Awesome. Thank you very much for joining us today. This is not quite the post-lunch. There's one after the post-lunch session. My name is Mohit Bansal. I'm one of the biopharma analysts here at Wells Fargo, and I'm joined by Dr. Helen Torley. Helen has been coming here longer than I have been here. Thank you very much for being consistent with coming to this conference. Yeah, we appreciate it, Mohit. That was a great opportunity. Thank you. I'll give the floor to you because there are exciting times. I mean, you, like, we were expecting a lot of launches, and now there are new launches there. You have been raising guidance consistently. Talk a little bit about the progress on the commercial side and the investment case in the company at this point. Yeah, so for those who are less familiar with Halozyme, just let me give a little bit of background. We are the pioneers in hyaluronidase to be used for a large volume subcutaneous delivery. This has resulted in our core platform, which is called ENHANZE®, which we license to leading pharmaceutical companies to allow them to transform their IV drugs to be able to be given subcutaneously or underneath the skin. We've hit 10 approvals to date, and I'll talk about those in a moment in a lot more detail. We also have an auto-injector platform. This is also very consistent with our passion to be able to make treatments fit the patient's life rather than the patient's life having to rotate around it when they're suffering from a grievous illness. It's also very consistent with a trend we're hearing more and more from pharma and biotech, which is at-home delivery of biologics. Everybody wants that. We have a small volume auto-injector that delivers up to 2.25 ml. We also have a high-volume auto-injector, which is something that we have invented by being able to combine the two technologies I mentioned, the ENHANZE® with our auto-injector technology. That can deliver between 3 ml and 10 ml of a biologic drug at home or in the physician office in under 30 seconds. These are very attractive, growing opportunities. Mohit mentioned our second quarter. We were able to raise our revenue guidance. Now for the year, we expect $1.3 billion in revenue. The largest majority of that is our royalties, which we're getting from the ENHANZE® platform. That's $825 million- $860 million this year, which is a 46% - 51% year-over-year growth. That really is going to continue to grow, obviously, because these are royalties. We have a very profitable business. Just to give you a sense, we expect our EBITDA to be at least $865 million this year, also a growth in the high 30%. A lot of this is driven by just three products that launched in 2020 and 2023. That is Darzalex® subcutaneous, VYVGART® Hytrulo, and also PHESGO®. Just between 2024 and 2025, we had four additional launches for Opdivo® subcutaneous, Tecentriq® subcutaneous, Ocrevus® subcutaneous, and now Rybrevant®, all of which are going to start to contribute meaningfully in 2026 and beyond. You can see we've got layers upon layers of royalties from very exciting large drugs that's leading to very strong cash flow for the company. To close on the introduction, for the cash flow for the company, we invest first in the business in terms of our capital allocation. We have been very good at returning capital to shareholders through share repurchases. We're up to $1.8 billion since 2019, including $303 million this year. We also plan to use our capital to add additional growth to add to the strength of the current business and are looking to add new delivery platforms. That is Halozyme Therapeutics in a nutshell today, a very exciting time with 14 catalysts this year, 11 of which have already occurred. Got it. Awesome. I think VYVGART® has been pretty strong this year so far. I mean, you can look at your guidance as well as VYVGART® 's consensus expectations. They have been going up. When you talk to your partners, how are you thinking about long-term growth and then also updating your number? You have this policy to update once a year in the beginning of the year. How do you think about expectation, internal expectation changing over a period of like the last six months or so? Yeah, we do. We actually, a couple of years ago, put out five-year guidance, and that was based on the approved product. As Mohit said, it'll be our practice to refresh that in the beginning of 2026 as well. We have updated guidance twice this year in 2025. I think you can expect that we will be, just if you look at the numbers, moving forward to update 2026, 2027, and 2028 as well. It really is, I mentioned, the strength of some of the products. Just to talk about what's going on, the two updates to our guidance this year have been driven by Darzalex® and VYVGART® Hytrulo, if I focus there. Darzalex® has been on the market since 2015. It is still growing at 20% year-over-year, but it's still surprising us with its incremental growth. I think this is coming from its ability to penetrate into the frontline patient population