Amneal Pharmaceuticals, Inc

Hello everyone and thank you for your patience. The annual Pharmaceuticals second quarter 2024 earnings call will begin shortly. In the meantime, if you would like to register a question, please press star one on your telephone keypad. Thank you. Good morning and welcome to the Amniel Pharmaceuticals second quarter 2024 earnings call. I'll now like to turn the call over to Amniel's Head of Investor Relations, Tony DiMeo.

Good morning and thank you for joining Amniel Pharmaceuticals second quarter 2024 earnings call. Today we issued a press release reporting Q2 results. The earnings press release and presentation are available on amniel.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 this section entitled Cautionary Statements on Forward-Looking Statements for Factors that May Impact Future Performance. We also discussed non-GAAP measures. Tony Doan- Information on use of these measures and reconciliations to gap or in the earnings release and presentation. Tony Doan- On the call today or shirag and shinto patel co founders and co CEOs tosses coney Dara CFO our commercial leaders Andy boyer for generics Joe render for specialty and Jason daily chief legal officer, I will now hand the call over to shirag.

Shirof, Thank you, Tony good morning to everyone. We are delighted to report strong Q2 results, raise 2024 guidance, and share the recent approval of Crexon for Parkinson's disease. Today, MNIL 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. MNIL has grown consistently each of 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 more proud of this progress and the strong foundation we have built. Let me now discuss how well we are positioned for sustainable growth, long-term growth, in each of our business. Starting with specialty business, we continue to grow our key branded products in neurology and endocrinology. This week's US FDA approval of Crexant, formerly known as IPX203, is a watershed moment for MNEO. We're excited to launch Crexon in September. Our launch plan and market access strategy leverages 10 years of RITERI commercial experience and our deep market understanding of patients, providers, and payers. We expect 300 to 500 million in US peak sales in total, With the addition of Crexon, 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 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. Robust supply chain and regular cadence to 30 new launches each year. We're number one in quality, complex new product portfolio and customer fulfillment in the United States. In injectable, we have 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're also focused on providing unique, ready-to-use 55B2 products that can improve hospital pharmacy efficiency by eliminating medication preparation steps. We have launched our three 55B2 ready-to-use injectables with more to come. Turning to biosimilars, we have built a strong business with a 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 to 2027. With our most recent addition, Omalizumab, we have now expanded beyond Onco to Allergy. This product represents $2.6 billion of 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 to 5 billion today to 20 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 to 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 MNIL products in key markets, and we'll start supplying products in the fourth quarter. We expect international revenues will add $20 to $30 million in 2025, build to $50 to $100 million by 2027, and rapidly scale after that. This represents the new growth factor for MNIL in the long term. Finally, our EVCARE distribution business has more than doubled since we acquired it in 2020. This robust growth is driven by ongoing expansion across all three of EVCARE's channels, distribution, government, and unit dose. We are especially proud to serve military veterans through EVCARE's government channel. Now we expect over six hundred seventy five million dollars in our revenue in 2025. Overall, as we continue to grow and further diversify, we are providing more patient providers and payers with access to high quality, affordable and essential medicines as as we are having a profoundly positive societal impact. We have demonstrated that Our growth is durable and sustainable over long-term. We believe the true potential and value of MNIL is yet to be realized. I'll now hand it to my brother, Chintu.

