Amneal Pharmaceuticals, Inc. Q2 FY2024 Earnings Call

Good morning and welcome to the Amneal Pharmaceuticals Second Quarter 2024 Earnings Call. I'd now like to turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Good morning and thank you for joining Amneal Pharmaceuticals second quarter 2024 earnings call. Today, we issued a press release reporting Q2 results. The earnings 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 for factors that may impact future performance. We also discuss non-GAAP measures. Information on the use of these measures and reconciliations to GAAP are in the earnings release and 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; and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

Thank you, Tony. Good morning to everyone. We are delighted to report strong Q2 results, raise 2024 guidance, and share the recent approval of CREXONT for Parkinson's disease. Today, Amneal is a global diversified pharmaceutical company that provides access to high-quality, affordable, and essential medicines for patients, providers, and payers. We're a deeply purpose-driven company on a remarkable journey of expanding in key areas of medicine and delivering sustainable long-term growth. Amneal has grown consistently over the last five years. Revenues are up from $1.6 billion in 2019 to over $2.7 billion expected in 2024. Adjusted EBITDA is up from $339 million in 2019 to about $620 million expected in 2024. We could not be prouder of this progress and the strong foundation we have built. Let me now discuss how well we are positioned for sustainable long-term growth in each of our businesses. Starting with the Specialty business, we continue to grow our key branded products in neurology and endocrinology. This week's U.S. approval of CREXONT, formerly known as IPX203, is a watershed moment for Amneal. We are excited to launch CREXONT in September. Our launch plan and market access strategy leverage 10 years of Rytary commercial experience and our deep market understanding of patients, providers, and payers. We expect $300 million to $500 million in U.S. peak sales. In total, with the addition of CREXONT, we expect Specialty revenues of over $500 million in 2027. We continue to evaluate branded opportunities to add to our pipeline, and we are excited about the future of this segment. Next, our affordable medicines business, which is our Generic segment, has grown consistently every year since 2019. This durable growth profile is driven by our ever-expanding portfolio of retail, injectable, and biosimilar products. For the first half of 2024, revenue growth has accelerated to 14% due to our diverse portfolio of complex and high-demand medicines, a robust supply chain, and a regular cadence of 30 new launches each year. We're number one in quality, complex new product portfolio, and customer fulfillment in the United States. In injectables, we've expanded our portfolio to over 40 products for the hospital market with a deep pipeline. We have now tripled our manufacturing capacity to 60 million units to drive growth at scale. Importantly, we are helping to address market shortages in hospitals and clinics as we provide 12 commercial injectables currently on the shortage list. We are also focused on providing unique ready-to-use 505(b)(2) products that can improve hospital pharmacy efficiency by eliminating medication preparation steps. We have launched our three 505(b)(2) ready-to-use injectables, with more to come. Turning to biosimilars, we have built a strong business with the successful launch of our first three products, and we are on track for over $125 million in revenue in 2024. The next phase of biosimilar growth will come from five additional pipeline products we have added in the past few quarters. They're all expected to launch between 2025 and 2027. With our most recent addition, omalizumab, we have now expanded beyond oncology to allergy. This product represents $2.6 billion of the U.S. market today, and we see a significant biosimilar opportunity for this molecule with less competition. Overall, the U.S. biosimilar market is estimated to grow from $4 billion to $5 billion today to $20 billion to $30 billion by 2030 from a manufacturer's perspective. We see biosimilars as the next wave of affordable medicines. With adoption rates over 80%, biosimilars are increasing access and driving affordability for important biologic therapy for patients. We look to build a significant biosimilar portfolio through in-licensing and vertical integration over time to be one of the top global biosimilar players. Next, internationally, we are just beginning to gain traction. In India, we are building a customized portfolio of specialty products. In other geographies, we are working with partners to commercialize select Amneal products in key markets, and we'll start supplying products in the fourth quarter. We expect international revenues will add $20 million to $30 million in 2025, build to $50 million to $100 million by 2027, and rapidly scale after that. This represents a new growth vector for Amneal in the long term. Finally, our AvKARE distribution business has more than doubled since we acquired it in 2020. This robust growth is driven by ongoing expansion across all three of AvKARE's channels: distribution, government, and unit dose. We are especially proud to serve military veterans through AvKARE's government channel. Now we expect over $675 million in AvKARE revenue in 2025. Overall, as we continue to grow and further diversify, we are providing more patients, providers, and payers with access to high-quality, affordable, and essential medicines as we are having a profoundly positive societal impact. We have demonstrated that our growth is durable and sustainable over the long term. We believe the true potential and value of Amneal is yet to be realized. I will now hand it to my brother, Chintu.

