Amneal Pharmaceuticals, Inc. Q3 FY2021 Earnings Call

Hello everyone and a warm welcome to Amneal's Third Quarter 2021 Earnings Conference Call. I would now like to turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Good morning and thank you for joining Amneal's third quarter 2021 earnings call. Today, we issued a press release reporting our financial results. The press release and a presentation are available on our website at amneal.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's 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 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 discuss certain non-GAAP measures. Important information on our use of these measures and reconciliation to US GAAP may be found in our earnings release and the appendix of today's presentation. On the call this morning are Chirag and Chintu Patel Co-CEOs; Tasos Konidaris CFO; Andy Boyer and Joe Todisco Chief Commercial Officers for the Generics and Specialty segments; and Steve Manzano, General Counsel and Corporate Secretary. I will now turn the call over to Chirag.

Thank you, Tony and good morning everyone. Amneal achieved solid third quarter results with net revenue of $529 million, adjusted EBITDA of $135 million, and adjusted EPS of $0.21. Our third quarter performance builds on the strong momentum we have seen these last two years and we believe the best is yet to come. Let me provide a few updates across the business. I'll start with our Generics business which is built on our core competencies in R&D, manufacturing, and commercial excellence. Over the last several years our robust innovation engine has significantly strengthened our portfolio with increasingly complex products. Our extensive manufacturing and operational capabilities allow us to manufacture most of these products in-house which accelerates our time to market and improves margins. Our commercial teams have done an excellent job working with customers to bring these impactful products to market and provide access to these affordable medicines for patients. As a result, strong execution is driving performance including sustained higher levels of profitability. Notably, adjusted Generics gross margins were 45% in 2021 year-to-date, which is a remarkable increase from 36% in 2019. Last quarter, we highlighted what makes our Generics business durable and different including the pace of new launches and our increasingly complex portfolio. There are two points to reiterate. First, a third of our current Generics revenue comes from products launched since 2019. Second, half of our current revenues and over 85% of our pipeline is non-oral solids, demonstrating how our business is increasingly diversifying with more complex products, leading to more durable revenues and higher profitability. Aligned with our new 2.0 strategy to expand our portfolio with increasingly complex products we are excited to announce the acquisition of Puniska Healthcare, which is a pivotal step in growing our injectable business. Today, the overall US institutional market from a manufacturer's perspective is around $5 billion in size and growing. While at the same time there's a history of shortages for sterile injectables and a need for more capacity. Currently, Amneal is in this market with about $125 million in annual revenue. We shared last quarter that our goal is to more than double by 2025 and our aspiration is to be in the top five. This acquisition allows us to accelerate our injectable strategy for the United States and international markets. Moving to our Specialty business. We are continuing to advance our strategy and expand our portfolio. We remain focused on growing the business organically advancing our pipeline and pursuing inorganic opportunities, focusing on neurology and endocrinology. First, the team is driving strong commercial execution, leveraging our expanded endocrinology sales force this year. In the third quarter, we saw continued strong performance of our two largest specialty products, Rytary and Unithroid. Second, we continue to advance our Specialty pipeline. Most notably, we are pleased with the positive Phase III data for IPX-203 and the potential this technology has to help Parkinson's patients achieve more good on time with less frequent dosing. We do not view IPX-203 as a line extension of Rytary. Rather, we believe IPX-203 will be a distinct innovative therapy for the treatment of Parkinson's disease that will have a broader market appeal with patients and prescribers. We are advancing our pre-market work and we are excited about the commercial opportunity that IPX-203 represents. We continue to advance the programs across our Specialty portfolio and Chintu will discuss this in more detail. Finally, as a mission-driven company focused on providing affordable essential medicines for patients, we were delighted to release our inaugural sustainability report yesterday, which highlights our ongoing efforts in driving environmental, social, and governance initiatives at Amneal and provides important insights on our business and its impact on stakeholders. For example, in terms of access and affordability, our generics medicines were responsible for saving patients nearly $10 billion in the United States last year alone. In addition, on the environmental stewardship side, we have implemented a clean renewable geothermal energy system at our Brookhaven, New York facility to significantly reduce our environmental impact. With that, I'll turn the call over to Chintu.

