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

June 10, 2020

NASDAQ US Health Care Biotechnology conference_presentation 41 min

Earnings Call Speaker Segments

John DeRosa McNeil

analyst
#1

All right. Hello, everyone, and welcome to day 2 of the 41st Annual Global Health Care Conference. By way of introduction, I'm Jack McNeil. I'm an associate on the U.S. SMID Biopharma and EU Biotech team, standing in for Graig Suvannavejh today. And with us, we have Helen Torley, CEO of Halozyme Therapeutics. So Helen, welcome back. I know you and Graig did this a year ago.

John DeRosa McNeil

analyst
#2

And I thought maybe we could talk about maybe what's changed for Halozyme in the past year. What are some of the major milestones you've hit and? What's top of mind today?

Helen Torley

executive
#3

Yes. Thanks. And delighted to be back here. Thank you. Yes, 2019, I think people may be aware that in November, we got the readout of our PEGPH20 data. That was our oncology program. Unfortunately, that data was negative. But I'm pleased to say that through careful planning of the company, we were immediately able to transition the company and make some important structural changes that allow us to focus only on our ENHANZE business. We moved swiftly and decisively. We stopped all oncology activities and downsized the company actually by 55%. As a result, we do anticipate that 2020 is going to be our first year of sustainable profitability at Halozyme, actually with profitability in this quarter, the second quarter. And we're able to do that because of our low, lean, leverageable expense base now where people focused on the ENHANZE business and with a very exciting forward-looking story on ENHANZE. At top of mind, obviously, are the recent approvals of DARZALEX SC, both in the U.S. and Europe. We have got a PDUFA date with Roche for Perjeta/Herceptin fixed-dose combination in October this year. And very excitingly, we're seeing a growth in the breadth of our portfolio of development products with an expectation of 3 Phase III starts this year, 5 Phase I starts this year, all of which is leading to near-term milestone revenues, which will, over time, translate into royalty revenues. And this is why I think we're such a unique and exciting story where with our low expense base, we've got this terrific story of growing revenues that's resulting in increased free cash flow, which we're able to use to return value to our shareholders. So it's been an exciting time. We're obviously disappointed in the PEGPH20 data not working, but we have a terrific and strong business model as we execute in 2020.

John DeRosa McNeil

analyst
#4

All right. Excellent. That was a great summary to kick things off. So maybe, as you touched on now your business is all kind of built around the ENHANZE technology platform. So maybe for people who are a little newer to the story, could you kind of walk us through what's special about ENHANZE? What makes you differentiated? And what successes you've seen to date with the platform?

Helen Torley

executive
#5

Yes. So ENHANZE is our proprietary platform based on ruPH20 (sic) [ rHuPH20 ], which is an enzyme called hyaluronidase that targets and breaks down something called hyaluronan. Hyaluronan is present in -- under your skin in the subcutaneous space. And it's part of what makes it impossible to inject more than about 1.5 milliliters of fluid underneath your skin. It serves as a barrier and prevents that ability to inject. When we combine our ENHANZE platform, the ruPH20 (sic) [ rHuPH20 ] [indiscernible] product, we're able to facilitate the injection and dispersion of actually up to 500 milliliters at one time in a subcutaneous injection. And most of our partners are 15 milliliters. And so if you've got an important IV biologic, and I'll mention Herceptin, Rituxan, daratumumab that today have to be given by long IV infusions, what we've been able to demonstrate and gain global regulatory approvals for now is the ability to transform those into subcutaneous injections that are given in just 5 minutes. So you go from hours to just 5 minutes. And the administration is one of the benefits, but there are also other potential benefits, the ability to go from weight-based dosing to fixed dosing, reducing the complexity of injections. And with daratumumab, we saw a very interesting reduction in the infusion-related reactions as well. There's a potential to get new intellectual property associated with the co-formulation to expand the exclusivity of the co-formulation. And those are just some of the ways that our ENHANZE technology has really been embraced by these large pharma companies and biotech companies as a way to bring meaningful differentiation to often they're already successful products or products that are in late-stage development, where they're looking to the competitive future environment and saying, "Am I going to be able to gain leadership and keep leadership? Or would having a subcutaneous drug give me an edge?" And so companies like Roche, Bristol-Myers Squibb, Janssen, many companies are coming to Halozyme, argenx, because of the competitive differentiation that ENHANZE can bring.

