Amneal Pharmaceuticals Inc Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Christopher Schott - JPMorgan - Analyst : Great. Thanks so much for the questions. Maybe just to start off with, I just had a couple on CREXONT. Can you just elaborate on these first few months of the launch? It seems like the ramp's going really nicely. But I was wondering is there any surprises from perspective in terms of either where the patients are coming from or just any dynamics of how physicians are integrating this into their practices? And maybe just a second one on CREXONT while we're at it, can you just give us the latest in terms of where formulary access stands and how you're seeing that trending? Chirag Patel - Amneal Pharmaceuticals Inc. - President, Co-Chief Executive Officer, Co-Founder, Director Thank you, Chris. We're so excited beyond our expectations. And the patient testimonials are amazing. This is where you feel so good that the patient that wasn't able to walk now walks. They're taking fewer capsules a day, lasting longer. So it's arguably right now, it's only four months, it's performing as the best CD/LD formulation and absorption ever seen in this category. And this is straight from the most well-known KOL saying it's the best absorption he has seen and he called it a miracle drug. And we keep hearing that from all across the MDS, even started from general neuro. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 28, 2025 / 1:30PM, AMRX.OQ - Q4 2024 Amneal Pharmaceuticals Inc Earnings Call We're going after the long term care, so we're covering all corners of the market now, all 100%. Where (inaudible) we covered only 20% which is the (inaudible) market with MDS. We have broadened our market reach. The teams are doing great. We're so excited. There's already 1,000-plus prescriptions per week just in four months. It would have taken two years to get there. So amazing feedback. Formulary access is awesome as well. And to discuss that further, I'll pass it on to Joe Renda, our Head of Specialty Business.

Question: Christopher Schott - JPMorgan - Analyst : Excellent. And maybe just one last question for me, just a bigger picture with the strong top line, you thinking about either organic investment into the business or external BD any differently than the past? I'm just trying to get a sense of how you're thinking about balancing longer term investment and top line growth versus the drop through of that growth in terms of the near term margins. Thank you. Chirag Patel - Amneal Pharmaceuticals Inc. - President, Co-Chief Executive Officer, Co-Founder, Director Thanks, Chris. So we're so fortunate to have a solid organic pipeline in affordable medicines. So we've been affordable medicines and the retail GX. We have a leading portfolio in inhalation, ophthalmics, microsphere. Just drug device combination products. So one of the best portfolio we have. Then comes to the injectable which we have 12 or so more 505(b)(2) injectables to come, ready-to-use, peptide, microspheres. Very excited. Biosimilars, we have in-licensed the product as we've been very upfront about it that this is -- and very long-term focused that this is over 10 years business, it is, and we've been investing for a long time. We need to become vertically integrated. So have manufacturing with us, R&D with us, full pipeline, global market. And just like in complex GX, we're here to stay. Our mission is to become America's number one affordable medicines company. So biosimilar expansion is a must. So we will allocate capital towards biosimilar. And then always looking for specialty portfolio addition. Beyond DHE, we're looking at either a couple of programs internally which we are not ready to discuss yet and working with few outside potential that we can either bring it in-license or buy those products. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 28, 2025 / 1:30PM, AMRX.OQ - Q4 2024 Amneal Pharmaceuticals Inc Earnings Call

Question: David Amsellem - Piper Sandler - Analyst : Thanks. So I've got a couple. So you cited GLP-1s, peptides in 2028. Are those launches in ex-U.S./emerging markets? Is it Trulicity? Is it comp in the United States? Is it a combination of those things? I'm just trying to get a sense of what you're thinking regarding that 2028 number that's on slide 6. And then secondly, with the Metsera collaboration, you're constructing the new facilities. But you've also talked about beyond peptides vertically integrating your biosimilar business. And so I guess my question here is how should we think about growth in CapEx over the next several years? And how that plays into your overall debt paydown strategy because it sounds like there's significant expansion of your infrastructure that's going to be happening. So just wanted to get your thoughts there. I'll leave it there. Thanks. Chirag Patel - Amneal Pharmaceuticals Inc. - President, Co-Chief Executive Officer, Co-Founder, Director Thank you, David. So first question on GLP-1 by 2028, all of the above, what you mentioned, ex-U.S., could have a product like Trulicity, could have other contract manufacturing business. So that is how we see the GLP-1 through our partnership with Metsera. The growth in CapEx, as we had laid out, Metsera is contributing $100 million. We expect government incentives to be around $100 million. We're investing $100 millio, $150 million of our CapEx over three years. So it's manageable CapEx. As you would have noticed, we increased our CapEx projection for this year about $100 million. We're not on biosimilars. We're not going to start building from scratch. We're going to do certain M&A to bring the capacity already there and pipeline that is already there. And it will require incremental CapEx for those. But we do not know exactly how much. But you can see, in the ballpark, we will continue to be $70 millio, $100 million ongoing on CapEx. But our EBITDA keeps going up, our cash flow is improving, our interest expense is coming down. So no problem. (inaudible) invest here and keep making -- we have the awesome infrastructure already for many things, and this will be additional, a great infrastructure to have.

Question: David Amsellem - Piper Sandler - Analyst : It is. Thanks.

Question: Leszek Sulewski - Truist Securities - Analyst : Good morning. Thank you for taking my questions. Can you provide any latest commentary around naloxone, any additional contracts that you signed with other states? And then second, haven't really heard much commentary on UNITHROID, maybe provide some puts and takes around long term opportunity there. And then lastly, you did comment on delevering and you deleveraged faster than you anticipated. Is there a new target for 2025? Thank you. Chirag Patel - Amneal Pharmaceuticals Inc. - President, Co-Chief Executive Officer, Co-Founder, Director Good morning, Les. Naloxone, the states are slowing moving. So we haven't -- after California, we're close to a few states. But haven't signed anything new beyond California which was the largest state by far. You have to add another 20 states to get to California. And we're working through the distributors as well who already have the state contracts. So naloxone's moving. It's a three-players market; however, not much in it. So we're emerging and is well-positioned in all these states in longer term contracts. And it is a frustrating process at state level. But we have a team that keeps working on it and we expect to grow this business. But as it is, what we have forecasted, we should be able to provide about 2.5 million kits this year to the market and going up to 4 million kits in 2026. So that's what we're working towards. UNITHROID is like Synthroid. The patient which favors consistent therapy, and that is what we provide. It has a consistent growth profile over time. We see it going the same way.

Question: Leszek Sulewski - Truist Securities - Analyst : Great. Thank you for that color.

Question: Balaji Prasad - Barclays - Analyst : Good morning, everyone. So it's great to see the consistent progress and the healthy outlook. I'll try to read a couple of questions on topics, not a lot. But Tasos, starting with you, firstly on the guidance and EBITDA margins, 2025 EBITDA range seems to be at around 20.9% to 22.5%. I'm surprised to see that even at the higher end there is limited (inaudible) expansion. So how much of a drag has RYTARY LOE been on this? And are there any other factors at play? One. Two, I'm sure everyone will be happy to say that's not a big M&A shop and the focus will be on continuing to delever. So is this going to be more of a consistent deliverage year-over-year or are you comfortable with the bump-up in net leverage on the back of any deals? Lastly, Chirag, I was just curious, combining your recent approval of limited (inaudible) issues with (inaudible) and that they can't supply, they evidently need a supplier, do you see any scope for you to monetize your approval early either in the form of a supply deal or an accelerated launch out of January 2026? Thank you.