Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) Q4 2023 Earnings Call Transcript

Ken Myszkowski: Yes, look, those are all things that we consider as we look at the array of funding opportunities ahead of us. The paying some amount of royalties on these is relatively cheap for us because we’re not stacking royalties. We don’t owe royalties on any of these assets. And so — and presumably also those royalties will be capped, presumably they would not go, indefinitely. But you’re right, as we look at all these opportunities, we need to take all those things into consideration. Look, we see ourselves as a commercial company and we think we can create a lot of value as a commercial company. And so assuming that the relative cost of capital while holding on to these assets is reasonable, then that’s something that we would do.

Operator: And our next question comes from David Lebovitz from Citi.

David Lebovitz: Just piggybacking on the last question. As far as any licensing agreements you’re looking at, are you planning to wait until after the pivotal data? And also, what activity level are you intending to really take within the partnership? Is this something where you’re going to be very active licensing to kind of one of these royalty companies? Or would this be something more specific where you’re basically giving control of the asset to a larger pharmaceutical player?

Chris Anzalone: The answer to that just depends upon the asset, of course. We have done and will continue to do asset licenses like we do with HSD or HBV or AAT. Well, I guess AAT is a little bit different, because we definitely need to profit share there. But — or Lp(a), we will do those going forward, depending upon the asset. Look, here’s our goal. We have a very large pipeline and it’s only going to get larger, and so we’ve got plenty of room to license out some individual assets. What we wanted to be — what we want to end up with is a series of verticals where we can concentrate commercial build out, and we can give our commercial team, several drugs to hold in the bag to sell into various channels. I think we can do that, you know, given our franchises with pulmonary muscle, cardiometabolic, CNS, et cetera, adipose, et cetera.

So I think we can do that. And as we look at how to cluster those, we will find that there are some outliers, if you will, some that may not fit well into a commercial strategy, and those would be the easy ones those would be the easy ones to license out. We also have the opportunity to do platform deals. We talked about this in the past, I like that a lot. We now have 5 platforms, 5 different cell types that we can address. I like the idea of working with partners who can bring in targets to us and we can help to create drugs for those partners. That for me is found value as long as those targets are not what we’re working on right now. And so maybe it’s an unsatisfying answer because we’ll be doing a number of different things, but that’s the way we see the waterfront.

And again, if we are 1 or 2 asset company then the answer would be much simpler. But we are a 20 plus asset company. And so we have the ability to structure a number of different partnerships and go-to-market strategies for ourselves.

Operator: And our next question comes from Luca Issi from RBC Capital.

Luca Issi: I have a quick one, maybe Javier, if I may. I was under the impression that you were planning a cardiovascular come trial with APOC3. While it sounds to me that you’re not planning cardiovascular come trial either with APOC3 or ANG3. Assuming that that is correct? What drove the change in strategy? Was this informed by conversations with the FDA? And is this related in any sort, form or shape with the numerical worsening in glycemic control that we’ve seen for APOC3? Any color there much appreciated. Thanks so much.

Javier San Martin: Thank you for that question. It’s really important. And I think this highlight how dynamic is drug development today, how fast science change and advance. If we go back, I would say, 6 to 9 months when we already were thinking and working on a simple trial design for plozasiran or ARO-APOC3, the focus was triglycerides and the field was focused on triglyceride as a key component of the receivable base. In the last 6 months, I think that focus changed, and I’m saying in the last 6 months because I don’t know if you call into the KOL webinar at the American Heart Association of Dr. [indiscernible] showed a slide when you see the number of publications in remnant cholesterol as a company of residual risk in the last 10 years, which was 10 or 20 paid procedure versus 1,000 in the last one year.

That means the change in this field is happening as we speak, and the understanding that it’s not just PG, but it’s remnant cholesterol in its the totality of the atherogenic lipoprotein. It’s a new development. And frankly, 6 months ago or 9 months ago, it wasn’t a key component of our decision making, and it is now and it’s been in the last 3 months. So now when you look at the 2 molecules and you focus on the concept of totality of atherogenic lipoproteins, not TG or no TG only, because remember for TGA proceed has better efficacy than H2, but when you look at the totality of atherogenic lipoproteins, it will H3 reduce LDL cholesterol by 20-plus percent, reduce remnant cholesterol by 80%, so it is substantially different. The population that we should address may not be exactly the same, and that’s something that we’re thinking and talking to experts right now.

So I think we’re changing following the science. We did have conversation with some experts. We did not have any conversation about this with the FDA yet, and within the next month or so, we’re going to be close to make a decision and start to define our next step from the regulatory perspective and from the clinical trial design perspective.

Chris Anzalone: And I don’t think this was, I don’t think you are getting towards this, but let me just say. Our increasing interest in ANG3 that doesn’t reflect a lack of confidence in APOC3. We were moving forward to that forward on that as you point out for CVOT. But as the science has been moving, as Javier said, over the last 6 months, we’ve had this growing wait a minute moment, where we should be looking also at ANG3. Just to ensure that we are pushing the best candidate that we can into a specific type of CVOT. We are still moving as quickly as we can. Obviously, with FCS, we’ll be finished with that Phase 3, I think, in the second quarter. We’ll be starting the sHTG Phase 3 early 2024. Now we’ve got a little bit of time to figure out kind of where we’re going to place our bet with the CVOT.

Operator: And our next question comes from Brendan Smith from TD Cowen.