Okay, let's get started. Welcome, everybody. Welcome to our conference in Miami. I have the pleasure of having Dr. Helen Torley, CEO of Halozyme Therapeutics. Helen, welcome. Thanks so much for making time for us. Before we delve into Q&A, I'd love to get your overview of the business and maybe key things to look forward to in the next 12 months or so.
That's great. Well, thanks for the invitation, Michael. Pleased to be here. This really is an incredibly exciting time at Halozyme. When you think about the amazing adoption that we're seeing for argenx's VYVGART Hytrulo prefilled syringe being used by patients at home, on the back of the phenomenal success of DARZALEX subQ, where 96% of patients in the US get the subQ version, this is just an amazing time for us. And it's that adoption of subQ, which really feels as though its time has come, that led us to the recent acquisition of Elektrofi for its Hypercon technology, which promises the opportunity for more patients to be able to receive their biologic therapy at home in a simple autoinjector. And so by adding the Hypercon to our portfolio, we now have three leading technologies that are driving the success of Halozyme.
ENHANZE is the tried and tested large volume rapid subQ delivery, which is now approved for 10 products and is responsible for the strong royalty revenue growth you see. It can be used alone or in combination with our high volume autoinjector, which is another one of our core technologies. For Elektrofi's Hypercon technology, as I mentioned, we expect this to be used at home via autoinjector, small volume autoinjector, because it promises to be able to get drugs down to 2 mL or less, but it also could be used with our high volume autoinjector. And so we have an unsurpassed set of technologies now for meeting the partner target product profiles of how they want to deliver their drugs to be competitive.
In particular, in areas like inflammation and immunology, neurology, nephrology, cardiovascular, and even oncology, there is more and more interest and excitement about treating the patients at home on demand by the patient. That really is our goal. I mentioned with ENHANZE, we have 10 products approved. That is leading to very strong revenues. Our revenues, we upped our guidance recently to $1.3 billion-$1.375 billion. That is driven by about 50% growth in our royalties year over year, which we expect this year to be $850 million-$880 million. Because we have a largely royalty business, our EBITDA is growing almost at 50% to be at least $880 million this year, up to $930 million. An incredible profile, and importantly, coming from being able to deliver on partner goals for subcutaneous delivery.
Come back to Hypercon again. This represents a great opportunity to expand our tab into a space we haven't really been before, which is this small volume delivery at home.
Got it. A lot to unpack there. That's excellent. So just concentrating on the base ENHANZE business just for now, you've raised guidance three times this year, which for the most part was driven by your bread and butter, DARZALEX Faspro, Phesgo, and VYVGART . But as we think about 2026 and beyond, it's those newer products that launch that will really start to meaningfully contribute, like subQ OCREVUS, OPDIVO, TECENTRIQ, and RYBREVANT. So for each of these newer products, maybe perhaps catch us up on the royalty duration of each product and when the rates step down.
Yeah, you called our three blockbusters that are driving revenue today our bread and butter. I like that. I just go beyond it to say that it's going to continue to feed us for many years to come, Mike, because they really are remarkable products. And if I take a step back and say there's really three drivers of our revenue mid to long term. The first are those three blockbusters, so DARZALEX, Phesgo, and VYVGART Hytrulo. Second to that are the ones you just mentioned, the four products that recently launched, so OCREVUS, TECENTRIQ, OPDIVO, and RYBREVANT. And then the third one will be new deals. And an example of that would be the Merus deal that we just signed that will be in the next year delivering royalties as well, we believe. And starting with the blockbusters, it really has been a remarkable story for DARZALEX.
Launched in 2020 with our technology, annualizing out to about $14 billion-$15 billion this year and expected to grow to $18 billion by 2028. Globally, more than 90% of the use is subQ with ENHANZE. So that growth between $14 billion and $18 billion is all Halozyme growth. So there's a lot more still to come. And that's driven by J&J investing in new indications, but also the compounding effect of so much use in the frontline settings. So very attractive there. Phesgo will continue to grow from $3 billion-$3.5 billion. That's very nice. That's all subQ sales for us at a mid-single-digit royalty. And then VYVGART Hytrulo. What a story that really has been, as I know you follow closely. The recent launch of the prefilled syringe is helping fuel growth, annualizing, looking at the last quarter growth to $4 billion at the moment.
Analysts project that to $8 billion just on the current two approved indications. Again, mid-single digit royalty for Halozyme. So you can see why we can't forget about them. Those are the core. They are still growing. Now, on top of that, we will add the next set of products, all of which have just recently launched and are beginning to contribute, as you see in 2026, and will hit their stride in 2027 and 2028. And then new deals like Merus, but we have other deals waiting in the wings as well. And so multiple drivers. And when we think about the durability of those revenues for these products, because of the opportunity to get core formulation patents, all of the products will go to at least 2030 in revenue.
Almost everyone will go to the mid-2030s, and then several will go into the early 2040s in terms of the duration of time we get royalties. And so it's an incredible story. And our goal is to continue to add new products and new royalty streams to keep feeding this phenomenal growth that we see.
