Amneal Pharmaceuticals, Inc. (AMRX) Q3 2023 Earnings Call Transcript

Amneal Pharmaceuticals, Inc. (NYSE:AMRX) Q3 2023 Earnings Conference Call November 7, 2023 8:30 AM ET

Company Participants

Anthony DiMeo – Head-Investor Relations

Chirag Patel – Co-Founder & Co-Chief Executive Officer

Chintu Patel – Co-Founder & Co-Chief Executive Officer

Tasos Konidaris – Chief Financial Officer

Joe Renda – Senior Vice President & Chief Commercial Officer-Specialty

Harsher Singh – Senior Vice President-Biosciences

Conference Call Participants

Leszek Sulewski – Truist

Balaji Prasad – Barclays

Operator

Good morning, and welcome to the Amneal Third Quarter 2013 Earnings Call. I will now turn the call over to Amneal Head of Investor Relations, Anthony DiMeo.

Anthony DiMeo

Good morning, and thank you for joining Amneal Pharmaceuticals Third Quarter 2023 Earnings Call. Today, we issued a press release reporting our Q3 results. We announced certain unaudited preliminary results for Q3 on October 23. Our earnings 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 US GAAP are in the earnings presentation.

On the call today are Chirag and Chintu Patel, Co-Founders and Co-CEOs, Tasos Konidaris, 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 hand the call over to Chirag.

Chirag Patel

Thank you, Tony and good morning everyone. We delivered another very strong quarter with $620 million of revenue, which is up 14%, adjusted EBITDA of $154 million, up 22% and adjusted EPS of $0.19, up 36%. We saw growth in all three of our business segments and reduced net leverage to 4.6 times.

Given the strength of our year-to-date performance, we are pleased again to raise our full year 2023 guidance. We are excited about our continued momentum, which underscores the strength of our strategy and solid execution. As we have discussed throughout the year, we believe Amneal is at an inflection point, poised to drive significant top and bottom line in 2024 and beyond.

I’ll start with a quick overview of our company and then walk through what we saw in each of our businesses during the third quarter. At a high level, Amneal is a world-class global diversified pharmaceutical company, fulfilling our mission to provide access to high-quality and affordable essential medicines. In our affordable medicines business, our generic segment, we have retail, injectables, biosimilars and international. Our strategy continues to focus on expanding our portfolio with impactful complex and high level high-value products.

For the first nine months of 2023, generics revenues were up 7% compared to last year, reflecting a meaningful acceleration from the steady 3% CAGR we delivered from 2019 to 2022. We expect high-level digit — high single-digit top line growth in generics to continue, driven by our diverse portfolio and cadence of over 30 new product launches every year.

In injectable, our goal is to be top five in the United States institutional market. There are two key factors that we believe differentiates Amneal and will drive our success. The first is expanding capacity and capabilities and the second is an expanding portfolio. In 2023, we have executed on both. We successfully brought online two new sites, which doubled our manufacturing capacity. Currently, we have 35 commercial injectables with over 25 new launches planned by 2025, as we continue increasing production and expanding our portfolio in a market, plagued by shortages, we are well positioned for higher injectables revenues in 2024 and over $300 million by 2025.

In biosimilars, our three commercial products continue to see strong uptake. Our largest product ALYMSYS was at 6% market share as of September, which is remarkable in the first three quarters post launch. We expect $60 million in biosimilar sales this year more than double that next year and over $200 million in 2025.

In addition, we expanded our partnership with mAbxience who we work with on ALYMSYS to add two formulations of denosumab and oncology biosimilar to our pipeline. This is part of the next basket of biosimilars for Amneal. By 2024, we look to add two to three more biosimilars to the pipeline. We see biosimilars as the next wave of affordable medicines and are committed to being a leader in this space.

Internationally, we are leveraging our US FDA proved portfolio to expand our reach and drive profitable growth. In India, we have our local infrastructure and are expanding our local portfolio. In other geographies, we are working with partners to commercialize our products. For example, we now have two products approved in China. We expect international expansion will add $50 million to $100 million revenues by 2027 and scale further over time.

In our affordable innovations business, our specialty segment, we are focused on neurology and endocrinology therapeutic areas. Our commercial teams continue to drive growth in our key branded products RYTARY for Parkinson’s and UNITHROID for hypothyroidism. As you know we received a CRL for IPX-203 seeking additional data in July.

