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spk04: mostly from a competitive standpoint, mostly from payer reimbursement challenges, et cetera?
spk06: Yeah, so great question. So let me start, and then Brian, I think, will add to it. So overall, obviously, ATA is quite a complex product. It has multiple indications. It's promoted in quite a few therapeutic areas. I think the opportunities, what we have seen is, We have seen a stabilization in naive patients and even growth in our naive patients, which is really a big step forward versus previous years. We have seen that now over the last two quarters, and they're really happy to see that improvement in the business. I mentioned in the prepared remarks it's the returning patients that have been a challenge for us in the first quarter. The returning patients are patients that have been on drugs sometime in the last few years, and getting a prescription again. We feel, and we have looked into this, that the key reason for that is the restructuring of Salesforce that we did early in 22. We've restructured the Salesforce, so we now have a sales rep that visits all therapeutic areas, so they're geographically put down, but they focus the all therapeutic areas within their geography. And we think that upset the returning patients because of relationship with the doctors. We already see that improving significantly in April. So we feel really good about where we are coming out now on the returning. It's much more stable as we see after the first quarter. So that's the key reason. Obviously, there is a competition in the market that came to the market last year. We see that. The market has grown a little bit. The overall market has grown a little bit due to that. But clearly, obviously, when you get a competition on a product like ACT-R, we will feel it. But probably the biggest impact is the affordability. It's the issue because you need a pre-approval for reimbursement for every prescription. These are patients that are getting this, which have gone through multiple therapies before they go on ACT-R. We have shown that in our multiple clinical trials how important this product is. So we are working very, very hard with the payers to find the opportunity for the right patients to get reimbursement for this product. So that's an ongoing challenge. It's a big challenge. It has been the challenge over the last few quarters, but we feel now we understand how we need to work, where the focus is, and also what are the right patients that benefit from Aftab.
spk05: I think just to touch on your one point around seasonality, it is hard to bucket exactly, but if you look back historically, the first quarter has been the lower quarter because of seasonality, and that's really impacted by benefit plan resets. Typically, once you get through the holiday season, it takes a little bit before ordering resumes. I think you could probably look back historically and see the seasonality impact.
spk04: And then you mentioned affordability many times. I get that you're talking to the payers to determine what are the best options, but what are the initiatives that you're implementing to address the affordability aspect?
spk06: So we are looking at everything under the sun is to understand what patients benefit the most. working with the payers to get the patients that really need ACTA at the end of the day to get them reimbursed. That's the main thing for us. Obviously, the patient scope is so that we understand very well where ACTA play a role. After 70 years on the market, there's a deep understanding and through our clinical programs, there's also a deep understanding with doctors But the main thing is with the payers to understand what patients should really get after at the end of the day.
spk04: And that 15% to 20% guide for this year, does that fully adjust for all these initiatives that you're talking about, the full success of these initiatives, or is it just partial success of these initiatives and there's incremental upside?
spk06: No, we are obviously guiding 15% to 20% based on the initiatives we are taking on today, of course.
spk04: Okay. And then just lastly, on the new delivery method, at what point do you just decide that you're not going to move forward with this partner given their challenges and you're just going to move to another partner? And if you were to do that, what is the turnaround time to actually getting that? Because it seems to be an important part of your strategy here. Is this another year to two years out or do you think you could actually accelerate that?
spk06: Now, so, Rishi, you can trust us on that. There's no stone left unturned in bringing this product as quickly as we can to the market. Obviously, I can't talk about the detailed strategy behind that, but you can be assured we are doing everything possible to bring this important treatment to the patients as quickly as we can.
spk04: Great. I'll have Pacquiao. Thank you.
spk08: Great. Thanks, Rishi. Operator, any other questions?
spk02: I'm showing no other questions in the queue.
spk07: Okay, great. We'll go ahead and wrap then. Thanks to you. Thanks, Catherine. We want to thank you all for your interest in Malincron. We look forward to engaging with you all in the coming days ahead. If you have any questions, the best way to get a hold of Derek and I today will be via email, and we'll obviously work to get back with you guys as quickly as possible. Thanks for your interest, and have a nice day.
spk01: This concludes today's conference call.
spk02: Thank you for participating. You may now disconnect. Music. Thank you. Thank you. Thank you. music music Thank you. you
spk01: Good day, and thank you for standing by. Welcome to the Mallinckrodt first quarter 2023 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'll need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 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.
