Halozyme at Goldman Sachs Conference: Subcutaneous Innovation Drives Growth

On Monday, 09 June 2025, Halozyme Therapeutics Inc. (NASDAQ:HALO) presented at the Goldman Sachs 46th Annual Global Healthcare Conference. The company highlighted its leadership in subcutaneous drug delivery, driven by its ENHANZE technology, while also addressing ongoing litigation and strategic growth opportunities. Despite challenges, Halozyme remains optimistic about its future prospects.

Key Takeaways

• Halozyme projects robust royalty revenue growth of 31% to 37%, driven by products like DARZALEX and FESGO.
• The company is focused on expanding its subcutaneous drug delivery technology, ENHANZE, which offers improved patient convenience and reduced infusion reactions.
• Ongoing partnerships and new product launches are expected to contribute significantly to future growth.
• Halozyme is actively engaged in protecting its intellectual property through litigation and fair licensing practices.

Financial Results

• Royalty Revenue Growth: Halozyme anticipates royalty revenues of $750 million to $785 million, with a projected growth rate of 31% to 37%.
• DARZALEX Growth: Currently a $12 billion brand, DARZALEX is expected to grow to $17.5 billion by 2028, with 95% of sales from the subcutaneous version.
• FESGO Performance: FESGO achieved over $700 million in Q1, growing at 50% year-over-year, capturing nearly 50% market share.
• Share Repurchases: Since February 2019, Halozyme has completed $1.55 billion in share repurchases, with an additional $250 million repurchase underway.

Operational Updates

• DARZALEX Conversion: The shift to subcutaneous administration reduces treatment time from 3-4 hours to 3-5 minutes.
• FESGO Reimbursement: Strong adoption in China, driven by reimbursement policies.
• Vyvgart Hytulo Launch: The prefilled syringe launch allows for a 20-minute subcutaneous injection, enhancing patient convenience.
• Ocrevus Market Expansion: The subcutaneous version is expanding market reach, with early launches showing 50% of patients new to Ocrevus.
• Amivantamab Infusion Reaction Reduction: Subcutaneous administration reduces infusion-related reactions from 66% to 13%.

Future Outlook

• ENHANZE Deals: Halozyme expects to sign new ENHANZE deals this year, maintaining momentum.
• Auto Injector Development: Ongoing agreements for small and high volume auto injectors.
• New Drug Delivery Platforms: Exploring over 30 potential new drug delivery platforms.
• CMS Guidance: Awaiting final guidance on Part B drugs, with clarity expected within 2-3 months post-June 26 comment deadline.
• Growth Catalysts: Twelve catalysts are fueling growth for key products, including DARZALEX, FESGO, and Opdivo.

Q&A Highlights

• IRA Impact: Partners prioritize the clinical benefits of ENHANZE over potential IRA impacts.
• Clinical Meaningful Difference: Focus on demonstrating clinically meaningful differences with ENHANZE, as defined by the FDA.
• CMS Comments: Halozyme will submit comments regarding Part B guidance by June 26.
• MDACE Patents: Litigation seeks damages for past infringements, with MDACE patents separate from ENHANZE, expiring in 2034 in the US.

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

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Unidentified speaker, Interviewer, Goldman Sachs: Good good morning, everyone, and and thanks for joining us here at the Goldman Sachs Healthcare Conference. We’re thrilled to be joined today by the team from Halozyme. And maybe we could just start with an overview of the company. In particular, I’d love if you could focus on some of the key value drivers recognizing there’s a lot going on.

Unidentified speaker, Speaker, Halozyme: 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 two platforms to do that, our enhanced hyaluronidase enzyme where we’re the pioneer in discovering that use for it and also commercializing it, and also our auto injector business. I think a bit of 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 07:30 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 till twelve. Mhmm.

For him, it was a three 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 two weeks, which, you know, he was very grateful to be on the drug, but he found it draining. When DARZALEX subcutaneous with our enhanced 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 the from his home to the hospital, and treated back because DARZALEX SubQ is just a three minute injection subcutaneously.