John DeRosa McNeil

analyst
#6

Okay. Excellent. So you touched briefly on daratumumab, subcutaneous formulation and its recent approval in the U.S. So could you maybe talk to us a little bit more about kind of what the impact of that approval is, both maybe from a perspective of patients and physicians, for your partner, J&J and then also the longer-term impact to your P&L and your revenue opportunity?

Helen Torley

executive
#7

Yes. I think daratumumab is to date perhaps one of our strongest value propositions. Everybody knows daratumumab, used for patients with multiple myeloma, often has to be given in a long IV infusion, often 4 to 6 hours we hear for patients, but it can be even longer than that because the dose has to be titrated based on does the patient have a hypersensitivity reaction to it. What we were able to do with the subcu was to transform it into a 15-milliliter subcutaneous injection that is given over 3 to 5 minutes. That is pretty remarkable for a patient when you think about this lifelong or very long-term therapy instead of 4 to 6 hours in an infusion suite, even more scary today, a simple 3- to 5-minute subcutaneous injection. So we're very excited about that. I mentioned we also saw the benefit of a reduction in infusion-related reactions. These are in the pivotal study, were reported at about 35% with the IV, and it was 13%, 1-3 percent, with the subcu. Speaking to physicians, that's meaningful. The infusion-related reactions require extra attention and supervision. So that's another potential benefit then as well. We're very excited to see that the FDA granted Janssen 5 of the 7 U.S. indications. And in Europe, they got all of the indications that are on the label. And so now the subcu can be used by all -- virtually all of the patients in the U.S. and all of the patients in Europe. So that is, I think, very important. I'll start with Janssen. Why was this important for Janssen to develop a subcu? At the time they did this deal with us, it was actually 2014. And at that time, there actually were several anti-CD38s in development, which were purported to have a more convenient dosing regimen. Instead of the 4 to 6 hours, perhaps it would only be 2 to 3 hours. I think Janssen very smartly thought, "What do I need to do to think forward all these years and have the most convenient dosing?" And that's when they started working with us, end of 2014, to develop a subcu. And I think we're all thrilled to be able to deliver that in just 3 to 5 minutes. Now daratumumab already a $3 billion brand, supposed to be $4 billion this year, growing to $8 billion. A lot of that growth is going to happen through expansion in the frontline setting. That's where the duration of therapy is the longest, and it's actually the biggest population. You can imagine that these patients, they actually stay on therapy for a long time. It is much easier, we believe, for a patient to be getting the subcu every 2 or 3 weeks rather than having to go in and have the IV. And so Janssen has said the subcu is core for their increased penetration into the frontline setting. They also stated that its core for increased use in community. Today, in the U.S., and we're also hearing in Europe, there are capacity constraints in the infusion suites, particularly because of daratumumab because a patient will block a chair for an entire day. And so you can't get the throughput of patients. So one of the things that the ease of the subcu could be is, "Can patients receive care closer to home in the community, where today, they have to refer to hospital infusion suites?" And so it's very important for Janssen and core to their future growth to get towards the $8 million to $10 billion people think it would be. And for Halozyme for our P&L, I'll just take a step back and say the sign of our contract is when we sign a deal, we license exclusive access to a target for a partner. PD-1 is a target, anti-CD38 is a target. We receive an upfront payment for that. As the product is -- goes through development and commercialization, we receive in the recent agreements up to $160 million per target in milestones. An example would be the U.S. approval was -- resulted in a $15 million milestone to Halozyme. So that obviously is a very nice way. Our milestones of how we, obviously, are able to increase our revenue. And then finally, upon commercialization, we receive across all of our contracts a mid-single-digit royalty on average. There's variance. We can't give the individual rates per each of our contracts. But it is on average a mid single. So we make money in those ways with our contracts. And so daratumumab specifically, with the milestones we're receiving for U.S. and European approval and the expectation with this value proposition that there's going to be a robust uptick, very important launches for Halozyme this year.

