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spk02: Greetings. Welcome to the Coru Medical Systems fourth quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Greg Hodachick. You may begin.
spk03: Thank you, Shamali, and good afternoon, everyone. Earlier today, Kourou Medical Systems released financial results for the fourth quarter and full year ended December 31st, 2021. A copy of the press release is available on the company's website. During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to many risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements. I encourage listeners to have our press release in front of you, which includes our financial results as well as commentary on the quarter. During the call, management will discuss certain non-GAAP financial measures and in our press release and accompanying investor presentation and our filings with the SEC, each of which are posted on our website. You will find additional disclosure regarding these non-GAAP measures, including reconciliations of these measures with comparable GAAP measures in our press release and accompanying investor presentation and those filings. For the benefit of those listening to the replay, this call was held and recorded on Wednesday, March 2, 2022, at approximately 4.30 p.m. Eastern Time. Since then, the company may have made additional comments related to the topics discussed. And please reference the company's most recent press releases and filings with the SEC. Joining us on the call today is Linda Tharby, President and CEO of KORU Medical Systems, and Karen Fisher, KORU Medical's Chief Financial Officer. Linda, please go ahead.
spk01: Thank you, Greg. Good afternoon, everyone, and welcome to Coro Medical Systems' fourth quarter and full year 2021 earnings call. Before reviewing our Q4 2021 highlights from the year, I would like to start by thanking our incredible team. Our company is supported by a talented and growing group of individuals who believe in our mission to improve patients' quality of life by developing and delivering high quality therapeutic drug delivery solutions for use in the home. Each quarter we continue to build upon our foundation and Coro Medical today is a stronger organization due to each individual's continued dedication and hard work. Today we will be using a slide deck to guide our comments. I will begin with a brief overview of Coro Medical systems and our fourth quarter highlights. followed by an update on our strategic milestones delivered during the quarter. I will then turn the call over to Karen to discuss the quarter and year-end financials in more detail. I will then review our 2022 guidance before ending with a few closing remarks. After our prepared remarks, Karen and I will be happy to open the call up for Q&A. Prior to jumping into Q4 highlights, I wanted to begin with an overview of who we are today and how we are positioning ourselves to deliver continued value to our customers and shareholders. We have enabled over 25,000 patients to receive at-home subcutaneous immunoglobulin treatments or SCIG treatment via our market-leading Coru Medical Freedom Infusion System. We have a proven pharma partnership model with over 11 commercialized drugs and indications on our freedom infusion system and registrations in over 26 countries. As we continue to grow our business, we have a scalable foundation from which we can build. We have a recurring monthly consumables revenue stream supported by our specialty pharmacy partners who deliver to our patients in their home. As we look to the future, our goal is to expand our total addressable market from $300 million today to over a billion dollars through continued penetration of sub-Q therapy into the broader IG market. Further, our intent is to add new drugs to our CORU system as the overall growth in drugs in the pipeline for sub-Q delivery in the home continue to expand. We will continue to solidify our position as a market-leading SCIG home infusion platform and further establish CORU Medical as the premier at home large volume drug delivery infusion company. Turning to our results for the fourth quarter, we reported net revenues of 6.5 million, an increase of 60% or 28% on an adjusted basis for 2020 stocking. This represents a return to double digit growth and our fourth consecutive quarter of positive sequential growth. On a year-on-year basis, we had strength across all three businesses, domestic core, international core, and novel therapies. The fourth quarter year-on-year growth was driven by double-digit pump growth in the U.S. domestic core market, with our growth outpacing the overall market. Higher consumables due to new business wins in international core markets, and through initial revenues recorded for new agreements in our growing novel therapies pipeline. While we don't expect this level of growth for each quarter in 2022, it is important to note that we are outperforming the underlying market for sub-QIG therapy and we look forward to continuing this momentum. In December, we held an investor day and rolled out our vision 2026 intended to drive the company to the next phase of value creation. I want to reiterate the plans we discussed and the key milestones related to our vision. Our five-year plan is designed to generate approximately 60 million in revenue by 2026, and importantly, drive our addressable market from 300 million to over a billion dollars, as we move from being a leader in large volume home sub-Q IG infusion to being a leader in the much larger market of large volume sub-Q drug delivery. We know that to support our