Halozyme Therapeutics, Inc. (HALO) Earnings Call Transcript & Summary

June 9, 2025

NASDAQ US Health Care Biotechnology conference_presentation 35 min

Earnings Call Speaker Segments

Corinne Jenkins

analyst
#1

Good morning, everyone, and thanks for joining us here at the Goldman Sachs Health Care Conference. We're thrilled to be joined today with the team from Halozyme. And maybe we could just start with an overview of the company, in particular, about if you could focus on some of the key value drivers, recognizing there's a lot going on.

Helen Torley

executive
#2

Yes. So thanks for the opportunity to be here talking about Halozyme, which is a -- we are a leader in rapid large volume subcutaneous drug delivery. We have 2 platforms to do that, our ENHANZE hyaluronidase enzyme, where we're the pioneer in discovering and commercializing it, and our auto-injector business. I think to bring color on what we do, if you'll indulge me, I'd like to tell a story of a patient we met recently who talked about his treatment journey from first being diagnosed with multiple myeloma. He is in Southern California, and he was sent to one of the cancer hospitals up in Los Angeles. He described his day as starting before sunrise. He had to get up to the hospital by 7:30 in the morning, see the doctor, wait for his blood test. They had to order the IV DARZALEX subcutaneous -- sorry, the IV DARZALEX and then get it up from the pharmacy. And so by the time all of that was done, he was getting his treatment anytime from 11:30 until 12. For him, it was a 3-hour infusion. Then there was an observation period of at least an hour. And so by the time he was back in the car, he was hitting the lovely Los Angeles traffic to get home. And he described his experience as an absolutely exhausting sunrise to sunset trip every 2 weeks, which he was very grateful to be on the drug, but he found it draining. When DARZALEX subcutaneous with our ENHANZE technology became available, he was able to go to a local hospital. It took a lot less time to get it up from the pharmacy, and he was in -- from his home to the hospital and treated him back because DARZALEX subcu is just a 3-minute injection subcutaneously, it was just 90 minutes. Absolutely different, he said, in how he responded his recovery and the clinical benefits he was experiencing from the treatment. And that's our passion. That's what we do. In addition to DARZALEX, we have 2 other products that are driving our strong revenue growth today in our royalties, which are also PHESGO for breast cancer and VYVGART HYTRULO for a range of neurological indications. Behind that, we have 4 products that have just launched, all of them blockbuster products as well, that includes OCREVUS subcutaneous, TECENTRIQ subcutaneous, OPDIVO subcutaneous and amivantamab subcutaneous. And as I'm sure we'll talk about, each of those has got new indications, new regional approvals, new reimbursement happening that are all going to be very important catalyst for continued strong growth. And then our small volume auto-injector business is complementary and on top of that, where we've got 2 products with a partner as well as our own proprietary product line. So a terrific and growing subcutaneous drug delivery business.

Corinne Jenkins

analyst
#3

Beautiful. Maybe I'll start with some of the recent CMS draft guidance that came out for the IRA negotiations around Part B drugs. We were kind of waiting for those. And they were distinct from the Part D guidance in that there was some language around the fixed dose combination of products and what would be eligible for negotiation versus what isn't. How are you interpreting -- maybe you can provide us sort of the like quick what was said in that guidance, how it differed and how you're interpreting sort of this updated language.

