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spk08: Good day, and thank you for standing by. Welcome to the Malin Cry Q4 2022 earnings announcement. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Dan Special, Chief Investor Relations Officer. Please go ahead.
spk05: Thank you, Tanya. And I'd like to welcome everybody to today's call. With me this morning are our CEO, Siggy Olson, and Brian Reasons, our CFO. Siggy will start with an overview of the business performance, and Brian will take you through the financials. Before we begin, let me remind you that you'll hear us make some forward-looking statements, and it's possible that actual results could be materially different from our stated expectations. Please note these forward-looking statements are made as of today, and we assume no obligation to update them, even in the event that new information or factual results for future expectations change materially. We encourage you to refer to the cautionary statements contained in our SEC filings for a more in-depth explanation of the inherent limitations of such forward-looking statements. We will also provide selected non-GAAP-adjusted measures related to our financial performance. A reconciliation of these non-GAAP measures is included in our earnings release, which can be found on our website, mallincroft.com. We use our website as a channel to distribute important and time-critical company information, and you should look at the investor relations page of our website for this information. As noted in our earnings release, our fourth quarter ended on December 30, 2022, and the comparative period we will be discussing this morning is the predecessor quarter ended December 31, 2021. As a result of the application of Fresh Start Accounting, the company's GAAP financial statements for the periods prior to June 16, 2022, the date of our emergence, are not comparable to those periods subsequent to June 16, 2022. Further, the results in the quarter compare a normal 13-week period to a 14-week period in 2021. While the exact quantification of the impact of the extra selling week in 2021 is extremely difficult to determine, we believe it reduced reported quarterly net sales growth rates of the company as a whole by approximately six to nine percentage points. The numbers we were discussing this morning make no adjustment for that comparison, and are presented on a constant currency basis unless otherwise noted. For the quarter, Mallinckrodt reported a GAAP net loss of $250 million and a net loss of $911 million for the 2022 fiscal year. After adjusting for specified items, our non-GAAP adjusted EBITDA was $176 million for the quarter and $675 million for the fiscal year 2022. With that, I'll turn the call over to Siggy. Siggy?
spk03: Thanks, Dan, and good morning, everyone. I'm pleased to be with you today to discuss our successful quarter for Malincross and share some color on what is ahead for our company. I'll start by briefly touching on a few key highlights about our full-year performance. We executed well, and I'm incredibly proud of how we finished the year, exceeding our EBITDA guidance and achieving the high end of net sales guidance for the year. Brian will provide a further color on the financial results as well as guidance for 2023 later in the call, but I wanted to kick things off with these positive results as they tie directly back to our strategic initiatives. As you may recall, we have been focused on executing our three near-term strategic priorities, strengthening the balance sheet stabilizing our portfolio and making the right investment in our pipeline. We are beginning to see evidence of solid execution of these initiatives in the full year results. We achieved net sales at the high end of our guidance range, reflecting our team's efforts to stabilize the portfolio and EBITDA exceeding our guidance range as we continue to focus on disciplined cost controls and making thoughtful investments in our pipeline. We also saw a slight increase in cash on hand during the fourth quarter and believe our liquidity will allow us to continue making important investments in the business. For our portfolio, we made a solid progress in the launch of Turlevas and we continue to see a strong engagement from the clinical community on the role of Turlevers in treating and reversing hepatic renal syndrome, including discussion of Turleprecin in a 2023 review article from the New England Journal of Medicine. Early clinical consensus appears to align with published clinical guidelines, which recommended the use of Turlevers as a first-line therapy for appropriate patients. We also recently welcomed Dr. Peter Richardson as chief scientific officer to oversee efforts to advance our pipeline and round out our executive committee. Peter brings 30 plus years of research and development experience and a proven record of executing clinical programs and advancing product development pipeline to Malacroft. We are fortunate to have him on board. Good progress throughout the year in achieving other key objectives, including putting in place a full management team, adding industry leaders to the board as independent directors, and working to reinvigorate our company's culture. 2023 is a pivotal year for the company, and we stand ready to navigate the opportunities and the challenges we have ahead of us. I am pleased with our efforts to date. and I have a great confidence in Malenkrot's long-term ability to drive value for stakeholders. Now, let's do a deeper dive on the performance across the business segments during the fourth quarter, beginning with specialty brands. First up is Aktargel, which we believe is showing an early sign of stabilization. We were pleased to see the overall market for ACTA grow slightly in 2022. We are also encouraged by the stabilization in patient demand and continue to work with payers to ensure appropriate access for patients that need this therapy. With our continued commitment to the product, ACTA remains a top choice for prescribers and we are continuing to work closely with them to make this therapy available to as many appropriate patients as possible. That said, there is a competition in the market which is expected to continue to have an impact on performance in 2023, where we anticipate the product revenue will decline by roughly 10% from 2022. As mentioned last quarter, Development of our Acta Next Generation