Michael DiFiore: Got it. Very helpful. Thanks again.
Operator: Thank you. And your next question comes from the line of Mohit Bansal with Wells Fargo. Please go ahead.
Mohit Bansal: Great. Thank you very much for taking my question, and congrats on the progress. I have two questions. I’ll ask first. So, in terms of the partnership terms discussions, in general, do you expect the newer deals to have some kind of different kind of terms or you think they could be generally the same and no meaningful change there?
Helen Torley: Yes, I think Mohit, the way to think about it is, there’ll be a difference if the partner is asking for exclusive rights to target versus non-exclusive, obviously, with the economics for non-exclusive being lower as we have the opportunity to license that to multiple companies. Also, if it is a partner who has a product that is in earlier stages of development, there may be an opportunity for you to see a different distribution between less payments while the product is in development, while it’s getting derisked and more of a weighting of the payments and a different balance of the royalties based on once it has achieved regulatory approval and is derisked. So, there could be a few of those nuances across these agreements. But obviously, each of these will offer a new royalty revenue stream for Halozyme for the mid-single-digit for an exclusive deal and probably be lower than the mid-single-digit if it’s a non-exclusive deal.
Mohit Bansal: Got it. That’s super helpful. And then, one clarifying question. So, I mean, the press release mentioned that there was a little bit lower bulk rHuPH20 sales. Should we read anything into it or it was just like a one-off thing?
Helen Torley: Yes, I’ll ask Nicole to address that.
Nicole LaBrosse: Yes. Thanks for the question. So, we were expecting that for the first quarter. You might recall going into the year, we had indicated that our API sales, just based on our partners’ ordering patterns and as we enter into firm periods for our orders, we did have line of sight to the fact that those orders would be more weighted to the second-half of the year. So, this is all in line with our expectations.
Mohit Bansal: Got it. Super helpful. Thank you very much.
Operator: Thank you. And your next question comes from the line of Corinne Johnson with Goldman Sachs. Please go ahead.
Corinne Johnson: Hi, I wanted to clarify one of the comments you made on the term discussions you’re having being a mix across ENHANZE only auto-injector and auto-injector only and just kind of the difference for the breakdown there. And then, on the auto-injector with ENHANZE partnership, are these companies have already gone through or find without doing the human factor studies you’ve highlighted as being a key focus for one of the potential partners? Or will that be another item that you need to check off before announcing a deal? Thanks.
Helen Torley: Yes, thanks, Corinne. In terms of the discussions, that definitely more conversations happening around ENHANZE only, that is, and again, that is based on the volume of the drugs that we’re discussing predominantly. For those where there is a product that is falling into the — for example, 3 to 10 ml, we are having discussions with several companies with regard to high volume auto-injector and its applicability, really to give state-of-the-art delivery for that company. And then, there are a few conversations on small volume. That really is a lesser focus for us, as we have a unique set of circumstances where our HVI is the best. It’s in areas where somebody’s looking for high reliability or there is a high viscosity drug.
So, that really is how to think about the number of conversations we’re having. I would say in the conversations on the HVI, as I mentioned, all companies will want to hold it and test it. That definitely is something that we’re seeing. Again, it’s something that hasn’t been done before. This is a breakthrough, and so they want to test it. Whether they’ll want to do human factor studies, I don’t think we know that yet, but certainly companies are wanting to evaluate it themselves in terms of understanding how it delivers, et cetera. So, we’ll have to stay tuned for any more information as to whether there’ll be more human factor studies. But definitely, there is an evaluation period where they want to play with it themselves.
Corinne Johnson: Okay, thanks.
Operator: Your next question comes from the line of Jason Butler with Citizens JMP. Please go ahead.
Jason Butler: Hi, thanks for taking the question. Helen, I’m wondering if you’re able to comment yet on the sales potential for the Wave 4 pipeline, or give us some context about how that magnitude might compare to the Wave 1 or Wave 2, or Wave 1, 2, or 3. And then, secondly, can you just give us an update on XYOSTED and specifically, what are you seeing in the market in terms of promotion sensitivity, just in the context of your measured spend on that product, thanks.
