Company or the first company to present, actually, is Kamada Ltd. With us, we have the CEO, Amir London, and the CFO, Chaime Orlev. There are 30 minutes for the presentation. There should be some time at the Q&A. If you do have a question, you can type it into the Q&A tab at the bottom of your screen. That, it's all yours, Amir.
Thank you, Chaime, and thank you, everyone, for joining us this morning. In the next 20 minutes or so, I'll give an overview of Kamada. Dual-listed on the NASDAQ and the Tel Aviv Stock Exchange, a leading biopharmaceutical company. I'll leave some time for questions. Please feel free to engage in the Q&A session. One second. Okay. This is our introduction slide. I think maybe the most important slide of the presentation basically provides kind of an overview of the company. Kamada is a global leader in the area of specialty plasma therapeutics. We have a portfolio of six FDA-approved products. The company is commercial, profitable, generating cash with significant growth over the last few years and a significant growth roadmap moving forward. We have designed and structured our growth over four main pillars, which I'm going to describe throughout the presentation.
A little bit about our numbers. For this year, 2025, we guided the market that we will be selling between $178-$182 million and that our EBITDA will be between $38-$42 million. We are running at approximately 22% of EBITDA from top line. As of end of 2024, we had over $78 million of cash, and the company has been growing 15% CAGR over the last few years. The FDA-approved products are listed below: KD-RAB, CYTOGAM, HEPAGAM, VARIZIG, and GLASSIA. The first five products are all specialty immunoglobulins, which are being given to patients at different acute conditions. I'll talk about it in a minute. GLASSIA is alpha-1 antitrypsin given chronically to patients suffering from alpha-1 deficiency, a severe lung disease similar to COPD, but because of a genetic disorder.
Kamada has been an extremely innovative company over the last 10 to 15 years. We were the first to develop a liquid ready-to-use alpha-1 product. We were the first to develop an inhaled nebulized AAT, which is currently in a phase three pivotal study. Back in 2020, we were the first company globally to develop, manufacture, and bring basically to treatment plasma-derived anti-COVID immunoglobulins for patients that were suffering from the COVID pandemic. We were the first to run a study and demonstrate safety and efficacy of Anti-herpetic immunoglobulin for children, for pediatric populations. We've been very agile and fast in the way that we've been able to develop our programs. We've also been very active in developing the vertical integration of the company over the last few years. We're currently operating in over 35 countries through a network of our own teams as well as distributors and partners.
The US is our biggest market, and then Canada, Latin America, some European countries, and Israel. The management team has been working together for quite some time. I've been with the company for now over 10 years. Chaime, CFO, been over seven years, and the rest of the team anywhere between three, four, five, up to 10 years and more. Well experienced in the areas of plasma products all the way from plasma collection through R&D, clinical, medical, manufacturing, supply chain, and commercialization. We've been very good in delivering our commitments. If you go back and you look at our annual guidance, since we started giving guidance to the market, we've always been very successful in guiding the market in terms of our top line and bottom line, as well as different other strategic programs that we have been planning and executing.
These slides provide kind of an overview of the last four years, four to five years in terms of top line and bottom line. As I said, we're growing significantly. In 2021, we sold $104 million. Last year, $161 million. We guided the market we'll be around $180 million this year. If we're looking at our profitability, from a $6 million EBITDA to a midpoint of $40 million in this year. It's not just we're growing, but we're also growing in a profitable way. Economy of scales, the mix of the products, the focus on more profitable markets, and the fact that we'll be able to expand and increase our activity globally has been very profitable in the way that we've been growing the business.
As I said, in 2021, $6 million out of $104 million, basically around 6% EBITDA, while this year we are running at over 20%. 2024 was a successful year. We generated over $47 million of cash from operation, resulting in year-end strong cash position of $78.4 million. Recently, we announced for the first time since the company was founded that the company is paying dividend on the 2024 results. We are paying $0.20 a share. Basically, the payment will be in April, April 7th, so around two weeks from now. When I compare 2024 to the previous year, 2023, you see the progress and the increase and the growth in every aspect of our financials. Our revenues went from $142 million to $161 million. Gross margin went up by four percentage points. Earnings per share from $0.15 to $0.25. It is a 70% increase.
Adjusted EBITDA grew by 42% from $24 million to $34.1 million. As mentioned, paying cash for the first time, paying dividends for the first time, totaling approximately $11.5 million, $0.20 per share. Going back to what is generating this growth and moving forward also for the next few years. With six FDA-approved products, all of them specialty products, unique products, how-to-make products with kind of a difficult entry barrier for competitors, we have been able to grow this business in the US and across the US in over 30 territories over the last few years. We have a good projection moving forward in our ability to continue growing this in the different territories. We also have what we call a distribution portfolio. These are products that we did not develop, but we basically represent companies in the Israeli market.