It was just ninety 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 two other products that are driving our strong revenue growth today in our royalties, which are also FESGO for breast cancer and Vibgart Hytulo for a range of neurological indications.

Mhmm. Behind that, we have four products that have just launched, all of them blockbuster products as well that includes Ocrevus subcutaneous, Tecentriq subcutaneous, Opdivo subcutaneous, and Amibantamab 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 catalysts for continued strong growth. And then our our small volume opto injector business is complementary and on top of that where we’ve got two products with a partner as well as our own proprietary product line. So a terrific and growing

Unidentified speaker, Interviewer, Goldman Sachs: subcutaneous drug delivery business. 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. They weren’t distinct from the Part B or 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 wouldn’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.

Unidentified speaker, Speaker, Halozyme: Yes. So what the CMS guidance is focused on is fixed combination drugs of two active ingredients and our hyaluronidase enhanced 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 deriving a clinical difference and a clinically meaningful difference at that. And so that’s where we’re very focused in in our interpretation of this and responding as they 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’ve 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 sub q compared to the IV has lower infusion related reactions. A patient 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 sixty six percent infusion related reaction rate with the IV reduced to thirteen percent. Mhmm.

That’s clinically meaningful. Even down to, other adverse events with the sub q, serious adverse events and multiple programs are reduced by fifty percent, and 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 non inferiority but remarkably, amivantamab was able to show in an exploratory analysis an overall survival benefit.

So now we’ve got, 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.

Unidentified speaker, Interviewer, Goldman Sachs: 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 that their definition of that aligns with the FDA’s current definition. Is that the right way to understand it?

Unidentified speaker, Speaker, Halozyme: Yeah. I mean, what what they’re they’re of ultimately saying, and thus derives clinically meaningful benefit. That that really is what they’re looking for is is how we are how we read that, and and many of our partners have a 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. Know, take you back to that patient. That patient’s life was transformed by having the subcu versus the IV.

Unidentified speaker, Interviewer, Goldman Sachs: So you talked about how ENHANZE kind of shows all this 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?

Unidentified speaker, Speaker, Halozyme: The 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 our products. Sometimes you need to go to the phase three publications for even more granular data, but all of it’s very easily accessible.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. In terms of timeline for additional clarity, sort of what are the key dates that we should know about for the year?

Unidentified speaker, Speaker, Halozyme: 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 two to three 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 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 on the market are expected to be launched in January sorry, is announced in January of twenty twenty six.

Unidentified speaker, Interviewer, Goldman Sachs: 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?

Unidentified speaker, Speaker, Halozyme: Yeah. We we hope that, yeah, we get our comments picked up to be clear that it’s a clinically meaningful benefit and clinical and what clinical meaningful benefit would would mean. You know, 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 Yeah. Fixed combination of two active ingredients for its clinical benefit. That is that is who we are.

Unidentified speaker, Interviewer, Goldman Sachs: 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?

Unidentified speaker, Speaker, Halozyme: We we we think it will be for everything because it’s a policy Yeah. Decision, and it it would be very hard to for CMS to make clinical judgments. Sure. I I think going with where the FDA has gone is just an easier thing for them to execute.

Unidentified speaker, Interviewer, Goldman Sachs: And when is the first drug that would include a hyaluronidase co formulation potentially up for negotiation?

Unidentified speaker, Speaker, Halozyme: You know, it’ll be done, as I mentioned, on the 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 is is going to be. So we’re we’re anxiously awaiting to see because it really if you have a 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.

Unidentified speaker, Interviewer, Goldman Sachs: In terms of just your ongoing conversations with potential partners, this uncertainty, how how is it factoring into those conversations?

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

Okay. I think that’s

Unidentified speaker, Interviewer, Goldman Sachs: 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 a focus on what you think are the biggest growth levers.

