Halozyme Therapeutics, Inc. (HALO)
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Goldman Sachs 45th Annual Global Healthcare Conference

Jun 11, 2024

Moderator

Beautiful. Thanks so much for joining us this morning at the Global Healthcare Conference, and thank you so much, Helen, for joining us from Halozyme. Maybe we'll just start. I think perhaps it's easiest always just to start with an overview. So if you could, an overview of the company and the key competencies that you guys have.

Helen Torley
CEO, Halozyme Therapeutics

Yeah. So with Halozyme, our vision is to transform the treatment experience for patients receiving high-volume biologics, to allow them to receive their treatment in a way that fits their life, rather than to have the restrictive approach to IV treatment dictate how they're recovering from whatever disease they have. We do this with our subcutaneous delivery technologies that instead of hour-long IV infusions, allow patients to receive treatment via short subcutaneous injection, often in just minutes. And we know this is strongly preferred by patients. Many studies have been done now that show that over 90% of patients prefer subcutaneous delivery over IV. The approach to subcutaneous delivery is very well established in oncology, and we're seeing growing momentum in inflammation and immunology and neurology areas as well, which is just incredibly exciting.

Now, that's the core of our business, our ENHANZE business. We also have auto-injectors. Just to say, we have got seven approved products already. With ENHANZE, we're expecting two more approvals this year and 1 more approval in 2025. So that'll be 10 approved products by the end of 2025, and we've generated a lot of experience, obviously, with this. With more than 800,000 patients treated, we have a well-established safety database, and we've demonstrated strong market acceptance and commercial success, which is very, very exciting. Our business model is simple: We license our technologies to leading companies to allow them to transform their IV drugs to subcutaneous, and we receive, on average, a mid-single-digit on royalties on the net sales of the products. And this is what's driving the strong momentum of the revenue at Halozyme.

We recently updated our 2024 guidance, and if you look at our website, you can also see guidance that goes out to 2028, or an outlook, a five-year outlook, that is driven primarily by the expected growth and momentum of the ENHANZE business, our auto-injectors, and we also have a commercial business as well. So all of those are what's driving, I think, a very exciting growth story for Halozyme. And I'm sure we're going to talk about some-

Moderator

Yeah

Helen Torley
CEO, Halozyme Therapeutics

... of those opportunities in more detail in a moment.

Moderator

Yeah. You referenced the guidance. You just, you took the step of introducing a multiyear guidance earlier this year. You updated it last week. Maybe talk to us first about, like, why you felt this was an appropriate time to put out that kind of guidance, and then we'll talk about some of the details.

Helen Torley
CEO, Halozyme Therapeutics

Yeah. At the beginning of the year, I was reflecting on my 10-year tenure at Halozyme, and I realized that I was more excited at any time in my history at Halozyme on the opportunities that lie ahead for us. And so we were at the beginning of the year, and I realized I had unique insights really into the growth drivers, our accomplishments, and where the company was going to be able to go. And so we wanted to establish a forum where we'd be able to provide more insights and detail on that and share that excitement and the story of where this growth would come from. So we did the investor event in January and shared the guidance.

We actually, at the start of the year, had a vision that we would use it again, and I'm very pleased to say that came true just last week, when we were also able to share an update on the issues of an EU patent that allowed us to further update the guidance. And so, we're going to use that forum, Corinne, to be able to share meaty news, and we have lots going on at Halozyme, so expect more updates throughout the year as we find those events that we want to make sure we can share with our investors so that everybody understands the business we have, because we have a very exciting business that on the face of it looks simple. We're a licensing business. We've got great technologies.

We've got great IP, but it's the nuances that we find sometimes that can lead to lots of questions, and I'll just use an example of the 2024 revenue. We were getting lots of questions about the loss of exclusivity of our composition of matter patent in Europe. We used that forum in January to have our Chief Legal Officer, Mark Snyder, walk everybody through the co-formulation patents because those are just a unique feature of our business that allow us to have durable revenues at the mid-single-digit royalty rate, without a step down, except in the case of Janssen. And it was very good, I think, for our investors to get that level of detail, have everybody understand just-

Moderator

Mm-hmm

Helen Torley
CEO, Halozyme Therapeutics

... what a unique business model we have and the amazing long durability of revenues that we're going to have.