We're also taking this model to the MENA region from our office in Dubai. These are products that we are distributing and providing like a full-scale type of turnkey solution to our partners from regulatory registration all the way to commercialization in those specific markets. In addition, we're looking to expedite and accelerate the growth through M&As, in-licensing, and different types of Business development (BD) transactions. We are very proactive now searching for the right opportunities. We'd like to engage in opportunities which are within our current scope of activities or to leverage existing infrastructure that we have in order to execute on those transactions. We're currently, as I said, screening for opportunities. I hope that something will mature already in 2025, allowing us to accelerate our growth. As I mentioned, we have close to $80 million cash.
The main purpose of this cash is for BD and M&A transactions. Plasma collection. As of basically 2021, we established our own plasma collection. Plasma is our main raw material being collected from donors in the US market and then being used for our own needs production-wise, but also to sell it to external partners. We started this line of business in 2021 through an acquisition we've made. In 2024, sorry, last year in September, we opened a very large collection center in Houston. Last week, basically this morning, we announced that last week we opened our second large center in the city of San Antonio, also in Texas. Each one of those centers, once it reaches its peak capacity, will contribute between $8-$10 million to our top-line business.
Two centers, new centers, will be between $16-$20 million of additional business. In the future, if needed, we will consider opening additional centers. Each one of those will contribute between $8-$10 million to our top line. Inhaled AAT, a phase three pivotal study in an area that we're already active in, alpha-1 deficiency, targeting a market of over $2 billion. We are the most advanced company in a phase three pivotal study to try and bring to market a new technology, investigational product that could be a game changer in this significant market. I'll talk about it throughout the presentation. Moving on and looking at those four pillars over the course of the next five to six years. Organic growth is already happening, as you've seen on the chart.
M&As, as I mentioned, we are expecting to have at least one transaction already in 2025 and contributing to our growth moving forward. Plasma collection, the centers that we've opened will reach the peak capacity and collection contribution starting in 2026, 2027, and we have positive contribution to our business. Then inhaled AAT pivotal study, we expect results in late 2028, early 2029, top-line results. If the study is successful, we expect the product in the market in 2029, 2030 with significant top-line and bottom-line contribution to our business. Talking about two or three of our main products, which have been the main growth drivers over the last few years. Anti-rabies immunoglobulin for people that are exposed to a potentially rabid animal. Rabies is a deadly disease.
If someone has been exposed, they need to go to the and get a full protocol of what's called post-exposure prophylactic treatment. Anti-rabies immunoglobulin is an important part of this treatment. There are only two products approved by the FDA, our product and a competitor's product. When we launched the product, the competitor had the majority of the market, but we've been able successfully to take a significant market share over the last few years. In 2024, we sold to our distributor partner $50 million of the product, which they basically marked up and sold it for more than that. In general, we are running at around 40-50% market share. We expect to continue growing this business moving forward. With the US success, we also have kind of leveraged it in other countries.
We won the Canadian and Australian and Israeli, some Latin American countries. We won the tenders, and we are one of the top two or three global players in this important life-saving therapeutic market. We have a minimum commitment from our partner in the US to buy from us at least $135 million of the product over the next three years, 2025, 2026, 2027. This will continue to be a major contributor to our business and moving forward. Our second largest product in the US is CYTOGAM. CYTOGAM is an anti-CMV immunoglobulin. It's used part of solid organ transplantation, primarily for high-risk patients, what we call the mismatch patients, where the organ is infected, is CMV positive, and the patient is CMV negative. This is like the leading cause for organ rejection post-transplantation.
In general, we're looking at around a 23% increase in US organ transfer over the last five years. Specifically for lungs, which are the main organ that we are focused on, we're looking at a high single-digit growth annually. In 2024, we sold $23 million of the product. This was a 31% increase compared to the previous year. We are doing a lot of work in terms of generating new clinical and medical data, working with the US KOLs in order to support the product promotion and sales. We expect to continue growing it primarily in the US, but also in the Canadian market. As mentioned earlier, in addition to our own proprietary products, we have additional lines of business.
One of them is the distribution business focused primarily on the Israeli market, but also recently we've taken this business model also to the MENA region, working with companies from our office in Dubai. The lead or the biggest opportunity here has to do with a portfolio of biosimilar products. We are representing Alvotech in the Israeli market. We expect the biosimilar portfolio to add between $15-$20 million per year within the next five years. This will be a significant growth engine, profitable growth engine to our business in the plasma space. As mentioned, main focus in terms of our growth for the next few years comes from our BD, M&A, in-licensing opportunities. We are focusing on products which are synergetic to our existing commercial or production activities. We have a strong financial position and our commercial footprint.