Helen Torley

executive
#4

Yes. So what the CMS guidance is focused on is fixed combination drugs with 2 active ingredients. And our hyaluronidase ENHANZE enzyme is noted by the FDA and all of the labels to be an active ingredient. So that isn't changed. What the CMS is very focused on is understanding a clinical difference that the active ingredient is driving a clinical difference and a clinically meaningful difference at that. And so that's where we're very focused in our interpretation of this and responding as CMS has asked for as to what constitutes a clinically meaningful difference. The FDA defines that as how a patient feels, functions and survives. And I think that's a great definition for a clinically meaningful difference. And so we have the benefit of our partners having done head-to-head clinical studies. So you really can see the difference in the clinical profile. I'll give you a few examples. In multiple studies now, we've seen that the subcu compared to the IV has lower infusion-related reactions. A patient who has an infusion-related reaction feels unwell. They have low blood pressure, they're sweating, they even can have rigors. It can lead to anaphylaxis and death. And so where you are being able to see a difference between a 66% infusion-related reaction rate with the IV reduced to 13%, that's clinically meaningful. Even down to other adverse events with the subcu, serious adverse events and multiple programs are reduced by 50%, which are serious adverse events are hospitalization and death, again, incredibly meaningful in terms of the patients. Often, people ask about efficacy. Most of our studies are done to show noninferiority. But remarkably, amivantamab was able to show in an exploratory analysis an overall survival benefit. So now we've got some -- if you think about all of this, all of these impact how a patient feels, functions and survives. And this is where we are going with the thrust of our argument and why we're so confident that ENHANZE will be seen to deliver that clinically meaningful difference as an active ingredient. And that's exactly what CMS is wanting to understand with regard to assuring that we're meeting their guidance.

Corinne Jenkins

analyst
#5

Okay. And I think the CMS guidance says something about biologically active against the disease state, and it sounds like what you're looking to gain clarity on is their definition of that aligns with the FDA's current definition. Is that the right way to understand it?

Helen Torley

executive
#6

Yes. I mean, they kind of ultimately are saying, and thus derives clinically meaningful benefit. That really is what they're looking for is how we are -- how we read that. And many of our partners have a very similar understanding and are going down a very similar path, just to make sure it's well understood, all of the clinical impact of ENHANZE. I'll take you back to that patient. That patient's life was transformed by having the subcu versus the IV.

Corinne Jenkins

analyst
#7

Sure. So you talked about how ENHANZE kind of shows all the stuff. And would you expect that the clinical benefits once you get clarity here would need to be on label? And can you talk about what's already on label for these programs?

Helen Torley

executive
#8

The great news is because the head-to-head studies are done to get approval, all of these factors I'm talking about are found in the labels of our products. Sometimes you need to go to the Phase III publications for even more granular data, but all of it is very easily accessible.

Corinne Jenkins

analyst
#9

Okay. In terms of time line for additional clarity, sort of what are the key dates that we should know about for the year?

Helen Torley

executive
#10

Yes. CMS has requested comments on their Part B guidance by June '26. And so we'll be ready to be putting in our comments with regard to that. What has happened in the past, and there is no clear guidance as to what's going to happen next, but just trying to translate what's happened in the past. Within 2 to 3 months, generally CMS has moved forward to finalize the guidance and often takes some of the comments from the comment letters that have come in and imports them into the final guidance to say, we heard this. We are making a change. We heard this. We are bringing this clarity. That's what we would expect to happen this time. And then the 15 drugs that are the highest sellers in B and D that are eligible based on the timing of how long they've been in the market are expected to be launched in January -- sorry, announced in January of that 2026.

Corinne Jenkins

analyst
#11

Okay. So in terms of kind of like a best case scenario, what exactly would look like clarity here in terms of the updated language?

Helen Torley

executive
#12

Yes. We hope that we get our comments picked up, to be clear, that it's a clinically meaningful benefit and clinical -- and what clinical meaningful benefit would mean. I think a great outcome would be even just that the language is identical to what was in the Part D guidance because the Part D guidance very clearly covers fixed combination of 2 active ingredients for this clinical benefit. That is who we are.

Corinne Jenkins

analyst
#13

Okay. And then in terms of the like clarity, I assume -- or maybe you can just tell me, do you expect the same to be applied across the entire portfolio? If one formulation is protected, then all are protected? Or do you expect this to be kind of a case by case?

Helen Torley

executive
#14

We think it will be for everything because it's a policy decision, and it would be very hard to -- for CMS to make clinical judgment. I think going with where the FDA has gone is just an easier thing for them to execute.

Corinne Jenkins

analyst
#15

And when is the first drug that would include a hyaluronidase co-formulation potentially up for negotiation?

Helen Torley

executive
#16

It will be done, as I mentioned, on the next 15 drugs in terms of sales, and this is the first time Part B drugs are eligible. We don't have visibility into Medicare versus commercial sales. And so it's a little hard to know exactly what it is going to be. So we're anxiously awaiting to see because, really, if you have a drug that is skewing towards a younger population, even although its overall sales might be large, it may not make it into the list.