Thank you, Chirag, and good morning everyone. First, let me thank our nearly 6,500 Amneal team members, who work hard every day to make health possible. Since our return as Co-CEOs, we have been focused on operational excellence and cost efficiencies and we have seen tremendous progress with sustained high levels of profitability. Today, we see the result of nearly 20 years of that continuous improvement mindset, as we are constantly improving our execution, whether that's process improvement, gaining supply chain efficiencies or better inventory management, including reducing obsolescence and the lowest level of backorder in our history. Since the inception of Amneal, we have maintained a commitment to the highest standards of quality and current good manufacturing practices. The team continues to maintain its stellar manufacturing quality track record with currently no open or pending issues with the FDA and an impeccable compliance history at all our sites. I'm incredibly proud of our team. As you are aware, the FDA issued an untitled letter raising concerns around bioequivalence studies performed by Synchron Research Services. The FDA assigned the BX code for applicable products, which impacted several manufacturers. For our handful of impacted products, the bioanalytical data and statistical analysis for most was completed by a different CRO, North Synchron. Additionally, Amneal monitors and independently audits all CRO studies as part of our normal process and validated these results. We completed our responses to the FDA, as we want to restore AB rating in a timely manner. Turning to the injectable business. As Chirag highlighted, the Puniska acquisition advances our strategy to meaningfully expand in injectables. Today, we have 25 commercial products for the US institutional market with more approved and a rich pipeline of over 40 injectable launches planned. This acquisition accelerates our deep R&D pipeline with enhanced R&D capabilities and speed. By acquiring the state-of-the-art facility and adding five sterile injectable production lines, we are also expanding our capacity which will provide more supply and allow us to be more opportunistic in pursuing business. We expect FDA inspection and approval of the site by the end of 2022. We believe this acquisition is the cornerstone of our plan to be a leading player in the global injectable market. Now I will walk through our company's innovation agenda and provide an update on our progress. First, in Generics, our strategy prioritizes innovating across complex product categories such as inhalation, injectables, implants, drug-device combinations, and ophthalmics. We believe Amneal is differentiated from its peers in our ability to successfully innovate and launch products in these hard-to-make complex areas. NuvaRing and Sucralfate are great examples. Our internally developed R&D and manufacturing capabilities drive this fast-to-market complex innovation. Overall, we feel great about our generic pipeline which is now over 85% non-oral solids. Currently, we have approximately 125 products in our pipeline and another 100 products with ANDA spending. We expect to file 25 to 30 ANDAs and launch 20 to 30 new products each year. We are very pleased with the new product launches in 2021 such as Zafemy, Abiraterone, and TobraDex. Last week, we announced the approval of dexamethasone, an important steroid used for a number of medical conditions, including treatment of respiratory symptoms associated with COVID-19. This represents another CGT designated approval which provides 180-day exclusivity. Amneal has the highest number of CGT designated products in the industry. In short, the wheel of innovation constantly turns at Amneal and we see a long runway for our R&D engine to drive growth and sustain high levels of profitability. Second, we remain focused and excited about global expansion, as we pursue opportunities to leverage our portfolio and out-licensing in select markets with our partner Fosun, we are filing 10 products in China in the near term and look to start commercializing in 2023. Outside of China, we are actively working with partners in our geographies and we will share more as we progress. We see global expansion as another vector for sustained growth. Third, we look to enter the biosimilar market in 2022. We have three oncology biosimilars Neupogen, Neulasta, and Avastin all filed and under review with the FDA. We expect to receive our initial approvals next year. Beyond this, we are evaluating additional opportunities with partners where Amneal can be first or second to market in biosimilars. Fourth, we continue to advance our specialty pipeline as we look to launch at least one new specialty product per year starting in 2022. Starting with the biggest one IPX-203. Recent Phase 3 results showed IPX-203 met its primary endpoint by demonstrating superior good on time from baseline in hours per day when dosed on average three times per day compared to immediate release CD/LD dosed on average five times per day. In a post-hoc analysis, IPX-203 resulted in 1.55 hours of increased Good On time per dose compared to IR CD/LD, and we believe IPX-203 has the potential to help Parkinson's disease patients achieve more good on time with less frequent dosing than IR CD/LD. We see a broader market appeal for IPX-203 as compared to Rytary, which represents only 5% of the broader CD/LD space, and we expect to submit our ANDA in mid-2022. In addition to IPX-203, we continue to advance the rest of our Specialty pipeline. First, our ANDA for the DHE autoinjector for migraine and cluster headache is pending FDA approval with launch expected in mid-2022. Second, we expect to file our ANDA for K127 for Myasthenia Gravis in the second half of 2022. Third, we plan to file our IND application for K114, a modified-release T3 product for hypothyroidism, in the middle of next year. These are all 505(b)(2) programs for which the risk level is relatively lower than new molecular entity programs. We look to share additional programs in the near future as we further expand our pipeline utilizing our proprietary drug delivery technology platforms GRANDE and KRONOTEC. We expect these technologies will provide a wellspring of new opportunities. Now I will turn the call over to Tasos.

