Kamada Ltd. (KMDA) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Kamada virtual Analyst Day. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Kamada website following the conclusion of the event. I'd now like to turn the call over to Bob Yedid from LifeSci Advisors. Bob, please go ahead.

Tara, thank you very much, and thank you all for participating in Kamada's investor meeting. We're very excited about the strategic transformation at Kamada and about the positioning -- and their positioning in the marketplace, which we'll learn about more in just a few minutes. Before we begin, I'd like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of the company. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, Forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of the conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. With that said, it's my pleasure to turn the call over to Amir London, CEO. Amir?

Thank you, Bob. Thank you, everyone, for joining us today. Good afternoon. I want to extend a warm welcome to all of you, investors, analysts and partners, to come at this Investor Day. We're excited to have you participate and learn about the dynamic strategic transformation that Kamada has undergone in the last few months. We are emerging into a vertically integrated specialty plasma company with a portfolio of 6 FDA-approved plasma-derived therapeutics, additional revenue-generating growth engine and a promising advanced critical -- clinical pipeline. I'm joined today by my colleagues, Chaime Orlev, our CFO; and Jon Knight, our newly appointed Vice President of U.S. Commercial Operations. And we together will outline our growth strategy and answer your questions. We believe that Kamada is well positioned to win as we have successfully completed the 2 strategic acquisition last year, made important addition to our management and operating teams. As Jon will describe, we are building a strong commercial team in the U.S. to market and sell these proprietary products in the local U.S. market. We're also going to leverage our distributor partnership across 30 countries to grow the business. Moreover, complementing our strong and effective capabilities, we're vertically integrated into a specialty plasma collection with acquisition of a collection center early last year, and we are going to utilize this existing FDA license and know-how that was acquired as part of this transaction to open additional collection centers in the U.S. Our further integration has strengthened the company and will meaningfully enhance Kamada's growth opportunities and profitability for the coming years. As a background about myself, I've been this company's CEO for the past 7 years since July 2015. Prior to that, I held the role of our Senior Vice President of Business Development. And prior to joining Kamada, I worked for over 20 years in different senior management and international business development positions in the biopharma industry. With that, I'll now turn it to our CFO, Chaime Orlev, to introduce himself. Please, Chaime.

Thank you, Amir, and thank you to all of you joining us today for this exciting event. Our objective today is to share Kamada's key upcoming growth catalysts and review their expected financial impact on our business. As a reminder, for full year 2022, Kamada expects total revenue of $125 million to $135 million, which would represent a 20% to 30% increase over 2021 revenue, with EBITDA margins of 12% to 15%. Beyond 2022, the growth catalysts you will hear about today are anticipated to drive revenue growth at a double-digit rate in the foreseeable years ahead. As Amir noted, we're thrilled to have transformed our business in such a short period of time and look forward to executing on the many opportunities that lie ahead of us. We believe we are well on our way towards becoming a fully integrated global leader in the plasma-derived specialty products market. Importantly, the positive outlook of our business is driven by multiple factors: chiefly the diversity of our commercial operations, which comprises of multiple revenue-generating sources, including the recently acquired portfolio of 4 FDA commercial products, KEDRAB business in the U.S., our Israeli distribution business and the royalty income on GLASSIA sales by Takeda. With that, let me now provide you some brief background on myself. I have served as Kamada's CFO since December 2017. Earlier in my career, I served in various senior finance position in the biotech industry, including at Chiasma and Oramed Pharmaceuticals. I also previously served as CFO for Huntleigh USA Corporation, a leader in the U.S. aviation security sector. Now let me turn the floor over to my colleague, Jon Knight, to introduce himself. Jon?

Thank you, Chaime, and we certainly appreciate all of you joining us today on the call. I consider it an absolute privilege to be with you here today, and I'm thrilled to have recently joined this dynamic company with a multitude of compelling growth opportunities ahead of us. As Amir stated, I'm Jon Knight, and I was recently appointed Vice President, U.S. Commercial Operations, with responsibilities for our U.S. commercial activities related to our recently acquired portfolio of 4 FDA-approved plasma-derived hyperimmune commercial products. You will hear a lot about these products on today's call. I have served in a variety of commercial leadership positions during my nearly 25-year career working in the life science industry, primarily focused on commercializing innovative specialty plasma products. I'm very proud of the fact that during this time, I have led and supported the launch and growth of multiple successful plasma-derived pharmaceuticals, and I am excited to leverage the significant experience at Kamada. My professional background includes commercial leadership positions at Nabi Biopharmaceuticals, Cangene bioPharma, Cardinal Health, CIS by Deloitte, Prometic Life Sciences, and most recently, TherapeuticsMD. Importantly, when I was at Nabi Biopharmaceuticals and then Cangene bioPharma, I launched and managed the ongoing sales and marketing activities for 2 of our 4 recently acquired plasma-derived products before they were sold to Saol Therapeutics. I'm highly confident that Kamada has tremendous opportunity to further penetrate the U.S. market with each of our products, and I am delighted to be leading our U.S. commercial initiatives with hospitals and physicians. I have already begun building out our U.S. commercial team with multiple senior staff members, all of them experienced sales and marketing professionals with established relationships with relevant U.S. health care providers. Today, Amir will detail the market potential for our products in the U.S. and discuss how we intend to leverage these significant commercial assets. With that, I now turn the meeting back over to Amir who will take us through today's presentation. Following this, we will gladly take your questions. Amir?

