For joining us. Good evening, everyone, and thank you for joining us. Today we're delighted to be hosting Helen from Halozyme, and just wanted to go ahead and kick off with the first question. For an opportunity for Helen to speak at a high level about the business operations and driving growth through pipeline candidates that you've laid out and through portfolio diversification through business development, would love if you could talk about the business and give us a broad overview. Yeah. Thanks for this opportunity. Halozyme is a profitable biotech company. We're focused on bringing forward disruptive solutions that can improve the treatment experience and potentially also improve outcomes. We do this through two drug delivery technologies that focus on subcutaneous delivery, and we also have a specialty pharmaceutical business as well. When we think about our drug delivery business, the two sub Qs, the first one is called ENHANZE, and the second one are through our proprietary differentiated auto-injectors. ENHANZE is the largest revenue driver for us today. This is the technology that when combined with leading companies' IV products, enables them to be given in rapid subcutaneous injections. We make money through royalties, which are on average mid-single digit, milestones, and also through product sales. Today with five approved products and what's very exciting about our pipeline is that in the next two years, by 2025, we anticipate four additional approvals, bringing us from five to nine products with royalty revenue streams for ENHANZE. These are very exciting products. All of them are approved as an IV already. The TAM that analysts project for these products by 2028 is $35 billion. Clearly what's going to matter for Halozyme is how much is going to be in the subQ. You can imagine that is a tremendous growth driver for us, for ENHANZE for the future. Behind that, we actually have another 10 products that are in development, two in phase III and another eight in phase I. Robust pipeline, and I will say we plan to sign additional deals to expand that pipeline even further this year. Our auto-injectors are differentiated in that they are highly reliable and can work for very viscous products. We've got approved products today, the largest of which is Teva's EpiPen, that's generating royalties as well as product sales. We have an exciting product in development from Idorsia, which is called selatogrel, that is for prevention of secondary MI. Nice volume of revenue coming from our small volume auto-injectors. These are for volumes up to 2.25 mLs. What excited us about acquiring the auto-injector platform was actually the ability to combine ENHANZE with the know-how on auto-injectors to create a novel auto-injector for the market, and that would be one that can deliver up to 10 mL in under one minute. We've been making very nice progress with that and hope to sign deals this year. We've got clinical data by middle of this year demonstrating feasibility, so that's another very nice opportunity to grow and drive the growth of the company. This will be an incredible year expanding our pipeline, advancing the candidates that are in development and signing additional deals. Great. Yeah. Thank you so much. I want to shift to one of the important products in your portfolio, DARZALEX. DARZALEX FASPRO, this quarter, you increased share of total DARZALEX sales as a percentage of total DARZALEX sales from 86% to 88%. Is there still room to grow, or do you think it's gonna be a pretty steady state from here? You've also pointed out the consensus estimates expect total DARZALEX sales to double from $8 billion in 2022 to $16 billion by 2028. Can you describe some of the downside risks to getting there? Yeah, let's think about that 88%. That's 88% share of sales in the United States is subQ DARZALEX today. I will say outside the U.S., it's over 80%. nine out of 10 patients in the United States today, when they get DARZALEX, get it as subQ. That's within three years of the launch. That's remarkable. Now I'll translate that to the analyst projections, which is going from $8 billion in revenues last year to $16 billion in revenues by 2028. That is driven by the subQ. That's where the growth is going to come. What is driving that is the assumption that the use of subQ is really helping aid the penetration into the frontline patients. Frontline patients, there are more of them, that's the largest population, but those patients also stay on therapy longer. This is why there's going to be a doubling of DARZALEX revenue between now and 2028 driven by the subQ. We do see a lot of excitement and growth there. In terms of downsides, you know, I really have to give a lot of credit to Janssen. They have done an amazing job generating the clinical data to establish DARZALEX as a backbone of therapy with multiple different regimens at every line of therapy. My projection is they're going to remain the mainstay of therapy, particularly in these early lines of therapy because of the strength of the data. We do ask questions about the evolution of CAR-Ts. I think all of those are advancements for patients. They tend to be today, relegated to being used in later line patients and will also, I think, because of the production challenges, not be able to expand into the very large populations in front line. I don't see a lot of downsides there. It's a remarkable drug doing a lot of good for a lot of patients. Yeah. Then you also pointed out earlier the 5 to 10 milliliter capacity that you