TG Therapeutics, Inc. (NASDAQ:TGTX) Q1 2024 Earnings Call Transcript

Mayank Mamtani: Yes. And that bodes well for that size of that pancake downstream. Yes. I guess, last question on the subcu target product profile, Mike. Just would be helpful to understand how you and even some of the KOL feedback, now that we know what the subcu profile for OCREVUS would look like at launch, now that all the data is out there, was just curious, Mike, as you design the human bioequivalent study, what differentiating attributes are in mind as we think about that product profile? And thanks again for taking my question.

Michael Weiss: Yes. So look, the OCREVUS subcu is not a true patient administered at home product today. So that is yet to be created – or not created, but to be available or even studied as far as my knowledge. So that’s still yet to come. I mean, our goal is to have something that is a patient-administered, patient-friendly product, again, more along the lines of what was done with ofatumumab. So I don’t know how much markets they are in. We think there’s a lot of room to thread the needle here and come up with a product profile that accomplishes the goals of being both convenient and easy to use.

Mayank Mamtani: Got it. Look forward to [indiscernible] update. Thanks, Mike.

Michael Weiss: Thank you.

Operator: Our next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald. Please proceed with your question.

Prakhar Agrawal: Hi. Good morning and thanks for taking my question. And congrats on the quarter. So just following up on the subcu Briumvi question. I’m trying to understand, like what’s your base case assumption on where the dosing frequency could land for subcu Briumvi? I guess, the reason I’m asking is if it ends up being once a month, would you still go ahead with the subcu development? And I have one more.

Michael Weiss: Yes. I mean, I think the bottom line is we probably would, but I don’t think that’s going to be necessary. So I don’t know that, that’s a scenario that is likely. But yes, I mean, it’s early to tell. And again, I think if we feel like we’ve got something that has a good opportunity to make a dent in the market, we’ll go forward. And certainly, once a month could be – could have some impact in the market. Obviously, it probably has less impact than something that has a less duration, and we’ll do the math on that in that concentration and less frequency. But I’m not so concerned that, that’s an issue here.

Prakhar Agrawal: And when do you expect patients to be dosed for subcu Briumvi?

Michael Weiss: We would hope to have first patients dosed within the first half of this year. So hopefully, in the next few months here.

Prakhar Agrawal: Got it. And lastly from my side, we’re seeing a lot of data on CD19 antibodies and other autoimmune indications. What’s your view on CD19 versus CD20? And obviously, there is a theory that targeting CD19 could achieve broader coverage of the B-cell compartment compared to, let’s say, a CD20. So just wanted to get your perspective there. And do you have a CD19 in early-stage pipeline?

Michael Weiss: So yes, I mean, we do have a CD19. It’s our azer-cel CAR T therapy. It is a CD19. So we think CD19 is a great target. We think it’s hard to know if the broader coverage is a positive in all settings. There are some diseases that are characterized by plasma cells that may be impacted by CD19 or maybe expressed in CD19 or that may be helpful. NMO is one that folks talk about quite frequently as more potentially CD19 driven. So we think there are areas where CD19 may be helpful. But overall, we think the overall opportunity in CD20 and CD19 is going to be hard to distinguish in most diseases. And the CD19, when they hit – hits pre-B-cell in addition to B cells, CD21 hits matured B cells. So in terms of recovery, you may see a difference there. So I think there’s a lot of things to balance when you think about CD19 versus CD20. But from an activity standpoint, in most diseases, I don’t know if you’re going to see a material difference.

Prakhar Agrawal: Yes. I guess, my one clarification. I was asking about the CD19 antibody, not the CAR T. Do you have a CD19 antibody in early stage, even preclinical?

Michael Weiss: We don’t, we don’t. I don’t find that to be a product of interest to us at this time.

Prakhar Agrawal: Thank you.

Operator: Our next question comes from the line of Eric Joseph with JPMorgan. Please proceed with your question.

Noah Eisenberg: Hi. Good morning, guys. This is Noah on for Eric. Thanks for taking our question. We were just wondering if there were other exclusive procurement opportunities similar to the contract that you just secured with the VA?

Michael Weiss: Adam?

Adam Waldman: Not sure I understand the question. Could you clarify?

Noah Eisenberg: Yes. We’re just wondering if there are other opportunities for [indiscernible] exclusive access contracts with other providers going forward?

Adam Waldman: Okay. Got you. Okay. Understood. I don’t have any updates at this time on that question.

Noah Eisenberg: Got it. Thank you.

Operator: And our next question comes from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your question.

Corinne Jenkins: Good morning. So maybe a couple of questions from us. One, you’ve stated that you guys are probably close to reaching profitability in the next quarter or two given the revenue guidance versus the OpEx guidance. How are you thinking through profitability versus kind of like it’s ramping or extending your R&D or SG&A spend to support the [launch] and future development? And then from a technical perspective on the subcutaneous formulation areas, what else is left to do before you’re able to enter the clinic?

Michael Weiss: Sure. So thinking about profitability, the – I don’t think those questions you asked are mutually exclusive or points, right? So we have – we will continue to invest in the Briumvi launch. We’ve noted that we have an increased budget in OpEx to approximately $250 million for the year. So I think there’s some room there to even grow. From a product standpoint, similarly, we are interested and continue to build among the Briumvi opportunity, the azer-cel opportunity. And we’ve said that we’ll continue to look for additional external opportunities. So I don’t know that we’re fixated on the exact profitability numbers. I know that it may – as EPS becomes something of interest. But I don’t think the future is exclusive.