where patients live longer and stay on therapy longer. We're beginning to see that compounding effect, which is why analysts project that Darzalex® will grow from $13 billion - $18 billion by 2028. That is all sub-Q. The market is converted to the sub-Q using our technology, and we get a mid-single-digit royalty on that. That's a little bit why we're going to see that there's a potential for an update there. VYVGART® Hytrulo, what an amazing product, very recently launched at $1 billion in the second quarter, 100% year-over-year growth. A lot of that driven by the subcutaneous launch, being able to increase the number of doctors using VYVGART® in both GMG and CIDP, which are the two indications they have The very recent launch of the prefilled syringe, which includes the VYVGART® Hytrulo, which is the one that has our technology, also increasing the number of doctors prescribing. Many of the doctors who use the prefilled syringe had never used VYVGART® before the launch of the prefilled syringe last quarter, but also new patients coming in. Patients want that 30-second at-home delivery, which is what our technology, plus the great VYVGART® Hytrulo, has been able to deliver for patients. Simple to use. Use it before you go to work, get their life back. That's exactly where we want to go. For VYVGART® Hytrulo, just the beginning. Looking out several years, the studies are ongoing to expand the GMG opportunity to seronegative and ocular. The use of biologics, it simply is going to bring more people into the market. Organics actually predict it's going to double the number of patients than the number they predicted at launch at GMG. CIDP growing nicely, but three additional indications in phase III development with the sub-Q in myositis, Sjogren's disease, and also in, I always forget the third one, thyroid eye disease. All of those potential before 2028, 2029, to just continue to fuel amazing growth for VYVGART®. Those two alone are driving it. Remember, we're also behind that PHESGO®, Opdivo®, Rybrevant®, Ocrevus®, and Tecentriq®, which have just launched. It's a very exciting time at Halozyme as the company's focus is on new indications being launched, new reimbursement, new countries. That is why we predict that continued strong durable growth for many years to come. Got it. How have been the launch trajectory of these PD-1s at this point? PD-1, PD-L1s, so Tecentriq is there, and also Opdivo is out there. How has been the progress so far? If I look at the history, there have been buckets. was really rapid. PHESGO was slower, but it is still like now it is maturing to a really nice level. Would it be more like a PHESGO situation or more like a situation? Yeah, Darzalex® had a couple of things going for it. I think firstly, it had a much improved safety profile with reduced infusion-related reactions. I think that does differentiate it, but that bodes very well for physician adoption of Rybrevant®, where with our technology compared to the IV, where the infusion-related reaction rate is 76%, it's going to go down to the teens. That would be a good analog in that case. For the PD-1s, I do think PHESGO® would be a good analog. It's a very recent launch for Opdivo®; just got approved in the first or launched in the first quarter of this year, just got the J code, the permanent J code on July 1st. What Bristol-Myers Squibb has shared so far is they're very pleased with the adoption they're seeing. It's being used in all of the indications. I think by that, they mean indications which are where there's no IV therapy. It's maybe with oral therapy or monotherapy, but also in regimens where there is IV therapy. That's exciting to see and used in academia and in the community. When you think about it, this enables a five-minute subc-Q injection the physician can do in his office. That's going to be very attractive. So far, they're very pleased with what they've seen, but they did say that the J code in July will be an accelerator for use of the drug. Roche has not provided a lot of detail on Tecentriq®. It is a switch strategy, and I would imagine it'll very much parallel what we are seeing with Opdivo®. Got it. How do you think of your discussion, where do you stand on Ocrevus® in the same launch trajectory? Yeah, Ocrevus® is, again, a different case. It's very exciting. Our initial launches were all IV to sub-Q. Ocrevus® and VYVGART® are great examples where the sub-Q is expanding the market and expanding the overall sales that are possible for the drug. I described VYVGART® earlier. For Ocrevus®, what Roche has said is they expect the availability of sub-Q to expand their market by $2 billion. That's bringing in new physicians who can't use the IV Ocrevus®, and it's bringing in new patients who perhaps can't get to the infusion suite. Ocrevus® IV is an up to six-hour infusion and observation period. That's an entire day in an infusion suite. There are just not enough beds, and not everybody wants to do that. With our sub-Q technology, it's a sub-Q injection that takes just 10 minutes. That's transformative. More patients can be treated, and it all can be done in physician offices. So far with that launch, what Roche has commented on, they're seeing exactly what they hope to see. 6,500 patients are already on Ocrevus® sub-Q worldwide. Of those, 50% are brand new to Ocrevus®. That's that market expansion they talked about to get another $2 billion overall. 