Good morning and welcome to the Jefferies 2024 Global Healthcare Conference. It is my pleasure to now introduce Siggi Olafsson, CEO, Bryan Reasons, CFO, Jason Goodman, Chief Strategy Officer at Mallinckrodt. Just a reminder that this will be a 20-minute presentation with five minutes of Q&A. Thank you and good morning, everybody. Great to be here in London, although the weather isn't very nice welcoming us this morning. First of all, we are probably the oldest company presenting at this conference, so we are just celebrating 157-year-old birthday this fall. So it's been a long time coming. It's also a company that's gone through ups and downs over the 157 years, and clearly the last few years have been challenging for the company. But what I want to show you today is a little bit where we are, what we have done in the last three years to improve the business and the situation we have in the business today, because I feel the actions we have taken have put us up for a very successful business, and we showed that in the third-quarter results that we had two weeks ago. Our business today operates in specialty brands, where we have a U.S. brand business actively promoting three products in the U.S. And then we have a specialty generics business in the U.S. again, which includes both finished dosage and the large API manufacturing. Briefly on the three brands, Acthar Gel is probably the best-known brand. It was first approved in 1952. Mallinckrodt acquired the brand in 2014. It's approved for 19 different indications in five therapeutic areas, and it's really used for how to treat diseases, only approved in the U.S. market. TERLIVAZ is the new part of the family. TERLIVAZ was approved at the end of 2022. The indication for TERLIVAZ is hepatorenal syndrome, which is one of the end-stage indications in liver failure with patients. We are launching that into the U.S. hospitals as we speak. And the third product is INOmax. INOmax is a nitric oxide gas indicated in the U.S. to use for neonates, neonate units, the blue baby syndromes, and other respiratory diseases. But it's indicated for cardiovascular disease outside of the U.S., for example, in Japan. So it has a pretty wide range of usage. The generics business, as I mentioned, is a finished dosage business and API. We are the largest API producer in the U.S. in terms of volume. We are also the only paracetamol API producer in the U.S., but we also produce a lot of API for controlled substances, both opioids, but also ADHD and abuse-resistant drugs and other things like that in our plants. We have three API plants, all in the U.S., and three finished dosage plants to supply the U.S. market. The third-quarter performance was outstanding. We delivered a revenue of $505 million and an EBITDA of $161 million. But really, the highlight for the quarter was two things. First of all, the performance of the generics business, which showed the seventh consecutive quarter of growth, which is quite amazing in today's environment in the U.S. But also, at the same time, by showing this growth, we have, I believe, the best controlled system to be able to handle controlled substances with regards to suspicious order monitorings and other systems like that. That's a very expensive system, but we really are proud of the system we have in place to manage that more than anything else. And then we have Acthar Gel. Acthar Gel has been a challenging story over the last five, six years. Many people didn't believe that we would be able to stabilize that business. When I joined the company as a CEO two and a half years ago, I said, "We need to stabilize it before we grow." So third quarter was the third quarter in a row where Acthar has been growing. And we are now forecasting Acthar Gel to grow 10% year on year for the first time in many, many years, probably in eight years that we forecast growth for this product. So still, you know, a product approved in 1952, you can show a growth in that product going forward. So I told you at the start that we have seen a lot of challenges in the business. The business has gone through restructuring. But from mid-year 2022, when we exited the first restructuring, we really have had a good story to tell. The first thing to mention is we saw that after the first restructuring, that simply wasn't sufficient for the company to grow. The debt level was too high after the first restructuring. So what we did in 2023, we did the prepack Chapter 11, which we filed in August of 2023, and we came out in November last year. And that really gave the foundation for the company to reduce the debt, increase the cash flow of the business, and give this company the chance to service the patients around the world with the products that we have. So that was a key part of how we have addressed the balance sheet and given the foundation to allow us to grow going forward. But also, since June of 2022, we've had a great success story with the FDA. We got approval for TERLIVAZ at the end of 2022. That had been a long story of back and forth with the FDA. It had taken multiple Complete Response Letters, but in the end, we delivered that late 2022. We then got approval for EVOLVE. EVOLVE is a new and a better, technically better machine to deliver the nitric