Thank you, Chintu. For the third quarter we reported total net revenue of $529 million, up 2% adjusted gross margins of 45.4%, up 570 basis points, adjusted EBITDA of $135 million, up 19%, and adjusted EPS of $0.21, up 31% all year-over-year. Our growth is primarily driven by new product launches, operating efficiencies, and it also includes substantial investments in R&D and our specialty commercial presence to drive long-term growth. From a balance perspective, I'm happy to report that both gross and net debt continued to decline with net debt to adjusted EBITDA of 4.6 times compared to 5.3 times in December 2020 and 7 times in December 2019. In addition, our improved operational performance and lower levels of debt were cited as key reasons for the recent upgrade for our long-term debt by the rating agency Moody's. Let me now start with our Generics segment. For the third quarter, net revenue of $347 million was up $5 million or 1.5% year-over-year. Growth was driven by the strength of new product launches and the diversity of our increasingly complex portfolio. New products launched in 2020 and 2021 accounted for $45 million of growth this quarter. From a product perspective, Zafemy and Abiraterone, which were launched earlier this year, were strong contributors to growth. On a year-to-date basis, Generics recorded $1 million in net revenue, up 2%. Adjusted gross margin for Generics was 43.6% in the third quarter, substantially higher than the 37.4% in the prior year. Gross margin expansion was driven by bringing substantial value to our customers through new product launches, as well as operating efficiencies including in-source manufacturing and procurement savings. Moving to the specialty segment. Net revenue of $93 million for the third quarter was up $5 million or 5.6% year-over-year. Specialty centers on neurology and endocrinology with Rytary and Unithroid. Both brands continue to grow nicely and in the aggregate recorded $57 million in net revenue, up 13% year-over-year. As expected, this growth was partially offset by declines in our promoted brands. We expect continued strength in Rytary and Unithroid as Q3 total scripts from both were up high single-digits and new scripts were up double-digits. Adjusted gross margin for specialty was 78.7% in the third quarter, representing a 440 basis point improvement year-over-year due to the favorable product mix. On a year-to-date basis, Specialty recorded $277 million in net revenue, up 3% year-over-year with Rytary and Unithroid growing up 10% combined. In the AvKARE distribution segment, third quarter net revenue of $89 million was down $1 million or about 1% year-over-year. Growth was impacted by the prior year comparison due to timing issues. Adjusted gross margin for AvKARE was 17.2% in the third quarter, which was 270 basis points higher year-over-year. Total company adjusted EBITDA of $135 million for the third quarter was $21 million higher than the prior year quarter. Gross profit growth added $33 million was partially offset by $8 million in higher R&D as we incorporated the Kashiv specialty acquisition and $10 million in higher SG&A due to our sales force expansion and higher expenses as the economy opens. Adjusted diluted third quarter EPS of $0.21 was driven by strong EBITDA performance, partially offset by higher taxes. From a cash perspective, operating cash flow was $82 million in the third quarter and $179 million year-to-date as we continue to expect $220 million to $250 million for the full year. In addition, we closed the third quarter with $311 million in cash and cash equivalents, and our intent is to utilize a portion of that to fund the $93 million purchase price of the Kashiv acquisition. From a timing perspective, approximately $73 million of the purchase price is funded in November, while the remaining $20 million is to be funded in mid-2022. As Chirag and Chintu mentioned earlier, we're very excited about the capabilities this acquisition gives us, and we expect it to begin adding meaningful revenue and EBITDA starting in 2023 and accelerating substantially after that. As for the nine months through the year, most of our 2021 new product launches are behind us, we're updating our full-year guidance. On the top line, we're tightening our expected net revenue to about $2.1 billion, which represents mid-single-digit year-over-year revenue growth. We're very pleased with this organic level of growth which reflects the depth of our Amneal pipeline, the resilience of our commercial portfolio, and headwinds driven by the lack of flu season and lingering COVID-19 impact. At the same time, we are raising our 2021 EBITDA full-year range between $530 million and $550 million compared to the previous $500 million to $520 million range, reflecting high double-digit growth versus 2020. We're also raising our EPS guidance range to $0.78 and $0.88 compared to the previous $0.70 and $0.85. Our operating cash flow guidance remains the same at between $220 million and $250 million and we're slightly lowering our CapEx expectation to $50 million and $60 million compared to the previous range of $60 million and $70 million. In summary, we feel great about our quarterly and year-to-date performance of solid top-line and double-digit adjusted EBITDA growth and our ongoing positive trajectory. Let me now hand it back to Dr. Chirag.