delivery device has been completed, but we do not anticipate a launch in 2023. We continue to work towards a resolution of a regulatory matter involving one of our partners not specific to our device. We remain optimistic about the important role the device will play in our portfolio if approved, an easier and more patient-friendly version of Acta's gel for single-unit doses. We'll continue to update you on any developments on the resolution of the third-party matter as the year progresses. I'm excited to share our progress with Turleverse this quarter. In September of last year, Turleverse became the first and only FDA-approved therapy to improve kidney function in adults with HRS with rapid reduction in kidney function, a devastating condition with a high mortality rate. Since approval, we have been working hard to engage with hospitals to gain formulary inclusion of Turlewa's, and we have made good progress in a short amount of time since approval. As we indicated last quarter, while this process takes time, we have gained formulary approval in vast majority of those hospitals that have reviewed the product. What's more, there are over 100 additional reviews scheduled in the coming months. The significant enthusiasm we have hearing from the key opinion leaders community combined with the product's inclusion in treatment guidelines will be key to gaining formulary access. We expect to have more to share in the coming quarters and remain very optimistic about the future of this product. Looking at INOMAX, this product continues to be a market leader backed by our best-in-class INOMAX total care service offering. While we continue to face competition that is expected to persist in 2023, we expect to continue to be the market leader in nitric oxide for these critically ill newborns. Our top focus here is our planned launch of INOMUX Evolve, the next generation delivery system of INOMUX. If approved, we remain on track to launch this year and we are excited to bring this product to market. With enhanced automation and streamlined design, we expect INAMAX Evolve to provide a meaningful advancement in the delivery of our products to help improve clinician experiences. We have seen a strong level of interest for this new option to come to market and are looking forward to adding it to our offering lineup later this year. Moving to Theracos, this is the world's only fully integrated and validated ECP system to enhance the patient's ability to fight disease. It represents a platform technology that we believe has the opportunities for geographic expansion and potential label expansion over time. We have historically seen this product as a consistent mid to high single digit grower and we were pleased to see a sequential growth for Theracost in 2022 as we navigated the impact of stem cell transplantation due to the pandemic. We believe we are entering 2023 on a positive note with a clear pathway to returning this product to its historical growth trajectory. For Stratagap, Stratag has been well below expectation to date. Despite this, We still believe this innovative treatment option for adults with deep heart health sickness burns has an important place for patients and doctors and provides a significant improvement to orthopathy. We are continuing our conversation with burn surgeons and physicians to drive adoptions as well as working on improved pathways for reimbursement. Turning to amethyst, our focus remains squarely on the Japanese market, the Marley Cross expects exclusivity into 2026, and strong utilization trends continue. We'll continue to see annual price reduction in the Japan market and the loss of exclusivity, but we expect this product to generate a good cash flow in the years ahead. As a reminder, at the beginning of the year, the U.S. market became fully generatized with multiple launches. As we stated in the prior quarter, this will result in a roughly $75 million reduction in amethyst royalties for 2023. Now let's turn to our specialty generics sector. Specialty generics continued its strong performance and has proven to be an important part of the Malincroft business. We expect this to continue into 2023. As we discussed in our previous earnings call, we anticipated that our scheduled Acid Amino Fan or APAP production shutdown in fourth quarter would impact the performance of the product family in the quarter. But we have seen improvement in outputs from recent upgrades as it returned to full operation. For the remainder of the portfolio, We have been pleased by the performance of the finished dosage products, which helped to offset the APAP shutdown and the extra selling week in the prior year. Bigger picture, our specialty generics business continued to benefit from a well-deserved reputation for producing high-quality generic medicines and active pharmaceutical ingredients. We are the only manufacturer of APAP in the U.S., and we made important investments in our U.S. manufacturing capabilities. These upgrades will benefit us over the long term as the ability to offer customers a stable supply becomes more important than ever. Our efforts in specialty generics have set us up for what we believe to be a strong 2023. We believe this business will stabilize in 2023 and has the potential to grow due to the consistency of supply and quality. We closed out 2022 with a strong performance in the fourth quarter, and we are confident that we are well positioned as we kick off 2023, which will be an important year for Malincroft. We have some real opportunities ahead. namely continued investment in the launches of Perlibas and Stratagraph to support their future and looking to gain approval and launch the next generation INOMAX Evolve products. At the same time, we are prepared to face challenges this year and so on, including the loss of royalty due to generic competition in the U.S. for Ametisa and ACTAR competitions. While there are some clear challenges to the business, I believe we are taking the right steps to mitigate these operational impacts, and we are seeing an encouraging sign across both business segments. We expect Pericost to return to growth this year, and believe our strong performance in specialty generics will continue. The medical community's enthusiasm around Turley Wells exceeds our initial expectation And we are excited to drive this launch forward as 2023 progresses. With that, I'll turn the call over to Brian.
