Halozyme Therapeutics, Inc. (HALO) Earnings Call Transcript & Summary

June 13, 2023

NASDAQ US Health Care Biotechnology conference_presentation 35 min

Earnings Call Speaker Segments

Corinne Jenkins

analyst
#1

Great. Welcome to day 2 of the Goldman Sachs 44th Annual Healthcare Conference. Before we get started this morning, we are required to make certain disclosures and public appearances about Goldman Sachs relationships with companies that we discuss. The disclosures relate to investment, banking relationships, compensation received or 1% or more ownership. We are prepared to read aloud disclosures for any issuer during the sessions upon your request. However, these disclosures are available in our most recent reports available to U.S. clients on our firm's portal. In addition, updates to those disclosures are available by ticker on the firm's public website at www.gs.com. Goldman Sachs agrees to host this conference on the basis that no third-party speaker will provide confidential or material nonpublic information. In addition, by attending this conference, you provide Goldman Sachs the right to record and redistribute the conference information. The views of third-party speakers do not necessarily reflect those of Goldman Sachs personnel. All right. With that, underway. I want to say welcome to the CEO from Halozyme, Helen Torley. Great to have you here this morning. Now maybe we can just start by providing a brief overview of the company, with maybe a focus on what you expect to be key value drivers over the next 12 to 24 months.

Helen Torley

executive
#2

Yes. It's our pleasure to be here. Halozyme is a profitable biotech company. Our mission is to bring forward disruptive solutions that contains the treatment experience for patients and potentially also outcomes with 2 terrific platforms that are used for enabling subcutaneous drug delivery, and we license them to our partners. And we actually also have a specialty commercial business as well. We make money by licensing our technology to leading companies. ENHANZE is a great example and our largest revenue driver, that is able to convert IV drugs to subcutaneous. And in return for that license, we receive milestones, royalties and also a margin on net product sales. Our auto-injector platform is very differentiated. It's used by Teva as an example, and we use it in our own proprietary drug XYOSTED and I'll talk later. I'm sure about just why we think that has got a unique position in the small volume auto-injector area. Great catalysts this year. We plan to and have been growing our revenues and our EBITDA substantially. And that is because of the opportunity to bring more and more products forward into the clinic and into commercialization. And we've got several important catalysts this year that will add to the 5 products that we already have commercialized that are using our ENHANZE technology. This year, there are 2 pending approvals. One is for efgartigimod subcutaneous, which has got a PDUFA date of June 20 and also Tecentriq subcutaneous, which is the PDUFA date of September 15. So that's very exciting. And I will say in our projections for this year, we don't include royalties for those, but we do have some milestones. So that's exciting. And in addition, we've got multiple data readouts, some 4 Phase III data readouts in the second half of this year. One is for chronic inflammatory demyelinating polyneuropathy, which is another efgartigimod indication. Ocrevus subcu readouts leading to another potential approval potentially next year. And then data readouts for efgartigimod in idiopathic thrombocytopenia purpura and also pemphigus. And that's just an example of the exciting momentum of our portfolio, when we're moving from Waves 1 and 2 being approved adding Wave 3, which is a very large dynamic and exciting opportunity.

Corinne Jenkins

analyst
#3

Great. Maybe we'll start on the commercial front. You obviously released 2023 guidance earlier this year, revenue up in the mid-20% range, EBITDA up 30% year-over-year. We're half way through the year. So I guess, how are we tracking versus those expectations? And what do you view as some of the puts and takes to getting there this year?

Helen Torley

executive
#4

Yes, as you mentioned, very strong guidance [ in them ]. What you should note is we're growing revenue, but we're also growing EBITDA. And our goal is to grow EBITDA even more strongly than revenue, but also our EBITDA margin. And as an example, last year, EBITDA margin was in the 45% to 50%. This year it's in the 50% to 55%, and that's part of our differentiated business model. We are off to a strong start to the year. We reported our first quarter earnings, which were very much in line with our expectations. Our royalty revenues are the core driver. We had a first quarter in line with our expectations and what we talked about is the expectation we're going to see strong quarter-on-quarter of growth, driven by continued growth of DARZALEX FASPRO in particular, but also with Phesgo. Milestones is the other key driver of our overall revenues. Again, based on latest communications from partners, we expect our milestones to be very much in line with our expectations. And then I'll mention also Xyosted, our testosterone product that is tracking to our expectations as well. So we do expect to be able to deliver this revenue growing to $815 million to $845 million this year with EBITDA in line with the $415 million to $445 million.

