Welcome to the Halozyme Therapeutics Investor Update conference call and webcast. At this time, all participants have been placed on a listen-only mode, and the floor will be open for your questions following the presentation. If you would like to ask a question at that time, please press star one on your telephone keypad. If at any point your question has been answered, you may remove yourself from the queue by pressing star two. So others can hear your questions clearly, we ask that you pick up your handset for best sound quality. Lastly, if you should require operator assistance, please press star zero. I would now like to turn the call over to Tram Bui, Head of Investor Relations. Welcome, everyone, to Halozyme's Investor Update call. Let me begin by briefly reviewing today's format. We will have a presentation followed by a Q&A session. During the presentation, we will be displaying a slide deck that will advance with each speaker's comments. There will be an opportunity for Q&A after the presentation. On today's call, we will be making forward-looking statements. I would refer you to our SEC filings for a full list of risks and uncertainties. I will now turn the call over to Dr. Helen Torley, our President and CEO. Thank you, Tram. I'm pleased to welcome everyone to today's Investor Update call, in which we are continuing our focus on Halozyme innovation. This series is designed to share additional details on key elements of Halozyme's business that we think will benefit from more in-depth discussions and presentation by Halozyme experts. A key focus will be highlighting the science and innovation behind Halozyme's drug delivery technologies that deliver the next leg of innovation. Today, we will discuss Janssen's European collaboration patents that have been opposed in the European Patent Office. We'll then highlight exciting new developments in, and additions to, Halozyme's patent portfolio that create potential new technology licensing opportunities for Halozyme. Mark Snyder, our Chief Legal Officer, will provide the update on the Janssen European patent opposition and on how Halozyme's innovations have resulted in these new patents. Thank you, Helen. I am first going to cover the recent developments in the opposition proceedings for Janssen's European collaboration patents and why we continue to project no impact on Halozyme's royalties for Darzalex Faspro and Darzalex subcutaneous, sold worldwide into twenty thirty-two. After that, I will turn to a discussion of some exciting new developments in the Halozyme patent portfolio that relate to modified human hyaluronidases that are different in their amino acid structures from ENHANZE and are not part of our enhanced licensing platform. I am talking about separate patents from those that Halozyme currently licenses and that represent a potential new licensing opportunity for Halozyme. Turning now to the Janssen European collaboration patents, there are three main points I will make. First, Halozyme maintains its projected royalties for sales of Darzalex subcutaneous in Europe into twenty thirty-two. This assumes at least one of the two existing granted Janssen European collaboration patents remains valid, or the current pending patent application is granted and remains valid through twenty thirty-two. Second, Halozyme also maintains its projected royalties for Darzalex Faspro in the United States through twenty thirty-two. It is important to note that the European proceedings have no impact on the different Janssen collaboration patents that apply in the United States. And third, we do not expect the decision by the opposition division of the European Patent Office today for Janssen's European patent number three eight two seven eight four five to have any impact on the ability of other enhanced licensees to obtain future collaboration patents. The revocations of Janssen's patents have been primarily based on the timing of publication of a clinical trial protocol by Janssen that occurred before the priority date of the European patents. There has been no change in the patentability standards that would impact other inventions when unexpected results are obtained that can form the basis of non-obviousness or inventive step for the invention. Let me now explain in additional detail the basics of opposition proceedings in Europe. Moving to the next slide, Janssen has two granted European collaboration patents and a third pending patent application. A European patent opposition is essentially a request to the European Patent Office to reconsider its decision to grant the patents based on information that was published and available to the public before the priority date of the patent. In this regard, only granted patents can be opposed. Oppositions must be filed at the European Patent Office within nine months after a patent is granted to be considered. The decision of the European Patent Office in an opposition of whether to maintain the patent or to revoke it is made by the opposition division of the European Patent Office. Decisions of the opposition division are not final if they are appealed, and once an appeal is filed, the patent continues to remain valid, even if revoked by the opposition division, until there is an appellate decision and no further appeal is possible. Appeals commonly take two years or more to reach a conclusion. Yesterday's decision by the opposition division to revoke European Patent 3827845 will not be a final decision if Janssen decides to appeal the decision. Only after such an appeal is decided, where there is a decision adverse to Janssen, would the patent be finally revoked. The same situation applies to Janssen's other European collaboration patent that was granted before European Patent 3827845, that was revoked