... Hello, and good afternoon. Thank you all for joining. My name is Jason Ellis, and I'm a Managing Director in our Biopharma Investment Banking team. I am pleased to welcome you all to the Kamada presentation at the Wells Fargo Healthcare Conference. Today we have with us Amir London, who is the CEO of Kamada, and we'll be walking through some detailed perspectives on the company. So, Amir, take it away. Okay. Can you hear me? Yes. Okay. Good afternoon, and thank you for joining us today. So I walk you through the Kamada presentation. Okay. So Kamada is, of course, a publicly traded biopharmaceutical company. We're commercial stage. We have six FDA-approved products. Company's been growing significantly over the last few years. I'll show you in a minute kind of our chart, you know, since 2021, over double-digit growth, both on the top line and bottom line performance. We guided this year that we'll be selling between $178 million and $182 million, so midpoint of $180 million, and the bottom line in terms of EBITDA, we guided will be between $40 million and $44 million. We just kind of raise our guidance, you know, at the end of the second quarter earning call. As I mentioned, six FDA-approved products, highly focused on profitability, on growth, on kind of our main growth engines. We do have what we call our four pillars of growth, combined of organic growth, six products over thirty-five different territories, where we are marketing the product, either directly or through a network of distributors. We're highly focused on accelerating the growth through M&As or in-licensing of additional products. I'll talk about it later. We do have opened recently, plasma collection centers. That is another kind of engine in our growth, allowing us to be more vertically integrated, and we have a phase III pivotal study for the inhaled AAT, which I'm going to talk about. In general, our technology and our expertise is in what's called a specialty plasma-derived products. I think you, most of you be familiar with the plasma space, so there are a few kind of giant companies, Grifols, CSL, Takeda, a few other kind of mid-range companies. They all focus on IVIG and albumin more of the kind of commodity side of the business. We focus on specialty plasma products. So our portfolio are alpha-1 antitrypsin, and five different products that are called basically our specialty immunoglobulins, which are the KEDRAB, CytoGam, HepaGam, VARIZIG, and WinRho product. They're all kind of niche product, hard to make products, so you need to have a very sophisticated supply chain of high-titer plasma in order to be able to make the product. Three of the products are made by us internally at our own facility. Three are outsourced to an external CMO that makes the product for us, and the main market is the U.S. and Canada. We're also a big supplier to the WHO, mainly for the Latin America operation, PAHO, and we sell in additional 35 different countries around the world. So how do you make those products? You start with high-titer specialty plasma, meaning that you've got donors that are either being vaccinated or being screened for the high titer against a specific virus. This plasma is being collected. It goes through many different type of tests, highly regulated environment, highly regulated industry. In general, in order to sell the final product in the U.S., the plasma also has to be collected in the U.S. So it has to be basically FDA-regulated from the plasma collection all the way to the finished product. Then it goes through different steps of purification in order basically to purify those specific antibodies from the plasma. It goes through a viral inactivation to make sure the product is safe, and of course, at the end, going to be filled into the syringe or vial and being available and distributed in the different markets. As I mentioned, global network, global reach. Some countries we sell direct, U.S., Canada, in the Middle East, and in other countries, we work through a network of distributors. Management team have been working together. I've been with the company for eleven years. Management have been working together for quite some time. Highly experienced senior executives in this field of specialty plasma products. So as I mentioned, this is our growth over the last few years. So we started 2021, you see around $100 million. This year, we guided $180 million, and on the EBITDA side, started with $6 million, and this year will be over $40 million EBITDA. I think important to mention how we've also been able to grow the rate of EBITDA from top line, so starting on 6%-7%, now we are running to around 24%-25%. So this is, of course, testimonial to the fact that we've been able to grow the business in a very effective, efficient, profitable way. The economy of scale, you know, being more of focused on the, on the U.S. market, where the kind of the, the best, opportunities and the best, price and profitability for our products. If I take and compare the first six months of the year to previous year, you see that how we've been growing on all different metrics, financial metrics. So you see that on the revenue, 11% growth, same on the gross profit, earnings per share, 58% growth, and adjusted EBITDA, 35% growth. Earlier this year, for the first time, we actually paid dividends to our shareholders, and this is something that we might continue doing in the future based on our profitability and cash availability. So those four pillars of growth, as I mentioned, six approved product. Thirty-five different countries allows us to have kind of very nice metrics of opportunities to grow the business. It's not that we are highly depending on one product or one territory, but we have the opportunity to grow the business in multiple areas, multiple territories, multiple products, and that's organic growth. We believe that the current business, what I mentioned, a $180 million dollar, we can continue growing it way over the $200-$250 million dollar business just by continuing to grow the existing product. But we're not settling for that. We would like to