Corinne Jenkins

analyst
#5

Great. Maybe keying on DARZALEX FASPRO for a second. Obviously, that's seen pretty impressive growth over the past couple of years. How do you think about drivers of growth from here, particularly with conversion already in your 90%?

Helen Torley

executive
#6

It sounds like FASPRO is the subcutaneous version of DARZALEX. And as the audience may know, it's Janssen's drug. It's used in patients with multiple myeloma. And Janssen has really done a fabulous job, but having their DARZALEX IV established in all lines of therapy, beginning with the third line moving into second and now into first line. This year, overall, DARZALEX still -- will deliver over $8 billion in revenue. And today, in the United States, 9 out of 10 patients receiving DARZALEX receive the subcu. That's just in 2 years. So that's been a phenomenal conversion. And the reason it's been that strong conversion is for a patient, the difference is the -- difference during 6 hours plus, often in an infusion suite and 3 to 5 minutes. That's a remarkable experience for the patient. It also saves the health care system money, because it takes less nurses and doctors. And importantly, it frees up capacity in the infusion suites, where capacity constraints are a real, real issue. Future growth is going to come from continued penetration, particularly into the frontline population. That's the largest population in multiple myeloma, and it's the population -- it's got the longest duration of therapy. And this is why analysts are projecting the growth from $8 billion to $16 billion for DARZALEX, which is driven by the subcu, obviously, since I mentioned 9 out of 10 patients in the U.S. and more than 8 out of 10 outside the U.S. are receiving DARZALEX as the primary form of their treatment. So phenomenal growth to come really through just an expansion of the market, which is very exciting to be a part of.

Corinne Jenkins

analyst
#7

Yes, absolutely. You mentioned Phesgo. Obviously, that's beginning to contribute more -- more meaningfully to the royalty revenues. So what do you view as the natural peak for Phesgo conversion from here? And how -- like what's the cadence to getting there?

Helen Torley

executive
#8

Yes. Phesgo, one thing I'm very certain of is it's going to continue to grow. Today, we're sitting at about 35% share of sales. And when Roche talks about that, its share of that Perjeta and so it's about 35% with it being higher outside the U.S. than inside the U.S. at this point in time. Now what Phesgo is a fixed-dose combination of Herceptin and Perjeta and so instead of the patient receiving sequential Perjeta and Herceptin, which can take many hours to get a 5-minute to 8-minute subcutaneous injection. Again, an amazing value proposition, especially for a population of women, many of whom our mothers are in the workforce, it's just is freeing them up from sitting in infusion suites. And so what we're going to see based on the strong value proposition is continued conversion in the U.S. and continued conversion outside the U.S. So we project quarter-on-quarter growth of share that's just going to continue. It was a little slower in its uptake than DARZALEX, but it's going to just keep growing as the value proposition is embraced in all countries of the world.

Corinne Jenkins

analyst
#9

Right. As you think about the read across from Phesgo and DARZALEX, to some of your pending oncology approvals, particularly Tecentriq like you mentioned this year, Opdivo is obviously in late-stage development. How do you think about the opportunity set for those agents relative to just kind of what you've seen to date?

Helen Torley

executive
#10

Yes. And so, very excited about then that, that would be mentioned earlier, at Tecentriq potential approval in September 15. Again, so let's start with the value proposition, why this matters. Tecentriq IV can take generally between 30 to often 60 minutes. Instead with Tecentriq subcu, it's just 5 to 8 minutes. Infusion suites are busy. This is going to be a boon not just for the patient, but also for our health care systems around the world. And what's very exciting here is that for a number of the indications with Tecentriq, specifically non-small cell lung cancer and melanoma, Tecentriq is either used alone or with oral regimen. And so for the first time, we're going to see the possibility that these patients are going to be able to be treated with a regimen that does not require them to be sitting in an infusion suite. We're very excited about what that will mean for patients and the potential conversion. Now the other indications, which would be non-small cell lung cancer, small cell lung cancer and hepatoma, those indications are given with IVs. But remember the sequencing of many chemotherapies can mean a very long time in the infusion suite for patients. And so the ability to insert a rapid subcu reduces the overall treatment time for the patient. And as we've been in recent research tools, it also frees up the tariff for another type of patients come in, perhaps you only need a short infusion. So perhaps someone with Crohn's. And so all of these dynamics, we think are very positive for what we're going to see with the immuno-oncology product as well.