Moderator

Yeah. The guidance you shared was very detailed, but maybe you could give us some of the highlights in your view, in terms of revenue growth or EBITDA growth, and also what was the update last year or last week? What it is.

Helen Torley
CEO, Halozyme Therapeutics

Yeah, let me start with the update last week because when we'd given the guidance in January, we had projected it predominantly driven by the royalties on the Wave one and two and three products. Now, the Wave two products are DARZALEX and Phesgo, and then the Wave three products are the five products that are launching between 2023 and 2025. We chose to focus on those products because they were largely de-risked. All of those products, and it's ten products in total, have either launched, have positive phase 3 data, or with the exception of amivantamab, which now also has positive phase 3 data. So an amazing track record of success there, and that is a driver of our strong revenue growth and royalty revenue growth. Now, I mentioned the dynamics of the co-formulation patent.

What we chose to do in that presentation was also show that for all of the products, except for DARZALEX, there was no step down, and that showed that all of these were continuing with the mid-single-digit royalty rate till at least 2030 in all cases, out past 2030 in a number of cases-

Moderator

Mm-hmm

Helen Torley
CEO, Halozyme Therapeutics

... and even out to 2040, in the case of VYVGART and Tecentriq. The one product that we did show a step down was DARZALEX. That's a unique contract, as we'd shown, and in our guidance, we had shown a step down by 50% in 2024. Now, what was exciting about what we announced last week was we had a new European patent issued. This is covering the product that is produced from our manufacturing process. And excitingly, this will now stop the step down for the DARZALEX. It will maintain now at the original royalty rate out till March of 2029, and it was that difference that allowed us to update our guidance last week.

So we're now showing, for example, royalty rate growth between 2023 and 2028 has a CAGR of 20%, achieving $1 billion by 2027, just to give an example. Our total revenues are over $1.5 billion by 2027 as well. So just amazing growth and with a highly profitable business, and so our EBITDA growth is even stronger and going very nicely and enabling our business.

Moderator

Perfect. There is a similar patent under consideration here in the U.S., so maybe just talk to us about what could play out with that patent this year and how it would impact the guidance if it, if it did so?

Helen Torley
CEO, Halozyme Therapeutics

Yes, so for the U.S., there's also a patent pending around the product produced from the manufacturing process. This is a slightly different process in the United States. We filed this also last year, and we expect that to be taken up by the patent office this year. Now, what we can't be certain of is the exact timing-

Moderator

Mm-hmm.

Helen Torley
CEO, Halozyme Therapeutics

as to how long it's going to take the U.S. Patent Office to review it. What's going to be very important to us are the claims that are ultimately granted, if that patent is granted. But I will say that our legal team has got strong confidence in this reissue patent being issued. Once again, if the claims are similar to what we saw in Europe, that is going to prevent a step down in the U.S. royalty rate for Janssen, which is set to step down in 2027. But in the case of this patent issuing, would maintain the royalty rate until 2029 at the full mid-single digit royalty. High confidence that's going to issue.

Moderator

Mm-hmm.

Helen Torley
CEO, Halozyme Therapeutics

But we don't make that presumption. So in our projections at this point in time, until the patent issues, we will not be updating-

Moderator

Sure

Helen Torley
CEO, Halozyme Therapeutics

... it to show the reflection of what is very nice value. And let me just dimensionalize the impact of some of these patents, because for Europe, we project that the increase in revenues in 2025 will be $55 million. In 2028, it's $100 million. Now, I want to put that in context and think about it, so that that actually is equivalent to us signing a new deal, the product already being a blockbuster, and us beginning to drive revenue from day one. Substantial revenue for day one. So you can see the value of-

Moderator

Mm-hmm

Helen Torley
CEO, Halozyme Therapeutics

... these patents, given we're working with such exciting products like DARZALEX.

Moderator

Sure. So we'll come to some of the commercial products in a minute, but I want to talk for a second about business development. Obviously, this is a kind of key driver of your business, kind of in the 2030 and beyond-

Helen Torley
CEO, Halozyme Therapeutics

Mm-hmm

Moderator

In particular. So you've spoken at the recent quarterly update about a number of late-stage conversations regarding potential pipeline deals across your portfolio. Maybe you could provide an update on the status for kind of conversations in that realm.