kind of accelerate the growth, so we are screening for opportunities for in-licensing and M&A opportunities. First, we started by looking at the plasma space. We've been growing this, and now we're looking at a bit more kind of broader in terms of leveraging our existing U.S. commercial infrastructure, and we are optimistic that, you know, some of those opportunities that we're screening will actually mature over the next, you know, few months. So this will have positive impact on our profitability already in 2026. In terms of our plasma collection, so we opened two large plasma collection centers recently, one in Houston, one in San Antonio. The plasma collection centers have two objectives. One is specialty plasma, anti-rabies, anti-D, anti-hepatitis, that we are going to use for our own needs, already starting using it, and the normal source plasma that we are going to sell to external parties. Each one of those centers is going to have a capacity of around 50,000 liters annually. Around 40,000, 40-plus thousand liters will be sold to external parties. This is around $8-$10 million of additional revenue that is going to basically help us grow our top line performance. Last but not least, inhaled AAT, which is like a phase three pivotal study. I'm going to talk about it in a minute. That's in a space currently around $1.3-$1.4 billion market for Alpha-1 deficiency that we are hopefully going to compete in the future if we are successful in the current phase three study. I'm just going to cover now two of our lead products. One is KEDRAB. KEDRAB is an anti-rabies immunoglobulin product used for as a PEP, post-exposure prophylactic, for patients that were exposed to a potentially rabid animal. They go to the ER. They need to get our treatment in order to protect them, in parallel to getting vaccines. The reason that it's important to get the immunoglobulin is because if you only get the vaccine, you're not protected for the first fourteen to twenty-one days, which could be deadly. Important to give the full protection. We launched the product in the U.S. in collaboration with a company called Kedrion in 2017, and since then we've grown the market. There are only two products on the market. Our competitor is Grifols and us. Market is currently around 50% each, and last year we signed an extension to the deal, which is Kedrion, which gives us $180 million for the next four years. We already kind of finished the first year with above that minimum volume, $50 million, and continue to grow our market share. It's a highly profitable business for us, and we're leveraging that success in the U.S. also for other markets. We won the Canadian tender, we've won the Australian tender. We're supplying some European countries. We have a big supply, a big order coming from the WHO for the Latin American business. So there are only, like, two or three different companies that make those types of unique products, and we are one of them with kind of global leadership. Second product to mention is CytoGam. CytoGam is an anti-CMV immunoglobulin, which is used as part of solid organ transplantation, especially when there is high-risk patient, what's called mismatched patients. When the organ is CMV positive and the recipient, the patient, is CMV negative, so the part of the protocol is to give those patients a boost of the anti-CMV immunoglobulin in order to protect them against infection. We are investing in addition, creating, generating additional data. We have a very strong advisory board. We have a commercial, a medical team that is calling on transplant centers in the U.S. in order to grow this product. CMV is the number one reason for organ rejection as part of organ transplantation, so there is a good unmet medical need here and a good opportunity to continue growing this business. In addition to our own proprietary product, we have what we call the distribution segment, distribution business. Company was originally founded in Israel, and through that establishment, we also representing and distributing products in the Israeli market, which are not our products. Companies that don't have their own subsidiary in Israel are using a local distributor, and we are competing on that market. In that regard, in addition to the product that we currently have in the portfolio, we signed for additional few biosimilar products. We are representing Alvotech, for example, in the Israeli market. We expect this to be around $15-$20 million of additional business. Already launch our first product in 2024, launch another two products in 2025. We're expecting to continue launching between two to three products every year in the coming years in the Israeli market. We are now expanding this business model of not just selling our own products, but also being a distributor in the MENA region from an office that we opened in the Emirates in Dubai, representing additional companies in that region. I spoke about the M&As and about the plasma business, which is our plasma collection, and I'll talk about the inhaled AAT business. Alpha-1 antitrypsin deficiency is a genetic disorder. People that are born with lack of self-sufficient production of the AAT protein. There are believed to be close to 100,000 patients in the U.S., similar number in Europe. It's a highly misdiagnosed disease because the main complication symptoms are lung disease, similar to COPD. So many of the patients are misdiagnosed, actually being treated for the COPD symptoms and not for the underlying reason, which is Alpha-1 deficiency. Physicians, pulmonologists that have the awareness that their COPD patients might be suffering from Alpha-1 deficiency can test for Alpha-1 deficiency. If patient is being identified as deficient, they are being put on augmentation therapy. They will get a weekly infusion. This has been the treatment since the Alpha-1 has been basically discovered, talking about the late eighties, early nineties, and there are a few players in that space. Back in the day, it was Baxter. Now it's part of the Takeda portfolio, CSL, Grifols, and in twenty ten, we got approval for our