Corinne Jenkins

analyst
#11

Great. And then I guess, when do you expect to start seeing those contribute to royalties, you mentioned not necessarily this year. But...

Helen Torley

executive
#12

Yes, I think it will be a case of as ever in the United States, taking time to get the J-code and get physicians comfortable with reimbursement, we'll start to see contribution in 2024. And obviously, we expect a nice build after that. Outside the U.S., reimbursement country by country. And so we are expecting European approvals as well with countries beginning to contribute in 2024. Germany, U.K. tend to come first. Sometimes it can take many, many months for France, Spain to come on. So it will be a nice build beginning to contribute meaningfully '24, '25 and beyond.

Corinne Jenkins

analyst
#13

The other approval you mentioned this year is obviously with efgartigimod or Vyvgart. That will be the first significant launch in autoimmune indications. So how do you think about the differences in that therapeutic area versus oncology? And what are your expectations in terms of conversion?

Helen Torley

executive
#14

If we think about the first indication is going to be in patients with myasthenia gravis and we've talked to and have treated patients with myasthenia gravis. They're really, really keen to get back to the normal life, get back to work, get back to what they want to do. And so the ability to be able to have a shorter subcutaneous injection, I think, is going to be very meaningful for many patients, and particularly those who have the active lifestyle and want to get back into the workforce as an example. I was just reading some papers on the weekend and the biggest capacity constraints in infusion suites are between the hours of 11 and 1. Everybody is wanting to indicate the treatment in the middle of the day. And that's because people want to be working and receiving their treatment. And so, subcu because it's shorter will allow physicians to treat more patients and be able to keep that throughput going. So I think it's going to mean a lot for patients.

Corinne Jenkins

analyst
#15

Great. Ocrevus subcu is coming in the second half potentially this year. Could you remind us what that target product profile looks like and how it compares to the infusions that are available?

Helen Torley

executive
#16

Yes. Ocrevus for those who may not be familiar with it, is Roche's drug for patients with multiple sclerosis. It's actually the #1 prescribed MS drug today and has got some terrific long-term data for patients. It's given as an IV today and between the treatment time and the observation time, the patient needs to be in the chair for between 3.5 to 6 hours. So it's very lengthy. It's a day long commitment to the patient, but it also is for their caregiver, who is looking after them. We don't have the data for the Phase III study. That's one of the readouts in the second half of this year. But we do know the study is designed for the first and second injection to have the treatment and observation time be reduced to just 1 hour versus the 3.5 to 6 and then subsequent injections, the goal is that it's turned into a 10-minute treatment and observation experience. Roche talks about this as being incredibly important to open up patients, who today haven't been able to go to the infusion suites, because there isn't space for them or it's too far away, to allow patients to receive their treatment more simply, perhaps closer to home. And so this is an opportunity to build and expand the market as well as reduce the burden for patients and reduce the capacity constraints on infusion suites.

Corinne Jenkins

analyst
#17

Yes, understood. How do you think about the incentive structure of ASP plus 6% as it relates to conversion, particularly in some of these indications?

Helen Torley

executive
#18

So there's 2 elements. I think the ASP plus 6%, which we expect to be very similar between the IVs and the subcu drugs, the overall cost of the drug. We understand is generally not very different in market. There was a small difference in infusion fee, which the physician gets from an IV versus subcu. And as we're seeing with daratumumab, that have not made a difference. And I think we're going to see this team in the autoimmune CNS area. The physician is going to look at the patient and identify what is the best option for that patient. And we're both Roche and argenx have been positioned in subcu, ease the opportunity for market expansion. Yes, there will be a conversion, but there will also be the opportunity as we saw with DARZALEX to further expand the market by offering a more patient-friendly treatment and faster treatment that will allow that expansion to happen.

