Knight Therapeutics Inc

TSX:GUD

Earnings Call Transcript 2021-Q1

[Operator]

Good morning, ladies and gentlemen. My name is Paul, and I will be your operator today. Welcome to Knight Therapeutics Inc. 2021 First Quarter Financial Results Conference Call. Before turning the call over to Jonathan Ross Goodman, 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 [e-mail], or via phone at [phone]. I would like to remind everyone that this call is being recorded today, May 14, 2021. And I would now like to turn the meeting over to your host for today's call, Jonathan Ross Goodman. Please go ahead, Mr. Goodman.

[Jonathan Ross Goodman, CEO & Director]

Good, as in G-U-D, morning, everyone, and welcome to Knight Therapeutics First Quarter 2021 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. Since founding Knight in 2014, we have set out to build a rest of the world pharmaceutical company that brings innovative products that help to lodge the patients. Since our 2014 founding, Knight has deployed or invested over $900 million of capital while generating over $270 million in net income. Today, we commercialized pharmaceuticals in Canada and 10 Latin American countries with nearly 700 talented people. We are in the business of making people better while creating shareholder value. I have been faithfully reporting quarterly results to shareholders for the last 27 years, or 104 quarters. Effective September 1, 2021, I will assume the role of Executive Chairman, and then talented and get-stuff-done, Samira Sakhia, will assume the role of President and CEO. In addition, Jim Gale, who has been Knight's Chairman since founding, will transition to the role of Lead Director. I will continue to direct Knight's strategy and remain focused on nonoperational areas where I can add the most value. I have worked side-by-side with Samira for 18 years, where I've had the privilege of watching her develop into a seasoned top-class executive. Knight is my baby, and I would not -- and I would only entrust its stewardship to the best and brightest. I will now turn over the call to Samira, who will walk through our corporate updates.

[Samira Sakhia, President, COO & Director]

Thank you, Jonathan, and good morning, everyone. As I said yesterday, I started as CFO of Paladin in the summer of 2001, and it has been a privilege to have worked hand-in-hand with and learned from Jonathan for the last 20 years. I'm honored and humbled to take on the role of President and CEO of Knight and to lead an exceptionally talented and dedicated executive team and Knights across Canada and Latin America. Over the last 18 months, we have executed on a transformational acquisition and remain focused on executing on our strategy of building on our pan-American ex-U.S. footprint. We will continue on our mission to license late-stage innovative products, acquire underpromoted products in big pharma and develop branded generic products that improve the lives of patients in Canada and Latin America. As for the quarter, I'm excited to report that our key launch wins in Latin America, including Cresemba, Halaven and Lenvima as well as Trelstar and NERLYNX in Canada grew 116% combined compared to the same period last year. Subsequent to the quarter, we executed on another transformation transaction with the acquisition of Exelon from Novartis for Canada and Latin America. Turning now to the NCIB, which we launched in July last year. Under this NCIB, Knight can purchase up to 10.9 million common shares until July 2021. During the quarter, we purchased approximately 3.6 million common shares for an aggregate cash consideration of $18.6 million. Subsequent to the quarter, we have purchased an additional 512,000 common shares for an aggregate cash consideration of $2.7 million. I'll now turn the call over to Amal for an update on BD activities.

[Amal Khouri, Chief Business Officer]

Thank you, Samira. As we previously announced, 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 Exelon trademark withing 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 we will be selling across our entire territory. At closing, we will pay USD 168 million in cash and an additional milestone payment of up to USD 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 $150 million to continue to execute on more business development opportunities. The closing of this transaction is subject to antitrust clearance in Brazil. At closing, we will enter into a transition service period during which Novartis will continue to distribute and sell Exelon until the transfer of marketing authorizations on a country-by-country basis. During this transition period, we will receive a net profit transfer. And once the marketing authorizations are transferred, we will begin distributing the product through our own local affiliates on a country-by-country basis. Our business development team will continue to focus on leveraging our broader footprint to continue and position ourselves as a partner of choice for Canada and LatAm. I will now turn the call over to Jeff to go over the commercial update.