I’m pleased to report that we had a successful type A meeting with FDA last month and we are working diligently towards the 2024 approval and launch which Chintu will discuss shortly. We expect specialty revenues to be over $500 million by 2027. Finally, in our healthcare segment we continue to see robust growth across all three channels: distribution government VA/DoD unit dose. We expect AvKARE revenue of $500 million in 2023 and over $600 million by 2025.

I’ll now pass it to Chintu.

Chintu Patel

Good morning, everyone. Thank you, Chirag, and thank you to the global Amneal family who work hard every day to help make healthy possible for so many. We are laser focused on executing our strategy to be an innovative and diversified global pharmaceutical company capable of driving sustainable growth in the key areas of medicine. The successes of 2023 are clear proof points that we are on the right track. I will touch on how operational excellence, strong supply chain and highly productive R&D engine profiler strategy.

First, we remain focused on driving operational excellence and efficiency as Amneal has one of the best service levels in the industry. As part of our efforts to drive continuous cost efficiencies globally, we are transferring production for about 30 products for cost improvement and also working on many operational excellence programs for long-term savings. In addition, we have strengthened our supply chain by expanding our infrastructure, particularly in injectables.

We have doubled our injectables capacity with four facilities and 19 production lines, while the injectables market continue to face supply shortages. Importantly, about 30 of our commercial ANDA and pipeline injectable products are on the US FDA shortage list. Amnneal is very well positioned to help address drug shortages in the US. At the same time, we remain committed to maintaining our stellar quality track record. Since 2005, the US FDA has conducted nearly 100 successful inspections with no observations or only minor 483s. Overall, our high-quality global operations are at scale to support sustainable long-term growth.

Second, innovation is the lifeblood of any growing pharmaceuticals company and that’s certainly the case for Amneal. In generics, we are on track for over 40 new launches in 2023 with 33 year-to-date. This is well above our normal cadence of 30 per year. Also, it’s more than just the number of new launches. It is the complex idea of these products, less competitors and the increased value of our diversified portfolio. Our pipeline is deep with 166 products pending approval or in development. Accordingly, we expect over 30 new launches next year and for years after that.

In addition, while we have shifted towards complex innovations, we have also improved the efficiency of our R&D operations. We are doing more R&D with less spend, which results in a better ROI on projects.

Let me share some more details on R&D. Overall, we have 88 ANDAs pending with FDA, of which 64% are non-oral solid products. Behind that, we have 78 pipeline products, of which 90% are non-oral solids. We have shifted our focus to high-value complex categories with approximately 45% of pending ANDAs and over 60% of our pipeline expected to be first to market, first-to-file or 505(b)(2) products.

In Injectables, we have launched 10 new products year-to-date including two high-value products in Q3 with potassium phosphate and calcium gluconate bags. Also we recently received approval for methylprednisolone acetate, which is in shortage.

Further, we are advancing a number of complex injectables in our pipeline. In Q3, we filed our first to 505(b)(2) ready-to-use bags as planned. We expect to file several long-acting injectables in the near-term as well. As a result, we expect a strong cadence of impactful new injectables to continue in 2024, including the launch of already approved Pemry-DRTU.

After injectables, we see inhalation as Amneal’s next key growth area in complex generics. Our pending ANDA for a generic version of Narcan is under priority review and we look to launch in the coming months upon approval. This important over-the-counter product improves access to a critical overdose tripped.

In addition, we have two key meter-dose inhaler ANDAs pending for generic version of QR and Pro. In biosimilars, our first three oncology products are seeing excellent uptake and we have added two additional molecules to the pipeline. We are also evaluating opportunities to be vertically integrated over time. Please see our catalyst slide for the list of recent and upcoming launches.

Turning to specialty R&D, we continue to work to advance our 505(b)(2) pipeline. On IPX203 as Chirag highlighted, we had a successful Type A meeting with FDA last month to align on the path to approval. As agreed with FDA, we are in the process of completing a small routine QT study in healthy patients. We will complete the study in the coming months and we will resubmit our NDA in early 2024. We are working diligently towards an IPX203 launch in the second half of 2024 pending FDA approval. We continue to see IPX203 as a critical innovation that meaningfully advances the standard of care for Parkinson’s patients.

In summary, we are driving operational excellence and executing our innovation strategy, which together are fueling our ability to drive sustainable growth. I will now hand it over to Tasos.

