Hello and welcome to Amneal's First Quarter 2022 Conference Call. My name is Alex and I will be coordinating the call today. [Operator Instructions] I would now like to turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Over to you Tony?.

Good morning and thank you for joining Amneal's first quarter 2022 earnings call. Today, we issued a press release reporting our financial results. The press release and a presentation are available on our website at amneal.com. And a replay of this call will be posted after the call.

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 review 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 certain non-GAAP measures. Important information on our use of these measures and reconciliation to U.S.

GAAP may be found in our earnings presentation. Beginning is the first quarter of 2022 the company will no longer exclude R&A milestone expense from non-GAAP financial measures. In our press release we provide revised prior period results reflecting this change.

On the call this morning are Chirag and Chintu Patel Co-CEOs; Tasos Konidaris, CFO; Andy Boyer, Generics; Joe Todisco, Specialty; and Jason Daly, our Chief Legal Officer and Corporate Secretary. I will now turn the call over to Chirag..

Thank you, Tony. And good morning, everyone. The first quarter was a good start to the year with the revenue of $498 million and adjusted EBITDA of $100 million as expected. We are on track to achieve our full year, 2022 guidance commitments of continued top and bottom line growth.

Building on our consistent results and continued success in executing our strategy over the last several years, we are expanding in high growth areas, including Specialty, Injectables, and now Biosimilars. As a global essential medicines company, underlying our strategy is our focus on affordability, access and addressing unmet patient needs.

Looking forward, as we continue to execute, we see our growth profile accelerating, our business mix increasingly diversifying and our impact on global healthcare expanding. Let me now provide a few updates across our businesses.

Starting with Generics, our business continues to grow as our productive R&D engine continues to diversify the portfolio with new complex medicines. As a result, Amneal has a low product concentration with our largest Generics product represents only 5% of total company revenues. And our top five Generics products are only 17%.

With our focus on more complex and higher barrier products over half of Generics revenue today is non-oral solids as compared to 35% a few years ago. The mix shift towards complex medicines is continuing as 86% of our pipeline is non-oral solids.

Accordingly, we expect durable growth in this business, and we continue allocating returns into high growth areas. In regards to our injectable business, as we have shared with you in the past, this is a key growth area for Amneal.

We are pleased that Injectables will grow approximately 30% this year to more than $160 million in revenue as we are well on our way of achieving $300 million plus by 2025. We look to scale our business with expanded capabilities, increased capacity and new products in our portfolio.

We believe these initiatives will drive substantial and sustainable growth in Injectables for years. In Biosimilars, we are very excited to enter the U.S. biosimilar market with the upcoming launch of our first three oncology products.

We are pleased with the approvals of RELEUKO, a filgrastim biosimilar and Alymsys a bevacizumab biosimilar, which are wonderful achievements by team Amneal and our partners. In addition, we expect approval for a third biosimilar like filgrastim in the next few weeks.

As we have shared with you in the past, we have positioning Amneal to play a large, critical and long-term role in the fast growing $28 billion U.S. biosimilar market. We estimate the market size for these three products based on net revenue is approximately $4 billion of which about half is Biosimilars. Together, we see peak cells for these three U.S.

biosimilars of $200 million. This is the first time we are sharing a Biosimilars’ revenue estimate for us. We are also looking for additional opportunities where we can be early-to-market as we build our portfolio through in licensing to start and vertical integration in time to become a meaningful player in biosimilars.

In healthcare our distribution business, we saw continued nice growth in Q1. We expect sustainable growth driven by strong commercial and operational execution as we expand across multiple distribution channels. In international, we are leveraging our portfolio of complex generic, Injectables, Specialty and Biosimilars medicines to meet local needs.

We believe this strategy will add considerable revenues in time and be highly profitable as we utilize partners and our existing infrastructure. In China, we are making good progress with our Fosun partnership and we look to be a commercial later this year or early next year.