Good morning, everyone. Thank you, Chirag, and thank you to the global Amneal family, who help make healthy possible with their deep passion, great talents, and hard work. I will begin with CREXONT and then discuss our core strength in innovation and operations, which we have a long runway for sustainable growth. We're very excited and delighted to receive the U.S. FDA approval of CREXONT that has the potential to change the treatment paradigm for Parkinson's disease. IPX203 has been our number one R&D program for years, and its successful approval this week is a remarkable accomplishment by our team. As a background, Parkinson's disease is a degenerative neurological disorder that severely impacts everyday life. Over 90% of Parkinson's patients today are on carbidopa-levodopa therapy. However, over 40% experience wearing-off symptoms within 2.5 years after diagnosis. Some patients take up to 10 immediate-release doses per day and still experience motor fluctuations. CREXONT promises to ease this burden for patients and improve their daily living. CREXONT is an innovative formulation consisting of IR granules for rapid onset and ER pellets for long-lasting efficacy. CREXONT delivers more 'good on' time with less frequent dosing. For Phase III post hoc analysis, CREXONT showed 1.6 hours more 'good on' time per dose than IR. As a leader in the Parkinson's space, we are proud to advance the standard of care for patients. In Specialty, we are continually evolving our R&D efforts to move up the value chain. Next up is the DHE auto-injector for migraine and cluster headache. We are on target to complete our ANDA response in Q4, which would put us in a good position to launch in the second quarter of next year once approved. Let me touch on our industry-leading complex generics portfolio. We have launched 15 new products year-to-date and are on track to launch over 30 again this year. Our pipeline remains deep with 80 new product ANDA pending, 63% of which are non-oral solids. In addition, we have 65 pipeline products, 94% of which are non-oral solids. Our world-class global infrastructure is optimized and ready to support the commercialization of our pipeline. Within our R&D organization, we have enhanced our efficiency, execution, and scientific capabilities to develop complex products on shorter timelines and at a much lower cost. As a result, we are allocating more investment toward external R&D, especially in biosimilars and Specialty. I will now touch on a few key programs. First, our recent launch of naloxone nasal spray is going well. With this product, we are expanding access to a critical rescue medicine for treating drug overdoses. We started distribution to retail pharmacies and the state of California in the second quarter. Next, our first major inhalation product, albuterol sulfate, has an FDA goal date in the fourth quarter. This is the first in a series of inhalation launches we have planned over the next several years. We are also on target to file our first Respimat product by the end of 2025. Inhalation is a new vector of growth for our business. In injectables, we launched nine new products so far this year, including our first 505(b)(2) products, PEMRYDI and FOCINVEZ, and our recently approved potassium phosphate bag. We have developed our 505(b)(2) injectable strategy uniquely based on feedback from many stakeholders. As a result, we have built a curated pipeline of unique injectable product presentations. We look to launch two to three 505(b)(2) injectables each year, with about 15 currently in development. Our other complex injectable R&D programs in microspheres, liposomes, and drug/device combinations are also advancing nicely in our pipeline. Next, in biosimilars, we are thoughtfully expanding our portfolio. Building on the success of our first three commercial products, we have in-licensed five additional biosimilar pipeline candidates since December of 2023. First, we expect to file our two denosumab biosimilars for Prolia and XGEVA in Q4 this year. After that, we expect to file our pegfilgrastim on-body injector and prefilled auto-injector products. In addition, we are excited to add omalizumab, our biosimilar for Xolair, to our pipeline. Our partner recently completed Phase III trial enrollment, with expected BLA filing by Q4 of 2025. This marks our expansion in biosimilars beyond oncology to immunology and our commitment to being a leader in this space. We will opportunistically add more molecules, particularly in less crowded categories, to our pipeline and look to be vertically integrated over time. Internationally, we have distribution partners in place for key developed and emerging markets. Our team has completed over 150 product registration filings since last year through the first half of this year. We are registering products globally, including in Europe, Canada, China, and emerging markets. International expansion is a key area of focus for us at Amneal. Moving to operations, quality remains at the center of everything we do. We make continuous investments in automation, digitization, and AI technologies to support quality and advance our global infrastructure. This year, we had several successful FDA inspections at our sites. Amneal's success is grounded in our deep commitment to operational excellence, exceptional customer service, driving efficiencies, and maintaining a robust supply chain. Across our supply chain, we are focused on what we call the three Rs: redundancy, resiliency, and reliability. We are focused on long-term cost savings by validating secondary sourcing, operational excellence, and moving production in-house. In addition, drug shortages remain a challenge for the U.S. supply chain, and we are doing our part to address shortages, especially for injectables. We have expanded our injectables manufacturing capacity in recent years to 19 production lines, which will allow us to drive long-term growth in injectables. Overall, Amneal is expanding and growing in key areas of medicine: specialty brands, biosimilars, injectables, complex generics, international, and distribution. We are deeply passionate about our company's mission and purpose and the good work that remains ahead. Amneal is part of the solution in addressing several of the critical health care challenges in the U.S. today. I will now pass it over to Tasos.

