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spk08: Good morning and welcome to Amniel's second quarter 2021 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Amniel's Head of Investor Relations, Tony DeMeo. Please go ahead.
spk02: Good morning, and thank you for joining Amniel's second quarter 2021 earnings call. Today, we issued a press release reporting our financial results. The press release and presentation are available on our website at amniel.com. We are conducting a live webcast of this call, a replay of which will also be available on our website after its conclusion. Please note that certain statements made during this call regarding matters that are not historical facts, including but not limited to management outlook or predictions for future periods, are forward-looking statements. These statements are based solely on information that is now available to us. We encourage you to review the section entitled Cautionary Statements on Forward-Looking Statements in our press release and the presentation which applies to this call. Also, please refer to our SEC filings which can be found on our website and the SEC's website for a discussion of numerous factors that may impact our future performance. We also discussed certain non-GAAP measures. Important information on our use of these measures and reconciliations to U.S. GAAP may be found in our earnings release and the appendix of today's presentation. On the call this morning are Chirag and Shintu Patel, co-CEOs, Tassos Konidera, CFO, Andy Boyer and Joe Tedisco, Chief Commercial Officers for the Generics and Specialty segment, and Steve Manzano, General Counsel and Corporate Secretary. Shintu and Tassos are in separate locations today, so hopefully we maintain good connectivity. I will now turn the call over to Chirag.
spk06: Thank you, Tony. Good morning, everyone. I'm pleased to share with you MNIL's strong second quarter results with net revenue of 535 million, adjusted EBITDA of 151 million and adjusted EPS of 25 cents. As a matter of fact, these results are the highest levels our company has delivered since 2018 and a testament to the soundness of our strategy and excellence in execution by our global team. As you will hear from Tasos later on, all three business segments, generic, specialty, and distribution, perform very well. And at the halfway point of the year, we remain confident in our ability to meet or exceed our financial guidance for 2021. Let me now discuss each of these three segments and provide updates on key initiatives. Over the last two years, we have significantly strengthened our genetics portfolio through our core competencies in R&D, manufacturing, and commercial excellence. As a result, we have seen an increased cadence of new, more complex product introductions, creating substantial value for MNEO as well as our customers and patients. Since we rejoined MNIL two years ago, we have demonstrated consistent generics performance while increasing adjusted gross margins from 30% in third quarter of 2019 to 47% in this most recent quarter. That's a significant improvement. In generics, we are often asked what makes our generic business durable. Fortunately, The answer is many things. Let me share a few highlights with you. First, a third of our current generics net revenue come from products launched since 2019. That's a meaningful portion of the business. This fact reflects the robustness of our R&D engine. Second, for about half of these new products, MNIL was either first or second to be approved for that product, which speaks of the ingenuity of our team. Third, our business mix is increasingly from more complex products, which provides more durable revenues at higher profitability. Over the course of time, we have been successful in migrating our business towards less commoditized products, and we expect that to continue. As a result, about half of our current revenue base is non-oral solids, while 80% of our R&D pipeline is non-oral solids. That's a significant and deliberate shift in MIX towards a more complex product portfolio. Fourth, our excellence in manufacturing and leading operational capabilities allow us to manufacture the majority of our products in-house. That's driving our speed of execution and higher profitability. I hope these thoughts demonstrate the soundness of our strategy, which, along with solid execution, makes us confident in the sustainability of generics performance over the long term. In addition, we continue to bring certain generic products into select Overall, we see global expansion as another factor for long-term sustainable growth. Let me now move on to our specialty business, where we are continuing to build our specialty portfolio. We are focused on growing the business through organic growth, advancing our R&D pipeline, and pursuing suitable inorganic opportunities focused primarily in neurology and endocrinology. First, to drive organic growth, we strategically invested to expand our endocrinology sales