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spk02: Hello, everyone, and welcome to the Amniel Pharmaceuticals first quarter 2023 earnings conference call. My name is Emily, and I'll be your moderator for today's call. After the presentation, you'll have the opportunity to ask any questions by pressing start, followed by the number one on your telephone keypads. I'll now turn the call over to Amniel's head of investor relations, Tony DiMaio. Please go ahead.
spk04: Good morning, and thank you for joining Amniel's first quarter 2023 earnings call. Today, we issued a press release reporting our full Q1 results. We announced certain unaudited preliminary results for the first quarter on April 17, 2023. The press release and presentation are available at amneal.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. please see the section entitled Cautionary Statements on Forward-Looking Statements in the Earnings Presentation and our SEC filings for a discussion of factors that may impact our future performance. We also discuss non-GAAP measures. Information on our use of these measures and reconciliations to U.S. GAAP are in the earnings presentation. On the call today are Chirag and Shintu Patel, co-founders and co-CEOs, Tasos Conideres, CFO, Our commercial leaders, Andy Boyer for Generics, Joe Renda for Specialty, Harsher Singh for Biosciences, and Jason Daly, Chief Legal Officer. I will now turn the call over to Shirab. Thank you, Tony.
spk08: Good morning, everyone. We delivered a very strong first quarter results with $558 million of revenue, growing 12%, and adjusted EBITDA of $116 million, growing 16%. We saw robust stop-line growth in Q1 across all three business segments, generics, specialty, and healthcare, reduced our net leverage to 4.9 times, and affirmed our full year 2023 guidance. Taking a step back, for those who are newer to the MNIL story, we are a global pharmaceutical company with an expanding portfolio of approximately 270 products. Our strategy focuses on launching new products in high-growth and high-impact areas of medicines, such as complex generics, injectables, biosimilars, and specialty. Since 2019, we have significantly diversified our business, fueled by the productivity of our R&D pipeline and strategic investments to build our global platform. As a result of MNIL's diversification, We have seen continuous strong financial performance since 2019 as we have delivered substantial revenue and EBITDA growth. In 2022, approximately 500 million of our top line performance came from products launched since 2019. We see our momentum accelerating in 2023 and beyond, underscored by our strong Q1 results and 2023 outlook. In short, we are very well positioned for sustainable long-term growth, accelerating profitability, and continued deleveraging. I'll now briefly walk through how are we executing on our key strategic priorities across our businesses. First, in the generic segment, our diverse portfolio of approximately 230 retail generic products is continually expanding. moving up the value chain of complexity and generating durable top line growth since 2019. Our strategy to diversify with more complex products has been deliberate over the years. To give you context, we expect about 55% of 2023 generics revenue will be from complex products, up from 35% in 2019. We feel great about the breadth and depth of our R&D pipeline, which we expect will continue to deliver 20 to 30 new product launches every year and continue to differentiate our business as we move towards complex products. We have been on a remarkable journey these last four years, and the team has been hard at work focusing on the highest value products and complex generics, with many nearing the finish line. Altogether, we expect continued strong execution and growth of our business. In injectables, similar to where we are today in U.S. generics, our goal is to be a top five U.S. injectable business and also a global player. Today, we have about 30 institutional products with over 30 new launches expected by 2025. We are executing very well on our injectables growth strategy by expanding our portfolio, building key capabilities, and adding capacity. Our commercial strategy centers on our ability to be a differentiated supplier of a growing portfolio of injectables for hospitals with a resilient supply chain in a market impacted by shortages. To that end, Today we are pleased to share a major milestone with the successful USFD inspection this week of our fourth