay $168 million in cash and an additional milestone payment of up to $12 million upon the achievement of certain conditions. The transaction will be funded with Knight's cash, and we expect to have remaining cash of at least CAD 100 million to continue to execute on more business development opportunities. The closing of this transaction is subject to antitrust clearance in Brazil, which is expected to take between 45 to 90 days. At closing, Knight will enter into a transition service period during which Novartis will continue to distribute and sell the product until the transfer of the marketing authorizations on a country-by-country basis. During this transition period, Knight will receive a net profit transfer, and once the marketing authorizations are transferred, Knight will begin distributing the product through its own local affiliates on a country-by-country basis. Over the last 15 months, our business development team has been focused on leveraging our broader footprint to position ourselves as the partner of choice for Canada and LATAM. Our focus remains on executing on our strategy of in-licensing and acquiring branded pharmaceutical products as well as potential bolt-on M&As. I will now turn the call over back to Samira. Sorry. Thank you, Amal. In the last 18 months, we have transacted for over CAD 600 million in key business development opportunities, including the acquisition of Grupo Biotoscana, as well as the acquisition of Exelon. Our team is focused on integrating and strengthening the operations with systems and processes while continuing to execute on our strategy of building a reputable specialty pharmaceutical company through business development as well as through commercial and medical excellence. We are thrilled to add Exelon, an established medically important brand, to our portfolio of specialty CNS products and to continue supporting this important therapy in an area of such high unmet need. This concludes our formal remarks. I would now like to open up the call for questions. Turning over to you, Kate. 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@knighttx.com or via phone at 514-678-8930. Our first question today is coming from Andre Uddin. Please announce your affiliation, then pose your question. Andre Uddin, Research Capital. Good morning, everyone. Just had a couple questions. In terms of the market share of Exelon, in terms of brand and generics, can you just talk a little bit about that in terms of the different regions? Sure, Andre, I am going to be turning the call over a whole bunch of times over to Amal as she is the closest to this. Amal, can you take it over, please? Sure. Good morning. I think to comment on market share across the territory is a little bit difficult because the IQVIA data is not as good as what we're used to having in Canada. To give you a sense, I think your question specifically was in relation to generics. When we look at Exelon, the product is sold in an oral form, which is the capsules. The capsules have been genericized for a long time. The market is, I would say there's a lot of generics, and brand share you can assume is lower as expected in a genericized market. The bulk of the sales, however, are in the patch form, where generic competition is much more limited. If we look at, especially within Latam, we actually have some branded generic competition, not pure generics. In some markets, in some countries, we don't have any branded generics. That's to give you a sense of what the generic competition looks like across the territory. Just in terms of Canada, if you look at the patch, I haven't checked yet. Does Sandoz have a generic version of it? If not, is there any Novartis agreement to prevent Sandoz from launching a generic patch? Sandoz has a generic patch in Canada that we didn't buy that. That was not part of what we bought. They continue to sell. If you look at the data, again, they have been on the market for a few years. I think the generic impact has been seen, and they don't have a generic patch outside of Canada and the rest of our territory. Okay. All right. Thank you. Thank you. Our next question today is coming from Douglas Miehm. Please announce your affiliation, then pose your question. Yeah, RBC Capital Markets. Maybe, Amal, you can walk through what the last three years of revenues associated with Canada and the other countries looks like. Secondly, just with respect to the margins anticipated on this product, can you walk us through what that's going to look like from a gross and EBITDA perspective? Finally, as it relates to revenue recognition and timing during that transition period, how exactly is that going to look? Sure. Let me start with your first question on historical sales. As I just mentioned before, Canada, you see in the last few years, the generic patch having launched. If you look at that time period, the decline is really in Canada because of the genericization. In the rest of the territory, it's been relatively flat. On the margin guidance, we're not providing specific guidance, but if you compare to what we have today, it's going to be a better margin versus what we have today overall. I think your last question was on timing of the transition and revenue recognition. Maybe just to give you the context on how the transition will actually work. First we need to close, which is going to be following antitrust clearance. Once we close, we're going to enter into a transition period, and during that time, Novartis will continue to distribute the product for us in the territories, and we will be most likely recording that profit transfer as net revenue. You're going to have it at 100% margin during the transition period. Once the marketing authorizations transfer on a country-by-country basis, we start recording sales, cost of sales, other expenses, et cetera. You're going to see how we're reporting that changes over time, depending on the transition and then which countries we start taking over. Okay. Sorry, how are you going to audit how they calculate net profit? There is the reporting. Again, we're talking about a big company in terms of reporting. They also follow IFRS. In terms of reporting the sales and the profit transfer reporting. Okay. Thank you very much. Okay. Thank you. Our next question today is coming from David Martin. Please announce your affiliation, then pose your question. Good morning, David Martin from Bloom Burton. One follow-up to Doug's question. The patch recently genericized in Canada, how many years ago was that? Are the sales of the patch still declining in Canada, or have they stabilized somewhat now? It's not a recent genericization. It's been a few years, and I would say, the big cliff you already saw, I would say, over two years ago, so the decline is stabilizing. Okay. Next question. How promotion sensitive will this be in any of your territories? Is there any