have. Can you sort of lay out in your different waves, you've laid out like Wave 2, Wave 3, Wave 4, of those waves and the different product candidates within each one of those, what proportion falls into that sort of bucket? Yeah, I so we can talk about the commercialized products. For a lot of our products that are in development, the partners have not disclosed the volume as yet. I would say as an example, Herceptin is more in the 5 ml range. Phesgo, which is Roche's fixed-dose combination of Perjeta and Herceptin, is at 10 mls. That will give you some example that there certainly are products in our portfolio today that are of those ranges. What is amazing about ENHANZE is we can inject volumes of up to 300 mls- 600 mls in one setting. ENHANZE on its own is going to be able to continue to be driving larger volumes. We see the high volume auto-injector working with the patients, or the products where it's 5 to 10 mls, and then we also have our small volume auto-injectors as well. We're covering a very wide range of patient needs in terms of being able to deliver subcutaneously, tend to be much shorter injections, tend to be associated with lower patient burden and also less cost for the healthcare system. Very, very nice offerings across the board. Yeah. I think on your last couple earnings calls, you've talked about some new deals that you'd like to explore and sign. Maybe if you can give an overview of what those are and why you're looking to explore those. Yeah. We continue to look to expand our portfolio. We can grow with our current partners. I'll just say that our current ENHANZE partners tend to take exclusive rights to access use of ENHANZE with a specific target. All of our current partners, and we have 12 today, there are 20 open slots. We do expect two targets to advance into the clinic this year, more potentially next year. We're going to grow and expand by our current partners moving more products into the clinic. We're also in active discussions with a wide range of biotech and pharma, talking about the benefits of ENHANZE alone if it's a higher volume drug, ENHANZE with high volume auto-injector if it's going to be that 5 mls-10 mls, or the small volume auto-injector, depending on what the partner needs are. We're actively in conversations. We do expect and plan to sign deals in each of those categories this year. I will say there's a particular interest in the high volume auto-injector because there's nothing quite like that in the market today. People frequently say to us, like, "We've always wanted something like this." We're very excited about that opportunity. We signed the deal with Antares in May of last year. We had a working prototype in place by December, which we took into animal testing. We're very excited that by the middle of this year, we expect to report out human feasibility testing for our high volume auto-injector. The way it will work is we plan to sign an agreement with a partner, and they will then customize exactly what they want that high volume auto-injector to be like. What is their volume? What kind of primary container do they want? What needle depth, et cetera? Look for that this year as we talk with a wide range of people with regard to moving forward with us to take this high volume auto-injector from prototype to an actual development stage device and then to a commercial stage device. Great. In terms of one of the pipeline candidates, argenx's VYVGART, they have CIDP data that's now expected in July of 2023, so it got delayed a little bit from the second quarter. Can you give us an idea of next steps, assuming the data reads out positive? I guess when could we see them achieve approval and ultimately launch? The CIDP data, this was an event-driven study, which is why they couldn't be absolutely exact as to when they would get to the target number of events. They did announce this week or last week that they have reached that. They're now going through the process of data collection and cleaning. That really is what is causing this timeline to July to make sure that is done appropriately, particularly as the study is ongoing. There are patients still being treated. They want to assure the integrity of the study. Generally, argenx hasn't given a timeline. All I'm talking about is my experience here. The time from database lock, final lock to submission is anything usually from 3 to 6 months. There is the potential for a submission later this year, I would say in CIDP. I would expect a 10-month review clock. This could be a potential launch in 2024. Again, I'll stress argenx hasn't provided specific timelines on that. Yeah. Shifting to the VYVGART subQ for myasthenia gravis, can you share why you might have confidence that it could get approved in the June PDUFA date? I guess this might be a more important product in terms of the revenue potential? Certainly the myasthenia gravis indication, just based on the prevalence of that particular autoimmune disease and the need, it represents a very attractive opportunity. Analysts are now projecting overall VYVGART with all its indications to get to about $7 billion in revenue by 2027, and a large proportion of that is in the generalized myasthenia gravis indication. The IV form was approved about just over a year ago. Very nice uptake in its first year, $401 million, and very nice sequential growth between fourth quarter and first quarter. I think with the IV, they're very nicely demonstrating that this mechanism of action, the anti-FcRn, is offering something important