[Jeff Martens]

Thank you so much, Amal. Building on our hard work of 2020, the first quarter of 2021 was directed to executional excellence on our new launches. Our revenues on a constant currency basis increased by $4.1 million or 10% versus the prior quarter driven by the launch of Cresemba, Lenvima, Halaven, NERLYNX and certain BGX products as well as Trelstar, which Knight started to commercialize in April of 2020. In addition, in March, we launched Ibsrela for the treatment of irritable bowel syndrome with constipation in Canada, which is now covered by most private insurance companies. We finalized our commercial leadership structure with the addition of a country manager in Colombia. So now today, the management of our commercial operations is organized in 5 regions comprised of Brazil, Colombia, South LatAm or SOLA, North LatAm or NOLA in Canada. Over the remainder of the year, we will focus on the execution of our new launches and will prepare for the upcoming launches of Lenvima in Halaven in Colombia as well as Lenvima, Halaven and Cresemba in Ecuador. I'll now turn the call over to Arvind to go over our financial results.

[Arvind Utchanah, Chief Financial Officer]

Thank you, Jeff. In the course of this conference call, I will refer to EBITDA and adjusted EBITDA, which are both non-IFRS measures. Knight defines EBITDA as operating loss or income, excluding amortization and impairment of intangible assets, depreciation, purchase price accounting adjustments and the impact of accounting under hyperinflation. Adjusted EBITDA excludes acquisition costs and nonrecurring expenses. In addition, constant currency is also in non-GAAP measures, excluding foreign currency fluctuations. Financial results at constant currency obtained by translating the prior period results at the average foreign exchange rates in FX during the current period, except for Argentina, where we only exclude the impact of hyperinflation. I am pleased to report that for the first quarter of 2021, revenues were $46 million, an increase of 1% compared to the same period last year. The growth of revenues from our new launches was offset by the depreciation of our LatAm currency. As for gross margin, we reported $20.6 million or 45% compared to $19.9 million or 43% in the same period last year. The increase is mainly due to lower inventory provision and product mix, partially offset by renegotiation of certain license agreements and the depreciation of the LatAm currencies. Excluding the impact of hyperinflation, the gross margin would have been 47% for the quarter. Our operating expenses decreased by $3.8 million compared to the same period in 2020. The decrease is mainly explained by $1.1 million of bad debt provisions recorded in Q1 of 2020 compared to none this quarter. $1.5 million depreciation of the LatAm currencies, and the remainder is due to restructuring activities and cost-saving measures put in place as a result of the pandemic. Moving on to EBITDA. The EBITDA for the quarter was $5.2 million compared to an EBITDA of $1.2 million in the first quarter of last year. Adjusted EBITDA was $5.6 million for the quarter compared to adjusted EBITDA of $3.2 million in the same period last year. The increase of $2.4 million or 75% is driven by the previously mentioned increases in gross margin and decrease in operating expenses. Now moving on to certain items that are not reflected in our adjusted EBITDA. During the quarter, we generated $2 million of interest income from our cash, marketable securities and strategic loans. This represents a decrease of $2.7 million or 57% compared to the first quarter of 2020 due to declining interest rates as well as a decrease in our cash, marketable securities and strategic loan receivable balances. In addition, we recorded interest expense on our backlog of $660,000, a decrease of 42% compared to the same period last year due to a decrease in interest rates in Brazil as well as our average loan balance outstanding. Furthermore, we recorded a net gain on financial assets measured at fair value through profit or loss of $9.5 million during the quarter, which is mainly coming from our strategic fund investments. I want to remind listeners that our financial assets are subject to equity price risk. And I would like to point out that an investment held in one of our funds has seen a material decline in its share price subsequent to the first quarter. Should the share price remain at the current levels, Knight would record a loss of over $15 million in the second quarter of 2021. Finally, Knight generated cash inflows from operations of $17 million in the first quarter of 2021 as compared to cash outflows of $21 million for the same period last year. The significant increase in cash from operations is driven by an improvement in our operating results and working capital as well as interest collected on the maturity of certain marketable securities during the quarter. I will now turn the call back to Samira.