force this year, and accordingly, we are seeing continued Well, in spite of continuing COVID-19 headwinds, we are pleased with year-to-date performance of our two largest specialty products, Rytary and Unitroid. Second, in terms of advancing your pipeline, we expect to share our upcoming Phase III clinical data for IPX203 in the coming weeks. Furthermore, we continue to advance our broad R&D specialty pipeline projects, which are in various stages of preclinical and clinical development. Chintu will touch on innovation in more detail shortly. As we have discussed in the past, we continue to pursue complementary commercial stage assets and late stage clinical programs to leverage our existing specialty commercial infrastructure. That is exactly the rationale for our recently announced licensed BHE pre-filled syringe auto-injector for acute migraines and cluster headaches. We expect to begin our commercialization efforts in the second half of 2022 once this 55B2 product is approved. Let me now move on to our air care distribution business, where we saw solid performance again this quarter. As a reminder, AvCare plays in three main channels, that is, the federal government, the institutional market by leveraging unit dose packaging, and a niche distribution channel. We are focused on the growth and profitability of AvCare as we continue to launch numerous new products, expand its unit dose offerings, and ensure strong commercial and operational execution. Finally, as a mission-driven and purpose-led company, I would like to share more about our ongoing efforts in driving environment, social and governance initiative at MNEO. We truly integrate ESG into every aspect of our business. Underlying everything we do and stand for at MNEO is our mission of providing affordable, essential medicines for patients. Since our founding in 2002, we have always been committed to the highest quality standards and good manufacturing practices. And our industry-leading quality track record speaks for itself. We also believe that our people are our greatest asset. It's our people who generate innovations, operate our plants, and drive the commercial success of our business. We hope you will read more about this inaugural sustainability report, which will come out later this year. With that, I'll now turn the call over to Chintu.
spk01: Thank you, Chirag. Adding to those points around ESG, we always strive for improvements across the organization. For instance, MNIL is known for its best in class quality system, and we are constantly looking for ways to push that quality bar higher. Most importantly, it is our people that drive the success of MNIL. As always, we would like to recognize the service of our nearly 6,500 associates who work very hard every day to make healthy possible. We thank them deeply. On our call last quarter, we shared how the pandemic was impacting our organization and team in India. Thankfully, the local situation has improved considerably. However, we are saddened by the toll the pandemic has had on our MNIL family and their loved ones. The India team has demonstrated tremendous courage and resiliency, and we are very proud of our team. now let me provide some key updates on our operations and our innovation agenda two years ago when chiraj and i returned as co-ceos we stated our key priorities were to optimize global operations improve supply chain and enhance margins these goals continue to be key area of focus two years later we are seeing considerable progress across all those initiatives Most notably, our product offerings are much more diversified across numerous therapeutic areas and multiple drug delivery mechanisms with much improved profitability. This is a remarkable improvement in two years. Next, our innovation strategy has been well thought out and delivered over the years. Looking back, we have a rich history of innovating across numerous drug dosage forms categories. We believe MNIL is differentiated from its peers in its ability to deliver innovations across these complex dosage forms. Our internally developed R&D and manufacturing capabilities built methodically over time are driving the velocity of innovations we are seeing today, and we believe that these are competitive advantages for us. Since these are internally developed innovations, we also have better control over the vital supply chains for these products. Going forward, we will continue to prioritize complex products across different dosage forms, such as inhalation, injectables, implants, drug-device combinations, and biosimilars. Overall, we feel great about our current generics pipeline. Today, over 80% of our pipeline is non-oral solid products. We are very pleased with our new product launches in 2021, such as Zephyrmi, Abiretron, and recently approved Trovadex, which is a complex ophthalmic suspension product. Later this year, we expect several additional meaningful approvals. On Capaxone, we expect to launch in the first half of 2022. On vasopressin, we