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Earnings call · FY2024 Q4
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Good morning and welcome to the Amnil Pharmaceuticals 4th Quarter 2024 Earnings Conference Call. I would now like to turn the call over to Amnil's Head of Investor Relations, Tony Dimeo. Please go ahead.
Good morning and thank you for joining Amnil Pharmaceuticals 4th Quarter 2024 Earnings Call. Today, we issued a press release reporting Q4 results. The earnings press release and presentation are available at amnil.com. Certain statements made on this call regarding matters that are not historical facts, including but not limited to management's outlook or predictions, are forward-looking statements that are based solely on information that is now available to us. We see this section entitled Cautionary Statements on Forward-Looking Statements for Factors that May Impact Future Performance. We also discussed non-GAAP measures. Information on use of these measures and reconcilations to GAAP are in the earnings release and present date. On the call today are Shirag and Shintu Patel, co-founders and co-CEOs, Tasos Konideris, CFO, our commercial leaders, Andy Boyer for Affordable Medicines, Joe Renda for Specialty, and Jason Daly, Chief Legal Officer. I will now hand the call over to Shirag. Thank you, Tony.
Good morning, everyone. At Amnil, we are much more than another genetics company. We are an American biopharmaceutical company with a track record of excellence in delivering high-quality, complex pharmaceuticals at speed and scale. We are a leader in an essential industry, providing millions of patients with access to affordable and innovative medicines. 2024 was an exceptional year where MNIL delivered stellar financial performance with double-digit revenue and adjusted EBITDA growth and reducing net leverage below four times. All segments grew revenues double digits. This broad-based performance reflects the strength of our diversified business, strong execution, and continued investment in growth areas. Beyond financial results, we took major strategic steps in 2024 to enhance our long-term growth profile and expand our future potential, including launching Crexon, establishing our GLP-1 collaboration, and adding to our biosimilars pipeline. The first important milestone we achieved in 2024 was the successful launch of CREXONT. We are so excited by the strong response from prescribers and inspiring patient testimonials. Early traction has exceeded expectations with market share reaching about one percent in just four months and on track to exit the year at three percent plus. As a point of reference, Rightery has six percent market share currently 10 years since its launch. We are very confident in achieving U.S. peak sales of three to five hundred million for Crexon. Our specialty business grew 14 percent in 2024 and our goal is to grow specialty to over 500 million by 2027. This growth will be driven by Crexont, Unithroyd, Ungentis, and upcoming launch of DHE and other branded products. We aim to add more branded opportunities to our portfolio over time. Second, in 2024, we entered the high growth weight loss and obesity space, a new category for MNEO, through a strategic collaboration with Medsera, a clinical stage biotech company developing next generation therapies. This unique collaboration represents a new integrated business model to drive innovation at scale between two organizations. It is a logical extension of MNEO's strategy that leverages our expertise in complex manufacturing and track record of delivering high quality innovation at scale. Amnil is MetSera's preferred global supplier for the U.S., Europe, and other markets. In addition, we look to commercialize MetSera products in 20 emerging markets, including India. To support this effort, we will leverage our existing peptide capabilities and building two new high-volume peptide manufacturing facilities. With the global weight loss market projected to exceed $150 billion by 2030, this initiative is a powerful new long-term growth driver for MNEO. Over time, we see this as a very large opportunity for MNEO with three avenues for value creation. One, the Met's collaboration, which is our top priority. Two, providing CMO offerings to other large companies. Three, providing skill to deliver on generics weight loss therapies. Third, our affordable medicine segment, historically referred to as generics, includes retail products and our rapidly-growing injectable and biosimilar products. The affordable medicine segment generated revenues of $1.7 billion in 2024 as growth accelerated to 15%, fueled by new launches and a diversified complex portfolio over three components of the segment. This is a massive business that remains the foundation of MNEO. and we expect it will continue to grow tremendously going forward within this segment our injectables business is expanding quickly we have a growing