TG Therapeutics, Inc. Price & Performance (TGTX)

TG questions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors, that can be found in our SEC filings. In addition, any forward looking statements made on this call represent our views only as of today and should not be relied upon representing our views as of any later date. Specifically disclaim any obligation to update or revise any forward looking statements. Conference call is being recorded for audio rebroadcast on TG's website www.tgsnerapeutics.com, we'll be available for the next thirty days. I'd like to turn the call over to Mike Weiss, our CEO. Great. And thanks, Jenna.

Thanks everyone for joining us this morning.

I'm really excited to be able to host this call just following the Actrim's conference that was held last week. These meetings are really so energizing for me. They're great venues. Not only to present and review data, but to interact with so many healthcare providers all in one place And I have to say, by and large, the feedback on Brion V and the TG team was overwhelmingly positive. You don't know how gratifying it is to hear how our team can make a real impact on the patient experience And even more gratifying is to hear the stories from healthcare providers of how BRIUMBI is impacting their patients especially challenging ones, the anecdotes about patients who who have challenging times on prior therapies and then followed by a positive experience on Brionvi is really why we do, I myself and everyone at TG do what we do every day.

So with that, thought I turn to the business of today. 2024 was an exciting year for TG TG. Marked by outperformance and growth across various aspects of our business. As noted at the JPMorgan Conference, our full year 2024 U. S. Revenues of $310,000,000 far exceeded our target guidance heading into the year which we believe is reflective of the value Brimby brings to those living with MS. Significant progress also during the year launching and enrolling clinical trials to improve the patient experience on BrionVie which led to the presentation of several meaningful data sets during the course of 2024 and most recently we updated our ENHANZE study at the ACTRUM conference. You may recall in 2024, we presented first data emerging from the ENHANZE trial where we demonstrated the preliminary safety of a thirty minute maintenance infusion as well as the feasibility of switching individuals from another anti CD20 [indiscernible] without the need for the four hour introductory dose, Actharms, we updated the thirty minute cohort showing consistent safety tolerability profile as previously presented Now with over eighty patients treated with a thirty minute infusion, In addition to our company sponsored studies, presented at Actharms, Doctor. John Foley from the Rocky Mountain Multiple Sclerosis Clinic presented the first ever real world experience data from his practice from over 160 individuals with MS treated with BriumVie.

The results seem to be consistent with the overall safety and tolerability of Buryomvie as seen in our ULTIMATE-one and two clinical trials And interestingly, in a subset of patients previously treated with Ocrevus, who experienced a wearing off effect between their Ocrevus infusions did not report this effect while Ambriandi And that subset, there were nineteen patients, and sixteen of which, so eighty five percent did not experience the wearing off effect after switching to Briombe. [indiscernible] Since this is an independent presentation, of externally generated data, is not included in our publications library. But I would encourage those who are interested to access the data through the Actrim's website. Also during 2024, at the Actrimis Conference in September, at the Actrims Conference, so very distinguished We presented the long term follow-up data from the open label extension study of the OPTIMATE one and two Phase three trials. The data showed after five years of ReONVUE treatment, ninety two percent of patients were free from disability progression and in the fifth year of treatment, an annualized relapse rate of zero point zero two was observed This is equivalent to one relapse [indiscernible] every fifty years of treatment. Additionally, the overall safety profile remained consistent over five years of continuous pre owned retreatment with no new safety signals emerging with prolonged usage, With 20 landscape, we believe this data was important to many HCPs and individuals with MS.

I also wanted to share some clinical progress which we made during the year as well. Some of this for these studies, we haven't yet presented the data. Late in 2024, we started a new cohort to enhance study that combined the starting dose which is one hundred and fifty milligrams given over four hours and the first maintenance dose which is four fifty milligrams given in one hour two weeks later, and we combine that into one single six hundred milligram fusion which effectively eliminates the need to get two infusions in the first two weeks of starting BrionVape. While we haven't presented data from this cohort yet, from the data we have seen in over fifty patients, we feel confident that this approach is achievable in a four hour infusion which is the same timeframe as our currently approved starting dose We look forward to launching one or more pivotal trials this year with the goal of potentially incorporating all or some of the updates explored in the HANDS study into the IV BRIANBI label as soon as possible. Another key effort for us is developing and commercializing a subcutaneous formulation of Briombe. As we've discussed in the past, currently the majority of MS patients starting on anti CD20 will choose an IV delivered every six months.

And the remainder nearly forty percent are now choosing to self administer a subcu at home. With almost forty percent of new starts going on a self administered sub queue, We believe Subcu Briumvy would represent a meaningful expansion opportunity for TG and most recently at the JPMorgan Conference we were pleased to share that we believe the preliminary data from our bioavailability studies support at least every other month dosing [indiscernible] The currently self administered subcu is taken once per month So if we are successful, we could cut the number of injections per year in half. This is an exciting development for us we look forward to commencing a pivotal trial around the middle of the year and providing additional information on this program later this year. Beyond Brionvi and MS, I'm pleased to announce that we've started treating individuals with myasthenia gravis or TG in the exploratory study, We think MG is a good place for us to begin to explore Briomi outside of MS I look forward to hopefully sharing some data later this year We also plan to continue to evaluate other areas outside of MS where we believe Bria may offer a meaningful treatment option for patients.