Thank you, Tasos. In summary, Amneal is executing well on all fronts. Solid performance across the business and sustained higher profitability reflects the diversity, durability, and increasing complexities of our portfolio. Looking forward, we see continued growth and strong profitability. We'll now open the call to questions.

Our first question comes from David Amsellem of Piper Sandler. David, your line is open. Please go ahead.

Okay, thanks. So just a high-level question as a starting point, given today's acquisition and where you're taking the business in terms of the mix of specialty brands, biosimilars, and complex generics. I can't help but wonder, how you're thinking about your base oral solids business and is that a business that you're going to look to strategically exit or pare down over time? Just how are you thinking about that lately, particularly given the acquisition today? And then secondly, regarding biosimilars, can you just talk about the potential for interchangeability of anything you have in the queue? And how important interchangeability getting that is for your business or really for any biosimilar just get your philosophical thoughts given that we saw a recent interchangeability designation for one of the Humira biosimilars recently? And then lastly any thoughts on the Copaxone generic. Just wanted to make sure I didn't miss anything on that product in your prepared remarks, but anything you could add on that would be helpful? Thanks.

David, good morning. Good to hear from you. So on your first question, the Amneal 2.0 strategy as we had clearly laid out that we are diversifying our business away from oral solids. This does not mean we're getting out of oral solids, because we have fantastic extended release multi-layers oncology, all those complex oral solid products as well. We're pretty much very less into the commodity oral solid cortex and that we are reducing further. But it still produces the cash flow, which allows us to utilize and allocate that capital to the proper areas that we are growing. We're diversifying our sole reliance on the retail business into the injectable business, which is today 125 million and our aspiration is to be in the top five. This acquisition provides us with accelerated R&D development and accelerated launches through excellent lines, and state-of-the-art facilities in injectables in India. So we are very excited to be now meaningfully adding contributions in injectables. The third piece is the international markets. This and other facilities also allow us to go to China, which we are excited about. We haven't shared any details yet, but we are very optimistic about those products and opportunities from 2023 onward and building a strong business in China as well as Africa. The fourth is the biosimilars, and I'll take my shot on biosimilars first and pass it on to Chintu for interchangeability. So my view on biosimilars remains that it is an evolving market, much needed and it will be highly competitive, so more of a payer-driven and PBM-driven market developing. Yes, for the buy and build would be separate economics, but the payers will still drive it. So interchangeability and intervention by CMS covering all biosimilars would be really helpful for penetrating 20%, 30%, 40%, or 50% market share to go to more of a 70%, 80% volume penetration and that will be fantastic for biosimilars. And with or without interchangeability, I think, it needs to get there to realize true savings on biosimilars, which present a huge potential. Chintu, do you want to comment on interchangeability?

