Knight Therapeutics Inc

TSX:GUD

Earnings Call Transcript 2023-Q1

[Operator]

Good morning, and welcome to the Knight Therapeutics First Quarter 2023 Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Samira Sakhia, please go ahead.

[Samira Sakhia, President and Chief Executive Officer]

Thank you, Debbie. Good morning, everyone, and welcome to Knight Therapeutics first quarter 2023 conference call. I'm joined on today's call with Amal Khouri, our Chief Business Officer; Arvind Utchanah, our Chief Financial Officer; and Jeff Martens, our Global VP of Commercial. I'm excited to report an impressive first quarter results with revenues of over $82 million and a 29% growth compared to the same period last year and record adjusted EBITDA of over $18 million, representing growth of 37% compared to the same period last year. This strong performance is a testament to the hard work and dedication of our team and the continued success of our portfolio across all of our therapeutic areas.

In addition to the continued progress of our marketed products, we launched palbociclib in Argentina and obtained the regulatory approval in Chile. Palbociclib is an internally developed branded generic product indicated for the treatment of locally advanced or metastatic breast cancer and is being marketed as Bapocil or Palbocil in our region. We also submitted tafasitamab or MONJUVI for regulatory approval in Argentina for the treatment of DLBCL. Turning now to the NCIB. During the quarter, we purchased approximately 2.2 million common shares for an aggregate cash consideration of over $10.8 million. Subsequent to the quarter, Knight purchased an additional 1.1 million common shares for aggregate cash consideration of $5.4 million. With this additional purchase, Knight has completed approximately 73% of the July 22 NCIB at an average purchase price of $5.04 per share.

I will now turn the call over to Jeff to provide more details on our product results.

[Jeff Martens, Global Vice President of Commercial]

Thank you, Samira. In the first quarter of 2023, as Samira mentioned, we have delivered strong revenues of over $82 million, an increase of more than $16 million on a constant currency basis or 25% versus prior year. We grew across all of our therapeutic areas, mainly due to our innovative and promoted portfolio. Let me start with the performance of our oncology hematology portfolio. During the quarter, revenues, excluding hyperinflation, were $29.1 million, a growth of $5.3 million or 22% versus the same period last year. Our key promoted brands included Halaven, Lenvima and Trelstar as well as the addition of Akynzeo contributing $7.6 million of incremental revenues, which was partially offset by a reduction in sales of certain mature and branded generic products due to their life cycle and the entrance of new competitors.

As per our infectious disease portfolio, we delivered revenues of $30.8 million, excluding hyperinflation. This portfolio grew by approximately $7.8 million, excluding the impact of the plant transition and termination of our Gilead agreement effective July 1, 2022. This growth is due to our key promoted brands, the buying patterns of certain customers as well as deliveries we made in relation to previously announced Amazon contract with the Brazilian Ministry of Health.

Now, moving to our other specialty portfolio. During the quarter, revenues, excluding hyperinflation, were $22.7 million. The portfolio grew by approximately $6.2 million, excluding the change in accounting treatment for Exelon. This growth is mainly due to advanced purchases of Exelon in certain countries due to the commercial transition from Novartis to Knight and the purchasing patterns of certain customers.

I will now turn the call over to Arvind to provide an update on 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 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 noncurrent 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 nonrecurring expenses. Knight defined adjusted EBITDA per share as adjusted EBITDA over the number of common shares outstanding at the end of the respective period.

I will first cover the sales we made in relation to the onetime contract on Ambisome with the Ministry of Health in Brazil. In December 2022, we signed a contract for a total value of $18.4 million, of which $7 million was delivered in 2022, $2.4 million in Q1 2023 and $9 million in April 2023. In addition to the full amount of the 2022 contract of $18.4 million, subsequent to the first quarter of 2023, Knight received an order for an additional $9 million from the Ministry of Health, which was also delivered in April 2023. In summary, in Q1, Knight recorded $2.4 million of Ambisome revenues for the MOH Contract. And in Q2, we expect to record $18 million in relation to the MOH contracts. We do not expect further purchases from the MOH for Ambisome.

Now moving to gross margin. For the first quarter of 2023, excluding the impact of hyperinflation, we reported a gross margin of $41.4 million or 50% of revenue compared to $33.8 million or 53% of revenue in the same period last year. The decrease in gross margin as a percentage of revenues is due to the change in product mix, including the change in accounting treatment of Exelon.

