Kamada Ltd at H.C. Wainwright: Strategic Growth and Expansion

On Monday, 08 September 2025, Kamada Ltd (NASDAQ:KMDA) presented at the H.C. Wainwright 27th Annual Global Investment Conference. CEO Amir London outlined the company’s robust financial performance and ambitious growth strategies, highlighting a focus on specialty plasma products. Despite a positive outlook, challenges in expanding plasma collection and regulatory approvals remain.

Key Takeaways

• Kamada Ltd. anticipates revenue of $190 million this year, with EBITDA expected to grow to over 20%.
• The company is expanding its U.S. market presence through acquisitions and increased commercial activities.
• The inhaled Alpha-1 Antitrypsin (AAT) therapy, targeting a $2 billion market, is in Phase 3 trials.
• Kamada Ltd. is actively pursuing M&A opportunities to enhance growth and expects significant contributions from plasma collection centers.

Financial Results

• Revenue is projected to reach $190 million for the current year, with $89 million generated in the first six months.
• EBITDA is expected to grow from 6% to approximately 22%-23%, with adjusted EBITDA increasing from $16.6 million to $22.5 million.
• Gross profit rose by 11%, and earnings per share (EPS) increased by 58%.
• The company maintains a strong cash position with reserves of approximately $66 million.

Operational Updates

• Kamada Ltd. distributes products in over 35 countries, gaining significant market share in the U.S. for Kedrab.
• The company is expanding its distribution model to the MENA region, with a new office in Dubai.
• Two plasma collection centers have opened in Texas, with FDA approval for the Houston site and expected approval for San Antonio in 2026.
• The inhaled AAT program is undergoing a Phase 3 clinical study, with interim analysis results expected by year-end.

Future Outlook

• Kamada Ltd. is actively seeking M&A opportunities in the plasma and pharmaceutical sectors, focusing on commercial-stage assets.
• The company plans to maximize the capacity of its plasma collection centers, each expected to contribute $8 to $10 million annually.
• The inhaled AAT therapy could revolutionize the $2 billion alpha-1 deficiency market, with significant growth potential.

Q&A Highlights

• The Phase 3 inhaled AAT study includes secondary endpoints using CT scans to measure lung density, with the primary endpoint being FEV1.
• Kamada Ltd. paid a one-time dividend in April, focusing on M&A opportunities for future growth.
• The company is satisfied with its current plasma collection centers and plans to maximize their output.

For a detailed understanding, readers are encouraged to refer to the full transcript below.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Lucy Lai, Research Associate, HCLibRite: Good morning, everyone. My name is Lucy Lai, a Research Associate at HCLibRite. It’s a great pleasure to welcome you all to HCLibRite’s 27th Annual Global University Conference. Thank you for taking the time to join us today. Hope you find these sessions insightful and engaging. I’m delighted to introduce our next speaker, Mr. Amir London, CEO of Kamada Ltd., a global biopharmaceutical company focused on specialty plasma therapeutics. Mr. London, please.

Amir London, CEO, Kamada Ltd.: Thank you. Thank you very much, and thank you for having me today. I’ll take the next 20 minutes just to walk you through the Kamada stuff. Please feel free to ask questions when I complete the presentation. Apologies for some of the titles. Something changed a little bit, but the content is correct. We have a pharmaceutical company focused on specialty plasma products. It’s a very big kind of niche within the biopharma in general. It helps to make products. A lot of legacy into the plasma industry every year except for the product. Commercial stage for quite some time. Every single gathered the market will sell between $178 million to $182 million. 15% EBITDA over the last few years. Guide the market that I will be going from $40 million to $44 million. Around 22% to 23% of EBITDA on pipeline.

We’ve seen this improve over the last few years as we continue with commercial business. We are positive, cash positive, generating cash, profitable company. This year, we continue to generate cash. We have currently around $66 million. We have very clear strategies that we’ve started implementing a few years ago to basically continue to be vertically integrated. We find what we call the focus of running transactions in access to opportunities. Plasma collection business, which I’m going to talk about. We have a, which is a Phase 3 clinical trial currently. We’re doing equipment in a market which is currently $0.3 billion. We’re growing significantly. We expect the market to be around $2 billion by the time that hopefully we’ll have positive results for the current period of study. These are the six assets. I mentioned specialty plasma products.

I’ll talk in a minute about specialty plasma products and a little bit about the supply chain. In general, the Kedrab site around here, around the first five are what’s called specialty in the medical. The AAT is a protein, which the current standard of care is augmentation treatment for deficiency disease called alpha-1 deficiency. This is a natural taking a very complicated supply chain and simplifying it. We collect plasma and we source plasma and we have to sell a final product. The plasma also needs to come from the U.S. This is part of FDA control and FDA internal requirements. We collect, source plasma, which we sell out to external clients. We mainly focus on what’s called specialty plasma. Specialty plasma have high potency against a specific virus like anti-rabies or anti-hepatitis or anti-CMV. We identify those patients. We either vaccinate them, we screen them.