Thank you, Chintu. I'll start with our strong second-quarter results, then move to our first half, and then discuss our higher 2024 guidance expectations. Five months ago, during our March 1 earnings call, we outlined how our growth will meaningfully accelerate in 2024. We laid out an array of growth drivers, including biosimilars, new products, our Specialty portfolio, continued AvKARE expansion, and strong execution across our business. What we said we would do, we are doing. With strong momentum across our diversified business, we're driving accelerated top and bottom-line growth and continuing to reduce our debt levels. Let me now turn to our second-quarter results. Q2 revenues of $702 million grew 17%, with growth across our three business segments. Q2 Generics net revenue of $427 million grew 14%, driven by our diverse portfolio of complex products. Biosimilars generated $30 million in revenue, driven by Alymsys. New products launched in 2023 and 2024 added $36 million to Q2 revenue growth. Additionally, our base portfolio continued to perform very well, driven by robust demand for our complex portfolio and our strong execution by our supply chain and commercial teams. We're working incredibly hard to ensure the needs of our partners and patients are being met on a daily basis. Our second-quarter Specialty net revenue of $104 million grew 7%, driven by our key branded products, including the recent addition of ONGENTYS. Q2 AvKARE net revenue of $170 million grew 33%, reflecting continued strong growth across all three sales channels. Our overall second-quarter adjusted gross margins of 41% continue to be very robust and in line with expectations. Our second-quarter adjusted EBITDA of $162 million grew 11%, reflecting robust revenue growth and operating expense leverage. Our second-quarter adjusted EPS of $0.16 declined $0.03 as higher EBITDA was offset by interest expense and higher sales outstanding. Looking at our first half financial performance, total company revenues grew 18%, with double-digit revenue growth across all three segments: Generics, up 14%; Specialty, up 11%; and AvKARE, up 33%. Our first half adjusted EBITDA of $315 million is up 20% year-over-year. With continued broad-based strength across our business and operating expense leverage, we are pleased to raise our full year 2024 guidance. We now expect 2024 full year net revenue between $2.7 billion and $2.8 billion, up about $150 million from prior guidance, reflecting 13% to 17% year-over-year growth. Due to higher revenues, we now expect 2024 adjusted EBITDA of $610 million to $630 million, up from $580 million to $620 million, which reflects 9% to 13% year-over-year growth. We expect 2024 adjusted EPS between $0.57 and $0.63, up from $0.53 to $0.63 in prior guidance. Our increased 2024 guidance reflects the ongoing strong performance and momentum across our businesses, continued investments in R&D as we grow our biosimilars pipeline and our commercialization efforts around the upcoming CREXONT launch. The addition of CREXONT is an important new catalyst that bolsters our long-term top and bottom line growth profile. Combined with the array of growth drivers we have highlighted today and those not yet disclosed, we're confident in our ability to drive sustainable long-term top and bottom line growth. Let me now turn to our cash and our balance sheet, where our strong financial performance is translating into higher cash generation and deleveraging with our key pillars of value creation. We now expect higher operating cash flow of $280 million to $320 million in 2024, up $20 million from prior guidance, excluding legal settlements. Also, we continue to steadily reduce debt as net leverage has decreased from 7.4x in 2019 to 4.4x in the second quarter. We plan to pay down over $100 million in debt in the second half of 2024, including $40 million already paid down in July. We expect to reduce net leverage to about 4x by the end of this year, on our way to below 3x over the next few years. I will now turn the call back to Chirag.