Helen Torley
CEO, Halozyme Therapeutics

Yes. So, I will say we're in conversations with multiple companies, and one thing I can say for certain is that we are the gold standard for rapid subcutaneous delivery of biologics. There's that comes from the seven products that are now approved, and importantly, the $hundreds of millions, if not $billions, of dollars of value we've helped create for partners by either helping expand the market, or add to their competitive differentiation. And so we gave an update on our last quarterly in terms discussion. That's a stage that happens before we move to negotiation of the... Some technical discussions with another set of companies. Everybody seeking to use the technology to be able to enable rapid subcutaneous delivery of their biologics.

We're talking to a range of companies, from big pharma to midcap biotechs, with people really jumping on the trend that we're seeing is just increasing to recognize that subQ delivery is the way of the future in multiple—I mentioned earlier, oncology, neurology, inflammation. The recognition of the benefit for patients, also for the healthcare system, but also competitive differentiation is really top of mind for just a broad range of companies.

Moderator

Yeah.

Helen Torley
CEO, Halozyme Therapeutics

Very happy with the progress, very happy with the set of opportunities that we have ahead of us there.

Moderator

Maybe you just answered this question a little bit, but if you could, give us a flavor of where you're fielding the most interest with respect to the kinds of partners, but the kind of products also seeking to make into a subcutaneous formulation.

Helen Torley
CEO, Halozyme Therapeutics

Yes. So, yeah, I did mention it just in terms of talking to pharma, talking to midcap biotech. We've traditionally worked mostly with monoclonal antibodies. I would say that has expanded to conversations also including bispecifics, antibody drug conjugates, RNA therapies, and the more innovative therapies like nucleic acids, with people really wanting to understand the full impact that ENHANZE can have-

Moderator

Sure

Helen Torley
CEO, Halozyme Therapeutics

... on their clinical profile. And one thing that's very exciting is many companies have used the subQ technology to be able to convert from already approved IV, which is terrific. We have a very clear and rapid path for that, and we're 11 for 11 success in companies doing that. We're more and more talking to companies who are thinking subQ from the start. And subQ from the start is something we've always talked about, but we're now seeing more interest in that. And why that's important is, if you do subQ from the start, you get to optimize your dose. When you're delivering subQ with ENHANZE, we cause the Cmax, so the peak concentration in the blood, to be lower.

You get a more extended profile, and if you can balance that safety-efficacy profile, you can actually turn out with a much better clinical profile from the drug than if you are restricted to what was the dose you chose to do IV. And so those are the types of conversations we're having. I'm sure we're gonna talk about amivantamab and lymphatic trafficking-

Moderator

Yep.

Helen Torley
CEO, Halozyme Therapeutics

-in a moment, but that actually has been an area. Just does deliver subQ, but you can profile. That, that, that's, that's a value add.

Moderator

Sure. And how should we think about the cadence of new partnerships this year, both with respect to the ENHANZE co-formulations, but also the auto-injector business you bought a couple years ago?

Helen Torley
CEO, Halozyme Therapeutics

Yeah, very happy with the set of opportunities we have. I like to say, trying to peg exact timing is a fool's game. It's a, you know, really hard to do, but, with the set of opportunities, I'm very confident in what I will say.

Moderator

Okay. In terms of in this space, but how are you seeing the competitive landscape over the past couple of years as compared to when you first got into it?

Helen Torley
CEO, Halozyme Therapeutics

Yeah, I mean, once again, as we have such a strong lead in this area, obviously with seven approved products, soon to be 10, and the fact that we now have over 800,000 patients that have been exposed, what we're finding is very much that pharma companies and biotech companies, they're risk-averse. They want something that's tried and tested. They want a clear regulatory pathway. And so we definitely are the gold standard here, and that's why people come to us.

Moderator

Okay. Maybe we'll talk about some of the specific products. You have to start with DARZALEX, right? So since its approval in 2020, it's obviously been a very successful product for both you and for Johnson & Johnson. How do you think about the drivers of growth from here, particularly given the conversion rate is already quite high?