are working with FDA on their CRL and we expect to respond in the third quarter. We believe that puts us on a path to have approval as soon as the first half of 2022. Having said that, we never rely on one product as we have a very large and diversified pipeline. Let me now discuss our injectable business, where we have made significant progress over the last two years and expect substantial growth in the years ahead. We view injectables as an attractive and strategic opportunity for MNIP. Today, we have about 25 commercial injectable products with approximately $125 million in annual revenues. We see this business more than doubling over the next four years based on our rich pipeline as we look to meaningfully expand our offerings for the institutional market. Our talented R&D team is focused on developing a variety of injectable products in complex areas such as drug-device combinations, peptides, long-acting injectables, large-volume parenteral bags, and others. Each of these injectable categories requires R&D and manufacturing expertise that we possess at MNIL, and which have been barriers to entry for others in this space. We look to share more about new injectable products approvals in the near terms. Further, we look to leverage our complex generics portfolio by outlicensing certain products internationally through partnership. Our existing partnership with Fosun is progressing well, where we expect to have about 10 products filed in China by the end of the year. Let me now move on to biosimilars. We were pleased that our BLA for Avastin was accepted by the FDA in June. We now have three oncology biosimilars currently filed and under review. We expect to start commercializing these products in 2022. Beyond these first products, we are actively evaluating additional opportunities via partnership models where we can be first or second to market. Looking forward to 2022 and beyond, we are highly confident in the long-term growth prospects of our generic business. Bolstered by new product launches, the diversity and durability of the business has never been stronger. Going forward, we expect the pace of new product launches in complex generics will continue. At any point in time, we have approximately 100 products in our pipeline and another approximately 100 products with ANDA spending. Currently, we expect to file 25 to 30 ANDAs and launch 20 to 30 new products on an annual basis. These innovations will constantly turn to MNIL as we continue to refresh our pipeline. We see a long runway for innovations in generics, and as a result, we expect the trend of durable generic revenue growth and profitability to extend for some time. Turning to our specialty pipeline, We look forward to sharing our Phase III clinical trial data for IPX203 in the coming weeks. The Phase III clinical trial has completed with the last patient out and we are performing the data analysis now. As a reminder, IPX203 is our next generation levodopa treatment for Parkinson's disease. Immediate release carbidopa levodopa is a first-line therapy in the treatment for Parkinson's disease. We are hopeful that our Phase III data will demonstrate increased on-time versus IR while meaningfully decreasing the dosing frequency per day. We believe that IPX203 has the potential to be a larger product than RITERI and would help us drive further market leadership in the management of Parkinson's disease. Beyond IPX203, we continue to advance our development activities for K127 for myasthenia gravis, K114, a modified D3 product for hypothyroidism, and K128, a modified release trihexyphenidyl for psilorrhea and movement disorders. On K127, we are currently in the clinical study phase and we expect to complete the pivotal PK study in the second half of 2022. On K114 and K128, we expect to file the IND application for each in 2022. These are all 505 programs for which the risk level is relatively lower than the new molecular programs. As a reminder, our specialty programs utilize the proprietary drug delivery technology platform from the Kashyap acquisition. GRANDE is the gastric retentive drug delivery technology utilized in K114 and K127. Kronotek is an advanced osmotic oral delivery technology that provides timed, customized, and pulsated drug release to match the timing of disease symptoms. To build our longer-term specialty pipeline, we continue to evaluate further programs that can leverage these unique technologies. We remain well positioned to launch at least one specialty product per year going forward, now starting next year with the DHE auto-injector. In summary, our strategy is centered on delivering affordable, essential medicines for patients and creating value for all our stakeholders. The company continues to execute well across three businesses, generics, specialty, and distribution. With this distinct combination of people, products, and purpose at MNIL, Shiraz and I share the vision, excitement and confidence in the road ahead. I will turn the call over now to Tasos.
