Amneal Pharmaceuticals, Inc. (AMRX) Earnings Call Transcript & Summary

Good afternoon, everyone. I'm Ekaterina Knyazkova from the JPMorgan team. Pleased to be introducing Amneal. And from Amneal, we have Chirag Patel, the company's Co-Founder and co-CEO. As a reminder, we're going to have Chirag make a presentation here, and then we'll open it up to a Q&A session. If anybody has any questions, you can ask those through the Ask A Question button on your screen. And with that, let me turn it over to Chirag.

Thank you, Ekaterina. Good afternoon, everyone. Hopefully, everybody is safe and healthy. And we hope to come out of this COVID crisis together very soon. We thank Amneal employees who have worked very hard and -- like frontline workers during the pandemic, showing up to the labs and plants every day here in the U.S., New York, New Jersey plants, as well as India and Ireland. So we thank all our employees for excellent work in keeping the supply chain going through this very, very difficult times. With that, let me start with Page 4. For some of you may not know Amneal and our history. We started Amneal, very humble beginning, my brother, myself, along with our father, who was a pharmacist, scientist, and humbly built up the company. The passion has been to deliver something new to the patient. The affordability was at the key when we started the company. And still today, we strive to bring more and more affordable medicines for American patients. Through our strategic, initially inorganic acquisitions, and from 2009 and onwards, putting a lot of focus on organic growth, creating one of the best engine, R&D engines, in the industry, paid off. And we grew tremendously. We were the highest growing company in our industry for many years. We saw the intense competition coming in, in generics back in the days of 2016, '17, with the FDA approving more products and 3 buying groups consolidating. Therefore, we pursued the acquisition of Impax and merged the company. We went public. A lot of headwinds came in '18, so that's only the growth year we had, is from '18 to '19. We're back on track. And I would love to share in the future slides, the further slides, that how tremendously excited we are to bring back the growth. It's been 15 months back at the helm. Me and my brother are back as co-CEOs. And we have built up excellent pipeline within Generics as well as now in Specialty and added Distribution business, which allows one step closer to customers. With that, let's go to Page 5, please. So this is 3 areas of growth that we've been focusing on. And we've been talking quite a bit. As you know, our foundation is Generics. And I'm pleased to say that when we finished our 5 years review, we got all the teams together. The mojo, the passion is back. Pipeline is revitalized. We see growth in Generics. Generics includes injectables, all dosage forms: so injectables, inhalations, transdermals, oral solids, all kind of oral solids, liquid products, topical products and biosimilars. So it's a pretty broad category, and this is why we're seeing growth in our Generics business. We did experience growth in even in COVID year, '19 to '20. And '20 to '21, we expect high-margin launches as well as additional pipeline expansion. So very excited about this and adding Kashiv Specialty Pharma, which is recently announced acquisition, even adds more complex generics to our portfolio. So we basically, arguably, have one of the best R&D engine in our industry, and our track record shows that as well. So very excited for our Generics business. We are also very keenly focused on margin expansion. This, as you know, Generic business requires reinvestment, requires R&D investment, requires a quality and CapEx investment. Therefore, to operate the company above 40% is necessary in the Generics business. And we are almost getting there. And we -- the new product launches as well as operational efficiency will further expand the margins. Additional thing, what we are doing is expanding. We have a great 300-plus products portfolio. Some of them are lucrative, and the market we looked for first was China, and we have a partner, Fosun, in China where we are expanding the partnership. We have already filed products with Chinese FDA, and we would expect to ship those products from our U.S. plant as well as Indian plants. And the pricing we are seeing in Chinese markets are better than the U.S. market, which surprises us, but not entirely. The second leg of our growth is Amneal distribution. We acquired AvKARE about a year ago. Excellent acquisition for us, expanded our government business, which requires TAA-compliant manufacturers, which we -- having 50% capacity still in the United States, we're taking advantage of that and putting more products with VA and DoD. We have won a number of national contracts and keep winning them. Also, we are pursuing the products for strategic national stockpiling and other BARDA initiatives. Along with that, there is a tremendous bipartisan support to reshoring certain essential medicine to the United States, which Amneal also recommends that, that is a must for the country, for our supply security as well as we need to bring back -- to have search capacity, bring back talent. And it is -- seems like the support from both parties is tremendous along with the incoming administration. So we're very excited about reshoring opportunities as well. On Amneal specialty, this is where we're going to spend a bit more time today, is that we -- part of the Impax acquisition, we acquired