vision, we will need a strong foundation, and we did great work this year in building the foundation for an even better company. We hired over 30 new employees this year, bringing our total headcount to over 80, with a specific focus on commercial excellence, particularly in U.S. sales and marketing and novel therapies, on quality and regulatory to build to biopharmaceutical standards, and in beginning to build out our innovation capabilities in research and development. We also progressed our outsource manufacturing agreement, enabling a dual source of production, and driving future gross margin improvement. And we ended the year securing a new facility and a prime recruiting location in northern New Jersey that will become a center of excellence for our new products. Our plan will be driven by two pillars of growth, including increasing core SCIG penetration and extending that subcutaneous home infusion leadership position into new novel therapies. The first pillar is focused around accelerating our penetration in the SEIG market we participate in today. This market is significantly under-penetrated with less than 15% of total IG drugs administered today delivered sub-Q. The first area of focus in this area is on new patient starts. We are building our funnel and increasing our work with our pharma partners through the clinical development and regulatory approval process to gain on-label indications. Once a drug receives regulatory approval, our pharma partners begin their physician detailing, and we have recently increased our level of training and support to their efforts. The second target area is SCIG pre-fills. Prefills have grown rapidly since their introduction about 18 months ago and now represent about 3.5% of the total market. We see tremendous growth potential in prefills because of their convenience for the patient. As we have seen our ex-US drug label expand, you will see further efforts in 2022 to define our international core sub-Q strategy. Turning to our second pillar of growth, our goal is to extend our leadership position in sub-QIG drug delivery into novel therapies or new sub-Q drugs in development. Our team has identified a robust target list that spans all three clinical trial phases. We have identified close to 1,000 new drugs in development and are targeting roughly 100 of those whose volume has been established as over 10 mLs. We are projecting five new large-volume drug candidates going through phase three trials with Coro Medical by 2026, and we have assumed one additional new commercialized drug by 2023 to drive top-line growth towards our five-year goal. We continue to build momentum as a broad drug delivery partner due to our patient satisfaction, form factor with capability to handle drugs over 10 mL, our safety profile, and track record of regulatory clearances. We have the proven capability to ensure we can support the drug through approval and through the channel with our specialty pharmacy relationships. Underlying our success in both of these areas is a renewed focus on innovation. This is a major area of strategic investment for the company as we define opportunities to simplify and improve the infusion process for our patients. Innovations include line extensions and product improvements all focused on improving comfort and convenience of the infusion process for patients. Additionally, we are investing in a next generation system that will retain core freedom infusion system qualities and further improve convenience and add capabilities such as connectivity. Now let's transition to the progress we have made in Q4 in executing on our strategic initiatives. Regarding the first pillar, increasing SCIG penetration, a critical driver is additional FDA clearances for on-label indications. The company committed to having three new on-label indications before the end of 2021, and I'm happy to report that we achieved that in the fourth quarter, making a considerable step forward. In November, we received 510 clearance for the use of our Freedom Edge infusion pump system to be used with Isentra, 20 ml pre-filled syringes. Hyzentra is the most prescribed SCIG product and the first to be available in a pre-filled syringe format. The pre-filled syringe market has significant penetration potential due to its convenience, and this FDA clearance will be an essential growth driver for us. In late December, we received FDA 510 clearance for on-label use of the Freedom 60 infusion system for two additional SCIG drugs, Octopharm's Cutiquig and Griffil's Zembify. This FDA clearance is a significant milestone as it allows us and our partners to market the Freedom60 as an on-label infusion device for two of the faster growing drugs in the market. In addition, we are in the FDA review cycle and expect to have Apellis M. Pavelli on-label indication by end of Q2 2022. and an EU label indication in Q1 for Apella, Sobeys, Aspavelli. Having these new clearances gives us and our drug partners the green light to promote the Freedom 60 for these drugs to our customers, which we believe to be a considerable advantage. We're excited to hit three of the eight total 510 commitments we had made for the five-year vision. They demonstrate the strong capabilities of our clinical, research and development, and regulatory leadership team. Regarding our second pillar of growth, expanding novel therapies, we have made significant advancements to our pipeline. During the fourth quarter of 2021, we closed four new novel therapies agreements. We define a closed agreement as an agreement for current or future revenues based upon an exchange