Amneal Pharmaceuticals - Earnings Call - Q1 2021

Transcript

Speaker 0

Hello and welcome to the Amneal First Quarter twenty twenty one Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note today's event is being recorded. I would now like to turn the call over to Amneal's Head of Investor Relations, Tony D'Amel.

Speaker 1

Good morning and thank you for joining us for Amneal's first quarter twenty twenty one 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 amneal.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 expressed 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 ks and are revised and updated on our quarterly reports on Form 10 Q and current reports on Form eight ks, you can also find on our website and on the SEC's website at sec.gov. We also discuss certain non GAAP measures.

You will find important information on our use of these measures and our reconciliations to U. S. GAAP in our

Speaker 2

earnings

Speaker 1

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 reference throughout the presentation. On the call this morning are Shiraag and Shintu Patel, our Co CEOs Tatas Konenderas, our CFO Andy Boyer and Joe Todisco, 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 Sharag.

Speaker 3

Thank you, Tony, and welcome to Amneal. Good morning all and thank you for joining us this morning. First, I want to acknowledge the public health crisis in India. COVID-nineteen 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-nineteen 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. Generics pharmaceutical industry on foreign manufacturing. We believe it remains critically important to make more products in America for America. Fortunately, Amneal's significant domestic manufacturing base, superb quality record and The U. S.

Domicile enabled us to work closely with federal and state legislators and public policymaker 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 and 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 oil 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 and 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 IPX-two zero three and Kashyub 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 generics and ultimately increase profitability.

We are executing well towards these goals as generics 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 Kashiv Specialty Pharmaceuticals. With Kashiv, Amneal 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 healthcare distribution business where we saw solid top line and profitability performance this quarter.

As we have discussed in the past, AvKARE 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 generics 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, Amneal 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.

Speaker 4

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 medicine 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 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 Amneal's DNA and part of our culture. As Shirag state, R and D is the growth engine for our industry and we continue to invest in our future pipeline. I will start with generics. We believe that we are at an exciting time for Amneal two point zero as we begin to see the benefits of the transition of our development activities 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.

Zafamy, which we launched in March and is a complex hormonal batch is a perfect example of our genetic strategy in action. Zafami received CGT designation, which grants it one hundred and eighty 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 the CGD designated industry wide, Amneal 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. Or 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 towards specialty pipeline, IPX-two zero three 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, IPX-two zero three 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, sixty percent of PD patients or roughly six hundred thousand 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 Rytary is an extended release carbidopa levodopa 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. Demonstrate a clinically superior efficacy profile versus immediate release and will boast a much more convenient dosing regimen.

As a result, we believe that IPX-two zero three 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 trihexifrenadil for the treatment of Thyloria 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 Amneal to new heights.

Chirag and I share excitement and confidence in the journey ahead. I will turn the call over now to Tasos.

Speaker 2

Thank you, Chidu. 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 our efficiencies. As a result, in the first quarter of this year, we reported net revenue of $493,000,000 adjusted EBITDA of $126,000,000 and adjusted diluted EPS of $0.20 In addition, we generated $148,000,000 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 $313,000,000 was down $40,000,000 or 11% compared to Q1 twenty twenty. This decline was not surprising and was primarily driven by an almost nonexistent flu and cold season, which adversely impacted products like generic Tamiflu as well as higher purchases last year at the onset of the COVID-nineteen pandemic.

On a pro form a basis, as we adjust for the various discrete events, generic net revenues grew low to mid single digits. We continue to be very pleased with the performance of our new product launches, where products launched since January delivered over $36,000,000 in net revenue growth, offsetting price deflation as well as the lingering negative impact of the pandemic. From a product perspective, epinephrine, alurine, hemothyroxine and sucralfate were strong contributors in the current quarter. In addition, Zafem is performing very well. And as you may remember, we launched it in March, 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%, two fifty basis points higher than Q1 twenty twenty and six thirty 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 $96,000,000 up $8,000,000 or 9% from Q1 twenty twenty. As a reminder, our Specialty segment centers around neurology and endocrinology with our promoted brands Ryder and Unithroid.