Unidentified speaker, Speaker, Halozyme: Yes. So we obviously have a very robust and growing royalty revenue business this year. We’re projecting growth of 31 to 37 to revenues in our royalties alone of 750 to $785,000,000. That robust growth continues to be driven really by three key products. DARZALEX that we’ve talked about, FASPRO is its name in The U.

S, sub Q outside The U. S, as well as FESGO and Byvecart HYTULLO. 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 Darzalexam, that is a $12,000,000,000 brand now. 95% of it is with the subcu version.

The subcu version takes patients from a three to four hour infusion to a three to five minute injection under the skin subcutaneously, dramatic as we’ve talked about. It is a product that because J and J has done a super job of continuing to invest in new indications, particularly in frontline, is projected to continue to grow. It’s projected to grow to about £17,500,000,000 by 2028 from the 12,000,000,000 it is today, and that is virtually all subcutaneous. And so that is why even though 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 in therapy longer, that’s going to keep growing royalty revenues coming in from DARZALEX for years to come. Second product is FeSgo, that is Roche’s product for breast cancer.

Now that achieved over $700,000,000 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 FESCO, 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 revenues today is Vyvagot HiTrule approved in two 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 three things that are really resulting in us having updated our guidance this year.

Right behind that, we have four products that launched within the last year that are also working today to get all of the reimbursement and coverage in place from where we expect growth to be contributing and growing in 2026 and beyond. Those are Opdivo subcutaneous, Tecentriq subcutaneous, Ocrevus subcutaneous, and Amifantamab subcutaneous, each of them large de risked 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’s in place.

Unidentified speaker, Interviewer, Goldman Sachs: You mentioned Vivgard 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 and indications where only the subcu is approved? And what do you anticipate seeing with the prefilled syringe availability in terms of an inflection or kind of continued growth?

Unidentified speaker, Speaker, Halozyme: Yes, so Vibesartan High Trullo is approved as a sub q now in generalized myasthenia gravis and also in chronic inflammatory demyelinating polyneuropathy, so both neurological indications. You ask where we are seeing the conversion. Actually are seeing conversion of IV to sub q patients who have been started on myasthenia gravis. Importantly, for CIDP, that is a subcutaneous only indication. And so we are also seeing both in gMG and CIDP sub q right to are just experiencing that much shorter, more convenient treatment.

And with the availability of the prefilled syringes that just got approved in April, Patients are now able to receive the therapy as a twenty 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 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 earlier in the disease therapy. And in CIDP, this is the first new indication if you like or a new treatment and therapy launched 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.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. As you think about the Opdivo, Tecentriq markets and also the Ribrovant and Ocrevise de novo, 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?

Unidentified speaker, Speaker, Halozyme: 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 The US 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 SubQ, it is a ten minute treatment period and a very short observation period afterwards. 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 sub q is going to expand the market. So Ocrevus is already an 8,000,000,000 drug as an IV, but with the sub q, 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 SubQ. And so the early launches are showing that about fifty percent 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 of the 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 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 US 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 is is a different profile, and we’re very excited by its profile. It is a product that is Johnson and Johnson’s for a specific type of non small cell lung cancer. As an IV, very long infusion, five, six hours, but also associated with that very high rate of infusion reaction, sixty six percent. That, I I think, is fair to say was limiting uptake of the drug. With the subcu version, the infusion related reaction rates was reduced to fivefold as was the time.

So in fact, you know, and only a thirteen percent incidence of infusion related reactions coupled with the fact that in an exploratory analysis, the efficacy was statistically significantly better than for the sub q. And so what a value proposition. And at ASCO, I just heard John Reed, the the head of the r and d innovation, commenting on the fact that subcu is the reason why J and J is so confident this is going to be a $5,000,000,000 brand. That’s all going to be sub q. So that that’s a just a terrific example and new growth to to come.

Unidentified speaker, Interviewer, Goldman Sachs: 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 the right run rate. Is that still kind of the right way to think about new partnerships coming on board, particularly as we get closer to that enhanced LOE in 2027?