Thank you, Jon. And again, hello, everyone. I'm very happy to walk us through our presentation over the next 30 to 40, 45 minutes, and then we'll take questions. So as you know and as my colleagues just described, Kamada is a vertically integrated global leader in the specialty plasma-derived therapeutics. After the acquisition we've done late last year, we have 6 FDA-approved products. In addition to that, we have multiple short- and long-term growth drivers that I'm going to describe and go over today. We gave our guidance for 2022, which includes 20% to 30% growth compared to last year. We expect to be selling between $125 million to $135 million with a 12% to 15% EBITDA margins, which represent over 2.5x compared to last year. And we will show you today and demonstrate our global leadership in the specialty plasma product segment in general being highly innovative products in that unique space. So 2021 was an exciting year for us. We basically have significantly advanced our strategic transformation. We have made 2 acquisitions. Late in the year, we acquired a commercial portfolio of 4 FDA-approved products from Saol, which, as I mentioned, as I will show you today, has positioned us as a worldwide leader in that space. We are building a focused sales and marketing infrastructure in the U.S. market. We are leveraging -- already leveraging our distribution capabilities in over 30 countries to promote the new products, and we're starting to see the results that we were expecting. And we are focused, primarily in the U.S., in the solid organ transplantation field, an area of significant opportunity, an area which is growing around 6% year-over-year in the U.S., and we have multiple products for that space. And Jon is building his sales team around those transplant centers around the country. Beginning of 2021, we acquired an established specialty plasma collection center in Texas, U.S., in Beaumont -- the city of Beaumont, which is the first step in vertically integrating plasma collection into our business. We are in the process of leveraging this FDA license to open additional centers. So to summarize this significant transformation area that we had, basically, Kamada has evolved and is evolving into being a global leader vertically integrated in the plasma space. We are working on maximizing the value of this expanded product line globally, U.S., Canada and international markets. And as for the presentation, you will see how many different diverse lines of business we have already developed and we are continuing to develop in the years to come. So going quickly through our management team. So here today with me are Chaime and Jon, but we have a very strong team that is basically providing all the needed management infrastructure. If it's a COO, the VP of Marketing and Sales responsible for international sales, of course regulatory affairs and PVG, quality, human resources and our general counsel. So we have a very experienced management team. We've been running together for quite some time. The addition of Jon to the team is highly valuable, and we are leading Kamada to a great success. This is a slide that shows the 6 FDA-approved products. I'm going through each one of them over the next few slides, the legacy product, GLASSIA, and KEDRAB and the 4 new products, WINRHO, CYTOGAM, HEPAGAM and VARIZIG. In terms of our international reach, you see here the map that shows where we are currently active. So we have our own sales team that Jon is leading in the U.S. market, experienced in specialty plasma products. We have a local sales team in the Israeli market where we have what we call our distribution segment of $30 million sales last year, and we're expecting to more than double this over the next few years. We have a sales office that we've opened in Dubai, which is responsible for the MENA region, an area where we see great opportunity to grow the business, especially the new products that we acquired last -- late last year. We are focused on product life cycle management for the existing product, of course, commercialization of the product, business development activities. And I will also show you our pipeline focusing on inhaled Alpha-1 Antitrypsin being a huge opportunity ahead of us. So all the countries here in blue are where we have a local distributor or we work direct over 30 countries where Kamada is currently operating in. As mentioned, we have -- we've given a focus for the year between $125 million to $135 million, 12% to 15% expected EBITDA and looking at different activities that we are implementing in the different growth engines. We are focusing double-digit growth on an annual basis in the foreseeable future. The 6 pillars of our activity include the immunoglobulin portfolio in the U.S. market; Israeli distribution business; GLASSIA royalty payments from Takeda, which started in March of this year; our Kamada plasma business; the inhaled AAT, the most advanced clinical trial for Alpha-1 deficiency; and our unique expertise in the rapid development of new plasma therapies, which was also demonstrated when we were the first company globally to develop and use an anti-COVID immunoglobulin in the Israeli market. I'll go into each one of those pillars throughout the presentation, and I will summarize the presentation going back to that slide. So let me start with KEDRAB, our anti-rabies immunoglobulin in the U.S. market. The U.S. market for anti-rabies is approximately $150 million. We launched our product in 2018 in collaboration with Kedrion, who is our commercial partner for the U.S. market. In -- the product was launched and, in the first year, we already had 10% market share. Second year, 20%. Then COVID started, and there was an overall slowdown in the market. But we continue growing our market share. And as of last year, we've been at 27%. We expect to continue growing that market significantly. It's the only anti-rabies product with FDA-approved label confirming safety and effectiveness in children. So it's a major competitive advantage. We've leveraged this FDA approval also to get an approval in Canada and Australia, and we launched the product in those 2 important territories. We are selling it in addition to international markets in Asia and Latin America, and we are a key supplier for the WHO in the Pan American region under the PAHO, Pan American Health Organization. So 2021, that was a year that was still impacted by the COVID pandemic. As of starting -- as of beginning of 2022, we started basically going back to the pre-COVID numbers. As I said, we expect to continue growing our market share, and this is going to be a significant growth driver for Kamada over the next few years. The other 2 of the additional 4 products are focused on the solid organ transplantation segment, especially in the U.S. market. That is an area -- sector, which is growing around 6% a year. CYTOGAM and HEPAGAM are used for transplant patients -- transplanted patients, in general an area of significant unmet medical need, and as I said, growing number of procedures in the U.S. and international markets. CMV, which CYTOGAM is indicated for, is one of the most common infections experienced by transplant recipients, estimated up to 50% in solid organ procedures. So there is a significant