Helen Torley
CEO, Halozyme Therapeutics

Yeah, as you point out, this really is a remarkable story. So we're four years into the launch for the subQ version, which was in 2020. So we're really at the start of what's going to be an incredible continued growth journey with DARZALEX. Last year, the sales were about $9.7 billion. If we look at what and most of that is the subQ, because as you point out, over 90% conversion in the U.S., over 80% outside the U.S.

Moderator

Okay.

Helen Torley
CEO, Halozyme Therapeutics

Now, analysts project we're going to see the DARZALEX dollars by 2028. We agree with that, and the driver of that is the ability, with the subQ, to further increase penetration into the front-line population, and importantly, patients in the front line stay on therapy far longer. And so if you imagine that that growth, the $8 billion, is virtually all subQ, that is just, I think, phenomenal growth. Think about it, $8 billion, we receive on average a mid-single-digit royalty in Europe now to 2029. Strong probability-

Moderator

Okay.

Helen Torley
CEO, Halozyme Therapeutics

-that's going to be the case until 2029 in the U.S. as well. That is exciting about the continued growth-

Moderator

Yeah.

Helen Torley
CEO, Halozyme Therapeutics

and we're excited for a phenomenal job that Janssen has done and their great vision with even a new frontline indication pending-

Moderator

Yeah

Helen Torley
CEO, Halozyme Therapeutics

... with the FDA, that I think is going to further accelerate this potential to add another $8 billion in 4 years.

Moderator

Yeah. Another one of the products is Phesgo. Obviously, that's begun to contribute more meaningfully in the past couple of years. You've highlighted that improvement in conversion in the U.S. I guess, where do you think the natural peak is in terms of U.S. conversion, and what are some of the factors that drive that?

Helen Torley
CEO, Halozyme Therapeutics

Yeah, another ENHANZE success story, and for people who are less familiar with Phesgo, this is Roche's product, which is Herceptin and Perjeta, which is for breast cancer patients, where with the subQ, it transforms the treatment experience from hours for sequential IV treatments to just five to eight minutes for the subQ. So, strong patient preference for this. Over 85% of women prefer to receive the subQ because of the shorter treatment duration, but more comfort in receiving their treatment as well. And so 40% global conversion, that has just been a great growth story, quarter-over-quarter sequential growth there. And we expect to continue to see that, frankly, to continue to grow.

I don't want to put a cap on it, Corinne, because it's just has demonstrated this ability in the U.S. and outside the U.S. to have more and more clinics adopting it and increasing the penetration within the clinic because of the very strong value proposition, but also the patient preference for this therapy.

Moderator

Yeah.

Helen Torley
CEO, Halozyme Therapeutics

So, a lot more to come with Phesgo as well.

Moderator

As we look at those two products, how do you think about read-through to other near-term oncology launches? We've got Tecentriq and Opdivo upcoming, and how do you think about the opportunity set for those agents in terms of conversion?

Helen Torley
CEO, Halozyme Therapeutics

Yes, Opdivo, so Bristol's nivolumab, $9 billion in revenue last year. Now, we know the PDUFA date is going to be December of this year, and Bristol has talked about the fact that on approval, there is going to be about 75% of the opportunity covered by the initial label. And so, that's a phenomenal opportunity of the 75%, of the $9 billion. Once again, analysts are projecting that to grow to $13 billion over the next several years, and so, we again, a value proposition, which is going to take our long therapy. A very strong one there, and we, we do see very nice uptake happening there.

Similarly for Tecentriq, and this will be the fourth launch for Roche, who have got great, deep experience and has demonstrated strong success with flexibilities to convert markets to subq, particularly outside the U.S., but with Phesgo, as we've just talked about, also seeing success in U.S. as well. So I'm very excited about once again, the value proposition and what we're going to see with conversion, where those two products are going to be about $20 billion in addressable market by analyst projections by 2028. So it's another very large opportunity for SC conversion for us to add to the revenues.

Moderator

I think there's also been some experience with Phesgo about biosimilars and the introduction of things like that. So talk to us about how, what you've seen with the biosimilar context and how that would impact your expectations for both Opdivo and Tecentriq over time.