Tasos Konidaris

Thank you, Chintu. Let me first start with the four pillars of value creation from Amneal. That is diversification, strong financial performance, cash generation; and fourth overall debt reduction.

First starting with increased diversification. Chirag and Chintu touched on this throughout the overview of Amneal’s strategy and business highlights. Since 2019, the portfolio is remarkably more diversified with new lines of business. In 2019, oral solid generics represented 53% of total revenue. Now in 2023 with new complex generic launches growth in injectables and specialty and the addition of biosimilar in AvKARE, the portion of oral solid generic revenue is less than half of that at only 26%, of the total company revenues. The higher level of diversification was intentional and driven by our desire to deliver consistent financial performance, despite the typical ups and downs of any business. As a result, our diversified portfolio is driving sustainable higher levels of growth and profitability, as well as increased future visibility.

Let me now move to our second pillar, for strong financial performance. As an example, since 2019, our annual revenues have increased by over $800 million or 50% while adjusted EBITDA is up about $200 million or 60%. Consequently, our third quarter strong financial performance is not an isolated event and reflects strong execution, across our strategic choices for a number of quarters and years.

Let me now go into a bit more detail of our third quarter results. Total net revenue was $620 million, growing 14%. Adjusted EBITDA of $154 million growing 22%, adjusted EPS of $0.19 growing 36%. All three business segments grew revenue substantially this quarter.

Q3 Generics net revenue was $391 million, growing 12% driven by our new biosimilars and new complex generics as new launches in 2023 and 2022 added $14 million in Q3 revenue growth. The acceleration in generics growth in 2023, reflects the continued shift towards a diverse complex portfolio and the addition of key new products that are added to growth.

Next, in Specialty net revenue was $97 million, growing 9% driven by Unithroid and Rytary. Q3 after net revenue of $132 million, grew 25% which reflects strong execution in new product introductions by the team. Q3 adjusted EBITDA of $154 million, reflects strong revenues, durable gross margins and tight expense management.

Looking at our Q3 year-to-date results. Total company revenue growth is 11%, with generics up 7% and specialty growing at 5% and AvKare growing at 28%. Combined with stable gross margins and operating expense leverage, year-to-date adjusted EBITDA grew 16% and adjusted EPS grew 11%.

Let me now move to our 2023 full year guidance, where given the continued strong performance across the business, we’re raising our full year 2023 expectations again this quarter. We now expect net revenue of $2.37 billion to $2.42 billion, which reflects high single-digit revenue growth. Due to higher revenues, we are raising our 2023 adjusted EBITDA guidance to $540 million to $550 million and adjusted EPS range between $0.51 [indiscernible].

Let me now move on how strong financial performance is translating, into the third pillar of value creation. That is higher cash generation. In 2023, in conjunction with higher profitability and our efforts to drive working capital improvements, our center year-to-date operating cash flow on an underlying basis has grown about 40% to $295 million compared to $213 million for the first nine months of 2022.

Going forward, we’re focused on converting an increased amount of higher EBITDA to operating cash flow, as a fraction of targeting further working capital improvements and thoughtful CapEx investments.

In addition, as you may have noticed on Form 8-K, we filed on October 17, we made important progress on a key legacy item, that is transitioning from an Up-C Corp structure to a more traditional C-Corp structure. This transition was highly technical in nature but has substantial cash flow benefits to our company as it enhances investor transparency and servload by having only one class of common stock.

This leads me to the fourth pillar of value creation and that is deleveraging. With higher cash generation and many of the historical improvements investments to expand our portfolio and infrastructure already made, we’re in a very good position to further reduce debt.

From 2019 to now net leverage has come down from 7.4 times to 4.6 times in the most recent quarter. We’re focused on delivering consistent debt reduction over the course of time and we feel confident in our ability to achieve net debt to adjusted EBITDA below 4 times in 2025.

I hope this overview of the key pillars of value creation for Amneal. Going forward, we’re confident that the increased diversification of our business strong financial performance higher cash generation and further deleveraging will create substantial value.

Let me now hand it back to Chirag.

Chirag Patel

Thank you, Tasos. In summary, Amneal has never been in a better position to drive substantial sustainable long-term growth and we believe the best days are ahead for our company.

Let’s now open it up Toni for Q&A.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] We will now take our last question from Balaji Prasad from Barclays. Balaji your line is now open. Please go ahead.