Unidentified speaker, Speaker, Halozyme: Yes. We absolutely expect to sign an enhanced 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 early or earlier this year about the fact that we signed a small volume auto injector development agreement. We signed a high volume auto injector 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 the companies we’re talking to for technical review and then for actual approval. We we love the demonstration that with the small and 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 enhanced deal this year, but more to come after that.

Unidentified speaker, Interviewer, Goldman Sachs: 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 are what is the development agreement versus the commercial agreement? And how do they translate one to the next?

Unidentified speaker, Speaker, Halozyme: Yes. I’ll just say we’re seeing strong interest in our small volume auto injector. It 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 of a biologic in just thirty seconds. And so for each of these cases, the development agreement is with a current partner, 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. Mhmm. 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 a market expansion opportunity for us bringing in new royalty revenue streams with product sales on the device.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. So these are products that are already partnered with ENHANZE, and then this will be an additional kind of

Unidentified speaker, Speaker, Halozyme: royalty you get? Or they could be products that are not yet nominated and coming forward. So they are hopeful, and the opportunity is to expand our our enhanced number of royalty streams.

Unidentified speaker, Interviewer, Goldman Sachs: 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 injector piece of the business?

Unidentified speaker, Speaker, Halozyme: Yes. 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. Great.

Maybe I’ll turn to you, Mark, for

Unidentified speaker, Interviewer, Goldman Sachs: a second to talk about the Merck litigation that’s ongoing around the NDA suite of patents. You introduced that NDA suite last year. Maybe a few follow-up questions there. How do those patents fit relative to the ENHANZE specific patents? And can you just clarify whether ENHANZE is kind of caught up in the NDA piece?

Mark, Speaker, Halozyme: Absolutely. So to be very clear, ENHANZE is not part of MDACE. MDACE patents and the ENHANZE patents are entirely separate entities, if you will, portfolios of IP rights. And our MDACE portfolio really represents an upside to Halozyme. It’s an upside because the modified human hyaluronidases that are encompassed by our IP rights are are things that either companies maybe cannot work with us on or would like or or cannot work with us on or do not want to work with us on our enhanced portfolio, it gives them the opportunity now to get access to these intellectual property rights.

And remember, we we are the pioneer in this space, whether it’s the enhanced technology or these modified human hyaluronidases, we are the pioneer in developing those for subcutaneous administration of IV. We, because of that pioneer position, have very broad scope of rise and an extensive portfolio that cover MDACs.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. One of the things that’s part of that MDs you’ve said is that the KEYTRUDA subcutaneous patent that is currently under review infringes on the MDs patent. So can you enumerate some of the specifics of those patents that are being potentially infringed upon and walk us through the timeline around litigation?

Mark, Speaker, Halozyme: 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 03/02/2026 with the decision to follow by 06/02/2026. That’s really where the action is. That’s where we’re going to have a opportunity to present a trial on a full record

Unidentified speaker, Interviewer, Goldman Sachs: Mhmm.

Mark, Speaker, Halozyme: And deal with the merits. We feel very confident that we’ll prevail on the merits in that in that trial. So that’s really where the action is. Yeah. Recommend you getting out and getting a ticket quick for a front row seat and not to miss that.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. You mentioned the PGR that’s ongoing, the post grant review process. I think it’s for one of the patents, so it is 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, Speaker, Halozyme: 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 infection 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.

Okay. And it will prevail.

Unidentified speaker, Interviewer, Goldman Sachs: 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, Speaker, Halozyme: So I’m not gonna presuppose what Merck may or may not do, but there is litigation pending. We filed litigation back at the April 2024 for 15 different patents that are in our MDace US portfolio. So that litigation is filed in the New Jersey district court, and we’ll see what happens with that case. But it’s it doesn’t encompass all the same patents that are in this other process that’s happening in the patent.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. And what are the timelines for that, the litigation process, assuming it goes on as currently planned?

Mark, Speaker, Halozyme: Litigation right now in the district court takes about a couple 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.

Unidentified speaker, Interviewer, Goldman Sachs: 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 what are some of the key things that could come out of that?

