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spk09: And welcome to the Amniel first quarter 2021 conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then two. Please note, today's event is being recorded. I would now like to call over to Amniel's head of investor relations, Tony DiMeo.
spk08: Good morning, and thank you for joining us for Amniel's first quarter 2021 earnings call. Earlier this morning, we issued a press release reporting our financial results. The press release, as well as the slides that will be presented on this call, are available on our website at amniel.com. We are conducting a live webcast of this call, a replay of which will also be available on our website after its conclusion. Please note that today's call is copyrighted material and cannot be rebroadcast without the company's express written consent. I would like to remind you that statements made during this call stating management's outlook or predictions for future periods are forward-looking statements. These statements are based solely on information that is now available to us. we encourage you to review the section entitled Cautionary Statements on Forward-Looking Statements in our press release and presentation which applies to this call. Our future performance may differ due to numerous factors, many of which are listed on our most recent annual report on Form 10-K and are revised and updated on our quarterly reports on Form 10-Q. and current reports on Form 8K, which you can also find on our website and on the SEC's website at sec.gov. We also discussed certain non-GAAP measures. You will find important information on our use of these measures and our reconciliations to U.S. GAAP in our earnings release. Included in the appendix of today's presentation, you will find U.S. GAAP financial metrics that correspond to some of our U.S. non-GAAP measures we referenced throughout the presentation. On the call this morning are Chirag and Shintu Patel, our co-CEOs, Tasos Konideras, our CFO, Andy Boyer and Joe Tedisco, our chief commercial officers for the generics and specialty segments, and Steve Manzano, our general counsel and corporate secretary. I will now turn the call over to Chirag.
spk06: Thank you, Tony, and welcome to MNEO. Good morning, all, and thank you for joining us this morning. First, I want to acknowledge the public health crisis in India. COVID-19 has challenged the world in many ways, but even by the standards set over the last year, the situation in India is very challenging, and access to medical care is limited. We are working diligently with Indian government officials, charitable foundations, and other pharmaceutical leaders to utilize our expertise resources to secure critical care medications and equipment. Our hearts are with our colleagues in India, as well as all those who continue to fight COVID-19 around the world. As an essential business, we are proud of the investments we continue to make in protecting the health and well-being of our employees. In addition, We are also ensuring the continuous supply of medicines for patients and customers in the United States. Our robust global supply chain is operating well, and the efforts of our procurement, quality, and manufacturing teams have been truly heroic. Finally, this latest COVID outbreak is a reminder of the dependency of the U.S. genetics pharmaceutical industry on foreign manufacturing. We believe it remains critically important to make more products in America for America. Fortunately, Amniel's significant domestic manufacturing base, superb quality record, and the U.S. domicile enable us to work closely with federal and state legislators and public policymakers to provide meaningful solutions. We look forward to sharing updates as we make progress. Turning now to our financial and operating results, I'm extremely pleased with our first quarter results and how the full year is shaping up. We remain confident that our momentum, the strength of our commercialized and pipeline assets, solid execution will deliver another year of strong top and bottom line performance, consistent with our guidance. Let me now provide you with an update on key initiatives across our business. First, we believe companies in our industry are only as strong as their R&D organizations. Innovation is growth and we continue to invest in product development in both generics and specialties. In generics, we have established a well-oiled engine to replenish our development portfolio and drive increasingly complex product launches. Our strong innovation capabilities are a major reason we have delivered growth in an industry experiencing secular pressure. While our base business faces competition, our R&D team is constantly moving us up the value chain with higher barrier to entry products that have longer tails of revenues and profits. In specialty, We are acutely focused on executing the development plans for IPX203 and Kashif specialty pharmaceuticals programs we acquired earlier this year. Shintu will touch on innovation in greater detail shortly. Second, we are excited to see our manufacturing and supply chain continue to improve every quarter. When we came back, it was one of our first public goals, optimize our global operations, reduce excess overhead and cost, improve our margins in genetics, and ultimately increase profitability. We are executing well towards these goals, as genetics gross margin in first quarter grew to 45%. Going forward, we are pursuing additional efficiencies to improve margins over time. Third, we know the execution of strategic, accretive, and creative transactions can help us accelerate our growth. Just after the end of first quarter, we completed our acquisition of Kashif Specialty Pharmaceuticals. With Kashif, M. Neal gained best-in-class small molecule formulation and development talent. which we expect will drive substantial organic long-term value across our portfolio. We also gained several near-term NDA programs across neurology and endocrinology that we expect to begin to launch as early as 2023. But we're not stopping there. Given our existing commercial infrastructure in neurology and endocrinology, we are pursuing complementary commercial stage assets as well as late-stage clinical programs to provide near-term synergistic revenue streams. We believe we are uniquely positioned to drive substantial value to all stakeholders and further strengthen our balance sheet over time. Finally, we continue to grow our AvCare distribution business, where we saw solid top line and profitability performance this quarter. As we have discussed in the past, AvCare represents a strategic long-term opportunity for us as we focus on the federal government channel. This business is buoyed by... Favorable tailwinds, including the continued stream of branded pharmaceuticals going genetics every year. As we look towards the rest of 2021 and beyond, Shintu and I could not be more excited about our business and confident in our strategic direction. Today, MNIL is truly firing on all cylinders, and we expect continued strong financial and operational performance as we move forward. With that, I'll now turn the call over to Chintu.