Good morning, everyone. Thank you, Siraj, and thank you to the global MNIL family who helped make HALDI possible with their deep passion, great talents, and hard work. I will begin with facts and then discuss our core strengths in innovation, and operations which pave a long runway for sustainable growth. We are very excited and delighted to receive the US FDA approval of Kraxon 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 two and a half years after diagnosis. Some patients take up to 10 immediate release doses per day. and still experience motor fluctuations. Kraxon promises to ease this burden for patients and improve their daily living. Kraxon is an innovative formulation consisting of IR granules for rapid onset and ER pellets for long-lasting efficacy. Kraxon delivers more good on time with less frequent dosing. Per Phase III post-hoc analysis, Kraxon 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 NDA response in quarter four, 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 18 new product A&D 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 a lot less cost. As a result, We are allocating more investment towards external R&D, especially in biosimilar 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 recipe mat product by the end of 2025. Inhalation is a new vector of growth for our business. We launched nine new products so far this year, including our first 55B2 products, BAM Ready and Fosing Vans, and recently approved Potassium Phosphate Bag. We have developed our 55B2 injectable strategy very 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 22355B2 injectables each year with about 15 currently in development. Our other complex injectable R&D programs in microspheres, liposomals, and drug-device combinations are also advancing nicely in our pipeline. Next, in biosimilar, 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 Danosumab biosimilar for Prolia and Xchiva in Q4 this year. After that, we expect to file our PAK field grasting, on-body injector, and pre-filled auto-injector products. In addition, we are excited to add Omalizumab, a biosimilar for Zoled, to our pipeline. Our partner recently completed phase three trial enrollment with expected BLA filing by quarter four of 2025. This marks our expansion in biosimilars beyond oncology to immunology and our commitment to be 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 MNIL. Moving to operations. quality remains at the center of everything we do. We make continuous investment in automation, digitization, and AI technologies to support quality and advance our global infrastructure. This year, we had several successful FD inspections at our sites. MNIL's success is grounded in our deep commitment to operational excellence, exceptional customer service, driving efficiency, 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, MNIL is expanding and growing in the key areas of medicine, specialty brands, biosimilars, injectables, complex generics, international and distribution. We are so deeply passionate about our company's mission and purpose and the good work that remains ahead. Emily is part of the solution in addressing several of the critical healthcare challenges in the US today. I will now pass it over to Kassos.

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 1st 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 after 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 reducing 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 our leases. 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 Agentes. Q2 Avacure 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% continued 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 healthcare 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're pleased to raise our full-year 2024 guidance. We now expect 2024 full-year net revenue between $2.7 and $2.8 billion, up about $150 million from prior guidance, which reflects 13% to 17% year-over-year growth. Due to higher revenues, we now expect 2024 adjusted EBITDA of 610 to 630 million, up from 580 to 620 million, which reflects 9 to 13% year-over-year growth. We expect 2024 adjusted EPS between 57 and 63 cents, up from 53 to 63 cents 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 Crexham launch. The addition of Crexham 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 were 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 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 7.4 times in 2019 to 4.4 times 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 four times by the end of this year, on our way to below three times 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 Crexant, we expect the momentum to continue building with additional catalysts on the horizon. As we look forward, we're excited for 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.

Thank you, Chirag. If you'd like to ask a question, please press star 4x1 on your telephone keypad now. If you change your mind, please press star 4x2. When preparing to ask a question, please ensure your device is unmuted locally. The first question comes from David Anselm from Piper Sandler. Please go ahead.

Hey, thanks. So just a couple for me. First on Crexon, can you talk about how you see the payer landscape evolving, particularly Part D, just given the eventual loss of exclusivity for RITARI. So just help us understand, you know, what you think access will look like, how restrictive you think the landscape could be with RITARI 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, you know, the obvious suspects here that you're looking to file on down the road? Wanted to get your thoughts there. Thank you.

Thanks, David. Good morning. So, as you know, Rytary has the highest coverage among the Parkinson's products, and we expect similar coverage for Crexon or even better on initial discussions with all the payers have been good we're very smart strategy on the pricing to make as we know we're going after almost 30 percent of the market share therefore we have devised a great pricing plan where it's more affordable for seniors especially the part d and with the new Part D out of pocket, we expect the adoption for this product and the coverage would be even better. And the fulfillment of prescriptions will be better than previously. We used to lose 20 to 30% prescriptions due to coverage or due to donut hole. We expect that to be much better going 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. So we're intending to leverage that. And to Chirag's point, we're also going to be building a pretty comprehensive patient support program. to ensure reimbursement and patients actually get on paid therapy, to Ashraq's point. So the experience that we've leveraged with Raitari really enables us to ensure access for Crexon.

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

Yeah, hi, Derek. Good morning. So as you know, Amnil is very focused on a complex product development. And we have spent many years of understanding the anti-peptide space and the drug device combination. So we are in a pretty good shape. As you mentioned, Xternetide was the first GLP that was developed 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 pipeline. We have not disclosed which ones, but we do have a deep understanding of uh api peptide and manufacturing with drug device combination so we have a good pipeline in this category of drug stay tuned david that's helpful thank you thank you the next question is from les louis wilkie from tourist securities please go ahead

Good morning. Thank you for taking my questions, and congrats on the approval of Crexon. Just three questions for me, so maybe first to focus on Crexon now that it's approved. I would imagine you have an improved profile across your lenders. Any consideration for a chunky BD plan for their advanced or specialty portfolio, or does the focus remain on internal pipeline with some tuck-ins along the way? Second question is on residual investments in CapEx. I believe you maintained $60 to $70 million guidance. We're 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? Thank you.