John DeRosa McNeil

analyst
#8

Okay. Great. And so obviously, as you alluded to daratumumab, is maybe a $10 billion peak opportunity, and you're getting mid-single-digit royalties on that. The other important piece of that equation, though, is what percentage of that $10 billion is subcutaneous versus IV? So maybe if you could talk about how you view subcutaneous conversion rates? And what will be the hurdles to just getting that up to even 100% conversion down the line?

Helen Torley

executive
#9

Yes. I can say we did some research with physicians to understand how they would look at the availability of subcu for new patients and for ongoing patients, for whom it would be a switch. And we certainly did see a very positive and favorable reaction. This challenge in the infusion suites of overseeing and being able to treat all the patients is real. And so the subcu, based on the value proposition, was definitely seen very positively for new patients. For the ongoing patients, the physicians said that they would offer them the option. Their impression was the majority of patients would jump at the chance of being in the subcu, spending less time in the infusion suite. And so I think because of the potential for patient benefits that we've talked about because, of the infusion suite capacity constraints, frankly, perhaps even the impact of COVID-19, once all of the key logistics are in place, we expect to see robust uptick. We haven't given a specific projection, but we think it will be robust just as I talk about what the value proposition is. There are some logistical things that just take a period of time to get in place. And any launch in the U.S. and Europe, you want to make sure for the U.S., that you're got formulary coverage, you've got your J code; in Europe, there needs to be reimbursement. But I expect once all those are in place, we will see robust uptick based on the value proposition I've just mentioned.

John DeRosa McNeil

analyst
#10

Okay. So maybe moving to some other products and partnerships. Could you talk a bit about Perjeta/Herceptin? And maybe what the opportunity in subcu formulation is there? What the improvement in infusion time could look like relative to what it looks like in DARZALEX?

Helen Torley

executive
#11

Yes. What Roche has done with us, I think, is remarkable. To our knowledge, it's the first time 2 therapeutic antibodies have been combined together in a single injection. And so what Roche has done is create a fixed-dose combination of Perjeta and Herceptin with ENHANZE for patients with HER2-positive breast cancer. And so the study that they did, that will be part of the approval, pending FDA review, is called the FeDeriCa study. And that compared the IV formulation, which is 2.5 hours, given the sequential injections for induction and then on average 1.5-or-so hours for the maintenance dose because you have to give the Perjeta, then pause and then get the Herceptin. And what they did was compare that to a 5- to 8-minute subcu, and they demonstrated success in that study showing non-inferiority. So for patients with HER2-positive breast cancer, upon approval, what they would have would be an option to receive their therapy in just 5 to 8 minutes. Now Roche has in the past talked about the option even of this being delivered at home over time. But I think when -- again, when you think about what this means for patients that is huge just to have that more convenience, less burden receiving your therapy. Perjeta is actually already a very successful drug for Roche. I think people sometimes forget it's actually a bigger product than daratumumab today, and is expected to grow. And it's growing by increased penetration into what they call the APHINITY indication, which [ will lead to ] HER2-positive on early adjuvant and neoadjuvant breast cancer patients. And with the fixed-dose combination, I certainly think it brings a very nice opportunity to continue what's already been success in the U.S. Roche has stated, they're 46% penetrated into this population in the U.S. And in Europe, we don't know what the penetration is. Roche doesn't talk about that. But we do know that when the product got its initial approval, there were questions about the cost benefit analysis. I think the ability to have a fixed-dose combination, Roche has talked about that, giving them pricing optionality. I can see a path where that pricing optionality may result in a stronger value proposition for Europe and the ability to penetrate Europe even more. So a very strong story once again. And certainly, one of the stars of the Roche portfolio, important to Roche Perjeta is, and we do expect this to be another successful launch upon approval. Now the PDUFA date in the U.S. is October 18. And for Europe, it was filed roughly at the same time, so we might expect an action date in Europe end of this year, early next year as well. So very exciting to have 2 such important products launching with the ENHANZE technology in 2020.