spk05: Good morning everyone. Thank you Chirag. As always, I would like to begin by recognizing our employees whose tremendous dedication inspires Chirag and I every day and drives our continued success in making healthy possible. The team's relentless commitment to delivering medicines for our customers and patients, even in these trying times, is truly remarkable. To our employees, we thank you for your service and are filled with gratitude for all you have contributed. Our employees in India have demonstrated amazing courage and we are actively supporting them to ensure they get the care they need in light of the most recent COVID outbreak. Our India team has continued to ensure our supply chain remains strong and the flow of products is uninterrupted. From the beginning of the pandemic, we focused on building an even more resilient global supply chain, which has led to strong inventory levels across all locations. These are unprecedented times and we pray for those who have lost family members to this terrible virus in India and across the world. Now let me provide a few key business updates. First, I'm happy to share that we are advancing key initiatives across the company to improve efficiencies, which will save cost and expand margins. For example, while we manufacture most of our genetics in-house, we are transferring several products from external manufacturing partners to our facilities, which will reduce cost and improve supply chain. Many of these types of initiatives will help improve our gross margin in a sustainable way. And as always, we continue to uphold the highest standards of good manufacturing practices and integrity across every aspect of our business. From the very beginning, we have prioritized quality and compliance at all levels. It is truly in MNIL's DNA and part of our culture. As Chirag said, R&D is the growth engine for our industry, and we continue to invest in our future pipeline. I will start with genetics. We believe that we are at an exciting time for MNIL 2.0 as we begin to see the benefits of the transition of our development activity towards complex dosage forms. drug-device combinations, and other high-value programs. Over 80% of our pipeline is non-oral solid products, and an increasing share of that is drug-device combinations. Zephyrme, which we launched in March and is a complex hormonal patch, is a perfect example of our generic strategy in action. Zephyrme received CGT designation, which grants it 180 days of exclusivity. And given the complexity of its development and manufacturing, we believe it will have limited competition even post-exclusivity. Of the 80 generics approved with a CGD designated industry-wide, MNIL has launched 10, by far the highest number in our industry. Looking forward, we will continue refreshing our pipeline. We expect to deliver at least six to seven high-value products on an annual basis. In addition, we are actively looking to expand our high-value complex generic portfolio into select international markets via external partners. Our existing partnership with Fosun is proceeding nicely. Together, we have already filed four products in China and expect to file another five by the end of the year. And this is just the first of multiple international collaborations. Overall, we see global expansion as another vector for long-term sustainable growth. Next, biosimilar will be an increasingly meaningful component of our pipeline going forward. As we have shared in the past, we think the biosimilars market will behave more like complex generics over time. We believe our core strength in high-quality manufacturing, innovation, and strong commercial execution will position us extremely well in this space. Currently, we have filed three biosimilar products which we expect to launch over the next couple of years. Beyond that, we are actively evaluating additional opportunities via partnership models where we can be first or second to market. We believe biosimilar will be a key strategic opportunity for us over the next five to ten years. Turning to our specialty pipeline, IPX203 is the most advanced of our four specialty pipeline programs and is currently in phase three clinical trials with an estimated launch in 2023. As a reminder, IPX203 is our next generation product for Parkinson's disease. We expect the product will offer a material improvement over dietary and existing therapies In the United States, 60% of PD patients or roughly 600,000 people are on some form of levodopa therapy to help manage off time, which are periods of drastically reduced motor function due to low levels of dopamine. Immediate release carbidopa levodopa is a first-line therapy for Parkinson's. Our current leading product, RITERI, is an extended