Anthony DiMeo

Operator, we can go to the next participant and put Balaji back in queue. Thank you.

Operator

Okay. No problem. We will now take our next question from David [Indiscernible].

Unidentified Analyst

A couple. So, first, I wanted to ask you about AvKARE and its role in the organization going forward. I mean, is that a business that do you think might be non-core over time? How do you think about it strategically? That’s number one. Number two regarding injectables and all the launches that you signed are these mostly shortage products are — is it a mix of shortage of products and complex products? I’m just trying to understand how to think about the product mix care and injectables and what the margin structure for injectables is going to look like over time margin structure vis-à-vis your corporate margin structure? Thanks.

Chirag Patel

Hey, David, how are you? Good morning. On AvKARE as you know we are very few remaining US manufacturers. That is where most of the business is driven through TAA compliant products. So it is a strategic business for us. It grows as you can see the number of products for VARD plus we have a niche unit dose as well. And as you know we have a partner who is expert in this area is running the business.

So I would — I mean, exact definition of core non-core but it is very strategic at this point for us but we are open to evaluate options in the future. It is a strong business highly profitable and we are very committed to it. The second part I’m going to pass it to two gentlemen since we have everybody today in the conference room we’re going to start with my brother and he’ll pass it to Harsher.

Chintu Patel

Hi, David. Good morning. On Injectable we have a very big portfolio and we invested for the last two years on expanding our R&D capabilities and also infrastructure. So we have a very wide variety of dosage form capabilities PFS large bags auto injectors liposomal peptides microspheres. These are complex categories and some are also volume. So we have now capabilities to play value and volume game both in the injectable space going forward where our current capacity was around $20 million — $25 million, whilst our PFS combination of different products it has gone up to about $70 million. So that’s a big shift.

So second question on shortages we have about 30 products that’s pending approvals are already approved. And the shortage products goes keep in and out but Amneal is very much passionate about addressing the shorter issue. And we — as soon as we have a product we try to help alleviate the shortages.

And some of the launches your question was it’s a mix. Some are first-to-market products some are complex products like MPA multidose. So it’s a combination of both and that’s what we’ll see in coming years and we are confident to launch 20 new products also in injectable in 2024. So a very strong pipeline which we expand to about 80 products by 2025. Harsher, anything to add?

Harsher Singh

David, I’ll just build one thing to frame your comment right which is — I think shortages and complex products are not mutually exclusive. Often the biggest shortages are on complex products. As you see us launch our last six months a pretty good proxy for the portfolio, which is premixed bags electrolytes which are a structurally short category where there are structural issues in the market over the long-term that we hope to address and single product opportunities where we have structural strengths like the corticosteroids, methylprednisolone and others. But you should expect us to continue to proceed along the pathway like that.

Chirag Patel

And David on the margin.

Unidentified Analyst

If I may just – yes, final one.

Chirag Patel

Its okay. Your last point goes impact to the margin. So injectables in general and the areas we play are just they’re going to be accretive to the overall gross margin of the company. So this is one of the reasons why we think about the future we feel confident about enhancing and increasing our financials not only top line profitability and adjusted EBITDA and cash growth.

Unidentified Analyst

Okay. Got it. That was my last question. Thank you.

Chirag Patel

Thanks, David.

Operator

Thank you, David. [Operator Instructions] We will now take our next question from Leszek Sulewski from Truist.

Leszek Sulewski

Good morning. Thank you for taking my questions. Just first on the Rytary front the script growth has been good. I call the sales page was a bit light. So just perhaps maybe walk us through some of the pricing dynamics in 3Q. Was there any discounting in the GTN front? And then secondarily on the IPX 203, can you provide a little bit more details around the feedback from the FDA regarding your Type A meeting and the study design that you expect for that? And then also how are you thinking about the commercial launch in the second half?

Tasos Konidaris

Great. Thank you, Les. I’m going to have our Chief Commercial Officer, Joe Renda answer the Rytary question and then we’ll move to my brother for IPX two or three more details please?

Joe Renda

Yes. So your question on Rytary nothing has changed with our contracting strategy. We’re still fortunate enough with Rytary to have the best coverage of any prescription product in the Parkinson’s space. We have about 70-or-so percent commercial coverage and about 60 or so percent Part D coverage. We actually — the growth we’ve seen has been in the latter part of the year. If you look at Q3 and Q4 as an example our NBRx growth is at around 20% to 22%, which is significantly higher than what we saw at the same time last year. So we are seeing both NBRx growth with Rytary as well as TRx growth. So we’ve been really pleased with the pattern that we’re seeing as we round out this year. And overall this year it looks like our growth will be higher than what we’ve seen in previous years with Rytary.