portfolio of over 40 injectable products and launch our first 355 B2 injectables in 2024 these differentiated ready-to-use solutions improve hospital efficiency by eliminating medication preparation steps and errors in addition we see biosimilars as the next major wave of affordable medicines for patients biosimilars improve the affordability of and access to key therapies for amniil we see biosimilars as a long-term growth factor where we are well positioned to lead. Our first three biosimilars generated $126 million revenue in 2024, just their second year on the market. We have built our pipeline with five additional biosimilars expected to be filed this year and commercial launches planned for 2026 and 27. In 2024, we added our largest opportunity, Omalizumab, a biosimilar for Zolaire, targeting 2.8 billion U.S. market. By 2027, we expect to have six commercial biosimilars in the United States market. Looking forward, the global biosimilar is projected to grow from about 33 billion today to 75 billion by 2030. Given the cost, complexity, and development timelines, lines, we see a relatively limited number of market participants. A recent IQVA report highlighted the significant white space opportunity in biosimilars. There are over 100 biologic products with patents expiring over the next 10 years, and only 10 percent currently have biosimilars in development. The report estimates that biosimilars for the other 90% would save American patients about $100 billion per year. We believe success in biosimilars will be driven by product selection, speed to market, R&D, manufacturing, and customer service. Similar to complex genetics where Amnil is a leader, we are well positioned to be a major biosimilar player. our strategic focus has been in licensing an initial portfolio and building a commercial platform to start next our goal is to be vertically integrated and leverage our proven ability to develop manufacture and commercialize complex pharmaceuticals at scale finally our rev care segment is a highly durable business with long-term contracts and recurring revenue streams across three channels, distribution, government, and unit dose. In 2024, healthcare revenue grew 25%, and we expect continued double-digit growth, reaching over $900 million in revenue by 2027. This business adds stability and diversification to MNIL's portfolio. Overall, MNIL is an essential player in an essential industry. Over 90% of prescriptions in the United States are for affordable medicines, yet account for only 10% of commercial value. Amnil fulfills over 162 million scripts for American patients each year. We are the largest U.S. manufacturer of affordable medicines. Currently, amnil is number four in the U.S. retail market base on value, and our goal is to become top five in the u.s injectables and u.s biosimilars market in coming years over our company's history we have built a successful track record of innovation execution and growth amnil is uniquely positioned in the pharmaceutical industry with a broad and differentiated portfolio across affordable medicines, specialty, and distribution to drive sustainable growth. I'll now pass it to Chintu.
Thank you, Chirag, and good morning, everyone. And special thanks to our dedicated employees for making MNIL a purpose-driven company focused on execution and delivering value to our stakeholders. Today, I will provide an update on our strategic priorities across operations operations, innovations, and our portfolio. First, our world-class global operations remain a key competitive advantage. MNIL has a stellar quality track record and a world-class operational infrastructure with an extensive manufacturing footprint in the United States, Ireland, and India. Over our history, the FD has conducted over 105 successful inspections with either no or only minor observations. Further, we continue to invest in digitization, automation, and operational efficiencies to drive innovation and growth across different usage forms. We are committed to enhancing our operational excellence and cost efficiencies across our global infrastructure. Amid chronic drug shortages and supply chain challenges in the U.S., MNEW stands out with is industry-leading quality, resilient supply chain, and high customer fulfillment rates. A key highlight is our collaboration with MetSera in the GLP-1 space, where our partner's portfolio is moving swiftly to the drug development phase. MNIL already has the infrastructure and capabilities for peptide development and injectable manufacturing. As part of this collaboration, we will build two state-of-the-art manufacturing facilities, one for peptide drug substance production and another for advanced sterile field finish manufacturing. These investments will enable large-scale production, positioning Amni as MedSERA's preferred global supplier while leveraging our R&D expertise and quality leadership in this fast-growing category. Next, in innovation, we