release carbidopa-libidopa product designed to provide better on-time for moderate and severe patients compared to generic immediate release. In this patient population, an hour or two of additional on time can be a large improvement in quality of life as off periods can be stressful and painful. We expect IPX203 will demonstrate a clinically superior efficacy profile versus immediate release and will boast a much more convenient dosing regimen. As a result, we believe that IPX203 has the potential to be a much larger product than Rytary and help us drive further market leadership in the management of Parkinson's disease. We are excited to see top-line data in the second half of this year. The integration of Kashif Specialty Pharmaceuticals is proceeding well. This deal has expanded our specialty product pipeline significantly in both endocrinology and neurology. We have K127 for myasthenia gravis, K128, a modified trihexyphenidyl for the treatment of pyloria, and K114, a modified T3 product for the treatment of hypothyroidism. With the addition of these programs, we are well positioned to launch at least one specialty product per year starting in 2023. And we believe the various drug delivery technology platforms we acquired will also provide a wellspring of new branded products for years to come. To summarize, we build this company to deliver affordable, essential medicines for patients and create value for all our stakeholders. The company is executing well. Our pipeline, our technologies, our commitment to quality, and most importantly, our people are elevating MNIL to new heights. Chirag and I share excitement and confidence in the journey ahead. I will turn the call over now to Tasos.
spk07: Thank you, Chintu. Our first quarter financial momentum reflects the relevancy and diversification of our product portfolio, successful new product launches, and our focus on execution and driving of efficiencies. As a result, in the first quarter of this year, we reported net revenue of $493 million, adjusted EBITDA of $126 million, and adjusted diluted EPS of $0.20. In addition, we generated $148 million of operating cash flow and further reduced our net leverage. Let me now move to our segment results, starting with generics, where net revenue of $313 million was down $40 million or 11% compared to Q1 2020. This decline was not surprising and was primarily driven by an almost non-existent flu and cold season, which adversely impacted products like generic tummy flu, as well as higher purchases last year at the onset of the COVID-19 pandemic. On a pro forma basis, as we adjust for the various discrete events, generic net revenues grew low to mid-single digits. who continue to be very pleased with the performance of our new product launches, where products launched since January of last year delivered over 36 million in net revenue growth, offsetting price deflation, as well as the lingering negative impact of the pandemic. From a product perspective, epinephrine, alluring, pembothairoxide, and subchlorophyte were strong contributors in the current quarter. In addition, Zafemi is performing very well, and as you may remember, we launched it in March of this year, so there is only one month of it in the current quarter. Looking ahead, we expect a step-change increase in generic net revenue due to continued new product growth, strong commercial execution, and the fact that the seasonal nature of the flu and high purchases last year due to the pandemic are behind us. Adjusted gross margin for generics was 44.6%, 250 basis points higher than Q1 2020, and 630 basis points ahead of full year 2020. This growth reflects our strategy and solid execution in transitioning to more complex generics, as well as the efforts of our team to drive supply chain efficiencies and favorable pricing on certain manufacturing materials. Let me now turn to our specialty segment with net revenue in line with our expectations of 96 million, up 8 million or 9% from Q1 2020. As a reminder, our specialty segment centers around neurology and endocrinology with our promoted branch, Rider and Unitroid. Both brands continue to grow, and in aggregate, they delivered 56 million, up 11% versus Q1 2020. This growth, as well as improvements in our gross to net, offset declines in ZOMIC due to its upcoming loss of exclusivity. Adjusted gross margin for specialty was 78.4%, 380 basis points higher than Q1 2020, and 420 basis points ahead of full year 2020, mostly due to a favorable product mix. Let me now move to AdCare, which reported net revenue of 84.7 million, up 26.7 million, or 46%. As a reminder, the acquisition was closed in January 31, 2020. As a result, the current quarter reflects three months of sales versus two months last