oxide. We got that approved by the end of 2023. Again, had been a long time in development in Mallinckrodt and great to bring that new product to the market or new machine to the market to be enablers to service the patients, but also the hospitals significantly better. And then earlier this year, we got approval for Acthar SelfJect. And SelfJect is a self-delivery device for patients that use Acthar. I will talk about that a little bit later. But really, it's such an improvement to this old drug in today's environment to help and support the patients, but also help the product to continue to grow. Last but not least, earlier this year, we announced the divestiture of Therakos. We divested Therakos, one of our brand products, to CVC for $925 million with adjustment, the customary adjustment to that number, of course. Therakos, really good product, has been showing growth, was showing growth in third quarter. We expect this transaction to close in the next few weeks. At the end of this transaction, the net debt of Mallinckrodt will be below one, which is a game changer for the company and really changes the environment for how to operate the business and what we can do in the future. The goal of this whole thing was to restructure the balance sheet, reduce the debt, but also stabilize the company and turn it into a growth company. We managed to do that this year. We are showing growth. Our guidance that we gave now at the end of third quarter is a revenue of $1.9 billion-$2 billion and an EBITDA between $590 million and $620 million. That includes we have taken out of that guidance that we expect not to have Therakos in December. Really a big improvement in profitability, in revenue, and also obviously in the cash flow of the company. That's the essence of the business, was to address the balance sheet, restructure the debt, pay down the debt, and turn the company back into a growth story. This is really the phases, what we have been doing. The first phase in 2022 and 2023, the goal was to reduce the debt burden. We restructured it. We looked to stabilize the business because Acthar was declining very fast up until 2022. We needed to find a way to stabilize that. Also, we had the competition on INOmax, so the goal is to stabilize that also. So those were the first last year and the year before. This year, the idea is basically pay down the debt after restructuring, and we will do that with a divestiture of Therakos and turn the company into a growth, which we are doing this year. And really to build the foundation just commercially, but also in the pipeline to build this into a growth company again. Because clearly going through two Chapter 11s is a challenging environment for a company. One is challenging, two is very challenging. I think I can safely say that. So, really, how we have managed the business, how we have taken it in phases, I think to be where we are today after everything that's gone on over the last four years is quite extraordinary to still have a growing business because many companies going through this don't end on their feet like we are doing now. So I mentioned two standout businesses. And the first one to mention is the generics business. Seven quarters in a row of growth, year-over-year growth. And with the challenging environment in the U.S. generics, this is quite extraordinary. We have a strong API business that has three manufacturing plants. Two of them are allocated to paracetamol API or APAP API, as they call it in the U.S. And then we have one general manufacturing plant of API. We have a large manufacturing plant up in Hobart, New York, for the finished dosage. And then we have two smaller plants to supplement the larger plant that we have to give us the flexibility of the business in that. This business was not doing well in the 2020-2021. It was struggling, but I think with increased focus, with being the leader in our compliance program, where our focus is, focus on the monitoring of our business, work hand in hand with the DEA. There are fewer players in the market supplying controlled substances, but you have to have a first-class system to be able to do that. It's the key. It's our entry ticket to be able to operate. This is to be able to have that kind of a system, that kind of a monitoring that is in place in the generics business going forward. The growth in this business has been both introduction of new products. We have introduced quite a few new products, but they all have that in common. They are controlled substances and need this extra management around it. We haven't tried to go into commodity generics. Our manufacturing plants, both API and finished dosage, they're all in the U.S. And I simply cannot compete with a low-cost manufacturing in India. We recognize that we have our R&D focus on what we can compete in. We have our cost structure in place. We are backward integrated into the API. We really have gotten this into an art to find a niche in the market where we can operate and do a good job and do a job that is needed for the patients in the U.S. So really proud of what the team has done here. Enormous turnaround since 2021 on this business for Mallinckrodt, but also Acthar, that's the second product that really has come through and shown