opportunity to reverse declines, grow sales? How many CNS reps do you have in each of the major territories, and do you plan to add to those? Hi, David. That's a great question. On this product, what we are expecting is revenues will stay flattish. That's really because we do expect some declines in some of our countries. We do expect to do some promotion in some of the countries as well. We have a really small sales force today in CNS with CYKLOKAPRON and Auvelity, and we may expand in a couple of territories. Okay. Thank you. Thank you. Our next question today is coming from Tania Gonsalves. Please announce your affiliation, then pose your question. Good morning, guys. This is from Canaccord Genuity. I think most of my questions have been asked already. Just a couple from me. I think you talked about once the transaction actually closes, there will be a period of marketing authorization transfers on a country-by-country basis. Could you talk to how long that takes on average? Sure. Again, it varies by country. I would say, overall, I think we're looking at transition period to last up to 18 months. Again, within that time period, some countries will transfer faster than others. Perfect. Thank you. I think you also licensed the IP and trademark from Novartis. Is there a specific term on that license deal? No, it's perpetual. Great. That's all for me. Thank you. Thank you. Our next question today is coming from Eduardo Garcia. Please announce your affiliation, then pose your question. Hi, good morning. Eduardo Garcia from National Bank. Thank you for taking my question. I have actually a couple here. Wanted to know which countries are you planning to target first when you're doing the whole transition period? We have to work on a transition plan with Novartis, and there are a lot of considerations to look at. Of course, I would say the general answer would be focusing on the bigger markets and ensuring those transfer well. Okay. Thank you. I wanted to understand how the sales trended last year, how the pandemic impacted, and how do you see in the near future? In the last year, I'm sure you've been hearing us talk about the COVID impact in general and specifically on the FX in our region. That also, there was an impact. The FX impact, of course, you would see it on this product as well last year. Overall, in terms of COVID impact on the product, this is primarily a pharmacy product, and it's a chronic therapy. We would have expected the impact on it to be less than what you would see on more acute care type therapies. Okay. Thank you. I have one more question. Do you expect Novartis to launch more generics in other geographies? Again, the product already has generics in different markets around the world and branded generics in our territory. Regardless of who the players are, we really look at it as how brand retention works in these markets. In LATAM, brand retention is much better than what we see in Canada and the U.S., for example. That's really how we're looking at the market. Okay. Thank you very much. Thank you. Our next question today is a follow-up from Douglas Miehm. Your line is live. Yeah. I just wanted to follow up on this whole generic question. In Canada, we have seen the patch generic. You're saying that two-thirds of the revenue are coming from Brazil and Colombia. Besides the capsules, has the patch been genericized in those two countries, and would it be Sandoz's intention to genericize the product in those countries? In Brazil, we don't have any generic or branded generic competition to the product. It is something that although we would be expecting new entrants into the market. In Colombia, there is already a branded generic to the patch. Again, whether it's Sandoz or any other generic, the impact eventually and the market dynamics would be the same regardless of who the seller is. Again, I would keep in mind that this is mostly if we talk about generic competition, we're really talking about branded generic competition. Yeah. Okay. Thank you very much. Thank you. Once again, ladies and gentlemen, if you have any questions or comments, please press star one on your phone at this time. Our next question is coming from David Martin. Your line is live. Thanks for taking a second question. What is the price differential between brand and generic in LATAM? We know in Canada the differential is lower than it is in the U.S. Is it even closer, the pricing, brand and generic in LATAM? It really varies a lot from country to country. Again, it's one thing. When you think about discounting versus generics, again, here we're looking at wherever we have competition, it's branded generics. Pricing strategy is different, because they still have to promote the product as well. It is different dynamics from when you're looking at pure brand versus generic price differential. Again, it varies from country to country, so it's really difficult to give a general answer. How about in Brazil specifically, where you could see new branded generic competition? How close are the prices there? I can't predict what they're going to decide to price at. Today, there is no competition. There's no branded generics for the patch in Brazil. Okay. I just meant in general, where does Brazil set on the spectrum of brand to generic differential? I would have to get back to you on that, David. Okay. You mentioned that you may promote in some territories. What characteristic of a territory would lead you to promote there? Sure. maybe I can- Hi, Maybe. I can start this one off. Go ahead. David Martin, it's really about where we think that over the next few years, whether there is a branded generic in the territory or not, that we can capitalize on either slight growth or retaining our share. That's really what we're going to be trying to do. Again, remember that our bigger markets is really about two-thirds of our sales are in Brazil and Colombia. In Brazil, we don't have a BGx that has launched today. Okay. Thank you. Thank you. Our next question is coming from Tania Gonsalves. Your line is live. Thanks so much. Could you guys provide any information on what the milestone payments are linked to? Sure. It's related to certain MA renewals and transfers. You also bought the rights to manufacture the drug. Will you be using the same CMO as Novartis, or will there be a transition happening? The plan is to use the same CMO, particularly for the patch. We're not planning on disrupting that. Perfect. Thank you. That's all. Thank you. We have no further questions in queue at this time. Thank you, Kate. Thank you for your continued support and confidence in the Knight team, and joining us for this conference call. Thank you, ladies and gentlemen. This does conclude today's event. You may disconnect your lines at this time, and have a wonderful day. Thank you for your participation.
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