for patients. The way it works with the development of the sub-Qs, what argenx has done is to do a bridging strategy. Once the IV is approved, that, the FDA has a database that gives them a lot of information about efficacy, but even more importantly, the safety of the product. When our partners are developing sub-Q, they tend to do a phase I study to pick the dose of sub-Q, where they're trying to make sure that whatever parameter they're trying to demonstrate is similar between the IV and sub-Q, that they've picked the right dose to achieve that. For argenx, for the program, they got agreement with the FDA to do to show similarity between the IV and the sub-Q. They actually are measuring reduction in IgG levels, which is one of the markers of efficacy as you're trying to reduce the autoantibodies that are causing the myasthenia gravis. They've already reported out the data to show that they did achieve the primary endpoint of the subQ study, which was a reduction in the IgG levels. Because of met the primary endpoint and had discussions with the FDA with regard to the study, they obviously have gone forward to do that submission. We're not privy to the conversations that are happening, so I can't really comment beyond that. But certainly argenx has said they feel very confident in the study design and the quality of the data that they have submitted. And on their recent call, they also commented that they are gearing up for the launch. All of those I take as good signs that we're going to see the approval and the PDUFA date of June 20th with a subsequent launch thereafter. One last question on argenx before I move on to another one of your partners. The other two opportunities with four key data readouts are in idiopathic thrombocytopenic purpura and pemphigus. Can you frame these opportunities in these indications for investors? I mentioned that generalized myasthenia gravis was the biggest indication. There's an estimated, according to argenx, 63,000 patients with a addressable disease in the United States. Interestingly, idiopathic thrombocytopenic purpura is one of the next largest indications with over 55,000 patients. Almost the same size as generalized myasthenia gravis. Pemphigus is a smaller indication. It's about a quarter of the size. In all of these indications, they are serious autoimmune diseases. Patients have limited choices today, often steroids, immunoglobulins. They don't get persistent responses over a long period of time. High unmet need. I think we're going to see some very nice response to the data in each of these indications, should it be positive when it reads out. ITP and pemphigus in the fourth quarter and, you know, a doubling of the opportunity there, if those are positive compared to just the generalized myasthenia gravis. As you probably know, it's a strategy to add even more indications. I think Tim, who is the CEO of argenx, has talked about 12 to 16 indications. There is just a huge unmet need, and this is the first in-class anti-FcRn, and I think it's going to be expanding its uses over the next several years. Yeah. I just wanted to go back to something you said at the beginning about Teva's EpiPen partnership with Halozyme. I'd love to hear more about that from you. Maybe it's the Teva analyst in me, but I'd love to get your thoughts on it. Yeah. We are the manufacturer of the EpiPen that Teva is using for it's for prevention of allergic reactions. It's a very nice demonstration of one of the points of differentiation of the auto-injector platform. You can imagine if you've got these severe allergic situations, you want to have a high confidence that what you're going to inject is going to work. We are very happy that we produce the highest reliability auto-injectors you can get on the marketplace. That is why Teva is partnered with us and why we have this high degree of reliability, is to make sure that patients can have confidence in the acute setting where they need to inject themselves, that it is it is gonna work. How do you see that in terms of revenue potential for Halozyme? Maybe if you could frame that opportunity. Yeah. This is a mature product and so, it's reached a very nice share in the marketplace, and it's not one we see as growing, but it's contributing revenues to Halozyme today in two ways. One is we receive royalties, but we also make money on product sales. Think of it as a nice stable backbone for the future for generating a nice amount of revenue for us. Yeah. One point on when the PDUFA date for VYVGART was delayed, you mentioned that it doesn't impact your guidance because of the timing of the milestone payments. Was there any expected shifting of royalty revenue from the launch timing, or for most of your launches, do you typically like estimate a slower ramp rate, and so it's negligible for pretty much all of your products in the early stages in your forecasting? Yeah. With regard to VYVGART, for our guidance this year, we did include an approval milestone, so that did shift from the 1st quarter to the 2nd quarter. We were conservative with regard to the royalties. That is just knowing the U.S. system, it can sometimes take a period of time for reimbursement to get in place and for physicians to be comfortable. We have a de minimis amount of revenue in for royalties in 2023, expecting the ramp in 2024. I'll just say we have another approval this year, subcutaneous atezolizumab, same type of thing. The PDUFA date is September 15th, so we have a milestone in for that, and we actually have no