opportunity to grow the product in the U.S. and international markets. With that said, some more details about CYTOGAM. So it is the only plasma-derived immunoglobulin approved for its indication in the U.S. and Canada. As I mentioned, significant growth opportunities as transplant market continues to grow. The international guidelines for the management of CMV in solid organ transplant provide recommendation for prophylaxis treatment of CMV, immunoglobulin in high-risk groups. And we believe that there is also significant potential for a new indication where CMV is posing a threat. The product was originally manufactured and sold by CSL. Then it was acquired by Saol, and this is part of the portfolio we bought from Saol late last year. Important to mention the product is already on its way to be manufactured by Kamada at our facility in Israel. We are in the tech transfer process. We expect to submit the file to the FDA later this year and to have an approval by mid next year. And that's going to be an important addition to our plant operation and profitability. HEPAGAM B is the only FDA-approved product for post-transplant prophylaxis of hepatitis B in liver transplants. It's sold in a few other international markets. It holds the largest HBIg market share in the U.S., and we already see significant growth opportunities outside of North America, recently had some initial sales in the international markets. And we believe that there is a significant opportunity to continue growing that business as number of liver transplants grows in the international markets where we are active and operating. Varizig, similar to CYTOGAM, is the only plasma-derived globulin approved in the U.S. and Canada. It's approved for post-exposure prophylaxis of varicella in high-risk individuals. It's included in the Red Book of Pediatric Infectious Disease. In the U.S. and Canada, although there is high vaccination rate, there are still pockets of areas -- pockets of populations of low varicella immunity. With the immigration trends, we see it in places we haven't seen it in the past. In international markets, varicella is still a major burden, especially in countries where there is no active vaccination. Interestingly enough, over the last 2 years, there's been a significant increase in number of varicella cases. It is believed to be linked to the COVID pandemic, either to long COVID effect or to the vaccines -- the vaccinations itself. You see here the headlines from a paper that was published in Brazil about the increased number of hesper zoster cases, and those are the people that require VARIZIG as a treatment. So we do see a significant increase in the need for the product and demand for the product. And we are supplying that demand, and we expect these product sales to grow significantly over the next 2 years. WINRHO is the leading anti-D product for hemolytic disease of the newborn HDN in Canada. And in the U.S., it's mainly used for ITP, which is a blood disorder. It is a very strong international brand. It's being used in many countries. We are seeing a great opportunity to expand its sales in the MENA region, and we're already actively pursuing those opportunities. Kamada has a legacy product called KAM-RHO D, which is also approved for HDN for hemolytic disease of a newborn. It was developed by Kamada. It's a leading product in various international markets, focusing on Brazil and Russia, but those territories where WINRHO is not registered. So we don't have like a self-competition between the 2 products. We basically expanded our global leadership in the HDN space by acquiring the WINRHO product. In terms of ITP, recent findings showed the nearly 20,000 cases of newly diagnosed ITP -- acute ITP cases every year in the U.S., and that's the one of solution, which is available for the physicians. Physicians, over the last few years, haven't been any proactive promotion of the product for those cases. And with Jon and his team, this is something we are starting to do in the U.S. market. Importantly to say that what I just mentioned about the lack of proactive promotion and increase of awareness is also true for the other 3 products, for VARIZIG, HEPAGAM and CYTOGAM. So the previous owners of the product did not promote the product over the last few years. And now with us starting to be active, proactive and promote, we do see the significant opportunity ahead of us in the U.S. and Canadian markets to grow the business. And this is, of course, in parallel to what I just mentioned, leveraging Kamada's strong international presence and network of distributors to grow the business in the international markets. Moving to GLASSIA, the product that was our first FDA approval already in 2010. So as you may remember, this was the first liquid ready-to-use product, which also had self-infusion label approval of FDA in 2016. The product, since its approval in 2010, was licensed originally to Baxter. Then over the years, it moved to Takeda, and they have a license in the U.S., Canada, Australia and New Zealand. From 2010 until 2021, we manufactured the product and supplied it to our partner. In 2021, as part of the original licensing agreement, Takeda completed the tech transfer of the product and basically moved it to its own facility, receiving FDA approval. From that point, Takeda started self-manufacturing. And a few months ago, they basically started selling from their own manufacturing, and we moved into the royalty phase in our collaboration with Takeda. Royalties will be at a 12% rate on the Takeda net market sales through August of 2025. And then it will go down to 6% until 2040. So we have a very long tail of 18 years of cash flow generated through those royalties paid to Kamada by Takeda. March 2022, a few months ago, the last month of the previous quarter, was the first month of royalty payments, and we received $1.4 million for that month. This is exactly in line with our expectations. We expect to see between $10 million to $20 million per year for the next 18 years, and $1.4 million is within that range. And as I said, based on our modeling and expectations, it meets those expectations. GLASSIA is also marketed in Israel by Kamada. And other international markets where it's not part of the transaction with Takeda, we're using local partners. And our biggest markets are Russia, Argentina and Brazil. We are also active in registration of the product in additional countries, mainly in Latin America. Moving on from our commercial product, the 6 commercial products, which I mentioned, the KEDRAB, GLASSIA, CYTOGAM, HEPAGAM, VARIZIG and WINRHO, moving on to our clinical development. So our leading clinical program is the next generation of the GLASSIA, which is an inhaled Alpha-1 Antitrypsin treatment. So GLASSIA, as other IV treatments, is a weekly augmentation, which is given to the patients who are suffering from Alpha-1 deficiency. In general, Alpha-1 deficiency is still highly undiagnosed disease. But over the last few years, there's been better disease awareness and diagnosis, and this contributes to the fact that the market is growing between 6% to 8% annually. You see on the chart here how the market has been growing over the last few years and how it's expected to continue growing. So currently, we are at