Helen Torley
CEO, Halozyme Therapeutics

Yeah, I'll talk about actually maybe Herceptin and biosimilars, because we get recently updates from Roche with regard to how that's going, and that Herceptin launched in Europe in about 2013, 2014. Biosimilars came in 2017, 2018. They'd converted the market to 60% subq by the time biosimilars came in, and there was an onslaught of biosimilars, three or four, very quickly, lots of price erosion. To this day, so from 2020, 2018 to today, what Roche tells us is that the subq share is sticky. Once a clinic in Europe has moved to a subq, they're not going back, despite the fact that there is price difference for the biosimilar-

Moderator

Sure

Helen Torley
CEO, Halozyme Therapeutics

... and there's no pressure from the health authorities, and that's because delivering subq reduces the overall cost of care so meaningfully, and the patient preference is so strong for subq, that biosimilars did not take over, those converted markets. And so for companies, I think that's a very important thing people are considering, is the ability for the patients to remain on subq and a lot of drivers supporting that, rather than biosimilars, where the price just is chased down into the-

Moderator

Sure

Helen Torley
CEO, Halozyme Therapeutics

... into the ground.

Moderator

Sure. We're also monitoring some near-term launches in the autoimmune space. So you've got VYVGART Hytrulo, kind of ongoing. Ocrevus is coming, I think, much anticipated. So what are some of the features of the autoimmune therapeutic landscape that you think maybe differ or are similar to oncology as you think about how this could, how this could go?

Helen Torley
CEO, Halozyme Therapeutics

Yeah, but specific to VYVGART, I actually liken it very much to the story. There was like FASPRO, the subq version I just mentioned. VYVGART launched in 2021, the end of 2021, as an IV for myasthenia gravis, so an autoimmune disease. The subq launched by 18 months after, in mid-2023. And so argenx was very smart, saying, "I'm only a year into building this market," because VYVGART is a first-in-class anti-FcRn, so it's a new mechanism of action. High unmet need in the market, but new mechanism of action. So, what they saw with the IV was they had strong success with the launch, with the positioning of the drug and use more being towards later, stages of disease.

So what they did with the subq, launching 18 months afterwards, they didn't want to cannibalize this market they'd just grown. They wanted to use the subq to gain more adopters of the product and to move therapy into the earlier lines.

Moderator

Mm.

Helen Torley
CEO, Halozyme Therapeutics

So they're using the subq very strategically to expand their market and expand awareness and use of VYVGART overall. And so that is, I think, a very smart strategies and one that we know based on the first quarter report is bearing very nice dividends for them. Now, that's in the indication of myasthenia gravis. Just to say that in June is the PDUFA date for CIDP. This is a terrific opportunity, high unmet need in the market today, where the VYVGART Hytrulo, which is given in just 30-90 seconds, versus in CIDP, hour-long therapy, to be able to receive your immunoglobulins, which is the common area. It is a subq-only launch, so all of the launch in the subq.

So this all tells us that subq is going to be the key driver of VYVGART Hytrulo for argenx, and so we're very excited with regard to that.

Moderator

Okay. And I think Roche has said that Ocrevus subq could drive at least $2 billion in, I think, incremental sales there. As you've noted, that's not probably the full scope of the product opportunity. So talk to us about how you think through the upcoming ocrevus launch.

Helen Torley
CEO, Halozyme Therapeutics

Yeah, now, this is a product that's later in its life cycle, so ocrevus is the established leader, leading therapy for multiple sclerosis, both in Europe and the U.S., and that's really because of the phenomenal data they have and the long-term data they have. The IV for patients can take anything from 3.5-6.5 hours. What the subq is offering is just a 10-minute treatment. I think you can imagine that is going to be transformative for patients.

Now, what Roche has talked about is that their growth of ocrevus, despite the success, so about an $8 billion brand today, they feel the growth has been limited because not every neurologist has got access to IV infusion capabilities, because you need this for the care and giving of the patients who are receiving IV ocrelizumab. And so subq is offering the opportunity for care to move into the community hospitals or even the physician's office is the vision. And that's where that $2 billion number is coming from, Corinne, where it's going to expand the market-

Moderator

Mm

Helen Torley
CEO, Halozyme Therapeutics

... as the people who didn't access to therapy before. That's obviously very exciting. For patients who are on the IV, though, they will also have the opportunity to be able to transform their treatment experience from 3.5-6.5 hours, going 2 hours away to an academic center, perhaps for their infusion, to going to their local community hospital and getting treatment in just 10 minutes. That is transformative, and so we're gonna see a mix with ocrevus between market growth and some conversion as well. It's going to be just a great win-win for patients and a big win for Roche as well.