and largest injectable site. As we ramp up commercial production later this year, in line with our plan, we expect the next revenue inflection point in 2024. We remain on track for over 300 million injectables revenue by 2025. Next, in biosimilars, We're very pleased with the initial market penetration of our first two biosimilars, Alemsys and RuLuCo. Since their launch in Q4, our commercial team is executing very well by adding new customers outlets for both products and driving substantial pull through as usage rates of our biosimilars have doubled month over month since launch. In particular, we are seeing strong market adoption of our Olympsis product, which is our Bevazizumab biosimilar referencing Avastin. This month, we plan to launch our third biosimilar, Filnetra, and we'll have three U.S. oncology biosimilars in the market. Based on our strong commercial execution and trajectory, we are well on our way of achieving this year's target of $40 to $60 million. more next year and over 200 million in peak cells beyond these three initial biosimilars we are working to expand our portfolio with additional molecules where we can be early to the market and vertically integrated from development to commercialization over time our goal is to be a top five biosimilar player in the united states over time internationally We are leveraging our diverse portfolio of US FDA-approved products to expand into new geographies. In India, we're expanding MNIL's brand presence and leveraging our local teams and infrastructure as we focus on the hospital market. Around the rest of the world, we are working with distribution partners. We expect meaningful incremental revenue and profits over time. Next, in the specialty segment, We continue to grow our branded products in Rytary in Parkinson's and Unitheroid in Hypothyroidism, delivering strong growth again in Q1. In parallel, we are advancing our pipeline of new CNS and endocrinology products. On IPX203, we are one step closer to delivering a new impactful therapy for Parkinson's patients as we head towards the June 30th PDUFA date. As we expand our portfolio, we expect over $500 million in specialty revenue by 2027. In the third segment, AvCare, we see continued momentum across the multiple channels, distribution, federal government, and unit dose. We expect this business will continue to deliver durable, double-digit growth going forward. driven by the ongoing expansion of the distribution channels. Overall, we are proud of the strong momentum across M-MIL. Each quarter, our portfolio is incrementally larger and more diverse as we launch new, increasingly complex products. We are leveraging our key capabilities and global footprint to operate at scale across our business. As we execute, we look to build upon our sustainable growth profile and drive higher adjusted EBITDA levels. I want to touch briefly on our capital allocation strategy, which Tasos will discuss further. To be clear, reducing debt and strengthening our balance sheet has been always our key priority. As a result, Our net leverage has reduced from 7.4 times in 2019 to 4.9 times this quarter. And our goal is to be below four times net leverage by the end of 2025. I'll now hand it over to Chintu.
spk07: Good morning, everyone. Thank you, Chirag. Let me begin by thanking the MNIL family who work hard every day to make healthy possible for so many. We are very excited about our strong start to the year and the great progress we are seeing across our organization. I will touch on how our strong foundation in operational excellence and highly productive R&D engine continues to propel our company strategy forward. Starting in operations, we are focused on operational excellence and efficiency, super quality, and expanding our global capabilities particularly in injectables. Let me provide more color on each. First, we remain focused on operational excellence and driving efficiencies. The team has done an excellent job as we move manufacturing for over 30 products to low-cost locations, and we are on track to achieve our in-year operational efficiency goals. We are taking various other measures to lower cost and expand our margins. In addition, our prudent capital spend focuses on driving operational efficiency, automation, and supporting long-term growth. Second, from a quality perspective, MNIL has maintained a superb track record and commitment to the highest standards of quality over the years. Since 2005, the US FDA has conducted over 90 successful