launched CrackZone, which is a remarkable new treatment for Parkinson's disease, designed for rapid onset and extended efficacy. CrackZone delivers more good on time with fewer doses. Our open-level Phase 4 study is underway to generate additional real-world evidence. We are pleased with early adoption and wonderful testimonials from patients positioning Crackson to become the leading branded Parkinson's therapy. Next in our specialty pipeline is the DHE auto-injector for migraine and cluster headache. This innovative presentation of a well-known molecule is intended to help patients avoid emergency room visits during these painful episodes. We project peak sales of $50 to $100 million and look forward to launch later this year pending FD approval. Next, I will touch on our complex generics portfolio. We expect to launch 20 to 30 new products each year. This year, so far, we have launched key complex products such as Masalamin, Aurolimus, and Momentum Donors Appeal, which has 180-day exclusivity. Last week, we received approval for linalodidamide, which we launched in early 2026. This cadence of approvals and new launches reflects the breadth and depth of our R&D pipeline. Currently, we have 76 products pending approval, of which 61% are non-oral solids, and 56% in development, of which 93% are non-oral solids. We continue to optimize our R&D portfolio, allocating more resources towards biosimilars and specialty over time. In 2024, we launched 12 new injectable products, including our first 355B2 products, PEM-ready, Fosinvas for oncology, and potassium phosphate are ready-to-use IV bags. Our fourth 5.5B2 injectable Boruzo for multiple myeloma is approved and set to launch in Q2 with 10 to 12 additional 5.5B2 injectables in development. We will meaningfully expand our injectable portfolio. Other complex injectable programs, microsphere, liposomers, and drug device combinations are progressing as well. With our R&D capabilities and infrastructure of 21 manufacturing lines in injectables, Amnil is well positioned to be a leader in the injectable space in the coming year. In Biosimilar, we are strategically focused on expanding our portfolio. We are very excited about the Biosimilar market given the upcoming wave of biologics LOEs, clarity on the regulatory pathway, and continued adoption by clinicians. Building on the success of our first three commercial products, we have in-licensed five additional biosimilar pipeline candidates. The BLA filings for two denazumab biosimilars were submitted. Next, the supplemental BLA filing for Pac-Filgrastim OBI and auto-injector is expected in Q2. after that the bla filing for omalizumab a biosimilar for zoler is expected by the end of the year we look to further expand our portfolio and be vertically integrated over time to be a leader in the biosimilar industry in summary we are focused on driving execution across development manufacturing and commercialization throughout our diversified and growing business. With that, I will hand it over to Tassos.
Thank you, Chintu, and good morning, everyone. 2024 was a very strong year of execution across all our business units with excellent financial performance well ahead of our original guidance metrics. In addition, net leverage declined to 3.9 times compared to 4.8 times at the end of 2023. as we grew EBITDA and we paid down debt. Strategically, as Chirag and Chintu highlighted, we're driving the ongoing diversification of the business through new launches and pipeline expansion in biosimilars and GLP-1s, which provides a strong foundation for long-term growth. In 2025, we expect continued top and bottom-line growth with lacking our ability to offset the right-to-reliberal of exclusivity due to the breadth and depth of our commercial portfolio and strong pipeline. I'll review our strong performance in Q4, touch on our full year results, and discuss guidance for 2025. In the fourth quarter, revenues of $731 million grew 18% with double-digit growth across all three segments. Our affordable medicine segment grew 21%, to $439 million. New product launches added $54 million to Q4 revenue driven by recent complex launches. Biosimilars generated $39 million in Q4 revenues and grew 49% versus the prior year. As G2 mentioned, MNEO's continued success in R&D, superb quality track record, and supply consistency share competitive advantages driving sustainable growth, portfolio diversification, and value to customers, providers, and patients. Q4 specialty revenues grew 16% to $121 million, driven by our branded products. Our Parkinson's franchise, which includes Craigsaw, Right Arena and Gentes generated $64 million in Q4 revenues, including 3 million from CrackZone. As we shared, we're very pleased with the initial launch success of CrackZone and its early trajectory well ahead of RITARI's launch. In Q4, our AdCare segment grew 14 percent to 170 million, reflecting continued growth across the distribution and government