[Samira Sakhia, President, COO & Director]

Thank you, Arvind. Looking ahead, we remain committed to building a leading pan American ex U.S. specialty pharmaceutical company. After closing Exelon, we will have at least $150 million in cash to continue to execute on our strategy to in-license and acquire innovative pharmaceuticals as well as developing our branded generic products for Canada and Latin America. I'll now turn the call back over to Jonathan for his concluding remarks.

[Jonathan Ross Goodman, CEO & Director]

Thank you, Samira. Thank you for your support and confidence in the Knight team. And this concludes our formal remarks. We will now open the call up to questions. Operator?

[Operator]

[Operator Instructions] Should there be any further questions, please contact Knight's Investor Relations department via e-mail to [e-mail] or via phone at (514)-618-8930. [Operator Instructions] The first question is coming from David Martin of Bloom Burton.

[David C. Martin, MD & Head of Equity Research]

Congratulations to both Samira and Jonathan. First question, Samira, do you have any changes in mind for when you take over as CEO? Or will it be pretty much stay on the same path?

[Samira Sakhia, President, COO & Director]

Dave, thank you. And definitely, it's business as usual. We're -- when it comes to what the strategy is, this is exactly what we set out to do. This is what we were doing before at Knight, and this is what we'll continue to be doing, in licensing and acquiring and bringing innovative products that help patients.

[David C. Martin, MD & Head of Equity Research]

Okay. As far as the $150 million you'll have on hand after the closing of the acquisition, what about the money that's tied up in loans and investments in funds now? Do you consider that as accessible capital if you have a larger acquisition in mind?

[Samira Sakhia, President, COO & Director]

So right now, the -- as far as the financial assets are concerned, we may borrow against them because what we've seen is -- if we were to sell them, we're likely not to receive the value that they're worth on the balance sheet. The other thing that we're looking to do after closing of Exelon is add debt into our -- into the balance sheet in local currency to hedge against the currency exposure there. So that's really what's going to give us a little bit more flexibility in capital.

[David C. Martin, MD & Head of Equity Research]

Okay. And the last question is just a housekeeping question. What exchange rates do you use when you report a quarter, the rate at the end of the quarter or the rate as the revenues come in or something else?

[Samira Sakhia, President, COO & Director]

I'm going to turn that over to Arvind to answer.

[Arvind Utchanah, Chief Financial Officer]

So in terms of the conversion, the exchange rate is really the average for the Q. It's converted from each -- functional currency of each of our entities to Canadian dollars using that rate. The only exception that I would say to that rule is Argentina. The accounting rule under hyperinflation is different. And I would refer you to -- we posted on our website an illustration of how the conversion works for Argentina, and I would point you out to that example posted online.

[Operator]

And the next question is coming from David Novak of Raymond James.

[David Novak, MD & Healthcare Research Analyst]

First and foremost, congratulations, Samira, on the new title. There's really nobody better suited to lead Jonathan's baby into the next stage of life. A couple from me this morning. I suppose first on the financial assets. I know you guys mentioned a variance here at AVIR were mark-to-market mid-May. The company in question looks like they're working on a COVID antiviral, which I suppose explains the equity performance as the market looks to vaccine uptake. I'm just wondering if you could help me understand how Knight ended up with such a significant exposure to that specific equity. Did Sectoral just take an outsized position here to the tune of, I guess, it looks like 30% allocation. Is that what's going on there?

[Samira Sakhia, President, COO & Director]

Arvind, do you want to take that?

[Arvind Utchanah, Chief Financial Officer]

Yes. So first of all, on the first question on AVIR. This was an investment made by one of our funds. So it was not a direct investment made by Knight. And even though we're saying like there will be a reversal of gains with this decline that you mentioned. We are still sitting on -- of an overall profit based on the cost base of where the fund entered into that company. So the fund really invested in the company pre-IPO.