royalties in this year for atezolizumab because of the approval and launch year happening close to the 4th quarter. little bit of. Yeah. A conservative, approach there. Moving on to Roche, your partner with subQ Tecentriq, it has a PDUFA date in September 2023, and Roche expects it to be the only subQ anti-PD-L1 on the market for a full year. Maybe if you could share some of your expectations regarding expected conversion rate from IV, maybe both at peak and 1 year. The IV, atezolizumab, is usually administered over the actual infusion time over 30-60 seconds. With the subQ, that's going to be able to be done in just 7 minutes. When we think about the settings where atezolizumab is used, they have a series of indications that are either alone or with oral therapy, and that includes the indications of some of the types of non-small cell lung cancer, as well as melanoma. That, I think, is going to be a great place. There's gonna be patients with cancer who are going to be able to receive PD-L1 with whichever chemotherapy without having to go to a hospital infusion suite. That's just gonna be remarkable for patients. That is a very clear and exciting setting. Atezolizumab is also used in settings with IV chemotherapy. Those would be indications, some non-small cell lung cancer, but also hepatocellular carcinoma. There the patients are receiving IVs often sequentially, which can be quite a long time, and if any of you have had family members who have gone to infusion suites, it is a tiring, exhausting place to be. The ability for giving the atezolizumab in just seven minutes after the IVs, as an example, will be meaningful for patients, but it'll also free up the chair in the infusion suite. We see great reasons for use in both of those settings. Roche has not given out any specific guidance as to what they think the peak conversion will be, but I will say from the point of view of adoption, we have consistently seen very rapid adoption outside the U.S.. Outside the U.S., where there's a very strong focus on the overall cost of care, subQ, because of the much shorter infusion time, and the reduced healthcare resource utilization, gets adopted very fast, and the conversion happens fast. In the U.S., we see a range of adoption. DARZALEX is a great example when 50% had converted in five months. That was a great example. Phesgo has been a slower uptake because each clinic is making their own decisions how to implement it and adopt it. Bottom line, both outside the U.S. and in the U.S., just like with Phesgo, we're going to see over time a very nice adoption, I believe, of Tecentriq because of what it means for patients, number one, but also what it's doing for the healthcare system in freeing up chairs for patients as well as allowing patients to be treated in the doctor's office outside the expensive setting of the infusion suites. The other product I wanted to touch on was XYOSTED. Maybe if you can lay out, you know, maybe what the product does and how you think about it as well as conversion for that. Is that going to be a quicker conversion rate or a slower and why? XYOSTED is one of the products that we acquired when we acquired Antares. It's a great demonstration of the auto-injector technology. It actually is an oil. Patients are injecting subcutaneously an oil that includes testosterone replacement treatment of about 1 ml in seconds. The way this market works is about 8.5 million TRXs written every year for testosterone replacement. The majority of those today are intramuscular. The patient has to draw up from a vial, go through all of the making sure they're giving the right dose, and then inject into the buttock. Instead of that, with our auto-injector, they simply twist off the cap, put it on their leg, press a button, and in seconds, that's them treated. They can carry it around with them. They can self-inject anywhere. The whole goal with XYOSTED is to convert this IM market into the subQ. For the patient, it's virtually painless. Let me tell you, 99.4% of men felt no pain with the sub Q auto-injector. Lots of reasons for why we'll get this conversion. Today, we are under 5% share of this market, so huge opportunity for us to grow. Recently attended an ad board and just incredible enthusiasm and recognition of for many patients how this is going to be a great option for them to start and stay on testosterone therapy. Our focus there is really on the switching, making sure that we've got coverage and affordability in place. The IM I mentioned is generic. Patients will most likely have to go through the generic first, but the generic doesn't always work, and the patient can't always take it. What we want to do is make sure that we have got the programs in place to make sure that when a physician writes a script for XYOSTED, it gets covered and the patient can afford it, and that's where our focus is with XYOSTED. Our goal is to get to $100 million in revenue for XYOSTED this year. That will be about 20% increase from the run rate that we saw after the acquisition, and we project growth to continue from there. Yeah. Next I wanted to touch on IRA, and I know you've mentioned on the earnings call multiple times that you're waiting on guidelines before you share some thoughts. I wanted to ask it in a different way maybe. How are you sort of preparing the business ahead of the guidelines and maybe in a defensive way, particularly on potential adverse event impacts from on products which have co-formulation patents? How are you preparing for it ahead of guidelines? One