Sure. Hi, David. Good morning. Before addressing biosimilars, I just wanted to add that regarding Specialty. We are equally focused on building our Specialty pipeline organically and inorganically. As I mentioned in my opening remarks, we have a good pipeline of products which shows good promise going forward and we are also looking at inorganic assets to acquire. So along with the injectable complex generics, Specialty also remains the focus and we are very happy and excited about where we are in building our pipeline. Coming to biosimilar interchangeability, David, I think from the time side is very good and exciting. That gives comfort to the physicians and the patient that when the products were interchanged, the immunogenicity or efficacy perspective shows statistical differences that were not significant to raise any concerns. But the main driver would be, as Chirag mentioned, would be the payer and how the reimbursement occurs to have a lot more growth in the biosimilar industry. We see biosimilars as a must. I think over time, whether it's through the regulatory pathway, interchangeability, or other areas, I think it's going to evolve and be a more acceptable norm going forward. Regarding your last question on Copaxone, due to COVID delays and adverse CMO, we are not forecasting its launch in 2022. It is most likely to be a 2023 launch in the first half.

Okay. Thanks so much.

Thank you.

Our next question comes from Nathan Rich of Goldman Sachs. Your line is open, Nathan. Please proceed.

Hi. Good morning. Thanks for the question. Chirag, you highlighted the gross margin performance in the Generics segment. I know the goal for a while had been to get back to 40% margins. You're now solidly there. So as we think about the opportunity going forward, could you maybe give us an updated view on where you think gross margins for that segment could go especially as you shift the portfolio to more complex products? And then, maybe Tasos a follow-up for you, could you maybe just talk through the updated revenue outlook moving that towards the lower end of the range is kind of what changed relative to your prior expectations? Thank you.

Thank you, Nathan. Good morning. We have brought most of our manufacturing in-house from third-party manufacturers, which is helping improve our margins. We have worked on operational efficiencies, including plant utilization, and back orders are virtually eliminated, addressing supply issues. We are also developing algorithms to reduce returns and proactively engaging with our customers, which are all contributing to better margins. As we continue to launch more complex and injectable products, we expect to see further margin improvements over the next few years. Our goal is to achieve higher gross margins as our product complexity increases, and with most of our products manufactured in-house, we are not sharing economics on the majority of them. That reflects our gross margin outlook for Generics. Tasos, would you like to add more?

Sure. Good morning, Nathan. From a top line perspective, our range was $2.1 billion to $2.2 billion, and we're currently guiding at $2.1 billion, which represents a 5% organic increase from the prior year. We are pleased with this. There are a few factors at play. Firstly, our new product introductions have exceeded our expectations as they were launched earlier in the year than we anticipated. This has significantly contributed to our gross margin improvement and is a key reason for the increase in our EBITDA guidance. However, we did not foresee the complete absence of a flu season, which resulted in a $40 million loss due to no sales of Tamiflu and some other products. This has been the largest detriment to our top line. Additionally, we have been trying to project the impact of COVID-19, but there are still lingering effects that have affected everything. In summary, the three main reasons for our current situation are: slightly worse performance from our legacy products due to the lack of flu season, better-than-anticipated performance from our newer products driving up our EBITDA guidance, and the ongoing impacts from COVID-19. Does that clarify things?

Great. Yeah, thanks very much.