inspections with no OAIs or warning letters. We are very excited to share the successful US FDA inspection this week of our largest injectable site. We look to commercialize products from this site starting in third quarter. This is an important cornerstone of our injectables growth strategy by increasing our capacity and capabilities across all areas. We now have 19 production lines across various dosage forms, including vials, pre-filled syringes, cartridges, LVP bags, and emulsion. Over the last two years, We have invested over $150 million in capital and tremendous energy to bring two new injectable sites online. As a result, we are now at scale in injectables with four manufacturing locations, doubling the capacity we had a few years ago, and a deep R&D pipeline that provides a clear runway for long-term injectables growth. With our expanded infrastructure, we are well positioned to be a top five U.S. injectable business and a global player. Let me move to Generics R&D, where we are continually adding new products to our pipeline, In the first four months of 2023, we have launched 10 new generics, and we are on track to deliver over 30 new products this year. Overall, we have 99 ANDS pending with the U.S. FDA, with 63% representing non-oral solid products. This includes 32 injectables, 10 ophthalmics, 10 topical, 6 oral liquids, and 4 inhalation products. Behind that, we have 81 pipeline products with 89% representing non-oral solid products in complex categories, which tend to drive higher profitability and have longer product lifecycle. Over one-third of our pending ANDAs and two-thirds of our pipeline are expected to be first-to-market, first-to-file, or 55B2. In injectables, we see our cadence of innovation continuing as we remain on track to file 10 to 15 more ANDAs in 2023, including many complex injectables. We look to file our first 505 ready-to-use bags this year as well. In inhalation, we recently completed clinical trials for generic ProAir and look to submit our ANDA shortly. In addition, we shared last quarter our new partnership to in-license the SoftMIS technology platform for the development of RecipeMed inhalation programs. Also, we are pleased with the progress of our MDI programs and expect to submit additional NDAs in the coming years. Next, let me highlight a few notable upcoming new product launches. First, as discussed last quarter, we are very excited about our ANDA for naloxone nasal spray, our generic version of Narcan, which is currently under priority review with the US FDA. We believe this product, now over the counter, will improve access to a critical life-saving opioid overdose treatment for millions of people across America. In addition, we are on track for the July launch of an authorized generic version of Zyram, which is a key therapy for narcolepsy. A list of our notable launches is included on the Key Growth Catalyst slide in the presentation. We have added a number of new programs to the list this quarter. Turning to specialty R&D, we are expanding our portfolio through our pipeline. We have our PDUFA date for IPX203 coming up on June 30th. We see IPX203 as an important innovation that advances the standard of care with a broad market appeal for Parkinson's patients. Accordingly, we continue to see IPX203 as a $300 to $500 million peak sales opportunity. In addition, we are making good progress on international licensing opportunities for IPX203, which is pending approval so that this new therapy can reach the global patient population. Next in biosimilars, we are very excited about the value MNIL can bring to this space. Our first oncology biosimilars are seeing strong update in the market, and we see tremendous opportunity to expand our portfolio through partnership for future molecules. We see biosimilars as a key long-term growth driver. Looking globally, we see 2023 as a foundational year for our international expansion strategy. our R&D team is well positioned to leverage our rich portfolio and find key products in markets around the world, including Europe, China, and other emerging markets. We have begun registering selected products this year as we pursue over 50 product opportunities in different emerging market countries. We have a dedicated team at MNIL focused on driving international expansion. In summary, we continue to drive operational excellence and execute well across our innovation strategy, which is fueling our ability to drive sustainable growth. I will now hand it over to Tasos.
