Protalix is traded publicly under the ticker symbol PLX. My name is Ram Selvaraju, and I'm a Managing Director and Senior Healthcare Equity Research Analyst in H.C. Wainwright's equity research division. We cover Protalix with a buy rating and a 12-month price target of $10 per share. Presenting for the company will be Chief Financial Officer and Treasurer Eyal Rubin. Eyal, it's a pleasure to have you with us. Thank you.
Thank you, Ram. And thank you for the long-standing relationship with the H.C. Wainwright. My name is Eyal Rubin. I'm the CFO of the company for the past six years. Protalix is not a new company. It's a 30-year-old company based on a very unique technology of expressing complex human protein through plant cell insufficiency. We're actually the only company in the world that expresses complex human protein through plant cells. All other companies do it through mammalian cells using CHO systems. We have two approved and commercial products. The first one is Elelyso for the treatment of Gaucher disease, licensed and commercialized by Pfizer globally, other than in Brazil, where we sell directly to the Ministry of Health. And the Elfabrio for the treatment of Fabry, commercialized by Chiesi. That's a private Italian company. We're going to speak about the relationship with them shortly.
We have a clinically validated platform, as I mentioned, Protalix, where we part a platform where we express complex recombinant human protein through plant cells. This is the platform that both products were manufactured and produced and developed on. This is also the platform that we are using for our pipeline assets at present. We have expertise in rare genetic disease. I think that for a small biotech, headquartered in Hackensack, New Jersey, but the R&D and manufacturing based in Israel, it's a significant achievement to bring two drugs to the market, which I think shows, improves the knowledge and the expertise in this space. I think that Protalix is in a very unique spot. We're a cash and revenue-generating entity at this point. We have reported $53 million in revenues a full year, fiscal year 2024. We're also generating cash.
Very few biotechs, at least to my best knowledge, are in this spot at present. Promising development in the portfolio. I would say interesting, promising is a strong word, but definitely the PRX-115, I think, is a very interesting asset we're going to touch on. The PRX-119, which is long-acting DNase, one for the treatment of NETs-related diseases, we're going to go into clinics in the second half of this year with an indication that we have landed on just earlier this year. This is how the product and the pipeline look like. First two products up on top. Obviously, we're looking at their research programs. In the rare disease, we have disclosed that we're looking into renal rare disease, ADPKD, Alport, FSGS, these types of programs. Let's start with Elelyso. Not much to speak about.
Unfortunately, despite the great clinical success, this is one of the, I think, great commercial failures. This was licensed to Pfizer. Unfortunately, out of a $1.5 billion market, they're selling $50 million globally. The only market that we're selling directly is in Brazil. As I mentioned, we're selling something around $12 million a year. Prices in Brazil are 1/3 of prices in the U.S. Means that in U.S. terms, we're talking about $39 million, $36 million-$39 million, which is a sign that the drug works. It's not Diet Coke. The problem is probably with commercialization. Again, this is approved in 23 markets. We hope that in the future, we'll be able, in a form of a partnership, to take it back from Pfizer. Once we'll have something relevant on the table, obviously, we're going to share it.
The second drug, which is the value driver at present, is Elfabrio. It's a drug for the treatment of Fabry. Fabry is a lysosomal storage disease. It prevails in one in every 40,000-60,000. In the past, by the way, male or female were perceived to be carriers and not patients. It's an excellent disease. Women are more sophisticated. They have double X. So if one is defected, it compensates. We have an X and Y. If one is defected, obviously, we're in trouble. I'm not going to touch on the symptoms and treatment, but the market last year was $2.2 billion. There are three drugs in the market, two ERTs, excluding ours, and an oral formulation. We'll speak about the competitive landscape in a second.