Now moving on to our operating expenses, excluding hyperinflation. For the first quarter, our operating expenses were $34.8 million, an increase of $2.9 million compared to the same prior year period. The increase is mainly due to our expanded commercial and medical activities as well as certain variable costs such as logistic expenses, which rose as a function of higher sales. I also want to remind everyone that Q1 2022 – in Q1 2022, we had limited infill activities due to the COVID environment, mostly specifically Omicron.

Moving on to adjusted EBITDA. For the first quarter of 2020, we reported $18.2 million, an increase of $5 million or 37% compared to the same period in prior year. In addition, Knight's adjusted EBITDA per share was $0.17, an increase of $0.05 per share or 45% over the same period in prior year. Now moving on to gains to our – losses on our financial assets, which are not reflected in our adjusted EBITDA. In the first quarter of 2023, we recorded $11.8 million of net unrealized losses on financial assets measured at fair value through profit or loss. This loss is driven by mark-to-market adjustment of underlying assets, mainly as a result of a decrease in the share prices of the public traded equities held by our strategic funds.

Moving on to our cash flows. During the first quarter of 2023, Knight generated cash inflows from operation of $3.7 million, a decrease of $9.2 million compared to the same period in prior year. The decrease in operating cash flow is a result of an increase in working capital. The investment in working capital is due to an increase in inventory primarily for Ambisome in anticipation of the deliveries under the Ministry of Health Contract as well as timing from payments from certain customers which were settled in April.

I will now turn the call back to Samira for concluding remarks.

[Samira Sakhia, President and Chief Executive Officer]

Thank you, Arvind. I will now discuss our financial outlook for fiscal 2023. I would like to remind everyone that this guidance is provided on a non-GAAP basis due to the difficulty in predicting Argentinian inflation rates. We have revised our forecast and now expect to generate revenues of $300 million to $320 million, an increase of $20 million on the lower and upper range. In addition, we expect adjusted EBITDA to be between 14% to 15% of revenues. The increase in financial outlook is primarily due to an improvement in the forecasted LatAm currencies against the Canadian dollar, primarily the Brazilian real and the second MOH order for Ambisome in Brazil.

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 our foreign exchange assumptions, which may materially impact our results and forecast. Looking ahead, we remain committed to building a leading pan-American ex-U.S. specialty pharmaceutical company. We have over $160 million in cash, cash equivalents and marketable securities, and we generate cash from operations, which positions us well to continue to execute on our strategy to in-license and acquire innovative pharmaceuticals as well as develop our branded generics product portfolio. Thank you for your support and confidence in our Knight team. This concludes our formal remarks.

I would now like to open up the call for questions. Debbie?

[Operator]

We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Doug Miehm with RBC Capital Markets. Please go ahead.

[Doug Miehm, RBC Capital Markets]

Good morning everyone. First question has to do with Exelon. And you do describe that there was buy in, I'd say, a little bit associated with the quarter. And I'm just curious, as you think about Q2, would you expect some headwinds in Q2 and then things to normalize as we look out to the second half of the year?

[Samira Sakhia, President and Chief Executive Officer]

So there is a lot going on in Exelon. There's first, the change in accounting. The transition is a little bit of phasing and it will normalize. The third thing that we are obviously, and we've discussed this before, is we do face generic competition in certain of our countries. So we do know that a generic has now launched in Brazil. We're not changing our – like – as we explained in our guidance, we're changing really because of currency and the MOH order and the phasing, and we don't really try – we don't manage to quarters. We're managing to the year, and we expect to continue to retain the brand.

[Doug Miehm, RBC Capital Markets]

Okay. That is fair. Then as you think about the political landscape, I know there's been chatter about this over the last several months. But specifically in Brazil and Colombia, have there been any changes relative to, I guess, a couple of months ago when you last discussed this point.

[Samira Sakhia, President and Chief Executive Officer]

It's similar status in Brazil. There really hasn't been any updates in Colombia, the reform has been published. But how the reform will be implemented is not clear, and there is a significant amount of debate in the – in Congress about this. And as the entire country is watching as are we.

[Doug Miehm, RBC Capital Markets]

Excellent. Okay. Thanks, Samira.

[Operator]

The next question is from David Martin with Bloom Burton. Please go ahead.

[Antonia Borovina, Bloom Burton]

Hi, there. This is Antonia on the line for Dave. Just wanted to elaborate a bit more on the earlier commentary. So are you thinking – given the strong quarter, are you thinking that the generic impact of your branded generics business might be less than expected when you reported fourth quarter results? And also, when do you expect additional compensatory launches of your own branded generic pipeline?