spk07: Thank you, Catherine. I'd like to welcome each of you to the call today. With me this morning are Mallinckrodt CEO, Siggy Olesen, and CFO, Brian Reasons. 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 this morning you'll hear us make some forward-looking statements. and it's possible that actual results should 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 of new information, or if the actual 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. The 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 to the investor relations page of our website for this information. As noted in our earnings release, our first quarter ended on March 31, 2023, and the comparative period we will be discussing this morning is the predecessor quarter ended April 1, 2022. As a result of the application of Fresh Start Accounting, the company's GAAP financial statements for the periods prior to June 16, 2022 may not be comparable to those periods subsequent to June 16, 2022. Further, unless otherwise specified, the net sales percentage changes we will discuss will be on a constant currency basis. With respect to our results, Malincott reported a GAAP net loss of $249 million for the first quarter, but after adjusting for specified items, our non-GAAP-adjusted EBITDA was $124 million for the quarter. With that, I'll turn the call over to Siggi. Siggi?
spk06: Thanks, Dan, and good morning, everyone. We appreciate you joining us to discuss Malincroft's first quarter results. We have a solid start to 2023, and we were pleased with our overall performance in the first quarter, despite some top-line softness on after-deal. Brian will provide details on our financial results later in the call, and I'll kick things off with updates on the business and progress of our strategic initiatives. As we have discussed, we are focused on three priorities to stabilize the business in the near term and position Malincrot for long-term sustainable growth. Strengthening the balance sheet, stabilizing our portfolio, and making the right investment in our pipeline. We again increased our cash on hand, demonstrating that disciplined cost management and strengthening the balance sheet are top of mind in every decision we make. It is great to see further improvement on this front. We have sales growth in the specialty generic segment this quarter, underscoring the quality of our products and services as well as a unique advantage of our domestic supply capabilities. In specialty brands, Turleverse was again a highlight as we continue to gain formulary inclusion in hospitals and saw high levels of interest from the medical community. I'll share more details on that in a moment. Separately, We are working very closely with the FDA on our 510K pre-market notification application for Inomux Evolve, the next generation delivery system of Inomux. And we remain on track for the planned launch late this year. Interest levels for the launch of this new option continue to be encouraging, and we are focused on preparing to successfully bring Inomux Evolve to the markets. Diving into our performance across our business segments during the quarter, beginning with specialty brands. I'll start with ACTA. We were disappointed with its product net sales performance in the quarter, which was driven primarily by continued scrutiny on overall specialty pharmaceutical spending and the entrance of a new competition in 2022. Softness in the quarter also came from a slower than expected returning patient volumes driven primarily by affordability. Notwithstanding, ACTA remains a critical product in Malincroft's portfolio and future, both for its high clinical value to patients and favorable position with prescribers. We expect these pressures will continue to have an impact on ACTA's performance throughout 2023. That said, we will continue to work closely with prescribers and payers to expand appropriate patient access as well as address affordability with payers. We remain confident in ACTA's long-term prospects and will also continue to drive the submission of the ACTA Next Generation Delivery Device pending resolution of third parties' regulatory matters we have previously mentioned. Now, Let's turn to an ongoing launch in our branded portfolio, Terlewas. Since Terlewas became the first and only FDA-approved therapy to improve kidney function in adults with hepatorenal syndrome type 1 last year, we have continued to see a positive momentum and significant enthusiasm from the medical community for this product. While net sales, as expected, were modest in the quarter, I'm glad to report that TurleyWAS is ahead of our launch expectation to date. We continue to gain rapid formulary inclusion at many of our targeted hospitals, which accounts for 50% of US HRS patients, demonstrating the success we have had in our engagement with hospitals and the broader medical community. Building on this momentum, We are continuing to execute additional formulary reviews with hospitals that treat HRS, which are scheduled in the coming months. We are already witnessing product utilization and the ensuing benefit this product has for critically ill patients. We are also in the early days of assessing usage cycles for the product, which will allow us to provide an update mid-year on our long-term expectation for Telus. Moving on to Inomax, we saw sales track slightly higher versus fourth quarter. That said, we expect Inomax to face persistent competitive pressure this year that will impact revenue performance. But in all, this quarter demonstrates that Inomax continues to be the market leader in nitric oxide for critically ill newborns. And, as previously noted, we look forward to bringing INOMAX Evolve, our next-generation delivery system, to the market. Now, looking at Theracos, while performance was essentially flat in the quarter from last year, we still anticipate the product will see sequential net sales growth throughout the year. as it returns to a historical mid-single-digit growth rate. We remain encouraged by the sustained recovery in stem cell transplant procedures since the pandemic and expect the transplant rebound coupled with a geographic expansion to provide a pathway to growth over the course of 2023. Though the launch of Stratagraph has been challenging, we have undertaken a number of steps to strengthening the utilization. We are pleased to report that the FDA has determined that severe or burdensome xenotransplantation-related