Good morning, everyone, and thanks for joining us here at the Goldman Sachs Healthcare Conference. We're thrilled to be joined today by the team from Halozyme. 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. Yeah, 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 were the pioneer in discovering that use for it and also commercializing it, and also our autoinjector business. I think to bring color in 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 and then get it up from the pharmacy. By the time all of that was done, he was getting his treatment anytime from 11:30 A.M. till 12:00 P.M. For him, it was a three-hour infusion. There was an observation period of at least an hour. By the time he was back in the car, he was hitting the lovely Los Angeles traffic to get home. He described his experience as an absolutely exhausting sunrise to sunset trip every two weeks, which 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 and back, because DARZALEX subcutaneous is just a three-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. That is our passion. That is what we do. In addition to DARZALEX, we have two other products that are driving our strong revenue growth today and our royalties, which are also FESGO for breast cancer and VYVGART HYTRULO for a range of neurological indications. 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 AMIVANTAMAB subcutaneous. 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. Our small volume autoinjector 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. A terrific and growing 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 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 wouldn't. How are you interpreting—maybe you can provide us sort of the quick what was said in that guidance, how it differed, and how you're interpreting sort of this updated language? Yes. What the CMS guidance is focused on is fixed combination drugs with two active ingredients. Our hyaluronidase enhanced enzyme is noted by the FDA in all of the labels to be an active ingredient. That is not changed. What the CMS is very focused on is understanding a clinical difference, that the active ingredients are deriving a clinical difference and a clinically meaningful difference at that. That is where we are 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. I think that is a great definition for a clinically meaningful difference. We have the benefit of our partners having done head-to-head clinical studies. 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. 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 in multiple programs are reduced by 50%, which are serious adverse events that 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. Now we've got—if you think about all of this, all of these impact how a patient feels, functions, and survives. This is where we're 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. That's exactly what CMS is wanting to understand with regard to assuring that we're meeting their guidance. Okay. I think the CMS guidance says something about biologically active against the disease state. 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? Yeah. I mean, they're kind of ultimately saying, and thus derives clinically meaningful benefits. That really is what they're looking for, is how we read that. 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. Take you back to that patient. That patient's life was transformed by having the subcu versus the IV. You've talked about how ENHANZE kind of shows all this stuff. Would you expect that the clinical benefits, once you get clarity here, would need to be on label? Can you talk about what's already on label for these programs? 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's very easily accessible. Okay. In terms of timeline for additional clarity, sort of what are the key dates that we should know about for the year? Yes. CMS has requested comments on their Part B guidance by June 26. We will 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 is going to happen next, just trying to translate what has 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 is what we would expect to happen this time. 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 announced in January of 2026. 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? Yeah. We hope that we get our comments picked up to be clear that it's a clinically meaningful benefit and what clinically 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 two active ingredients for the clinical benefit. That is who we are. Okay. In terms of the 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? We think it will be for everything because it's a policy decision, and it would be very hard for CMS to make clinical judgments. I think going with where the FDA has gone is just an easier thing for them to execute. When is the first drug that would include a hyaluronidase co-formulation potentially up for negotiation? It'll be done, as I mentioned, on the next 15 drugs in terms of sales. This is the first time Part B drugs are eligible. We don't have visibility into Medicare versus commercial sales. It's a little hard to know exactly what it is going to be. 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. Sure. In terms of just your ongoing conversations with potential partners, this uncertainty, how is it factoring into those conversations? Yeah. I will say that partners want to use ENHANZE for the clinical benefits I've talked about. That clinical benefit is translating for them into competitive differentiation and commercial success. The IRA has not been, since it started this conversation two years ago, a big focus of our discussions. It 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 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. Yeah. So we obviously have a very robust and growing royalty revenue business this year. We're projecting growth of 31%-37% to revenues in our royalties alone of $750 million-$785 million. 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., subcu outside the U.S., as well as FESGO 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 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&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 $17.5 billion by 2028 from the $12 billion it is today. That is virtually all subcutaneous. 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. 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. It is obviously on a robust growth trajectory, in part driven by getting reimbursement in China, where the adoption has been very strong. That is only subcutaneous sales. There is no IV of FESGO. With that projection, I gave you a multi-billion dollar brand projected to grow as it converts more and more of PERJETA. The third product that is driving our revenue today is VYVGART HYTRULO, approved in two neurological indications today and is really seeing very dramatic uptake in both of those. That is expected to be fueled even more by the launch of the prefilled syringe, which happened just a few months ago. 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 have 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 AMIVANTAMAB 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 very strong growth once all the reimbursements are in place. 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 and indications where only the subcu is approved? What do you anticipate seeing with the prefilled syringe availability in terms of inflection or kind of continued growth? Yeah. 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 ask where we're seeing the conversion. We actually 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. We are also seeing both in gMG and CIDP subcu right to are just experiencing that much shorter, more convenient treatment. With the availability of the prefilled syringe that just got approved in April, patients are now able to receive the 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. In CIDP, this is the first new indication, if you like, or a new treatment therapy launch in many, many years in the alternate from IVIG. The convenience of therapy versus having to have an IVIG is pretty dramatic. We are seeing very nice uptake in that indication too. Okay. As you think about the OPDIVO, TECENTRIQ markets and also the RYBREVANT and OCREVUS de novo, I guess, can you talk to me about what are the right analogs as we think about conversion, paces of conversion, maybe marrying that back to your existing product launches? Yes. Maybe I'll start and break it down into the different types of indications. 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 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. We are 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. OCREVUS is already an $8 billion drug as an IV. With the subcu, doctors who do not 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. The early launches are 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 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. 