channels. New product launches and continued strong execution are key drivers of AdCare's strong performance. Moving down the P&L, Q4 adjusted EBITDA of $155 million reflects robust revenue growth, consistent gross margins, and some targeted R&D sales and marketing investments in high-growth areas. Q4 adjusted EPS of $0.12 declined $0.02 as higher adjusted EBITDA was offset by interest expense. In summary, Q4 reflected strong year-over-year revenue growth of 18 percent and adjusted EBITDA growth of 9 percent. Moving on to the full year of 2024, total revenues were $2.8 billion, up $400 million or 17 percent year-over-year, and it was ahead of our original and revised guidance of about $2.6 billion. Each segment grew double digits with affordable medicines of 15%, specialty up 14% and healthcare up 25%. 24 adjusted gross margins were strong at 42.4% with affordable medicines gross margins expanding by 110 basis points, reflecting in product launches and operating efficiencies. Full year 2024 adjusted EBITDA of 627 million was ahead of original guidance of 580 to 620 million and grew 12%, which includes a substantial increase in R&D and sales and marketing to enhance our already strong pipeline and support new launches. From a cash flow perspective, 2024 operating cash flow was 348 million, excluding one-time legal costs well ahead of original guidance of 260 to 300 million the strong performance was driven by higher adjusted ebda and good work by our tips to drive substantial working capital improvements and some timing benefits we're also glad to report that as part of our efforts to reduce leverage we paid down 182 million of gross debt in 2024 and reduced net leverage to 3.9 times times, as compared to 4.8 times at the end of 2023, and going further back, 7.4 times net leverage at the end of 2019, to achieve net leverage below four times one year ahead of our publicly stated target. In summary, very strong full-year 2024 results with revenue growth of 18 percent, adjusted a dividend of 12% and substantial debt reduction while continuing to invest for long-term growth. Let me now move on and discuss our full-year guidance for 2025. On the top line, we expect 2025 total company net revenue of 3.0 to 3.1 billion, reflecting strong growth of 7 to 11%. First, in the affordable medicine segment, Second, we expect continued double-digit growth in 2025 due to the uptake of products launched throughout 2024, some new launches expected in 2025, continued by a similar growth and injectables expansion with a number of new 505 B2 products. Second, in the specialty segment, we expect 2025 revenue of approximately $400 million, which includes expected correction sales of approximately 50 million and expected dietary sales between 120 to 140 million, given the loss of exclusivity in the third quarter of 2025. Third, in the AppCare segment, we expect continued double-digit growth in 2025, driven by ongoing new launches from MNIL and other suppliers across its channels. Moving down the P&L, we expect 2025 adjusted gross margins between 41% and 42%, similar to 2024. We expect adjusted EBITDA between 650 and 675 million. Reflecting growth between 4% to 8% due to top-line growth, baritory loss of exclusivity, as well as incremental sales and marketing investments to maximize the substantial commercial opportunity ahead of us. That is, cracks on biosimilars, 505B2s, and injectables. From an EPS perspective, we expect 2025 adjusted EPS between 65 and 70 cents, which reflects adjusted EBITDA growth, and lower interest expense as debt levels have been reduced and interest rates are beginning to come down. Moving to cash flow, we expect another strong year of cash generation 2025, which allows us to continue reducing gross debt and net leverage. For 2025, we expect operating cash flow excluding potential legal settlement costs between 280 and 310 million. Depending on timing of settlements, we may incur approximately 25 million of costs, which are substantially lower than prior years. From a capital allocation perspective, we continue to prioritize investments to further diversify our business and drive sustainable growth, particularly high growth areas such as specialty, biosimilars, and GLP ones. In 2025, we expect capital expenditures of approximately $100 million net of reimbursement related to the facilities we're building as part of our Majera collaboration. In addition, we continue to be laser-focused and continue to reduce our debt levels. Looking to the balance sheet, our strong financial performance and disciplined capital allocation is driven higher cash generation and continued delivering. Recognizing our delivering progress and improved financial profile, we're pleased to receive one-nots credit upgrades from S&P and Moody's a few months ago. Now that net leverage is below four times, our focus is on driving net leverage to be low three times in the next few years. Let me now turn the call back to Chirag.