We’re able to quantify the potency of antibodies through multiple steps of production, cross-fractionation, purification, antiviral activation, and then formulation and fill and finish. Like I said, very sophisticated how to make products. A lot of put into the science of plasma making, plasma product making. There are only eight companies that I’ve been through. I’ll tell you that. I really focus on the specialty side, which means that kind of smaller than that, but kind of how to make those better, kind of, I’d say, price or better economics to run of product. The fact that we want to imagine this plasma space, many cases see the first to do, first to make something. As an example, we were the first company to actually develop anti-COVID antibodies, anti-COVID in the medical through convalescent plasma.

Actually, you know, we’re bringing it to treatment, serving a lot of, first company to bring a plasma product to be developed as a drug nebulized in a Phase 3 clinical trial. The first to actually do a clinical trial in pediatric population for antibodies and get an extension approval based on this. In terms of commercial, as I said, over the last few years, focus primarily in Canada. This is one of the more international teams where we’re working with a network of distributors currently in over 35 different countries where there are Kamada products being distributed. Management is working together for quite some time, highly experienced, very focused on whether the company and enjoy working together. This is how the chart looks over the last few years. From this year, like I mentioned, we’re going to sell $190 million.

If it was the first six months of the year was $89 million, we’re right on track to meet our target. We’re going from $6 million to around $40 million plus this year. As I mentioned earlier, we’ve added from pipeline of 6% to over 20%, 22% shows that we’re growing a very effective, efficient way and we plan to continue growing that way. Compared to the first six months of the year to the previous six months, to the previous year, EBITDA is 11%, gross profit again 11%, annual per share growth of 58%, and we’ve grown our adjusted EBITDA from $16.6 million to $22.5 million. We’re right on track to meeting our annual guidance. As you saw, we are improving, growing in all different financial metrics of the company.

I mentioned four companies, which have a sixth FDA approved product in those over 30 different countries where we continue pushing, being very proactive in taking market share, registering the product, which markets, and growing the business. We have a very nice path forward in terms of continuous organic growth through continuing with the current progress we’re making. M&A transactions, we’re focused on areas where we’re currently active with the plasma products, transplantation-related products. We’re focusing on the U.S. market and we expect, we hope that one of those transactions will actually mature over the next few months so we can have a positive impact already in 2026. We would like to kind of accelerate the growth of our growth with additional acquisition, as I mentioned. Plasma collection centers, I’ll talk about those two items, plasma collection and inhaled ammonia, I have a separate slide for that.

This is how the growth is kind of predicted over the next few years. The revenue is happening. M&A, as I mentioned, we are planning to have a transaction either over the latest year or into next year. We would like it to be a commercial stage asset so it will have direct, immediate positive impact on our EBITDA, accelerate the growth already in 2026. Plasma production centers are already open. We are growing VAMPIC cells expected in those two, three centers between 2026 to 2028 with a positive contribution of around $8 to $10 million per center. We inhabit the IoT, I’ll get to it. Two products that I decided to present today represent you is called Kedrab in the U.S., Kamada-BX U.S. This is a very unique product. Only three companies in the world currently know how to make it at FDA or European standard.

Ask for them and see a sell. We’ve been part of this product in the U.S. since its launch in 2018 with a company called Kedrion. We’ve been taking significant market share, currently around 50% market share in the U.S. and we’ve been able to leverage the U.S. success also in other markets. We won the Canadian tender, Australian tender, and Israel. We’re a big supplier to the WHO in the Latin American activities. This is a highly profitable product. Again, very hard to make products. It’s used when people are exposed to potentially an epidemic. They need to get what’s called post-exposure prophylactic because this is a deadly virus, of course, that if you’re not treated, it’s basically death. Continue to make market share, continuing to kind of develop our presence and global leadership in that space. Very little competition, if at all.

CytoGam, a similar product in terms of the fact that it’s in specialty plasma in the realm. This is used as part of cell transplantation, especially in the high-risk patients. Seeing that it’s a virus, it’s a question of injection post-transplant. There’s a population at high risk, which I call the mismatched population, where the organ itself is seemingly positive, the recipient is seemingly negative. It doesn’t guarantee that there is room to immune suppress treatments or even at a greater risk. Obviously, this is management basically what we’re promoting that as part of the procedure, the patients will get kind of a boost of anti-CMV immunoglobulins. That’s a product that has been kind of neglected before we acquired it in 2022. The previous owners didn’t do much field work, didn’t do any post-marketing research, did not collect any new data.