spk02: Thank you, Siggy. I'll begin by walking through our results for the fourth quarter and fiscal year in more detail before turning to our expectations and guidance for 2023. Belincroft's total net sales in the fourth quarter of 2022 were $489 million, is compared to $597 million in the fourth quarter of 2021, a decrease of 18% on a constant currency basis. Our specialty brand segment reported net sales of $321 million is compared to $397 million, a decrease of 19%, primarily due to the impact of competition, reduced utilization of certain products due to the continued impact of the pandemic, continued scrutiny on overall specialty pharmaceutical spending, and the impact of the extra selling in the prior year. During the quarter, Axargel contributed $141 million in net sales, and our critical care product, Ionimax, generated $80 million in net sales due to the continued impact of competition in the market. We look forward to bringing the next generation device to market, which we believe will further differentiate our product from offering from competition. Theracos had 62 million in net sales. And as Ziggy mentioned, we expect this product to return to normal growth in 2023. Amity's in net sales were 34 million as we experienced continued pressure in the US from an authorized generic introduced last year. As a reminder, we still expect to lose roughly $75 million in US net sales in 2023 due to the loss of the U.S. as the market fully converts to a generic marketplace with multiple entries. Turning to our especially generic segment, we reported quarterly net sales of $169 million as compared to $200 million last year, a 16% decrease primarily due to a decline in the APAC business which was impacted by the scheduled maintenance shutdown of our facility during the fourth quarter and by the extra selling week in the prior year. The company's net loss for the fourth quarter was $250 million as compared to the net loss of $204 million. Diluted loss per share for the fourth quarter was $18.94 with adjusted EPS of $4.07. Mellancroft's adjusted EBITDA was $176 million in the quarter, as compared to $232 million. This reflects a decrease of 24%, primarily due to lower net sales and growth in investments associated with launches of Turlevez and Stratagraph, partially offset by reductions in SG&A and R&D expense as a result of the company's initiatives to improve its overall cost structure and the favorable impact from foreign currency. With respect to operating metrics in the quarter, adjusted gross profit as a percentage of net sales was 64%, driven by mix. Adjusted SG&A as a percentage of net sales was 25.2%, reflecting our investment in launches of Turlevaz and Stratagraph, offset by continued savings from cost containment measures, organizational changes, and favorable FX rates. and R&D as a percentage of net sales was 6.1%. The company ended the quarter with roughly $610 million of liquidity as we maintained cash and cash equivalent of $410 million in an undrawn accounts receivable credit facility up to $200 million. Total principal debt outstanding at the end of the fourth quarter was $3.534 billion with net debt of $3.125 billion. Mellencrott repurchased $48 million principal amount of its second lien notes due in 2025 and 2029 below par, capturing 21 million of discount during the year. Now let me transition to recap Mellencrott's full year 2022 performance. Mellencrott reported full year net sales of $1.914 billion and adjusted EBITDA of $675 million. This reflects the meaningful strides we've already made to strengthen our company. To echo Siggy's comments, we are incredibly proud of how we finished the year. With that in mind, I'd like to give some context on the 2023 guidance shared in our earnings release this morning. As we've mentioned before, we anticipate the next 12 to 18 months to be the trough for the company from an adjusted EBITDA and operating cash flow perspective, as both of these are expected to decline in 2023. We anticipated reductions are due primarily to the loss of Amateza U.S. royalty streams, expected Axar decline of roughly 10% from 2022, and investments in launches of Turlevez and Stratagraph. and the planned launch of InaMax Evolve. Our guidance for 2023 includes total net sales of between $1.7 billion and $1.82 billion, and adjusted EBITDA of between $510 million and $560 million. Overall, I'm pleased with the execution of the business in the quarter as we progress into 2023. We remain acutely focused on our upcoming debt materials and continuing our effort to improve the balance sheet. I'll now hand the call back to Siggy for some closing remarks. Siggy?
