Hello, everyone and welcome to the Amneal Pharmaceuticals First Quarter 2023 Earnings Conference Call. My name is Emily, and I'll be your moderator for today's call. [Operator Instructions] I will now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo. Please go ahead. .

Good morning, and thank you for joining Amneal's first quarter 2023 earnings call. Today, we issued a press release reporting our full Q1 results. We announced certain unaudited preliminary results for the first quarter on April 17, 2023. The press release and presentation are available at amneal.com.

Certain statements made on this call regarding matters that are not historical facts, including but not limited to management's outlook or predictions are forward-looking statements that are based solely on information that is now available to us.

Please see the section entitled Cautionary Statements on Forward-Looking Statements in the earnings presentation and our SEC filings for a discussion of factors that may impact our future performance. We also discuss non-GAAP measures. Information on our use of these measures and reconciliations to 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 turn the call over to Chirag. .

distribution, federal government and unit dose. We expect this business will continue to deliver durable double-digit growth going forward, driven by the ongoing expansion of the distribution channels. Overall, we are proud of the strong momentum across Amneal.

Each quarter, our portfolio is incrementally larger and more diverse as we launch new increasingly complex products. We are leveraging our key capabilities and global footprint to operate at scale, across our business. As we execute, we look to build upon our sustainable growth profile and drive higher adjusted EBITDA levels.

I want to touch briefly on our capital allocation strategy which Tasos will discuss further. To be clear, reducing debt and strengthening our balance sheet has been always our key priority. As a result, our net leverage has reduced from 7.4 times in 2019 to 4.9 times this quarter. And our goal is to be below four times net leverage by the end of 2025.

I'll now hand it over to Chintu..

Good morning, everyone. Thank you, Chirag. Let me begin by thanking the Amneal family, who work hard every day to make healthy possible for so many. We are very excited about our strong start to the year and the great progress we are seeing across our organization.

I will touch on how our strong foundation in operational excellence and highly productive R&D engine continues to propel our company strategy forward. Starting in operations. We are focused on operational excellence and efficiency, super quality and expanding our global capabilities, particularly in injectables. Let me provide more color on each.

First, we remain focused on operational excellence and driving efficiencies. The team has done an excellent job as we move manufacturing for over 30 products to low-cost locations. And we are on track to achieve our in-year operational efficiency goals. We are taking various other measures to lower cost and expand our margins.

In addition, our prudent capital spend, focuses on driving operational efficiency, automation and supporting long-term growth. Second, from a quality perspective, Amneal has maintained a super track record and commitment to the highest standards of quality over the years.

Since 2005 the US FDA has conducted over 90 successful inspection with no OAIs or warning letters. We are very excited to share the successful US FDA inspection this week of our largest injectable site. We look to commercialize products from this site starting in third quarter.

This is an important cornerstone of our injectables growth strategy by increasing our capacity and capabilities across all areas. We now have 19 production lines across various dosage forms, including vials, prefilled syringes, cartridges, LVP bags and immersion.

Over the last two years, we have invested over $150 million in capital and tremendous energy to bring two new injectable sites online. As a result, we are now at scale in injectables with four manufacturing locations, doubling the capacity we had a few years ago and a deep R&D pipeline that provides a clear runway for long-term injectables growth.

With our expanded infrastructure, we are well positioned to be a top five US injectable business and a global player. Let me move to generics R&D, where we are continually adding new products to our pipeline. In the first four months of 2023, we have launched 10 new generics and we are on track to deliver over 30 new products this year.

Overall, we have 99 ANDA spending with the US FDA with 63% representing non-oral solid products. This includes 32 injectables, 10 ophthalmics, 10 topical, six oral liquids and four inhalation products.

Behind that, we have 81 pipeline products with 89% representing non-oral solid products in complex categories, which tend to drive higher profitability and have longer product life cycle. Over one-third of our pending ANDAs and two-thirds of our pipeline are expected to be first-to-market, first-to-file or 505(b)(2).

In injectables, we see our cadence of innovation continuing as we remain on track to file 10 to 15 more ANDAs in 2023, including many complex injectables. We look to file our first 505(b)(2) ready-to-use bags this year as well. In inhalation, we recently completed clinical trials for generic ProAir and look to submit our ANDA shortly.

In addition, we shared last quarter our new partnership to in-license the Soft Mist technology platform for the development of Respimat inhalation programs. Also, we are pleased with the progress of our MDI programs and expect to submit additional ANDAs in the coming years. Next, let me highlight a few notable upcoming new product launches.