Helen Torley: Yes, happy to do that. So, for the Wave 4, as we talked about, between Wave 4 and Wave 5, we have nine products that are in development now, which we’re obviously very excited about. We aren’t giving projections for Wave 4, but I certainly can say that we’re excited about some of the products that I mentioned earlier, including Nivolumab+Relatlimab, which Bristol Myers Squibb talks about being a blockbuster brand, and also TAK 20%, which has a very high potential as well. And then, behind that is ViiV’s N6LS. So, some of the other products are a little earlier in their development, and there aren’t good estimates as to their potential, but I think all of them, we can say, are meeting substantial patient unmet need.
But a little premature for us to be giving projections on Wave 4 and Wave 5, but a very exciting set of products across multiple therapeutic areas. With regard to XYOSTED, we have a very focused and clear strategy for XYOSTED with our sales representatives really focusing on driving and identifying the patients that are not doing well on IM therapy and having the conversion and assuring that the patient is connected to all of the great services that we provide to assure affordability. We feel we’ve got the right size of the sales force, the right amount of promotional spend, which actually is less than last year because we’ve been able to optimize that as we understood better. So, we’re at, I think, the right footprint and operating expense to be driving this very nice growth that we saw last year to 100 million and we’re projecting, as strong pay-go over the next five years with the current footprint that we have, which is less than 100 representatives.
Jason Butler: Great, thank you.
Operator: Your next question comes from the line of Brendan Smith with TD Cowen. Please go ahead.
Brendan Smith: Hi, thanks very much for taking the question. Maybe first on the latest repurchase program, actually just wondering if you can confirm over what period of time you expect to complete the $750 million, excuse me, and how we should think about the cadence of buybacks, whether you’re kind of planning for steady increments in each quarter or if you’ll concentrate it more in certain parts of the year. And then, I just wanted to ask quickly about the VYVGART Hytrulo pipeline. Can you maybe remind us which indications are going directly into the ENHANZE Sub-Q or if there are some where they either plan to use IV exclusively or IV first and then run confirmatory studies? I’m just trying to understand what part of that broader portfolio would be focused on the SC. Thanks.
Helen Torley: That’s great, thanks. Thanks, Brendan, and welcome. I’ll ask Nicole to address your share repurchase question.
Nicole LaBrosse: Yes, thanks, Brendan. So, for the $750 million authorized plan, we did not time-bound that plan, but to give you a sense in how we’ve performed historically, our prior two plans, and especially the prior plan, which was a similar size, we completed in less than three years. So, you can think about that level of cadence of historically how much we have repurchased, totaling to date $1.3 billion deployed to share repurchases. So, it continues to be an important pillar of our capital return strategy, but the specific cadence is something that we continue to monitor as we deploy our cash amongst the pillars and really balance it between investments in our current business as well as investments in growing the business through M&A.
Brendan Smith: That’s great.
Helen Torley: And I’ll take the question on VYVGART Hytrulo. So, obviously Tim Van Hauwermeiren, the CEO of argenx, has talked about his vision that patients with autoimmune disease are going to be able to self-administer by VYVGART Hytrulo over time where possible. And this really is, you’re going to see reflected in his development portfolio where more and more indications are moving towards subcutaneous. What I can say based on what’s being shared publicly is that obviously generalized Myasthenia Gravis started as an IV, but the sub-Q obviously launched beginning last year. CIBT this year — CIBP this year, sorry, is a sub-Q indication only. And pemphigoid, I believe, is a subcutaneous indication only. We’re delighted this quarter to be announcing that with argenx that they’ve started two sub-Q studies in TED that are Phase 3 registration studies.
And as far as I’m aware, there are no IV studies that are listed on clinicaltrials.gov, so I think that’s a strong opportunity to be another Sub-Q only indication. I think this will roll out to more information on these over time as our argenx articulates how they’re going to go towards all of the 15 indications. But I think to meet Tim’s vision of this, or VYVGART really being transformative for patients with autoimmune disease, that’s my expectation the majority of indications will be Sub-Q.
Brendan Smith: All right, great. Thanks very much.
Operator: Your next question comes from the line of Mitchell Kapoor of H.C. Wainwright. Please go ahead.
Mitchell Kapoor: Hi, everyone. Thanks for taking the question. I wanted to ask on DARZALEX, the ex-U.S. royalty step down in March, with that happening, how much volume growth in the coming quarters do you need to stay on pace for the 500 million royalty revenues? Or I guess, what would be the necessary performance of some of these Wave 3 launches that you would need to see this year to be successful and kind of meet that threshold?