by the opposition division in April 2023. The appeal of that decision is taking place in May 2025. Janssen's collaboration patents that are granted in the United States are unaffected by the opposition division decisions. Different collaboration patents and different patent laws apply in the United States. Janssen has six granted United States collaboration patents. The application of United States patent law would prevent a validity attack on Janssen's United States collaboration patents using the public disclosure that was relied upon by the opposition division in Europe. More specifically, United States patent law provides a one-year grace period for public disclosures by the patent owner before the priority date of the United States patents, and therefore cannot qualify as invalidating prior art for the United States patents. Turning now to slide five, which graphically represents Halozyme's projected royalties for sales of Darzalex subcutaneous outside the United States and Darzalex Faspro within the United States. The bars in the graph highlight that we are maintaining our prior royalty projections into 2032 for Darzalex subcutaneous and Darzalex Faspro. Janssen's collaboration patents extend the payment of royalties from 2030 into 2032. Since the patents remain valid unless revoked without the possibility of further appeal, we are maintaining our projections for royalties for Janssen's sales of Darzalex subcutaneous in Europe. Janssen's granted collaboration patents are valid and remain valid under our agreement unless they are finally revoked without any further possibility of appeal. As noted previously, the European opposition proceedings have no impact on our ability to continue to collect royalties on United States sales of Darzalex Faspro. As a result, we are maintaining our projections for royalties from worldwide sales of Darzalex Faspro and Darzalex subcutaneous into twenty thirty-two. Lastly, I want to explain with reference to slide six, why the revocation decisions do not have negative implications for other licensees obtaining future collaboration patents. To put it simply, Janssen publicly disclosed a clinical trial protocol before the priority date of its European patents. That public disclosure formed the primary basis of the legal analysis supporting the opposition division's revocation decisions, because some of the details of the clinical trial protocol were similar to those claimed in the patents. As a result, the hurdle was high under European patent law principles for Janssen to be able to argue non-obviousness or inventive step over the applicable prior art. In contrast, when unexpected results are obtained by other licensees for other co-formulations directed to other indications as evidence of non-obviousness, we are still very confident that new collaboration patents will continue to be obtained. The opposition division's decision did not alter the basic principles for patentability for future collaboration, inventions, and co-formulations. Due to the unique characteristics of every therapy or drug, the differentiated modes of action and methods of treatment, we do not expect prior non-obvious results to block the patentability for future innovations that utilize ENHANZE. What is non-obvious for any product is highly dependent upon the unique circumstances and known state-of-the-art for each product and therapy. I will now turn to the second topic for today's discussion, our exciting new patents covering modified human hyaluronidases. Moving to slide seven, I am very pleased to be able to tell you that Halozyme, the pioneer in developing human hyaluronidases for subcutaneous administration of medicines, has obtained multiple new patents that broadly cover modified human hyaluronidases that are other than and distinct from those patents that cover the truncated human hyaluronidase that we license as our ENHANZE technology. To highlight that these patents are separate and distinct from the patents we currently license for ENHANZE, we are referring to these patents as our MDASE patents. MDASE, spelled M-D-A-S-E, stands for Modified Hyaluronidase. The inventions covered by the MDASE patent portfolio can potentially be used to enable subcutaneous delivery of drugs and biologics in a manner similar to our ENHANZE technology. As I stated in my introduction, the MDASE patents represent a potential new licensing opportunity for Halozyme, in addition to our core licensing platform for ENHANZE technology. To the extent sellers of drugs and biologics cannot or decide not to engage with Halozyme on ENHANZE... The MDASE patents offer an opportunity to have access to Halozyme's pioneering intellectual property outside of ENHANZE through licensing the MDASE patents. Unlike the ENHANZE technology, Halozyme will not co-develop products or collaborate with MDASE licensees on their subcutaneous product development or supply active pharmaceutical ingredient for their MDASE licensed products. I will give you some more background on Halozyme's efforts that led to these new patent rights. Halozyme is the pioneer in developing human hyaluronidases for subcutaneous administration of medicines. Halozyme created the first soluble human-derived hyaluronidase that was active at neutral pH that we call ENHANZE. Our ENHANZE product is a truncated human hyaluronidase, but we did not stop there. Instead, Halozyme continued to innovate and experiment. Over many years and thousands and thousands of experiments, we created a very large and comprehensive library of modifications that can be made to human-derived hyaluronidases and characterize the effects of those modifications, including on stability and activity. That groundbreaking work and other research projects conducted by Halozyme created the