In the 25 million branded generics India market, we have launched our label there and are expanding our in market presence. Around the rest of the world, we are pursuing distribution agreements and look to share with you as we make progress.

In Specialty, we remained focused on driving strong commercial execution of our key branded products and advancing the pipeline. We expect continued full year growth from Rytary Parkinson's and Unithroid in hypothyroidism.

As our pipeline delivers new branded products, including [indiscernible] and DHE this year and IPX-203 next year, we see a Specialty business expanding very meaningfully over the next several years.

Before I pass it over to Chintu, I would like to acknowledge, Joe Todisco, who is moving on from Amneal to be a CEO of a biopharmaceutical company here in New Jersey. I want to thank Joe for his awesome contribution to Amneal over 11 years and his strong leadership. He has built a great team and has contributed to Amneal in a great way.

We wish all the best. And with that, I'll hand it over to Chintu..

drug device combination, peptides, long-acting injectables, liposomes, LVP bags and 505(b)(2) products. Overall, we are on track for over 14 injectable launches from 2022 through 2025.

As we have shared in the past, we believe the combination of our robust quality track record, increasing supply capacity and continued innovation positions us very well to scale our Injectables business and be a sustainable long-term supplier globally.

We are very excited about the large and growing biosimilars market and how Amneal is well positioned for near and long-term growth. The recent approvals of our first two years biosimilars and one more approval expected later this month is a watershed mark for Amneal. We are planning for Q3 launch of Releuko and Alymsys.

We expect to be one of a few companies with three U.S. biosimilars on the market in the oncology space. We were pleased that Alymsys received first cycle approval. This is a tremendous accomplishment by the team and demonstrates our core competencies in this space.

Combined with our partners we have substantial science, regulatory manufacturing and commercial capabilities needed in Biosimilars. We believe the key to success are having the right development path, manufacturing capabilities and being vertically integrated over time from development to commercialization.

We are actually working to enhance our key capabilities and expand our portfolio to drive growth organically and inorganically. As we target to add new biosimilar launches in the years ahead. We are very enthusiastic about our future in biopharmaceuticals particularly Biosimilars as the opportunity is coming to fruition now for us.

In international, we are advancing our strategies in China and India and the rest of the world. We see global expansion as another vector for long-term sustainable growth. In China we currently have five products filed with 10 to 15 expected by the end of 2022 and 20 to 30 over time.

In March we were pleased to be one of the companies to receive a sub-license to manufacture and commercialize Paxlovid in 95 low- and middle-income countries. We are evaluating distribution strategies to drive access to this COVID-19 treatment. In Specialty, we are expanding our branded portfolio and we see a number of growth drivers.

Our current Specialty pipeline represents $500 million to $1 billion U.S. peak sales. First, we expect to launch LYVISPAH for specifically in June. Next, we look to launch our DHE Autoinjector for migraines and cluster headaches later this year upon approval. For IPX-203, we completed our pre-NDA meeting with FDA.

At the American Academy of Neurology Meeting in April we presented two abstracts sharing top-line clinical efficacy results and post hoc analysis showing 1.55 hour is more good on time for those. We expect to submit our NDA in Q3 and pending FDA approval remain on track for launch in mid-2023. We see $300 million to $500 million in U.S.

peak sales for IPX-203. On K-127 for Myasthenia Gravis we expect to file our NDA by end of 2022, and are pursuing other indications. Also our other pipeline programs, K-114 and K-128 are progressing well. We look to share more on our expanding Specialty pipeline.

We are adding new 505(b)(2) programs that look to repurpose existing molecules, utilizing our drug delivery technology platforms, GRANDE and KRONOTEC. We billing these technologies differentiates us in Specialty. Overall we are very excited about our Specialty growth prospects and expect at least one new launch per year going forward.

To summarize our strategy for accelerated growth is built upon our strong foundation of innovation, super quality and operational excellence. Across the business we remained laser focus on execution this year. I will now hand it over to Tasos..