of products or services. In line with our strategy, two of the closed agreements are focused on increased sub-Q penetration with phase three trials with IG therapies, and two are in earlier phase trials for non-SCIG therapies. Among the four agreements, we are supporting trials for our current area of immunology, and we are expanding in new drug areas with new novel therapy agreements in respiratory and oncology drugs. Three things of note for novel therapies. First, we're expanding beyond immunology and immunoglobulin. Second is our PACE. improvement with four of the six agreements we have secured occurring in quarter four. And finally, we have over 50 new opportunities that we are pursuing in our pipeline. As reporting on our pipeline progress is fairly new, we will continue to mature and begin to expand both on total addressable market expansion as well as short-term commercial opportunities for products and services. With a strategy and a clear set of goals, milestones, and objectives, we look forward to and remain excited about the next phase of value creation at Coru Medical. Rooted in the strength of our foundation and existing business, we believe we have a pathway to execute on our innovation and strategic growth initiative areas. We are excited to continue updating our milestones as we extend our leadership position in the home sub-Q drug delivery market. I will now turn it over to Karen for a review of our financials.
spk00: Thank you, Linda, and good afternoon, everyone. As a reminder, prior to discussion on Q4 financials, I want to remind everyone of our three business areas. Koro Medical defines revenues into three areas, domestic core, international core, and novel therapies. The core revenues consist of our product sales for specialty infusion therapies that are cleared for use with the Koro Medical infusion system. Novel therapies consist of product sales to support feasibility and clinical trials of biopharmaceutical companies in drug development process, as well as non-recurring engineering service revenues to ready or customize the freedom system for clinical and commercial use. Each new signed agreement could represent potential revenues in subsequent quarters. Once cleared for commercialization, sales associated with these drugs will be reported as core revenue. I'm pleased to report net revenues for the fourth quarter of 2021 were $6.5 million, a 60% increase from the fourth quarter of 2020. Adjusting for net inventory stocking of $1 million last year, net revenue grew 27.6%, with growth in all areas of our business. Domestic core driven by pumps and consumables, international core driven by consumables and new key customers, and increased novel therapies revenues as we expand our pipeline and execute on our strategy. Sequential quarterly net revenue growth was 7%, driven by international core. Gross margin was 59% for the fourth quarter of 2021, an increase from prior year of 56.6%, driven primarily by price increases. Selling general and administrative expenses increased 1.9 million, or 63.4%, in the fourth quarter of 2021, compared to the same period last year. The increase was driven primarily by investments in commercialization, regulatory, and business development, all in support of our strategic plan and to build our novel therapies pipeline. Research and development expenses increased 1 million in the fourth quarter 2021, compared to the same period last year, driven primarily by increased headcount and consulting fees to support product development. As previously reported, we have engaged Galero in order to expedite our development efforts while we build our internal innovation capabilities. Net loss for the fourth quarter of 2021 was $1.1 million, or negative two cents per diluted share, in line with two cents per diluted share in the fourth quarter of 2020. The loss was driven by our investments in building our fed nation and execution on our strategic initiatives, as I just described. For the full year 2021, net revenues were $23.5 million, 2.8% lower compared with $24.2 million in the prior year. The shortfall was driven by lower year-over-year novel therapies, as there was a large clinical trial order in 2020. Domestic core net revenues for 2021 were 0.8% higher than last year, mostly driven by the price increase in the second half of the year. International core net revenues were up 14.5% compared to last year, driven by growth in new customers. For full year 2021, gross margin was 58.6% compared to 61.8% in 2020. The decrease was primarily driven by delays in the transition to a secondary manufacturing source and product mix, offset by price favorability in the second half of the year. For the full year 2021, selling general and administrative expenses increased 5.8 million, or 48.5%, compared to the same period last year. This increase is due primarily to investments in our team to support commercialization and business development for novel therapies. For full year 2021, research and development expenses increased $1.2 million compared to the same period last year, reflecting innovation expenditures related to our prior communicated engagement with Galero in order to expedite our development efforts while we build our internal innovation capabilities. For full year 2021, net loss was $4.6 million, or negative 10 cents per diluted share, a decrease of 7% per diluted share from the same period in 2020, driven by our investments to expand our foundation, innovation, and product development and commercialization efforts. I will now turn it back over to Linda for guidance and closing comments.