spk06: Thank you, Chintu. I'll first discuss first quarter results, then capital allocation, followed by a brief review of our full year 2023 guidance affirmation. We're very pleased with our first quarter results, with total net revenue of $558 million, growing 12%, adjusted EBITDA of $116 million, growing 16%, and adjusted diluted EPS of 12 cents in line with prior year. First quarter generic net revenue was $344 million, an increase of 26 million or 8% versus the prior year. Strong performance was driven by new product launch in 2022 and 2023, which added 31 million of revenue and stable performance in the rest of our broad portfolio. In addition to this strong performance, we're very pleased by the continued evolution and the refreshing of our generics portfolio. As an example, products launched and added since 2019 now account for 42% of our generic revenue, which bodes well for continued growth and profitability. Q1 specialty net revenue of $92 million increased 7 million, or 8%, versus the prior year, driven by Unitroid, up 39%, and Rytory, up 14%, which reflects strong commercial execution as well as substantial patient needs. Our out-of-care business continues to perform exceedingly well with Q1 net revenue of $122 million, up $27 million, or 29% compared to the prior year due to continued expansion of our distribution channel. We're very proud of the work our Apcare team is doing in increasing market share and providing our customers with new products and innovative solutions. Q1 2023 adjusted gross margin of 39.4% compares to 43.5% in the prior year was in line with our expectations, reflecting discontinuation of a handful of legacy products, timing of fixed overhead absorption, and our mix of business. Our first quarter adjusted gross margin represents the low point of the year as future quarters will benefit from new product launches, operating efficiencies, and manufacturing plant utilization increases. First quarter adjusted EBITDA of $116 million increased 16 million or 16% versus the prior year. This strong performance reflects our revenue growth Higher investment in sales and marketing to support our biosimilar and specialty brands, offset by tight expense management across the remaining operations. First quarter adjusted diluted EPS of 12 cents was in line with prior year, as higher interest expense offset our adjusted EBITDA growth. From a cash flow perspective, we generated operating cash flow of 140 million, which includes our interest expense, and $85 million payment related to the OPANA ER settlement that we announced last year. The strong performance was driven by robust cash collections related to our high accounts receivable balance at year-end 2022, as well as the continued strength of our top-line growth. Let me now turn to our capital allocation. Over the last few years, we've successfully increased profitability acquired key capabilities, and well-run businesses, reduced legacy legal exposures, and lowered leverage. As a result, we have grown annual adjusted EBITDA to over $500 million, compared to $339 million in 2019. We invested about $500 million in M&A, such as UpCare, new state-of-the-art injectable facilities, rebuilt our specialty R&D pipeline, and settled substantial legacy legal matters. In addition, we reduced net leverage from 7.4 times in 2019 to 4.9 times in the most recent quarter. With many of these investments now behind us, our intent is to prioritize debt reduction. We believe our strongest generation, bottom line growth, As many of these investments come to market, an active debt pay down will further reduce net leverage to below four times by the end of 2025. For full year 2023, we are affirming our guidance expectations. As a reminder, we expect total net revenue of $2,250,000,000 to $2,350,000,000 in 2023, which reflects continued single-digit growth driven by growth across all our three business segments. Also, we continue to expect 2023 adjusted EBITDA between $500 and $530 million, which includes incremental investments, particularly in sales and marketing, to support new launches and scale up in higher growth areas of the business. We expect adjusted EPS. between 40 and 50 cents, which reflects higher interest expense, including the potential refinancing of our term loan bid. On the cash side, we continue to expect 2023 operating cash flow between 200 to 230 million, which includes interest expense and excludes the already announced legal settlement cost of about $90 million, mostly related to OPANA-ER, and capital spend between 50 and 60 million. With that, let me hand it back to Shivaj.
spk08: Thank you, Tasos. In summary, we are pleased with our excellent start of the year. We expect our strong momentum will accelerate over 2023. MNIL remains well positioned for sustainable long-term growth with a diversified and expanding portfolio and key near-term catalysts happening all now including biosimilars, complex GX, injectables, and IPX203. As we continue to execute our strategy well, further diversify our business, and deliver profitable growth, we expect to drive higher levels of adjusted EBITDA and remarkably de-level the company. Let me now open the call to questions.
spk02: Thank you. If you would like to ask a question, please do so now by pressing star followed by the number one on your telephone keypad. If you change your mind and would like to be removed from the queue, please press star and then two. When preparing to ask your question, please ensure that your microphone and your device are unmuted locally. Our first question today comes from the line of Balaji Prasad with Barclays. Please go ahead.
spk03: All the details in the slides Also, congratulations on the injectables facility. So I think that's probably where I'll start with. Chirag, can you help me understand the broader or the current commercial opportunity in the injectables market? Is it addressing shortages or is the scope for a player with stronger pricing power or any kind of advantage there? And also just remind me about the current injectable size and what are the key contributors to take you to the $300 million portfolio? And the second question is on the biosimilar side. Can you give an update on how the environment for partnership in biosimilars is as you look to bring in more biosimilars into the U.S.? And lastly, on the same front, are the combined biosimilars revenues greater than $15 million in 1Q? Thanks.