Thank you, Nathan. Our next question is from Balaji Prasad of Barclays. Balaji, please go ahead.

Sorry, we can move on?

Balaji, please make sure you are unmuted. Unfortunately, we're not receiving any audio from Balaji's line at the moment. So we will move on to our next question which is from Elliot Wilbur of Raymond James. Elliot, please go ahead.

Thanks. Good morning. First question I wanted to ask was around the injectables segment, obviously expected to be a key driver of growth going forward. The question is, outside of some of the more differentiated complex filings that you have in your pipeline, can you win business in the injectable market on a molecule basis or do you really need a much larger, more representative portfolio to be considered attractive to the GPO buyers, which have very different needs than those of your traditional big three retail purchasers? That's the first question. The second question is just in terms of new product performance, obviously very strong year-to-date. It looks like it was at least 15% of the total top line, at least nine months ended September. Just trying to get a sense from you, what you're seeing in terms of the actual space erosion. Certainly, some other players have talked about accelerated erosion in terms of volume and price, and that definitely seems to be borne out when looking at industry metrics. You guys have been able to offset that, but I'm wondering if you're seeing some accelerated pressure on the base.

Thank you, Elliot. Good morning to you. To your first question, we've been in the institutional market since 2016. In 2017, we started launching our products. Today, we have 25 products in the institutional market doing $125 million or a little bit better this year. So we are already there and we have the relationships with GPOs, and there's a different sales force led by a different commercial head to actively build a relationship with institutional buyers. Yes, the portfolio matters and redundancy matters, and this is why we acquired a ready-made site to avoid waiting to build our own, which would have taken three to four years and a few hundred million dollars. So it is important because we've got the R&D pipeline and we needed the capacity. Today, if we have to order a new injectable line, it takes a couple of years because we are neutralizing the COVID vaccines and dealing with the associated FDA regulations. So we're determined to enter and we are committed to achieving the highest quality and R&D, and we are here to stay in the injectable market. We will grow from $125 million to much higher, aspiring to be in the top five. It also allows us to market those injectable products in international markets, further diversifying our portfolio. As for the base erosion, I've been addressing this concern since 2017. I consistently observe that the three buyers are constantly looking for opportunities to drive costs down, which isn't healthy for the industry as the manufacturers have to rationalize their portfolios if this pressure continues, which is rather irrational when considering the commodity products and how low they have gone, and this is quite concerning. But I'll have Tasos explain the details.

Hey, Elliot. Good morning.

Can I take a...?

Sure. Chintu, go ahead.

I just wanted to add on the injectable side. Earlier it's very exciting, because it triples our capacity overnight with acquisitions, and we become a value volume player. Plus, it gives us added and a very huge capacity called large parenteral bags, and there is very little competition for the bag segment. So it gives us differentiated dosage forms to enter, and we have a very strong and robust pipeline in that segment. On injectables, we are working on a lot of complex products, including microspheres, liposomal large parental bags, and many autoinjectors. That capacity is missing; we are even bigger players than we are today and we are very excited. It's the right deal at the right price, at the right time. Go ahead, Tasos.

Sure. I think the other part of your question was around the base business: do you see an acceleration of the decline or not? So for us, it's been a fairly steady decline. This decline has been about 12%. That is what we saw last year. That's what we're expecting this year. The other differentiating factor is if you look at the base business, you'll see what percentage of our Generic portfolio it accounted for. Back in 2019, the base business represented 93% of our revenue from our Generic revenue. This year, that part of the business will be about 64% of the business. So we have substantially reduced the year-over-year headwind represented by this continued downward pressure. Additionally, as the portfolio evolves to more complex products, this older segment won't be subjected to the same headwinds as traditional oral solids. So hopefully, that answers your question.

Next question, please.

Our next question comes from Balaji Prasad of Barclays. Balaji, please go ahead. Your line is open.