the specialty business, which we have then grown to be almost $360 million business. We see tremendous opportunity of growth there. We have existing marketed products which are growing. We had 2 pipeline products within the movement disorder -- 2 therapeutics area we have is movement disorder as well as endocrinology. With Kashiv Specialty acquisition, we added 2 pipeline products: 1 more in movement disorder and 1 in endocrinology. We're excited about those opportunities and walk you through, it's important to understand them each individually and what Kashiv Specialty brings to the table. Moving along, let me focus on Generics a bit more. So if we go to Slide 7, please. This is on the left side of the chart is our traditional mix of the products. So we had still 43% are ER, IR tablets. So that’s 50% are the oral solids, 50% other dosage forms, which is a good mix. But what we did now is our current pipeline only has 12% of IR, ER, where we -- tablets where we see tremendous competition. All other dosage forms, we are becoming better and better: ophthalmics, inhalation, nasal sprays, topicals, transdermals, we have a series of products we have launched and we're still launching them more, which are made in Piscataway, New Jersey. Injection and injectable bags, we just increased our capacity. And that's an untapped area for us. We are still a smaller player in injectable institutional marketplace, and we, with the new addition of the capacity, and we already have R&D capabilities, we are -- we already launched certain key products and injectables. We look forward to launch more products in injectable as well. So this migration drives for the more durable and high-margin launches. And our goal is to -- every one of you know that the generic industry, we have the competition every year for our existing products. We have certain price erosion. To offset that, we must come up with new product launches. This pipeline, just like in the past, at Amneal's track record, as you saw, allows us to not only offset those pressures, but allows us to grow substantially in Generics business from where we stand today moving forward. So very exciting mix, excellent scientific talent, and the team is delivering. We filed 30 products in 2020, and we look forward to do this similar number, but most of them are high-margin products and different dosage forms. So we have rationalized the portfolio to go for the more and more complex products. Moving on to Slide 8. They -- I will quickly walk you through. Injectables, we expect about 40 products to be launched. Ophthalmics, we have a pretty much entire portfolio of branded products in Generics, which is the 10-plus expected to launch as well between 2021 and '25. We already launched some products. There are key products coming in 2021 as well. Inhalation, 3 to 5 launches expected, '21 to '25. One is more likely to be in 2021, and we're very excited about it. On the right side, biosimilars, we have 3 pipeline products. Two are pending with FDA, Avastin and -- I'm sorry, Neupogen and Neulasta. Avastin is being filed very soon. It's at the final stage of compiling the application. So very excited. It's a different strategy on biosimilar. We are coming from behind. We did not want to invest initial hundreds of millions of dollars in biosimilars, so we in-license the products. The new FDA guidelines and analytical methodologies allows the new biosimilars to be developed for the U.S. market within $30 million to $50 million, unlike $100 million and $150 million before. So this allows us to be investing in more products going forward, in-license those products, so we're sharing the risk, and build the portfolio over 5 years. And we will become a material player in biosimilars. Marketing, we are well set. We know the touch points, where these products are sold. Many of those players, we interact with them for many years, the last 15 years. So it's -- we've got multiple things to offer. We're not a single or double biosimilar product company. We are here to stay. Quality. We are -- always pride ourselves. We are the #1 quality company in our industry. Same way we're going to be #1 quality company in biosimilars. So with that and using our specialty marketing team as well, we are well set to launch biosimilars product. We're -- very prudently. We're not rushing because as markets are shifting, more people are experiencing biosimilars, and the uptake is happening. It is -- more market share to biosimilars are going. We expect that to go even more. Competition. There will always be 3 to 5 players. The first movers will have advantage, but the third, fourth, fifth players will catch up to certain market share. And pricing pressures would continue on in biosimilars. Not like generics, but it will come as 4, 5 players are actively marketing their products. Moving on to 9. I already covered the Fosun partnership, and other, we are evaluating. I also covered the channel expansion and government business and unit dose, which we'll be launching this year as well as we have the entire portfolio of liquid Rx products. I want to now focus on specialty. In Page 11, our current products are doing really well. We're tracking Rytary to be $150 million, $160 million annual revenue products, net revenue; and Unithroid is going -- growing to be $60-plus million as well. We have our 2 advanced existing pipeline, IPX203, where we expect the readout in September, or say, let's call it, the third quarter next year and K127 follows after that. Very exciting data for IPX203 we have