We are looking forward for this to have positive contribution to the business. Let's talk about the plasma collection. In those centers that we are opening, we are collecting specialty plasma for own needs like anti-rabies, anti-D, hepatitis, while we're also collecting what's called normal source plasma, which we are going to sell to external parties. Recently opened the two new centers, Houston and San Antonio. Sorry, both of them in Texas, of course. We're looking for revenues between $8-$10 million per year for each one of those centers. Moving to the inhale the Alpha-1 product, which I mentioned earlier. Alpha-1 deficiency is a genetic chronic disease. People that are born with a body not producing sufficient levels of the AAT protein. The main complication of this disease is what's called a lung disorder.
Similar to COPD, those patients will develop a severe emphysema over the years. The treatment or the standard of care is basically to give them on a weekly basis the missing protein. It does not reverse the situation of the lung, but it really slows down the disease progression. This is still a highly misdiagnosed disease because the symptoms are similar to COPD, which is a chronic obstructive pulmonary disease, like the smoker's disease, if I may. In many cases, a patient will complain to the physician, to the pulmonologist about the symptoms, and they will be treated for the COPD symptoms without actually testing and diagnosing the Alpha-1 deficiency. This has been improving because there is better awareness and patients are asking physicians and physicians are aware that this COPD patient might be suffering from Alpha-1 deficiency. We see a steady market growth.
What used to be like a billion-dollar market now is around $1.3-$1.5 billion, continuing to grow around 7% a year, expected to reach around $2 billion by 2028, 2029. In our study, we've taken our product, which is currently given as IV, weekly infusion, and we developed it as a drug-device combination with a nebulizer. It can be given at home, non-invasive, on a daily basis as a nebulized inhale product going directly into the lungs. Because of this effective mode of administration, giving lungs, and the lungs are the target organ, we are giving one-eighth of the dose compared to the IV systematic treatment. We are in a phase three pivotal study. It is a double-blind randomized placebo-controlled study. The key endpoint is lung function measured by FEV1. We're also collecting CT scan data, lung density, and many other different parameters about the health of the patients.
Recently, we have announced that we reached positive feedback from the FDA, which is based on the positive safety data we presented to the regulators. The regulators agreed that they are in agreement with us that our proposed p- value of 0.1 instead of 0.05 will be sufficient in evaluating the trial efficacy primary endpoint. This allows us to reduce the sample size in the study from 220 patients to 180 patients. We also announced we're going to conduct an interim futility analysis by the end of this year. We are around 50% into recruitment. We are hoping to complete recruitment by end of 2026.
The study is a two-year treatment, meaning that last patient out will be by end of 2028 if we complete recruitment by end of 2026, meaning that we're going to have data readout in early 2029, if successful, submission and product launch in 2030. We also opened what's called an open-label extension, meaning every patient completing the two years randomized phase can roll into a treatment arm that will continue for additional two years. The advantages, it's non-invasive, at-home treatment, better ease of use, better quality of life compared to a weekly infusion, which the patients are required to receive currently, meaning they need to go to the clinic or have a nurse to come to the home.
All of this will not be needed once the inhaled, if and once the inhaled is approved, the most effective mode of treatment because we're going directly into the lungs and a very well-established safety profile, as I mentioned earlier. To summarize and to leave enough time for questions, Kamada is a global leader in the area of specialty plasma therapeutics. We have been very successful delivering on our commitments. The company is profitable, generating cash. Even recently announced that we are going to pay dividend, growing significantly double-digit rate every year, guided the market this year between $178-$182 million with a midpoint of $40 million EBITDA, close to $80 million cash, looking to turn this cash into business transactions, M&As in order to accelerate the growth, continuing with our organic growth and the plasma collection centers opening and ramp up.
We have the inhaled AAT as a potential game changer, transformational product in a $2 billion market with results expected in a few years. This is a nutshell, the company with our strengths and our plan moving forward for the next few years. I will open it for questions from the audience.
Great. Thank you very much, Amir. With regard to the plasma centers, as you said, you opened the third one today. Why is that important to Kamada to have its own supply of plasma?
There are basically two reasons for opening the centers. The first one is what we call the specialty plasma, which we need for our specialty immunoglobulins. Every liter that we collect instead of buying from an external supplier is cheaper, which means that our cost of goods are going to be lower once we have sufficient self-donated or self-collected plasma.