spk08: Thank you, Balaji. Let me start with the injectable strategy. As we have stated, that our strategy is to expand capacity, have redundancy in our supply chain, and that's exactly what we've been doing. We, our focus has been to introduce differentiated products, such as , we were first in the market and still as a major market share, cyclophosphamide, now LVP bags, the peptide-based products coming soon. So it's more driven towards complex products, which has the demand, less competition with supply chain security for our customers, for our hospitals. A very deep relationship we are building. We're also going to supply certain commodity products that are in shortages. And that's how we have built very strategically so far our injectable business and going forward It is built to be more even durable, more complex products, more relationship with hospitals and clinics, and bringing them what they need, which is shortage products as well, addressing shortage products. So today we do about $180 million, and we expect to be well over $300 million by end of 2025, and continue to grow from there after that. And that obviously also will include international revenues as these products have good international markets as well. On biosimilars, very excited with two launches, about to launch the third one. The team has done a great job all across as we always do great job in commercial side. Again, excelling with building relationship, using the old relationship that we had with the wholesalers, building new ones with the community oncologist and hospitals. We do have a Salesforce market access. We take the from our specialty cells. that help on marketing and market access as well. So with that, we are very, we're well on our way to reach this year's target, about 50 to 60 million. But that accelerates because we're accelerating in Q3 and Q4. So next year, significant uptake for these three products. And then we're working on the pipeline, which we haven't announced, as we have a stated goal to be the top five player in the United States in the long run. So we're going to be here. Our strategy is not just one year, two years, three years. It's to stay in the game for next 10 years. And we see highly valuable franchise as a biosimilars for the United States and for the global market.
spk07: Just to add one point to Chirag on the inject table. Thank you. Good morning, Balaji. This is Chintu. We have thirty-two pending ANDAs at FDA, and we continue to file about ten or fifteen every year. And now we are at scale with nineteen production line. So, to get to from our current revenue of about one seventy to one eighty, If you can just do the math, you know, 32 pending and 1015, and also all these are in a differentiated dosage from many are complex drug device, combination, cartridges, bags, peptides. uh we have some of the maybe long long depot long acting depot injections so we are very well positioned and we have now redundancy resiliency in our manufacturing footprint which is the biggest challenge in injectables so i think we are very excited uh with all the lines now going live and we'll be commercializing in third quarter from our newly uh fd inspected side and this gives us the leverage in multiple areas plus this Areas are also very lucrative for our international expansion.
spk03: Thanks, Ginger. That's helpful.
spk02: Our next question comes from Chris Schott with JP Morgan. Please go ahead, Chris. Your line is open.
spk00: Great. Thanks very much. Just two questions on guidance for me. Maybe first on the generic gross margin trends, can you just elaborate a little bit more in terms of what happened to gross margins this quarter and just how we should think about generic gross margins for the balance of the year? I know you mentioned there were some one-time issues, but I don't think you've had gross margins this low for a few years. I'm just turning my hands around what exactly is happening there and probably more importantly, just how to think about the next few quarters. And the second was on revenue growth. It seems to be obviously a very good start to the year with this quarter. But I think the go-forward guidance implies more modest revenue growth for the remainder of the year. Again, just similar question there. Just help me a little bit about the cadence of revenue growth as we think about the next few quarters and kind of drivers there. Thank you.
spk06: Hey, Chris. This is Stas. Good morning. Yeah, I mean, as you know, gross margin at any given quarter can fluctuate a little bit. For us, it was just. certain products, small product discontinuations, as I mentioned, and related kind of obsolescence product that we had to write off and just timing of our production line. So you're correct. It was like lower than it has been in previous quarters. But from our perspective, I expect, I fully expect Q2 to step up in the, you know, above 40%. And in terms of kind of full year expectations from a generic gross margin, I think we're going to be around 42%. Line with prior with prior year. So that's that's around on the on the gross on the gross margin in terms of from a revenue growth perspective. Sure. I'm going to take it. Sure.