Corinne Jenkins

analyst
#19

Great. So you've talked a bit about the expectation for additional deals this year. I guess, could you provide us a quick overview on what you expect to see by year-end in terms of new partnerships?

Helen Torley

executive
#20

Yes, in January, we talked about our goal this year to be signing one new ENHANZE deal -- one new ENHANZE deal with our high-volume auto-injector, and I'll talk about that in a moment, and a new small volume auto-injector deal. ENHANZE is you're obviously all very familiar with in terms of the deals we have. We've deals today with leading companies like Janssen, Bristol, Roche and also biotech companies like argenx. And we're talking to a number of companies of all sizes, bringing forward ENHANZE as an option to convert their IVs to a shorter, simpler, subcutaneous injection. With the acquisition of Antares, we've created the opportunity to develop what will be the first rapid ability to inject 10 mls via an auto-injector. And that is only possible by the marriage of ENHANZE with the Antares technology. Now that is an offering we're talking to a lot of people about. We're actually generating clinical data to show the feasibility of that, and we'll have that by midyear that data. There is a lot of interest from companies because nobody can do that to date. When you think about that for potentially a doctor's office to be able to get the treatment done in under a minute or patients going home treatment done under a minute for anything up to 10 mls that is an exciting new offering. So it's our goal to sign at least one of those as well. And then moving to our small volume auto-injector. That is what Teva uses in their EpiPen. It's differentiated by its reliability. It's a highly reliable device. And we also use it in our XYOSTED, which is a very viscous fluid. And so -- we expect to sign a small volume deal for somebody who's looking for that specialist need in terms of being able to deliver some harder to deliver therapies today.

Corinne Jenkins

analyst
#21

Great. As you think about this 3 potential deals, I guess, what's your conviction that you'll get all 3 of them done by year-end? Are there any -- you're more confident and than others? And what are some of the risks as you look? We've got 6 months left or so in the year.

Helen Torley

executive
#22

At this time, we remain in a very active dialogue with multiple companies on each of those. And so it definitely remains very much our goal to get those done. We always have a partner on the other side. And so they do play a bit of the impact on the timing based on how the conversations are going Corinne, and based on the interest seen, I remain confident that by the end of the year, when we will assign multiple deals.

Corinne Jenkins

analyst
#23

Great. How do you think about the relative value for Halozyme as you start to layer in these additional products, the ENHANZE plus auto-injector, for example?

Helen Torley

executive
#24

Yes. I think ENHANZE is essential to the high-volume auto-injector. So we actually think of those to traveling together. Without ENHANZE, you simply cannot inject a volume like 10 mls rapidly under the skin. And that's because the ENHANZE is needed to create those channels to allow dispersion of the fluid. Without that, and I just -- just think about your skin and think about putting in 10 mls, only a small amount goes in and then you start to get very strong back pressure. That causes the tissue to expand and swell and you end up with a big bubble, a fluid that sits on top of your skin. And the actual therapy will leak out of it because there's nowhere for it to go. That's obviously not the experience you want. So the marriage of the ENHANZE with the high-volume auto-injector is really a brand new and exciting offering for the clinic. And so I think of it as ENHANZE being the key driver for the high-volume auto-injector opportunity as well.

Corinne Jenkins

analyst
#25

Given that value, how should we think about the structure of partnerships, particularly with respect to the potential milestones or royalties?

Helen Torley

executive
#26

Yes. We -- ENHANZE has traditionally 4 exclusive licenses. I think I can point you back to [ beit ] Chugai for the type of structure we have. There is an upfront. There are milestones and on average, receive a mid-single-digit royalty on net sales, while there are valid patents. And that certainly for those exclusive licenses, we would be -- certainly, we would expect to go aim for ENHANZE for plus high volume, the ENHANZE deals are going to drive that format and value. And small volume, I mentioned that this is an offering that has a unique place in the marketplace. And I would expect to see value that very much reflects that unique offering that we're bringing forward.