Thank you, Chintu. Our first quarter financial performance was in line with our expectations, and thanks to the good work by all our colleagues who are pleased to re-affirm our full year 2022 guidance for continued top and bottom line growth.

For the first quarter, we reported total net revenue of $498 million, adjusted EBITDA over $100 million, and adjusted diluted EPS of $0.12. Our results include $5 million of R&D milestone expenses, which we no longer exclude from our non-GAAP results.

The annual run rate of these expenses is $50 million to $20 million and represents external collaborations to advance our R&D pipeline. As policy change there is no economic [indiscernible] impact to our business. Q1 generics network of $318 million grew $5 million or 2%.

Products launched in 2021 and 2022 contributed $14 million of growth offsetting the typical declines in the remaining portfolio. As we have said in the past, our focus and innovation in strong commercial execution is a key differentiating factor that enables our sustainable top line growth.

Consequently products launched prior to 2019 now accounts for about 65% of generics net revenue and declining fast. This reduced reliance on older, more prone to competition products bodes well for continued growth and profitability.

In Specialty, Q1 net revenue of $85 million declined $11 million or 11%, and represent the low point of quarterly revenue for the year. This performance reflects Zomig's loss of exclusivity as well as higher than typical quarterly reimbursement cost related to Lannett.

We continue to be excited by the total prescription growth of Rytary and Unithroid up 6% and 13% respectively, as well as the upcoming launches of like LYVISPAH and DHT Autoinjector. Our AvKARE net revenue of $95 million grew $10 million or 12% reflecting strong customer acquisition success in the non-federal distribution channel.

Q1 2022 adjusted gross margin of 43.5% was in line with prior quarter and reflects the dynamics. First, generics gross margin of 42%, a 300 basis points improvement from prior quarter. Second, AvKARE gross margin of 15% or 500 basis points declined from prior quarter due to mix of business.

And finally, $15 million of costs related to timing of our manufacturing production schedule. The last item is a timing issue and will improve the future quarters providing substance additional gross margin and profitability.

Q1 adjusted EBITDA of $100 million was actually a few million higher than the expectations we shared with you during our February early call. As I mentioned earlier, it also includes $5 million related to our reporting policy change and $15 million of manufacturing overhead allocation.

From an operating customer perspective we generated $120 million of cash, which we continue to deploy in driving sustainable long-term growth. Consequently, in the first quarter we invested $131 million to fully fund the previously announced acquisitions of Saol, Kashiv and Puniska Healthcare.

Looking ahead and consistent with our discussion in our February earning call, we expect substantial acceleration of top and bottom line growth over the course of this year. This growth will be driven by four factors. First, multiple new product introductions such as RELEUKO, LYVISPAH, Lioresal and other new biosimilars.

Second, strong underlying demand of key growth brands such as [indiscernible] unit growth. Third, favorable fixed overhead manufacturing absorption, and finally stability in our operating expenses. [Indiscernible] well understood and within our control, gives us confidence in delivering 2022 financial guidance.

Let me hand the call back to Chirag right now..

Thank you, Tasos. In summary, we are on track for another great year in 2022. We see momentum across our business, including our first U.S. biosimilar approval. We see these growth drivers building and accelerating our company performance this year, next year and beyond. I'll now open the call to questions..

Thank you. [Operator Instructions] Our first question for today comes from Gary Nachman of BMO Capital Markets. Gary, your light is now open. Oh sorry, Gary, you might be muted. Sorry, Gary I'm still not receiving any audio. Could you make sure? [Operator Instructions].

Operator, next question..

[Operator Instructions] Our next question comes from Mikaela Franceschina from Barclays. Mikaela, your line is now open..

Hi, I'm Mikaela on from Barclays on for Balaji Prasad. Just wondering by when can you realize your U.S.

peak sales guided of $200 million plus for your three biosimilars? And when thinking about your Biosimilars how do you plan to get vertically integrated and over what timeframe?.