year. Adjusted gross margin for the quarter for out-care was 19.6%, in line with Q1 2020, and 210 basis points higher than full-year 2020. While the top line was slightly lower than our expectations due to lingering effects of the pandemic, the business was able to overcome it by leveraging a more profitable product mix, as well as operating expense efficiencies. Total company adjusted EBITDA of $126 million was slightly ahead of our expectations, and $8 million below Q1 2020 reflecting three dynamics. First, higher gross profit primarily due to a favorable product mix and operating efficiencies this year. Second, we're making substantial investments in our R&D and sales and marketing to drive long-term growth. And third, the tough comparison to Q1 of 2020, where our adjusted EBITDA of 134 million was substantially higher than the 107 million average for the remaining three quarters of the last year. Adjusted diluted EPS of 20 cents was flat to Q1 2020, as our adjusted EBITDA performance and lower interest expense offset the very high prior year comps. Again, last year's first quarter of 20 cents in EPS was much higher than the 14 cents average of the remaining three quarters of 2020. From a cash perspective, operating cash flow of 148 million was ahead of our expectations and well ahead of the 49 million we generated in Q1 2020. we need to be mindful that this metric is inherently variable. Nevertheless, the strong performance was driven by top-line performance, lower DSO, and some favorable timing. As a result of our strong financials, in the quarter, we strengthened our balance sheet and our financial flexibility. Cash and cash equivalent in March 2021 was $456 million, compared to $347 million in December 2020, and our net debt-to-adjusted EBITDA ratio improved to 5.1x compared to 6.2x in March 2020. In summary, we're pleased with our top-line performance, higher levels of profitability, cash generation, and improved balances. Consequently, our full year 2021 guidance remains unchanged and we remain confident in our financial and operating performance for the remainder of the year. With that, let me turn the call over to Chirag.
spk06: Thank you, Tasos. We are pleased with our continued positive momentum through the start of 2021 as we continue to execute against our MNIL 2.0 strategic vision of long-term sustainable growth. I would now like to turn the call over to the operator to take your questions.
spk09: Yes, thank you. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To answer your question, please press star, then 2. At this time, we will pause momentarily to assemble the roster. And the first question comes from Greg Gilbert with Truist.
spk11: Thanks. I have a few. Chirag, I want to start with a high-level strategic question. I understand the desire for companies, including yours, to want to move up the value chain and have more durable products and brands. I certainly understand that. But also, I wonder why the generic industry in the US hasn't consolidated more, given what we've seen on the customer side. Do you think that's in the cards, sort of independent of your standalone strategy? Let me ask the other questions right up front. Tasos, maybe you could comment a little bit on the AvCare strength and how lumpy that is and what some of the drivers are there. And lastly, for Chintu, is generic Nexplanon a project that is interesting to you and perhaps underway and curious how challenging something like that would be compared to other projects you've had your team work on? Thank you.
spk06: Wow, Greg, you're so fresh this morning. Good morning. Consolidation in generics. That's the holy grail, I guess. As you know, it is tough. And the reason it is tough is the FTC requires to divest many products we went through with the impacts merger. We had to go back and forth with the agency and ended up divesting a lot of value away. and also moving the products from their plants, impacts plants, to Amniel, we lost a lot of revenue in between. So it becomes very hard. You look back and say, okay, why should we do that? Of course, there are lots of synergies we can pick up, but the overlaps are so many. So if we find a target without overlaps, Really good. And I hope, and it is needed, the consolidation is must. It's just what form it comes in. And if new players without overlaps, if they can emerge, which I think was generic, that was good. There are a couple of small companies. Do they consolidate together? Good. Good for the industry. And we need that. As you know, Indian companies have a very hard time doing anything. So they go on for a legacy of their families for many years to go, so they do not consolidate. It's a little bit of uphill slope. I hope I answered that question to you.