And beyond BruinVy altogether, on the pipeline front, we were pleased to have announced in 2024 that we entered into a partnership with Precision Biosciences to acquire a worldwide license to develop Azercell for autoimmune diseases.

As an allogeneic which means basically can be given off the shelf CD19 CAR T cell therapy we believe AcerCell has the potential to be first in class best in class treatment for certain autoimmune diseases Having said that, we believe there will be multiple winners in what we see as an extremely large market addressing a significant number of autoimmune diseases We are pleased to receive IND clearance Phase one study evaluating azacel in progressive forms of multiple sclerosis and look forward to enrolling our first patients into the Phase one study hopefully very soon. As you can see, we made a lot of progress on all fronts in 2024 and we plan to carry that momentum into 2025. One last but very important item I wanted to note.

During 2024, we were incredibly pleased to have three new patents issued by the U. S. Patent and Trademark Office providing patent protection for Brioamby through 02/1942 which included a composition of matter covering the glyco engineered attributes of Brio In summary, 2024 was a year of continued strong execution by the TG team. Including above expectations revenues for Briunvi, expansion of the Briombe patent portfolio with composition of matter patent protection now through 02/1942, The launch of Buryumvy outside The U. S. [indiscernible] the presentation of important data including five year follow-up data from the ULTIMATE one and two trials and data from the ENHANZE trial which we plan to use to support the launch of additional pivotal trials in 2025 we also made significant progress our clinical programs including preliminary bioavailability of subcutaneous briongine We treated individuals with MG with Briombe. And we opened our Phase one evaluating azurecell in progressive forms of MS. With that, me hand the call over to Adam Waldman, to write a more detailed review of the BuryomV U. S. Launch in 2024, our early performance in 2025, and our plans for the rest of the year. Adam?

Thanks, Mike, and good morning, everyone. Are pleased to report another quarter of strong commercial performance. We marking continued momentum as we closed out 2024. Despite a new competitive entrant, we delivered significant quarter over quarter growth reinforcing our confidence in Briampi's positioning and long term potential the relapsing MS market. As reported at the JPMorgan Conference in January, fourth quarter U. S. Net sales for Brionby were $103,600,000 representing 24% growth quarter over quarter 160% growth versus same quarter last year.

That brought our full year 2024 revenues to $310,000,000 approximately 250% growth versus 2023. The fourth quarter numbers and full year numbers exceeded our guidance and reflect the growing demand we are seeing from Briambi. Relvia is also gaining momentum internationally. As many of you know, we partnered ex North commercialization rights to Nurex Pharma, who launched Briombe in Germany in February of twenty four. Since then, they have launched in a number of EU countries, and The UK, And overall, the feedback from EU has been positive and we look forward to them continuing to expand the geographical reach of BriaMD in the future. [indiscernible] Our differentiation strategy remains strong. The confidence that physicians have demonstrated in continuing to prescribe Ryumby underscores its importance in the adult RMS treatment paradigm. Our recent five year data and real world experience continue to reinforce the unique value proposition of Brionby. An efficient infusion, combined with a proven efficacy and a consistent safety profile. The quarter over quarter growth we achieved validates the increasing confidence among prescribers, and patients in Briombe as a leading anti CD20 option in RMS. Our dynamic market share in the physician administered anti CD20 segment is increasing.

And we anticipate continued growth as physician experience and comfort with BRIOMBI increases. Additionally, our field teams have been highly With increasing adoption among high volume infusion centers, and academic neurologists. We remain committed to expanding patient education efforts and optimizing the overall treatment experience. Foundational work we have done throughout 2024 coupled with the strong adoption trends we are seeing today, set the stage for continued growth in 2025. Will maintain our focus on driving deeper penetration in the RMS market ensuring that Briampi reaches as many eligible patients as possible. Looking ahead to 2025, we expect multiple drivers to continue fueling our growth including expansion into additional infusion centers, academic and community practices. Direct to patient engagement efforts, Increased real world evidence supporting Briambi's efficacy, safety and tolerability and strengthening perceptions around payer coverage and access. Despite the typical challenges inherent in Q1, enrollments overall demand have been robust. With January and February being our highest month of total new patients into our hub, since launch. We feel confident in how the year has started and are now estimating $115,000,000 in U. S. BriaMV net revenue in Q1 and believe we are on track to meet or exceed our full year U. S. Guidance of $525,000,000 In closing, I want to thank our dedicated team for the relentless Over the past two years, we have built a strong foundational commercial infrastructure that has delivered exceptional results exceeding all expectations for the launch.

This success now provides a solid platform which to build potential blockbuster products in MS and capitalize on other autoimmune disease opportunities going forward. We have the team, we have the capabilities and the leverage to drive future growth. Including the opportunity to further strengthen our position in the RMS market, with enhanced IV administration options and the development of a patient administered subcutaneous formulation of Burambi.