seen in Phase II I'll share with you. With Kashiv Specialty Pharma, we have expanded our pipeline and added 2 more advanced programs, K114 and K128, which I'll share more information about. So let's talk about on Page 12, advancing our IPX203. So Phase III readout, as I mentioned, is third quarter this year. And we plan to file in '22, launch in '23. Now this is, speaking with KOLs, they're very excited about this product. And what we bring to patients and our commitment to Parkinson's patient to bring more innovation continues on. This is 2 more hours almost, providing a good "on" time and up to 8 hours relief. It is remarkable for them. It's 2 to 3x current IR. They fluctuate, go up and down. This product is even better than Rytary as well. So providing a good "on" time, and "on" without troublesome dyskinesia for almost 2 hours, that's remarkable for PD patients. And it's a pretty large -- unfortunately, there's 1 million patients already in the country living with PD, and 60,000 being diagnosed every year. And our Rytary, we already have the touch points with the commercial side from payers as well as the KOLs, and we'll listen to them. We take everybody's input and develop the product that really meets unmet need. On Page 13, this is a Myasthenia Gravis product. Orphan disease, 60,000 patients-or-so; causes excessive drooling, eyes and other muscles in the face. There is -- the current treatment is, again, it's outdated. We use our Kashiv technology, GRS technology, to provide 24-hour symptomatic release. And -- so the absorption's better and the variability is reduced as well. Let me talk more about Kashiv transaction on 14. So Kashiv Specialty Pharma, Amneal has a relationship with them since 2011. They developed, for Amneal, key generics products. Those products like EluRyng, Yuvafem, Aggrenox, and there are a bunch of more key products that came from Kashiv platform. This team came from Roche, New Jersey site with the formulation team. And it sits in Bridgewater, excellent R&D site which they acquired from Sanofi. And it also has specialized manufacturing capabilities, all GMV. They -- not only it brings the complex generics, but it brings the 2 key advanced technologies and 2 pipeline assets. And there are several assets that’s at the early stage as well. So on a strategic rationale, history of successful Gx, R&D collaboration, right? It derisked the deal because we are getting benefit of $15 million royalties that we used to pay to Kashiv for their generics product, we no longer will be paying. And all future generics products are royalty-free as well. It advances our strategic goal of growing our specialty pharma, and we are very keenly focused and committed in that business. The nice thing about where we are focusing are those products are 505(b)(2)s. The development cost are $30 million to $60 million. The time frame is a little bit longer than complex generics. And the revenue potential is $100 million to $300 million. So this sweet spot only certain spec pharma companies play. The big pharmas don't most of the time, and biotechs don't. So it leaves -- there are a lot of molecules which were designed so poorly 20 years ago, 30 years ago, using the latest and greatest technologies that we have, we can meet a lot of patients' need and what KOLs have been asking for a long time. So very excited about the Kashiv transaction. And the entire organic engine it has created in specialty products is just outstanding. Timing on Page 15. We would -- its closing is expected in 2021. And I'm sure you have read the terms of the deal, $70 million upfront and $30 million in January 2022. I'm mindful of the time. So going to Page 16, talks about the expansion of the pipeline. Two more products added. One in endocrinology. We're very excited about the T3 products in hypothyroidism. It's -- again, Cytomel is our old product, a lot of uneven peaks. This removes that, provides 24-hour proper absorption and the levels which would substantially reduce the side effects as well. Page 17, we talk about more about these products. With Myasthenia Gravis, 60,000 patients. The K128, which is for Sialorrhea and movement disorder is about 1.2 million patients because dystonia could be another indication as well as PD patient also uses that. And as you know, the hypothyroidism is a big issue. It's almost 12 million patients. But 20% of them are on T3 therapy, which currently is older technology and older formulation. So excellent opportunity for us. I'm not going to go over more of technology. I can take it on Q&A since I'm running out of time. But the GRS platform is very exciting platform. And on the Q&A, my brother, who is also Co-Founder and co-CEO, will explain more. He's very excited about these technologies and very knowledgeable about it as well. Moving on to, I already mentioned the complex Gx and collaboration with Amneal. Deal rationale, I have gone through it on Page 20. And I want to focus on Page 21. It's been a remarkable year. We grew our revenue almost 20-plus-percent, and these are mid-level of guidance. We haven't put out the final results out there, where it's closely aligned; and 25% plus EBITDA growth. The key thing is the leverage, leverage is going down to almost below 5.5, 5.4. We will end up around this year, which we are very focused to reduce the leverage going forward. So very excited about the '20, what we produced, but the '21 also, we have a good growth story coming up and we'll be sharing that on our earnings call. Thank you for listening. Have a great day.