Corinne Jenkins

analyst
#17

Sure. In terms of just your ongoing conversations with potential partners, this uncertainty, how is it factoring into those conversations?

Helen Torley

executive
#18

Yes. I will say that partners want to use ENHANZE for the clinical benefits I've talked about, and that clinical benefit is translating for them into competitive differentiation and commercial success. And so the IRA has not been since it started this conversation 2 years ago, a big focus of our discussions. So it really is people are really tuned in on the clinical benefit, not on any potential extension. So no impact on our discussions.

Corinne Jenkins

analyst
#19

Okay. I think that's a nice segue to kind of the ongoing portfolio and product launches that are underway. You have several utilizing ENHANZE co-formulation. Maybe you can run through some of those key products in your royalty business today with the focus on what you think are the biggest growth levers.

Helen Torley

executive
#20

Yes. So we obviously have a very robust and growing royalty revenue business this year. We're projecting growth of 31% to 37% revenues in our royalties alone of $750 million to $785 million. That robust growth continues to be driven really by 3 key products: DARZALEX that we've talked about, FASPRO is its name in the U.S., subcu outside the U.S. as well as PHESGO and VYVGART HYTRULO. All of this success is really important to have seen the dramatic uptake that's happening with these products, which just gives us great confidence in the continued commercial adoption of the newly launched products as well. If I dive into DARZALEX, that is a $12 billion brand now. 95% of it is with the subcu version. The subcu version takes patients from a 3- to 4-hour infusion to a 3- to 5-minute injection under the skin subcutaneously, dramatic as we've talked about. It is a product that because J&J has done a super job of continuing to invest in new indications, particularly in front line, is projected to continue to grow. It's projected to grow to about $17.5 billion by 2028 from the $12 billion it is today, and that is virtually all subcutaneous. And so that is why, even although we've converted the market because we're getting frontline patients and there's a lot more of them and those patients live longer, stay on therapy longer, that's going to keep growing royalty revenues coming in from DARZALEX for years to come. Second product is PHESGO. That is Roche's product for breast cancer. That achieved over $700 million in the first quarter, growing at 50% year-over-year. That has been kind of a more slow story than DARZALEX, but it's now approaching 50% share of sales and it's obviously on a robust growth trajectory, in part driven by getting reimbursement in China where the adoption has been very strong. And that's only subcu sales, there's no IV of PHESGO. So that's already with that projection I gave you, a multibillion-dollar brand projected to grow as it converts more and more of PERJETA. And then the third product that's driving our revenue today is VYVGART HYTRULO approved in 2 neurological indications today and is really seeing very dramatic uptake in both of those. And that's expected to be fueled even more by the launch of the prefilled syringe, which happened just a few months ago. So when you think about our royalties and that strong growth, those are the 3 things that are really resulting in us having updated our guidance this year. Right behind that, we have 4 products have launched within the last year that are also working today to get all of the reimbursement and coverage in place and where we expect growth to be contributing and growing in 2026 and beyond. Those are OPDIVO subcutaneous, TECENTRIQ subcutaneous, OCREVUS subcutaneous and amivantamab subcutaneous, each of them large derisked assets where we've got approvals in all major regions or at least one major region and poised for a very strong growth once all the reimbursement is in place.

Corinne Jenkins

analyst
#21

You mentioned VYVGART HYTRULO. Obviously, that's been quite a success. How should we think about the growth there, whether it's been driven by conversion within existing markets or approvals in indications where only the subcu was approved. And what do you anticipate seeing with the prefilled syringe availability in terms of an inflection or kind of continued growth?