spk03: Thank you, Brian. I'm extremely proud of the teams here at Malincroft. They made a tremendous push in 2022 following our emergence to build a stronger company and position Malincroft for the future, all while continuing to deliver high-quality therapies to critically ill patients. I know we have more work ahead of us, but I am grateful for their efforts. We are all eager to continue the work underway and take aggressive action to stabilize the business. I remain confident in all that we can achieve together and the important benefit we can continue to bring to our patients. So with that, we'll now open up the call for Q&A.
spk08: Certainly. As a reminder, to ask a question, please press star 11 on your telephone. Please wait for your name to be announced. To withdraw your question, please press star 11 again. As a reminder, to ask a question, please press star 11 on your phone and wait for your name to be announced. Please stand by while we compile the Q&A roster.
spk01: One moment.
spk07: And our first question will come from Rishi Parekh of JP Morgan.
spk08: Your line is open.
spk04: Morning. Thanks for taking my questions. Sorry, I joined late, so I apologize if you already addressed some of these questions. One, on Theracose, you expect to return to growth this year. Can you walk us through the drivers behind this growth? Is it mostly on-label? But are you also – what are you baking in for the off-label growth? And then can you just give us some context around pricing for this product?
spk03: Yes, Rishi, thanks for the question. Let me start on why we see the growth. So first of all, we saw a sequential growth in 2022. So fourth quarter came out better than the first three quarters. So we saw that. The main reason we see is the off-label use in graft-versus-host disease as a result of stem cell transplantation. As we have mentioned before on our call, the stem cell transplantation went down during COVID. We saw that with every wave of COVID, there was a less stem cell transplantation, and that impacted terracots approximately six to nine months later. And we saw that in the numbers So now we saw that in fourth quarter, we started to rebound on the volume, and that's why we are confident in the growth that we expect to see in 2023. So maybe on the pricing, Brian.
spk02: Yeah, not to get into the specifics of pricing, but overall, yeah, this historically has been a fairly stable brand.
spk04: Okay, and then... You know, the CARES tax money, and again, I apologize if you already mentioned this, I think you're expecting to receive about $140 million. One, is there a timing as to when you expect to actually receive it, and then what do you plan on doing with this cash?
spk02: Yeah, that's – I think you had just asked about our CARES Act refund. Yeah, that has gone through all the audits and everything that's required, and that's Yeah, we expect that to come in at any point.
spk05: Yeah, Rishi, what I'd add to that, too, is this is a current receivable on our balance sheet. It has been for the last two quarters at this point. And so, obviously, hopefully we receive this in relatively short order. Obviously, working with the government through that process, getting the audit completed was a significant step, and we believe it's just a matter of time before it's received.
spk04: In fact, I squeezed two more in. One, can you just remind me or reiterate what your launch costs were for Stratagraph and Turleves?
spk02: Yeah, we haven't given specifics, but, you know, if you look at our financials, you can see that, you know, last year probably close to $50 million.
spk05: Yeah, and I think as we move into 2023, obviously, Rishi, I mean, we're full launch on TurboVash at this point, and we certainly want to make sure that we invest appropriately in that to be able to get that off of the ground and launched appropriately. So fair to assume as our level of investment will increase now that we're in the first four-year launch.
spk04: And then, you know, this year is supposed to be your top year in EBITDA, as you've communicated today in your past call as well. But can you just help us or at least walk us through how we should think about the jump off from this trough number? You know, are you expecting double digit EBITDA gains in the following year? Or is it going to be, is the growth going to be more gradual as your two single products, you know, Turleves and Stratagraph ramp up and as those costs come down, like how should we think about the jump off from your trough EBITDA going forward? Is it, and then, and then, you know, long-term, You know, when you think about EBITDA, do you expect to see, you know, are you maxing it out at a valuation of a seven-handle in EBITDA, eight-handle? What do you think EBITDA is going to go when you start to think about the ramp-up in all these, in your two main drugs, or two new drugs, sorry?