So I guess to start the Q&A. So elaborate a bit more on why Kashiv and kind of why now? What was the trigger for kind of acquiring versus continuing to partner as you've done in the past? How much of this was confidence in some of the branded ops that the asset brought versus some improving margins on some of the existing partnered assets and perhaps maybe Generics pipeline? So how much of each of those pieces was it?

Very good question. So Kashiv is a very niche team. 75 people. We've been working together. As we have disclosed, it's a related party transaction. Their complex generics platform was already mature. So it was no-brainer to combine with Amneal. We were waiting for specialty platform to be mature. They have 500-plus patient data on both technologies and the advanced pipeline products we mentioned. That allowed us to strike a deal at right point to bring everything under our leadership. As a one team, we can produce a whole lot, and it fits the strategic rationale of Amneal to advance the specialty pipeline and specialty growth area. We see the specialty products provide us almost 10 years of durability, that patent-protected. And we have the commercial infrastructure for movement disorder and endocrinology to grow. So pretty big 2 therapeutic areas. Two technology platforms, which we can apply to several other products. This is a very exciting area. People obviously -- big pharma is on to more NCE and BLA and gene therapy. This is a huge unmet need, which we're addressing in several of debilitating diseases.

And then I guess just in the context of the transaction and just in general, the leverage profile, how comfortable are you with kind of the levers that you'll be having kind of exiting the year? How big of a priority is reducing outstanding debt? And then as well as what does this mean for kind of future [ business ] and kind of using balance sheet capacity? And how should we think about future transactions?

Excellent. So I have our CFO online as well. So Tasos, would you like to take this question, please?

Sure. Thank you, Ekaterina. So we've delevered substantially. So we think we're going to finish 2020 at about 5.4x, 5.3x net debt-to-EBITDA. A year before that, we were over 7%. And that has happened because we have been thoughtful in terms of increasing the operating performance of the business, number one. And number two, in terms of the business being a substantial amount of strength, so it doesn't require a substantial amount of cash to be reinvested into the business. So we're at scale. So our priorities right now -- so this year, in 2020, we probably will generate a couple of hundred million dollars of operating cash flow. So that's substantially ahead of the $2 million we generated the year before. So I think that gives us enough financial flexibility to: a, invest to drive organic revenue growth, because we don't believe there is anything that drives shareholder value creation as much as organic revenue growth; and then to allow us to do thoughtful acquisitions in the area of specialty to drive long term EBITDA. So right now, we're not looking to delever or start paying down debt for a couple of reasons: number one, debt is a pretty good rate. Number two, it doesn't come to fruition for another -- a little over 4 years, so it gives us enough flexibility. So driving organic revenue growth and thoughtful acquisitions will just allow us to delever and reduce that net debt-to-EBITDA below 4x. That's what we're trying to get.

That makes sense. And then looking back in 2020, you've made a lot of progress in recapturing kind of share for the base business. You've had some issues with that in 2019, and you've done a lot of progress in 2020. So as we think about going forward, 2021 and beyond, is there any more of that to be done? Or do you think that you've kind of optimized the base generic business and operations to the most kind of extent that you think you can?