that product that I think some of our investors at least thought would be in a negative spiral and we couldn't turn it around. The first goal was to stabilize it. My ultimate goal when I joined in June of 2022, I gave, I think, a speech that we wanted to stabilize Acthar in 18 months. We managed to do that and we have been growing in the first three quarters of 2024. There is a competition in the market, but it's not a generic competition, so it's a brand-to-brand competition. Acthar is a corticotropin hormone analog of a natural substance. It has, as I said before, 19 different indications. We have a large sales force. We have a large reimbursement team behind it. The big thing here is also we introduced a self-delivery device, a dosage that helps the patients to deliver the product, which is called Acthar SelfJect. We got the recognition from the Arthritis Foundation for the device of the ease of use for this because it's a hard thing with arthritis patients to inject themselves. This really was a step in the right direction. As you can see here, we only launched it in August. So far, we've been very pleased. It's still early. We know that there's a lot of things need to happen. Since August, we have had over 800 scripts. The interesting part on this slide is over 70% of the SelfJect scripts are for new patients, are for new patients that didn't get Acthar before. That is a key opportunity for this product, how we have been able to reposition it, to modernize in a way the older brand by introducing SelfJect for it. We are excited for this market. We still think there is a growth. This product is used very sparingly. It is a second line to fourth line. It is in the indication. This is never a first-line treatment, but this is absolutely necessary in the hard-to-treat diseases where it has been indicated for. We are excited about this business, doing well. The team, again, the Acthar team has done an outstanding job to stabilize this and turn it into growth. This is really the story. This is what we were doing. At the same time of stabilizing the business, turning it into growth, the goal was to reduce the debt, change the balance sheet, and look into what it does. At the end of 2022, prior to our second restructuring, we had a debt of 4.7x net debt. And simply, we needed to go into the second restructuring. We did that. And now at the end of when we close Therakos in the coming weeks, the net debt to EBITDA will be below one. This is a which hasn't been the story for Mallinckrodt for years and years and years. I can't find in the notes of the company when we last were below one times net debt to EBITDA. But at the same time, the team has executed on growing the business, maintaining the momentum, allowing Acthar to grow, turning around the generics business, introducing EVOLVE, introducing TERLIVAZ all at the same time. I couldn't be more proud of the team. But we wanted to have five minutes for Q&A, so I wanted to open it up with me, Bryan, the CFO, and Jason, the Head of Corporate Development. Any questions? Yeah, thanks for taking my questions again. Yeah, it's really great to hear you talk about the generics business because historically, I've known you as a generics company kind of through and through. Just wondering if there's anything in the pipeline that you're excited about that you've looked at going into 2025, 2026? No, so what we are doing in our generics business is we are focusing only on controlled products. There might be a little bit of hard-to-get other products, but our core, the core R&D, our products with pain products, ADHD, abuse-resistant product, difficult to formulate those. So that's really the pipeline that we focus on because I think part of what we did before was we were trying to be a supermarket to try to offer everything, and for a U.S.-based company with a U.S.-based infrastructure and a U.S.-based cost, we simply cannot do that, so we narrowed the scope and we increased the revenue. We basically by focusing, so there is nothing I want to call out in the pipeline except you should expect, hopefully, we are aiming for two to three products a year to maintain the momentum of the business. We are not trying to do the 15-20, which some of my old companies are announcing. We are more than happy with two to three to maintain the momentum of the business. Yes. What's your plan and what's the model you have for commercializing your assets outside traditional markets, maybe in emerging markets? So we do a little bit for INOmax in the emerging markets. So we do that usually through our partners' model. We are ourselves. We have our own business in Australia and in Japan and a little bit in Europe and Canada. But outside of these markets, we don't. Acthar is only approved in the U.S., and as it was approved in 1952, I think it would be challenging to get that through a regulatory agency today. It wasn't written on a calfskin or anything like that, but it still would need a significant upgrade to the dossiers to get approval in other markets, for sure. And then TERLIVAZ, we own the rights to U.S., Canada, and Japan. We don't own the rights to the other markets. Any last question before we drop? Very good. Thank you.
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