spk01: Thank you, Karen. Turning to expectations for fiscal 2022. Our outlook reflects several key drivers. Underlying market growth reflecting continued recovery from the COVID-19 pandemic related to new SCIG patient starts, plasma supply, clinical trial activity, and supply chain impact. Currently, we expect the SCIG market to recover and grow in the high single digits. Assuming this U.S. market growth, we believe that we will continue to outpace the market and grow our core IG business in the low to mid double digits. including a target of closing multiple new novel therapy agreements. We are guiding revenues for the full year in the range of 26 to 27 million or 10 to 15% growth in 2022. We expect a slower start in Q1 in the U.S. market due to the late Q4 Omicron impact on new patient starts as from diagnosis to the start of Coru Freedom Therapy could take between 30 and 90 days. We are reiterating our gross margin guidance to begin the first three quarters of 2022 roughly in line with 2021 and plan to exit the year at a 60% run rate as we expect the transition to our secondary source to be completed at that time. In order to support our strategic initiatives and drive top line growth, we expect to increase operating expenses to roughly 27 to 28 million for the full year 2022. Our operating expense includes continued investment in our strategic initiatives with near-term goals of expanding our TAM through securing additional new non-IG novel therapy deals, building our innovation pipeline, including advancements on our freezing system and development of our next generation product. You can expect a 10 to 15% run rate off of where we finished Q4 2021 that will then hold fairly consistent quarter to quarter. Looking at our balance sheet, we ended 2021 with 25.3 million in cash compared to 27.3 million at year end 2020. And we continue to believe that we are well capitalized to drive value as we execute on our strategic plan. We expect the majority of our investment to be an innovation with the remainder being split between efforts to drive growth through commercial efforts and selling and marketing and in strengthening our foundation, which includes investments in regulatory EUMDR and our new facility. We will continue to be very disciplined in our approach and deployment of funds with monitored milestones and stopgates in place to drive the execution of the plan. In closing, as we look back on our fourth quarter and full year 2021, I'm incredibly proud of our progress at Coru Medical. as reflected in our strong fourth quarter finish. We made several advancements in our strategic initiatives as we returned the company to double-digit growth. We added multiple new 510 clearances, expanded our novel therapies pipeline, and continued to build a strong team. We remain confident that the objectives we set going forward are achievable, and we look forward to providing updates as we hit additional milestones. Thank you. And I will now turn it back over to Shamali, the operator, for Q&A.
spk02: Thank you. And at this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. And our first question comes from the line of Matt O'Brien with Piper Sandler.
spk06: Please proceed with your question. Hi, good afternoon. This is Drew on for Matt. Thanks for taking the questions and congrats on a solid end to the end of the year here. I do want to start off on the guidance. You know, I think you're pointing folks towards high single digit growth for market, low to mid double digits for KORU. You know, maybe we could just start off on the market a little bit here. You know, what are you assuming from a COVID perspective? Maybe some color on Q1 would be nice. And then just with the number of factors that have influenced the market over the last couple of years, be it COVID, be it the transition to sub-Q, what data points are you using to triangulate on that high single-digit market growth rate?