Alpha-1 product, for GLASSIA. It was back then, it was the only liquid ready-to-use alpha-1 product. We also got on-label approval from the FDA for self-infusion for patients that are independent enough and can get the treatment at home. We've been growing this business through our collaboration with Baxter, then it moved to Takeda, and this is part of Takeda's portfolio. Takeda also acquired from us the technology. In 2021, they completed internalizing production of GLASSIA, and we moved from kind of a product manufacturing and a transfer price agreement into a royalty agreement that we've been being paid by Takeda since then. Having the liquid product also allowed us to develop a nebulized AAT. Now, as I mentioned, the disease is a lung disease. The target organ are the lungs. The current standard of care, which is a weekly infusion, it's a very inefficient type of treatment because only a very small portion of the AAT, of the drug, which is being given systemically, actually gets into the lungs. So we took this, and we worked on developing as a nebulizer. We partnered with PARI, a nebulizer called the eFlow nebulizer, and over the last, you know, few years, we've been running a pivotal phase III study in order to show that treating the Alpha-1 deficiency with a nebulizer as a much more efficient mode of administration, because we go directly into the target organ, into the lungs, is an efficient and effective treatment. It's a placebo-controlled study. It's under an FDA IND and a European CTA, so it's kind of a harmonious protocol between the two agencies that we've been able to develop. The study currently is at around 55%-60% recruitment. We're going to have an efficacy futility analysis by end of this year. Overall, the market right now is around $1.3-$1.4 billion market. Still on the kind of the legacy once a week weekly infusion treatment augmentation, but as I mentioned, a very inefficient kind of mode of treatment or mode of administration that requires to give very large volumes of the AAT protein because only a very small portion of it actually gets into the lungs. Because we're giving it with the inhaler with the nebulizer direct into the lungs, we can give one-eighth of the dose compared to the IV. So a much better much more effective mode of administration. You see here a chart of how the market has been growing. We believe, and this is public information, we believe that by the time, you know, that we have the data expected in 2029, the market is going to be around a $1.8-$2 billion market, and that we have potentially, if successful, we have a potential game changer in this market. We can take a significant market share in the Alpha-1 space. So as mentioned, study around 55% recruited. We expect to complete recruitment in end of 2026, so let's say early 2027. Two years treatment will bring us to beginning of 2029 as kind of last patient out and data read out. Primary endpoint is lung function measured by FEV1. We're collecting CT scan by CT scan lung density as a secondary endpoint, and we have multiple other kind of endpoint. A very holistic approach to data collection that we have implemented in that study. Non-invasive at home, a better quality of life for the patients. It's a once-daily inhalation session. It takes around 10 minutes. We did a lot of work on the human factor aspects in order to improve the drug device regimen, the drug device combination. We have very good safety data in the study so far, but as I mentioned, we are going to have futility analysis by end of this year that will give us hopefully very strong kind of back wind and positive trend moving forward. So to summarize, a global biopharmaceutical company with unique expertise in the specialty... in the global and specialty plasma space. Profitable business, growing year after year. You know, we have been showing double-digit growth in the years since 2021. We expect to continue growing. Guided this year between $178-$182 million, around 24%-25% EBITDA, between $40-$44 million, 6 FDA-approved product, and a very clear strategic roadmap of growth, moving forward to continue growing the company and bringing a lot of value to our shareholders. Thank you. ... So we have some time left, we can open it up to questions from the audience. Maybe I'll just kick it off. Amir, it'd be great for you to just talk a little bit about some of the kinda key drivers for KEDRAB and CytoGam. What are some of the dynamics that are really causing those products to grow, and how do you see that continuing on to the future? Okay. So when we launched KEDRAB, there were three, our product was the third product on the market. Grifols had the leading product, 95% market share. Sanofi had a very small product, and we launched our product. Sanofi decided to exit the space, and we were able to kind of take the market share. But what really helped us a lot was the fact that we did a post-approval, like a phase IV study, which was a pediatric study. Our competitor doesn't have on label that the product was tested on children successfully. We did a study, got positive results. We're able to expand the labeling, including the pediatric label, and that gave us, I think, a very strong kind of support from the physician, from the medical community to our product. Our partners, Grifols, Kedrion, are doing very excellent job promoting the product in the market, creating the awareness. I think in general, the fact that there are two players that are promoting the product in the market, it kind of, reassure the fact that there is a need to treat, every patient that actually been exposed to rabid animal coming into the ER with a full protocol, which includes the immunoglobulin and the vaccine. I think in the past, there were hospitals that were giving only the vaccine, so kind of the overall market, I think, has been growing through better compliance with the full protocol. Overall market is anywhere between $150-$200 million, and Kedrion has been doing a great job in actually growing our business in the market. On CytoGam, so as I mentioned, CMV is considered the number one reason