spk05: Thank you, Chintu. In the second quarter of this year, we reported total company net revenues of $535 million, up 15% versus Q2 2020. Adjusted EBITDA of $151 million, up 50%, and adjusted EPS of $0.25, up 92%. Our growth was balanced and driven by strong commercial execution across our three business segments, operational efficiencies, and targeted investments to drive long-term value. In addition, we continue to improve our balance sheet and further reduce net leverage to adjusted EBITDA to five times compared to 5.3 times in December 31st, 2020 and seven times in December 2019. Starting with generics, second quarter net revenues of 360 million were up 54 million or 18% year over year. The strength of new product launches and resiliency of our portfolio offset lingering COVID-19 headwinds and price deflation. Our quarterly growth rate of 18% also reflects favorable comparison to prior year where COVID-19 disrupted our supply chain. From a product perspective, Zafemi, Adirateron, and Ellering were strong contributors to revenue growth. On a year-to-date basis, Generics recorded 673 million in net revenues, up 2% organically year-over-year. As we have discussed in the past, a productive R&D pipeline is critical to ensuring a robust Generics business. We continue to be pleased with the performance of new product launches and products launched in 2020 and 2021 accounted for 61 million of revenue growth this quarter. as a result of the performance of new products and the resiliency of our more complex product portfolio were driving profitable growth while bringing more value to our patients and customers. Adjusted gross margin for generics was 47.1% in the second quarter, substantially higher than the 35% of the prior year quarter and ahead of our expectations. This 12 percentage point expansion reflects two key components. First, about half of the growth is due to operating efficiencies, such as insourcing of third-party manufacturing and procurement savings on certain materials. Second, the other half of the growth is due to favorable product mix and new product launches. For the second half, we expect some moderation in the generics gross margin due to mix of products and timing of manufacturing overhead absorption. Let me now turn to the specialty segment with net revenues of $89 million, down 6 million or 6% year-over-year, which was in line with our expectations. As a reminder, our specialty segment centers around neurology and endocrinology with our promoted brands, Reiter and Urethroid. Both brands continue to grow nicely, and in aggregate, they delivered $55 million in net revenues, up 6% year-over-year. This growth was offset by declines in ZOMIC due to increased competition and lower promotional efforts ahead of expected generics. Looking to the second half, we see continued strength in Writer and Unitheroid as second quarter total scripts for both were up high single digits and new scripts were up double digits. This growth reflects our action at the beginning of the year to increase our specialty sales force. Adjusted gross margins for specialty was 76.1% in the second quarter, which is 230 basis points improvement year-over-year due to favorable product mix. Let me now move to Avcare, our distribution business, where second quarter net revenue of 86 million were up 22 million or 35% year-over-year, again, in line with our expectations. Growth was driven by new product launches in the federal government channel and a favorable prior year comparison. Adjusted gross margin for Avcare was 18.9 percent in the second quarter, about 200 basis points lower than prior year due to product mix, but in line with our expectations. Let me now move to total company adjusted EBITDA, over 151 million for the second quarter, which was $50 million higher than the prior year quarter. The net revenue growth in our three segments added $62 million in gross profit, and that was partially offset by $4 million in higher R&D as we incorporate the cashier acquisition, and $8 million in higher SG&A due to our Salesforce expansion and higher expenses as the economy opens. Also want to be mindful that we had favorable comparisons to last year's second quarter due to COVID-19 impact. Adjusted diluted EPS for the second quarter of 25 cents almost doubled compared to the prior year quarter, driven by the very strong EBITDA performance partially offset by higher taxes. From a cost perspective, operating cost flow minus $52 million was in line with our expectations. As we have discussed in the past, operating cost flow is inherently variable quarter to quarter. In the first half, we generated $96 million of operating cost flow, and we expect a stronger performance in the second half due to timing of collections and cost expenses. In summary, We're pleased with the strong top-line performance and sustained higher levels of profitability driven by new products and the focus on efficiency and strong execution. As a result, our full year 2021 guidance remains unchanged and we remain confident in our outlook for the second half of the year. With that, let me turn it over to Shirag.
spk06: Thank you, Tatos. To close, MNU is driving strong performance across our businesses, which reflects the diversity and durability of our product portfolio. The story this year is the success of new complex product launches, which we believe will continue to differentiate MNU. As a direct result, we see sustainable growth and profitability going forward. We would now like to open the call to questions.
spk08: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Gary Nachman with BMO Capital Markets. Please go ahead.