John DeRosa McNeil

analyst
#12

Okay. Excellent. So as we think about the portfolio more broadly, obviously, you've put out guidance that you expect to reach $1 billion in royalty revenue in 2027. So could you maybe walk us through some of the moving parts of that guidance? And while, obviously, there are some partnerships that you haven't disclosed yet, it would be interesting to know how much of that is baked into that $1 billion royalty number and maybe where could any upside come from?

Helen Torley

executive
#13

Yes. If I can just clarify one thing. This $1 billion royalty is more of a potential. It's not a guidance. And just to be clear, this is a non-risk-adjusted number that we put out there to really illustrate that with our line of sight today to the number of products that are approved, that we've talked about, but also the 5 products we expect to enter the clinic this year, the combined effect of each of those if they are approved and achieve what we believe is our potential conversion, all add up to approximately $1 billion in 2027. And it really is to illustrate and the shape of the curve really shows us that the benefit of having a portfolio of products that are launching over time, one building on each other to be able to get to the potential for $1 billion. Now I will say it's a non-risk-adjusted number. We assume global launches in all indications. But I think if you even just look at some of the sell-side models. You don't have visibility to all of the products, but it does help paint this picture of a future of robust royalty revenue growth based on the already commercialized products we know about because included in there, obviously, are DARZALEX, Perjeta/Herceptin. Opdivo is another potential launch, TECENTRIQ, Ocrevus, efgartigimod. Think about those products, think about people's expectations for those products and the competitive differentiation that ENHANZE can bring. And that is what leads to this very exciting projection, all of the potential royalties for ENHANZE.

John DeRosa McNeil

analyst
#14

Okay. Great. And out of those products you just mentioned, so Ocrevus, Opdivo, efgartigimod, et cetera, are there any particular you'd like to discuss and maybe highlight the opportunity you see there?

Helen Torley

executive
#15

I think I'll mention argenx's efgartigimod just because of some very recent data on that, that people may have seen or people may have missed. Efgartigimod is targeting FcRn. We are very excited that argenx has already started a Phase II study with a subcutaneous version of efgartigimod in chronic inflammatory demyelinating polyneuropathy. And that started actually in the midst of the COVID pandemic, so kudos to argenx for that success. That is one indication. The second indication would be the potential to start is in myasthenia gravis. Very recently, they reported the very positive and very well-received studies from the ADAPT study showing the effectiveness of efgartigimod in this population. That study looked at an every 2 weeks' IV. What the CEO has talked about is now going to the FDA to talk about a bridging study to bridge this data with a subcutaneous version using ENHANZE. And so that conversation is expected to take place in 2020. And I think that's just another example of -- I think Tim talked about efgartigimod as a pipeline and a product. We're very happy that ENHANZE is part of that journey, and we can help with the competitiveness of the profile that argenx is going to be bringing to the market and, obviously, helping patients as well.

John DeRosa McNeil

analyst
#16

So if I can ask a little more specifically on that bridging study. So you mentioned earlier you expect some of your partnerships to initiate Phase IIIs this year, others to initiate Phase Is. So can you maybe speak a little bit to when along the path of the drug's development, it's sort of appropriate for Halozyme to get involved with the ENHANZE technology? And maybe what the puts and takes are in there?