It’s been kind of old data that was used and there were new product antivirals that were introduced to the market. It cost its market share. We are introducing the product of M&A. We’re collecting a lot of new data. We announced a few months ago that we are running a very large, comprehensive clinical program with 10 different studies done with U.S. KOLs in order to build data and in order to see the number one cause for organ rejection. It’s a big, big, big issue for the transplantation population and community. We hope that it doesn’t really help physicians or patients and also grow this business. It’s primarily focused on the U.S. market. In addition to our own proprietary products, we have what we call the distribution segment. Currently, it’s at Israel and we’re also kind of implementing this model also in the MENA region.

We have an office in Dubai responsible for the MENA region sales. It started with us basically importing into Israel plasma lab product, which we did not make ourselves. We wanted to have a complete portfolio plasma product to IVIG and albumin. This has grown significantly and currently we sell over 25 products representing over 15 different companies. The biggest thing is the fact that we got over the last two years also into the biosimilar space. We signed multiple agreements. We started launching a similar product in the market and we expect with the biosimilar segment will help us to grow this business by between $15 to $20 million a year over the next five years. It’s already starting. We launched the first two products in 2025. Two more products are going to be launched end of 2025, early 2026, and then everywhere between one to three additional products.

The entire portfolio is like 10 different products and we’re continuing to work with potential additional suppliers to bring additional products to the market. As I mentioned, we’re also taking this successful model and kind of copying and implementing it in the MENA region. Companies, international companies that don’t have their own subsidiaries in Israel and the MENA region, they need a partner that will give them kind of turnkey solution for registration, sales, marketing, logistics, pharmacovigilance, everything. As for the transactions, as I said, we’re proactive in looking for opportunities, screening some opportunities, and I’m hopeful that at least one of those transactions will mature over the next few months and have positive impact already in 2026, allowing us to accelerate our growth. Kamada plasma collection centers too that were opened over the last two years to be quarterly in Texas. They’re opening in San Antonio and Houston.

The Houston site just recently got FDA approval. Now we’re seeking European approval. San Antonio approval is expected at the beginning of 2026 and then European approval. As I mentioned, each one of those centers is built to collect around 50,000 liters at peak. Each liter of plasma is sold at around $200, so a little between $8 to $10 million of top line revenue contribution of those centers in total between $16 to $20 million. The specialty plasma, which is only a specialty collection site in Houston and San Antonio, is being used internally by us in order to improve our veteran integration and our cost of goods. Every bit of it we collect versus what we buy, for example, for rabies is just cheaper. It allows us to improve our profitability. We need to be able to show genetic disorder.

That is a lack of self-sufficient production of the alpha-1 protein. It’s a protein which is being produced in the liver. It has multiple functions in our body. Maybe the best known one, but it’s like a protective layer of the lungs. It binds to the neutrophils in the lungs and removes them. Patients with autoimmune deficiency do have this removal. They develop a severe emphysema in the lungs similar to the COPD symptoms, but because of alpha-1 deficiency. The standard of care since the late 1980s, early 1990s is weekly augmentation therapy. Patients basically once diagnosed will get for the rest of their life the weekly infusion. It’s a very inefficient mode of administration because the target organs are the lung, but you need to give very large volumes of the protein systematically in order to bring sufficient levels into the lungs.

The first company to develop a liquid ready to use alpha-1 product got approved in 2010 called Brizia, partnered back then with Baxter and with Baxalta Shire, and now it’s part of the Takeda portfolio. Takeda has been selling it in the U.S. market and Canadian market as of last year, the U.S. market since 2010. We are entitled for royalties that we are getting from them on their sales. Having the liquid also allowed us to develop a nebulized inhaled version partnered with PARI, the German company that makes nebulizers. This is a much more effective mode of administration because actually we go directly into the target organ into the lungs. It allows us to give one-eighth of the dose compared to the IV.

Again, low doses, no dosing done at home by the patient, no need to go to the clinic, no need for us to come to the patient home. The market currently is around $1.3, $1.4 billion, and that’s on the standard of care, which is a weekly infusion, growing between 6% to 8% a year through better diagnostics and not just patient living well on treatment. We’re targeting that market. We are in kind of midway into a Phase 3 clinical study. This has been a very long journey for us to reach this point. It’s a very complicated drug device combination that we had to solve many issues and challenges as the first product ever to be plasma derived product nebulized, reaching that far into a clinical study. We’re going to have an interim analysis by the end of this year, just a matter of a few months.