spk01: Sure. So, Drew, thanks for the question. There was a lot in there, so let me try and unpack that. So let's start with the market, which, as you know, we track the total IG drug that is delivered sub-Q into the marketplace. And overall, we saw that market on a full-year basis grow just over 1%, but are encouraged by what we saw in the fourth quarter, which fourth quarter grew about 7% versus quarter three. So that is encouraging. Having said that, as we look at early indications in January in the market, we think there's going to be a slight hangover from Omicron, that we all experienced in the latter months of quarter four. And generally what happens is our patients from time of diagnosis to time of start is about 30 to 90 days. So we project we're gonna start out of the gates still at double digits versus 2021 for our business, but a little bit of a slower start in the US market in particular. So- where we ended, I would project, quarter one being a double digit growth. I think I got everything. Karen, did I miss anything? I think so. Drew, did I miss anything?
spk06: No, that was perfect. Thank you.
spk01: Maybe there is one thing you asked. Sorry, what went into there? Obviously, market growth. We look at sub-Q conversions. We look at the Appellus commercialization. We look at pre-filled syringe. We've got a lot of assumptions that go on in there, but they get you to that number that I talked about.
spk06: Perfect. Very helpful. And then just on the spend side, it looks like you're getting to a little bit of a larger step up in OPEX here in 2022. Maybe you could just help us understand how those dollars are being allocated. Is it feet on the street where they're going to drive sales this year and next, or is the focus more going to be on building out the novel therapies pipeline where we should really start to think about those probably paying dividends in a couple years down the road?
spk01: First, I would say some of it is short-term, and you've already started to see the improvements. We made some significant investments first in our commercial capabilities. So in our U.S. sales and marketing teams, we added some new people and turned over that team. And you're already starting to see the impact of our growth that we recorded in Q4 in the U.S. markets. Second area for commercialization is we added a couple of new people to our novel therapies team to really drive. And again, you saw four agreements being secured in quarter four. So some of it is short term and you'll start to see that. The other area that we added significant experience and expertise in is in our quality and regulatory function. And again, you saw three new law on label indications occur. for the company, the first in several years. So you're starting to see some short-term impact there. And then I'll get into the other spends, which are going to be a little bit longer term, which are our R&D investments. So our R&D investments, you can see the company really had not invested a lot of money in this area. When I say not a lot, under a million dollars was the run rate that the company was looking at. We're really starting from a low basis here. And for us to really capture that billion-dollar-plus novel therapies pipeline, we're going to need to innovate on the product that we have today, a great product, high patient satisfaction. We need to make it more convenient, and we need to make it connected. That's going to open up that billion-dollar-plus addressable pipeline. So some of those R&D investments are going to take a little bit longer for us to pay off. And then we've got some investments in things like EUMDR, and we've got some investment, some minor investment in the building move. We're just breaking out of the seams here. The company, since its founding over 20 years ago, has been based in this site, and we need to be in a new location to attract some new talent. So we're moving to a great area for that. So in summary, short term, it's commercialization efforts, which you're seeing the benefit of almost immediately, along with quality and regulatory, which we're seeing the benefit of. In the mid to longer term, you'll see some product innovation introductions, and then a next generation system over the next two to five years, you'll see those.
spk06: Okay, perfect. That's very helpful as well. And just a quick last question from me here. You know, one of the big topics of conversation has been the pre-filled syringe side. It sounds like you're very excited about that. Can you just give us an update on where that stands commercially? Just any feedback, even if it's anecdotal, you've received so far. And then just can you remind us if any of your competitors have pre-filled products out there?