Helen Torley

executive
#17

So I would say that to date, and it's still the case, the majority of our partners come to us when they are approved or they're in Phase III. And that is because the most clear path and the most trodden path for approval is this bridging strategy, where if you have a large safety and efficacy database established with your IV formulation, you can do a clinical study to show the non-inferiority of the subcu formulation to the IV and be able to bridge to the larger safety database, meaning you can have a shorter, leaner, less costly development program. And so that is the path that Roche took with Perjeta/Herceptin with Rituxan and Herceptin, and it's a path that daratumumab took as well. On average, to date, we've seen that it is just 5 years from first-in-human to the launch. And so it's a very abbreviated time line when you can do this bridging study. And very importantly, I just want to highlight a precedent we're seeing that the FDA had talked about in the 2017 Rituxan Hycela ODAC to say that in future, they might not need a separate large, controlled clinical study for every indication in a company's label. Now that if you did meet that that might mean a very large and costly development program to be able to get all of your IV indication subcu. What we saw the FDA do with the DARZALEX label was based on one controlled clinical study called the COLUMBA study, it was 500 patients; and one Phase II study, single-arm, 250 patients, the -- Janssen was granted 5 of the 7 indications. So not needing to do all of those other studies to get this broad label. That is important as well because that further supports leaner, potentially faster development program. So this bridging strategy, I think, is a very exciting way to go, and it's fast, 5 years or less. It does not preclude somebody starting subcu development from the start. I will say for efgartigimod in chronic inflammatory demyelinating polyneuropathy, there is no IV program there. That is why argenx started a Phase II study. So they're doing a seamless Phase II/III study in that indication because they need to generate more data as would be in a traditional drug development program. They still plan to do it pretty fast, but you need to develop a slightly different pathway. So it's possible to do both. For Halozyme, we really are happy about as many marketed or Phase III positive studies because obviously a very de-risked situation. And so we have so far seen all 4 products that have entered Phase III testing, where it's an approved product, gain approval. And I think we're going to continue to see, in my view, the majority of the products are going to be with Phase III data or are already approved, but we're seeing more partners thinking about competitive differentiation much earlier there in the life cycle and recognizing, "Having an IV may just be an expense. Why not start the subcu?" So both pathways are open and being demonstrated at this point in time.

John DeRosa McNeil

analyst
#18

Okay. So maybe pivoting away from the pipeline and your portfolio a little bit. I think in our conversations with investors, the question that comes up pretty consistently is the durability of your IP suite and especially given the ENHANZE technology itself has sort of a limited patent life on it. So can you maybe talk a little bit about your strategy to kind of protect revenue beyond ENHANZE's loss of exclusivity?

Helen Torley

executive
#19

Yes. It's a great question. So just the base composition of matter patents expire in 2024 in Europe and 2027 in the U.S. What is more pertinent, though, is our royalty term. So per our agreement, we will receive royalties for the longer of 10 years after first commercial sale or at the last expiring patent. Now if we talk about the 10 years post commercial sale, that means a product launching in 2020, we will continue to see royalties until 2030. So even though the patents are expiring, we continue to see royalties. I will say that there is a step-down in the royalties to approximately half of the current rate, if there is no valid patent remaining. So we get a step-down in '24 in Europe, '27 in the U.S. But this is why, as an example, with so many upcoming launches in this 10-year window, we don't predict a cliff, as you might see in some companies, after the U.S. patent expires in 2027. Now also very helpful and incredibly important is there is also the possibility of co-formulation patents. So the co-formulation patents, they generally have the effect of extending the duration of time we get royalties, but also they can push out and delay the time of the step-down. And so that's another contributing factor that post 2027, depending on how many co-formulation patents are in place, will have a very strong impact on the shape of the curve. To date, Roche's received co-formulation patents for Rituxan, MabThera Perjeta/Herceptin. Janssen has received them for daratumumab, and we believe there is still a lot of opportunity. What the patent office is looking for is some form of novelty, when the co-formulation is done. On the Roche products, it was unexpected stability. On daratumumab, it was related to the reduced infusion-related reactions. And so co-formulating patents can be granted on pharmacokinetic parameters on expected things, pharmacodynamic, efficacy, safety. And so we have a long list of potential reasons for a novelty that we talk about with all of our partners to encourage them as they're evaluating their data to identify, "Is there an opportunity for a co-formulation patent?" We know of several partners planning some submissions. We don't know if they will be granted, but it is a very active area for us and very important, obviously, as I say, to extend the time under which Halozyme will continue to receive royalties.