[Samira Sakhia, President and Chief Executive Officer]

Sure. So the only reason we're really revising guidance is because of the MOH order and the change in currency FX rates. It's really not on the portfolio. When we look at local currencies, the portfolio is performing as expected. The – whether it's a little bit of lumpiness, we always expect that. We don't manage to quarters as much, and that's where it is. When it comes to the branded generic portfolio, it's really a bit of life cycle issues that we are dealing with. And if you look at our pipeline, we've expanded our pipeline dramatically, not just in the innovative portfolio with tafasitamab, Akynzeo, Pemi and Fostamatinib. We've also done a lot of work to in-license as well as continue the development of our own branded generics. The issue is really life cycle management, and it's a bit of a lumpy year because we're – the declines are going – the mature brands are declining faster than we are able to launch. And this is, again, why we are spending a lot of BD effort on each of our two portfolios to make sure we strengthen the pipeline going forward.

[Antonia Borovina, Bloom Burton]

Okay. And if I could just add an additional quick question. Are there any strategies you have to help mitigate the hyperinflation impact?

[Samira Sakhia, President and Chief Executive Officer]

So this is the revision of the forecast that we're talking about excludes hyperinflation. So this is really – the majority of the change here that we're seeing is we went from an expectation that there would be a slight decline in the Brazilian real to a slight appreciation in the Brazilian real. So that's not hyperinflation. That's just currency. And that's a macro issue between Canada, U.S., Brazil, I don't know how the global environment working. When it comes to hyperinflation, and this is exactly what – to reiterate, we don't include it in our forecast and how we manage Argentina is to make sure that Argentina is able to kind of ring sense that business. And please remember that what we manufacture in Argentina, we sell in Spanish-speaking South America. So it's exported out and the revenues go to Colombia, Peru, Ecuador, Chile, Uruguay, Paraguay so it's not all in Argentina.

[Antonia Borovina, Bloom Burton]

Okay, thank you.

[Operator]

[Operator Instructions] Next is Endri Leno with National Bank. Please go ahead.

[Andre Bodo, National Bank]

Hi. Good morning. It's Andre Bodo sitting in for Endri. With respect to Palbocil, I was hoping we could get some insight on progress and performance. Is that early signs that you're seeing there?

[Samira Sakhia, President and Chief Executive Officer]

Sure. So Palbocil was launched kind of a little bit later in the quarter. But if you look at on our financial – on the press release, what we do provide is the launches of the branded generics in the queue, the performance you see is about, I think, it's a little less than $0.5 million in change versus last year, and that's Palbocil is part of that contributor. So it's a nice brand, but it's not going to be – and as we've said, the issue that we have is that the launches that we're having are not making up for some of the declines that we expect this year.

[Andre Bodo, National Bank]

Okay. And maybe some color on the time line and the next steps for Bapocil?

[Samira Sakhia, President and Chief Executive Officer]

It's probably closer to – so Bapocil may launch in Chile. It's going to be in the back half of 2023 because there's more work to be done to produce for Chile. And then after that, it will be Colombia, but that will be a couple of years away.

[Andre Bodo, National Bank]

Okay. How would you characterize margins on the Ambisome contract with the MOH in Brazil with respect – relative to the rest of the portfolio?

[Samira Sakhia, President and Chief Executive Officer]

We don't disclose margin by product. And it's going to be in the range, like the margins that we've had historically is the margins that we will continue to have.

[Andre Bodo, National Bank]

Okay. And then lastly, with respect to what you're seeing in competition, are you seeing that elevated? Or is that something that you're expecting in the later in the year with respect to branded generics?

[Samira Sakhia, President and Chief Executive Officer]

We are expecting them a little bit later in the year. It's a little bit hard to predict, it's depending on the country and the region – depending on the country and the product. Some of the agencies are moving faster. Some of the agencies are moving slower, but we did expect – we do expect kind of starting in the back half of Q2. And as I said earlier, we do have the generic – the branded generic has launched versus Exelon in Brazil.

[Andre Bodo, National Bank]

Are there any – just as a follow-up, are there any like particular countries which are moving faster than others?

[Samira Sakhia, President and Chief Executive Officer]

Not really. Like it's – again, we see that there is branded generics in the review pipeline. It's hard to predict when they will come out.

[Andre Bodo, National Bank]

Okay, great. Thank you so much.

[Operator]

This concludes our question-and-answer session. I would like to turn the conference back over to Samira Sakhia for closing remarks.

[Samira Sakhia, President and Chief Executive Officer]

Thank you, Debbie, and thank you for your confidence in the Knight team and for joining our Q1 2023 conference call. Have a great morning.

[Operator]

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.