spk03: Yeah, so let me start by talking a little bit where the EBITDA comes from this point, from the kind of this year. I think the reason why we are optimistic is, first of all, we have two new launches. probably a bigger opportunity is Teluvas. We will have more information throughout the year when we hear back from the P&T committees on the formulary situation with Teluvas. So we are excited about it. I think we're getting all the right sign back. But what we have promised investors that hopefully by mid-year or so, we can start to talk about the potential for Teluvas and what the launch curve will be for that product. Because The formulary is so important in the launch curve on how quickly. We have seven years of exclusivity for this product. We are excited. We are working as fast as we can to deliver that to the market. But that will be a key and critical point to it. The second thing to keep in mind is the self-delivery device of ACT-R, which we expect to launch in 2024. That will help us to stabilize the ACT-R franchise. This is a single-dose delivery device preferred by the patients to be able to use the product by themselves and don't need the support to deliver that. We are still expecting that to be delivered to loans in 2024. Obviously, there are regulatory challenges with our partners that they are working on overcoming and we are supporting. But overall, that's the next step. Third thing which we are excited about is the Evolve. We are expecting to launch Evolve later this year. Evolve will be the next generation of INOMAX devices. That, I think, will again help us to stabilize the INOMAX franchise. We have the total care which differentiates with the competitors, but we have been open about that any competition impacts the pricing of the product So bringing Evolve to the market will even further help us to stabilize. And then last but not least, the jury is a little out on Stratagraph. We are excited about it. We see some effect in that product. But this is an amazing opportunity. I think this is a new science and technology to bring to the burn units and to the burn surgeons. The key opinion leaders are excited, but it takes a little bit more time than we expected to get that into the practice in the burn unit. So with all these things in place, plus you've seen over the last few quarters the stabilization of the generics, we are excited that, you know, 2023, the impact of the decline of ACTA and the impact of the decline of Ametisa and obviously the pricing of Inamax gives us this low point. but we really have the opportunity to grow from this point onwards.
spk02: Now, that was a very thorough answer, Siggy. I think, you know, the key is mid-year when we have better visibility of the launch slope on Turlevaz. You know, I think we'll, you know, we'll be able to give you a better kind of jumping off point at the end of the year.
spk01: Thanks, Rishi. Any other questions? One moment for our next question.
spk08: And our next question comes from Brendan Hall of Brain Asset Management, LLC. Your line is open.
spk06: Good morning. I just wanted to confirm on the prior question. That's $50 million launch for each drug or for both? Just to clarify that.
spk05: No, that'd be, that'd be cumulative. Yeah.
spk06: And the second question is on the opioid trust and the prepayment. I believe there is an 18 month extension opportunity to prepay that. I wanted to know how you guys are thinking about that in concurrence with opportunities to buy back debt and how you think about that cost of capital.
spk05: Yeah, sure. So it's a little difficult to hear you, but I think maybe just to summarize, the question was with respect to the opioid trust and the possibility of prepayment and really just broadly thinking about capital allocation, Brian.
spk02: Yeah, I mean, great question. Look, when we negotiated that, we put in an 18-month period that we could prepay that at a significant discount. Clearly, the capital market shifted since then. So We still have that opportunity, but we're looking at the capital structure holistically, monitoring the capital market. So from a capital allocation, if that's the best return on our use of liquidity, yeah, we'll do that. But certainly, delevering and other areas of our cap structure have become very attractive as well, right? But we have 18 months from emergence to capture that discount.
spk06: And how are those payments structured throughout the year? So, for example, the $200 million due in 2023?
spk02: Yeah, I think you asked how the payments are structured without a discount. So we had at emergence, we had a $400 million payment. And then on the next two anniversaries, we had 200 million and 200 million, and then 150, and it scales down from there. That's correct. Any other questions? That's available in our documents, SEC documents.
spk05: Any other questions, Brendan?
spk06: No, yeah. My question was just understand the schedule. If you pay above and beyond that, do you capture the discount for any amounts paid? That was the genesis of it.
spk05: Yes. Technically, that's how that would work. To the extent that we paid more, that would apply against the back end of the payment. That's right. At a discount. That's correct. Got it. Okay. Operator, any other questions?
spk08: And I'm showing no further questions. I would now like to hand the call back to Dan for closing remarks.
spk05: Thanks. Appreciate it. And thank you all for your interest in Malincroft. We anticipate filing our Form 10-K in the coming days. As a reminder, we'll be attending the Cowan Healthcare Conference next week. For those attending, we look forward to seeing you all. If you have any questions or are interested in meeting with us next week at the conference, let us know and we'll be happy to help. The best way to get a hold of us today will be via email, and Derek and I will work to get back with you all as soon as possible. All the best to you and your families, and have a nice day.
spk08: Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.
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