Leszek Sulewski

And last just on your point about the quarterly gross to net yes we had about $5 million $6 million of over unfavorable kind of timing gross to net adjustment related to Medicare rebates. So that’s why probably the quarterly net revenue growth is that a little less of the kind of volume growth. But that’s behind us and it was more of a onetime event.

Joe Renda

Highlight this onto IPX203 we had a very successful Type A meeting to align our path forward with FDA. So question was mainly on the safety bridge for carbidopa. And we have addressed that for the major — as we had one year of safety data on carbidopa and FDA is aligned on our data and what we had presented. And it leads to only one remaining question, because anytime carbidopa has been an old molecule there’s certain amount of carbidopa we had to do a QT breeding study.

So we are doing a small routine QT study in the 30 healthy patient, which we are starting very shortly in a week’s time and we plan to complete that study and file in first half of 2024 and launched product in second half of 2024. We are ready to launch the product from the commercial and also and from the manufacturing and product is ready to go. We are very excited on IPX203 and what value it brings to the patient.

Chirag Patel

Yes, it’s a much broader value less than Rytary. We’re going after an entire 1 million patient population and 90,000 new patients come on every year unfortunately. So it’s a large market and we want to change the habits of prescription of prescribing IR to start with. Why not IPX203? It’s much better formulation. It gives a good on time, longer time — longer good on time every day meaningful or huge impact on their daily lives. So — and we have lots of obviously data to go with and we never marketed to the broader audience of a broader patient population.

So that is — we are ready for the marketing strategy. We have learned a lot from Rytary launch. And obviously there’s a lot of support for this product as the clinicians have seen the results of this product. So, extremely exciting launch coming up. And not only in the United States we are in a final negotiation in Europe because Europe only has IR. And that be much needed for Parkinson’s patient there. And globally, we’re going to push it out to our mission to provide high-quality life-changing medications to affordable access to global population. Very exciting. And we’re filing the response on a…

Leszek Sulewski

Got it. Thank you for that color. One –

Chirag Patel

Go ahead, Les. Do you have follow-up.

Operator

Sorry, I muted his line. Let me put his line back up. Sorry, Leszek, your line is now open. Please continue.

Leszek Sulewski

Can you hear me?

Chirag Patel

We can Les. Go ahead.

Operator

Yes. We can hear you now.

Leszek Sulewski

Okay. That’s seems to be a lot of feedback on line. My follow-up question was regarding your recent refinancing agreement. So can you just perhaps walk us through some of the key aspects and changes in the covenants and things of that nature? Thank you.

Tasos Konidaris

Yes. Thanks, Les. So we’re pleased to report that after as you know refinancing our term loan B, which was due May of 2025 was one of our key priorities of this year. And I think we’re very pleased with the outcome so far. So after just a lot of very positive support from our existing lenders and a number of new lenders we successfully priced and allocated about $2.3 billion, which is about 90% of our Term Loan B.

And with that, the key thing was we extended the maturity by three years to May of 2028. So essentially a couple of hundred million dollars are due in May of 2025 and $2.3 billion have been pushed out to May 2028. It’s essentially 4.5 years from now which gives us a substantial amount of additional runway for the company to continue the diversification path that we began a few years ago, increasing our cash generation that I spoke of and reducing both absolute debt and net debt to adjusted EBITDA.

As we expected the pricing was pretty much in line with our expectations. So you may have seen on Bloomberg made it was software plus 550 basis points. That’s a couple 100, 200 basis points over the existing loans. So that was within our expectations. So that leads to about $50 million of increase in interest expense, which the unwinding of BPC, I spoke about will more than offset that increase. So from an overall cash perspective that increase in interest expense, which we fully expect will be more than offset by our change in corporate structure, which will save us about $60 million plus year-over-year.

In terms of covenants and so forth, there is nothing kind of big material changes that I can fully recall. And the final thing I would mention is as we need to keep in mind that our interest expense growth is limited, partially because a 3 billion of our debt is fixed. So we have a swap in place, we were able to amend that swap to kind of reduce our interest expense associated with this refinancing. So, a great outcome from our perspective. I’m going to thank both our existing lenders into our term loan for being supportive and working with us over the last few months, because as we know the capital markets held be pretty choppy.