Got it. Got it. So just in terms of a macro perspective and consideration, I know CMS plans for Part B IRA price negotiation was a white-hot topic a couple of months ago, but then it seemed to just really die off. Maybe just catch us up on why you think this may not be as big of a worry as people originally thought.
Yeah, I think there was just a bit of confusion out there with regard to a number of factors, Mike, with regard to the IRA. And this relates to when a product is co-formulated with ENHANZE, which is an active ingredient, will the subQ be bundled with the IV for price negotiations? We have, based on the Part D guidance, felt that it was very clear to say that because it's an active ingredient, it would not be bundled. The Part B guidance came out and led to a bit of confusion and CMS asking for feedback on that. But the clarity we got more recently, I'll start with the One Big Beautiful Bill Act. The One Big Beautiful Bill Act made it very clear that if a product has got multiple orphan indications, it will not be included in IRA price negotiations.
And if a product has a first indication that is an orphan and the second that is a non-orphan, it will only be subject to price negotiations at the time of the non-orphan. Translating that into potential for Halozyme impact, it means that DARZALEX will not be in the IRA negotiation. It means that OPDIVO cannot be included until 2029, at which time we can be pretty confident IV biosimilars will be available, and the availability of biosimilars stops products from being included.
So as we looked at our portfolio and we put a position statement, if anyone wishes to read it on our website together with our very comprehensive letter to CMS on the IRA, we see no to minimal impact ever for the IRA on Halozyme in terms of our future revenue stream, either because the products are highly commercial or because they're orphan or because there's going to be biosimilar products available. So I think it was overinflated for a period of time with regard to that. Now, I will say what CMS said in their Part B guidance is they're going to revisit it potentially next year, but they also said they recognize the complexity of what they proposed. They are basically challenged with trying to decide is the active ingredient having any clinical benefit. For ENHANZE, we reduce infusion-related reactions significantly for patients. That's been demonstrated.
We have improved overall survival with one product. We meaningfully improve the treatment experience for patients. That we argued very strongly is clinical benefit. Is CMS going to be able to decide for or against that? And so I will say our advice from Washington, DC, is the statement they put in there to say, should such a policy ever be affected, is very telling. There's a good chance it's not going to because it was very, very hard to execute. Even if it is, though, my most important message today is the way the law has been structured, the way the policy is written, there is minimal impact to Halozyme.
Excellent. Excellent. I want to spend some time on the Elektrofi merger if we can. So around the time of the EvoTech announcement in late 2024, you said at the time that there really weren't any viable targets, drug development targets that had analogous businesses to yours to pursue. Why wasn't Elektrofi in play back then? Was it simply because they weren't ready to sell? And what changed now?
Yeah, we obviously, as a leader in subQ delivery, monitor the entire space, and we've been keeping a very careful eye on progress companies have been making for a period of time. What I can say is that we're now very excited at the stage that Elektrofi is at. And that's because they've been able to de-risk the asset by signing three major deals, one with Lilly, one with argenx, and one with J&J. And importantly, they're at a value inflection point with the expectation to enter the clinic with two products by the end of next year. And these are products that are already commercial blockbuster products. So that's very exciting to see. So really, I think from a Halozyme perspective, the timing was just right. The company has advanced the technology.
We already saw from meetings we had the week before last with the team that there are many areas that we can do knowledge transfer of things that Halozyme navigated over the years that will be able to help speed the pace of development and commercialization of Hypercon. And that, again, is what we look for in an acquisition. Where are we bringing value? And you'll see us continue to do acquisitions where we can see that value. But I think kudos to the Elektrofi team. They had advanced things very nicely. Now we can add our expertise to help accelerate things.
Got it. So on the topic of Hypercon formulated products, how should we think about the IP of these products? I mean, and how does this at least partially solve for the ENHANZE IP overhang in 2029?
Yeah, well, let me start with the ENHANZE. And just to reiterate what I said earlier is we do expect long durable revenues for ENHANZE that are really driven by these core formulation patents that are going to take our royalties out to the mid-2030s for most products and then into the 2040s for many products. But for Hypercon specifically, this is an opportunity for companies to use this technology to be able to take products that perhaps have a concentration of 100 mg per mL and be able to deliver a product at 400 mg per mL to 500 mg per mL. So five times higher concentration, still with amazing syringeability. And that's the ease of ability to inject it. The IP for Hypercon goes to the mid-2040s, which is obviously very exciting as well.
The deal structure turns out to be very similar to ENHANZE in terms of mid-single digit royalties. I think what's also important is every product is already available and it is reformulated to a Hypercon version. There is absolutely the potential to get new IP for that product because it is a different formulation. We'll have different properties and impact on clinical benefit for patients. So we do see the opportunity to be getting additional patents when people reformulate their product with the Hypercon technology.
Now, I got it. And it just kind of harkens back to the CMS discussion we were just having before. So since Hypercon products don't really have any new active ingredient like hyaluronidase does with ENHANZE, would it be correct to assume that these Hypercon products will be tied to the original IV launch too in the eyes of CMS?