Thank you, Tassos. In summary, 2024 was a remarkable year for Mneal. We delivered broad-based double-digit growth and took key strategic actions to further position our company for sustainable long-term growth. MNIL enters a new chapter of growth in 2025 with tremendous momentum across our business and we are so excited for what's ahead. Let's now open the call for Q&A.
Thank you. To ask a question please press star followed by one on your telephone keypad now. If you change your mind, please press star, all by two. When preparing to ask your question, please ensure your device is unmuted locally. The first question is from Chris Schott from JPMorgan. Your line is now open.
Thanks so much for the questions. Maybe just to start off with, I just had a couple on CrookScience. Just kicking off a little bit, can you just elaborate on these first few months of the It seems like the ramp's going really nicely, but in terms of either where the patients are coming from.
Thank you. Thank you, Chris. We're so excited beyond our expectations. The testimonials, patient testimonials are amazing. This is where you feel so good that the patient that wasn't able to walk now walks. They're taking fewer capsules a day, lasting longer. So it's arguably right now, it's only four months, it's performing as the best CDLD formulation and absorption ever seen in this category. And this is the straight from the most well-known KOL saying it's the best absorption he has seen. And he called it a miracle drug. And we keep hearing that from all across the MDS, even started from General Niro. We're going up to the long-term care. So we're covering all corners of the market now, all 100%. We're right there. We covered only 20%, which is the fluctuators market with MDS. So this is we have broadened our market reach. The teams are doing great. We're so excited, there's already 1,000 plus prescriptions per week, just in four months. And it would have taken two years to get there. So amazing feedback. Formularity access is awesome as well. And to discuss that further, I'll pass it on to Joe Renda, our head of specialty business.
Thanks, Shraak. Thanks, Chris, for the question. And yeah, to Shraak's point, we're very pleased. with the performance we've seen thus far. The team has really executed well the plan. The response from the market has been remarkable. We continue to hear from physicians literally every day the patient responses that they're getting. You asked about formulary access, and so far, we've been very pleased with the response from the payers. Right now, we're somewhere in the neighborhood of about 30% coverage rate. We anticipate that to go up this year in the neighborhood of 50%. Our goal has always been to catch or surpass Rytari coverage, which is around 70%. We anticipate bringing on at least one, two, maybe even three major commercial payers this year. So the coverage conversations have been very good. The payers are also seeing the demand generation that's happening in the market. So that's further exciting them about bringing Crexon on formulary. And we're also getting great response from the advocacy organizations. So we're partnering very closely with the advocacy organizations across the country. They're also helping spread the word of how favorable Crexon has been. So just to give you a point of illustration, when you look at the way Crexon has performed in Launch versus Rytari, we're three to five times where Rytari was at this point in Launch.
So very good uptake in the market, very pleased. and we look for more to come yeah interest last thing I would add is this is we're making tracks on the global product so creating global access so we have a partner in Canada South America Mexico we have partner in Europe we're and we will market in India and we're looking for a partner in China and Japan so this is would be a truly a global product as you know I tell you was never available outside of the United States. Millions of Parkinson's patients across the globe. And this will be the best therapy that they will get for their day-to-day living with Parkinson's.
Maybe just one last question. Either organic, invest any differently.
Thanks, Chris. So we're so fortunate to have a solid organic pipeline. In affordable medicines, so within affordable medicines and retail GX, we have a leading portfolio in inhalations, ophthalmics, microsphere, we're just drug device combination products. So one of the best portfolio we have. Then comes to the injectable, which we have 12 or so more, 5-5B2 injectables to come. ready to use peptide microspheres so very excited biosimilars we have in license the product as we've been very uh upfront about it that this is a and very long-term focus that this is a over 10 years business it is and we've been investing for a long time we need to become vertically integrated so have manufacturing with us r d with us full pipeline global market uh and we are just like in complex gx we were here to stay our mission is to become america's number one affordable medicines company so biosimilar expansion is must so we will allocate capital towards biosimilar and then always looking for specialty portfolio addition Beyond DHE, we're looking at either a couple of programs internally, which we are not ready to discuss yet, and working with a few outside potential that we can either bring it in license or buy those products.