We believe that Chiesi, our commercial partner, it's a private Italian company, which is one of the challenges that I'm going to speak about in a second. It also relates to the drop in the share price that happened on the back of releasing the first quarter results. We think that they believe, based on the penetration and the number of patients, the number of vials that we know on a monthly basis, that they are poised to capture anywhere between 15%-20% of the market. If you make the calculation on the back of a napkin, by 2030, this market, according to global data, should be $3.1 billion. If you make 20% out of $3.1 billion, it's like $620 million in sales to Chiesi. At these levels, Protalix is entitled to get anywhere between $130 million-$150 million in sales. Margins on biologics are 90%- 92%.
Make the math yourself. It's something around $110 million-$135 million net. Look at multiples in the M&A market in 2024, net sales anywhere between eight to 15, let's say even four. We're talking about a $180 million market cap company. We're traded at $166 million. Every CFO will tell you that on the value, they think that this one, as I was told by many investors last week during the bioequity week, that's a screaming buy. That's what we believe in. We have a very tiered royalties agreement with Chiesi. 15%-35% on sales conducted outside the U.S. and 15%-40% on sales conducted in the U.S. and up to additional $500 million, half a billion in commercial and regulatory milestones.
Looking at the landscape, Fabrazyme by ex-Genzyme, now Sanofi, once every two weeks, approved in 2001 in Europe, 2003 in the U.S., fully approved in 2021. This is the gold standard. Replagal, which is approved outside the U.S., was rejected in the U.S. 3x already. 0.2 mg/ kg, again, IV. And ourselves, that's the three ERTs in the market. And Amicus, Galafold by Amicus, that's an oral formulation based on chaperone technology. According to their publication, this drug can fit up to 1/3 of the overall patient population, given the fact that it's expressed through or using or based on chaperone technology. What we did with this drug, we PEGylated the enzyme in a way with a 2.5 kDa PEG. The PEG creates a covalent bond and wraps the chains.
It basically masks the fact that an enzyme was infused into the body, into the circulation. In return, the body obviously does not attack it. Fewer IRR, TAEs, SAEs, and longer half-life. The half-life of Elfabrio is 78.9 hours compared to up to two hours in both Fabrazyme and Replagal. It means 40-fold. Chiesi is a private Italian company. Their sales were EUR 3.4 billion in 2024. They have over 7,000 employees, 31 markets with direct presence, and 89 markets that they have partnerships in. The problem with Chiesi is that it is a private company. They do not disclose the numbers. They do not mention patients. We hear loud and clear from investors that this lack of transparency creates, I would say, tension, which obviously impacts our share price.
The market is expecting to get clear numbers, clear guidance, which we are unable, obviously, to share given the agreement that we have with Chiesi. Again, just the potential forecast, and we said out loud, we're talking about annual net sales from Chiesi exceeding $100 million by 2030. This is without the once every four weeks. As I mentioned, our competitors are infusing once every two weeks. We initially have submitted to the agencies an alternate dosing regimen once every four weeks. It was not approved on label back then in May 2023. However, we are in discussions with the agencies. As we've disclosed publicly, we are expecting to hear back from the EMA by September or October of this year. If approved, we're entitled to get dozens of millions of dollars in regulatory milestone. Obviously, we believe that that's going to be a joker in terms of penetration.
Obviously, naive patients, mild patients, early diagnosed ones, women, for them to be prescribed once every four weeks, checks and ticks all the boxes, ease of care, cost of care, patient quality of life, this is something that will assist significantly and tremendously Chiesi with their penetration. We believe that if this happens, a 25%-30% market share in each of the continents that that's going to get approved is a viable and a feasible target. The FDA, as a matter of strategy, Chiesi have decided a lot of numerous discussions with the FDA to wait on the EMA decision. Once and hopefully approved by the EMA, we believe they're going to have a stronger case going to the FDA. Not that we expect them to follow. They have their own pride and their own responsibility.