spk07: Tassos on Apcare. Yeah, good morning, Tassos. Let me try this, if that works. So, Apcare overall is growing nicely. So, last year, we did about almost $300 million. This year, it will grow mid-double digit. So, feel good about the top line growth. Profitability, you know, we knew that when we did the deal, profitability for the business is around, you know, high double digits. So last year it was 18%. And, you know, Q1, you know, we're seeing a 20%, you know, so we're pleased with that improved level of profitability. One of the things we like about the business, about more than 50% of that $300 million growing double-digit this year is the government business. And what we like about this, many of the contracts are long-term contracts. So it gives us a nice, stable platform that we can grow over time. And for that reason, we cannot turn the growth rate overnight, right? But it embeds us with our government customers, and the team has a lot of expertise. So all over time, who are looking to grow that segment, not only by leveraging third-party products, but also MNL products, which, as you can imagine, provide a nice, much more profitable growth there. The rest of the business is a number of other more distribution-like businesses with low single margin business, and that's been growing nicely, and that's where we're looking for more operating efficiencies over time. So I think, you know, overall, I think the business, again, this year is going to grow double digits. I think for the next few quarters, it will be, you know, low 80s to low 90s million dollars in terms of quarterly revenues, and profitability should be in that 18% to 20% gross margin. Hopefully, Greg, that helped.
spk06: And just to add a bit, we're also growing the unit dose business by launching 8 to 10 of our own liquid products out of branch work in for healthcare next year.
spk05: Chintu? Hi, Greg. Good morning. So good question on Nexplan. So MNIL, as you know, has been investing into a complex generic space, and we continue to move up the value chain. And the products like Nexplan, which is a drug-device combination in plant products, takes on the top of the most complexity from the development and from the device perspective, and also how to conduct and work with FDA. With Kashif's acquisitions, we acquired some of the talent that is required. I will not get into the particular product, but MNIL, we have the good knowledge on how to develop these three to five years long implant products. We have the very good drug device group within the organization. We understand the formulation and the other challenges and the PK studies and other regulatory requirements. But absolutely, MNIL is moving up and it's part of our portfolio. Not the particular product, but anti-drug device combination implying category is something we are very excited, and we have the knowledge, and we are working aggressively to bring that to the market.
spk11: Thanks, gentlemen.
spk09: Thank you. And the next question comes from Daniel Busley with RBC Capital Markets.
spk02: Hey, good morning. Thanks for the questions. Maybe sticking with the big picture theme, as we think about the business longer term, in your view, what is the ideal revenue mix between generics and specialty and also, I guess, U.S. versus OUS? Clearly right now you're still more heavily weighted towards U.S. generics, but what would you ideally like to see when we look at the business five years from now and how does business development play into that? And second, how should we think about the cadence of additional generic new launches over the remainder of this year, and how important are those to the anticipated step change increase in generic revenue that you mentioned?
spk06: Thank you, Daniel. So the big picture, how do you see MNIL growing? So MNIL 2.0. So we said the complex genetics is a driver of the business within genetics, right? We go within complex genetics, all kind of dosage form. And Shintu mentioned the device products, the inhalation products, injectable products. And as we have said it a year ago, that biosimilars, we put them in a complex genetics. So that segment going from somewhere at 1.4, 1.5 billion to a high level in five years, we're not going to give you exact number now, but there is enough growth for us because of all these scientific developments capabilities and investment we have made over the years to produce this. So it will be excellent growth in that one segment of the business. The specialty We have our own pipeline. We haven't given forecasts for that pipeline. IPX203 is moving nicely. So is K127. And we are very serious on, and we got the platform, we got the technology. And one thing MNIL does really well is once we get in, we do it. We finish the job. So it's a long-term view for us, five, ten years. We'll build this specialty business to be at a great level, more contribution on EBITDA than revenue. I don't want to say the mix exactly, but it is on a tremendous growth trajectory, and also it will be complemented by a creative, strategic M&A because we have the strength. We've got the cash flow. We've got the complex generics complementing the specialty. Our Parkinson's disease side, we like to consolidate as many products as we can. Same thing on endocrinology. It's how our T3 comes, and then there's more to come. So very excited and very targeted on those two areas. Do you want to take this?
spk07: Yeah, good morning. Yeah, just in terms of overall new product launches are critical to us, right? But we are really not relying on any additional new product launches to lead to that step change I spoke to. Based on the product portfolio that we currently have, we're very confident on the step change, number one. Number two, as new products come in, those new products will be fueling growth mostly towards Q4 and into next year.
spk02: Great. Thanks for the call.