First, as discussed last quarter, we are very excited about our ANDA for naloxone nasal spray, our generic version of Narcan which is currently under priority review with the US FDA. We believe this product now over-the-counter, will improve access to a critical life-saving opioid overdose treatment for millions of people across America.

In addition, we are on track for the July launch of an authorized generic version of Xyrem, which is a key therapy for narcolepsy. A list of our notable launches, is included on the key growth catalyst slide in the presentation. We have added a number of new programs to the list this quarter. Turning to specialty R&D.

We are expanding our portfolio through our pipeline. We have our PDUFA date for IPX203 coming up on June 30. We see IPX203, as an important innovation that advances the standard of care, with a broad market appeal for Parkinson's patients. Accordingly, we continue to see IPX203 as a $300 million to $500 million peak sales opportunity.

In addition, we are making good progress on international licensing opportunities for IPX203, which is pending approval so that this new therapy can reach the global patient population. Next in biosimilars, we are very excited about the value Amneal can bring to this space.

Our first oncology biosimilars are seeing strong uptake in the market, and we see tremendous opportunity to expand our portfolio through partnership for future molecules. We see biosimilars as a key long-term growth driver. Looking globally, we see 2023 as a foundational year for our international expansion strategy.

Our R&D team, is well positioned to leverage our rich portfolio and file key products in markets around the world including Europe, China and other emerging markets. We have begun registering selected products this year, as we pursue over 50 product opportunities in different emerging market countries.

We have a dedicated team at Amneal, focused on driving international expansion. In summary, we continue to drive operational excellence and execute well across our innovation strategy, which is fueling our ability to drive sustainable growth. I will now hand it over to Tasos. .

Thank you, Chintu. I'll first discuss first quarter results, then capital allocation, followed by a brief review of our full year 2023 guidance affirmation.

We're very pleased with our first quarter results, with total net revenue of $558 million growing 12%; adjusted EBITDA of $116 million growing 16%; and adjusted diluted EPS of $0.12 in line with prior year. First quarter Generics net revenue was $344 million, an increase of $26 million or 8% versus the prior year.

Strong performance was driven by new product launch in 2022 and 2023, which added $31 million of revenue and stable performance in the rest of our broad portfolio. In addition to the strong performance, we're very pleased by the continued evolution in the refreshing of our Generics portfolio.

As an example, products launched and added since 2019, now account for 42% of our Generic revenue, which bodes well for continued growth and profitability.

Q1 Specialty net revenue of $92 million, increased $7 million or 8% versus the prior year driven by Unithroid, up 39%; and Rytary, up 14% which reflects strong commercial execution as well as substantial patient needs.

Our AvKARE business continues to perform exceedingly well, with Q1 net revenue of $122 million, up $27 million or 29% compared to the prior year due to continued expansion of our distribution channel.

We're very proud of the work our AvKARE team is doing in increasing market share, and providing our customers with new products and innovative solutions.

Q1 2023 adjusted gross margin of 39.4% compares to 43.5% in the prior year was in line with our expectations reflecting discontinuation of a handful of legacy products timing of fixed overhead absorption and our mix of business.

Our first quarter adjusted gross margin represents the low point of the year as future quarters will benefit from new product launches operating efficiencies and manufacturing plant utilization increases. First quarter adjusted EBITDA of $116 million increased $16 million or 16% versus the prior year.

The strong performance reflects our revenue growth higher investment in sales and marketing to support our biosimilar and specialty brands offset by tight expense management across the remaining operations. First quarter adjusted diluted EPS of $0.12 was in line with prior year, as higher interest expense offset our adjusted EBITDA growth.

From a cash flow perspective, we generated operating cash flow of $140 million which includes our interest expense and $85 million payment related to the Opana ER settlement that we announced last year.

The strong performance was driven by robust cash collections related to our high accounts receivable balance at year-end 2022 as well as the continued strength of our top line growth. Let me now turn to our capital allocation.

Over the last few years, we have successfully increased profitability acquired key capabilities and well-run businesses reduced legacy legal exposures and lowered leverage. As a result, we have grown annual adjusted EBITDA to over $500 million compared to $339 million in 2019.

We invested about $500 million in M&A such as AvKARE; new state-of-the-art injectable facilities; rebuilt our specialty R&D pipeline; and settled substantial legacy legal matters. In addition we reduced net leverage from 7.4x in 2019 to 4.9x in the most recent quarter.