Thank you, Tasos. Q2 was an outstanding quarter on many fronts as we achieved strong performance and raised our full-year outlook. With the approval of CREXONT, we expect the momentum to continue building, with additional catalysts on the horizon. As we look forward, we are excited about the opportunities ahead to increase access to high-quality, affordable medicines, improve lives, and create value for our shareholders. Let's now open the call for Q&A.

The first question comes from David Amsellem from Piper Sandler.

Just a couple for me. First on CREXONT. Can you talk about how you see the payer landscape evolving, particularly Part D, just given the eventual loss of exclusivity for Rytary? So just help us understand what you think access will look like, how restrictive do you think the landscape could be with Rytary being available as a generic. So that's number one. Then number two, just wanted to pick your brain on complex generics, particularly interested in what you're thinking regarding GLP-1 generics. I think you called out an exenatide pen in your slides. Are there others, the obvious suspects here, that you're looking to file on down the road? I wanted to get your thoughts there.

Thanks, David. Rytary has the best coverage among Parkinson's products, and we anticipate similar or even better coverage for CREXONT. Our initial conversations with payers have been positive. We have a strategic pricing plan aimed at capturing nearly 30% of the market share, making it more affordable for seniors, especially under Part D. With the new out-of-pocket requirements for Part D, we expect even greater adoption and coverage for this product. Prescription fulfillment should improve compared to the past, where we lost 20% to 30% of prescriptions due to coverage issues or the donut hole. We believe this will be much more favorable moving forward. Joe, do you want to add anything?

Sure. Dave, thanks for the question. The only thing I would add from what Chirag said is that, remember, too, we've been in this market now for over a decade. So we've developed very, very good expertise in contracting with the payers. We're intending to leverage that. To Chirag's point, we're also going to build a comprehensive patient support program to ensure reimbursement and patients actually get on paid therapy, to Chirag's point. So the experience that we've leveraged with Rytary really enables us to ensure access for CREXONT.

And the second one, let me hand it over to my brother, Chintu.

So as you know, Amneal is very focused on complex product development. We have spent many years understanding the entire peptide space and drug/device combinations. So we are in pretty good shape. As you mentioned, exenatide is the first GLP that was developed into a pen, and most likely we'll be launching that product in the next quarter. That does give us the platform to develop more. We do have other GLPs in the pipeline. We have not disclosed which ones, but we have a deep understanding of API peptides and manufacturing with drug/device combinations. So we have a good pipeline in this category of drug.

Stay tuned, David.

The next question is from Les Sulewski from Truist Securities.

Congrats on the approval of CREXONT. Just three questions for me. So maybe first, the focus on CREXONT now that it's approved. I would imagine you have an improved profile across your lenders. Any consideration for a chunky BD plan to further advance your Specialty portfolio? Or does the focus remain on the internal pipeline with some tuck-ins along the way? Second question is on residual investments in CapEx, I believe you maintained $60 million to $70 million of guidance. I'm just kind of wondering how that second half of the year plans out and then also 2025. And then third, on the DHE auto-injector launch, I believe that was initially expected in kind of the earlier first half of next year. What's triggering the delay into the second quarter?