spk09: Thank you. And the next question comes from David Amselon with Piper Sandler. Thanks.
spk00: So just a couple. So on the biosimilars, you talk about, I know that this is a partnership model, but how should we think about you know, your net economics and how these three opportunities you've identified, what kind of margins they'll have relative to your overall generic margins, given the shared economics. So that's number one. Then number two is you've talked about other biosimilar programs, when are you going to be in a position to identify those other opportunities? And do you expect those other opportunities to have better economics or similar economics to Avastin and the GCSFs? And then lastly, is there anything that you can add on the Copaxone generic? And is this still part of your expectation that you you expect that opportunity to bear fruit later this year. Thank you.
spk06: Thank you, David. So our biosimilar strategy, as you pointed out, it's a partnership model to begin with, which is very cost-effective for us. We waited and we wanted to see how it develops because we did not want to spend or invest $150 million, $200 million per year. for biologic and the patent dance the the ticket of patents so we want to see how plus the the adoption of biosimilars which is all playing now nicely over now and over next 10 years we see biosimilar as a great business and not only biosimilars it will then just like in small molecular 55b2s biosimilars may end up into bio betters or follow on branded biologics because which So we've been very diligently working over the last couple of years to identify great partners. We understand that manufacturing is a key. I would put 80% value to a very high-end manufacturing and consistent manufacturing. And we are working on strategies on how do we become champion just like on a complex genetics for the manufacturing of biosimilars. And then R&D, we will establish our capabilities sooner than later. Margins, we expect them to be in, the split is almost like 60% in our favor, 40% to partner. We probably will continue with that model, which gives us around 25 to 30% EBITDA per product. If we do it in-house, whenever we start doing it, obviously it will go up to 35 plus percent. So that's the plan for now. And, you know, David, when will we announce the next partnership this year?
spk05: And David, your last question on Capaxon. Yes, we are working and the product can have launch later this year or early first quarter 2022.
spk00: Great. That's helpful. Thank you.
spk09: Thank you. And the next question comes from Elliot Wilbur with Raymond James.
spk01: Hi, good morning. This is Lucas Lee on for Elliot and thanks for the question. The question I have is, what drove the gross margin upside during the quarter? Is this sustainable? And how does that impact your prior expectations around generic gross margin trends? And as a follow-up, how are you thinking about the potential generic competition on ZOMIC? Thank you.
spk07: Dr. So, good day, Lucas. Good morning. We were incredibly pleased on the gross margin performance. And it was, as you saw, every business expanded margins, which is something we're very focused on improving profitability. Generics had a great quarter with margins of about 45%. We believe those are sustainable. My gut feeling is I think we're going to see some moderation, right, to the low 40s, some moderation. But I think we're going to finish the year on the generic side, most likely in the low 40s, which, as you know, is a substantial increase versus the 38% we delivered last year and the 35% we finished 2019. So, as you can see, we are executing in terms of what we had said over the last couple of years. We see generic margins going over 40%. that bridge this year. That's in terms of our expectations, so pretty much sustainable. And it's the same thing across the remaining other two parts of the business. On generic ZOMIG, I mean, this was not overall one of the things we are proud about we have created. We have created a very diversified business, much more so than three years ago. So, you know, we have out-of-care. That's a big part of the business. Specialty has grown. We have a portfolio of generic products, over 250 products. So we're not dependent on any single products. With that on ZOMIG, let me turn it over to Joe to kind of give us a little bit more insight.
spk04: Sure. Thanks, Tassos. With respect to specific generic competition on ZOMIG nasal spray, we're aware of two filers that are already publicly known, but we always do assume that someone else could be coming to market. We had preemptively launched an authorized generic earlier this year. We've got sufficient inventory of both labels, and we've taken steps to maximize the value of the product regardless of the number of generic competitors that come to market at the end of May.
spk02: Thank you. That's very helpful.
spk09: Thank you. And the next question comes from Dana Flanders with Guggenheim.
spk03: Great. Thank you very much for the questions. I just had two. My first is I was wondering if you could comment on just base business generic pricing trends. We are hearing some comments from the supply chain and other manufacturers that they're seeing a little bit more pressure this year, kind of independent of competition. So just wondering if you're seeing that as well. And then my second question, I was wondering if you could comment on just the unfortunate and sad situation going on in India with COVID. And wondering if you are seeing or expecting to see kind of shortages start to pop up impacting the U.S. market and just how Amniel's, you know, overall supply chain is just relatively positioned. Thank you.