Hi, good morning, everyone, and my apologies for missing the call earlier. Firstly on Puniska, Chirag, can you describe the facility that you're getting and the capacity and also any particular products on the pipeline side that you would like to call out? You mentioned that you're expecting FDA inspection and approval by the end of 2022. Is it linked to any specific products at all or is it overall site inspection? Second question on dexamethasone, I think you – if I heard you correctly, you stated that this was a CGT designated opportunity. So can you also provide some context around revenue expectations at least in the first 180 days? Thank you.

Thank you, Balaji. Chintu, would you like to explain the Puniska’s state-of-the-art facility?

Yes. Hi, Balaji. Good morning. The Puniska site is around 293,000 square feet, state-of-the-art, recently built in the last two years as a five-line European vial and immersion facility and large bag lines. So it gives us capacity of around 30 million to 35 million dosage forms out of that site and that caters to our requirements up to 27 as per our internal volume forecast. So from the FDA perspective, they do have products pending. We are not revealing the names of these products. They have two products pending: one vial and one bag product. So that facility comes with around 560 trained people and the R&D infrastructure is separate. Thus, it also provides us with added R&D manpower for injectables. Overall, this aligns with our strategic move to expand our injectable offerings. We are very excited as it provides us the needed capacity overnight.

Yes. And Balaji, this is the fourth facility. We already have three facilities focusing on oncology injections, along with two others, and this is the fourth one. On dexamethasone, we do not provide specific product revenue guidance, but we like these products because they represent niche areas where we can achieve better gross margins than other products. So it's a good product. We are expecting many of these products to be launched each year. This is why we're not reliant on any one big launch in a year, but multiple new launches coming up. We are also excited about the potential launch of the vaccine as well, and we have filed and responded to our CRL and expect that in the first half of 2022.

Understood. Thank you.

Thank you, Balaji. Our next question is from Gary Nachman of BMO Capital Markets. Please go ahead, Gary.

Hi. Good morning. This is Dennis on for Gary. Thank you for taking my question. Just a couple from me. Lately and as we've been hearing all the supply chain issues: is there anything that you've seen that you believe the supply chain issues could affect your fourth quarter or next year? And then another question on debt. You guys have been clearly lowering it. It was 7 times in 2019, 5.3 times in 2020 now we're at 4.6 times. Just curious is there a number that you're looking to get into or you're achieving towards? Thank you.

Thank you, Gary. Two very interesting questions on supply chain issues. Yes, they are happening. We fortunately have a very robust pre-planning and our team is excellent, which is planning pretty much a year out. But it's concerning. What’s concerning is the more inflation associated with supply chain. Significant measures have been taken by China to shut down certain KSM (Key Starting Material) input material and certain API facilities, and that is going to cause, and already we have API suppliers pretty much all asking for higher prices due to the increased costs. The inflation is here, so that is concerning regarding supply chain issues and these certain KSMs. As for debt, we have stated it’s under 4x as our target. We want to go as low as we can. That's how we prefer to allocate our capital. We're careful about it, going at the right time, the right deal, and the right price. There are times we don't win the deals currently in the seller's market because we are not prepared to pay extraordinary prices that are present in the market right now. We're confident in our organic pipeline and patiently waiting for the right deals. This gives us a fine balance to keep reducing our debt level and still adding new capacity and diversify our business, and that's exactly what we are doing. Thank you.

Thank you.

Thank you, Gary. We have a follow-up question from Elliot Wilbur of Raymond James. Please go ahead, Elliot.

Thanks. Just two quick follow-ups. I guess first for Chintu. You talked about the Synchron issue and the alteration of the TE code to BX from AB. I guess in looking at those products, we came away with the conclusion that they were all relatively commoditized and somewhat small in terms of the markets. But if you could just maybe give us a sense of what the current revenue base of the affected products is within your portfolio. And then bigger picture question, there's been a very noticeable slowdown in the rate of new ANDAs coming out of the FDA, and it seems to be even more difficult to pull off complex generics as obviously the timelines seem to get extended more and more every year. So that can both be a competitive advantage or a disadvantage. But I just wanted to get maybe your perspective in terms of what may be happening to the FDA with some of these more complex filings. Why we're not seeing more of them and whether or not you think that has led to or you have adjusted your longer-term expectations in terms of the timelines in which you expect some of these key products to be approved.