Hey, Les. Good morning. So we are steadfastly focused on getting to three times, 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 of R&D, and as my brother mentioned, that we internally for GX, now 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. 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. So that will remain as a BD plan. And then Obviously, after we get to three times, we will be very engaged in very smart business developments and acquisitions as we have our intention is to keep growing MNEO to the next level and next level. We have one of the best teams to do that and one of the best foundations in the industry. So we'll 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 certain specific areas which we'll share information when we have it. DHE Auto Injector has always been a first half launch and which allows us to, our specialty team, Focus on Crexon, and we're completing stability in the fourth quarter. It's our own site, so we don't expect any delays anymore. And after that, PES, so four to six months after that.

We expect approval sometime April, May.

Yeah, so April, May, we'll be launching it. Excellent. Thank you for the call. Thanks, Les.

Thank you. The next question is from Chris Schott from JPMorgan. Please go ahead.

Hey, thank you so much. This is Ekaterina on for Chris. Thank you for taking your questions. So just two, if I may. So first, just one about similar ,, 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 and 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, you know, the general pricing environment and anything that's kind of changing or something that you're kind of calling out or paying attention to. Thank you so much.

Thank you, Catalina. So Prolia and Exchiever, it touches both markets, the PBM as well as buying bill. And we have expertise in both commercial segment as we have been working with buying groups over the last 20 years, great relationship with them. So these are 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 will have the similar relationship. So we expect we like that what happened with Humira as aggressively when we knew this would happen eventually the biosimilars will gain 80% or so market share because it's designed to do that. So we're not worried about market penetration for both products and Humira lessons. were multiple lessons, right? And which has kind of stabilized the industry as well, as you have less competition developing biosimilars than what it used to be. And it's more of a play for companies like us, Teva, Sandoz, which are focused on biosimilars, who already have experience providing affordable medicines. And your second question on GX pricing, It's better than before. It was unsustainable in 2016, 17, 18, 19, 20 painful years. And, you know, manufacturers cannot just keep lowering prices. We have obligations to patients. We have obligations to quality systems. We have obligations to the government of United States as well. So we just, this is an essential industry, fills 92% of prescriptions. It is much needed. It has to be sustainable. And it's a robust industry. I don't know why you would, somebody would say, oh, GX business. We think about it, what we are doing. And part of GX now is injectables, biosimilars. It's a critical industry. And I hope we start getting respect that we deserve and pricing that we deserve.

Thank you so much. Thank you. The next question is from Balaji Prasad from Barclays. Please go ahead.

Hey, good morning. This is Shao Ong for Balaji. Thanks for taking our questions. So can you talk about how you see your Parkinson's franchise evolve now with Kraxmon approved? What will be the pace of ramp up look like in the next few years? 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 will cracks month impact your margin profile next year and over the next three years? Thanks so much.

Thank you. Uh, so we were now the leader in the Parkinson's, uh, we have, uh, on gentes, right. And now cracks on. uh we look to add more pipeline assets as well as continue to do research in parkinson's this is the area we know really well for 10 years and we we've been working closely with patient and providers and it is it is it's really touching our hearts it's it's the I think we can do more for this disease state, and we will continue to do so. And it's fantastic synergy, right? The COMT inhibitor with CDLD COMT inhibitor for certain patients increases the levodopa, or it keeps it longer in the brain, which is completely synergistic to market both products, Crexant and Angentis. And as we launch more products, which are specialty, biosimilars, even the inhalations, our margin profile should improve on the specialty side. It should improve on GX. And you see the margins, the healthcare margins obviously is the distribution business, so which are all going to be lower. So that's when you combine it, total margin will improve. Thanks, Chirag, and congrats on the approval again. Thank you very much.

We have no further questions, so I'd like to hand back to Chirag Patel for closing remarks.

Well, thank you very much. We're so excited and will 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.