Helen Torley

executive
#22

Yes. So VYVGART HYTRULO is approved as a subcu now in generalized myasthenia gravis and also in chronic inflammatory demyelinating polyneuropathy, so both neurological indications. You asked where we're seeing the conversion. We absolutely are seeing conversion of IV to subcu patients who have been started on myasthenia -- for myasthenia gravis. Importantly, for CIDP, that is a subcutaneous-only indication. And so we are also seeing both in gMG and CIDP subcu [indiscernible] who are just experiencing that much shorter, more convenient treatment. And with the availability of the prefilled syringe that just got approved in April, patients are now able to receive this therapy as a 20-minute subcutaneous injection, which they can do themselves or a caregiver can do at home or they can still go to the doctor's office for it. All of those are boding well for continued strong uptake. What argenx has talked about in generalized myasthenia gravis is continuing to have the subcu expand the number of prescribers because not every doctor wants to use IV-delivered therapy and to get patients who are earlier in the disease therapy. And in CIDP, this is the first new indication, if you like or a new treatment therapy launch in many, many years and the alternate from IVIg. Again, the convenience of therapy versus having to have an IVIg is pretty dramatic. And so we're seeing very nice uptake in that indication, too.

Corinne Jenkins

analyst
#23

Okay. As you think about the OPDIVO, TECENTRIQ markets and also the RYBREVANT and OCREVUS ZUNOVO, I guess, can you talk about what are the right analogs as we think about conversion, pace of conversion, maybe marrying that back to your existing product launches?

Helen Torley

executive
#24

Yes. Maybe I'll start and break it down into the different types of indications. So if we start with OCREVUS, OCREVUS is obviously a great drug given as an IV. It's a leading drug for myasthenia gravis in U.S. and Europe and has just got the best long-term data. Now for patients who receive it, though, it is a multi-hour infusion for treatment, and then there's an observation period. With the subcu, it is a 10-minute treatment period and a very short observation period afterwards. And so we're very excited that Roche is bringing forward this offering for patients. What Roche expects and has already begun to see is that the availability of the subcu is going to expand the market. So OCREVUS is already an $8 billion drug as an IV. But with the subcu, doctors who don't have access to infusion suites or patients who live too far away from infusion suites to be able to go for treatment are now able to get treatment with the subcu. And so the early launches is showing that about 50% of the patients are de novo to OCREVUS, really supporting Roche's point that this is going to expand the market. There are absolutely conversions. I talked about that value proposition for patients with a much shorter infusion time, the ability to have it closer to home. All of that is going to bode very well for, I think, a strong uptake. And this is the third product, as I just talked about, being introduced to neurologists. I think that familiarity in terms of subcu delivery with ENHANZE is going to be very positive there as well. Moving to oncology. We've got OPDIVO and TECENTRIQ, each of those products offering patients a much shorter treatment time. The companies are commenting, particularly Bristol, on the fact that early launch is going well. They're seeing strong and growing adoption across academic and community setting. And they're very excited that they're going to have their J-code on July 1. For those of you who are familiar with that, that's important in the U.S. for getting Medicare coverage and reimbursement. And so that's going to, I think, give a very nice boost there. And the final one I'll talk about is amivantamab. Amivantamab is a different profile, and we're very excited by its profile. It is a product that is Johnson & Johnson's for a specific type of non-small cell lung cancer. As an IV, very long infusion, 5, 6 hours. But also associated with that, very high rate of infusion reactions, 66%. That, I think it's fair to say, with limiting uptake of the drug. With the subcu version, the infusion-related reaction rates was reduced to fivefold as was the times of [indiscernible] and only a 13% incidence of infusion-related reactions, coupled with the fact that in an exploratory analysis, the efficacy was statistically significantly better than for the subcu. And so what a value proposition. And at ASCO, I just heard John Reed, the Head of the R&D Innovation, commenting on the fact that subcu is the reason why J&J is so confident this is going to be a $5 billion brand. That's all going to be subcu. So that's just a terrific example and new growth to come.

Corinne Jenkins

analyst
#25

Yes. In terms of the partnership conversations that you're having, I think in the past, we've talked about maybe like one a year being at the right run rate. Is that still kind of the right way to think about new partnerships coming onboard, particularly as we get closer to that ENHANZE LOE in 2027?