50% are coming from the IV. Very nice execution of this strategy they want, which is expand and switch. Obviously, patients are benefiting from that much shorter infusion time. I think the 50% switch is still better than what Roche was initially talking about, right? They were talking about this would be more like a newer market versus the switch market. I think they wanted to get everybody's mind around the fact, don't ask us for metrics on switch because that's not going to be how we judge success. I think they successfully did that. Got it. Very helpful. Thank you for that. With that, I think I want to switch to the partnership discussions because there are a lot of benefits you can provide to a prospective partner. Lifecycle management is one part, but again, you can expand the market like Ocrevus and Hytrulo. Talk a little bit about how these discussions are progressing and what appeals to your pharma potential partners at this point. Yes, we're very active in discussions with a whole range of types of opportunities. There are still opportunities which we call our traditional opportunity. That's an established IV drug that takes hours where the partner wants to move it to sub-Q to improve the patient treatment experience. Those are definitely still opportunities we're pursuing there. Also, companies, because they've seen the success in the market of the sub-Q drugs, we're talking to other companies who are developing drugs initially as an IV, but they're thinking of adding sub-Q in phase II or phase III. They launch with the sub-Q version or they launch shortly after the IV version with the sub-Q version, if you like. They want to de-risk it first and then move into sub-Q. We definitely are getting this, and I'd say the areas of focus are oncology, inflammation and immunology, neurology, and nephrology. Those are where companies are really beginning to think sub-Q earlier, sub-Q from the start because they recognize that potential to get drugs into the patient's hands at home and a simple auto-injector is where they want to go in all of those indications. The other area that is very active is subcutaneous drugs that are already developed. Now, today, if you don't use ENHANZE®, you are limited to 2 ml in a single injection. After that, you start to get a lot of pain and back swelling. ENHANZE® can enable, as an example, with VYVGART®, injecting 5 ml in just 30 seconds with no swelling, back pressure, et cetera. What companies are coming to us to talk about is they developed a drug with this, say the max was 2 ml, then it's in every two-week interval. They want to see, could they be more competitive if they went to a monthly interval? With our technology, you can do a single injection of 4 ml. That extended dosing is a whole new area of opportunity for ENHANZE®, where by being able to double the dose, if that doesn't cause any difference to the safety profile of the drug, in inflammation and immunology in particular, a lot of interest is everybody is playing on that patient convenience as a core differentiator for patients. Got it. Very helpful. In terms of IRA, we'll talk about IRA, but you have to talk about IRA here. Again, there could be some new guidance coming at some point here. I know initial read, us included, the read was probably this guideline is a little bit different from the previous guideline where probably two active moieties, the second active moiety would have to prove that it is adding to the core. What is your understanding there? Your products, can you prove that you are adding more than just a, like in case of Darzalex® fast flow, more than just a Darzalex®? Yeah, so you're right, Mohit. There was a difference in the description of the fixed combination drug in the Part B guidance that came up, just suggesting that, and asking for feedback, actually. This is a feedback question from the FDA. Should they be thinking that the second active ingredient, which is, needs to have active clinical effect on the disease and active action on the disease and thus deliver clinical benefit? It created a lot of confusion, the specific language that was there. Is it the fact that it acts on the disease or is it all that matters that there's clinical benefit? We have been very active in seeking to understand that and shape the policy world around that topic because it is very clear that if you define clinical benefit as how a patient feels, functions, and survives, we have data in all of those to say that the sub-Q delivery of drugs with impacts and improves all of those. I'll talk about our strategy to influence that, Mohit. We submitted a very comprehensive comment letter that