Mikaela, thank you and good morning. So the peak sales as you know we are working with getting a reimbursement in place, which would be in – should be in place by January 1, 2023. Commercial infrastructure is in place.

So we expect contributions this year adding up to more contribution in 2023 and peak else I would say somewhere between 2023, 2024 we should be able to achieve that. And you had a second question on political integration.

So as we are committed in a biosimilar for long-term, as we have previously stated that our strategy is dual, one is to license from key partners – trusted partners and build our own capabilities. So we are exploring different options and should be able to be vertically integrated by end of this year or the beginning of next year..

Thank you..

Thank you. Our next question comes from David Amsellem from Piper Sandler. David, your line is now open..

Hey, thanks. I joined late, so I apologize if I missed this. But on the margins, I know you talked about the AvKARE being a bigger part of the mix. I just had a bigger picture question about the role of AvKARE in the organization and to the extent that you have periods where it's a bigger part of the mix, and there's some margin compression.

Do you see that as problematic, I'm just trying to get a better sense of where AvKARE fits and where is the margin profile given where you're taking the business, I guess acceptable? So that's number one. Number two is on Biosimilars. I think you laid out some assumptions about peak sales.

So I wanted to get your thoughts on just your view on share – volume share and ultimately how you're seeing overall penetration in the Filgrastim and PEG-Filgrastim and bevacizumab markets playing out of Biosimilars, and what your underlying assumptions are regarding pricing erosion, share and your penetration, that would be really helpful? Thank you,.

David, good morning. So I'll start with the big picture on AvKARE. AvKARE is a excellent cash flow business for us and also allows us to put more products in federal healthcare market, which is VA and DoD as you know we are one of the top two there. So margin could fluctuate it in that business. They have three businesses within AvKARE.

One is the federal government, which is steady and margins, and then they have unit dose business which is growing, and the third business is pure distribution business for City of Philadelphia, and they have added few more cities. So it's a great business. It will fluctuate between 15% to 20% of gross margin and we keep adding the top line.

So we should be focused on top line as well. Anything else on AvKARE Tasos..

No, you are spot on. It's a sustainable business. It is growing both top line and bottom line. David is correct. The overall margin of that business is less so than the rest of our business, but we're really focused on total absolute dollars return there..

Yes..

And whether or not one quarter AvKARE in this situation 15% gross margin versus 18%, that's where it's going to fluctuate and doesn't really move the needle that much from a total company perspective.

So the key driver there is Specialty, which continues to be almost 80% in our generics, which as you know over the last three years, we've grown it from mid-30s to substantially more than 40%,so that will be then..

Yes, and our second question, thank you, Tasos, on Biosimilars. The excellent part is the commercial team is in place, led by Harsher Singh and excellent team with a couple other people added from ADC and Pfizer. And a small team, which added 21 people in institutional sales plus contracting salesforce.

As we have always done a great job in commercialization, we will do a great job in commercialization here as well. And we have understood the market. So as you know, you say quasi branded products, we’re going to get the reimbursement code in place. We’ll do so.

Bevacizumab we are competing with Amgen and Pfizer and obviously the innovator and we would try and maximize our market share to about 15% to 20%. We're more focusing on oncologic clinics, integrated regional systems, so many avenues to get there as well. We will have the 340B pass-through status, which is always helpful.

And then for the GCSF, we have the pass-through status as well, Filgrastim. And it’s a little bit more competitive with the three active players. But we'll try to with our 340B unique position, we may be able to get again 15% to 20% market share or more. And for PEG-Filgrastim would be a little bit more competitive since there are five active players.

So we will try to penetrate different channels. And it should be very helpful to have [indiscernible] with PEG-Filgrastim. So that would be a nice launch as well. So all three very excited and the future of biosimilar we are very excited as well..

Okay. That's helpful. And just if I may follow-up, just to be clear on the shared economics, you just remind me the margin profile of the biosims. I mean, that's not going to be net margins that are going to be higher than corporate operating margins, right.