over a $1 billion market for Alpha-1 treatments, all of them augmentation treatment given as a weekly IV infusion. With that pace continuing, we are looking at over $1.5 billion market starting in 2025. The annual reimbursement level is around -- between $80,000 to $100,000 per patient per year. Kamada is at the leading edge of developing a new treatment for this current standard of care, which has been the weekly infusion for, I think, almost the last 30 years. So we are running the InnovAATe study, which is the most advanced study for Alpha-1 deficiency. And it's targeting to be the leading next-generation augmentation therapy. And I'm going to talk a bit about it. So what is our inhaled treatment? It's a once-daily inhalation treatment using a nebulizer. It's, of course, a noninvasive treatment done at home by the patient, expected better ease of use and quality of life for those patients compared to the current IV standard of care, which requires a patient either to go to the clinic once a week or to have a nurse come into their home. It is the most effective mode of treatment for delivering therapeutic amounts of the AAT directly into the airways, and this has been proven in multiple disposition study that we have done over the years. We've studied the product in more than 200 individuals to date, including a Phase II/III study that was done in Europe and Canada. And we have an established safety profile. In that Phase II/III study that we have done, we've demonstrated positive effect on lung function, which is the primary endpoint for our existing pivotal study. We've shown that in patients that were treated over a 1-year course, there was a lower -- a slower decline in FEV1 compared to placebo group. Because the inhaled treatment goes directly into the lungs, into the target organ, it's enough to give one ace of the dose compared to the IV treatment, making it a very cost-effective treatment and, of course, allows favorable market access opportunities upon approval. As I mentioned, that's a leading and new innovative treatment in clinical development in a Phase III study also with orphan protection, both in the U.S. and Europe. So to summarize that section, a significant marketing opportunity, the most advanced clinical development program for Alpha-1 deficiency. As I said, over $1 billion opportunity ahead of us, and we are progressing. We just announced a few weeks ago that we are opening 6 new clinical sites across Europe for the study, and we are expediting recruitment with a goal to advance the study as soon as possible. As I mentioned earlier in the presentation, beginning of 2021, we acquired the plasma collection center in Beaumont, Texas, currently focusing on the collection of hyperimmune plasma for specialty immunoglobulins. That has been a strategic transaction for Kamada, basically advancing us a plan to becoming fully integrated specialty plasma company. We are in the process to open additional centers in the U.S. We are focusing on the Texas area. And the new centers we are going to open will also collect normal source plasma. Average annual revenues for a mature plasma collection center is between $8 million to $10 million. So with our plan to open multiple centers over the next few years, this would be an addition to our top line, to our profitability, and of course, on our ability to be independent in the collection of multiple plasma types for our hyperimmune products. In general, as I mentioned at the beginning of the presentation, Kamada has proven over the years that we're not just a commercial company, that we're not just evolving into being vertically integrated, but also being a very innovative company in the specialty plasma space and being very fast in our ability for rapid development of hyperimmune therapies. A good example of that is the COVID IgG. So when the pandemic started, we were the first company globally in less than 6 months to develop an anti-COVID immunoglobulin and to test it -- to manufacture it, of course, and to test it in human. We signed back then late 2020 a supply agreement with Israeli Ministry of Health. And until now, the product is being used under a named-patient basis or part of clinical study that was sponsored by the Israeli Ministry in COVID patients throughout Israel. So we have an advanced, unique and also very agile FDA-approved IgG platform technology for immunoglobulins. We have proven tech transfer capabilities. We last year completed the transfer of GLASSIA manufacturing to Takeda. We are well advanced in CYTOGAM manufacturing transfer to our plant in Israel. And we plan in the future to also transfer the other products we acquired last year. So Kamada has evolved throughout the years through our own clinical development as well as acquisition of the product into a leader in that very unique space. Another segment of activity that we've developed over the last few years is what we call the distribution segment, and that's in the Israeli market. We are an exclusive distributor for leading biopharmaceutical companies. We are presenting over 15 companies into the market. We have over 20, 25 products, which we sell. It's grown to $30 million in annual sales and gross margins between 13% to 15%. And it generates another stream of solid cash flow for Kamada. Over the last 2 years, we've added a significant expansion to that business. And those 3 agreements with biosimilar companies, the leading one is Alvotech for a portfolio of 11 biosimilar product candidates, which we plan on registering and commercializing in the Israeli market. Expected launch will be between this year, late 2022 to 2028, and this would be after receiving regulatory approvals first from EMA and then from the Israeli Ministry. The overall business opportunity for those 11 products is over $40 million annually, and this is in addition to the $30 million, which we currently sell from the existing products. So we are looking at a business opportunity of over $70 million with improved margins because the new products are being launched at higher margin than the current portfolio. So to summarize, Kamada has developed significant growth catalysts over the last few years. For this year, we have given projection that we will be growing 20% to 30% compared to last year with 12% to 15% expected EBITDA margins, generating cash and, of course, being profitable. We expect to continue that growth both on the top line and the bottom line over the foreseeable future in double-digit rates over the next few years. That growth comes from a multiple diverse catalysts and business streams. So the U.S. business with the recently acquired IgG portfolio; the Israeli distribution business currently $30 million expected to grow over -- to over $70 million; the GLASSIA U.S. royalties from Takeda that started a few months ago and expected for the next 18 years to be between $10 million to $20 million; the inhaled Alpha-1, which is a significant opportunity ahead of us, and we are expediting the opening of new sites and recruitment of patients into the study; Kamada plasma as another important component in our vertical integration and our unique ability and pipeline of new specialty, innovative plasma centers. With that, I'll transfer this now back to Tara to open the call for questions.