technology protected by the MDASE patents. Given Halozyme's early pioneering efforts, these patents have priority dates going back to two thousand and twelve and will remain valid to twenty thirty-two outside the United States, with several of the MDASE patents in the United States remaining valid to twenty thirty-four. Why are we showcasing these patents now? As an intellectual property licensor, Halozyme is always looking for new opportunities to commercialize its discoveries and to enable others to bring forward new solutions and therapies that help patients. Although our ENHANZE technology is already the de-risked gold standard for conversion of intravenous therapies to subcutaneous administration, we recognize not every drug and biologic supplier might be able to or select to use ENHANZE. In those cases, the MDASE patents could open up new opportunities for licenses that importantly, do not impact our ENHANZE business when a modified human hyaluronidase is chosen by a drug or biologic supplier as an alternative to ENHANZE. Also, importantly, we will not be supplying any additional active pharmaceutical ingredient other than ENHANZE to licensees. Similarly, MDASE licenses will not result in the same type of partnered collaborations that we have with our licensees for ENHANZE. It's our expectation that we will only offer MDASE patent licenses to pharmaceutical companies that sell co-formulated or co-administered products in the same manner that we license our ENHANZE technology and that the licenses will be non-exclusive. Lastly, I will note that we are open to making available additional licenses to our high-volume auto-injector technology to our MDASE licensees and entering into high-volume auto-injector development collaborations with MDASE licensees for rapid, high-volume subcutaneous delivery. Our MDASE technology and the high-volume auto-injector technologies are complementary, and MDASE licensees may wish to use them together to potentially facilitate high-volume injections at fast rates. Today, I have provided more context to the recent opposition of Janssen's European Patent 3827845 and shared with you these new technology developments based on Halozyme's innovations. We look forward to our future and our existing and new opportunities to commercialize our discoveries and innovations to bring many more and better therapies to patients. Let me now turn it back over to Helen. Thank you, Mark. Our strong IP is one of the reasons I have such strong conviction in the exciting growth and revenue durability for Halozyme. Our extensive patent portfolio related to ENHANZE and the MDASE patents are a clear demonstration of our leadership as the inventor and innovator in the field of application of hyaluronidase to enable subcutaneous injection. Added to this, ENHANZE is the most technically, regulatorily, and commercially de-risked technology for rapid, large-volume subcutaneous drug delivery, with eight global approvals to date and soon to be 10. We are the gold standard. And finally, we are proud that ENHANZE has been used to treat more than eight hundred thousand patients, creating an extensive safety database and track record that sets a very hard standard to achieve. Operator, we will now open the call for questions. Thank you. The floor is now open for questions. At this time, if you have a question or comment, please press star one on your telephone keypad. If at any point your question is answered, you may remove yourself from the queue by pressing star two. Again, we kindly ask that you limit yourself to one question and that you pick up your handset when posing your questions to provide optimal sound quality. Our first question is coming from Brendan Smith with TD Cowen. Please go ahead. Hi, everyone. Thanks for taking the questions and thanks for putting this together this morning. Maybe just a couple quick ones from us. First, can you just confirm maybe what kind of driving the thinking behind the different strategies with the MDASE licenses, just in terms of being non-exclusive, and not, like, formally partnered in the way that you did with the ENHANZE products? And then just want to make sure that I'm understanding the co-formulation patent stuff in the EU correctly, that there's one revoked, and it seems like there's still one or more in place. Kind of just wondering what the material differences are, kind of, very high level between what's still there and what's not, so we can understand why this one was revoked. Thank you. Thanks, Brendan. I'll ask Mark to start actually addressing the question on the co-formulation patents in Europe for Darzalex. Thanks, Helen. Brendan, yes, we do. There is a third patent application that's pending in Europe, and Janssen is currently prosecuting that with the European Patent Office. It's based off the same parent application disclosure as the other two granted patents that were opposed, but they're currently working through the prosecution, patent prosecution process with the European Patent Office, and we're optimistic that they will have patentable subject matter. All right. And I'll just in terms of the thinking behind the ENHANZE and the MDASE, as we mentioned, we ENHANZE is clearly the gold standard for delivering subcutaneous drugs that require large volumes. And we do anticipate that we'll continue to license ENHANZE to new partners. But as Mark mentioned, we anticipate there could be sellers of drugs and biologics who can't or decide not to work with Halozyme on ENHANZE. And for those who are utilizing or wish to utilize our pioneering modified hyaluronidase IP, that's the circumstances where they can license the MDASE. Now we're doing that non-exclusively, and we also, because we are dedicated to our ENHANZE partners, will not be