Helen Torley

executive
#26

Yes, we absolutely expect to sign an ENHANZE deal this year and for that to be the cadence moving forward. That's historically been what we've been able to see. And this is supported by a couple of things. I think we talked earlier this year about the fact that we signed a small volume auto-injector development agreement. We signed a high-volume autoinjector development agreement. And this is what's giving us confidence that we're going to sign an ENHANZE agreement because we're continuing with multiple conversations. There are several steps within the companies we're talking to for technical review and then for actual approval. We love the demonstration that with the small and high-volume development agreements, you get through them, you just have to patiently work through the process. And so I'm pleased with the progress we're making in several conversations, which gives us the conviction on ENHANZE deal this year, but more to come after that.

Corinne Jenkins

analyst
#27

Okay. You mentioned the small and high-volume auto-injector development agreements earlier this year. Can you talk to us about what that means? What is the development agreement versus the commercial agreement? And how do they translate one to the next?

Helen Torley

executive
#28

Yes. I'll just say we're seeing strong interest in our small volume auto-injector. It really does have a differentiated profile, meeting the highest possible standard on reliability. And so for companies who are looking for that reliability and who may have a product that is more viscous or they want a special customization of the device, that's where we're seeing interest with regard to that. The high-volume auto-injector, unique offering in the market. We are the only company that offers the ability to deliver 10 mls of a biologic in just 30 seconds. And so for each of these cases, the development agreement is with a current partner, a different partner in each case, and it outlines all of the steps and responsibilities to get a product -- an auto-injector ready for clinical development testing. Once you've got that clinical development testing underway is when we'll talk the commercial terms. And in each case, we expect these to be really related to product sales for the device. But for the case of the HVAI, it absolutely has to be used with ENHANZE because you cannot inject that volume without causing damage that fast. And so the HVAI will be associated with royalties. It's market expansion opportunity for us bringing in new royalty revenue streams with product sales of the device.

Corinne Jenkins

analyst
#29

Okay. So these are products that are already partnered with ENHANZE, and then this will be an additional kind of royalty you get?

Helen Torley

executive
#30

Or they could be products that are not yet nominated and coming forward. So they are hopeful, the opportunities to expand our ENHANZE number of royalty streams.

Corinne Jenkins

analyst
#31

Okay. Now that you've got a couple of these in place, what should we think about in terms of cadence of new development agreements around the auto-injector piece of the business?

Helen Torley

executive
#32

Same process as is going on with ENHANZE. We're in conversations with companies and we're just working through the process. And we're already hard at work with each of these companies on meeting and kicking off the development of the auto-injectors.

Corinne Jenkins

analyst
#33

Great. Maybe I'll turn to you, Mark, for a second to talk about the Merck litigation that's ongoing around the MDASE suite of patents. You introduced that MDASE suite last year. Maybe a few follow-up questions there. How do these patents fit relative to the ENHANZE specific patents? And can you just clarify whether ENHANZE has kind of caught up in the MDASE piece?

Mark Snyder

executive
#34

Absolutely. So to be very clear, ENHANZE is not part of MDASE. MDASE patents and the ENHANZE patents are entirely separate entities, if you will, portfolios of IP rights. And our MDASE portfolio really represents an upside to Halozyme. It's an upside because the modified human hyaluronidases that are encompassed by our IP rights are things that either companies maybe cannot work with us on or would like -- or cannot work with us on or do not want to work with us on our ENHANZE portfolio, it gives them the opportunity now to get access to these intellectual property rights. And remember, we are the pioneer in this space. Whether it's the ENHANZE technology or these modified human hyaluronidase, we are the pioneer in developing those for subcutaneous administration of IV. We -- because of that pioneer position, a very broad scope of rights and extensive portfolio that cover MDASE.

Corinne Jenkins

analyst
#35

Okay. One of the things that's part of that MDASE, you've said, is that the KEYTRUDA subcutaneous patent that is currently under review infringes on the MDASE patents. So can you enumerate some of the specifics of those patents that are being potentially infringed upon and walk us through the time line around litigation?

Mark Snyder

executive
#36

Yes. I think that really, the very most important thing to understand is that with the first file PGR instituted for trial, that trial will take place on March 2, 2026 with the decision to follow by June 2, 2026. That's really where the action is. That's where we're going to have an opportunity to present a trial on a full record and deal with the merits. We feel very confident that we'll prevail on the merits in that trial. So that's really where the action is. Recommend you getting out and getting a ticket quick for a front row seat and not to miss that.