spk07: I'll take the first question on pricing. And we're seeing just a high level. We're seeing consistent behavior, as you're hearing from some of the other manufacturers. But I also want to point out, this is exactly what we planned this year. As a reminder, in our guidance, we assumed mid to high single-digit deflation. As you mentioned, it's coming in certain areas. Certain areas, it's coming a little worse than that. But our ability to get new product launches, actually ahead of our own expectations. And our ability of our supply chain to drive operating efficiencies and the new markets of growth that we are seeing by the commercial team is offsetting that and ultimately is increasing our profitability in a sustainable way. So pretty much very happy how the company is dealing with this and so forth. As in terms to India, let me turn it over to Sirag. I think he has a good perspective on that.
spk06: Thank you, Tasso. So the situation is very grim. There are local lockdowns, but pharmaceuticals being an essential industry, it is allowed to operate. The inventory levels are... For MNIL, it's very good, three plus months, and we have secured the APIs, and if you count overall inventory, it's almost four to six months. So we don't expect, as far as the MNIL is concerned, any shortings from our product. may face based on where they're located and how much pre-planning have they done. But for now, next month or two should be fine. We expect the situation to improve hopefully after one month. And in India, we're doing everything we can to help the situation with oxygen concentrators or with working on supplying or donating remdesivir and steroid products. We got Indian government license to sell. We never sold anything to local market from our U.S. FDA approved plant in India. So, and everybody is assisting. Many countries have, as you know, offered lots of help. So, there's enough, seem to be enough Remdesivir. I was on the call with Iliad. They had 15 million vials they would produce this month. So, they're all trying to help. Same thing with Pfizer, and hopefully the more vaccines will help. will be available besides just AstraZeneca. So it's very grim there, and we hope it improves soon.
spk05: Thank you. And just to add just one point, we were very proactive in vaccinating many of our MNIL India employees. A large population of our employee base has been vaccinated, and that has led to very good attendance and a strong supply chain. We are working diligently with everyone to make sure we do everything to provide help and support. But our supply chain still in this current situation is very, very strong.
spk09: Thank you. And the next question comes from Nathan Rich with Goldman Sachs.
spk12: Good morning. Thanks for the questions. Maybe, Tasso, starting with you, I just wanted to make sure that I understood the revenue cadence for the generic segment. You called out the $23 million headwind related to the mild flu and cold season. I'm assuming that that revenue doesn't come back over the balance of the year. Is that a fair assumption? If so, it looks like your underlying view of the business got better. It sounds like pricing trends have been consistent. But you did mention the traction with the new product introduction. Is that what is driving the implied increase in outlook over the remainder of the year? And then just as a follow-up, as we think about the margin opportunity for complex generics, how should we be thinking about those margins relative to maybe the generic segment average? I think you had maybe mentioned biosimilar margins, EBITDA margins being north of 30%, if I caught that number right. Where would you feel like the kind of complex generic average kind of be relative to margins for that segment? Thank you.
spk07: Yeah. So, good morning. So, yeah, I think that $23 million, right, in Q1 related to low flu season, et cetera, that's not going to come back. So, I think you're spot on. But nevertheless, you know, the rest of the year remains unchanged or slightly ahead of our own initial projections. And that really reflects new product introductions and primarily there's a family launch just doing extremely, extremely well. That's number one. And the margins, I think we see sustainability in the low 40s for the rest of the year on the generic side. So that bodes well for increased profitability over all of the generics versus our initial expectations. In terms of the new product, the complex generics, you know, overall the generic margin is in the low 40s, right? So you can assume that's substantially more so than that, substantially more so than that, and primarily during the first, call it, you know, six, seven months where we have an exclusivity. So that kind of bodes well as we think about next year and the year after that about improving gross margins of the generics. You know, biosimilars, I think it's early stages. I think the first three biosimilars we have in place just because there is just more competition at this point in time and because it's, you know, much more partnered. I think the EBITDA that Sirak talked about earlier on, call it, you know, the 30%, I think that's a good number. Over time, as we enhance our manufacturing capabilities external expertise, I think we see those going up from there.
