TG Therapeutics Inc Q3 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Edward White - H.C. Wainwright & Co - Analyst : Good morning. Thanks for taking my questions. First, I wanted to ask a big picture question. You mentioned in the press release that you expect to see continued growth in 2025. I just wanted to get your thoughts on the size of the anti-CD 20 market in MS in 2025 and your thoughts on market share, not only for BriamD but also IV versus sub-Q.

Question: Edward White - H.C. Wainwright & Co - Analyst : Okay, thanks. And just a question on the announced Fuji Film, secondary us based manufacturing, your gross margins have been pretty consistent this year quarter over quarter. Will this agreement have any impact on gross margin.

Question: Edward White - H.C. Wainwright & Co - Analyst : Great. Thanks Adam and thanks to everyone. Congratulations.

Question: Michael DiFiore - EVERCORE ISI - Analyst : Hey guys, thanks so much for taking my question. And congrats on the quarter two for me. Were there any inventory channel dynamics during three Q and separately? What was the TRX script count in three Q? And, and how many new patient scripts have been received in the hub? I noticed that wasn't included in your, in your print this morning. Thank you.

Question: Michael DiFiore - EVERCORE ISI - Analyst : Got it very helpful. Thank you.

Question: Eric Joseph - JPMorgan - Analyst : Hi, good morning. Just, just picking up on the the, the plan to adapt for a faster infusion time. Just coming out of the the enhance updated XS. Can I get you to elaborate a little bit more on sort of what you, what might be needed to support a label indication for either a shorter infusion or skipping a loading dose for switch patients? You mentioned, you know, possibly needing randomized data. Would the focus there be exclusively on safety? And would you need to assess more than one infusion per patient as part of that as part of a trial like that?

Question: Eric Joseph - JPMorgan - Analyst : Okay, great. And maybe a follow up if I could with respect to the subcu initiative, can you talk a little bit about sort of what you are tracking in addition to safety to kind of verify or, or sort of assess how long of a dosing interval you could ultimately move forward with a pivotal study.

Question: Eric Joseph - JPMorgan - Analyst : Is there APD component? Are you looking at a sort of a B cell decline?

Question: Eric Joseph - JPMorgan - Analyst : Okay.

Question: Tara Bancroft - TD Cowen - Analyst : Hi, good morning. Thanks for taking the questions. So thinking about your guidance, it assumes just over or I guess just under 20% sequential growth and that's, that's incrementally higher than, than, you know, the 15% from Q3. But I was wondering, looking ahead now, should we assume steady growth like this from here on out or a similar cadence of growth like in, in 2025 like you saw this year and last year with a heavy Q2 and, and, and seasonal impacts. Just, just a bit on how you would vision near near term dynamics here would be really helpful. Thanks.

Question: Tara Bancroft - TD Cowen - Analyst : Okay, great. Thanks. And just a quick follow up on, on the previous question about sub Q. You know, I understand you, you mentioned a lot of expectations there, which was helpful, but can you tell us what volume and, and perhaps dosing interval that you're ideally targeting with, with the subcu formulation?

Question: Tara Bancroft - TD Cowen - Analyst : Great. Thanks so much.

Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc - Analyst : Guys and congrats on the quarterly results. I guess for Adam, can you expand on the rates of persistence you're seeing and how it compares to other therapies in the space?

Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc - Analyst : Okay, great. And just to follow up on the enhanced data and the questions with respect to when you could see that incorporated into clinical practice. When, when do you think you could complete the studies necessary to have that available and, and, and update the label? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 04, 2024 / 1:30PM, TGTX.OQ - Q3 2024 TG Therapeutics Inc Earnings Call

Question: Mayank Mamtani - B. Riley Securities - Analyst : Good morning to you. Congrats on a strong quarter and thanks for taking a question. So on, the revenue split, if you are able to share between maintenance and maybe new degree on the patients. And, and if, if you are able to confirm, you know, at what juncture, you know, the maintenance patients overwhelmingly take, take care with the, the new two BMD patients. And, and did you comment by any chance on the share for new two CD 20 versus newly diagnosed, I MS patients. And, and would love to hear any, any color you're seeing in the marketplace on within the intra city 20 class switches you know what percent patients set up for grabs. We'd, we'd love to hear any perspective on that.

Question: Mayank Mamtani - B. Riley Securities - Analyst : Yes. Yes, that's, that's accurate.

Question: Mayank Mamtani - B. Riley Securities - Analyst : They asked that because one of our recent surveys indicated, you know, up to 20% of those patients might be up for grabs. So hence the question and, and then lastly on the biologics manufacturing expansion implication, are you able to comment on any long term supply goals that that you may have in mind between the Korea and us facilities in any way to quantify that would be, would be very helpful, Mike. Thanks again for taking the question.

Question: Cory Johnson - Goldman Sachs - Analyst : Good morning guys. Maybe a couple from us. You talked about the bulk of growth in your, you know, patient patients coming from the hospital setting, I guess, remind us what portion of MS patients are taking care of there and, and why do you think that's been such a good source of new patient growth for you? And then my second question is if you think about 2025 could we see study or even maybe accelerating new patient growth on an absolute basis into year three as you get kind of like, well into the launch here?

Question: Cory Johnson - Goldman Sachs - Analyst : Helpful. Thank you guys.

Question: Prakhar Agrawal - Cantor Fitzgerald - Analyst : Hi, good morning. And thank you for taking my questions and congrats on the quarter. Maybe firstly, now that subcu has launched, what are you seeing on the ground in terms of where it's gaining more share from even qualitatively? And the second question, you'll start generating obviously a lot of cash over the next few years, maybe on the broader capital allocation priorities. Is there any plans to expand the share buyback program or any any other mechanisms you can explore on the capital allocation front?

Question: Roger Song - Jefferies - Analyst : Great. Congrats for the quarter and thank you for taking my question. Most of my questions relate to Brown has been on and then maybe just a follow up on the capital allocation for those additional pipeline. So one is in terms of the brain, the expanding to MS indication when you start the trial later this year. And then would you be able to give us provide some proof of concept data to support the plan? Number one, number two is in terms of the allogenics and cell therapy. Do you expect to give us some data update next year? And then what will be the, what will be the principle to share the data in terms of the number of patients and then the maturity of the data? Thank you.