laid out the policy and legal arguments as to why this change was not good policy for CMS to do and frankly wasn't necessary and urged that they stuck to the same language that was in Part D. We further spent the majority of the letter articulating all of the very well-demonstrated and repeatedly demonstrated benefits of sub-Q delivery with ENHANZE. I've mentioned infusion-related reactions. If you have an infusion-related reaction when you're receiving a drug, it will make you feel terrible. You will have low blood pressure. You'll be sweaty. You'll have a headache. You could have anaphylaxis and you could die. The next time you go in, the doctor will lower your dose. They might delay your dose. All of those can impact your outcome. Infusion-related reactions are very serious. With our sub-Q technology, we caused a threefold reduction in IRRs with Darzalex, and we caused a 6-7 fold reduction with amivantamab. That is clinically meaningful benefit. There is nobody who could ever argue that's not clinically meaningful benefit. With all of our drugs now used to Tecentriq, we reduced the rate of serious and severe adverse events by 40%. It's been pretty consistent in our profile that sub-Q is better tolerated, which means patients may stay on therapy longer. Importantly, with Rybrevant® we also were able to demonstrate a statistically superior outcome in terms of overall survival with the sub-Q versus the IV. All of those are incredibly meaningful benefits, as well as keeping people out of infusion suites where they pick up infections. Our letter, we believe, is very compelling. We believe we will prevail to have CMS listen to all of the arguments, which, and the legal and policy ones are very powerful as well, but there should be no change between the two. I will say, Mohit, you talked about the reaction. There's also been a change, and maybe we could just talk about the One Big Beautiful Bill as well, because that provided a bit more additional help for people in thinking about would the IRA have an impact on Halozyme. The One Big Beautiful Bill clarified that if a product has got multiple orphan indications, it will also be excluded from the Inflation Reduction Act. This is very relevant to us because one of the first drugs up for potential consideration is Darzalex®. Its first two indications of multiple myeloma, and only indications of multiple myeloma and amyloidosis, are both orphan. Darzalex® will not be included in the IRA. It may have biosimilar competition. It's a very important drug for us, but it is excluded for that. For Opdivo®, the very first indication is an orphan drug. That will defer any consideration for Opdivo® for a year as well. All of this, we just say we think on a policy basis, recognizing that fixed combinations of two active ingredients where there is clinical benefit shouldn't be treated the same in Part B as Part D for Halozyme. The actual how that language lands will not have a very big impact in our long-term revenues for those reasons I've just articulated. We still believe it's better policy to keep it the same. Darzalex® may never be included. Darzalex® we believe will not be included, yeah. Got it. Very helpful. Do we have any thought process on when we could hear from the CMS here? Our DC team seems to say September, October. There's no specific statutory timeline. September, October would be what it is based on precedent. Got it. Very helpful. Do your potential partners talk about the Inflation Reduction Act, these guidelines at all? No, I mean, they really don't. We've never made it a big part of our conversation with partners. If you think about it, they're looking for competitive differentiation. That's what they want to do with their products. We focus on this aspect of the IRA, which was a big bill our investors do. I cannot remember the last time anyone outside of an investor group spontaneously asked me about the IRA. We are focused on wrong things, basically. Helpful to know. Thank you very much for this. Maybe talking a little bit about the other side of litigation, the Merck litigation that is going on here. There are different facets to it. One is the PGR, and then you have launched a lawsuit yourself here. Can you talk a little bit about, you know, just walk us through what is going on here and what could be the timelines at this point? I mentioned at the start that Halozyme is a pioneer in hyaluronidases. We did thousands of experiments 15, 20 years ago, which resulted in us moving forward with as the platform that we licensed to our partners. At the same time, we created many different modified hyaluronidases. By that, it means that it doesn't have an identical amino acid structure to ENHANZE, which is a modified human. is the identical structure to human hyaluronidase segment. The modified changes in and out the sequence of amino acids. We have filed a lawsuit against Merck, who's using Alteogen's modified hyaluronidase for their subcutaneous Keytruda in district court, alleging that they are infringing on our modified