Both brands continue to grow and in aggregate they delivered $56,000,000 up 11% versus Q1 twenty twenty. This growth as well as improvements in our gross to net offset declines in ZOMIG due to its upcoming loss of exclusivity. Adjusted gross margin for Specialty was 78.4%, three eighty basis points higher than Q1 twenty twenty and four '20 basis points ahead of full year 2020, mostly due to a favorable product mix. Let me now move to Abcare, which reported net revenue of $84,700,000 up $26,700,000 or 46%. As a reminder, the acquisition was closed in 01/31/2020.

As a result, the current quarter reflects three months of sales versus two months last year. Adjusted gross margin for the quarter for AvKARE was 19.6%, in line with Q1 twenty twenty and two ten 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 $126,000,000 was slightly ahead of our expectations and $8,000,000 below Q1 twenty twenty, 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 and D and sales and marketing to drive long term growth. And third, the tough comparison to Q1 of twenty twenty, where our adjusted EBITDA of $134,000,000 was substantially higher than the $107,000,000 average for the remaining three quarters of the last year. Adjusted diluted EPS of $0.20 was flat to Q1 twenty twenty as our adjusted EBITDA performance and lower interest expense offset the very high prior year comps. Again, last year's first quarter of $0.20 in EPS was much higher than the $0.14 average of the remaining March. From a cost perspective, operating cash flow of $148,000,000 was ahead of our expectations and well ahead of the $49,000,000 we generated in Q1 twenty twenty.

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 $456,000,000 compared to three forty seven million dollars 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 balance sheet.

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 Shiroc.

Speaker 3

Thank you, Tasos. We are pleased with our continued positive momentum through the start of 2021 as we continue to execute against our Amneal two point zero strategic vision of long term sustainable growth. I would now like to turn the call over to the operator to take your questions.

Speaker 0

Yes, thank you. We will now begin the question and answer session. And the first question comes from Greg Gilbert with Truist.

Speaker 5

I have a few. Sharag, 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 U.

S. 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 upfront. Tassos, maybe you could comment a little bit on the AvKARE strength and how lumpy that is and what some of the drivers are there?

And lastly, for Tinto, 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.

Speaker 3

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 Impex 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 plans, impacts plans to anneal, 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 it pick up.

But the overlaps are so many. So if we find a target without overlaps, you're really good. And I I 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, I think it 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 it's a little bit of uphill slope. I hope I answered that question to you. I'll pass

Speaker 2

it on AvKARE. Yes, good morning. Let me try this if that works. So AvKARE overall is growing nicely. So last year we did about almost $300,000,000 This year it will grow mid double digit.

So feel good about the top line growth. Profitability, we knew that when we did the deal profitability for the business is around high double digits. So last year was 18%. And Q1, we're seeing a 20%, 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 $300,000,000 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 government customers and the team has a lot of expertise. So over time, we're looking to grow that segment, not only by leveraging third party products, but also Amneal 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 what we're looking for more operating efficiencies over time. So I think overall, I think the business again this year is going grow mid double digits. I think for the next few quarters, it will be 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, helped.

Speaker 3

And just to add a bit, we're also growing the unit dose business by launching eight to 10 of our own liquid products out of our Branchburg, New Jersey site. So that should be a nice uptick for healthcare next year. Chinthu?

Speaker 4

Hi, Greg. Good morning. So good question on Nexplan. So Amneal, as you know, has been investing into a complex generic space and we continue to go up the value chain. And the products like Nexplanar, which is a drug device combination implant product, sits 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 cash use acquisitions, we acquired that some of the talents that is required. I will not get into the particular product, but Amneal, 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 Amneal is moving up and it's part of our portfolio, not the particular product, but anti drug device combination, implant category is something we are very excited and we have the knowledge and we are working aggressively to bring that to the market.

Speaker 5

Thanks gentlemen.

Speaker 0

Thank you. And the next question comes from Daniel Busby with RBC Capital Markets.

Speaker 6

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?

Speaker 3

Thank you, Daniel. So the big picture, how do you see Amneal growing? So Amneal two point zero. So we said the complex generics is a driver of the business within generics. Right?

We got within complex generics, all kind of dosage form that Shinto mentioned, device products, the inhalation products, injectable products. And as we have said it a year ago that biosimilars we put them in a complex generics. So that segment going from somewhere at $1,400,000,000 1,500,000,000.0 to a higher 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 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 forecast for that pipeline. IPX-two 03 is moving nicely. So is K-one hundred twenty seven. And we are very serious on and we got the platform, we got the technology.