Corinne Jenkins

analyst
#37

Okay. You mentioned the PGR that's ongoing, the post grant review process. I think it's for one of the patents that was implicated. But there's multiple patents that are kind of in dispute and under PGR potentially. Could you talk about how many there are, what the overlap is? Just help us kind of -- for people who are not experts on patents, think about what specifics we need to be following along with.

Mark Snyder

executive
#38

We -- just really to tell you, we think that the issues of importance are going to be in this first trial. That's really where the action is going to be. That's really the thing to be paying attention to. There's other things that are going on. But really for people to focus on, that's the next big event that we would like people to be paying attention to. That's where we think that we'll be dealing with the merits, as I said on this full record. And it will prevail.

Corinne Jenkins

analyst
#39

Okay. I think there is kind of like a litigation piece that goes on in parallel in some ways to this, but that it could be kind of paused while the PGR was determined. Is that your expectation, that the litigation piece will kind of pause and wait to see the outcome of the PGR?

Mark Snyder

executive
#40

So I'm not going to presuppose what Merck may or may not do, but there is litigation pending. We filed litigation back at the end of April 2024 for 15 different patents that are in our MDASE U.S. portfolio. So that litigation is filed in the New Jersey District Court, and we'll see what happens with that case. But it doesn't encompass all the same patents that are in this other process that's happening at the patents.

Corinne Jenkins

analyst
#41

Okay. And what are the time lines for that, the litigation process, assuming it goes on as currently planned?

Mark Snyder

executive
#42

Litigation right now in the District Court takes about a couple of years to get to trial. And to remind you, what we're seeking there really is damages for their past infringements, and we would be seeking enhanced damages for their willful infringement and on top of that, an injunction, which is essentially asking the District Court to stop the infringement going forward when we prevail on the infringement side of things.

Corinne Jenkins

analyst
#43

Okay. Can you walk us through the range of potential outcomes that could come from this PGR process March into June next year? What are some of the key things that could come out of that?

Mark Snyder

executive
#44

The PGR process is different. And I know it's hard for people sometimes to sort of conflate the 2 with the infringement. But the PGR process really only deals with the claims of invalidity. And as I said, there will be a trial. That trial will be on the full record. There will be evidence developed and then we'll get a decision by June 2, 2026.

Corinne Jenkins

analyst
#45

Okay. Yes, I wish I was a better patent person, but we need people like you on stage to help walk us through it. Okay. And then how does that inform any -- if it does, the litigation, are there decisions in the PGR that would be kind of more beneficial for your case or less beneficial for your case? What are -- how do those things flow together?

Mark Snyder

executive
#46

So we knew the invalidity claims are things that you have to deal within -- in litigation involving patents. And so we're pleased to be able to deal with them at trial on this full record. And so those are the issues that will be addressed. And as I said, we should have a decision by June 2, 2026.

Corinne Jenkins

analyst
#47

Obviously, the KEYTRUDA subcutaneous is the most high profile of the potential products that would be encapsulated within this MDASE suite of patents. Are there any other products? And would they kind of all flow the same way if they're using the Alteogen technology?

Mark Snyder

executive
#48

No. These are just relating to what's been accused, which is the KEYTRUDA subcutaneous format. But there aren't any other products right now.

Corinne Jenkins

analyst
#49

Okay. And I think this kind of -- you mentioned this, that ENHANZE is separate. But in the case the outcome is not what you wish on the MDASE patents, any implications to ENHANZE?

Mark Snyder

executive
#50

No, there are no implications at all. And as I said, yes, they are entirely separate. And so MDASE will be determined on its own merits.

Corinne Jenkins

analyst
#51

Okay. Is there anywhere else that you would like to seek like licenses for the MDASE? Are you fielding any sort of inbounds? Or is this kind of, I guess, specific case here?