John DeRosa McNeil

analyst
#20

Okay. Great. So maybe pivoting, once again, if we could talk a little bit about your kind of longer-term plans for business development. As you alluded to earlier, this is going to be your first year of sustained profitability. So as you have more cash flow coming in the door, talk about maybe how you would deploy that?

Helen Torley

executive
#21

Yes. So with regard to capital deployment, where we've focused initially is we obviously are doing a share repurchase at this point in time. We initiated that at the end of 2019 with a 3-year plan to repurchase up to $550 million in shares. We've already repurchased about $250 million of that, demonstrating a very strong commitment to doing that and plan to, pending market conditions and other factors, complete approximately another $100 million this year. So that was our first commitment to our shareholder return through our capital deployment strategy. We will continue to evaluate, "Do we continue that? Do we do other forms of capital return for shareholders?" But in addition, we have highlighted that it could be that we will be able to acquire an additional platform that would have the goal of accelerating the top line growth of the company, while at the same time, not creating an excessive dilution for our shareholders. Now people always say to me, "What type of platform is that? Have you found one?" We really are just at the beginning of looking at that. We think it's an important concept. And we've done a scan of the landscape, and we've found some initial companies. What's really important is it needs to fit a certain profile. We do not want a high-risk event. We do not want to have something that is highly dilutive. So we've got to identify something that Halozyme's talent can add to the growth of, that is already derisked and where we see the opportunity for high-margin, high-growth products. It may -- so we're looking now. Its early days. We're in no urgency. We're very excited about the ENHANZE profile and the growth it's going to give. If this, however, turns out to be the right way to accelerate value to our shareholders, we want to stand ready to do that type of transaction.

John DeRosa McNeil

analyst
#22

Okay. Excellent. And so on this topic, a lot of speakers this week have discussed the current M&A and BD environment. So I'm curious if you have any thoughts on just without mentioning specifics necessarily, the types of assets that are out there? And what prices would look like after the markets rallied so significantly over the past couple of months?

Helen Torley

executive
#23

Yes. As I say, we're pretty early in our looking. There's a range of assets out there that are still private companies. Some are already public companies. So it's probably premature for me to comment. But it is the type of technology that perhaps somebody has licensed to 1 or 2 companies. They are perhaps struggling to license to other companies, but we're -- Halozyme with our BD expertise, our relationships with large companies, we believe we can accelerate the value of. So still premature in how we're looking. But I will say there are a lot of very interesting technologies out there that could fit our financial profile. We just haven't completed that analysis as yet, and that will be ongoing work.

John DeRosa McNeil

analyst
#24

Okay. Great. So as we talk about business development, again, maybe without getting into specifics, what do you see as the potential for future partnerships? And are there maybe any kind of longer-term tailwinds, whether it's a renewed focus on biologics, oncology, anything like that, that you think could provide a further pipeline of partnership opportunities for you?

Helen Torley

executive
#25

Yes. We've had a very active, probably the most active set of discussions since my time of joining Halozyme in 2014. We did see a slow down a bit in March and April as a result of the COVID-19 distraction, companies actually doing clinical studies or trying to make sure their own studies are on track. But I'm very happy to say we're right back on track now in June in a very active range of conversations. And so if I summarize what people are looking for, it's competitive differentiation. People are recognizing that the product as they're developing it coming to the market may be okay for a period of time, but there's somebody close behind them that has an enhanced profile. And so people are more and more, I think, taking lessons from Janssen and from Roche and from argenx realizing the time to do this is not once you've actually been in the market, had some success and see a road. You got a plan early in your life cycle to be ready with the next wave of products. And so mostly focuses on competitive differentiation and across a whole range of therapeutic areas. For us, it's always very hard to peg when a deal will be signed. But I will say, I remain very confident that we will sign more deals just based on the breadth and the quality of the conversations we're having today.