Hopeful that the results will be successful and we can kind of expedite the recruitment into the study. We had a big success with the FDA after working with them on the different complexities of the study, mainly in terms of recruitment, that they agreed they’re going to evaluate the study based on a P value of 0.1, 10% instead of 5%. This allowed us to reduce the sample size of the study from 220 to 180 patients. As I mentioned, we are close to around 100 patients that have already been recruited into the study. There are major advantages in terms of the study, in terms of the treatment compared to the current standard of care, and we are hopeful that the future analysis will be successful to expedite recruitment into the study.

To summarize, a virtual company focused on specialty plasma therapies, portfolio of six marketable products, profitable, care generating, revenue-driven, with unappealable growth that are actually happening as we speak of gaming growth, M&A transactions, plasma collection capabilities, and the inherent AAT pivotal study, which could be a game changer in a $2 billion market. Thank you. We’re happy to answer any questions.

Operator: Thank you. Please.

Unidentified speaker: Would you mark the Phase 3 study for inhaled AAT? The secondary endpoint is a CT scan. When do you anticipate the duration of observing CT scans will be? If there have been discussions with presumably the FDA about that duration, they all need potential.

Amir London, CEO, Kamada Ltd.: Yes. As I said, there is this secondary endpoint, which is lung density measured by CT scan. Each patient has three CT scans throughout the study. I forgot to mention the study is a two-year treatment. Patients are basically having the start, after one year, at the end of the second year, at study conclusion. For the primary endpoint, it is FEV1. It’s lung functioning measured by FEV1. This is measured, I believe, 11 times throughout the study. In the previous study that we’ve done, we’ve done a Phase 2 kind of a TK study that we’ve shown that we’re bringing sufficient therapeutic levels of AAT into the lungs, into the ULF, and this has been the basis for the current dosing of the study. It’s once daily. We have a very small subset of patients that actually went through CT scanning in that study.

We had the Phase 2, 3 studies that we’ve done in Europe, which was focused primarily on exacerbation. This was our primary endpoint. We did not meet the primary endpoint of that study, but we met a statistical significance on FEV1. This has been the basis for the current study design. After getting the data from those two studies, we actually kind of went back, did a lot of homework, and came back to the FDA and to the MEA and reached the harmonized protocol that basically looks at those endpoints. FEV1 is primary because FDA does not accept CT scan as a primary endpoint. They look at the cell rate at that point. Also collecting a lot of kind of supporting data, six-minute walk. Patients have like a daily diary where they feel how they feel, things like that. Yes, please.

Unidentified speaker: How long did FDA and Kamada switch to the quarterly?

Amir London, CEO, Kamada Ltd.: I didn’t hear it. Add a dividend. Okay. We paid basically in April. It was based on 2024 results. We didn’t declare like an official dividend policy. This was considered like a one-time exception, maybe. Basically, we’ve taken a decide based on our cash availability, based on the profit of the cash. We are focused on doing a transaction and kind of accelerating the growth through licensing growth and M&A opportunities. We had a very strong 2024 year and we felt that it’s a good time also to pay dividend. Maybe we also plan the future. We’ll see.

Unidentified speaker: In terms of the FDA transaction, I believe you mentioned you’re looking at more commercial leading type. Is the scope still more constrained on the plasma derived products? In terms of the collection center, are you expanding that as well? There were some other relevant pieces.

Amir London, CEO, Kamada Ltd.: Good question. When we started, there was an acquisition in 2022. We took around two years to integrate the acquisition. This was the plasma collection center, the 10-meter plasma collection company that we opened additional sites and the acquisition of the four assets that we acquired from sell. Around, let’s say, mid-2024, we started saying we felt that we have no other bandwidth to move forward in terms of cash and focus to go for the next transaction. We started primarily looking at assets in the plasma space, but there are very few, kind of limited space. We broadened the search. We’re looking also into transplantation in general because this is an area that we have our own commercial medical team calling and we basically have a good coverage of those centers in the U.S.

We recently also broadened this a little bit even further because we’re looking at also what I call pharmaceutical, maybe specialty pharma, not just specialty plasma. It’s a little bit broader than that. Plasma collection currently, we’re happy with the three centers that we have. We’re planning to grow those centers to bring them to peak collection, peak sales. Acquisition there on that’s a very strong justification for that. Prices of centers in the past were too expensive compared to opening a center ourselves in terms of investment. We chose to go in the opening path and not in the acquisition path. We also know this could be opportunistic. If we have good centers to acquire, we might consider this. Right now, this is not our main focus.

Operator: I think there’s no more questions. Thank you. Thank you so much.

Amir London, CEO, Kamada Ltd.: Thank you very much.

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