[David Novak, MD & Healthcare Research Analyst]

Okay. Got it. Great. And just looking at revenues by therapeutic area here. It looks like you guys are seeing a nice uptick in infectious diseases, which I guess might be helped by Cresemba here. But despite the launch of neratinib and other onc therapeutics, the oncu line is still a bit under pressure. Is that a function of continued COVID impact on hospitals and patients not being managed in a timely manner in LatAm? Or is there additional color you could add there?

[Samira Sakhia, President, COO & Director]

Jeff, do you want to take that one on?

[Jeff Martens]

Sure. Yes. So the infectious disease piece, both Cresemba, and we are seeing ICUs full of patients in many of our LatAm countries where Cresemba can definitely benefit some of those patients. When a patient with COVID gets aspergillosis, they obviously need and require urgent care. Additionally, we're starting to see maybe some potential traction with AmBisome in the same area for Brazil in ICUs. As for the hem/onc piece, yes, we have continued to see decreased treatments for our oncology portfolio in LatAm for several of our brands. Some of them like a Halaven, which is an infused product in hospital is challenged because of that. While others, which are oral, like a Lenvima benefit, where doctors are looking to treat those patients externally. So it's a bit of a mixed bag. But I mean, please, Samira, anything that you'd like to add?

[Samira Sakhia, President, COO & Director]

No. That's exactly right. All of these products are actually, whether it's Halaven, Lenvima and Cresemba, they're in launch phase, and it's also promotional efforts are a little bit tougher, and that's also on NERLYNX and Trelstar in Canada. We are seeing traction. When I look at Cresemba, which was launched pre-COVID in Mexico, it is chugging along a lot better because it is a great product and provides a lot of clinical efficacy and benefit.

[David Novak, MD & Healthcare Research Analyst]

Excellent. That's helpful. And just looking at revenues another way by jurisdiction, Argentina seems to be disproportionately under pressure relative to other key territories. Do you guys largely attribute this to the ongoing pandemic, hyperinflation, currency, things like that? Or is there additional color around Argentina, specifically you could provide?

[Samira Sakhia, President, COO & Director]

No. It's really a currency issue and the pandemic. The -- Argentina is a great pharma market. Unfortunately, right now, the financial crisis isn't really allowing us to show -- to obtain the results that we'd like to get.

[David Novak, MD & Healthcare Research Analyst]

Got it. Great. And then just lastly, a small housekeeping item. The -- on the nonrecurring expenses, there's $874,000 in inventory write-offs. And you mentioned an insurance claim. Is that claim expected to hit in Q2?

[Samira Sakhia, President, COO & Director]

All right. I think that was for last year. Arvind, do you want to take that?

[Arvind Utchanah, Chief Financial Officer]

Yes. This was really a claim [indiscernible]. And write-offs are so due to a temporary transfusion when we're shipping the product. I don't believe we provide any further updates on the claim, but we were working through it.

[Operator]

[Operator Instructions] And the next question is coming from Endri Leno from National Bank.

[Endri Leno, Associate]

Congrats, Samira, on the job. A couple for me. First, I just wanted to ask, was there inventory building in the quarter as there have been building or depletion in the prior quarters? Or do you think it is in a good spot right now at the wholesalers?

[Samira Sakhia, President, COO & Director]

Arvind, do you want to take that first? And then I'll add if necessary.

[Arvind Utchanah, Chief Financial Officer]

Sure. Yes. So I mean, throughout 2020, we've been really working hard in really setting up process and controls and really making sure we have an efficient allocation of working capital. And this really paid off, like you see it at the end of 2020 and really in this quarter where we see the current levels, I think, as more stable levels going forward. But also to keep in mind that depending on timing of purchases and sales, there could be fluctuation in working capital going forward.

[Samira Sakhia, President, COO & Director]

And on the other side, I'm going to add just to inventory in the trade. One of the things we know is -- and it's similar to Canada, where Q4 is -- because of the holiday season, it's usually a little bit higher. We saw that. Unfortunately, it's really hard with COVID to know how much was wholesaler buildup versus just a reaction to COVID. Once the market stabilizes post-COVID, we'll have a better idea.