And one thing Amneal does really well is once we get in, we do it. We finish the job. So we it's a long term view for us. Five, ten years, we'll build the specialty business to be to be at a great level on a more contribution on EBITDA than revenue. And I don't want to say the mix exactly, but it is on a tremendous growth trajectory and also it will be complemented by accretive strategic M and A because we have the strength.

We got the cash flow. We got the complex generics complementing the specialties. So Parkinson's disease side, like to consolidate as many products as we can. Same thing on endocrinology is how our T3 comes and then there's more to come. So very excited and very targeted on those two areas.

Speaker 2

Do you want to take this? Yes, Daniel. Good morning. Yes, 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 we have, we're very confident on the step change, number one. Number two, as new products kind of come in, those new products will be fueling growth mostly towards Q4 and into next year.

Speaker 6

Great. Thanks for the color.

Speaker 0

Thank you. And the next question comes from David Amsellem with Piper Sandler.

Speaker 7

Thanks. So just a couple. So on the biosimilars, can you just talk about I know that this is a partnership model, but how should we think about, 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 those the shared economics. So that's number one. Then number two is you talked about other programs, 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 G CSFs? And then lastly, is there anything that you can add on the Copaxone generic? And is this still part of your expectation that you expect that opportunity to bear fruit later this year? Thank you.

Speaker 3

Thank you, David. So our biosimilars 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 150,000,000 $200,000,000 for biologic and the patent dance, the ticket of patents. So we want to see how plus the adoption of biosimilars, which is all playing now nicely over now and over next ten years, we see biosimilar as a great business. And not only biosimilars, it will then just like in small molecule or 55B2s, biosimilars may end up into BioBetters or follow on branded biologics because which could be brought earlier in the market.

So we've been very diligently working, over last couple of years to identify great partners. We understand the 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 and D, 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, David, when will we announce the next partnership this year?

Speaker 4

And, David, your last question on COPAXONE. Yes. We are working and the product can have launched later this year or early first quarter twenty twenty two.

Speaker 7

Great. That's helpful. Thank you.

Speaker 0

Thank you. And the next question comes from Elliot Wilbur with Raymond James.

Speaker 7

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 ZOMIK? You.

Speaker 2

Lucas, good morning. This is Tassos. We're 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 about 45%. We believe those are sustainable.

My gut feel 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, 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%. So I think we'll be pleased to cross 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, was not overall one of the things we are proud about we have created. We have created very diversified business, much more so than three years ago. So we have Advair, that's a big part of the business.

Specialty has grown. We have a portfolio of generic products, over two fifty 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.

Speaker 0

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 May.

Speaker 8

Thank you. That's very helpful.

Speaker 0

Thank you. And the next question comes from Dana Fernandez with Guggenheim.

Speaker 9

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 Amneal's overall supply chain is just relatively positioned?

You.

Speaker 2

Hey, Dana, this is Tassos. I'll take the first question on pricing. And we're seeing just the high level, we're seeing consistent behavior as you're hearing from some of the other manufacturers. But also when I point out, this is exactly what we planned this year. So 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, coming it's a little worse than that. But our ability, right, 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 market share growth that we are seeing by the commercial team is offsetting that and ultimately is increasing our profitability in a sustainable way. So we're 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 Siroc, I think has a good perspective on that.

Speaker 3

Thank you, Tasos. So situation is very great. There are local lockdowns, for machine tools being essential industry, it is allowed to operate. The inventory levels are for Amneal is very good, three plus month, 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 M and A is concerned, any shortage from our product. Others may face based on where they're located and how much preplanning have they done. But for now, next month or two should be fine. We expect the situation to improve hopefully after one month. And I'm Neil 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 US FDA approved plant in India. So and everybody is assisting many countries have as you know offer lots of help. So there's enough seem to be enough remdesivir.

Was in the call with Gilead. They 15,000,000 vials that will produce the seed this month. So they they're all trying to help. Same thing with Pfizer and hopefully the more vaccines will will be available besides just AstraZeneca. So it's a it's it's very green there and we hope it improves.

Thank you.

