Amneal Pharmaceuticals Inc Q1 2025 Earnings Call Transcript

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

Question: David Amsellem - Piper Sandler - Analyst : Hey, good morning and thanks. So I have a couple of questions on biosimilars and generic injectables. First, on biosimilars, can you just give us a refresher on what you expect the 25 contribution, top line contribution. To be particularly interested in how big you think Amneal's could be. I REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 02, 2025 / 12:30PM, AMRX.OQ - Q1 2025 Amneal Pharmaceuticals Inc Earnings Call think you in the past have cited it as being about $100 million of contribution, but I just wanted to just level set those expectations for biosimilars for this year. And then secondly, you talk about vertical integration regarding your biosimilar business. I guess my question here is when do you think that's going to actually come to pass and How should we be thinking about not just the next couple of years but sort of the next five years as we think about the cadence of new launches and just your overall thoughts on contribution for biosimilars to the top line. So that's on biosimilars and then on injectables. I know you've cited shortages, but you've also cited more complex products. I guess if you think about, the business, is there a lean into one versus the other and just help us better understand what you think injectable top line contribution is going to be this year. Thank you. Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director Well thank you David and good morning. Biosymbolism we're in line with what we have said around $150 million to $60 million in total contribution or top line with others being a leading product. You're in the ballpark somewhere between $90million to $100 million. That's what we are driving towards. So that's the current existing products. And then your question on vertical integration. We're looking at options and, we expect to execute on options. By probably the end of this year, maybe beginning of next year, because we see time as that essence now would like to be very a big player in biosimilars, having the development capabilities, having manufacturing capacity in the United States and in India or other locations in the world, and I have this week, as we said, this is there's a voiding biosimilar. There's so many products we can work on and when we do look to vertically integrate, we will hope that the partner has a big pipeline and the contribution from a biosimilar business over 5 years and 10 years is going to be very significant. It is the whole, as the value of the biosimilars are huge. The total branded value is $250 to $300 billion and about 100 losing exclusivity over the next 10 years. So there is it's. About execution, the market dynamics on the commercial side we believe will work it out over time just like how it worked out in GX, but not exactly like GX because competition here is very less from the supplier standpoint right now we see about somewhere 7 to 10 active companies in the United States that work in the work on the pipeline, serious pipeline. So I know it's a long answer, but it's a very important vertical for us biosimilars to grow, and it's in our wheelhouse. This is what we do. We complex development device combination similar is a very complex manufacturing and great commercialization in the United States and work with partners in the international markets. So it's a great international opportunity. On injectable, I'll pass it over to my younger brother. Chintu Patel - Amneal Pharmaceuticals Inc - Co-Chief Executive Officer, Co-Founder, Director Hi. Good morning. On injectables over the last few years we have expanded our manufacturing footprints and R&D capabilities to work on complex and sometimes we have the capacity which we can work on certain volume products. We are very passionate about solving the drug shortage because we believe that drug shortage should not exist. And we have many products where does not affect or impact our ability on the complex development. So we are focusing on both areas. Our complex portfolio is moving very well. This year we'll be launching COSA. We have launched, many other 5 5B2 programs. We have a 10-12 pipeline of 552 injectable programs along with microspheress are making good progress. Our liposom is making good progress. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 02, 2025 / 12:30PM, AMRX.OQ - Q1 2025 Amneal Pharmaceuticals Inc Earnings Call We have deep expertise on drug device combination. We have now infrastructure of about 22 injectable lines with 3 to 4 locations and we are also looking to some manufacturing in the US in coming time also. So we are well positioned on injectables. It's a focused area and it's we're not leaning one over another. We are privatizing both space equally.

Question: Leszek Sulewski - Truist Securities - Analyst : Good morning. Thank you for taking my questions. First, I wanted to focus on (Ascare). How exposes AFCA to the federal government costs, if any, how are you positioning this business in the current environment, I guess. And then second, on, are you seeing any sort of FDA delays, whether it's on approvals or feedbacks on the generics front? and any sort of I guess initial potential from facility site visits delays as well. And then second, just kind of talk to us about the ongoing partnership selection and reckon X. I know you've identified EU and South America and Canada, but perhaps we should give us a little bit of timeline on other parts and then specifically in with your timeline to launch in India and the opportunity there. Thank you. Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director Well thank you Les and good morning. So VA this federal cuts do not apply to the pharmaceuticals. VA is actually expanding $18 million lives, so, and more, our veterans are becoming older, so more prescription drugs, so we see volume growth actually in VA DOD, so we do not see any issue there. The question on FTA, we haven't seen any delays from FDA at this point, so no issue there. And then Cracks on XUS, we have the partnership in place for Canada. Latin America, Europe, and now we just signed Southeast Asia. India, we're going to market by ourselves. Europe is the largest, I mean the largest market size will be for us, and partners doing a phase 4 additional small phaco for European requirements to get a proper reimbursement. And then India, we haven't gauged the exact market size, but it's a much needed all over the world. Only I is available for the last 30-40 years, and these patients really will benefit from taxon. And looking at China and Japan that those talks are going on right now. Chintu Patel - Amneal Pharmaceuticals Inc - Co-Chief Executive Officer, Co-Founder, Director Let's just to add one thing on FDA, none of our gold dates have been impacted. All of our products are progressing well, and it's part of the Gro user fee. Inspection plus all plants are approved and in a very good standing. That also benefits us from any potential delays, but as of today we have not seen any delays on our application or the bold.

Question: Chris Schott - J. P. Morgan - Analyst : Great, thanks so much for the questions. I said maybe to start with a two parter on tariffs. I know you have a different manufacturing footprint versus peers. So if we were to see tariffs applied to pharmaceuticals, do you see an opportunity to further leverage your US manufacturing footprint and just talk a little bit about what type of capacity you'd have to utilize if in fact we did see tariffs applied? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 02, 2025 / 12:30PM, AMRX.OQ - Q1 2025 Amneal Pharmaceuticals Inc Earnings Call My second question on the tariff front was for some of the products that are potentially exposed to tariffs and thinking about the affordable medicines portfolio, what is the ability to increase price on some of these products to offset some of those pressures, or is the goal of ENeil more to pivot the manufacturing to either your own capacity or third parties to avoid tariffs on those and then maybe one follow up after that. Chirag Patel - Amneal Pharmaceuticals Inc - President, Co-Chief Executive Officer, Co-Founder, Director Oh thank you, Chris. So if tariffs were to The common on genetics, pharmaceuticals, leveraging over US manufacturing footprint, we have, additional capacity. We have one ideal plant for a long time now, which we would restart if economically viable. We still have to do that. There is a long term economically viable, about $8billion to $10 billion more units of solids of liquid manufacturing, topical manufacturing, transdermal manufacturing we can produce in the United States. So we would, we are already set to go, but it has to be economically viable and your question on, increase in prices, obviously, look, if there are tariff related increases. We would work with our big customers, they have to participate in that, which is the CVS and UnitedHealth and Cigna. These are large companies, and there is some positive indication from the customers that they would. They would partner in if something has to happen because we, the last thing we want is any kind of discontinuation or shortages. So that's the news so far. Thank you, Chris.

Question: Chris Schott - J. P. Morgan - Analyst : Thanks so much.