Corinne Jenkins

analyst
#27

Great. Are there any partners or any other people, who are coming in interested that maybe you weren't previously able to get contact with that are now interested with the additional offerings?

Helen Torley

executive
#28

We've always had a very active outreach approach to our business development. And so I certainly can say that we're continuing to do both our outreach and also incoming. I think the area where perhaps we're seeing companies that we wouldn't have seen before, our company is interested in a small volume auto-injector, where they don't necessarily need ENHANZE because their volume is under 2 mls, but where they want to improve the patient experience with a great auto-injector, and perhaps it doesn't fit well with what's available off the shelf or they want to do some customization. Other than that, I would say for ENHANZE, we just -- we're always very active and proactive in our outreach. Lots of interest, though, from our current partners and potential new partners in the high-volume auto injector. I think, everybody is very interested in this upcoming data and are very excited about thinking about how that might fit into their portfolios.

Corinne Jenkins

analyst
#29

As you think about the cadence, should we expect the data first and then potential partnerships on the back of it as people look to see preserve mechanism or concept?

Helen Torley

executive
#30

I think -- that certainly is a possible scenario. We certainly are talking with people today, but just the way timing goes that we do know we're going to have the data in the middle of the year. So I think it's a possible scenario, yes.

Corinne Jenkins

analyst
#31

Okay. Maybe turning to the policy front because that's top of mind for many investors right now. We do like a lot of clarity. So with that in mind, how do you think about the ENHANZE partner products and how they'd be treated under the most recent Inflation Reduction Act?

Helen Torley

executive
#32

Yes. As you mentioned, it's very complex, and there's a lot of unknowns today, simply because CMS is not published, how they're going to treat the Part B drugs. I might mention many of our products, these are physician administered, therefore, fall under the Part B for Medicare not Part D, which has been already published. If we were able to say that the Part B guidance is going to be identical to the Part D, that would imply that because we are a fixed dose combination of one active moiety and one active ingredient, it should be treated differently from the active moiety. I'll use an example, daratumumab. That's an active treatment. It's an active moiety by the definitions. That -- the sales from that should be treated differently from when daratumumab is combined with ENHANZE because ENHANZE is an active ingredient. We enable the subcu injection. We reduced infusion-related reactions. So -- and the FDA in many documents defines us as an active ingredient. That's why our partners need to do clinical studies to get their approvals through separate BLAs. And so if Part D and Part B are the same, we believe subcu will be treated differently in terms of the timing of potential price negotiations. However, we can't confirm that at this point in time because we need to see the guidance. But I think the fact that we bring so much value as I've been describing throughout this conversation that is not possible with the IV. We have a very strong story of being an active ingredient that's contributing differentially to the patients.

Corinne Jenkins

analyst
#33

Great. And you mentioned, we don't have a lot of clarity now. When do we expect to get additional clarity?

Helen Torley

executive
#34

Latest we're hearing is, is it July is when the Part D guidance will come out. Nobody seems to know when the Part B guidance will come out. Some people are speculating it will be this year in the fall. But I think it isn't clear based on any publications as to exactly when that is going to come out.

Corinne Jenkins

analyst
#35

Okay. So as you think about like more [ gaming ] the scenario analysis, like under a more conservative approach for the policy, how do you think about the impact to your existing product portfolio? And then maybe we can talk about the business model as well?

Helen Torley

executive
#36

Yes. I think, it comes down to which products are going to be involved in price negotiation. And there's so many unknowns. It's really impossible to model, Corinne. So for Halozyme, what's going to matter is are any of our products going to be the top 10 and then the top 20 selling Medicare Part B drugs in 2028. The first half and there's a lot of years going to happen between now and then to see which are going to be the drugs and are the drugs used more in commercial? Are they used to it more in Medicare? There's not always great visibility to that. For a number of drugs and another important element is if a biosimilar is imminent, they actually will not necessarily be subject to price negotiation. CMS' guidance says, well, let the market dictate. So it's another factor that needs to be put in our biosimilar is going to come and how that's going to be treated. And so it's very hard to say. We have many products that are very strong products that are not very large or on any list today for Medicare. And so if we may have exposure with 1 or 2 drugs, but it's simply an unknown. And so we can't answer that question yet, and there's too many scenarios to be able to model it.