hyaluronidase patents. That court case, we're still waiting for our scheduling date, which we expect to hear about in the next weeks. The district court case, just to set expectations, will take a number of years to play out. We have asked for a number of remedies there, including that Merck pay us as a royalty, which we would expect to be at the mid-single-digit rate. There is a possibility also that there could be damages awarded to Halozyme if willful infringement is found, and that can be up to three times the amount of lost revenue for Halozyme. We've also asked for injunctive relief, which means that until there is a satisfactory resolution of the infringement, such as by paying a royalty, Merck would no longer be able to commercialize the product. Several years for that to play out to the very end. We're very confident we're going to win it. We are able to know the structure of their modified hyaluronidase that's being used because it's published in the patents and it's also available on the NIH website. That is what in part gives us such confidence in our ability to prevail because we know it is identical to sequences that we patented many, many years ago. At any time during that course, Merck can say, okay, we will take a license. We, of course, would be delighted if they wanted to do that. We don't necessarily want to get to litigation. We try to get them to take a license, but we will play that process out. That's a key one to watch because that is the one that is going to result in a potential license to Halozyme. I'll just say for clarity here, the MDase portfolio has nothing to do with the portfolio. It is all upside what happens on MDase. There can be no impact on ENHANZE® whatsoever, no matter what happens on the MDase. Just think about it as a great option for Halozyme Therapeutics for additional revenue for our license to Keytruda®. Mohit mentioned the PGR process. That's called the post-grant review process where companies can challenge newly issued patents within nine months of their issuance in the United States. That's what Merck has done with some newly issued. We've got 100 patents on MDase, but we've continued to process and have new patents issued. For some of the recent ones, Merck has challenged those. The PTAB agreed to institute four of them, which means that we will go forward to have those heard in a full PTAB review between March and June of next year. The outcome of that could be the patents are upheld or they're invalidated. It doesn't actually matter what the outcome there is because we have got patents that are in our district court case that are not subject to this PGR review because they were issued so long ago. You might say, why is Merck doing this? I think they are trying to get some of our patents knocked out to increase the chance of success. We're feeling very confident in, as the pioneer working in this area 10 years ahead of anyone else, that our patents will prevail and will prevail in the whole review of the validity of those patents as well. Some of the patents have gone past a nine-month window now. Even if Merck wins in all those PGRs, there are still patents where the district court has more patents than PGR right now. District court has more patents than PGR because we were issuing these patents in the 2010s, you know, I won't get the dates right, but we're talking about the 2012 to 2018 time frame, many years ago. Got it. Got it. PGR has no bearing on the. PGR has no bearing on a good number of the patents that are in our district court case. Got it. Very helpful. Can you remind us if, what is the, what are the timelines for the, like for patents, like how long these patents last for you? For the MDase patents, because these were issued a number of years ago when we were doing our work on the modified hyaluronidases, it expires in 2032 in Europe and 2034 in the United States. If we were to be successful in getting a license, the license would go to 2032 and 2034. Got it. Very helpful. Maybe talk a little bit about, you know, some of these, like, again, people are interested in new deals, but at the same time, you have partners with pretty much who is who of industry already. There are a lot of undisclosed targets there. What the progress has been on that side of the business, and then can we hear more about that? Yeah, so I mentioned our guidance is based on our currently approved product. If we're looking for other sources of growth, over and above that, we actually have four or five. Let me go through them. The first is new deals. I want to just mention that in the conversations that are happening at this point in time, we've made enough progress that I'm very confident that we're going to be signing at least one additional deal this year that should progress into the clinic next year. On average, there's about five years from our partners entering the clinic to getting approval. We're very excited about that. We currently have a pipeline of nine products that are in development. They're on our corporate