Nevertheless, we believe that this will assist in wrapping the information and sharing it with the FDA. Talking about our development portfolio, PRX-115, which is, again, talking about value drivers, we believe that that's the second one. PRX-115 is a PEGylated uricase for the treatment of gout. We, again, did the same thing, PEGylated the enzyme. It's a bigger PEG, 3.4 kDa PEG. Gout is not a rare disease. There are over 15 million patients in the U.S., of which 5% considered to be chronic, refractory, severe, uncontrolled, no matter how you call it. Forget about the 750,000 patients, which is 5% of 15 million, but physicians are talking about 80,000 patients. According to Amgen, Krystexxa is treating approximately 6,700 patients now these days. The potential, the market potential is enormous.
I'm not going to go into the method of action, but looking at the market, the market is $5.6 billion with a 6.4% CAGR. Krystexxa sales last year were $1.2 billion. What we did, again, we PEGylated. You can see the PEG that wraps basically the enzyme. Again, it's a plant cell-based recombinant Candida uricase that we're using. I'm going to jump because we are basing our pitch on the phase I results. The phase I was a single ascending dose, eight cohorts, 64 patients, eight patients in each cohort. That basically, if we scroll to the results, I hope that I have it here in the appendix. Looking at the slide, you can see that in the second, this one, in cohorts six, seven, and eight, I remind all of us, Krystexxa is infused once every two weeks with methotrexate.
That's like, it's not a combo therapy, but it's required. Looking here without methotrexate, cohorts six, seven, and eight, after 67 days, post a single dose, the uric acid in the plasma was still present. Furthermore, if you look at the next slide, in cohorts seven and eight, which are the highest dosing, obviously, after close to 90 days, the patient did not reach the 6 mg per deciliter bar, which is the bar that basically differentiates between a normal, healthy person and a gout patient. Obviously, the further up you go, the severe the disease is. It means that in theory, instead of infusing once every two weeks, we can drag it and try to infuse up to once in three months.
Obviously, the phase I protocol is not disclosed yet, but it's going to be a multi-arm, multi-center, highly prior to efficacy, which was agreed with the agency that if, again, and the disclaimer here that if the results are going to be significant, this can be considered as a pivotal trial. Means to say we're going to be able to submit based on this trial and then go for a confirmatory study as a phase III. Going back to the strategy without focusing too much, we've announced that we're looking at the rare disease, in particular, renal rare disease, ADPKD, Alport, FSGS. We want to also enhance our platform, try to express a work with exosomes, cargo loaders, and try to really enhance our capabilities in terms of the platform. We're not going to go crazy. We know what our capability is.
Looking at the last quarter, we're talking about $10 million. I'm going to speak about the share price in a second. $53 million in the fiscal year 2024. Cash as of the end of last quarter was $34.7 million. By the way, by the end of 2024, December 31st, we had $34.8 million. We're approaching a cash flow positive sufficient to support the ongoing operations. Means to say that including the phase II that we're running, we have sufficient cash without tapping the market. It all depends on our appetite to invest more in early stage clinical assets or to pursue faster. The PRX-115, that will dictate, obviously, our cash needs. A development portfolio that we think is interesting, promising, something that might create a lot of value to our shareholders. The company is a clean company in terms of the balance sheet. No debt, no warrants.
We've cleaned everything in March of this year and September of last year. In essence, this company is a fresh restart. We have straight common equity and ease up. That's it. That's all we have. Speaking about the elephant in the room for a second, on the back of releasing the first quarter results, the share crashed. I think that, again, I'm not trying to educate the market. The market is the market at the end of the day. We think that it was an unproportional reaction. The fact that we had zero sales to Chiesi doesn't mean that Chiesi don't do a good job. As I mentioned, we know their numbers in terms of vial sales, patients. They built up inventory ahead of the launch. They bought tens of thousands of vials. They bought last year significantly.
Part of the $53 million was $29 million sales to Chiesi. Can assume that they were not talking about a vial or two. Obviously, since we're talking about a year from launch in Europe, being honest, and a year and a change from the launch in the United States, it's going to be still choppy like any other rare disease launch. We don't expect every quarter they're going to have sales, but gradually, slowly, but surely, we will. Once this whole thing is going to clean up, we're going to see a growing revenue from Chiesi. With regards to Elelyso, it's a very stable revenue, both to Pfizer and to Brazil. We don't expect that this thing is going to change unless we're going to buy the rights. Not we, but a partner is going to buy the rights from Pfizer back and is going to turn this market.