Speaker 4

And just to add just one point, we were very proactive in vaccinating many of our our employee base has been vaccinated, and that has led to very good attendance and a strong supply chain. But we are working diligently with everyone to make sure we do everything to provide help and support. But our supply chain is still in this current situation is very, very strong.

Speaker 0

Thank you. And the next question comes from Nathan Rich with Goldman Sachs.

Speaker 10

Good morning. Thanks for the questions. Maybe Tassos, starting with you. I just wanted to make sure that I understood the revenue cadence for the generic segment. You called out the $23,000,000 headwind related to the mild flu and cold season.

I'm assuming that that revenue kind of doesn't come back over the balance of the year. Is that a fair assumption? And if so, it looks like your kind of underlying view of the business got better. It sounds like pricing trends have been consistent, but you did mention the traction with new product introductions. So is that what is kind of 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 margin 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.

Speaker 2

Yes. So good morning. So yes, I think that $23,000,000 right in Q1 related to low flu season, etcetera, that's not going to come back. So I think you're spot on. But nevertheless, but the rest of the year remains unchanged or slightly ahead of our own initial projections and that really reflects new product introductions and primarily the Zafemil launch just doing extremely, extremely well.

I think 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 overall of the generics versus our initial expectations. In terms of the new product, the complex generics, overall the generic margins it is in the low 40s, right? So you can assume that substantially more so than that, substantially more so than that.

And primarily during the first call it 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. 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 much more partnered. I think the EBITDA that Shirak talked about earlier on, call it, the 30%.

I think that's a good number. Over time as we enhance our manufacturing capabilities and our internal expertise, I think we see those going up from there.

Speaker 3

Yes, Nathan, this is Shirak. So what we see is durability for the complex generics and biosimilars. The complex generics may be shorter, biosimilars will be longer. And the margins and let's stay with 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 biosimilars just like first or second complex generics, it will be much higher than 30%.

Speaker 10

Thanks for the comments.

Speaker 0

Thank you. And the next question comes from Gary Nachman with BMO Capital Markets.

Speaker 8

Thanks. Good morning. Shiroc and Shintu, 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?

Speaker 3

Thank you. The portfolio on biosimilars, we have the oncology assets. So we'll go for a few more oncology assets. We will also go on to autoimmune and eye on side as well, because we are establishing a long term biosimilar or follow on biologics platform ten, fifteen years just like we did with complex generics. So we'll be pretty much looking at more of where we can navigate the patent, we can be first or second to market, even the small ones.

Those are the how we build the complex generics portfolio, those same thinking, same playbook we are using to come up with a biosimilar platform. BD side, on the biosimilars, actually assets are available because the companies invested in last ten years. Mostly they focused on R and D and then they got stuck because of the patent situation in The United States and advance and all those, you know how it goes with the branded companies. It takes time to really launch the biosimilars unlike Europe. So there is excess in manufacturing sitting out there especially in Europe and South Korea and China.

So we are tapping on to those and we do have existing two great partnership and we would probably expand to one more and manage with three partners. And we're very keen in bringing manufacturing to United States as well for many reasons including the pandemics and climate changes or emergencies. Have with our 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 more 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, the top line results second half of this year. And we like to consolidate the space. So that those are the main focus right now from expanding the portfolio in the BD side.

Speaker 8

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.

Speaker 3

Yes, 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

Speaker 2

the best

Speaker 3

quality Levothyroxine in the market. So those besides those, we pretty much have brought everything like 14 or so products in house from various CMOs, which allowed us to now produce more and more margins. So very, very highly efficient already.

Speaker 2

Yes, I think that's spot on the other areas, right. We spent close more than $500,000,000 kind of purchasing raw materials. So that gives us a nice opportunity for our strategic sourcing organization. The same way our customers are pushing for price that kind of goes down the supply chain, right. So I think that's an area of opportunity as well as efficiencies within our own global manufacturing footprint, right, the efficiencies of the plant.

So Chinto and his team are very focused in that. And we see this continue to produce income for us for the foreseeable future. Yes. Not done yet. Yes.

Just to give you

Speaker 3

an example, a year ago, back order was $30 million, last week is $1,000,000 So we have gained tremendous efficiencies all across New Jersey operations, operations in New York, India and now Ireland is coming up soon. So it's fantastic. Thank you.

Speaker 8

Okay. Very helpful. Thank you.

Speaker 0

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.