With many of these investments now behind us, our intent is to prioritize debt reduction. We believe our strong cash generation bottom line growth as many of these investments come to market and active debt paydown will further reduce net leverage to below 4x by the end of 2025. For full year 2023, we're reaffirming our guidance expectations.

As a reminder, we expect total net revenue of $2.250 billion to $2.350 billion in 2023 which reflects continued mid single-digit growth driven by growth across all our three business segments.

Also we continue to expect 2023 adjusted EBITDA between $500 million and $530 million which includes incremental investments particularly in sales and marketing to support new launches and scale up in higher-growth areas of the business.

We expect adjusted EPS between $0.40 and $0.50 which reflects higher interest expense including the potential refinancing of our term loan B.

On the cash side, we continue to expect 2023 operating cash flow between $200 million to $230 million which includes interest expense and exclude the already announced legal settlement costs of about $90 million mostly related to Opana ER and capital spend between $50 million and $60 million. With that let me hand it back to Chirag. .

Thank you, Tasos. In summary, we are pleased with our excellent start of the year. We expect our strong momentum will accelerate over 2023. Amneal remains well positioned for sustainable long-term growth with a diversified and expanding portfolio and key near-term catalysts happening all now including biosimilars, complex GX, injectables and IPX203.

As we continue to execute our strategy well, further diversify our business and deliver profitable growth, we expect to drive higher levels of adjusted EBITDA and remarkably delever the company. Let me now open the call to questions..

Thank you. [Operator Instructions] Our first question today comes from the line of Balaji Prasad with Barclays. Please go ahead..

All the details on the slides, also congratulations on the injectable facilities, so I think that's probably where I'll start with.

Chirag, can you help me understand the broader or the current commercial opportunity in the injectables market? Is it addressing shortages, or is the scope for a player with stronger pricing power or any kind of advantage there? And also just remind me about the current injectable size? And what are the key contributors to take you to the $300 million portfolio? And the second question is on the biosimilar side.

Can you give an update on, how the environment for partnership in biosimilars is as you look to bring in more biosimilars into the U.S.? And lastly on the same front, are the combined biosimilars revenues greater than $15 million in 1Q? Thanks..

Thank you, Balaji. Let me start with the injectable strategy. As we have stated, that our strategy is to expand capacity, have redundancy in our supply chain and that's exactly what we've been doing. We -- our focus has been to introduce differentiated products such as Triamcinolone.

We were first in the market and still has a major market share, cyclophosphamide, now LVP bags, the peptide-based products coming soon. So it's more driven towards complex products which has, demand less competition with supply chain security for our customers, for our hospitals a very deep relationship we are building.

We're also going to supply certain commodity products that are in shortages, and that's how we have built very strategically so far our Injectable business.

And going forward, it is built to be more even durable, more complex products, more relationship with hospitals and clinics and, bringing them what they need which is shortage products as well, addressing shortage products. So today we do about $180 million. And we expect to be well over $300 million by end of 2025.

And continue to grow from there after that. And that obviously also will include international revenues as these products have good international markets as well. On biosimilars very excited with two launches about to launch the third one.

The team has done a great job, all across, as we always do great job in commercial side, again excelling with building relationship using the old relationships that we had with the wholesalers, building new ones with the community oncologists and hospitals. We do have a sales force, market access.

We take the -- from our specialty sales that help on marketing and market access as well. So with that, we are very -- we're well over on our way to reach this year target about $50 million to $60 million. But that accelerates, because we were accelerating in Q3 and Q4, so next year significant uptake for these three products.

And then we are working on the pipeline which we haven't announced, as we have a stated goal to be the top five, player in the United States in the long run. So we're going to be -- here our strategy is not just one year, two year, three years it's to stay in the game for next 10 years.

And we see a highly valuable franchise as biosimilars, for the United States and for the global market..

Just to add one point to Chirag on the injectable. Thank you. Good morning, Balaji. This is Chintu. We have 32 pending….

Good morning..

…ANDAs at FDA. And we continue to file about, 10 or 15, every year. And now we are at scale with 19, production line.

So to get to from our current revenue of about $170 million to $180 million, if you can just do the math, 32 pending and 10, 15 and also all these are in a differentiated dosage from -- many are complex, drug device combination, cartridges, LVP bags, peptides. We have some of the maybe long-acting depot injections. So we are very well positioned.

And we have now redundancy and a resiliency in our manufacturing footprint, which is the biggest challenge in injectable. So I think we are very excited with all the lines now going live and we'll be commercializing in third quarter from our newly FDA-inspected site. And this gives us the leverage in multiple areas.