[Operator Instructions] So our first question comes from Anthony Petrone at Mizuho.

The overview is very helpful, and appreciate the time today. So I have a few questions. The first one will be a high-level overview question. And then I'll move on to a couple on CYTOGAM and inhalable. And so first, Amir, from the high-level standpoint, obviously, the business has now completely revamped and on solid footing here to successfully bridge the Takeda transition that occurred last year. And so just wondering, when we look forward, how much of the focus will be on execution with the current portfolio, harvesting the assets that are now in-house versus further follow-on business development and potentially licensing initiatives? And as I mentioned, I have a couple of follow-ups.

Thanks, Anthony. Great question. So with our own commercial team in the U.S., we can definitely independently advance the existing and new portfolio, leverage the U.S.-based activities also to expand marketing and sales activities in the international markets. So we believe there is a significant room to grow and to harvest, like you define, the existing portfolio both on KEDRAB as well as the 4 new products we acquired. And we are focused on that. This is part of integrating and leveraging Kamada international capabilities. I can say that although we've owned those products for like 6 months, we're already seeing that opportunity happening in various markets with various products. So we're very encouraged about what we have already seen in terms of harvesting the potential of the products, again, in North America as well as in the different international markets. We also plan, and that is -- inhaled is definitely one good example, through our own pipeline and product life cycle management, to generate additional and new opportunities. In addition to that, and I think now I answer your question, through synergistic acquisition or in-licensing of other either transplantation indicated products or plasma-derived therapeutics, we will continue to grow the business. This is applicable to the U.S. and Canada, but also for the MENA region where we operate our own regional sales office, as I mentioned. Upon completion of the establishment of our U.S. infrastructure and integration activities, which is going to happen over the next few months, our BD team will be looking for additional synergistic opportunities.

That's helpful. And maybe the follow-up to stay sort of high level and going back to the totality of the transaction executed in November. So $95 million upfront, $15 million for excess inventories and then some milestones over the next 12 years to the tune of $50 million brings in a $40 million portfolio with CYTOGAM as the largest asset within there. And so maybe if you can go a little bit deeper into the specific synergies that you expect on that portfolio in dollar terms and how long do you think it will take to realize those synergies. And then we can transition into specific questions on CYTOGAM.

I think there are 3 or 4 aspects to the synergies that we are seeing. One is it's not really a synergy. It's more of an opportunity. As I mentioned during my presentation, the products were not promoted in the U.S. market over the last few years. And we are looking at it in a different way. We believe there are opportunities to grow the business, to increase awareness by having a focused effort around those products. And maybe now I'll refer to Jon to speak about the commercial infrastructure that we are establishing in the U.S., and then I will continue in regard to the other synergies that we see. So Jon, please take it from here about the commercial infrastructure, and then I'll continue. Please, Jon.

