TG Therapeutics, Inc. (NASDAQ:TGTX) Q1 2023 Earnings Call Transcript

Mayank Mamtani: Got it. Yes, thanks for that entire color from both of you. And then on EU just quickly, I know it’s a little early. We are not in the market yet, but we know that anti-CD20 penetration may not have been that prolific that we’ve seen in the US. So, I was just curious to hear your thoughts on whether – what your understanding is, the reasons for that, and if at all, you expect that you could participate in that increased penetration of (indiscernible) going drug class in EU, if there’s any incremental color there. And then lastly, in your cashflow estimate, are you incorporating any EU revenues? And also on the cost side, doing additional clinical trials, for example the SubQ study is something, Mike, you talked about in the prior call, if there’s been any progress on making a decision on that, or if you’re just waiting for the Roche Phase 3 readout in the third?

Mike Weiss: Yes. So, on the EU revenue front, I don’t think we have anything incremental other than we do see nice growth ex-US for CD20. And I think as you noted, there’s a lot of potential to grow the CD20 class. And again, we think with BRIUMVIs best-in-class profile potential, we think that it’s a nice offering. We’ve had really good discussions with some KOLs in Germany. So, we do feel very good about the potential opportunity. And we agree with you that there’s plenty of room for growth of CD20 s outside the US. So, I don’t have much more for you on that, but I do take your point. In terms of cost of goods, the clinical trials, so in terms of some of the trial expenses, yes, I don’t see a major increase during the course of this year.

In terms of the SubQ development right now it’s a CMC project. So, we need to understand exactly what the properties, the physical, chemical properties of that SubQ will look like. So, that’s not going to really hit probably from a clinical trial perspective significantly this year. We have some other clinical trials that we’re working on that are not going to be costing that much, and we continue to lower the burn from the legacy trials. So, there’s still room to save money on clinical trials that we’ve had to carry on and carry forward, some for ethical reasons, but we’re winding those things down at this point. So, I think as those come down, some of the new clinical stuff that we’re doing will come in. But as Sean mentioned, I think our R&D line should be pretty stable throughout the year.

Mayank Mamtani: Thank you for taking my questions.

Operator: Thank you. Our next questions come from the line at Josh Schimmer with Evercore. Please proceed with your questions.

Josh Schimmer: Thanks for taking the question, and apologies if I missed this, but the cost of goods line is relatively low considering that you do owe a royalty. Was there capitalized cost of goods that you’re working through? And if so, how much and what do you expect the normalized cost of goods as a percentage of sales to be going forward? Thanks.

Mike Weiss: Yes, so that’s a great point. I’m going to let Sean handle that, but yes, we did capitalize from the inventory that we built up prior to launch. But go ahead, Sean, perhaps some more detail there.

Sean Power: Yes, that’s exactly right, Mike. Any goods that we produced prior to approval were expensed through R&D. So, the early part of the launch, we’ll work through that stack of goods, if you will. I don’t want to call it inventory because it’s not that. In the first quarter, we did capitalize some inventory on the balance sheet that amounted to about $25 million, and that will likely be the sole campaign in 2023, and then we’ll see some again in ‘24.

Josh Schimmer: Got it. Thanks very much.