Plus these areas are also very lucrative for our international expansion. .

Thanks, Chintu. That’s helpful..

Our next question comes from Chris Schott with JPMorgan. Please go ahead. Chris, your line is open..

Great. Thanks very much. Just two questions on guidance for me. Maybe first on the generic gross margin trends.

Can you just elaborate a little bit more in terms of what happened to gross margins this quarter and just how we should think about generic gross margins for the balance of the year? I know you mentioned there were some onetime issues, but I don't think you've had gross margins to slow for a few years and I was toing my hands around what exactly is happening there and probably more importantly just how to think about the next few quarters? And the second was on revenue growth.

It seems like you have obviously a very good start to the year with this quarter. But I think the go-forward guidance implies more modest revenue growth for the remainder of the year.

Again, just a similar question there, just help me a little bit about the cadence of revenue growth as we think about the next few quarters and kind of drivers there? Thank you..

Hey, Chris, this is Tasos. Good morning. Yes. I mean as you know gross margin at any given quarter can fluctuate a little bit. For us it was just certain products small product discontinuations as I mentioned and related kind of upsell license product that we had to write-off and just timing of our production line. So you are correct.

It was slightly lower than it has been in previous quarters. But from our perspective, I expect -- I fully expect Q2 a step-up in the above 40%. And in terms of kind of full year expectations from a generic gross margin I think we're going to be around 42% in line with prior year. So that's around on the gross margin.

In terms of -- from a revenue growth perspective, Chirag you want to take it?.

Sure. So Chris, we've been speaking for the last few years and you've been following Amneal this is the rocket about to be fired now right because it's well-positioned to drive sustainable top-line growth and meaningful adjusted EBITDA acceleration in 2023, 2024 and beyond.

And let me tell you how it is happening so -- and how diverse and how good that is that we're not relying on a two specialty products to make our life or our company right? We have Generics portfolio of 270 products driving durable profitable growth number three in the United States in value, number four in volume.

We are the only company that grew where everybody degrew. And we will continue to grow in next several years. Highly productive innovative R&D pipeline launching 20 to 30 new products every year 30-plus, we -- look at the diversity we have. Continued shift to complex products with capabilities across dosage forms.

It's essential business and we are providing essential services. $500-plus million revenue came from recent product launches; expanding in high-growth areas injectables and biosimilars; goal to be top five. You know that we did it before and we're going to do it again. Growing Specialty portfolio. I know you are not excited on IPX203, but we are.

We're very excited and we will -- you will see the strategy being rolled out and why we think such a need. We talk to Parkinson's patient everyday, KOLs everyday and a huge need to penetrate. RYTARY penetrated only 4% and 96% are on IR CD-LD, which is 30 years old technology and they experienced such a bad off-time everyday.

And we're determined to take this product out to as many general neuro as we can and even beyond that. AvKARE our distribution business growing double-digit. After big three there are not many players. So it gives us excellent chance to distribute our products directly in unit dose in government channels and niche distribution channels.

This is a sizable business now $450 million-plus. On top of that we are entering very meaningfully on international markets to further diversify the company. And all that with our -- most of the products made by us we have a global network of manufacturing sites, top of the class, number one in quality. We are the US champions.

What we need three OSD sites, four injectable sites, one nasal spray liquids in the United States, transdermal site in the United States, device base site in the United States, two API sites providing needed API for us and one inhalation respiratory site in Ireland.

So with all this, we are extremely well positioned for growth not just this year, but 2024 to all the way to 2030. Thank you. .

Our next question comes from David Amsellem with Piper Sandler. David, please go ahead..

On the Generics business, can you talk to products concentration? I'm specifically interested in contribution from Zafemy, this year and how you're thinking about the potential for competition that product down the road? I know it's a complex product.

But can you talk to that? And in general, are there -- beyond Zafemy, are there any other products we should be thinking about that have an outsized impact on Generics? So that's number, one. And then number two, helpful commentary on the deleveraging. But I guess my question is on, business dev and M&A.

What's your appetite or I guess capacity for deals? How large can you go? And how big of a priority are bolt-on transactions? Thanks..

Hi, David this is Tasos. I can take the first one and Chirag, can take the more strategic question. It's whether or not Zafemy or any other product in our portfolio has more competition or less competition, it does not make a big difference one way or the other.

Because we have done -- if you kind of go back for example, a number of years ago for example, levothyroxine was $180 million product for us. We don't have any such product anymore in the Generic segment, right? The biggest product may be a $50 million $60 million product.