Leszek Sulewski

Great. Thank you.

Operator

Thank you, Les. We will now take our next question from Nathan Rich from Goldman Sachs. Your line is now open. Please go ahead.

Unidentified Analyst

Hi. Good morning. This is Sarah on for Nate. Thank you so much for taking our question. I first wanted to start on the new corporate structure and the cash flow implications. Can you just talk about the peak expected restructuring savings and also the time line to realize these synergies?

Tasos Konidaris

Sure. Good morning, Sarah. So, as people know in this room, it took us a couple of years to kind of fully get our ramps around the legacy structure and really finding the best way that works for all our shareholders. So number one is, we expect to effectuate the change, essentially tonight. So as of tonight, we’ll have that new corporate structure and the savings will become immediate number one.

Our expected savings per year is about $60 million of cash every year. Like those historic levels of cash was exiting the company as cash from financing that was in that specific cash flow line. So those savings will be materialized and will be accretive to the company essentially — immediately as those kind of tax distribution payments is as of tonight. Great outcome. Some companies, I don’t know how much you know about that. Some companies, given one of those structures by paying hundreds of millions of dollars out, we did not — it costs us zero to unwind the structure. We feel great about the outcome.

Unidentified Analyst

That’s really helpful. Thank you. And then, I just wanted to dive into the strong AvKARE growth and the segment’s operating margin improvement. So can you talk about what drove the significant margin uplift in the quarter? And then also, I know GLP-1s have been a big area of focus. Is this also contributing to the strength in this segment?

Tasos Konidaris

Let me take this. So, AvKARE, as you may know, we acquired 65% of AvKARE in January 30 of 2020. And since then, even in periods of COVID and et cetera, that business has been proven incredibly resilient and growing. That’s point number one.

Point number two is part of our strategic rationale is — was how do we leverage MBL’s pipeline of products to accelerate the historic growth of AvKARE and that has played exactly as we thought. There’s been a tremendous amount of product flow from AvKARE to — from — excuse me from ML to AvKARE that has created a tremendous amount of value to the patients. and the buyers right and the ultimate customers of AvKARE.

So that growth has been driven by a couple of different reasons. Number one is overall demand in the marketplace as population ages right and we have a natural, what I will call, a tailwind, number one.

Number two there is simply kind of coming out of COVID, there is simply more product availability both from Amneal as well as the third-party providers that AvKARE works with. So, new product introductions fuel that.

Number three, we’ve talked about certainties in the marketplace associated not only with the injectables, but in general, complex products. So, AvKARE was able to kind of tactically take advantage of certainties in the marketplace this year and price accordingly.

So, that’s what why you see some of the increased gross margin in our performance this quarter and actually year-to-date versus prior years. So, overall, those were the reasons why the growth of AVKARE has been strong and we continue to expect — I’m not sure that the business will continue to be growing 25%, 30% topline every year but definitely we expect strong double-digit growth for the next few years to follow. Does that help Sara?

Anthony DiMeo

Yes. So, Sara, I just want to clarify that AvKARE is a niche government distribution business for VA/DoD where you have to invest in product development, product partnership way in advance. So, it’s a value-added distribution, not just simple distribution.

We do not distribute GLP-1s or anything. So, the growth is from value-added generics products from Amneal as well as other suppliers that AvKARE is set to do government contracting for long-term national contracts as well as FSS schedules and their unit dose business with the hospitals is growing as well.

Unidentified Analyst

That’s really helpful. Thank you.

Operator

Thank you. We will now take our next question from Balaji Prasad from Barclays. Balaji, your line is now open, please go ahead.

Balaji Prasad

Thank you. Hi, good morning everyone and apologies for missing the previous opportunities. Thanks again for that. A couple of questions from me. Firstly, it’s great to see the developments of the company over the past couple of years and especially the last two quarters the transformation has been pretty solid.

As I look out over the next one or two years, I would allow to understand the pushes and pulls that we can expect for the cash flow outflow for 2024, 2025, see how we can think about the cash flow trends for the next couple of —

Two, you’ve definitely flipped around the traditional generic model in looking on going after the markets in India and China. I’d love to get a sense of how large these markets can be, considering that both of these markets are different than the spectrum. India seems to be on a very strong growth platform, whereas China seems to have stalled. And how would you approach these markets differently? Thank you. Thank you.