Is that a fair way to think about it?.

Yes, so may be [indiscernible] would be higher because the bigger market. And PEGNG [ph] would be in line with corporate margins..

Got it. Okay. Thank you..

Thank you. Our final question for today comes from Gary Nachman from BMO Capital Markets. Gary, your line is now open..

Okay, great. Sorry, I missed you guys before just jumping around a couple of calls. I don't know if you touched on this. I obviously jumped on late.

But did you talk about how you expect gross margins to trend for the remainder of this year and sort of what additional initiatives you are taking to improve the gross margin further beyond this year? Just what sort of levers you think you have at this point? How much more there is to do on that front? And then with respect to the Specialty – yes, just one more, with respect to the Specialty business just how comfortable you are with the commercial infrastructure? And how much more you want to leverage that in terms of bringing new products in? Is that going to become a much bigger part of your business do you think over the next few years, or will it be relatively modest when you think of the overall company? Thanks..

Hey, Gary, I'll take the first one. Good morning. So as you know our Q1 gross margin was 43%. We are looking to in increase for the rest of the year. My gut feel is, we’ll finish the full year, probably about 45%, which is in line with where we were last year. That's number one.

Now, if you think about the growth drivers, how do we go from Q1 of 43% to let's say rest of the year of about 45%, there are a couple things. Number one is the first piece is just our internal manufacturing production plan. So better fixed overhead absorption and we're in control of that. It just reflects the demand and manufacturing operations.

So high confidence on getting that benefit. Second, is NPLs new product launches. So, as we had shared with you a few months ago, this year we expect new product launches to be more on the back end of the year and the pro end.

And as you know, by nature of the complexity of those products, they have substantial, greater gross margin than the rest of the portfolio. And then, the third is when you look at our Specialty business, as I said in Q1, that's the low point of terms of revenue, right.

Unit growth are expected to accelerate the growth and those products have higher gross margins. So those are the three levers..

Yes..

Thank you, Tasos. And Gary on Specialty, as you know, we had committed, we acquired impacts back in 2018 that form our Specialty platform. So excellent commercial capabilities already in place for Parkinson’s, for movement disorders, as well as endocrinology.

So very excited to have a great team in place, relationship for market access in place marketing teams are in place. And penetration, as you can see, will continue to grow right by 6% to 8% every year, units will by 10% to 12%. And we have excellent organic pipeline.

We got [indiscernible] being launched on June 1, we have DHE autoinjector based on the outcome at our partner’s site from the FDA, should be launched this year. IPX-203 next year with a much higher fixed sales because of the product profile and results what we have seen. K127 Myasthenia Gravis core product, which we're filing this year.

We also have government programs for that as well. And that is also expected to launch in 2024. And then we have two additional, and these, we acquired from Kashiv Specialty, K-114, K-128, along with K-127, and we are adding couple more pipeline assets in Specialty. And we have a separate team focusing on Specialty R&D.

We have two technology platforms which have been well tested over last 10 years. So with that today, our business is about $400 million in Specialty. These organic pipeline will add substantial revenue to it, and we are open for certain tuck-in deals for adding within these two specialty. And we are constantly evaluating those opportunities.

And I think more are being available with this biotech pool in the market and other conditions which are driving companies like us in a better of a driver's seat because of the constant cash flow from our Generics business, Injectables business, Specialty business allows us to sustain our growth and keep adding these assets. So very excited.

If you ask me a go on numbers, yes, we like to get to a $1 billion in Specialty sales. How long it will take? May be few more years, but excellent growth drivers. You are absolutely right. That part of the business is becoming very significant and much higher contribution than the Generics..

That's very helpful. Thank you..

Thank you. We have no further questions for today. So I'll hand back to Chirag Patel for any closing remarks..

Well, thank you everyone. I know it was a busy morning, so many people could not join. But everybody would join thank you very much. And have a great day..

Thank you for joining today's call. You may now disconnect..