requirements for stratagrafts are no longer warranted and has accordingly removed them. This is a great step as we work on removing access barriers to adaptation for stratagrafts which we continue to believe is an innovative treatment option that provides a significant improvement to autographing. We appreciate the FDA's cooperation and partnership. And looking ahead, we will continue to work with burn surgeons and physicians to drive uptake and seek improved pathways for reimbursement over a long term. On Ametisa, as expected, we saw the impact of the U.S. market becoming fully generalized with multiple market entrants. Internationally, the product continues to perform well in the Japanese market. Now, let's turn to our specialty generics segment. Specialty generics was a strong performer in first quarter, achieved double-digit growth versus the prior year, and continued to to be an integral part of the Marlin Cross business and an important diversification driver. This strong outperformance is underpinned by a long track record and reputation for producing high-quality US-manufactured medicines. Against the backdrop of disruptions in the drug market supply chain and shortage in certain therapeutic areas, notably for ADHD products, These differentiators put us in a unique position to step in and be a strong partner to our customers and ensure that patients continue to receive a high-quality product during this market disruption. We now expect specialty generics net sale to grow in 2023, which will also improve the segment's contribution to the company's bottom line. On previous calls, we noted that 2023 would be a pivotal year for the company. Ongoing launches of Turlewas and Stratagraph remains key priorities. We are also excited about the potential approval and launch of the next generation Inomax Evolve product later this year, and we remain focused on bringing stability to Akhtar over time and returning Theracross to growth. Overall, It was a solid start to the year, and we are pleased to be able to reaffirm our full-year net sales and adjusted EBITDA guidance despite the softer than expected ACTA performance. For ACTA, we now expect the sales to decline between 15% to 20% in 2023. Having a well-diversified business allows us to manage through these challenges and remain on track to deliver on our expectations and our strategic goals. Our ability to navigate headwinds is truly a reflection of the relentless effort and dedication of our teams to face challenges head on. While we still have work to do, our progress to date reinforces my confidence in Marlencroft's ability to drive a long-term value while continuing to deliver for our patients. With that, I'll hand the call over to Brian.
spk05: Thank you, Siggy. I'll now go into more details on our results for the first quarter. Mellancroft's total net sales in the first quarter of 2023 were $425 million, as compared to $491 million in the first quarter of 2022, a decrease of 13% on a constant currency basis. Our specialty brand segment reported net sales of $252 million, as compared to $339 million, a decrease of 26%, primarily due to the impact of competition and continued scrutiny on overall specialty pharmaceutical spending. During the quarter, Actar contributed $82 million in net sales. In our critical care products, Ionimex generated $83 million in net sales, Theracose had 59 million in net sales, and Turlevaz reported 2 million of net sales in the quarter. Lastly, amethyst and net sales were $25 million. In our specially generic segment, we reported quarterly net sales of $173 million as compared to $152 million last year, a 14% increase, primarily due to growth in finished dosage products on both opioids and ADHD as the broader market experienced disruptions in product quality and supply. The company's net loss in the first quarter was $249 million. Diluted loss per share for the first quarter was $18.93 with adjusted diluted EPS of $1.68. Mallinckrodt's adjusted EBITDA was $124 million in the quarter, as compared to $177 million last year. This decrease is primarily due to lower net sales and investments associated with the launches of Turlebaz and Stratagraph, partially offset by reductions in selling general administration expenses and research and development expenses, as a result of our initiatives to improve our overall cost structure. Moving forward, we expect our SG&A expense to grow as we continue to support new product launches and reintroduce long-term incentive compensation plans. With respect to operating metrics in the quarter, adjusted gross profit as a percentage of net sales was 59.9%, driven by product mix. Adjusted SG&A as a percentage of net sales was 27.5%, reflecting the company's balanced approach on investing in our launches and cost containment measures. And R&D as a percentage of net sales was 6.7%. We ended the quarter with roughly $680 million of liquidity. We reported cash and cash equivalents of $480 million, which included the receipt of the CARES Act refunds and maintained an undrawn accounts receivable credit facility of up to $200 million. Total principal debt outstanding at the end of the first quarter was $3.523 billion, with net debt of $3.043 billion. We entered into an interest rate cap agreement during the quarter, which serves to reduce volatility on a portion of our floating interest rate exposure. In all, we're pleased with the start of the year for the business overall and our ability to reaffirm our 2023 net sales and adjusted EBITDA guidance. We remain highly focused on improving our balance sheet in the months ahead. I'll now hand the call back to Siggy for some closing remarks.
spk06: Siggy? Thanks, Brian. Malacross began the year well, and I'm confident that we will continue to make good progress throughout 2023. I can personally attest to the strides we have made across the company to put the business into a stronger position for the future. While we need to stay intensely focused on our goals and priorities, it gives me a great pride to see what our teams have already achieved. I look forward to all that we will accomplish the remainder of the year for our patients and each other. And with that, we now open for Q&A.
spk01: Thank you. As a reminder, to ask a question, press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, press star 1-1. Please stand by while we compile the Q&A roster. Our first question comes from Rishi Parke from JP Morgan. Your line is open.