Hi Elliot. Thank you. So, on Synchron, as I mentioned, we have responded to all of the FDA queries. We have used a bioanalytical lab outside of Synchron. We have third-party independent audits, and we at Amneal audit and we are very optimistic that we have done a very thorough job that would yield a positive outcome from the FDA. I don't have a timeline that we can discuss for this, but we are working diligently to resolve this. We have about eight or so products that are impacted. We do have one product that is important, but we have not seen any material impact at this time, which is Zafemy, but we have not seen any material impact or patient concern or customer concern. Regarding approvals, Amneal has the highest first-review cycle approvals; I can say in the last three or so years or four years we have received more than 40 first cycle approvals—that’s in around 10 months. COVID did impact many companies from receiving approvals earlier. But at Amneal, because of its stellar quality track record, we never experienced any delay associated with pre-approvals or anything else. Even our inhalation plant in Ireland, we had an online auditing and our plant from a pre-approval perspective is approved by the FDA. Complex generics, yes, it’s a challenge depending on where you are. FDA is also learning many times with you as they are looking into the science and various ways of bringing these complex products. Depending on the product, it may take longer. But like with our transdermal products, and many other dosage forms, we have been working with the FDA and have a strong understanding of their expectations. So, we have that first-mover advantage on complex products, which helps our chances of getting approved. I think you are right: there are delays, and the number of approvals is fewer than in the prior year. But as far as Amneal, we continue to receive 30 or more approvals every year and we expect to maintain the same level next year with a few complex products. There have been some delays due to changes in FDA requirements or expectations, but overall, Amneal is in a better position than its competitors. Thank you.

Thank you, Elliot. Our final question comes from Greg Fraser of Truist Securities. Greg, your line is open. Please go ahead.

Great. Thanks for taking the question. Sorry if I missed this earlier, but did you comment on the outlook for new launches in the fourth quarter? And then, on the injectables business, in your outlook, you're expecting a lot of launches over the next few years and rapid sales growth. I'm curious if you expect some standout products to drive an outsized portion of the growth or will the growth be diversified across a broad portfolio of injectables? Thanks.

Hi, Greg. Good morning. I'll take your second question first. So injectables follow a similar strategy that we applied in the retail side, which is to focus on more complex, diversified products, including bags, vials, and autoinjectors. So it will be diversified and supported by some standout products that will boost international markets, especially those associated with high demand and pricing. We've observed strong levels of NPL, as Tasos mentioned for the whole year. We just launched a couple of small products, but they added up nicely in terms of contributions to margins. We continuously launch new products every quarter—typically five or six new products each quarter.

Just to provide more specific details, Q3, I think, we said it was about $45 million of growth. You should expect about the same level of growth versus the prior year in Q4.

Thank you, Greg.

Thank you, Greg. We currently have no further questions. So I would like to hand you back to Chirag Patel.

Yes. Thank you very much, everyone, for joining today's call. This is our eighth or ninth call, and we're pleased with the progress we’re making. We remain steadfastly focused on disciplined growth for the company and we see excellent opportunities as part of Amneal 2.0 strategy with diversifying our Generics business, which I like to call the affordable medicines business, along with Specialty products. We are in the early stages of our branded strategy at this point and executing well on Phase I of our 505(b)(2) products, and we will move up the value chain as we become really good at executing on the Specialty side of the business. So we're excited about both. Our international expansion on affordable medicine is very purpose-driven as well, and we will continue to bring more complex products and access to patients worldwide in select markets with select partners, and in certain markets, we may enter independently and very selectively. Overall, we are very excited. Thank you very much. Have a great day.

This concludes today's call. Thank you all for joining. We hope you have a great rest of your day. You may now disconnect your lines.