spk06: Yeah, Nathan, this is Chirag. So, what we see is durability for the complex genetics and biosimilars. So, complex genetics may be shorter, biosimilars will be longer. And the margins, and let's stay with the EBITDA margins, would be north of 30%. It may start out between 25 to 30 because of these products are highly competitive, the three we have filed. But as we come out as a first or second biosimilar, just like first or second complex genetics, it will be much higher than 30%.
spk12: Thanks for the comments.
spk09: Thank you. And once again, please press star then one if you would like to ask a question. And the next question comes from Gary Nachman with BMO Capital Markets.
spk10: Gary Nachman Thanks. Good morning. Chirag and Chintu, when you're having discussions with different parties about expanding your portfolio, what segments or technologies are you most focused on or where are you seeing the most opportunities at this point? So, I'm curious, how competitive is the BD environment for assets, especially biosimilars? Do you feel like sellers or partners are being reasonable? And what sort of advantages do you have in getting some of these deals done?
spk06: Thank you. The portfolio on biosimilars, we have the oncology assets, so we'll go for a few more oncology assets, but we'll also go on to autoimmune and on the I side as well, because we are establishing a long-term biosimilar or follow-on biologics platform, 10, 15 years, just like we did with complex genetics. So we'll be pretty much looking at more of where we can navigate the patent, where we can be first or second to market, even the small ones. Those are the how we build a complex genetics portfolio, those same thinking, same playbook we are using to come up with a biosimilar platform. We decide on a biosimilar, actually assets are available because the companies invested in the last 10 years, mostly they focused on R&D. And then they got stuck because of the patent situation in the United States and the advance and all those, you know, how it goes with the branded companies. It takes time to really launch the biosimilars in like Europe. So there is excess capacity in manufacturing sitting out there, especially in Europe and South Korea. and China. So we're tapping on to those, and we do have existing two great partnerships, and we would probably expand to one more and manage with three partners. And we're very keen in bringing manufacturing to the United States as well for many reasons, including the pandemics and climate changes or emergencies. We have to have biologics. manufacturing in the United States as well we in a war footing we put up a vaccine manufacturing expanded and it is helping we got our people vaccinated fast than other countries and we are now in a position to export that so I believe making it here would be very very advantageous And other deals we're looking at is on our Parkinson category, where we have a leading asset already, commercial asset. We have IPX203, which is coming up. They're top-line results, second half of this year. And we like to consolidate the space. So those are the main focus right now from expanding the portfolio and the BD size.
spk10: Okay. And actually, if I could just squeeze in one other, just back to the gross margin, how many products are you shifting from external to internal manufacturing and how will that be phased to help the gross margin efficiencies over time? And just talk about where you're getting most of the efficiencies in manufacturing. Thanks.
spk06: Yeah, sorry. So pretty much our work is done since we came back. We have brought in most of the products in-house. The partner products such as EpiPen comes from Pfizer and Philips, our trusted partner, very reliable, great partners. And we continue to expand that relationship. And our Levothyroxine, our Long Island partner, Jerome Stevens, is excellent over the years and one of the best quality Levothyroxine in the market. So besides those, we pretty much have brought everything, like 14 or so products in-house from various countries. So very, very highly efficient already.
spk07: Yeah, I think that's spot on. The other areas, right? you know, we spend, you know, close, you know, more than $500 million, you know, kind of purchasing raw materials. So that gives us a nice opportunity for our strategic sourcing organization. You know, the same way our customers are pushing for price, you know, that kind of goes down the supply chain, right? So I think that's an area of opportunity, as well as, you know, efficiencies within our own, you know, global manufacturing footprint. the efficiencies on the plant. So Chintu and his team are very focused in that. And we see this continue to produce income for us for the foreseeable future. It's not done yet.
spk06: Yeah. Just give you an example. A year ago, our back order was $30-plus million. Last week, it was $1 million. So we have gained tremendous efficiencies all across New Jersey operations, New York, India, and now Ireland is coming up soon. So it's fantastic. Thank you. Okay. Very helpful. Thank you.
spk09: Thank you. And that concludes both the question and answer session as well as the call itself. Thank you so much for attending today's presentation. You may now disconnect your lines.
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