of the benefits of our business, I started by saying we've got 20 products. The first defense is we have a very diverse portfolio. The IRA is going to impact the highest cost drugs in Medicare, and so by any means, that's only potentially, depending on how the guidance come out, is only going to impact one or two of our drugs. I think our best defense is to continue what we're doing, adding new product launches and assuring that those launches are successful because of the value and differentiation that subQ is going to bring. Let me just say a word, though, about some of the opportunity we also see. For the IRA, one of the biggest questions that's coming up is will subQ be treated differently from IV in terms of bundling it together to say, "Is it one of the largest drugs?" When we make a product with a partner, we co-formulate it and create a fixed-dose combination. In the IRA guidance for Part D, that we do not know yet if it'll apply to Part B, but it's an important distinction, we fit the description of two active ingredients. The rHuPH20 is active in enabling the subQ delivery, it also can bring additional benefits, such as reducing infusion-related reactions. In terms of preparation for the IRA, we want to be communicating broadly, including to key decision makers, how this is an advance for patients and how the rHuPH20 is directly driving that, by allowing the subQ, by reducing infusion reactions, by reducing the cost of healthcare. That will be another action that we will be taking, to help people distinguish and then recognize subQ should be kept separate from IV because it is independently bringing benefits for patients. Yeah. In terms of the second half of 2023 weighted milestones beginning in 2Q, maybe if you can provide us with some cadence, commentary on how you see that going from 2Q through 4Q? For our milestones, we had indicated for this year with the move of the VYVGART approval, we weren't expecting any milestones in the first quarter. We do expect at least one milestone in the second quarter, which is for the VYVGART approval. We see the rest of the milestones, which will be at a similar level in total to 2022 occurring in the second half of the year. The rest of our revenues, we do expect quarter-on-quarter growth in the royalty revenues. Our product sales will also see a step-up in the second quarter and remain pretty flat for the rest of the year. We're very happy with our guidance for this year, $815 million-$845 million as our revenue guidance, which is quite substantial. That's some 23%-28% increase over last year. This is really driven by the diversified business we started, our ENHANZE being the key driver, but the auto-injector revenues as well playing an important role together with our specialty commercial products. Yeah. Now, I know you were joking before we got started about this next question. With the stock trading, you know, around 52-week lows, and today was actually a great day 'cause you reported earnings yesterday and the stock is actually up 10%. You know, it's $35 a share approximately, and so it's trading around a low, low point. Wanted to give you an opportunity maybe to convince investors that this is a business to remain excited about. What do you think that they're misunderstanding, and what should they be focused on going ahead? Our fundamentals are unchanged. We have, as I started the presentation, an incredibly exciting set of catalysts over the next year and years that's going to result in very strong revenue growth for the company. Let's just think about this year. We'll go from having five approved products to seven approved products. We've got multiple additional data readouts this year as well, and we've got growth in as an example, our commercial portfolio. I think it's a little bit of an overreaction, obviously, to the IRA and just the uncertainty that came because of that. Our excitement and our projections, including the potential for $1 billion in royalty revenues in 2027, is unchanged. I would say this is a great buying opportunity for Halozyme. Yeah. If people are interested in the stock, there aren't many, I think, stocks you would find that with as exciting set of catalysts as we have. Maybe two questions. Let me start with the first one. On the mid-single-digit royalties that you mentioned, are there some products that are maybe that you have more favorable economics on and that might have more upside if they perform well as opposed to some of the other products in the portfolio? Across our products, it's on average a mid-single-digit royalty. Some of them are a little bit of a difference within that range, but I would say no, that's a pretty standard thing across our portfolio to have that mid-single-digit royalty for ENHANZE. Mm-hmm. There's different royalty structures on the auto-injector platform. ENHANZE is our key revenue driver today. I guess, to close, like, we have 20 seconds left, so maybe if you can talk about capital allocation priorities and then what can wrap it up. Yes. We've been very consistent in investing in our business, doing share buybacks. We've now completed $500 million of the $750 million planned share buyback. For the rest of the year, we'll continue to evaluate opportunity for M&A. We have a lot of free cash flow. We like to use that to do the appropriate M&A that would add ideally licensing platforms that can add then to and extend the revenue trajectory for Halozyme. Great. Thank you so much, Helen. Thank you all for joining us today. Hope you have a great day.