Corinne Jenkins

analyst
#37

Understood. As you think about you're having all these conversations with partnerships the uncertainty exists. How much is IRA factoring into your conversations? Or do you expect it to factor in once you get more clarity?

Helen Torley

executive
#38

And this is with potential partners?

Corinne Jenkins

analyst
#39

With potential partners? So like the business model.

Helen Torley

executive
#40

It really isn't coming up. I was asked that recently on our quarterly call. And I can say that it's still isn't coming up in conversations. I think my interpretation is companies expect there's still a lot to play out with the IRA and what it's going to be as a final. And people come to work with us because of competitive differentiation. They really have a reason, which is think about DARZALEX wanting to have the most convenient subcu treatment, when it was expecting other anti-CD38 Argenx having the first FcRn, but other FcRns coming wanting to have the most convenient one to be competitive versus all the other subsequent launch products. I think that's why we really are, from a partner perspective and the conversations we're having, IRA doesn't really come up. It's mostly about clinical development time lines, what will be the competitive differentiation is where the focus of the conversations remains.

Corinne Jenkins

analyst
#41

Yes, absolutely. In addition to the year guidance, you've also put out a target for 2027 royalties of $1 billion. Is what are the key assumptions that underpin that guidance or target? And what are the various puts and takes that could drive us above or below?

Helen Torley

executive
#42

Yes, this is a number we've had a few years ago to show the impact of the waves of launches we have. Today, our revenues, which are targeted, as I mentioned before, to get to $445 million at least are going to be driven by the Wave 1 and Wave 2 products. Really DARZALEX subcutaneous and Phesgo. We have 3 products or the next launches, those are going to happen between 2023 and 2025. And that's efgartigimod, Opdivo, Ocrevus and Tecentriq. When you think about the sales of those products, analyst projections are that those 4 products will get to $35 billion by 2028. And so for Halozyme thinking about us gaining a share of that and receiving on average a mid-single-digit royalty. Now that actually dwarfs the opportunity that we have today with DARZALEX and Phesgo, which is $20 billion. And so that is the next way to think about how we're going to grow. The next Wave, Wave 3 is an even bigger opportunity than Wave 2. And then we turn to Wave 4. The 10 products that are in or have completed Phase I development. If those continue in development, those have the opportunity to launch between '25 and '27. And that's an even bigger TAM than the $35 billion I just mentioned. And it's those waves of launches that is what gives us the sustained opportunity to grow royalty revenues. The other dynamic just to mention is also the durability and duration of our royalties. When we received co-form patents for novel findings, when we combine rHuPH20 with our partners or the partners receive the co-form patents, that can extend the durability and keep the royalty rate at the mid-single-digit royalty. And so there's a dynamic of both the number of launches, the growth of products year-over-year and also the impact of co-form patents that gives us the confidence and the potential to achieve $1 billion by 2027.

Corinne Jenkins

analyst
#43

Yes. More recently, you've also talked about growth from '27 to the early '30s. So what do you need to see to like get that to happen over the course of the latter half of the decade?

Helen Torley

executive
#44

Similar dynamic. I mentioned we've got products that are in Wave 4 that we'll be launching '25 to '27. Those are obviously very early in their launch. And so those have the potential to be continuing to grow '29, '30 and '31. We have about 20 products today in our projections. We expect new products to be coming into the clinic and being ready to launch in the '27 time frame. We call that Wave 5. Those will add to the revenue. And then once again, the impact of co-formulation patents maintained our royalty rate at the mid-single digit for the vast majority of our product and also extends the duration of revenue. So it's really these waves of launches, the multiple products and our expectation on co-form patents just give us strong growth, but also durability of revenue from ENHANZE.

Corinne Jenkins

analyst
#45

Absolutely. You've mentioned the Wave 4 and Wave 5 product that are kind of in the work. Are there any in particular you'd highlight or that we could see news flow for over the next couple of months or years?