spk04: Thanks for taking my questions. If we could just focus on ACT-R. One, I wanted to clarify the 15% and 20% decline that you're alluding to, is that for the full year or is that for the second quarter?
spk06: That's for the full year.
spk04: Okay. So I assume there's some seasonality to Q1, hence the reason why the decline is not going to be as much for the full year. But you also highlighted that There were challenges due to competition, pay and reimbursement challenges, and obviously the pricing being an issue. I believe a lot of this goes hand in hand, but do you think the competition is benefiting from the higher pricing and pay and reimbursement challenges, or are these all separate issues? And if it's all separate issues, is there a way to just bucket where the pressure is coming from? Is it mostly from a competitive standpoint? mostly from payer reimbursement challenges, et cetera.
spk06: Yeah, so great question. So let me start, and then Brian, I think, will add to it. So overall, obviously, AFTR is quite a complex product. It has multiple indication. It's promoted in quite a few therapeutic areas. I think the opportunities, what we have seen is we have seen a stabilization in naive patients and even growth in our naive patients, which is really a big step forward versus previous years. We have seen that now over the last two quarters and are really happy to see that improvement in the business. I mentioned in the prepared remarks it's the returning patients that have been a challenge for us in the first quarter. The returning patients are patients that have been on drugs sometime in the last few years and are getting a prescription again. We feel, and we have looked into this, that the key reason for that is the restructuring of sales force that we did early in 22. We've restructured the sales force, so we now have a sales rep that visit all therapeutic areas, so they're geographically put down, but they focus the all therapeutic areas within their geography. And we think that upset the returning patients because of relationship with the doctors. We already see that improving significantly in April. So we feel really good about where we are coming out now on the returning. It's much more stable as we see after the first quarter. So that's the key reason. Obviously, there is a competition in the market that came to the market last year. We see that. The market has grown a little bit. The overall market has grown a little bit due to that. But clearly, obviously, when you get a competition on a product like ACT-R, we will feel it. But probably the biggest impact is the affordability. It's the issue because you need a pre-approval for reimbursement for every prescription. These are patients that are getting this which have gone through multiple therapies before they go on ACT-R. We have shown that in our multiple clinical trials how important this product is. So we are working very, very hard with the payers to find the opportunity for the right patients to get reimbursement for this product. So that's an ongoing challenge. It's a big challenge. It has been the challenge over the last few quarters, but we feel now we understand how we need to work, where the focus is, and also what are the right patients that benefit from AFCA.
spk05: And I think just to touch on your one point around seasonality, it is hard to bucket exactly, but if you look back historically, You know, the first quarter has been the lower quarter because of seasonality, and that's really impacted by, you know, benefit plan resets. And typically, you know, once you get through the holiday season, you know, it takes a little bit before kind of ordering resumes. So I think you could probably look back historically and see the seasonality impact.
spk04: And then you mentioned affordability many times. I get that you're talking to the payers to determine what are the best options, but what are the initiatives that you're implementing to address the affordability aspect?
spk06: So we are looking at everything under the sun. It's to understand what patients benefit the most. working with the payers to get the patients that really need ACTA at the end of the day to get them reimbursed. That's the main thing for us. Obviously, the patient scope is so that we understand very well where ACTA play a role. After 70 years on the market, there's a deep understanding and through our clinical programs, there's also a deep understanding with doctors But the main thing is with the payers to understand what patients should really get after at the end of the day.
spk04: And that 15% to 20% guide for this year, does that fully adjust for all these initiatives that you're talking about, the full success of these initiatives, or is it just partial success of these initiatives and there's incremental upside?
spk06: No, we are obviously guiding 15% to 20% based on the initiatives we are taking on today, of course.
spk04: Okay, and then just lastly, on the new delivery method, at what point do you just decide that you're not going to move forward with this partner given their challenges and you're just going to move to another partner? And if you were to do that, what is the turnaround time to actually getting that? Because it seems to be an important part of your strategy here. Is this another year to two years out, or do you think you could actually accelerate that?
spk06: Now, so, Rishi, you can trust us on that. There's no stone left unturned in bringing this product as quickly as we can to the market. Obviously, I can't talk about the detailed strategy behind that, but you can be assured we are doing everything possible to bring this important treatment to the patients as quickly as we can.
spk04: Great. I'll have Pacquiao. Thank you.
spk08: Great. Thanks, Rishi. Operator, any other questions?
spk02: I'm showing no other questions in the queue.
spk07: Okay, great. We'll go ahead and wrap then. Thank you. Thanks, Catherine. We want to thank you all for your interest in Malincron. We look forward to engaging with you all in the coming days ahead. If you have any questions, the best way to get a hold of Derek and I today will be via email, and we'll obviously work to get back with you guys as quickly as possible. Thanks for your interest, and have a nice day.
spk01: This concludes today's conference call. Thank you for participating. You may now disconnect.
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