spk11: Hi. Good morning, guys. First, on the plan to double the generic injectable business in several years, is that all organic or are you assuming some inorganic growth as well? So talk about how much is in the pipeline there and some of the bigger drivers over the next few years. And then just on the specialty business, Talk about the additional endoreps on Unisroid. How much of a benefit are you seeing from that? Do you hope to leverage that with more assets through business development? And then just the expectations for IPX203 Phase 3 data that's coming soon, just what you're hoping to see from the data that would be meaningful in terms of that product. Thank you.
spk06: Thank you, Gary. Good morning. Let me start with your first question. which is on an injectable. So currently our expectation is all from the organic growth. We do have a solid pipeline of 75 injectable products, as Chintu mentioned, across the various complexities such as peptides, long-acting depot, the drug-device combination. So it's a very rich pipeline we have in injectables, and we have three plans to deliver that. So capital investments have been already made over the years, and we are ready to become a serious player in injectable market in coming years, and really highly valuable player. So that is your answer to the first question. For the second one, I would like to turn the call over to Joe, and you may want to address the third one, and Shilu, you may want to add on to that.
spk10: So we started building up the endocrinology field force or increasing the size in March of this year. We began hiring and training around 25 new sales reps, which doubled the size of that team. They essentially went live in the field in June, and we saw an immediate uptick in scripts. We can expect that trend to continue into the back half of the year. So we're very pleased with what we've seen with the promotion sensitivity of Unithroid. On IPX203, we expect to announce the top line results in the next couple of weeks. We're hoping to show a statistically significant improvement and good on time, while also meaningfully reducing the dosing frequency versus IR. Beyond that, I don't think we're going to comment on... Not at this point.
spk06: Only a couple of weeks left. Yes. Thank you, Joe. Chintu, would you like to add anything for Gary's question? No. No, you guys covered it. Thank you. Excellent. Fantastic. Let's move to the next question, please.
spk08: The next question comes from David Amsalem with Pfeiffer Sandler. Please go ahead.
spk07: Hey, thanks. So just a few. So first, you know, as the business evolves, what are your thoughts on potentially divesting some or parts of the legacy oral solids business and just getting out of oral solids or the more commoditized piece of the business. How do you think about that, or how should we think about that? That's number one. Number two is, can you just give us a roadmap regarding the competitive landscape for Zafimi and how we should think about other entrants coming in, particularly in 2022? And then lastly, on the DHE opportunity, Is it your view that this could be bigger than the footprint for the Zomig nasal spray? And what I guess I'm trying to get at here is not just how you're framing the opportunity, but how you see the acute migraine landscape evolving given the new entrance. So help us understand your thinking there. Thanks.
spk06: Good morning, David. Good to hear from you. So let me start with the first question, which is really a strategic question you did ask. And as you know, Endo adopted this strategy to divest out of the OSD, move over more on a diverse and more of a complex genetics portfolio. We do not like that strategy. We are a meaningful player in genetics business. We have a base of about 1.4 billion, so we have a long runway we can grow. And our customer appreciates when we are bringing oral solids, the commoditized product, as well as complex products. We are, as well as our operational efficiencies, are also increased by doing so. Of course, we have lowered our commoditized products development to almost 20%, and 80% still focus on the complex products. So we like to remain as an essential, meaningful company for the United States, which is driving the patient's need, reducing the cost, creating more access. So we believe we would play in oral solids as well. Your second question on Zephymi, I'd like to turn it over to Andy Boyer, our commercial head of genetics business.
spk04: Yeah, good morning. Thank you. Zephymi has performed extremely well this year. We're up to almost 35% market share, and we continue to grow, you know, our opportunity. We do expect additional competition at some point later this year. And as far as 2022, you know, we haven't commented on that yet, but it has performed extremely well.
spk06: Thank you, Andy. And Joe, would you like to touch on the issue, please? Sure.
spk10: Thanks, David. So we know that the migraine space is getting increasingly more competitive with all the new CGRPs that are launching. We've developed over the last few years with Zomeg nasal spray a large amount of intelligence in the migraine space. We're not looking to position DHE as a first-line therapy that goes out and competes head-to-head against the larger CGRPs. We know that it's going to be more of a niche second, third-line therapy. We're going to position it accordingly, and that's how we'll be marketing it. We're not going to comment beyond that on any other pricing or commercial strategy at this time, but we're mindful of the competitive nature of that space.