So we are steadfastly focused on getting to 3x, as Tasos mentioned, on a leverage profile. Until then, expect us to keep doing the R&D deals, and those are really good for us. We do have a large budget for R&D. As my brother mentioned, for Generics, the spend has gone down. It's still a good amount of spend but not as what it used to be in 2016, '17, '18, '19, right? So we have more dollars available for R&D deals, and we may acquire some of the commercial assets in the areas we operate, all on the branded side. That will remain as a BD plan. After we reach 3x, we will be very engaged in very smart business developments and acquisitions. Our intention is to keep growing Amneal to the next level. We have one of the best teams to do that and a strong foundation in the industry. So expect us to keep doing good business development over time. Your second question on CapEx: CapEx will go up from next year, and we'll share that detail. This year is in line. As we plan to expand, there are certain specific areas which we'll share information when we have it. The DHE auto-injector has always been a first-half launch, which allows our Specialty team to focus on CREXONT. We're completing stability in the fourth quarter at our own site. We don't expect any delays anymore, and after that, PAS, so four to six months after that.

We expect approval sometime in April, May.

The next question is from Chris Schott from JPMorgan.

This is Ekaterina on for Chris. So just two, if I may. So first, just on biosimilar Prolia and XGEVA, can you talk about your expectations for those markets? And are you expecting similar dynamics to what we saw with HUMIRA and kind of any learnings from how that market is evolving over time in terms of the contracting in the PBM stuff? And then, the second question is just on generic pricing. Can you just talk a little bit more about the broader environment? I think you've touched upon this in the prepared remarks but just what you're seeing in terms of shortages and just the general pricing environment and anything that's kind of changing or something that you're paying attention to.

Thank you, Ekaterina. So Prolia and XGEVA touch both markets, the PBM as well as buy and bill, and we have expertise in both commercial segments, as we have been working with buying groups over the last 20 years and have great relationships with them. Similar buying groups have been formed for biosimilar products, and we expect to have a fantastic relationship with them. Just like we are ranked top of the line today with our retail buying groups, we'll build similar relationships. We like what happened with HUMIRA, and we knew this would eventually happen. The biosimilars will gain 80% or so market share because it's designed to do that. We are not worried about market penetration for both products. And if HUMIRA declines, where multiple declines, it will stabilize the industry as well as the competition developing biosimilars. It's a play for companies like us, Teva, and Sandoz focused on biosimilars, where we already have experience providing affordable medicines. Your second question on Gx pricing: It's better than before. It was unsustainable in 2016, '17, '18, '19, '20; those were painful years. Manufacturers cannot just keep lowering prices. We have obligations to patients and quality systems, and to the U.S. government. This is an essential industry that fills 92% of prescriptions. It is much needed, and it has to be sustainable; it's a robust industry. I don't know why you would sell our Gx business. When you think about it, part of Gx now is injectables and biosimilars, so it’s a critical industry. I hope we start getting the respect and pricing that we deserve.

The next question is from Balaji Prasad from Barclays.

This is Vishal for Balaji. So can you talk about how you see your Parkinson's franchise evolve now with CREXONT approved? What will the pace of ramp-up look like in the next few years? And how do you expect to achieve synergy within the three assets of your Parkinson's franchise? And also, could you comment a little bit on how CREXONT will impact your margin profile next year and over the next three years?

Thank you. So we're now the leader in Parkinson's. We have ONGENTYS, Rytary, and now CREXONT. We look to add more pipeline assets and continue to research Parkinson's. This is the area we know really well for 10 years, and we've been working closely with patients and providers; it's very fulfilling. The synergy is fantastic. The COMT inhibitor with CD/LD and the COMT inhibitor for certain patients increases the levodopa and keeps it longer in the brain, which is completely synergistic to market both products, CREXONT and ONGENTYS. As we launch more specialty products, biosimilars, and even inhalations, our margin profile should improve on the Specialty side. It should improve on Generics, and you see the AvKARE margins, which are distribution business and will be lower. When you combine it, the total margin will improve. Well, thank you very much. We're so excited, and we'll continue to deliver great results and really make an impact for patients and providers in the United States and now slowly but surely expanding internationally as well. Thank you, everybody, and have a great day.

Thanks, everyone.

This concludes today's call. Thank you for joining. You may now disconnect your lines.