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 is 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. They're very excited that they're going to have their J code on July 1st. For those of you who are familiar with that, that's important in the U.S. We're getting Medicare coverage and reimbursement. That's going to, I think, give a very nice boost there. 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, five, six hours, but also associated with that very high rate of infusion reaction, 66%. That, I think it's fair to say, was limiting uptake of the drug. With the subcu version, the infusion-related reaction rates were reduced fivefold, as was the time. In fine section, though, 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. What a value proposition. At ASCO, I just heard John Reed, the head of the R&D innovation, commenting on the fact that subcu is a reason why J&J is so confident this is going to be a $5 billion brand. That's all going to be subcu. That's just a terrific example and new growth to come. 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 ENHANZE LOE in 2027? 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. This is supported by a couple of things. I think we talked earlier this year about the fact that we signed a small volume autoinjector development agreement. We signed a high volume autoinjector development agreement. 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. 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. Okay. You mentioned the small and high volume autoinjector development agreements earlier this year. Can you talk to us about what that means? What is a development agreement versus a commercial agreement, and how do they translate one to the next? Yes, I'll just say we're seeing strong interest in our small volume autoinjector. It really does have a differentiated profile, meeting the highest possible standard on reliability. 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 autoinjector is a unique offering in the market. We are the only company that offers the ability to deliver 10 mL of a biologic in just 30 seconds. For each of these cases, the development agreement is with a current partner, a different partner in each case. It outlines all of the steps and responsibilities to get a product, an autoinjector, ready for clinical development testing. Once you've got that clinical development testing underway is when we'll talk the commercial terms. In each case, we expect these to be really related to product sales for the device. 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. The HVAI will be associated with royalties. It is a market expansion opportunity for us, bringing in new royalty revenue streams with product sales on the device. Okay. So these are products that are already partnered with ENHANZE, and then this will be an additional kind of royalty you get. There could be products that are not yet nominated and coming forward. There are the opportunities to expand our ENHANZE number of royalty streams. 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 autoinjector piece of the business? Yeah. Same process as is going on with ENHANZE. We're in conversations with companies, and we're just working through the process. We're already hard at work with each of these companies on meeting and kicking off the development of the autoinjectors. 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 those patents fit relative to the ENHANZE specific patents? And can you just clarify whether ENHANZE is kind of caught up in the MDASE's piece? Absolutely. 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. 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. Remember, we are the pioneer in this space, whether it's the ENHANZE 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 a very broad scope of rights and an extensive portfolio that cover MDASE. 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 timeline around litigation? 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 2nd, 2026, with a decision to follow by June 2nd, 2026. That's really where the action is. That's where we're going to have an opportunity to present trial on a full record and deal with the merits. We feel very confident that we'll prevail on the merits in that trial. That's really where the action is. I recommend you getting out and getting a ticket quick for a front row seat and not to miss that. 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. 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 are 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 we'll prevail. 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? 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. 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 patent office. Okay. What are the timelines for the litigation process, assuming it goes on as currently planned? Litigation right now in the district court takes about a couple of years to get to trial. To remind you, what we're seeking there really is damages for their past infringement. We would be seeking enhanced damages for their willful infringement. 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. 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? The PGR process 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 invalidity. 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 June 2nd, 2026. 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. Then how does that inform, 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? How do those things flow together? We knew the invalidity claims are things that you have to deal with in litigation involving patents. We are pleased to be able to deal with them at trial on this full record. Those are the issues that'll be addressed. As I said, we should have a decision by June 2nd, 2026. 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 Altagen 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. Okay. I think you mentioned this, that ENHANZE is separate, but in the case that the outcome is not what you wish on the MDASE patents, any implications to ENHANZE? No, there are no implications at all. As I said, yeah, they are entirely separate. MDASE will be determined on its own merits. Okay. Is there anywhere else that you would like to seek licenses for the MDASE, or are you fielding any sort of inbounds, or is this kind of like a specific case here? Yeah. 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 a 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. 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. Okay. Remind me what the patent terms are on the MDASE patents that are at issue. The MDASE portfolio in the U.S. has expiries out to 2034 and outside the U.S. to 2032. 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. Yeah. We're in the fortunate position because of our high gross margin ENHANZE 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 ENHANZE asset. We are doing that through continuing to invest in new uses for it, as well as developing a new API. We're also investing in the high volume autoinjector. That's another great example of investing to build our drug delivery business and continue the lifecycle 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 underway at this time. 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. 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 have got strong IP that are something that we identify would be broadly licensable to the pharma and biotech industry. We are very active looking for those drug delivery opportunities and do not 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. Lots of action there. Now, if we don't find the right platform, we will consider other areas such as share repurchases. We're taking our time. We're looking for the right assets, which could be established assets that are de-risked or earlier assets that we would have to invest to develop if the price was right for those. We have a broad aperture and search ongoing at the moment. In the past, I think you talked about one of the priorities was 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? We have opened the aperture. We continue to ideally find something. I think I used to say it's not immediately accretive or accretive in a short period of time. That would be attractive. 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. 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? No, I'll just thanks for giving me this opportunity to close this career and just 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 very excited to have that. 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 three drugs that are driving our success today, DARZALEX, FESGO, and VYVGART HYTRULO. These are also applying to the OPDIVO, TECENTRIQ, OCREVUS, and AMIVANTAMAB subcutaneous. This gives us great confidence in continued strong royalty growth for years to come. Behind that, we have a pipeline of products in development and the opportunity to be signing additional new deals. It is a great time in Halozyme history. Perfect. Thank you so much. That brings us to time. Thanks everyone.