Helen Torley

executive
#46

Yes, they always start with the ones that are closest to approval because obviously, we're really driven by our royalty revenues. And so we have 2 of the Wave 4 products that are actually in the last 6 to 9 months have entered into Phase III products that are already approved as IVs and I stress that because when you think about risk of development and risk of approval, because the risk benefit of the drug itself has already achieved approval at the FDA. The activity to show that the subcu pK exposure is the same as IV allows us to have a rapid development program, but it also is lower risk because our partners are very expert at finding the right dose. And so I'll mention is Amivantamab, which is Janssen's drug, which is for EGFR-mutated patients with non-small cell lung cancer, approved as an IV grown nicely, that entered the clinic at the end of last year, but also Bristol's nivolumab/relatlimab, that seems to be one of the most exciting combinations of immune checkpoint inhibitors, approved as Opdivo like, again, growing nicely from everything we hear and the opportunity to turn that into a simple subcutaneous injection makes us very excited as well. And then we have a wealth of other products in that portfolio. I'll just mention 3 products and in the treatment of HIV, where [ ViiV ] as an example, with 2 of their products are seeking to get to very long dosing intervals to go from what is 1 or 2 months today to 4 or 6 months for the future. That's an amazing value proposition for patients. So we're very excited by that portfolio and the goals there too.

Corinne Jenkins

analyst
#47

Great. With respect to competition, obviously, Merck wasn't able to partner with you given your relationship with Bristol, but they do have a pending subcutaneous product for our KEYTRUDA. I guess how do you think about both the competition in terms of KEYTRUDA versus your own product profile as well as others, who are potentially bringing subcutaneous products to market?

Helen Torley

executive
#48

Yes, I've mentioned that we often license our targets exclusively. We license the ability to work on PD-1 exclusively to Bristol. And so we could not work with Merck in it. Based on publicly available information, it's people's belief that Merck is working with a company that comes from South Korea called [ Daejeon ], they're highly hyaluronidase. That is still in development, and it is not proven as I would consider ENHANZE as proven. And so -- in terms of impact, Corinne, we look at it that we are the tried and tested and very much the gold standard for hyaluronidase. We have over 700,000 patients, who have received our drugs commercially. And that's important because that establishes a very clear safety database that when partners come and want to work with us, one of their first questions is always what's your immunogenicity data. And so we can give them a very large database of information to say, no worries about that. We also have a very strong IP portfolio around our hyaluronidase. And we always take that very seriously, and we'll take all the actions we would need to take to defend against any potential infringers.

Corinne Jenkins

analyst
#49

Absolutely. How do you think about capital allocation in terms of how you're think you spending of -- making lots of cash, right, basically high-margin business, et cetera. How do you think about capital allocation from there? And any considerations with respect to the business development?

Helen Torley

executive
#50

Yes. So we do -- and that we have had -- since we became profitable, a very clear capital allocation strategy. First invest in the business. That is a modest investment, but we always want to do that to assure the durability and growth of our platforms. And the second is share buyback. We have been committed to that for the last 4, 5 years. And we are partly through a $750 million share buyback, where over the last 2 years, we've repurchased $500 million in shares and expect to do the next tranche of $250 million next year. And then the third area is leaving sufficient firepower for M&A. We acquired Antares last year. We are continuing to look to add to and expand our leadership in drug delivery by finding other technologies that companies can't do themselves, and we see the possibility of real strong licensing model and strong growth in revenue and durability. So all forms of drug delivery, not simply subcutaneous drug delivery, there could be potential opportunity there, and that's where we're looking.

Corinne Jenkins

analyst
#51

Great. the last deal you did, it was 2 or 3 years of you talking about it before, we saw what happened. So how do you think about the time from here to when we could see additional BD?

Helen Torley

executive
#52

We're very disciplined. That's I think one of the hallmarks of Halozyme. We have criteria that a deal has to meet that includes a financial criteria as well as operational criteria. And so we will find it, when we get something that fits those criteria. We don't rush it because we want to make sure that we can make any acquisition a huge success. And so we're actively looking is all I can say. And when we find something that meet our criteria and with confidence is going to be a great use of our capital for our shareholders. That's when we'll do the transaction.

Corinne Jenkins

analyst
#53

Great. Well, I think we're about at time now. Thanks, everyone, for joining us, and thank you, Helen, for all of your work.

Helen Torley

executive
#54

Thank you.

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