TG Therapeutics, Inc. (NASDAQ:TGTX) Q4 2022 Earnings Call Transcript

So we are evaluating whether we can come up with a better product for the subcu marketplace and then we know what that’s going to cost. If we do a subcu it’s going to cost us the $80 million to $100 million. So that’s again something we’ll have to consider. And you asked about whether it makes sense to do that investment. We’re doing the research now and the numbers to see, but first step is we’re doing an evaluation of rituximab, BRIUMVI to see if it €“ what the format of that subcu would look like. So again, I think we’re at the early stages of understanding that, and we’ll see how the two markets evolve. And I think the same thing goes for PPMS, right? It’s €“ we know that it’s going to cost somewhere in the order of $80 million to $100 million, and we’re just not sure that that all market participants view PPMS as a distinct indication from relapsing forms of MS.

So I think that’s something whether there’s really a full sum market there for us to invest into the folks who have studied the subcu and have approval subcu have also chosen not to run that study at this point. So I think there’s probably good reasons not to do it, but we’re evaluating that certainly we can consider doing some smaller studies just to understand the capabilities of our glycoengineered more efficient CD20 and PPMS before that helps.

Sahil Kazmi: Excellent. No, that’s very helpful. Thank you for that. And then maybe just one more question for Sean. Could you remind me of the cash position at the end of the quarter and how we should think about the R&D and G&A mix going through 2023?

Sean Power: The cash position at the end of the current quarter?

Sahil Kazmi: Sorry, at the end of the fourth quarter.

Sean Power: Right. So $220 million, which as we stated in the prepared remarks includes $45 million of available capacity under our facility. And then in terms of the R&D and SG&A mix, the guidance that we provided around OpEx as I said is exclusive of BRIUMVI inventory build. So I think it would be weighted to the SG&A side as opposed to R&D.

Sahil Kazmi: Okay. Great. Thanks a lot. Thanks for taking our questions.

Operator: Thank you. We take a next question from the line of Matt Kaplan with Ladenburg Thalmann. Please go ahead.

Unidentified Analyst: Hi, this is Raymond in for Matt. Thanks for taking our question. Yes. Just congrats on beating our internal goals for coverage. I just wondering if you could elaborate and how would you think about the access and coverage over the next 12 months to 18 months?

Michael Weiss: Adam, you want to go ahead?

Adam Waldman: Sure. As we said, our goal is to get the majority of covered lives before the end of the first half of the year. And we’re on track to do that. We feel good about where we are to date. What we said, I think in the past was we want to get to 80% to 90% before the end of the year, which we also feel good about at this point. And we’ll continue to work through all the processes, but we feel good with where we’re at so far. We feel like it reflects the value proposition of BRIUMVI. And we’re continuing to make progress and we feel good about the goals that, that we set for ourselves.

Unidentified Analyst: Thanks for that. And just to follow-up on that, I guess the J code, the permit J code would be when you estimate you would get that?

Adam Waldman: Yes, July 1.

Unidentified Analyst: Okay. Cool. Yes. And then I guess just touching on this, you mentioned the switching study, which is very nice. I was wondering is there any other kind of cadence of maybe postmarking studies and trials or registries that might help further flush up the commercial opportunity that you plan or €“ yes. Thanks.