providing the type of support we do to our ENHANZE partners. So they, we won't be providing the alliance management support, which includes our team serving as advisors on formulation work, for example, or development pathways, and we will not be supplying API, but they will be able to license our pioneering IP. That's the core distinction, really. So, Brendan, I think the message is still ENHANZE is going to be the core for our growth. We're anticipating additional growth from there, but this is another offering for those people who can't or choose not to work with us on ENHANZE. Got it. Thanks very much. We'll hear next from Michael DiFiore with Evercore ISI. Please go ahead. Hi, guys. Thanks so much for taking my question and for hosting this call. Just two for me. Helen, would you be able to just elaborate why a partner company might opt to proceed via the MDASE route versus the regular ENHANE route? And as a follow-up, is this MDASE technology the same as the room temp Enha that you referenced before in prior calls? Thank you. Yeah, thanks for that, Michael. Yeah, as we mentioned, we do anticipate the majority of people will continue to work with us in ENHANZE. When we think of the great track record we have there, and all of the successes we've had. But there are circumstances, you know, we've anticipated, can identify, where a maker or seller of drugs or biologics cannot or decides not to work with us, on ENHANZE. We're not going to elaborate more on that at this point in time, but there are circumstances where that might happen. What we want to do with this offering today is to make people aware that our pioneering modified hyaluronidase IP is available for license for anyone who is using or plans to utilize modified hyaluronidases to be able to deliver large volume drugs subcutaneously. On the room temperature will not be part of the MDASE licenses. That is something that Halozyme will continue to exclusively own and be able to execute on. It is separate and will be separate from what will be available for licensees to gain from access to the MDASE patents. Okay, got it. Thanks so much. Next, we'll hear from the line of Vikram Purohit with Morgan Stanley. Please go ahead. Vikram, your line is open. Please check your mute button. Hi, thanks for taking our question. This is Morgan on for Vikram. I just wanted to understand if you are aware if Janssen plans to file an appeal for this E.U. patent, and if so, what their timeline is looking like? Thank you. Yeah, I'll ask Mark to address that. Thanks, Morgan. Thank you, Morgan. We're not sure if Janssen will file an appeal. That's their decision to be taken. Our expectation is that it is likely they will do that, as they have with the first co-formulation patent that they appealed. The timeline is that there will be a written decision that will come from the opposition division at the European Patent Office. That will take probably several weeks for that to come out, and then there'll be, I think it's sixty days for Janssen to make up its mind to file a notice of appeal and to appeal the decision. That then kicks off an appellate process that would probably go out for a minimum of two years. Okay, thank you very much. We'll go next to Mitchell Kapur with HC Wainwright. Please go ahead. Good morning, everyone. This is Dan on for Mitchell. We were wondering, what's the current development timeline for the MDASE portfolio, and are there any ENHANZE collaborators who have noted interest in collaborating with the MDASEs? Could you just discuss in general the interest in the MDASE collaboration? Thank you. ... Yeah, we haven't actually discussed the MDASE portfolio before today, really with any potential partners. And we don't envision that our current licensees will want to license the MDASE patents, as they're unlikely really to have any need or benefit from it. So this is just making people aware that for those people who are considering using a hyaluronidase to take a drug subcutaneous, a large volume drug subcutaneous, that these patents are available for them to license, as we have got such an extensive database for our pioneering modified hyaluronidase intellectual property. So nothing to report on that yet in terms of interest, but we certainly look forward to hearing anyone who wants to apply for a license based on today's announcements. Thank you. And now we'll hear from the line of Mohit Bansal with Wells Fargo. Please go ahead. Great. Thank you for taking my question, and thank you for all the color you provided today. So I have two questions related. So first, just wanted to make sure, verifying this, that Janssen had two European patents, and both have been revoked, and there is one more application that is pending. Is that correct? If you can confirm that. And the second part is, in an event that, you know, your assumption is that at least one of those co-formulation patents will remain intact. If it is not, how does it change your royalty stream? Because it seems like you have 2029 patent for ENHANZE, and then the collaboration was only going to go till 2032 anyway, so does this still impact the royalty stream after 2029? Thank you. Yeah, Mohit, I'll ask Mark to clarify with regard to the status of which patents are intact, in Europe at this period of time. Thank you, Helen. So Janssen has two granted European patents, and even though they've now both of those granted patents have been revoked by the opposition division at the European Patent Office, they're still valid patents. They're not technically invalidated at this stage. Janssen has decided to appeal the first of the two, and our expectation is that it's likely Janssen will appeal the second one of the two. While they're under appeal, again, the patents remain valid unless there's