spk08: So, Chris, we've been speaking for last few years and you've been following and Neil. This is the rocket about to. Be fired now, right? Because it's well positioned to drive sustainable top line growth. and meaningful adjusted EBITDA acceleration in 2023, 24, and beyond. And let me tell you how it is happening and how diverse and how good that is that we're not relying on two specialty products to make our life or our company, right? We have a genetics portfolio of 270 products driving durable, profitable growth, number three in the United States in value, number four in volume. We're the only company that grew where everybody de-grew, and we will continue to grow in next several years. Highly productive innovative R&D pipeline, launching 20 to 30 new products every year, 30 plus. I mean, look at the diversity we have. Continued shift to complex products with capabilities across dosage forms. It's an essential business, and we are providing essential services. 500 plus million revenue came from recent product launches. Expanding in high growth areas, injectables and biosimilars. Gold to be top five. You know that. We did it before and we're going to do it again. Growing specialty portfolio. I know you're not excited on IPX203, but we are. We're very excited, and you will see the strategy being rolled out and why we think such a need. We talk to Parkinson's patients every day, KOLs every day, and a huge need to penetrate. The dietary penetrated only 4%, and 96% are on IR. CDLD, which is a 30 years old technology, and they experience such a bad off time every day. And we're determined to take this product out to as many general neuro as we can, and even beyond that. Avcare, our distribution business, growing double digit. After big three, there are not many players. So it gives us excellent chance to distribute our products directly in unit dose, in government channels, and niche distribution channels. This is a sizable business now, 450 million plus. On top of that, we're entering very meaningfully on international markets to further diversify the company. And all that with our most of the products made by us. We have a global network of manufacturing sites, top of the class, number one in quality. We are the US champions. What we need, three OSD sites, four injectable sites, one nasal spray liquids in the United States, transdermal site in the United States, device-based site in the United States, two API sites providing needed API for us, and one inhalation respiratory site in Ireland. So with all this, we are extremely well positioned for growth, not just this year, but 24 to all the way to 2030. Thank you.
spk02: Thank you. Our next question comes from David Amselm with Piper Sandler. David, please go ahead.
spk01: Hey, thanks. So, on the generics business, can you talk to product concentration? I'm specifically interested in contribution from Zafir this year and how you're thinking about, um the potential for competition uh that product down the road i know it's a complex product but can you talk to that and and um in general are there you know beyond zap may there any you know other products we should be thinking about that have an outsized impact on generics so that's number one uh and then number two um a helpful commentary on the deleveraging but i guess my question is on biz dev and m a what's your appetite or I guess capacity for deals? How large can you go and how big of a priority are bolt-on transactions? Thanks.
spk06: Hey, David, this is Tasos. I can take the first one and I can take the more strategic question. It's whether or not Zapfemi or any other product in our portfolio has More competition or less competition, it does not make a big difference one way or the other. Because we have done, if you kind of go back, for example, a number of years ago, for example, levothyroxide, right, was $180 million product for us. We don't have any such product anymore in the generic segment, right? The biggest product may be a $50, $60 million product. So that's part of why we kind of keep focused on how the business has been diversified over the course of time. And this is a differentiating factor for MNIL compared to any other generic company out there. So no one product kind of keeps us up at night. And the other thing is, as you said earlier on who already launched 10 new products, there's another 20 new products that are going to be launched whether or not we launch 30 products this year or 25 products this year. It's not going to make a difference in our performance. Yeah. So on the capital allocation piece, I mean, I'll give you my view is, as I mentioned before, we spent a ton of money and thoughtfully, right? We never did an acquisition that kind of bets the company. Many of them were talking acquisitions to fill out specific areas that are going to drive future growth. So as a result, I think at this point in time with the investments we have made, the interest rates being where they are, right? This is why you're hearing us kind of deprioritizing M&A and focusing more on that pay down. Chirag, am I, any other, any additional thoughts?