Great. Amir, thank you. So excited to share information with you about the team I'm building in the United States. So we have already started establishing our U.S. team, and we'll grow this effective operation. We'll maximize the potential of our products. So our main focus in terms of sales and marketing is the top 150 transplant centers in the U.S. To cover those centers, we need a highly focused and experienced small team of sales and medical affairs experts. The majority of this team is already in place. It's approximately 10 individuals. They've started working, and the rest of them are being recruited. Additional support functions, including marketing, national trade accounts and market access, finance and administration, those functions are either operating from our newly established office in New Jersey or from our existing corporate HQ. Our U.S. commercial office, which recently opened in New Jersey, this has added to our Kamada plasma subsidiary, which is based in Texas. So we've got the majority of the team in place. We're already active out in the market, and we're excited about the interactions that we're hearing with our customers. So Amir, let me turn it back over to you.

Great. Thanks, Jon. So building on what Jon said, so this is definitely a great opportunity that we see in the U.S. market. I can say that we had cases that Jon and his team called physicians, started speaking with them about the product. And they were told for the last few years no one actually contacted them in regards to those products. So we definitely see an opportunity by being proactive in that market of significant unmet medical need. In terms of synergies, so I'll just go back and describe some of them that I went through the presentation. One is, of course, the international presence that Kamada already has. We are active in 30 markets. It's a difficult entry, and Kamada is already there. So to establish a fully operational supply chain of plasma-derived products is a very, very specific, unique type of expertise that Kamada has developed over the last 30 years. You need to have a lot of experience in the supply chain, cold chain, regulatory aspects in order to be able to sell a plasma product in Brazil, Argentina, Canada, India, Thailand or Emirates. And Kamada already has that established infrastructure. So we are integrating the new portfolio to that existing system. And as I said, we are already starting to see significant results to that. So this is highly encouraging, and it's highly synergetic to what Kamada has built over the last 30 years. Secondly, Jon mentioned it, we have an established corporate that has experience with FDA-approved products, GLASSIA and KEDRAB, and with international markets. So talking about synergies, taking those products in-house, we have the infrastructure to support it, and it's very cost effective. Thirdly, upon manufacturing of the product in-house, and CYTOGAM will be the first of those products already next year, we are going to be fully vertical and we are going to be more efficient. So in terms of profitability and gross margins, we are going to grow the gross margin of those products by manufacturing it in-house. And this fully verticality, including plasma collection, also over time will help us with the cost of goods because we are going to supply a portion of the plasma by our own collection. So these are the main synergies both on the revenue as well as the cost aspects of the portfolio.

That's very helpful. And I'll transition into a few on CYTOGAM specifically, either for Amir, Jon or the rest of the team. The first high-level question would be looking at the CMV opportunity specific to transplant patients in the United States and Canada, how many overall patients are in that prevalence pool? That would be one. Is there any segmentation between the adult and adolescent populations? That would be the second question. And if so, is CYTOGAM approved across the entire age spectrum?

So the answer is yes, it is approved. It's also used in some cases -- over the years has been used off-label by physicians for different aspects of CMV. It is, as I mentioned, the only FDA-approved product in the U.S. and Canada for prophylaxis of the CMV disease. It -- in ex U.S. and ex Canada, there is an opportunity to grow the business to create awareness. It is a niche product that we need, and this is part of our marketing efforts that needs to increase awareness and attention of the physicians. And that's going to be a major focus of Jon and his team over the next few years. I will not go here into specific numbers of how many procedures a year are being done using CYTOGAM. Of course, we have this data, but this is not public information. Like Jon mentioned, we need to focus on the larger -- the largest 150 transplant centers across the U.S. We have the data, we have the information, and we started working in that focused way to increase awareness, to present the clinical medical data to the KOL and the physicians in order to grow CYTOGAM usage across the U.S.

And one last follow-up here would be just in terms of unit economics and dosing. It's an infusion therapy. And so is it possible to share the price per gram and the average dosing per patient for a CMV transplant?

It's a tricky question because dosing depends if it's done prophylactically or it's done as part of treatment after a patient has been exposed to CMV. So it's different dosing. I can share with you, of course, the product leaflet, pricing as well. There are listed price and there are actual price. I can share the public data with you after the call. I don't have it right now with me. It's a 50 ml vial, 2.5 grams per vial. Typical cost in the U.S. per vial will be somewhere above $1,000. So it's around $400 per gram on average for CYTOGAM. But it really varies case-by-case in terms of the cost per treatment, if this is what you're asking.

And then before I move on to inhalable, when we look at the $40 million portfolio, I think it was a little difficult to splice out exactly how much was CYTOGAM, but our prior notes at $25 million. And so when we sort of think over the next -- the near term and long term. So within the $125 million to $135 million for 2022, how much is CYTOGAM? And if we look outward 3 to 5 years, what perhaps can we expect in terms of the top line growth profile of that asset?

So in 2021, the portfolio of the 4 products, I believe it was $41.9 million, $42 million, $49.9 million (sic) [ $41.9 million ]. That was the revenues from the 4 products. We, of course, had it only from late November. So we just acknowledged the last month in terms of revenues. Gross profit, GP, was over 50% for the portfolio. So this is the numbers that we have seen buying the assets, buying the portfolio. In terms of growth potential, so we did not give public guidance of exact -- this $42 million will be $45 million or $50 million or $60 million or $70 million. But I've -- at the start of the presentation, I've talked about the specifics, how we're going to grow the business, what the potential is. And I can say and I can testify that we're already seeing the potential happening in multiple markets. So this is in terms of moving forward. In terms of profitability, we expect to continue seeing this over 50% gross margins. And upon self-production, this will grow even beyond that. Anthony, to answer your question, I forgot one thing to answer. CYTOGAM is over 50% of that business.