The next question is from David Adlam from Piper Sandler. Your line is now open.
Thanks. So, I've got a couple. So you cited GLP-1's peptides in 2028. Are those launches in XUS slash emerging markets? Is it Tricity in the United States? Is it a combination of those things? I'm just trying to get a sense of, you know, what you're thinking regarding that 2028 number that's on slide six. And then secondly, you know, with the Metzera collaboration, you're constructing the new facilities. But you've also talked about Beyond Peptides vertically integrating your body similar business. And so I guess my question here is, how should we think about growth in CapEx over the next several years and how that plays into your overall debt pay down strategy? Because it sounds like there's significant expansion of your infrastructure that's going to be happening. So just wanted to get your thoughts there. I'll leave it there.
Thank you, David. So first question, on GLP-1 by 2028, all of the above, what you mentioned, is the ex-US could have a product like Prolicity, could have other contract manufacturing business. So that is how we see the GLP-1 through our partnership with MetSera. The growth in CapEx, as we had laid out that Mexico is contributing $100 million. We expect the government incentives to be around $100 million. We're investing $100 million, $150 million of our CapEx over three years. So it's manageable CapEx, as you would have noticed. We increase our CapEx projection for this year about $100 million. we're not on a biosimilars we're not going to start building from scratch we're going to do certain mna to bring the capacity already there and pipeline that is already there and it will require incremental capex for those but we do not know exactly how much but you can see in the ballpark will continue to be uh 700 million uh ongoing on capex But our EBITDAs keep growing up, our cash flow is improving, our interest expense is coming down, so no problem. It's all that invest here and keep making. We have the awesome infrastructure already for many things, and this will be additional, a great infrastructure to have.
If I may just ask a quick follow-up. Regarding M&A, do you think that in terms of capacity, you know, help us understand, you know, how large you can go or what you're thinking about aspirationally in terms of sizing?
Well, David, we are focused, as Tasha said, that we're not going to be, we'll be four times leverage under four times. And over time, we want to go to three times. So we would have to find a creative deal, may include the cash on hand or limited cash, equity. So there's multiple ways to do it.
Hey, David, this is us. Let's kind of be clear, right? Continued leverage continues to be an organic revenue growth continues to be our top two priorities, number one. Number two, we're not a big M&A shop. I went on a big emanation of the last deal we did, which was, whatever, $300-some million deal, that was the Avcare deal five years ago, and I think universally that has paid for itself, you know, five times over. And it's the strength of our organic pipeline that puts us in a position, I think, to kind of do the right deal that makes sense financially, number one. Number two, it has to be strategic in nature, such as, you know, biosimilars. And number three, we have a high degree of confidence of executing well, and I think the way the teams have executed in terms of growing our biosimilars, essentially from nothing three years ago to something that probably in 2025, this year is probably going to be 150-some million dollar business. I think that's remarkable. So that's how we think about it, and so hopefully that's helpful. It is. Thanks.
The next question is from Les Luski from Truist Securities. Your line is now open.
Good morning. Thank you for taking my questions. Can you provide any latest commentary around Nalaxone? Any additional contracts that you sign with other states? And then, second, I haven't really heard much commentary on Unithroid.
Maybe provide some puts and takes around uh long-term opportunity there um and then lastly i i you know you did comment on the delivering um and you delivered uh faster than you anticipated is there a new target uh for 2025 thank you so um let's good morning uh naloxone the states are slow in moving so we haven't after california we're close to with a few states but haven't signed anything new beyond California, which was the largest state by far. You have to add another 20 states to get to California. And we're working through the distributors as well who already have the state contracts. So Naloxone is moving. It's a three-player market today. Tava is not much in it. So we're emergent as well positioned in all these states in longer-term contracts. And it is a frustrating process at state level. but we have a team that is key working on it and we expect to grow this business but as it is what we have forecasted we should be able to provide about two and a half million kits this year to the market and going up to four million kits in the next in 2026 so that's what we're working towards. Unitroid is like Synthroid their patient which favors consistent therapy and that is what we provide. It has a consistent growth profile over time. We see it going the same way.