Good question. As we have a broad portfolio, we're still looking at the products as we are bringing them in-house from contract manufacturers. There are opportunities to grow business. We enjoy tremendous relationship with our partners, our customers. So with our quality track records and supply track record, we keep getting more and more business. So we still have opportunities, not as much as we had it last year, but there is still some opportunities to keep growing the base business and launch new products.

And as we think about you getting to kind of like the 40% target for the Generics -- gross margin target for the Generics segment? How much of that is going to be what you just outlined versus how much of that is you launching some of these higher-margin complex opportunities?

It's a mix. Very hard to describe. But new product launches typically have the highest impact on margins. And our operational efficiencies that we are gaining by additional volume also helps us expand the margins. So it's a mix of when bringing in-house, the products in-house also helps. So we're now shooting for higher than 40%. 40%, we are almost there.

Got you. Got you. And then I guess just COVID-19 obviously had an impact on all sorts of businesses, but yours as well. Just talk about what impact that has had kind of like on the company in 2020? And then the year-over-year comparison as we think about most like the first half of 2021 and then maybe the second half as economies reopen and things like that, just kind of the ebbs and flows of that.

I think 2 impacts. One is people impact. So we operate in New York, New Jersey and India, which were hit hardest by the COVID in May, June time frame, so we had to work around that. We took a lot of safety precaution, so we're good as far as our employees are concerned. It then opened up in July, August. So we weathered through that storm of capacity and building more inventory or meeting demand. So we had certain back orders in May, June. Now we have reduced that drastically as of December last year. The second impact was all the acute procedures. So those were reduced. The physician visits and other -- the procedures, which were voluntary procedures that were delayed. So the demand we saw about 6%, 8% softening in May, June. July, August started coming back, and now, it's even higher than the previous year. So it's normalizing in that aspect as well.

And then just to kind of pivot to some of the growth opportunities. You often talk about biosimilars as an opportunity for Amneal. So I guess, just elaborate a bit more on the role you see Amneal playing and as well as your outlook on the broader biosimilar market. There's a debate going on in terms of like as more and more people enter, does this become genericized over time? Or kind of profits get competed away? Or is it like a quasi branded market where you need to have like the sales reps in place and things like that. Just your view on kind of that both -- the market overall and as well as the Amneal's role in it?

Excellent. We're learning, as everybody else, as the market is maturing. So definitely, it has matured, and it will mature even a lot more in coming years. First, let's start with regulatory. FDA is providing a lot of guidance and interactive meetings, where you can develop the product without going bankrupt, without using $200 million for development. So now, the players will come. The intent for biosimilar was to bring affordability. So we see it is -- the manufacturing is a huge challenge. Obviously, the quality, consistency, all of those things are higher barriers than the even complex generics. So we don't see this getting exactly like complex generics market because nobody can afford it, even though it's still going to cost $30 million, $40 million, $50 million, $60 million, depending on which biosimilar you're developing, even if you start now with the new guidance, new understanding, less burden on clinical trials. It is quasi specialty today where there are sales touch point. As doctors get more comfortable with it, it Is more of -- comes to the negotiating play with the PBM, insurance companies, wholesalers, the typical stakeholders that we dealt with in Generics, we will be doing it the same way now. Certain biosimilars fall under the retail market, so you have to deal with PBMs more. In retail side of the business, certain biosimilars fall under buy and bill, which is oncology-driven biosimilars, where you have to deal with oncology practices, less with PBMs and more with insurance companies. So that -- the whole dynamic is playing out, but at the end of the day, just logically thinking, when 4, 5 competitors come for the same products, it doesn't -- it's not protected. You will have a downward pressure. Yes, first one, second one will have advantage, but eventually, market is going to remain competitive, but good market. It is because so many biosimilars to be launched over the next 20 years. So we're very excited. We want to play smart. We will come from behind, which we are doing it. In 5 years, we'll become a very meaningful player. This is what we said about Generics back in 2010, and we did it in 2015. So same strategy we are applying on biosimilar. Very confident in launching biosimilars. And our partners are making it in America and Spain, so we're in good shape.