spk07: Okay. Thanks, guys.
spk08: Thank you. The next question comes from Balaji Prasad with Barclays. Please go ahead. Hi.
spk00: Good morning. This is Balaji. A couple of questions from me, and congrats again on the results. Firstly, on the generics industry, While Generics tends to see a lot of churn annually, the fact that you call out around one-third of revenues from new Generics launches over the last two and a half years, how does that compare to the industry standard? And kind of an extrapolation of the same question, new launches going by what you called out seems to be running at a $200 million run rate from 32 products, an average of $6 million per product. despite most of these being first or second market. Is that how we should think about the contribution from complex generates, or should we be expecting higher revenue for products, especially from the complex swings? Thanks.
spk06: Good morning, Balaji. Excellent question. Comparing the generic industry other players, it may not be a good comparison because some are already at a 3-4 billion range like Taiwan and Viatris, so they will have a harder time to match the one-third of our new product launches within two years. As we keep saying that we are at a right right revenue base as a total 1.4 billion. And we see tremendous growth in our genetics business from now to next five years. As you know, we build the company over time. And we're very excited about that. So that's that. And we have these wheel of innovation where we have 100 products pending at FTN, 100 in pipeline. Every year, we're launching 20 to 30 products. Out of that, six to seven are high-value products. The rest are highly competitive products. And then every year we're filing 25, 30 products. We're increasing our complexities of filing. It's more higher potential, higher revenue drivers we're filing. Drug device combination, inhalation products, the long-acting depot injectables, the bags, some of the 505 in the injectable space as well. The contribution, which is, you did the math, it could be 200 million, could be 250, could be 180, could be 300. It all depends on which products get approved within that year. But the key message is that we have enough to rotate every year into new products launches as we constantly face competition in our base business and reduction in prices due to the highly competitive nature of the genetics business. The complex products are also driving more durability. So even if we lose in the revenue when the competition came, like Allumin. We increased our market share and still maintaining the same revenue as last year. So we're building this durable portfolio as well. Did I miss anything, Tony? No. All right. So thank you, Balaji. Hopefully that answers your question.
spk00: Thank you, Chirag. That's very helpful. If I could just create a follow-up based on the guidance, can you also just describe the pushes and pulls towards the implied second half run rate? Thank you very much.
spk06: Thank you. Thank you, Balaji. So we're very pleased with our progress and continued momentum and remain very confident that we will deliver at the high end of our guidance or even above. For more details and, as you know, there are variables that go in the guidance, I'll turn it over to Tasos.
spk05: Thanks, Hiragai. Good morning, Balaji. um as sirac said you know first half and i think we feel great about the performance and as you think about the second half i don't think you should expect any anything substantially different right so i think you're going to have the normal play out of typical competitive pressures being offset by continuous new product introduction number one Number two, you know, I spoke a little bit about the generics gross margin kind of papering off a little bit because in the first half, you know, we were at 46%, 47% for the first half. So that's going to taper a little bit and continue to, you know, be thoughtful about the investments we're making to our business because it's all about driving top line and bottom line growth next year and the year after that. So I think the first half is a good indicator of how the second half is going to play out. Slight acceleration on revenues, little tapering down on gross margin, and I think when you look at the adjusted EBITDA, I think we have a good opportunity to be on the high end or exceed the high end of our guidance. Hopefully that helped out.
spk08: Okay, was there a follow-up? No, I think he said thank you. Thank you. Again, if you have a question, please press star then 1 on a touch-tone phone. The next question comes from Greg Frazier with Truist Securities. Please go ahead.
spk02: Good morning, guys. Thanks for taking the questions. Can you speak to the level of competitive intensity that you're seeing for your key generics and how price erosion has been trending relative to expectations? And then my second question is on FBE. Are you anticipating that Q3 will be strong as it has been historically, driven by the back-to-school demand? And how are you thinking about that, the FBE market, beyond this year? Do you think the market can continue to grow, or do you think erosion is more likely, at least in 2022, to do the vaccine-related demand requirements?