Okay. That's helpful. And I'll shift to inhalable, and I'll hop off in the queue here. So a couple on inhalable. Maybe high level, this is a complete redesign. My understanding is the company had 2 meetings with FDA Data Safety Monitoring Board, DSMB. Maybe just a little bit of background on those meetings. And as we look forward, twofolds would be, what is the time line for complete enrollment now that the sites are recruiting? And perhaps why do you view this program now as at least somewhat de-risked from the original trial?

Okay. Just one comment. DSMB meetings are not with the FDA. That's an external committee of physicians that basically look at the data on a protocol basis in an unblinded way in order to look if there are any red flags. We had 2 DSMB meetings, no red flags, and we basically were approved to continue with the study with no changes, meaning that the safety profile is good, is solid. We did not have any adverse events, severe adverse events that were linked to the drug treatment, and we had no dropouts in the study since it was started. So this is in regard to the DSMB. In regard to the study in general, so you're right, the current design or this pivotal study design is the result of many years of working and experiencing both on the medical and clinical, but also on the regulatory side of this program. We had multiple meetings and discussions with the FDA between the completion of the previous study in 2015, '16, '17 until we completed the design and launched this pivotal study in late 2019. It was also very important to us to be able to design and get an approval for a harmonized study that will basically be approved both by the European and the FDA. So we don't need to do 2 different pivotal studies, one in Europe and one in the U.S. So this was part of our efforts over the years to get to late 2019 and kick off the pivotal study under an IND -- FDA IND and a European CTA. What's happening now is that the moderation of the COVID pandemic allows us now finally to expand the ongoing study to new sites. And most recently, we basically started patient screening and recruitment in 3 new European sites, and 3 additional sites are being opened basically as we speak. Assuming successful study results, the overall time lines for the program through BLA and MAA submission are approximately 4 years. And this is based on the fact that the actual treatment per patient, the duration is 2 years per patient. So from last patient in, we need 2 years of treatment until the study will be completed.

That's helpful. And just to clean up the design a little bit, looking at clinicaltrials.gov, there's the inclusion criteria on severity for lung function measured by FEV1. I believe that range in terms of inclusion is 40% to 80% of predicted value.

Correct.

Can you remind us on the primary endpoint, what the percentage threshold for improvement from baseline is over the 104-week treatment window in order to hit statistical significance?

Yes. So the primary endpoint is measured by FEV1. We did not disclose all the information about what exactly the power is and what type of improvement we need to show. We did present -- and I don't have it here with me in this presentation, but it's public information. We did present, of course, the data from the previous study, what we have seen to be the significant reduction or slow in the rate of reduction of FEV1 decline of the treated group versus the placebo. As a reminder, the previous study was for 1 year. But this time, part of our agreements with the FDA and the European authorities, we need to do a 2-year study and basically to look at the FEV1 at the end of the term compared to the FEV1 at the beginning. In terms of patient population, we have revised the patient population because it's linked also to the endpoint of the study and to the severity of the disease. So in the previous study that we have done, the efficacy study, we're looking at exacerbations as our primary endpoint. And we have recruited into the study what we call frequent exacerbators, which are the most sick or the most severe patients. The current study, which is based on FEV1, is looking at a patient that are between 40% to 80% FEV1, as you mentioned. And these are less sick patients, and we believe that is the right design for the study, and it puts us in a higher likelihood of success.

Very helpful. Last final one for me. The Alpha-1 Antitrypsin market valued roughly at $1 billion today, a 6% to 8% growth profile on that underlying opportunity. Just as we look ahead and if we assume a favorable safety efficacy outcome on the InnovAATe study, where do you think a reasonable penetration assumption could be for inhalable over time?

So in our models, we definitely see a highly significant opportunity for a market that's going to be over $1.5 billion, a very traditional market with basically one treatment available to the patient. Coming with a new next-generation game-changing augmentation therapy, we believe, will be highly acceptable by the medical community and the patients. I think important to mention also that when doing the current study, majority of the physicians that took part in the previous study also wanted to participate in the current study. I think that's a very strong demonstration of the support that they give and their belief in this treatment. They know their patients the best. They want the best for the patients. And the fact they wanted to join the study, I think it's a very strong statement by the medical community. In terms of our expectations. So we're looking at the market at 2 segments. First one are existing patients, and second is, of course, naive patients or newly diagnosed patients. We believe that from the new diagnostic patients, we are going to take a significant portion of those patients will start the treatment on inhaled. It's better quality of life. It's an easier use. Those patients are usually less sick, and they would like to be mobile as much as possible. So the inhaled at-home, non-invasive treatment is definitely a preferred option for them compared to the need to go to the clinic once a week or to have a nurse come to your home. From the existing patients, we expect to have good penetration, but it's hard currently to estimate it's going to be 15% or 20% or 30%. But all in all, if you add the 2 together, you see how big of an opportunity in total it's for Kamada. Even if I just play with some numbers now, and I think about 25% market share in a $1.5 billion market, think about it, how big of an opportunity it is for Kamada and how huge of a benefit it's for the patients and the medical community. Also important to mention that in the inhaled treatment, because we go directly into the lungs, into the target organ, we need only 1/8 of the AAT quantity of those compared to IV. So this makes this treatment cost effective, very efficient, and this gives us a favorable market access opportunities if needed.