spk01: Thank you. Yeah. Okay, so maybe I'll just start with where the market is at, and then I'll bring it down right to a customer basis in our competition. So currently the market is about 3.5% penetration just over a year of pre-fills being launched. So we think that's fantastic. Currently the pre-fills are in a 5, 10, and 20 ml format, and Hyzentra is the only company with pre-fills on the marketplace. So we are working today on training. We're trying to get a white paper together to talk about the patient convenience factor. So we should have that out there, we hope, in the next quarter so that we can really begin to push into our specialty pharmacy customers clinical evidence that shows the advantage that the patients have seen both in reduced time to use the product and overall increased preference because of pre-fills. We believe that the market will continue to move. If you look at any market outside of IG, pre-fills, you know, if you think about the COVID vaccination that you received, that was in a pre-fill format, right? You didn't see anybody drying up out of a vial. So the broader market is in a pre-fill format, and we think SCIG will get there over time. And to date, we are the only pump that is approved for use with SCIG. that CSL pre-filled syringe. So we've got numbers in here for pre-fills. They start off pretty small, given it's 3.5% of the market, but it's really a three- to five-year strategy that we think we have the early leg in, and we're working very closely with all our pharmaceutical partners on their developments in this area.
spk02: Great. Thank you. And our next question comes from the line of Alex Nowak with Craig Hallam Capital. Please proceed with your question.
spk04: Great. Good afternoon, everyone. Hoping to stay on the IG market here for a couple questions. Maybe just expand on how things are going with regards to sub-Q conversion out there in the market, the increase of new patient stars. Is that starting to accelerate? And then where is supply kind of for plasma today and the uptake of these non-hyzentra sub-Q drugs?
spk01: Okay, so maybe I'll start with new patient starts overall. An early indication for us is our pump sales, which that's why we were so encouraged by the double-digit growth that we saw in the U.S. marketplace for pumps. So that to us is a great indication. If I look at, and we think most of that is likely being driven by our activities in the market and our increased share that we're driving in the marketplace. Regarding sub-Q conversion, we've done a lot of work on this one, Alex, and we're really beginning to unpack both the economic and clinical evidence that is already existing out there, but putting it together for our customers in a way that makes it easy to convert. Because what we're finding is once a patient starts on therapy, converting that patient base is difficult for us to do. I want to remind everyone, though, it doesn't take a lot, right? There's 300,000 patients on IV therapy. There's currently a shortage, as everyone knows, on IV sets for IV infusion. We're hoping that that shortage takes a little longer, and we might get some natural conversion over from that. But just converting 10% of that base is doubling our market. So it just takes a little bit to really grow that marketplace, and we are specifically focused on the new patient start. and ensuring that that new patient start, and via the growth in our pumps, we think we're beginning to make headway there. Supply with plasma, we do not see any concerns at this point. CSL reported some ex-US concerns, but we don't, in conversations with our drug partners, they're adding new capability in this area, so we don't see any major or long-term impact of plasma supply. Regarding non-IG, obviously we spoke about Aspavelli will be on our EU label indication in Q1, and we are chomping at the bit with our partners that appell us for Empavelli to be added to our label, and we're quite confident that we'll get that in Q2. We filed in December, so we were right on track with our filing, and we're hopeful that we have it by the end of Q2.
spk04: No, that's great. Very helpful. And I understand the guidance range that you set, kind of the puts and takes that you have there. You got to obviously include the kind of the on the cron impact in Q1, but also to the point here in Q4, you did have over 20% growth in Q4 when you back out some of the channel issues from 2020. So Just curious, if we have COVID clear here throughout the rest of the year, you combine that with pre-filled syringes, new sub-QIG drugs coming online, hopefully some more sub-Q conversion from IG. Could this business return to a 20% growth sort of number here in 2022? And just kind of what are the levers to get you there?
spk01: Yeah, so great question. And I think there are two levers that get us to that 20% growth area. The first one, as you note, is the IG market. If the IG market grows, right now we have it kind of high single digits. If it gets back to double digits, that's the biggest thing that's going to drive us there. Again, encouraged by Q4 versus Q3, but one quarter does not a market make, and so we're thinking about the Omicron impact. But that's number one. If the IG market grows double digits, that's going to help us. The second thing is more success in our novel therapies pipeline. Of all the progress we make in the organization we're excited about, that's probably the one that we're most excited about. The revenues that you see in quarter four are not reflective of the total value of the agreements that we signed. A number of those will come into effect through 2022 as we deliver on our commitments. And with more deals signed, that's what could push us over the numbers that we're communicating to you.