presentation if you want to see them listed. Two of them, as Mohit said, are not disclosed, but the majority are disclosed. The most advanced of those are two that are in phase III, where there is potential data readouts this year, and that's for Bristol-Myers Squibb's Opdualag. It's a fixed combination sub-Q of Nivolumab and Rilatlimab, as well as TAC881, which is a 20% IgG from Takeda. That's another opportunity. The seven products that are in phase II or phase I you can take a look at. That's another source of growth as those advance and make it into the commercial world. Within our current products, I used VYVGART® earlier, pipeline in a product. When you think about it today, we're all very excited about GMG and CIDP. Within the next several years, it could be three new indications, two of which, in terms of the prevalence, dwarf the opportunity that we've seen so far with VYVGART®. That's the thyroid eye disease and the Sjogren's disease. I would consider that another incredible source of growth for us as well. Our current partners, when they take deals with us, tend to have an idea of one or two targets they want to work on, but they often reserve the right to use targets with new ideas that come up over time. That results in new products progressing to the clinic this year. We've already had one this year. We're expecting a second one this year, and there's one at the beginning of next year as well. Each of these products progressing brings that new potential for another royalty stream. There's lots of opportunity for us to grow, not just dependent on the new deals. The current deals help us. The current products help us. We're very excited with regard to just the future. Why this is important is these are additional things leading to that durable revenue that we are projecting and that makes Halozyme Therapeutics such an exciting story. VYVGART® has a long tail as well, given the patents and everything here. Hytrulo has applied for a co-formulation patent, which would take the royalties for Halozyme on VYVGART® out till 2042. It's a long tail, and several of our other products are out to there. I'll just say that, as an example, Tecentriq® goes out to there, Opdivo® goes out to around about there. A lot of these royalty streams are going into the 2040s based on the co-formulation patent. There's a nice slide deck on their website if you want to really look at that over there. Thank you very much for that. Maybe we are coming to the end of this. One question I always ask every year, I'm sure you remember the question. One year down the line, Wells Fargo Healthcare Conference 2026. I hope you are here. I hope I'm here. If I ask you the question to look back at the year and say, like what will make you look back and say, this has been a great year for us? Yeah, I think we're going to see just amazing continued royalty revenue growth beyond our wildest expectations when we started the year and certainly continuing for the year. I mentioned 14 catalysts. I think it was an unprecedented number. We had a Rybrevant® new indication. Darzalex® has had a new approval, sorry. Darzalex® has had new indication approvals. VYVGART® Hytrulo is having new indication approvals, particularly with their prefilled syringe. We also have new reimbursement milestones such as PHESGO® in China that led to just an amazing growth of that product there. I think we're going to look back and we're going to say those 14 catalysts, 11 of which have happened, three of which have still to occur, which includes the approval of Darzalex® in smoldering multiple myeloma, Rybrevant® in the U.S., big and meaningful things. We'll look back and say that was an amazing year because there were so many products with catalysts that were meaningful in terms of expanding the opportunity. I'd say in addition to that, we will be excited to see the advancement of the pipeline in terms of additional products progressing and giving that great picture of how this is going to be an incredibly durable long revenue story. You know, M&A. We never know when we'll transact M&A, but we're very active. The benefit of our great cash model is that we do have sufficient cash to invest in the business, do the substantial share buybacks I've talked about, but also pursue our M&A ambitions. We're very actively looking for new drug delivery platforms that have got similar revenue profiles to what we see with ENHANZE® to bring in because we believe that is a very good use of our cash to add growth on top of this already very attractive and growing business. I can't say if we will because we're very patient and we follow our strict criteria on M&A. If we do find the right transaction, Mohit, we could have a new and exciting platform that is another offering for our great pharma and biotech partners and will hopefully allow us to expand even more beyond that. More progress and success, and hopefully we'll see it rewarded in the share price as well. Awesome. On that high note, thank you very much for joining us today. Great. Thank you.