I think that this is a story in a nutshell. We believe that the company is solid, progressing with value drivers, significant ones, the Elfabrio and PRX-115. Close to cash positive last year we were. This year, hopefully, we will. Again, the company is generating cash and revenue and accumulating and growing. If we look into the future, we believe that by 2030, this business is going to be somewhere around $120 million-$160 million, $170 million in sales. Total sales, I mean, including Elelyso, including Elfabrio. Obviously, we believe that if, and we heard it from many VCs that we've met, we're going to be able to mimic the phase I results in our PRX-115 phase II. This is an ace. We're talking about a billion-dollar company.
I'm not afraid to mention this figure because we heard it from a couple of VCs that for a $5.6 billion market with one approved drug at present, offering, if approved again and if successful, a better regimen, this is something that's worth a lot of money. Thank you for your listening and thank you for your attendance here today.
Maybe I could ask one quick question. Just to kind of contextualize the opportunity with PRX-115, is it reasonable to liken the competitive advantage and the paradigm shift with PRX-115 in the context of treatment refractory gout to the paradigm shift that was achieved with the introduction of Elfabrio?
I think personally it's going to be even stronger. Elfabrio was non-inferior to Fabrazyme. If approved, obviously, the once every four weeks, that's going to be a joker.
The PRX out of the gate, what we are aiming for is going to be at least once a month with no methotrexate or double or triple with methotrexate. That means that in essence, we are going to lower from once 24x- 26 x a year to 6x to 4x a year treatment, which is a completely different story. I think the PRX-115 is even stronger than the achievement by introducing such a drug to the market. Yes. It all depends on the top line and the sales, obviously. Sales are, as I mentioned, a matter of shipments. It is enough that the courier did not pick up the shipment for Pfizer and revenues glitch from December 31st, 2025 to January 2nd, like happened this year, actually. Not with Pfizer, but with Brazil. Hopefully we are going to be profitable.
Even if not, it's not that we're going to be in a tremendous loss. Last year, we were profitable, by the way, and we generated cash if you look at the fiscal year 2024 reports. That's going to be the trend. If it's going to be borderline, again, still, it's not the end of the world. All expenses and talk about third parties, meaning the CRO, the sites, pass-through costs, we're talking about $24 million over two and a half years. It's not big numbers. We're not talking about a $50 million trial. It's not a $90 million or $100 million that we had with the Elfabrio phase III. It's not the case.
One from direct purchase of Elfabrio to Chiesi and another from royalties from Chiesi's commercial sales.
When Chiesi orders $30 million worth of product, would Protalix also receive a 15% royalty once the product is sold to end customers?
Yes, so let me clarify because that's not how it works. When we are selling, we're selling directly to Chiesi. Every vial that we sell, we get the applicable royalties rate in the continent multiplied by the list price in this continent. This is the only revenue for product selling. There's no royalties on top of it. There's a different line of R&D services. Means all the support that we give Chiesi for registration in the various countries. And in case we're going to get regulatory milestones, this is going to be booked under R&D and license revenues. Commercial royalties, by the way, are going to be part of the product revenues. Means it appears on the first line in our P&L. September, October.
Yeah, so speaking of a potential approval, I think it's a long shot. Let's start with submitting, as you asked. As I mentioned, the strategy was to wait on the EMA decision and then go to the FDA. After, by the way, multiple discussions that Chiesi and us held with the FDA, and we know where their minds are. Once approved, God's willing if approved, but once approved, it's going to be easier, I guess, that in a matter of months later, we're going to really start pushing and hammering on the FDA channel to start and pursue and advance it in the U.S. as well. More questions? Thank you very much. It was my pleasure.