spk04: Okay. No, that makes total sense. And then two kind of just –
spk01: Europe is the third. I mean, we haven't invested a lot of energy in Europe at this point relative to strategic and looking at that area. I think Europe with more on-label indications coming in 2022 could also push us there.
spk04: Okay. Makes total sense. And then two housekeeping items here. Just the new office in New Jersey, is that going to become the main headquarters or will you be running two different facilities here in the future? And then You mentioned hitting three of the eight 510Ks that you're expecting. I know one of those 510Ks is Empivalve. What are the other indications or other 510Ks we should be watching for?
spk01: Okay. First question is, yes, it will become our headquarters, the facility located in Mahwah, New Jersey. And we have signed an extension just from a risk mitigation perspective that we will maintain the core roof facility in Chester, New York until the end of 2022. So we expect to move to the new facility in June, have production start up between Q3, and then close the existing facility in Q4. Regarding the 3, 5, 10-Ks, of course, they were the first one was the pre-fill for CSL, and the other two were Q2QEG and Zembify. And then what you see coming on the horizon, I can't talk about all of them because some of them are confidential, but the one I can talk about is the Aspavelli and Empavelli indications that I spoke about that we'll see in Q1 and Q2 of 2022. And then you can expect to see more of what we've talked about already, right? There's probably gonna be expanded pre-fill indications. You'll see some new product introductions from us that we hope to file by the end of 2022. And obviously other things beyond that. As soon as we know that we filed something, Alex, you and team will be amongst the first to know.
spk04: That sounds good. I appreciate the update. Thanks.
spk01: Thank you.
spk02: And our next question comes from the line of Kyle Rose with Canaccord. Please proceed with your question.
spk05: Good evening. This is Gibran on for Kyle. Congrats on the strong quarter and thanks for taking the questions. To start, within novel therapies, maybe how did the Q4 shake out in terms of US versus OUS contribution? And, Linda, maybe following up on one of the points you just made, as the novel therapies pipeline begins to commercialize and come online in the EU too, maybe how should we begin to think about longer-term OUS contribution?
spk01: Okay. So I think two questions. One is specific to novel therapies, and I want to make sure I have this right, Gibran. It's how many of the novel therapies deals were U.S. versus ex-U.S.?
spk03: Correct, yes.
spk01: Okay, so one was ex-US for registration in an ex-US market for a current on-market drug, and three are essentially what could be global. I mean, one is a product development initiative, and two are for drugs that likely will have global launches, but they're earlier in their phases. And then the second question was, how do we see our revenues breaking out over time? I think was the question. Today, domestic core is about 80% of our business. International core is about 20% of our business. I think over time, you can project that overall split between those two. We don't see changing dramatically with both markets growing double digits. I think the big change you'll see is our novel therapies growth continue to expand and represent growth about 20% of our business overall over the next five years, where today it represents less than 3% or 4% of our business. So that's going to be the biggest area we see expand in our business.
spk05: Great. That's helpful. Appreciate the color there, Linda. And then maybe just one more from our end. What did year-end patient numbers look like between PIDD and CIDP? And I know you had alluded to some of the dynamics in the Q1, but maybe anything specific to call out there. thus far this quarter?
spk01: Yeah, I wish I had those numbers. This is, we do not have numbers for patient starts for PIDD and CIDP. I can tell you overall that the overall growth in the market was about 7% in terms of overall drug, IG drug that went into the market, but I don't know the difference at this point between PIDD and CIDP.
spk05: Fair enough how to ask. Appreciate you taking the question.
spk01: Great. Thanks.
spk02: And we have reached the end of the question and answer session. I'll now turn the call back over to Linda Darby for a close remark.
spk01: Great. So I just want to end by saying thank you to the team for a fantastic effort in 2021, in particular in a very strong close to the year. And I want to thank all of our investors for your participation today. Thank you and have a great day. Stay safe and stay healthy.
spk02: And this concludes today's conference. You may disconnect your line at this time. Thank you for your
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