Helen Torley

executive
#52

Yes, we are, first and foremost, focused on ENHANZE. ENHANZE is the established tried and true market leader and gold standard in rapid large volume, and everybody talks about ENHANZE because of the experience, the track record and the commercial success it's seen. As Mark pointed out, MDASE, we will license for people who cannot work with ENHANZE. So perhaps they want to work in the target that's already taken or choose not to work on it. So it is not something we're actively promoting. We are not bringing any resources to make the API. We're not partnering with the partners in the same way as we do with ENHANZE. But if somebody is choosing to practice our invention by using a modified hyaluronidase for subcu delivery, we will ask them to take a license because we think that's only fair as this was our pioneering work that actually led to the discovery and use of hyaluronidases, including the modified hyaluronidases.

Corinne Jenkins

analyst
#53

Okay. And remind me what the patent terms are on the MDASE patents that are at issue?

Mark Snyder

executive
#54

So the MDASE portfolio in the United States has expiries out to 2034 and outside the United States to 2032.

Corinne Jenkins

analyst
#55

Okay. Great. Maybe we can spend a couple of minutes on capital allocation and business development. Maybe just to start, remind us all kind of like your pillars of capital allocation.

Helen Torley

executive
#56

Yes. We're in the fortunate position because of our high gross margin ENHANZE business to be able to execute in parallel our 3 pillars. The first one is very important. That is to continue to invest in maximizing our ENHANZE asset. We are doing that through continuing to invest in new uses for it as well as developing a new API. And we're also investing in the high-volume auto-injector. That's another great example of investing to build our drug delivery business and continue the life cycle of the great assets that we have today. We also are committed to share repurchases as a great way of returning value to our shareholders. We've completed $1.55 billion in share repurchases since 2019 and we actually have a $250 million share repurchase under way at this time. And we will continue to evaluate the right opportunities to do that. We've demonstrated the ability to have bought at great prices and seen great value occur after that, which is exactly the dynamic you want to see when you're doing these share repurchases. And then the third area is an important one as well. That is looking for potential new drug delivery platforms that we can add to and expand the number of platforms we have. We're always looking for innovative platforms that are -- have got strong IP that are something that we identify would be broadly licensable to the pharma and biotech industry. And so we're very active looking for those drug delivery opportunities. And don't think about it just being subcutaneous drug delivery. We've identified more than 30 types of drug delivery that potentially could be of interest to us. So lots of action there. Now if we don't find the right platform, we will consider other areas such as share repurchases. So we're taking our time. We're looking for the right assets, which could be established assets that are derisked or earlier assets that we would have to invest to develop if the price was right for those. So we have a broad aperture and search ongoing at the moment.

Corinne Jenkins

analyst
#57

In the past, I think you talked about one of the priorities is it was immediately accretive to the top line. Is that still kind of a parameter that you're focused on? Or are you, in particular, looking now at earlier-stage things? And talk to us about that.

Helen Torley

executive
#58

We have opened the aperture. We continue to ideally find something -- I think I used to say if not immediately accretive, accretive in a short period of time, that would be attractive. But for the right price, an early asset that has a very large and attractive TAM and that we see as being something the industry needs and wants, we would contemplate that as well.

Corinne Jenkins

analyst
#59

Okay. Great. I think that brings me to the end of my questions. Anything that you feel we haven't touched on yet that you view as really important to understanding the Halozyme story?

Helen Torley

executive
#60

No, I'll just -- thanks for giving me this opportunity to close this, Corinne. Just to say that we are very pleased with the amazing progress we're seeing. Halozyme in its history has now had 10 approved products. So we're very excited to have that. But importantly, we also have 12 catalysts that have occurred just in the last several months or are occurring now that are going to continue to fuel this growth, not just for the 3 drugs that are driving our success today, DARZALEX, PHESGO and VYVGART HYTRULO. These are also applying to the OPDIVO, TECENTRIQ, OCREVUS and amivantamab subcu. And so this gives us great confidence in continued strong royalty growth for years to come. And behind that, we have a pipeline of products in development and the opportunity to be signing additional new deals. So it's a great time in Halozyme history.

Corinne Jenkins

analyst
#61

Perfect. Thank you so much. And that brings us to time. Thanks, everyone.

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