This is going to have a positive impact on our gross margin and cost of goods. Also, being vertically integrated allows you basically to be more independent, allows you to be able to expand based on the plasma you're collecting yourself. In addition, the normal source plasma that we are collecting, we're going to sell it to external partners. It is just another line of business that adds to our top line and profitability. When we looked into this business a few years ago, we found that it's really from an economy of scales and efficiency, effectiveness, it makes sense that the center will be collecting normal source plasma and specialty plasma. This gives you a very wide kind of a better cost structure, allowing you to be more efficient in the way that you're collecting the plasma.
Do you think the three centers give you enough capacity and enough supply of the specialty plasma for your products, or do you anticipate opening more centers going forward?
Currently, that's our plan, the three centers. Based on the pace we're moving and the capacity and the actual ability to turn capacity into plasma, we'll decide if and when we need to open additional centers.
Right. With regard to the inhaled AAT drug, you indicated that you'll complete the interim fertility analysis early 2026. Is that the next milestone? Will investors see any data from that?
We're going to have the data by end of this year. It will be late 2025, not early 2026. Basically, the way that fertility analysis works, we remain blinded to the data. There is an external committee that is independent. They're going to see the data unblinded, allowing them to do the analysis, looking at the data up to that point, and basically from that data analysis, statistical analysis to drive some assumption related to the probability of success of the study moving forward. This will be the main next milestone in the study. You are correct.
You indicated that this treatment will be able to be done in the home as opposed to having the patient go to a clinic for intravenous administration. Does that give you more favorable reimbursement? Do the insurance companies prefer to have a treatment in the home, or have you even contemplated reimbursement yet?
In countries where it's currently reimbursed, the IV, like the U.S., for example, or Germany, Spain, Italy, if and when the inhale is successful, definitely reimbursement will be available because the payers are already paying for this today. To pay for alternative treatment that is more convenient, non-invasive, done at home will be a very favorable move for the payers. There are countries, especially in Europe, like the U.K., where currently the IV treatment is not being paid by the payers. It's not being reimbursed. In those countries, we believe, we hope that coming with the inhaled treatment based on successful efficacy study driven from a placebo-controlled study will allow us to convince those payers that they should pay for the inhaled treatment.
It's not only that we believe that this is a highly competitive product compared to the current standard of care, but also the ability to grow the market by getting reimbursement in countries currently not reimbursing for the IV treatment.
Right. One of the pillars for growth was acquisitions or M&A. Can you talk about what the pipeline looks like right now?
Yeah. As I said, we asked screenings for some opportunities. We're looking at areas which are relatively close to our current business because we'd like to leverage an existing infrastructure that we've built. Our current business is primarily in the plasma-derived, of course, but if you look at the specialty, infectious disease, emergency rooms, hospital products, transplant centers, and also, as I mentioned, we do have a distribution business in Israel and the MENA region. These are the areas where currently our main focus is. We are optimistic that we'll be able to execute on such a transaction, at least one already in 2025.
Now, the agreement with Kedrion, I believe it was $180 million over four years. You are one year into that agreement. Are you running ahead of schedule, at schedule, behind schedule?
Yeah. The original agreement was signed for basically eight years. The first four years, we had a pre-defined minimum commitment by Kedrion. We are talking about the KD-RAB anti-rabies immunoglobulin for the U.S. market. That is the scope of the collaboration. As you said, $180 million minimum, meaning $45 million on average per year. In 2024, Kedrion already ordered from us above the minimum. We sold them $50 million of the product, which means that for 2025, 2026, and 2027, their minimum commitment is $135 million, $45 million times three. We expect or hope that in reality, they will be ordering more than that.
Do you have other distributors selling outside the United States? How are those markets going?
Absolutely. We are a global leader in that space, in that specialty. As I mentioned, we won the tenders: Canada, some European countries, Australia, Israel, some Asian countries. We won a very large tender with an international organization, mainly supplying Latin America. We announced this earlier this year. It's like a $25 million agreement tender for the next three years, 2025, 2026, 2027, for a combination of KD-RAB and VARIZIG.
All right. We have just about a minute left. Do you have any closing comments before we sign off? Thank you for the very good questions.
I hope that the listeners have appreciated the verticality and the variety of growth engines and businesses under the umbrella of Kamada. Very clearly defined strategy moving forward. When I mentioned earlier about M&A or BD transaction, we are focused on commercial assets. We're looking to grow the business and keep at least this double-digit growth mode moving forward on an annual basis and in a profitable way. I think a very healthy business with a nice outlook moving forward.
All right. Thank you for the update. We look forward to talking to you soon to get further updates. Thank you, Amir. Thank you.
Thank you all.