an appellate decision that finally revokes each of those patents. There is a third patent application that's pending. That's not subject to an opposition because it's not a granted patent yet, but it's under review and being prosecuted by Janssen at the European Patent Office. And as I indicated earlier, we're optimistic that they will be patentable subject matter. Yeah, and Mohit, in terms of our expectations for the royalty durability with Darzalex, as you heard from Mark, we see no expectation that we'll be in a circumstance where we'll see a change, and are projecting our royalty revenues out to 2032, because of the impact of the co-formulation patent. Got it. Thank you. Next, we'll hear from the line of Corinne Jenkins with Goldman Sachs. Please go ahead. Good morning, guys. A couple from us. Maybe if you could just expand directionally, at least, on what the economics look like for one of these licenses for the ENHANZE royalties, including would you anticipate any sort of revenue opportunity prior to the drug's approval? And then also, could you expand? You mentioned something about how this could work alongside your auto injector offering. Could you expand on that comment, and then would that apply only when paired with the MDASE licensees, or is that how you're going to be thinking about offering a high-volume auto injector from here? Thanks. Right, Corinne, just with regard to the economics, we're anticipating a similar structure to what we do today with ENHANZE. It would be a milestone with a royalty structure. This obviously is because the MDASE technology has the potential to be used to enable and facilitate subcutaneous administration of drugs and biologics, and this is where the value we're going to see of them, MDASE technology is going to be realized. Importantly, we're not supplying all of the support services we do today to our current partners, but there will be economics, to be specific to your question, before the approval of the drug because of the milestone structure. We're very excited about our high-volume auto-injector, as you know. For this to be able to be used, hyaluronidase will need to be partly co-formulated with the partner product, otherwise, you wouldn't be able to inject the 10 mL in just 30 seconds. And so, similarly to what we're offering today with ENHANZE partners, if somebody would like to get access to the high-volume auto-injector, we are going to be open and able to work with them on that. We haven't discussed or communicated specific terms with regard to that, but we are excited to, again, as we work towards our mission of making new therapies fit the patient's life, we do see that will be an additional valuable offering for a broader set of potential partners. Okay, thanks for clarifying. Once again, if you have a question, you may press star one on your telephone keypad at this time. We'll hear next from David Risinger with Leerink Partners. Please go ahead. Yeah, thanks so much for taking my question. So, Helen and team, if you could just help us better understand these MDASE patents. So, slide seven says they are separate patents, distinct from enhanced patents and not included in enhanced licenses. So maybe you could just provide some more color on why they're valuable, meaning if your current enhanced partners do not need them, why would other companies need access to these patents? And then, tied to that, if you were to license these enhanced, or sorry, these MDASE patents to a company like Alteogen, would they then be free to launch the subcutaneous Keytruda in the U.S. without facing litigation threats from Halozyme? Thanks so much. Yeah, I will answer the first one. I'll ask Mark to respond to the second one. I think maybe, David, what I can just begin with is that this relates to modified MDASE or modified human hyaluronidases that are actually different in their structure from ENHANZE. And so I think that's the important distinction, and that's why they are separate from our ENHANZE portfolio, because they're not the same structure. As Mark mentioned, ENHANZE is a truncated human hyaluronidase, and we did thousands and thousands of experiments where we created this large, comprehensive library of modifications and characterized the effect of those modifications, including what happened to stability and activity, as examples. That's what the MDASE patent portfolio is. And that's why it's distinct and separate from our ENHANZE patents. Now, as we mentioned, there are companies who cannot or might elect not to take a license for ENHANZE, but who do want to access our pioneering modified hyaluronidase intellectual property. And so those are for people who have structures that are different from ENHANZE, as you can imagine. And so that really is what we're making public and available today for those people who are doing work in that area, in products that are different from structurally ENHANZE. So hopefully that helps, and I'll turn to Mark now just to comment on the specific question on Alteogen. Yes. Thanks, Dave, David. The specifics with regard to potential licensees, we're not going to be discussing today. But as a general matter, if a license is granted to a party, then that would prevent, yeah, them from any kind of litigation surrounding those intellectual property rights. But as Helen has mentioned, the folks that we anticipate wanting to take a license are going to be suppliers of drugs and biologics that want to provide a co-formulated or co-administered product with the hyaluronidase. Thank you. As there are no further questions at this time, that will conclude our question and answer session, as well as today's Halozyme Therapeutics Investor Update call. Please disconnect your line at this time, and have a wonderful rest of your day.