[Endri Leno, Associate]

Okay. Great. Next question is -- I mean first, congrats on launching those new products. But are you able to quantify what their contribution was in the quarter? And what I'm trying to get there is more kind of like how efficient were these launches versus a more normalized environment?

[Samira Sakhia, President, COO & Director]

So we're not providing kind of the -- we're not providing revenue by product. Part of that is both for confidentiality as well as competitive reasons. When we start to have market data, we'll start to disclose that more. The issue -- the other side is, as you know, when you're launching products, there is -- they're not profitable because there is a lot of commercial spend, you have a lot of people working, and they're not really -- they're just doing an uptake in revenue. We do expect all of the brands that we kind of outlined in the next 3 to 5 years to be big contributors, not just to the top line but also to the bottom line.

[Endri Leno, Associate]

Okay. Understood. One last one for me. Are there any significant renegotiation agreements coming up, let's say, in the next 12 months?

[Samira Sakhia, President, COO & Director]

Amal, do you want to take that one?

[Amal Khouri, Chief Business Officer]

Sure. I think what you should assume, Endri, is that there's always -- it's normal course to always have renegotiations and renewals coming up just because of the nature of the business. The other kind of -- on the business kind of side specifically. They've been -- they've had partnerships for a long time. And so it's normal course to be renegotiating and renewing.

[Endri Leno, Associate]

Okay. But we shouldn't be expecting any major impacts over the next year?

[Amal Khouri, Chief Business Officer]

We're not. We're not expecting any...

[Endri Leno, Associate]

Outside of the normal...

[Amal Khouri, Chief Business Officer]

Correct.

[Operator]

And the next question is coming from Justin Keywood from Stifel GMP.

[Justin Keywood, Director of Equity Research]

Congratulations on the appointment. For Exelon, I know the sales were USD 47 million last year. But just wondering if there was any pandemic impacts in that figures, and how sales have trended over the past couple of years?

[Samira Sakhia, President, COO & Director]

Amal, do you want to take that?

[Amal Khouri, Chief Business Officer]

Sure. So the -- in the last couple of years, I would say, if you look at LatAm specifically, I think sales have been relatively flat. In Canada, we have seen decline because of genericization of the patch, and just how generic dynamics work in Canada. On COVID specifically, it's really hard to tell. However, this is a chronic care product. So it's not a hospital -- it's not in hospital, and it's not acute, right? So if there was an impact, it would be really hard to parse out that impact. Because despite COVID, patients sort of continued their therapy. So that's really what I can tell you, and we're not seeing again any -- we're not seeing anything in the sales that would tell us that there was a COVID impact.

[Justin Keywood, Director of Equity Research]

Okay. And what's the split roughly of the sales between LatAm and Canada?

[Amal Khouri, Chief Business Officer]

What we had said is that 2/3 of the sales were Brazil and Colombia. So it's -- most of the sales are coming from LatAm. Canada is a small contributor.

[Samira Sakhia, President, COO & Director]

Sorry, just to add there, I think when we -- we also said that according to our IMS, like the Canadian sales are about USD 2 million.

[Justin Keywood, Director of Equity Research]

Okay. That's helpful. And what is the anticipated close date, again?

[Amal Khouri, Chief Business Officer]

So on the close date, the antitrust process in Brazil is going faster than expected. We're passed through the first level of review. So right now, we're expecting final clearance and hopefully closing in the next 2 to 3 weeks.

[Justin Keywood, Director of Equity Research]

And that would be much sooner than -- I think it was first described as it could close over a number of months, if I was correct?

[Amal Khouri, Chief Business Officer]

I think, yes. The initial estimation was 45 to 90 days. So this will actually be just under 45 days. It's going very well.

[Justin Keywood, Director of Equity Research]

Okay. And then just a final question on the global ERP system implementation. I know this was highlighted last quarter. Just wondering how that's going, and if there's a time line to complete that integration.

[Samira Sakhia, President, COO & Director]

Arvind, do you want to take that one?

[Arvind Utchanah, Chief Financial Officer]

Yes. I mean the update is that the integration is progressing well as planned. And in -- as we've disclosed it in the MD&A, we expect substantially most of the work to be completed in the next 12 months.