spk08: You covered really well. And David, we do not have that 2018 problem. The big leaky buckets on a big GX product is highly diversified across the business segments. Within generics, we have multiple products. with 10, 20, 30, 40, 50, and we'll continue to drive. And obviously our leads the way, but it's kind of a branded GX, if you would call it. And then M&A, look, we invested almost $600 million over the last four years, and that is paying off really well. We continue to invest almost 240, 50 million every year. combining R&D, internal R&D, external R&D, as well as CapEx, putting a new peptide side or putting a similar investment. So we have enough for next two, three years. So right now we're zoomed in. We love the consolidated business that we have different segments, diversification. Goal is to de-level, lower the debt amount, increase the EBITDA, And then from 2026, we would be in a much better position to think about anything big strategic. But right now, we're loving all the businesses, and they're all firing on all cylinders, which is a beautiful thing. There's not a weak link within any of the segments of our businesses.
spk01: Thank you.
spk02: Will we take our next question? As a reminder, if you would like to ask a question today, please do so now by pressing start followed by the number one on your telephone keypad. Our next question comes from Greg Fraser with Truist Securities. Greg, please go ahead.
spk05: Thanks. Good morning, folks. On IPX203, you mentioned in the slide the data generation plan that supports potential for early use. Can you expand on that? Are you planning additional clinical work? Can you just give us an update on your efforts to refinance the term loan B? When do you expect to finalize a refinancing and what are your expectations for terms for the new debt? Thank you.
spk07: Hi, good morning. So, we are very excited about how novel this formulation is compared to what is currently available in the market and how it can benefit the patient. It is a very unique formulation combined with immediate release with ER. Carbidopa levodopa, especially levodopa, has a huge problem of absorption throughout the GI tract and half short life. So the way the formulation is done, and our data shows as part of the clinical, that 1.5 hours of per dose improvement compared to IR-CDLD. And again, that's what goes in the label, but label and everything remains on a final negotiation. So it can help many, many new patients who are starting on an immediate-release carbidobalutabot therapy, which can take the fluctuations out and can stabilize the patient and can give a long, durable, good on time. So that's why we are excited. Current, our dietary product only offers over four percent of the patient and ninety six percent of patients still are going to a step up. So once we get the final label and what is on the label, IPX203 can be very, very helpful for the naive and the new patient and provide them awesome, good on time compared to the current therapies on the market.
spk06: Hey, Greg, on the refinancing, as you know, our term loan B doesn't come up for, doesn't become due in two years, right? So it's May 2025. So there is plenty of runway, right? Having said that, you know, I was here, I was a CFO in 2007, 8, and 9. So having lived through that, you know, you never know what happens to the capital market. So, this is why as a company want to be constructive and that's why we said, we would like to extend to kind of refinance our term loan be sometime this year. So, we're in active conversations with the market. We have a number of kind of great investors on our current term loan be. I'd love to see many of them have expressed an interest to kind of continue in our refinancing efforts. So we'll continue to try to be constructive with the market, but not at any cost and not at any terms. So, you know, our expectation is continue to focus in kind of getting it done before the end of the year. And if it goes beyond that, so be it. Thank you.
spk02: We have no further questions registered, so I'll turn the call back to Chirag for closing remarks.
spk08: Well, thank you. Thank you very much. So just closing out, just summarizing, Amnely is a diversified, differentiated, and growing across all businesses. It's a show-me story. We know that, and we've been showing it. We'll be showing more. That's what we are doing, and we are laser-focused on execution. driving higher EBITDA and deleveraging. And our future is very bright. And so we're very excited. All 7,000 employees are extremely excited to make MNIL the American champion and be the leading affordable medicine company for the United States. Thank you very much. Thank you.
spk02: Thank you, everyone, for joining us today. This concludes our call, and you may now disconnect your line.
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