Tasos Konidaris

Hey Balaji. Good morning. I’ll take the first one. So we think the next few years we continue to drive incremental revenue, incremental EBITDA and incremental cash. No question about it and the incremental cash.

So if you look at our cash to EBITDA this year, there was over 50% much more favorable than prior years, because we intentionally focused on certain working capital improvements, okay. Our expectation is that will continue to grow. So as EBITDA grows, operating cash will continue to grow. That’s point number one.

Point number two in terms of — you also know that CapEx were pretty much at scale. So we typically spend between $50 million $60 million maybe it goes a little higher maybe it was a little lower. But because we are at scale we don’t expect CapEx to substantially change, okay?

We talked about an increase of interest expense. So maybe that goes up call it $50 million year-over-year, okay. But also we will save year-over-year over $60 million of cash distributions related to the APC unwound. So the net of the two is a positive call it, $10 million to $15 million.

So — and the other thing is in terms of settling one of the other things you know about us is we’ve been very focused on kind of cleaning up legacy issues, okay? So back in 2019, we will — not only us, but the whole industry was facing substantial amount of liabilities and not a lot of clarity around it, okay?

So as you know a couple of years ago we settled the Opana ER. So last year we had $130-some million payment related to that. This year, we had an $86 million payment and there is only one payment of $50 million remaining in January of 2024.

So 2024 versus 2023, right, it’s $30 million less of a headwind, regarding the Opana ER, right? So that’s going to be positive. And then after that, right, Opana is behind us.

To step down the liabilities, we talked about opioids. Our team is working really hard. We’ve put a place holder a pretty well educated estimate of about $22 million in our balance sheet for that potential liability.

It may be a little bit more, maybe a little less. And as you know usually those liabilities get settled over a long period of time on multiple years. So we don’t believe that’s going to be, have a material impact at any given year.

So overall I think when you look at all of those pieces, I think there is more cash that stays in the company over the next few years and growing than in prior years.

Chintu Patel

Thank you, Tasos. And the International Balaji, we are two strategies we have. One is using Amneal’s own portfolio which is very huge on injectables and the retail side as well as in the future it could be biosimilars.

We are partnering in Europe. We have Orion, 100 years old Finland Company as our partner. So we’re working through their sales channel to sell the product Amneal’s products. Middle East we just signed up multiple partnerships. So we’ll be selling Ennis product in Middle East and US FDA approved sites approved products obviously has more premium than the other products.

We have finalized our term sheets on Southeast Asia as well and going now to South America Canada. So we’ll cover pretty much the entire world some parts of Africa as well. And basically it would be an incremental revenue of Amneal’s products, which are sold in the United States. So that’s the first strategy which we expect to go to $50 million $100 million plus it will keep growing because we have more and more products that we are launching.

And again, complex products in international markets are very good. We are not taking every product out there. It has to obviously make certain margins for us. And the second strategy is India strategy. That is a stand-alone strategy. That we are — we have direct marketing. We have spent quite a bit of time understanding the market and we have launched our sales forces in hospital several products including diagnostic in hospitals.

And now we are just expanded ophthalmology the eye care products portfolio in India and we will be entering oncology and CNS as well. So, pretty broad strategy because we believe India is growing at 14% 15% every year from a market and it has even more room to grow. So, we want to be part of that growth journey, and we have the science. We have the company’s reputation and set up in India.

So, we believe India can become a substantial market. It’s very small today like $10 million will keep growing but it has – it can go pretty long way in India. So that’s the international strategy we have.

Anthony DiMeo

Just Balaji to add one thing in India. We are looking at beyond our current portfolio especially in a rare disease and some other unmet areas in India because there is a huge unmet needs on many, many products. So, we are looking at certain branded aspect of product development and launching India specifics and that looks pretty exciting in that space, because there is a lot more awareness affordability and people are talking about health and prevention than the previous time. And the India market is shaping up very differently than what we have seen before. So we want to be there and we want to be a value-added something that is unique and new.

Balaji Prasad

Thank you all.

Operator

Thank you, Balaji. We have no further questions registered today. So with that I will hand over to Chirag Patel for final remarks.

Chirag Patel

Well, thank you very much everybody and have a nice day.

Operator

This concludes today’s call. Thank you all for your participation. You may now disconnect your lines.