Zai Lab Limited (NASDAQ:ZLAB) Q3 2023 Earnings Call Transcript

I think we — while this has been challenging given those factors that I mentioned we’ve been able to get off to I think a really good start in terms of the launch and launch activities. As you mentioned our sales in the third quarter for VYVGART really represents just a few weeks of commercial activity. Just a reminder to everybody we were approved right at the end of June. We shipped product from Suzhou in early September. So, just a little bit more than 60 days from approval by our count that is small of a gap between approval and shipping as we have seen. So, we’re quite proud of that. But again it only represents a few weeks of utilization from a commercial perspective in Q3. So of course, a decent amount of those sales represent initial stocking, but now that we’re through the end of October, we’re seeing really good physician acceptance and patient prescribing and utilization of VYVGART.

As you referenced, if you look at just our top 100 prescribers, more than 70% have already written a prescription or used VYVGART for their patients. And of those physicians, I think approximately half have already become repeat prescribers. So for launch metrics these are really good and exciting, I think indicators of overall demand and certainly we will expect as we get into the fourth quarter that utilization to continue and we’ll see certainly restocking.

— : One would be to the extent that there is channel inventory, we would make a pricing adjustment in line with whatever that NRDL price is that’s negotiated at the end. We also have seen in prior years as we have a lot of experience with drugs gaining NRDL access, I think we have physicians who are ready to start a patient on the drug in — sometime in September — in December and they know a listing is coming in January, you may see some delays in starts. So I think those things could impact the fourth quarter utilization, a little bit but overall, I think all the initial operational metrics and leading indicators are really positive for VYVGART and we’re really excited about the launch of this drug.

Unidentified Analyst: Got it. That’s very helpful. Thank you.

Operator: Thank you for the questions. One moment for the next questions. Next question comes from the line of Yigal Nochomovitz from Citigroup. Please go ahead.

Q – Yigal Nochomovitz: Hi, Samantha, Josh and team. Thanks for taking the question. Just a few more on the VYVGART launch. You comment on whether these early adopters were community or academic centers, and then were the patients new to therapy for gMG or had they previously been on IVIg? And then if you could comment overall, in terms of how many patients are currently on VYVGART and what the overall prescribing account number is? I know you mentioned the 100 top accounts, but how many total prescriber accounts are you focused on in China overall? Thank you.

Josh Smiley: Thanks, Yigal. It’s, Josh. I’ll try to cover some of that, as much as I can. I think first in terms of the accounts, and how we’re focused there are about 600 hospitals — so just a reminder there’s like 200,000 patients with MG in China, that are diagnosed and in some form of treatment about 1700,00 of those have gMG. So that’s sort of the universe we’re looking at. Of that 170,000 about 80% of those patients are treated at one of about 600 or about somewhere between 500 and 600 hospitals. So that’s what we’re really targeting over time, is that 80% of the business. If you then look and you sort of get down to prescribers, it’s coincidentally about the same. So we’ve got about 600 prescribers that are really our core focus and again they are spread across about 600 hospitals.

So, it’s very concentrated. We’ve got about 80 reps right now, that are focused on those accounts will grow that number to about 150 post NRDL and that will cover again 80-plus percent of the prescribing universe. So, when we talk about top 100 hospitals, that’s — that — or top 100 prescribers that’s — it’s a pretty concentrated group. In terms of patient numbers again, I would just say that we’re seeing really good utilization and prescribing patterns among our physicians. I think even given the challenges we’ve seen with anticorruption in the third quarter, if you look at just the top 200 hospitals of that about 600 that I mentioned, I think at least 75% of those hospitals we have reps that are able to get in and have in-person discussions and education with physicians.

So I think we’re off to a good start there. In terms of the – what those patients who are getting efgartigimod, look like most of them have had some kind of treatment in – for gMG. It’s a mix of IVIg steroids and other sort of older treatments. Again, I think the thing that we’ve said historically here is this is a well diagnosed population and they are treated just with older therapy. So I think it’s fair to assume that most of the patients who are getting VYVGART today are getting it and have had other treatments for gMG for sure. So I think that’s – and that’s really our focus with the initial patient group is to get those patients who are in – not responding well to current therapies and in many cases could be in an acute phase of gMG.

So sort of by – almost by definition I think these are patients who have tried other and have been on other therapies before. Thanks Yigal.

Yigal Nochomovitz: Okay. Thanks. And then if I could just – one quick follow-up Josh. You mentioned with respect to the inventory once you had the negotiations with NRDL that you take a pricing adjustment. But if that inventory flowed into the market before 2024 then it would reflect the NRDL price or would it not? Just – could you just clarify how that works mechanically?

Josh Smiley: Yes it represent – it would represent channel inventory that had been shipped in that’s already in the market and we just adjust – we would adjust the price to whatever the NRDL piece is. So you’ve seen this with ZEJULA over the last few years when we’ve had a new price either as a function of an initial listing or subsequent negotiation, we look at the channel inventory and make a price adjustment for that piece. So it will be whatever – whatever is in the market at that time again, I say that just to say that is just a common effect. We’ll describe that when we – if and when this happens when we report our next quarter sales. Again, though what I would say is we’re seeing good patient utilization today. So we expect there’s going to be a decent amount of patients who have already been on access and utilized VYVGART by the end of this year.

Yigal Nochomovitz: All right. Thanks.

Operator: Thank you for the questions. One moment for the next questions. Next question comes from the line of Anupam Rama from JPMorgan. Please go ahead.

Anupam Rama: Hey, guys. Thanks so much for taking my question. So on this VYVGART launch for gMG, how should we be thinking about reimbursement dynamics going into next year NRDL, self-pay any sort of private insurance contribution and how do you expect that to change over the next couple of years? Thanks so much.

Josh Smiley: Thanks, Anupam. It’s, Josh. First, we’re in the middle of NRDL negotiations for 2024 listing. As you recall our big focus was to try to get an approval in the first half of 2023. So that we would be eligible to roll right into these negotiations. We’re in the middle of those now so not going to comment on potential price. But if we end up with a mutually acceptable price and are able to move to a listing for NRDL for 2024 in the past that generally happens in January of the calendar year, so January of 2024. And once then that happens that would then supersede or take out any commercial or supplemental insurance or private-pay. So of course, that’s why we’re focused on making that happen because it opens up the market for the 170,000 patients, who we believe can benefit from this therapy.

So I think what – what’s the next important milestone is to conclude that negotiation and see where we end up on price. And if that’s the case then it becomes a matter in 2024 of getting that lifting and then getting that access pushed down to the – as I mentioned, the 500 to 600 hospitals that are critical to our patient base and that should – based on historical experiences that over time – takes a couple of quarters to get that all the way pulled through to all the hospitals. But again, with an acceptable price and NRDL listing in 2024 that — then we have basically open access for all of those patients who are suffering from GMG today. And of course, then that’s subject to the normal every two-year negotiation, but as Samantha mentioned in the upfront question, there’s been a lot of positive developments in how you renew price and go through these pieces this is the transparency and automatic renewal piece.