spk06: Good morning, Greg. This is Chirag. I'll take the EPI question and then pass it to Cassius for the genetics price pressure that we see every year. So, EPI, we're doing good. We had a growth, and it's growing compared to last year, and we expect that to grow slightly as we improve our supply chain. We're working with both of our partners diligently. It's Pfizer and Philips, and we're seeing good results. So we're upbeat, and, yes, Q3, Q4 would be higher as well due to the back-to-school and the higher demand. So it's more of our getting ahead on the supply chain. The market is there for us. And for your key genetics, competitive landscape, let me turn it over to Tarsus.
spk05: The second question was more around pricing, Greg. So, our price outlook has not changed since last time we spoke in May. So, the older the oral solids, the older part of the portfolio, we continue to see low double-digit price erosion. In terms of the overall portfolio, I think we're high single digits, so kind of in line with our conversation in May. So that's how this kind of plays out. But more importantly, right, you know in our business, this is part of the business, which is why we have invested substantially in complex and R&D pipelines. so as a result in cadence of new products allows us to offset the price deflation and the comparative pressures number one but at the same time more importantly increase the profitability of the business which is exactly how things have played out over the last you know two years because over the last two years we increased our generic margins from 35 percent in in 2019 to 38 percent last year and this year will be substantially over 40%. So we think that creates a lot of value for our patients, for our customers, but also for our shareholders. Around comparative pressures, we don't see anything that can substantially change our view of the business. At some point in time, Zafem is going to have competition the same way Levothyroxide had competition, the same way Ellering had competition. But our ability to provide excellent quality products, a very strong supply chain will allow us, I think, to continue to grow our business. So hopefully that helps.
spk08: Very helpful. Thank you. The next question comes from Daniel Busby with RBC Capital Markets. Please go ahead.
spk09: Hi, good morning. I've got a few questions on biosimilars. First, could you provide us with an update on your biosimilar Nubogen candidate? I think last quarter you were guided to a potential 2021 launch, and it looks like that's been pushed to 2022. And then more broadly, can you talk about the timelines and level of investment needed to place Amnion in a position to develop and manufacture biosimilar products in-house? Is this something that you're actively pursuing now, or is this more of a longer-term aspiration? And finally, to what extent are there potential business development targets that could help accelerate the development of in-house capabilities? Thank you.
spk06: Excellent. Daniel, good morning. An excellent question. We always get the biosimilar questions. We love it. So Nupurgen, the only reason it has moved to 2022 is the facility inspection in Chicago. FDA has resumed inspections, and they're prioritizing it. So hopefully they get to the facility as soon as possible. So that's for the Nupurgen. So we do expect, which is a much smaller product, as you know, than Neulesta, Thank you. since it is approved in the EU already by our partner, MapScience. We are very hopeful that we can launch Avastin as well next year, even though it may get pushed to 2023. So very exciting, all three. As we have mentioned, we build everything in the long term, so of course we are thinking to build the in-house capabilities. We have started certain activities, but we are at a nascent stage at this point. As we see this next 10, 15 years roadway, we want to do it smartly. We want to be efficient. We do not and cannot spend $100 million for product development. We have to spend $30, $35 million. We know that this is a highly competitive market, and it will remain so. And that was the purpose, to have a biosimilars act. But we'll definitely do what we do best, is to manufacture high-quality products, and do great science on biosimilars coming in next one, two, three, four, five years. As far as the business development, it's going on. We expect to license maybe two to three new products this year, and next year we will do the probably similar two to three external partnership while we start developing in-house as well. And yes, we could afford the capex and R&D as we smartly allocate the money towards next generations of manufacturing, which is biologics, and next generations of R&D, which is biologics as well. Hope that answers your question, Daniel.
spk09: Yeah, it did. Thanks for the call.
spk06: Thank you.
spk08: This concludes our question and answer session and M. Neal's second quarter 2021 earnings call. Thank you for attending today's presentation you may now disconnect.
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