Hey Les, good morning. From the leveraging perspective, you can expect us to continue to pay down debt and reduce net debt to EBITDA in 2025. Just depending on a number of scenarios around interest rates, refinancing, etc. We're targeting about give or take between $80 to $100 million overall reduction in gross debt, number one. This year, 2024, we finished net debt to EBITDA 3.9. My God, Phyllis, we're targeting 3.6 to 3.7 net debt to EBITDA, so another 0.3 or, you know, 0.2, 0.3 reductions in net debt to EBITDA. So we're going to continue going down the in a reasonable manner reduction of leverage gross and net debt to EBITDA.
Great. Thank you for that color.
The next question is from from Barclays. Your line is now open.
Hi. Good morning, everyone. So it's great to see the consistent progress in the healthy outlook. I'll try to get a couple of questions on topics not asked, but Tassel, starting with you, firstly on the guidance and EBITDA margins, 2025 EBITDA range seems to be at around 20.9 to 22.5%. I'm surprised to see that even at the higher end there is limited OPM expansion. So how much of a drag has Ritory LOE been on this? And are there any other factors at play, one? Two, I'm sure everyone will be happy to hear you say that you're not a big M&A shop and the focus will be on continuing to deliver. So is this going to be more of a consistent delivery year over year, or are you comfortable with a bump up in net leverage on the back of any deals? Lastly, Chirag, I was just curious, Combining your recent approval of Leonard White and Viatra's issues with indoor and that they can't supply, they evidently need a supplier, do you see any scope for you to monetize your approval early, either in the form of a supply deal or an accelerated launch out of January 2026? Thank you.
Let me take the first couple of them, Bilas, and good morning. So, number one is, you're correct. If you look at EBITDA as a percentage of revenue, and, you know, in 2024, we were at about 22.5%. You look at the guidance, we're more like, you know, 21%. So, it looks a little bit of a deterioration. I wouldn't read anything into this. This is driven by a couple of things. Number one is just, it's a mix of business. I've continued to grow faster than the rest of the business, and the simple fact is that business is slightly less profitable than the rest of the business. But frankly, we don't care. We're just looking at incremental dollars, right, and incremental costs that can help us fund our business and grow. So that's number one. And then, obviously, the combination of the RITER-E-LOE, right? RITER is a 90% margin product, right? and the need to kind of invest in CREXAN and kind of maximize kind of the slope of growth for that product. So that's what I would say. My gut feel is, you know, it's kind of, you know, we're barely into 2025. I think as we look at 2026, as we're anniversary, most of the right area LOE, the incremental investments, full-year investments of Crackson begin to kind of level off, I will expect to see EBITDA margin to begin increasing. So that's kind of on that. Number two, on the leveraging, I mean, you know, the company is not an autopilot. So, you know, in five years, we reduced leverage from 7.4 to, you know, 3.9, probably in 2025, We'll get 3.6. We'd like to see in a perfect world a gliding path of reduction. If at any given point in time there is a slight increase for a few months or for a year, I don't think our equity holders or our debt holders will be concerned because it will be the right decision that's going to begin kind of leading to, you know, further delivering over the course of time. So, that's how we think about that. Chirag, on the other question, I believe it's IP subject.
Subject to a settlement, Chirag, and thanks for the question, Balaji. This is Jason Daley, the Chief Legal Officer. Given the settlement dynamics, I think we shouldn't be talking too much about lenalidomide, but, you know, obviously we're excited for all the products that are in our portfolio and looking forward to launching them all.
Thank you.
We have no further questions. So I'd like to hand back to Shirag for any closing remarks.
Well, thank you very much.
Have a nice weekend. Thanks. Thank you, everyone.
This concludes today's call. You may now disconnect from the call and enjoy the rest of your day.
SEC filing · Item 2.02
Filed Jan 15, 2025 · complete as-filed document
SEC periodic report
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