Moderator

Sure.

Helen Torley
CEO, Halozyme Therapeutics

Clearly for Halozyme, because we receive on average a mid-single-digit royalty in net sales. We're very excited about the ocrevus launch. I think it's an underestimated drug in terms of just how much it does for patients, but also just how successful it has been.

Moderator

Yeah, very good. Last weekend, on the clinical side, we did see some data at ASCO. I thought it was very interesting. Maybe you could provide the highlights there.

Helen Torley
CEO, Halozyme Therapeutics

... Yes, so, Johnson & Johnson presented data with amivantamab, which was really very exciting. So, they're developing a subcu version of the IV drug that's called RYBREVANT. The IV drug takes a long time to infuse because it has to be given very slowly, because it has a high incidence of infusion-related reactions. Those are like an allergic reaction when you're getting the drug that can cause low blood pressure, sweating, dizziness, or even anaphylaxis. And, for patients receiving RYBREVANT, it often has to, the initial doses, be given over two days, and it takes up to five hours per dose. The data that was presented at ASCO was from the PALOMA-3 study. And this was following what I mentioned was our traditional approach, for patients wanting to convert IV to subcu.

It was a phase 3 study where the primary endpoint was pharmacokinetics. The study was successful in meeting its pharmacokinetic endpoint. What's important for that means that that supports the submission, and they actually, Johnson, has already filed for the subQ approval in Europe. So that was great for us. That's 11 for 11 in products that have done this IV to subQ bridging strategy, as which we call it. The data that will be meaningful in terms of product uptake are, number one, treatment was reduced from 5 hours for many patients down to just 5 minutes. Transformative. The infusion-related reactions were reduced by a factor of fivefold, 67%, down to just the teens. Again, we know that was a driver of the amazing uptake we saw for DARZALEX FASPRO.

So once again, we're going to see, I think, a very nice uptake with RYBREVANT. The interesting additional thing that was reported, ASCO, is the overall survival, which was actually listed as an exploratory endpoint, showed a statistically significantly better overall survival in the subQ arm versus the IV arm. Now, that is unexpected with the design of these studies. They are not designed to optimize the profile of the drug. They're designed to match the exposure to the IV. So something very exciting is going on there-

Moderator

Yeah

Helen Torley
CEO, Halozyme Therapeutics

as I'm sure you're about to ask.

Moderator

What's the hypothesis? Why did that happen?

Helen Torley
CEO, Halozyme Therapeutics

Yeah. So, why is not known at this point in time, but there's two hypotheses that, once, I think the company's had a chance to present data on the full PK profile will bring some more color, but also there's something intrinsic to the mechanism of action when you deliver a drug subQ with ENHANZE, that we believe is at play as well. Let me talk about the pharmacokinetics, and so it is possible that while the overall PK was non-inferior, which is what you want to say, that the overall exposure was in a similar range to what you see with the IV, it could be that the trough concentrations, so the lowest concentrations in the blood, were higher for a longer period of time for patients, and that could be causing greater efficacy.

So that is very feasible and possible based on what we know about what the ENHANZE does to the pharmacokinetic profile. So a bit more exposure for longer, phenomenal for patients 'cause that could be causing the response. The second thing is, when you give an antibody subcutaneously, it is not absorbed directly into the bloodstream. It is trafficked through the lymphatic system and goes to the lymph nodes. Now, the lymph nodes are where all of your immune cells live, and the drug is exposed there to T-cells and other efficacy enhancers. And so this is what we think may be happening.

That is, the lymphatic trafficking, which happens with ENHANZE®, very rapidly, that could be causing an elevation of the efficacy of the therapies when they're exposed to the immune cells. Now, this is not just some idle theory. I will say we have, for a number of years, been working with the world leaders in lymphatic trafficking, Dr. Porter, who is based in Monash University in Australia, and we have demonstrated with them in several animal models, that the use of ENHANZE® to deliver drugs subcu differentially adds efficacy to a range of oncology therapeutics.

And so again, the study wasn't designed in a way to know that, but it's certainly from our experience both of these are likely at play, and I think very exciting to see this finding of the increased overall survival.