for organ rejection. CMV is a big issue. Back in the day, way, way before we acquired the product, when it was owned by CSL, CytoGam was selling on a $100 million. Then with introduction of competitors, antivirals, CytoGam kind of lost a lot of its market share, but the CMV problem, CMV issue remained. It wasn't solved, and we are now generating new data that was not existing over the last few years because there was no one actually in the field collecting data and doing any type of clinical kind of work, clinical studies, medical work. We've been doing it. We have a very strong advisory board of CMV specialists, infectious disease specialists, transplant specialists, and we're collecting data, and we believe that this new data, this kind of very comprehensive, clinical program that we have launched two years ago, generating new data will allow us to show the benefits of using CytoGam, mainly prophylactically, and will allow us to continue growing the product. Great. Maybe one more. For the AAT product- Yeah. Assuming that you are successful and get some good data coming up toward the end of the year, how do you think about the next steps on that? Is that something that you would build some commercial capabilities around? You know, how do you see yourself really penetrating that market? Yeah. So on the Alpha-1, so first, as I mentioned, as you comment, yes, we are going to have this futility analysis by end of the year. This will be the first time since the study started that we're going to have an interim to kind of peek into the data, not as directly, you know, as a futility analysis being done. We're going to have an external DSMB. They're going to be unblinded to the data, and based on kind of the futility rule that we are defining, they will give us kind of the go, no-go moving forward. In terms of our future plans, we plan to partner this product. We believe that in order to compete with kind of the big guys in the Alpha-1 space, Takeda, Grifols, potentially maybe Sanofi, they are successful with the Inhibrx product they acquired. It requires a significant commercial footprint, which we are not planning to establish ourselves. We are highly focused on transplant centers, and this is where we would like to stay. So we are going to look for a commercial partner. We did start this effort a few months ago, but then when we decided to do the futility analysis, you know, some of those potential partners are waiting for the feasibility results that will be coming toward the end of the year, and then we'll continue this potential partnership process in order to bring in a commercial partner. Just in terms of the hyperimmune space, obviously, you mentioned in plasma-derived, more broadly, there's big players. You know, why is it that Kamada has been able to carve out this niche and the bigger players haven't really gotten into this as much? What do you see around the sustainability of that? Yeah. Basically, it's on the contrary. The big players, some of them were in the specialty, immunoglobulin, and they decided to exit the space. I think it was too small for them. You know, Sanofi had a product, back in the day, you know, Baxter, Takeda had products, CSL sold CytoGam to us. So, I think it's just kind of too small for them. They are focused on large, kind of industrial-scale, fractionation facilities. They are. Each one of those companies have three hundred plus plasma collection centers, so we're talking about kind of millions of millions of liters of plasma being collected, being fractionated. A $50 million market is too small for them to focus on. We've seen it with CytoGam and CSL, and that's exactly the right size for us. We have defined this as a strategy a few years ago. We identified the fact that the big guys are going to exit the specialty plasma space... and we kind of built our capabilities and expertise into that space, starting with anti-rabies, then the anti-D, then the CMV, varicella, hepatitis. So we built a franchise around that. It requires a very unique set of capabilities and expertise from plasma collection, hyperimmune, through a good understanding with the FDA regulations around plasma. It's very complicated supply chain, maybe the most complicated in the biotech space, because you start with, basically, you know, living organ, plasma, which has kind of variance between batch to batch in terms of the raw material, but you really need all the time to be able to make the product within those very strict specifications. A lot of unique expertise that we've built over the years in the U.S., Canada, Israel, and many other markets. Is it fair to say, I mean, just given, as you were mentioning, the complexity around the products, we haven't really talked about competition, but, you know, just given it's difficult to make, you have to have the hyperimmune antibodies- Yeah. Is that, you know, is that something that you're concerned about or that, that even needs to be considered, just given the complexity? We don't see new plasma companies being established. On the contrary, we see a lot of consolidation in the market over the last few years. The entry barrier is very high, because of the complex supply chain, because of the fact that you do need to have the plasma source. So we don't, we definitely don't see new competition from a direct plasma-derived competing product. We do see competition from non-plasma products, which are treating same, you know, disease. You know, if like, take the Alpha-1 space, for example. So Inhibrx, Sanofi, developing recombinant AT. There are new gene therapy, potential treatments that are in early kind of clinical studies. So it's not that we don't see competition. We don't see competition, exact competition in our plasma-derived expertise, and I think this trend is going to continue. I think there's going to be even further kind of consolidation, and we are building ourselves as the lead, leading global specialty plasma company, and that's our strategy, and we plan to continue in that direction. Thank you so much for presenting, and thanks for being here. Thank you very much.