John DeRosa McNeil

analyst
#26

Okay. Great. So maybe we can go back to on what you alluded to earlier, which is your share repurchase program. And maybe you could talk a little bit about what the implications there would be for your capital structure longer term, if you decided to kind of keep adding to that, and especially in light of the convert you priced last year?

Helen Torley

executive
#27

Yes. So as I mentioned, that we're very pleased to be so well underway with that initial $550 million. When that will expire and should be completed by 2022, whether repeating that or a version of that versus an alternate structure is the right decision, I think it's too premature to say, but it's certainly something that we are looking into to evaluate all the options and identify what is the best one in terms of our goal to return value to shareholders. Our convert comes due, as you mentioned. We're feeling very good about our options as to what we will do when that comes due. So I don't really have anything more to say about that at this point in time. Our free cash flow projections really do give us a lot of optionality at Halozyme in terms of what we're going to do.

John DeRosa McNeil

analyst
#28

Okay. Great. So maybe while we're on this topic, we could kind of go through what you've said previously about OpEx guidance and where you think margins are going to go maybe over the next couple of years just at a high level?

Helen Torley

executive
#29

Yes. When we did the restructuring, we gave a prediction that by the fourth quarter of this year, we would expect to be at an OpEx run rate of between $65 million and $75 million, excluding cost of goods sold. Very happy to say that we absolutely will be in this range, probably towards the upper range of it, $70 million to $75 million, with the majority of those expenses coming from our people expenses. We have about 120 terrific people dedicated to ENHANZE. They really serve as the very important role of supervising the production and release of the API. And then working with our partners in an advisory capacity to help them get to the clinic faster, help with the design of Phase I, Phase III, the regulatory filings. And so our employees are really the core to our success and the progress that we make. And so we expect that with our business model where employees support different partners at different times, we'll be able to maintain in the range of the $70 million to $75 million for a period unless we saw a rapid expansion in the number of partners and products in the clinic. If we did see that, just to give a sense of the type of impact that would have, because it's people, we may have to add a handful of people. So the increase in expenses would be modest because we'd be adding 5 people, for example, if we saw a significant increase over what we predicted in the number of people -- of products in the clinic. So what we love about our business model is how lean and scalable it is because all of our partners are at different stages, our PK experts, if they're working in one product in Phase I, when that finishes, they move on to the next product in Phase I. And so we can cover many partners with our small, very skillful team.

John DeRosa McNeil

analyst
#30

Okay. Great. So maybe while we're on this topic, we could talk a little bit about your current cash position. And obviously, you're -- you've really transformed over the last 12 months into a position of strength. But how do you feel about capital flexibility in the near-term as you're trying to manage repurchases and also continued OpEx?

Helen Torley

executive
#31

Yes. Well, we ended Q1 with $368 million in cash, obviously, a good strong position. It really comes down back to our business model. As we are looking forward, our projections are between 2020 and '22, as an example, the expected milestones in the range of $350 million to $450 million. We are obviously seeing the potential for some very nice royalty increases with the launches of DARZALEX and Perjeta/Herceptin. And so our story is one of increasing free cash flow, which is why I look to the future very excitingly, to say, our opportunity is to use this free cash in a way to return value to shareholders in the best way possible.

John DeRosa McNeil

analyst
#32

Okay. Great. So as we're getting into the last 5 minutes here, could we touch on what you see as the biggest catalysts for Halozyme over the next 6 to 12 months? And maybe we can kind of go through them one by one?