Moderator

Yeah. To the extent that that hypothesis does bear out, I guess, where would you see read-across, and how do you think that could impact your ability to kind of find additional partnerships, in particular the oncology, but any other space you think are relevant?

Helen Torley
CEO, Halozyme Therapeutics

It gets back to something I mentioned earlier, Corinne, that we are talking to companies about the impact of lymph trafficking. When you think about RNA therapies, nucleic acids, immune checkpoints, and other oncology therapeutics, if you're developing a drug subcu from the start, what a wonderful opportunity with ENHANZE to be able to optimize the profile. You can reduce the Cmax, which is often associated with side effects-

Moderator

Mm-hmm.

Helen Torley
CEO, Halozyme Therapeutics

and you can get the optimal PK profile to really get that efficacy you want with the additional potential benefit of the added lymphatic trafficking. And again, animal models certainly suggest this is all very feasible and possible, and so we are excited to already be talking to people about this based on the literature that's out there on the lymphatic trafficking.

Moderator

Great. We don't have a ton of time left, so I'll let you... Is there any other product in the pipeline that you're particularly excited about or think we should highlight in this conversation?

Helen Torley
CEO, Halozyme Therapeutics

... Yeah, I'll just continue maybe with amivantamab and then bridge to the Wave three products, because amivantamab is, you know, J&J itself talks about it being a $5 billion brand over time. And you can imagine with this profile where we have such a dramatic reduction in the infusion-related reactions, that we're very excited about this adding to our royalty revenues beginning in 2025, which is when we estimate the launches will happen there. And I will say that the amivantamab royalty rate in Europe will be similar to what we're seeing for DARZALEX. So the contract applies to DARZALEX and to amivantamab, so it will be at the full mid-single digit royalty rate until 2029, as well.

The Wave three products I just mentioned are: we talked about VYVGART, we talked about TECENTRIQ, Opdivo, ocrevus , and amivantamab. Those products are having $35 billion in analyst projections by 2028. And so when you think about that being the growth driver for Halozyme going forward, I'll contrast that to FASPRO and Phesgo being $20 billion. That's why we are so excited to be seeing this great success, 100% success in phase 3 for our Wave three of portfolio, because it's a larger addressable market, if you like.

Now, obviously, what matters to us is how much converts to the product, but now with a mid-single digit royalty to at least 2029 for all of these products, we're incredibly excited, and that's what's driving that some 20% CAGR for our royalties, which I think you'll agree is, is a remarkable growth rate.

Moderator

Yeah. You're in perhaps the unusual position as a biotech company of having plenty of cash. So how do you think about capital allocation, business development, and the like?

Helen Torley
CEO, Halozyme Therapeutics

Yeah. So for specifically to business development, we did our last acquisition, which was the acquisition of Antares in 2022. That acquisition is complete, the integration is complete, and I'm very pleased with how the commercial business, XYOSTED is doing, as well as our auto injector business as well. So that's an important part. With the progress in our other parts of our business, we are also seeing that by the end of this year, our net debt to EBITDA ratio will be down again. It will be 1.5 times. And, so you've seen in our projections, our EBITDA is growing nicely. So we're in a great position to be considering doing M&A. But because the business is so, so strong, we're in no urgency to do M&A.

And so what we will do is I'll, you know, use my usual discipline. We'll take our time, we'll find the right opportunity that has got the ability to add to the profile of the company, adding revenue, adding durable revenue. We're looking in the areas of drug delivery technologies, but we're also looking outside that, in adjacencies. Our business model is to be a leader in licensing technologies. I think we've demonstrated that, obviously, with great success with ENHANZE. Core to that is our strength in IP. We've demonstrated that recently with the expansion of our claims as it relates to ENHANZE. And so, we're gonna take our time. We're gonna find the right opportunity as it relates to M&A.

But we do think if we can find that, that will be the best way to return additional value to our shareholders using our capital.

Moderator

Perfect. With that, we're at time. Thank you so much for joining us, both here and on the webcast at the Goldman Sachs Global Healthcare Conference. Thank you so much, Helen, for the insights.

Helen Torley
CEO, Halozyme Therapeutics

Thank you so much. Appreciate it.

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