Very helpful. Congratulations on all the turnaround efforts over the last couple of years.

Thank you, Anthony.

Great. This is Bob Yedid from LifeSci. Maybe I could just add a couple of questions that are coming in to our -- the e-mail box. The first one is, obviously, you're building this commercial sales force here in the U.S. that Jon is very involved with. You have a couple of other products like your rabies IgG product, that's an [ outlight ] that you basically now distribute via Kedrion. Is that an opportunity to self-commercialize that product at the end of the distribution agreement?

So current collaboration with Kedrion is highly successful, and we see it in the excellent market penetration and market share that we are taking. The current agreement goes until early 2026, beginning of 2026. And we will evaluate the different alternatives as we get closer to this expiration of the current agreement. We will definitely do what's best for growing our business while continuing to provide the best service to our clients. In general, as I showed throughout the presentation, we believe KEDRAB is around 27% in 2021 in a $150 million market. We expect it to continue growing significantly in terms of its market share over the next few years. And if you apply this growth to the $150 million market with opportunity to internalize the sales and marketing of the product beginning of 2026, building on the existing infrastructure that we are currently building in the U.S. market, I think any one of our investors and analysts can understand the significant top line and bottom line opportunity ahead of us and can do the calculation how much it will affect our performance in the years to come.

Great. The other question is coming in from the audience is one about -- just following up on the inhaled AAT trial. And you've said that you're going to add 6 more sites. I think 3 you have opened now, 3 more by the end of the year. I guess the question is, will you add any -- how difficult it is to open a site and get it integrated into the trial? And will you add any U.S. sites?

So after a few years of -- 2 years, basically, because of pandemic that things have slowed down, it was almost impossible to open sites, and we wanted to carefully monitor the progression of the pandemic before we initiate new sites. So we are able and we are moving forward now with the opening of the 6 sites, as you mentioned. In the U.S., although the study is under an FDA IND and its results will be acceptable and applicable for marketing authorization in the U.S., it's more difficult to recruit patients because IV augmentation like GLASSIA is approved and almost fully reimbursed in the U.S., while in Europe, there are countries that it is not approved, IV augmentation or it's approved and not reimbursed. U.K. is a good example. So it's easier to recruit patients into a placebo-controlled study in such a case. This is why our main focus currently is on opening the sites in Europe. But I want to reemphasize what I said a minute ago. The study is under a U.S. FDA IND. So it's not important if the patients are recruited in the U.S. or Europe as long as we comply with the agreements that we reach with the FDA and we are working under that IND approval, and that's the case. So it's easier, it's quicker to open and recruit a patient to this specific study in Europe because of the special condition that in the U.S., there is fully reimbursed treatment, while in Europe, there are places where it's not available.

Got it. Maybe the last question is, Jon, just in terms of the size of the U.S. sales force, I think you said you're approaching -- or maybe in terms of the overall team, 10 people. Is there a need to expand it beyond that at least at the current time or plans to do it in the future?

Yes. Thank you for the question. You bet. So we're starting relatively small, and we will grow the business over time. So we're currently putting the team in strategic locations. We're covering the major population centers. We're covering clusters of transplant centers. So we're being very strategic in our approach. And my expectation is we move forward. When we begin to grow the business, then we'll continue to expand the team over time.

Great. Got it. Okay. I think just in interest of time, it's about 10 minutes after the hour. I very much want to say thank you to Amir, to Jon and to Chaime for participating in today's event. I think it's been a very interesting overview, and thanks to all of you for listening in and asking questions. Now with that, I'm going to turn it over to Amir for some closing remarks.

Thanks, Bob. Thank you for the LifeScience (sic) [ LifeSci ] team. Thank you, Chaime and Jon, my colleagues at Kamada management. So I think that -- and I thank you all for joining us today and for supporting Kamada and for the questions that were asked. I would like to go back just 1 minute to this slide -- that slide and basically to kind of close the presentation with another look at our significant growth catalysts and the significant strategic transformational transaction that we have done last year. We're highly focused on the implementation and execution. We are integrating the things together. We are growing the business. We just recently have reiterated our forecasted revenue for the year, 20% to 30% growth compared to last year, 12% to 15% expected EBITDA, double-digit growth expectation in the foreseeable future per year. So I think Kamada is definitely positioned for significant growth, especially in the current challenging times that we see for many, many other companies -- public companies. Kamada is a profitable, cash-generating business with solid growth catalysts ahead of us. And I promise you we'll continue to work hard and smart to grow the business and to bring value to our shareholders. Thank you very much for today's participation and looking forward to speaking with you again in the near future. Thank you.