[Justin Keywood, Director of Equity Research]

And in the next 12 months, is that progressive throughout that? Or is it a system that basically, you need to do all the work at the end of the 12 months, it's ready to go? Or just if you have any additional color on that time line?

[Arvind Utchanah, Chief Financial Officer]

Yes. No, no. It's really a progressive approach, given we have so many different entities and jurisdiction. And the way the ERP would work is also customized to the local rules for certain countries. So it's really a progressive approach and it's a rollout basically on a country-by-country basis for the next 12 months.

[Operator]

And next up, we have a follow-up from David Martin.

[David C. Martin, MD & Head of Equity Research]

Yes. Trelstar is you consider a launch product, but unlike some of your other launch products, that was already selling as you took it on. I'm wondering what kind of growth, if any, are you seeing with Trelstar since you've taken over sales?

[Samira Sakhia, President, COO & Director]

Sure. And I'm going to actually ask Jeff to answer that question.

[Jeff Martens]

Yes. Thanks so much for the question. Yes, we do consider it a relaunch. So when we acquired it, it was actually declining. So there was a lot of work that went into bending that curve. And I think Q1, we're starting to see the benefits of our work. So it was up by about 20% Q1 this year versus same time last year.

[David C. Martin, MD & Head of Equity Research]

Okay. Okay. And I think you said you have full reimbursement for Ibsrela now. Did I hear that correctly?

[Jeff Martens]

I'm happy to take that, Samira, if you...

[Samira Sakhia, President, COO & Director]

Yes. Please go ahead.

[Jeff Martens]

So on Ibsrela, the primary market is going to be private, and we have been able to obtain a large portion of the private coverage in Canada.

[Operator]

[Operator Instructions] The next question is coming from Doug Miehm from RBC.

[Douglas Miehm, Analyst]

Yes. And congratulations from me as well. Maybe you can talk, Samira, about the trends within the South American marketplace as we enter a new season with respect to COVID. And your thoughts on perhaps when you might see in light at the end of the tunnel here. And then the second question just has to do with margins. Gross margins were a little bit better than we thought they'd be. Can you maybe walk us through why that is? And what trends we could see with respect to those margins over the next while?

[Samira Sakhia, President, COO & Director]

Sure. So I'm going to kind of speak to COVID. The situation isn't improving rapidly. That being said, the -- each of the countries is slowly advancing through vaccine distribution. I note, for example, in Argentina, they are in lockdown. Our team is having to deal with another winter of lockdown. There is, as you see -- as you've seen in the news, there is a lot more talk about trying to get vaccines into developing countries and hoping that -- I think that, that will move things forward. And we're really, like our teams are looking at what we can do to also vaccinate all teams. I do think that things will start on the back end of this year to start improving because vaccine rollout will move faster. And we will see an uptake. There is obviously a lot of uncertainty, a lot of -- there's a bit of political unrest as well. But I think that as countries see a turn to the better, we're going to see an impact of that as well. And I'm going to ask Arvind to answer the question on margin.

[Arvind Utchanah, Chief Financial Officer]

So in terms of the margin, really, the improvement that you're referring to is really driven by product mix, where higher-margin products have outperformed expectations. And in terms of forecasting for the rest of the year, I would say it's really hard to predict because of currency. But what I can tell you is like we're still -- for the current business, it's, I would say, expectation should be low to mid-40s as what we guided to last year. And again, as we close Exelon, keep in mind, this will be a net profit transfer before the MAs are transferred on a country-by-country basis. And during that transition period, we will be recording net sales at 100% gross margin.

[Operator]

And there were no other questions in queue at this time. I'll now hand the call back to the Knight management team for any closing remarks.

[Jonathan Ross Goodman, CEO & Director]

It's Jonathan. Thank you for the confidence in the Knight team, and for joining our Q1 2021 conference call. Stay safe and be healthy.

[Operator]

Thank you, ladies and gentlemen. This does conclude today's conference. You may disconnect at this time, and have a wonderful day. Thank you for your participation.