Mark, Speaker, Halozyme: The the PGR process is is different, and I know it’s hard for people sometimes to sort of conflate the two with the infringement. But the PGR, process really only deals with the claims of of invalidity. And as I said, there will be a trial. That trial will be on the full record. There’ll be evidence developed, and then we’ll get a decision by 06/02/2026.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. Yeah. I wish I was a better patent person, but we need people like you on stage to help walk us through it. Okay. So 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 how do those things flow together? So we we

Mark, Speaker, Halozyme: knew the in invalidity claims are things that you have to deal with in in litigation involving patents. And so, you know, we’re pleased to be able to deal with them at trial in this full record. And so those are the issues that’ll be addressed. And as I said, we should have a decision by June second of twenty twenty six.

Unidentified speaker, Interviewer, Goldman Sachs: Obviously, the Keytruda subcutaneous is the most high profile of the potential products that would be encapsulated within the SIMDES suite of pens. Are there any other products, and would they kind of all flow the same way if they’re using the Altiagen

Mark, Speaker, Halozyme: technology? 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.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. And I think this kind of you mentioned this that ENHANZE is separate, but in the case that the outcome is not what you wish on the EmDace patent, any implications to ENHANZE?

Mark, Speaker, Halozyme: No. There implications at all. And as I said, yeah, they are entirely separate, and so MDACE will be determined on its own merits.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. Is there anywhere else that you would like to to seek, like, licenses for the MDACE? Are you fielding any sort of inbounds, or is this kind of, like, a specific case here?

Unidentified speaker, Speaker, Halozyme: Yeah. It are, first and foremost, focused on ENHANZE. Yep. ENHANZE is the established, tried, and true market leader in gold standard and rapid large volume, and and everybody about ENHANZE because of the experience, the track record, and the commercial success it’s seen. As Mark pointed out, at MDAYS, 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 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 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.

Unidentified speaker, Interviewer, Goldman Sachs: Okay. And remind me what the patent terms are on the MDS patents that are at issue?

Mark, Speaker, Halozyme: So the MDACE portfolio in The United States has expiries out to 2034 and outside The United States to 02/1932.

Unidentified speaker, Interviewer, Goldman Sachs: 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 your pillars of capital allocation. Yeah.

We’re in the

Unidentified speaker, Speaker, Halozyme: fortunate position because of our our high gross margin enhanced business to be able to execute in parallel our three pillars. The first one is very important. That is to continue to invest in maximizing our enhanced asset. We 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 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 $1,550,000,000 in share repurchases since 02/2019, and we actually have a $250,000,000 share repurchase underway at this at this time, and we will continue to evaluate the right opportunities to do that. We’ve demonstrated the ability to have bought 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 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 consent 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 a broad aperture and and search ongoing at the moment.

Unidentified speaker, Interviewer, Goldman Sachs: In the past, I think you talked about one of the priorities as 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

Unidentified speaker, Speaker, Halozyme: about that? We have opened the aperture. We continue to ideally find something. You know? I think I I used to say it’s not immediately accretive accretive in a short period of time.

That that would be that would be attractive. But for the the right price, an early asset that has a very large and attractive TAM Mhmm. And that we see as being something the industry needs and wants, we would contemplate that as well. Okay. Great.

Unidentified speaker, Interviewer, Goldman Sachs: Any 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?

Unidentified speaker, Speaker, Halozyme: No. I’ll I’ll just thanks for for for the 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 not had 10 approved products, so we’re 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 the three drugs that are driving our success today, DARZALEX, BEZZO and Vyvgart, HERTULIO. These are also applying to the Opdivo, Tecentriq, Ocrevus and Amivantamab Sub Q.

And so this gives us great confidence and continued strong royalty growth for years to come. And behind that, have a pipeline of products in development and the opportunity to be signing additional new deals. So it’s a a great time in Halozyme history.

Unidentified speaker, Interviewer, Goldman Sachs: Perfect. Thank you so much, and that brings us to time. Thanks, everyone.

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