Good. Good. And then on VASOSTRICT, I just wanted to touch upon that because I know that there's, I think, a court case coming up in February around IP. Just how should we think about that opportunity for Amneal? Yes, anything you can comment on kind of the VASOSTRICT opportunity?

It's very hard to comment on actively litigated cases, so I would pass on. It's -- February 1 is the court date it starts. Due to COVID, it was delayed, right, a couple of weeks. So we'll wait and see.

And then heading into 2021, any kind of bigger launches that you would highlight, kind of similar size to NuvaRing and some of the other kind of big ones we've had in 2020. Anything -- I know from a competitive reason, you probably don't want to say too much, but anything you can say in terms of 2021 new launches?

I'll pass it to my -- I'll pass it to Chintu.

Good afternoon, everyone. Yes. I mean, we are excited about our upcoming launches in 2021. Not saying the timing because of the competitive nature, but we have good, high-value 7 to 8 product launches in 2021. We just launched generic ZYTIGA, so it was a 2-player market only, a very good opportunity for us. And overall, I think we are comfortable around 30 new launches, 25 to 30 new launches in 2021. And then we'll continue and we are refreshing our pipeline. So we are just not on end of '21. Every year, we'll be able to bring 7, 8 high-value products in a differentiated dosage form. So we are very excited about the pipeline, short-term and long-term view and the launches. And Amneal has the best track record from approval to launch. That's something we have done. NuvaRing is a perfect example. We're manufacturing, everything is ramped up, all the automation, and we are consistently supplying the marketplace.

Good. And then maybe just to kind of on the back of that. Like on R&D priorities, it does seem that the company is increasingly focusing in on, be it complex generics or some of these branded opportunities. Is this kind of like a matter of just like reallocating kind of spend? Or should we think about kind of like an increase -- plans to kind of like increase R&D kind of over time as you're kind of developing some of these kind of higher value opportunities that probably also kind of require additional investment as well. So how should we think about that?

It's a good question. So R&D spend, we are highly disciplined. We are staying in the ballpark at which we have disclosed. Before, around $160 million to $165 million. We are just reallocating our R&D spend from generic to branded. We are focused more now on, not the volume number of products in generics, but the real value. Plus our understanding and learning and our teams are aligned so nicely on generic, where we have the speed in development, which brings the cost down. So we are staying within our guidelines of the total spend. We are just reallocating and reshuffling the spend in the bucket of more towards branded. And over a period of time, you want to get to 50%-50% allocation in our R&D spend.

So it's branded, it's 505(b)(2)s. And Generics platform is very matured and very targeted now. So we would -- we are reallocating certain dollars to specialty pharma.

Got you. Got you. And then -- so I think my last question. So Generics outlook, I think over the past several years, you've seen some companies kind of either scale down their U.S. footprint or just kind of pivot away from the market. So how do you see the market kind of evolving over time just 5, 10, 15 years from now? Just where do you see the market going and kind of your views on kind of the U.S. Generics market overall?

So U.S. generics market is here to stay. Without us, there is no affordability. We provided more than $2 trillion, as an industry, savings to the American people, and there are plenty of products coming in. And we do consider the injectables are obviously generics, so as biosimilars are similar in nature. They are generics. So it would grow depending on U.S. government certain interest and initiatives after the pandemic of reshoring manufacturing for essential drugs back to America. It would make a huge impact on how the industry evolves going forward. We believe that is a must for the nation to have certain capacity in the United States in case of pandemics or other emergencies or wars, you never know. So certain manufacturing, certain APIs of antibiotics, or certain other key antivirals, or even more biosimilars manufacturing should be in the United States. So in case of emergencies, it can be surged. Capacities built already, so we have supply security. And we bring back the talent, organic chemistry. All the other talent that we've been losing left and right, we need to bring it back and create many jobs as well. I sound like a politician, but at both sides of the aisle is supporting this, bringing back manufacturing to the United States. So we see a very bright future for Generics regardless in coming years. This is a highly complex business made simpler by just the force in the market. When you have 50 suppliers and 3 buyers, it's not going to be equal footing. So...

Great. Awesome. I think we're just right out of time. So thank you so much for the time, and this was very informative. Thank you.

Thank you very much, and have a good day.