So that's part of why, we kind of keep focused on how the business has been diversified over the course of time. And this is a differentiating factor for Amneal, compared to any other generic company out there. So, no one product kind of keeps us up at night. And the other thing is, as Chirag said earlier on, who already launched 10 new products.

There's another 20 new products that are going to be launched. Whether or not we launched 30 products this year or 25 products this year, it's not going to make a difference in our performance.

Yes, so the -- on the capital allocation piece, I mean I'll give you my view is, as I mentioned before, we spent a ton of money and thoughtfully, right? We never did an acquisition that can affect the company. Many of them were tacking acquisitions, to fill out specific areas that are going to drive future growth.

So as a result, I think at this point in time with the investments we have made, the interest rates being where they are right, this is why you're hearing us kind of the prioritizing M&A and focusing more on debt pay down.

Chirag, any additional thoughts?.

Tasos, you covered really well. And David, we do not have that 2018 problem, the big leaky buckets on a big GX products. It's highly diversified across the business segments. Within Generics, we have multiple products with 10 20 30 40 50. And we'll continue to drive and obviously, or a drag like leads the way.

It's kind of a branded GX, if you would call it. And in M&A, look we invested almost $600 million over the last four years and that is paying off really well. We continue to invest almost $240 million $250 million every year combining R&D, internal R&D, external R&D as well as CapEx, putting a new peptide site or putting biosimilar investments.

So we have enough for next two three years. So right now, we're zoomed in. We love the consolidated business that we have different segments diversification. Goal is to delever, lower the debt amount, increase the EBITDA. And then from 2026, we would be in a much better position to think about anything big strategic.

But right now we're loving all the businesses and they're all firing on all cylinders so -- which is a beautiful thing. There's not a weak link within any of the segments of our businesses..

Okay. Thank you..

[Operator Instructions] Our next question comes from Greg Fraser with Truist Securities. Greg, please go ahead..

Thanks and good morning, folks. On IPX203 you mentioned in the slide the data generation plan that support potential for early use.

Can you expand on that? Are you planning additional clinical work? And then, can you just give us an update on your efforts to refinance the term loan B? When do you expect to finalize a refinancing? And what are your expectations for terms for the new debt? Thank you. .

Hi. Good morning.So IPX203 we are very excited about how novel this formulation is compared to what is currently available in the market and how it can benefit the patient. It is a very unique formulation combined with immediate release with ER.

Carbidopa/levodopa especially levodopa has a huge problem of absorption throughout the GI track and half short life. So the way the formulation is done and our data shows as part of the clinical that 1.5 hours of per dose improvement compared to IR CD/LD. And again, that's what goes in the label but label and everything remains on a final negotiation.

So it can help many, many new patients who are starting on an immediate release carbidopa/levodopa therapy which can take the fluctuations out and can stabilize the patient and can give a long durable good on time. So that's why we are excited.

Currently, our Rytary product only offers over 4% of the patient and 96% of patients still are going to step-up. So once we get the final label and what is on the label IPX203 can be very, very helpful for the naive and the new patient and provide them awesome good on time compared to the current therapies on the market. .

Greg on the refinancing as you know our term loan B doesn't come up for -- that doesn't become due in two years, right? So it's May 2025. So there is plenty of runway, right? It's kind of having said that I was the CFO in 2007, 2008 and 2009. So having lived through that you never know what happens to the capital markets.

So this is why as a company we want to be constructive and that's why we said we would like to extend to kind of refinance our term loan B sometime this year. So we're in active conversations with the market. We have a number of kind of great investors in our current term loan B.

Love to see many of them have expressed an interest to kind of continue in our refinancing efforts. So we'll continue to try to be constructive with the market, but not at any cost and not at any terms. So our expectation is continue to focus in kind of getting it done before the end of the year. And if it goes beyond that so be it. .

Thank you..

We have no further questions registered. I'll turn the call back to Chirag for closing remarks..

Thank you very much. So just closing out just summarizing Amneal is a diversified differentiated and growing across all businesses. It's a show-me study. We know that and we've been showing it. We'll be showing more. That's what we are doing. And we are laser-focused on execution driving higher EBITDA and deleveraging. And our future is very bright.

And so we're very excited. All 7,000 employees are extremely excited to make Amneal the American Champion and be the leading affordable medicine company for the United States. Thank you very much. .

Thank you. .

Thank you everyone for joining us today. This concludes our call and you may now disconnect your lines..