Helen Torley

executive
#33

Yes. We've got to talk about -- we've touched on them all. I think the launches of DARZALEX, Perjeta/Herceptin. Three products entering Phase III and 5 products entering Phase I. Obviously, incredibly exciting for us as well. And so it's all about the momentum in our pipeline, which is a maturing pipeline. And the maturing is important because our milestones tend to increase as we get more mature, so the Phase IIIs are larger and the approval milestones are larger. And so that is the story Halozyme. And the potential for our current partners to be selecting and bringing new products into the clinic. Using an example, Janssen at the end of last year, nominated the target EGFR cMET. That's an exciting new product. That has the potential to enter the clinic. So we grow with our current partners, obviously, bringing more products into the clinic, which we see the potential for in 2021 as well, even beyond the 5 that we're seeing in 2020, and signing new deals. So we have a lot going on, and these are important, as you know, and meaningful catalysts in terms of the revenue potential.

John DeRosa McNeil

analyst
#34

Okay. Then maybe just a couple more questions kind of to wrap up. I think we might as well touch on kind of the broader competitive landscape. And you've mentioned why you consider ENHANZE to really be a differentiated product with a strong value proposition. But just at a high level, if you could talk about maybe to your competitors who also have similar platform technologies that allow for these subcu conversions and maybe what you're seeing there?

Helen Torley

executive
#35

Yes. We don't see any real, meaningful competitor today. Many of our partners will talk to us about or look at devices. Devices are not particularly effective for large volume injections. I mentioned DARZALEX's 15 ml. So is Herceptin. And so, actually, is MabThera. Devices today don't work totally well for the larger-volume, high-drug dose drug. So while our partners sometimes look to those, they always come back to us and shake hands. So we don't consider there is any real, meaningful competition. There is a company based in Korea that we hear is developing an alternate form of hyaluronidase. There's limited data. There's no clinical data that we've seen on this. And so we really don't know much about it to comment more than that. So we do feel that with our strong intellectual property portfolio and the value proposition we developed, if you have a large-volume, high-dose biologic, ENHANZE is going to be the way to do it in a way that takes away the back pressure, allows it to be given in a short simple injection, there isn't, we don't believe, any real comparison to that.

John DeRosa McNeil

analyst
#36

Okay. Great. That was wonderful. So maybe just in our last 60 seconds, I'll ask you a little bit of a bigger-picture question. Just given your company's position kind of at the intersection of all these different treatment modalities, might be nice, and you've touched on it before, just to talk about in light of COVID-19, how are people thinking about restructuring how to administer care and about the changes to the operations of infusion centers versus at-home administration? And what the impacts there are like?

Helen Torley

executive
#37

Yes. We're hearing a few comments on that, Jack. I don't think that I'm hearing anything that suggests there will be a wholesale difference in how care is delivered as a result of COVID-19. I do think patients are asking for options, not to go into the hospital. We heard Roche say that on their quarterly call with regard to Herceptin SC. Roche is doing an [ at-home ] study with Perjeta and Herceptin fixed-dose combinations. So I do think there's a patient preference that's coming in. I do think, though, the option of having subcu to help offset the capacity constraints in the infusion centers is going to be something people are going to look for more and more because it is a real challenge. And it's not just the challenge of getting the patients, the plan goes on time. There is also the increased costs of having the nursing staff working over ours. And so it all becomes part of a very important equation. So COVID-19, certainly, I think, will help accelerate that. But the actual challenges and restrictions in the infrastructure of care delivery is probably the larger catalyst that I'm seeing.

John DeRosa McNeil

analyst
#38

Okay. Excellent. Well, so we're on time, and I think that's a pretty good note to end on. So Helen, thank you so much. This was really informative. And obviously, we hope to do this in person next year.

Helen Torley

executive
#39

Yes. That's great, Jack. Really appreciate it. Thanks, everyone, for your attention.

John DeRosa McNeil

analyst
#40

All right. So long. Have a good day.

Helen Torley

executive
#41

Thank you. Buh-bye.

This call discussed

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