So maybe I'll just take a step back. As you know, we spent a lot of time talking to companies and are the leader in subQ delivery. Mike, companies come to us to consider subQ for primarily competitive differentiation or for the enhanced patient benefit. It really is not a CMS play. And so I think what we will see with Hypercon is it's going to be used similarly to ENHANZE. And sometimes it'll be used when a product is already launched because there is a life cycle management opportunity there. Excuse me. Sometimes it will be used right from the start because the company doesn't like the concentration and the product profile they're going to launch with. Sometimes it will be used in between, and it'll sometimes be used with orphan and non-orphan drugs.
We see this just as another great opportunity to deliver on what pharmaceutical companies are really looking for, which is meaningfully clinically differentiated products that make a difference for patients.
I see. So with the royalty term for DARZALEX Faspro, I think ending in 2032, any initial guess as to how many patients would be able to convert to the Hypercon DARZALEX at this point?
You know, we're not in a position to be able to talk about any of the targets that are in the agreement. What I can say is for the two products that are expected to enter the clinic, they are both blockbuster products today, and the phase I starts should come if they're in patient populations with visibility on ClinicalTrials.gov, and we're very excited about these products. I can't wait to be able to talk about them, but I'm going to have to wait till the companies have made them public before we are able to say anything, but I think there will be a super demonstration as to additional clinical benefits and competitive differentiation for the companies in terms of being able to continue to evolve and improve that patient treatment experience.
Got it. Got it. I'd be remiss if I didn't cover that we have at least one question on the Merck litigation regarding subQ Keytruda. Anything new to report on this front?
Yeah, I think first and foremost, just to assure everybody is understanding, we've got two separate patent portfolios. ENHANZE is what we license today to most of the partners we've talked about. But we also have something called an MDASE patent portfolio, which is a modified patent portfolio. What we're in litigation with Merck today is the MDASE patent portfolio. So anything that happens with relation to MDASE is all potential upside. There is no read-through into anything in ENHANZE. There's no risk to ENHANZE royalties or anything. This is all potential upside. So I do find it's always useful to just assure that's crystal clear. As we think about what's going to be next on the patent infringement case, we have initiated litigation against Merck alleging that they are infringing on 15 of our MDASE patents.
These are patents that were generated as early as 2011 when Halozyme was doing almost 7,000 experiments to identify and evaluate lots of different structures of modified hyaluronidases at that period of time. We expect to get the court order soon for what the timing is going to be for the district court case. But I will just say we do expect it to take a number of years for it to play through and come to fruition. We are asking for a permanent injunction. We're asking for triple damages in that litigation. But we would be very willing and open to grant a license to MDASE with Merck anytime during that process or even before we get into that process. We're confident that they are infringing. We're going to pursue this to the end. But we'd be very happy to come to an agreement with Merck at any time.
Got it. And just remind us regarding the PGRs versus the district court. In the worst case scenario, say all the PGRs result in an adverse outcome for you. How does that read through, if anything, to the district court?
Yeah, the district court case has got a series of patents that are absolutely independent from and cannot be challenged through the PGR process. And so just for everybody, the post-grant review process is something within nine months of a new patent being issued, you can challenge that patent being valid. We have continued as a licensing company to get new MDASE patents. So the ones in question through the PGR process are some of the more recently issued ones. We still have a core set of original patents that are in the district court case that cannot be touched through the PGR process. So it really will not have any impact on our district court case in the unlikely event we were not to prevail in the PGR review. We feel very confident we will prevail there as well.
I see. So in the final minute or two we have left, I want to touch upon the Merus deal and future ENHANZE deal. By the way, congratulations. I know this is a long-awaited deal in the making. But just simply, I mean, are non-exclusive deals becoming the norm, Helen?
Yeah. One of the things I think to notice about this particular deal is this is for a bispecific product. And what we have recognized is much more in our interest to do non-exclusive deals for bispecific products as opposed to being unable to work with either target with other potential partners. And so Petosemtamab happens to be an EGFR LGR5. And so what we are now able to do because we did this non-exclusively is we can still work with people in EGFR. We can still work with people on LGR5. And that was the reason why we were such strong proponents of an exclusive deal, a non-exclusive deal, I'm sorry. Historically, large pharma always wants exclusive deals, and we expect that to continue. So we will continue to see a mix of exclusive and non-exclusive deals.
But when it's a bispecific, it's going to be our strong preference that these deals are non-exclusive. It does allow us that flexibility to be able to work more expansively with more partners, which obviously is to our benefit and our favor.
I didn't appreciate the whole bispecific, how the whole bispecific aspect of it dictated the nature of the deal. Okay. So last 20 seconds, if you were to just have a lasting comment, what might the street be underappreciating about Halozyme at this point? What would you say?
Yeah, I think it is a strong growth trajectory that is underpinned by ENHANZE, as I just discussed, with long durable revenues and amazing blockbuster products that are just going to continue to grow for many years to come. Now supplemented by the exciting opportunity for Hypercon technology, which absolutely is going to be another ENHANZE on top of that. I don't think it's quite flowed through in people's mind just how exciting the combination of those two is going to be.
Excellent. That's all we have time for, unfortunately, but Helen, thank you so much for being with us.
Appreciate it. Thank you.