We believe this new option has the potential to significantly expand our R Mark allowing us to compete more broadly across the RMS space with potentially best in class products in both the IV and subcutaneous markets. These advancements will help drive sustained growth for years to come. We remain very excited about the future and look forward to updating you on the progress in the quarters ahead. With that, turn it over to Sean to discuss our financials. Thank you. Thank you, Adam, and thanks everyone for joining us.

Earlier this morning, we reported our detailed fourth quarter and full year 2024 financial results a press release which is available on the Investors and Media section of our website.

This morning, I'll start with a discussion of our revenue, for the fourth quarter and full year 2024, which Adam had briefly touched on, We are pleased to report U. S. BriaMD net product revenue $103,600,000 during the fourth quarter Our total net product revenue for the fourth quarter was $107,300,000 in addition, to U. S. Net revenue, includes approximately 3,700,000.0 of revenue for products sold to NeuroXpharm in support of the ex U. S. Commercial launch.

For the full year, we reported total global revenue of $329,000,000 which is predominantly comprised of $310,000,000 in U. S. BRIAN B net product sales and a $12,500,000 milestone from our partner for the ex U. S. Commercial launch of Briundi. As mentioned a moment ago, during the quarter, we recognized revenue for products sold to our partner NeuroXvone, It is worth noting that when looking at our COGS margin in the fourth quarter, it includes the cost of goods sold to our partner, than what we see commercially here in The U. S. Thereby giving the appearance of having an unfavorable impact on our gross margin.

Absent this infrequent occurrence, revenue related to the sale of goods to our partner, our gross margin has and should remain relatively consistent On the expense side of the ledger, we commenced the year with 2024 OpEx guidance excluding non cash items of approximately $250,000,000 And we're pleased to report that during the quarter, and full year 2024, our operating expenses have remained well controlled and below our guided ranges. For the fourth quarter and full year 2024, our OpEx was approximately 51,000,000 and $2.00 $6,000,000 respectively. Earlier this year at the JPMorgan conference, we guided that we expect our operating expenses to be approximately 300,000,000 for the full year 2025. As a result of the continued strong Briambi launch, and a strategic and disciplined approach to spending, We are pleased to report GAAP net income of approximately $23,000,000 or $0.15 per diluted share in both the three and twelve months twelve month periods ending December 31, 2024.

Last but not least, I'll close by touching on our cash position. We ended the fourth quarter with approximately $311,000,000 in cash, cash equivalents and investment securities. When excluding investments in inventory and share repurchases, we generated cash flow from operations in 2024 a trend which we expect to continue in 2025. Believe our existing cash provides us with a strong financial position to continue to support the Briandie commercialization and invest in our research and development efforts and our business operations for the foreseeable future. With that, I will now turn the call back over to the conference operator. TG begin the Q and A. Thank you. We'll now be conducting a question and answer session.

Our first question is coming from Bhakar Agrawal from Cantor Fitzgerald. Your line is now live.

Hi, good morning and thank you for taking my questions and congrats on all the progress. So maybe firstly, you mentioned about January and February being a strong growth. And 2025 guide to meaningfully exceed the $525,000,000 that you gave. So maybe just give more color around that what you're seeing, what are the biggest segments of growth as you look towards the rest of the year? And secondly, Okros has a high dose readout this year. Maybe if you can talk about where you see that product playing a role in the market, that would be super helpful.

Mike, do you want me to take that?

Perhaps the phone is on mute.

Yes, sorry about that. Yes, go ahead, Adam, why don't you go ahead.

Yes, Prakar, thanks for the question. Our growth just talking first question about the growth. Our growth comes from it's coming from a broad set of customers. With enrollment so far in both the academic and private clinic setting, a little bit more in academic now as I I mentioned, I think in previous calls, academic hospitals now counseling the majority of where we're seeing growth in our overall enrollments. I think that's being driven by a lot of things. The number of things that we talked about in the call, the five year data the real world experience, our expansion strategy, of course, with more people in the field versus we did a pretty significant expansion in 2024. So all those things are driving our growth that we're seeing. As I said, January and February were our best month in terms of new enrollments into our hub. And then for the high dose, I'll just start and I'll hand it over to Mike. It really depends on the the profile. Mean, we haven't seen much in terms of what the profile looks like, what the safety profile look like, what the infusion experience. So really hard to comment until we know more.

Yes. I'll just add to that. I think that's a fair point. I mean, we have very little to go on for the moment. We imagine it will be a relatively long infusion I assume they'll figure out they'll try to put it into some sort of subcu2 try to limit the timeframe, but the volume will be pretty dramatic. So yes, until we know more, I think we just have to wait and see.

Thank you. Next question today is coming from Michael DiFiori from Evercore ISI. Your line is now live. Hi, guys. Thanks for taking my call. Congrats on all the [indiscernible] Obviously, it seems like the pivotal Phase III subcutaneous trial for brimonidine coming around the middle of the year. To the extent that you can, I mean, has the subcu trial design been finalized? And can you confirm whether Q2 months or or Q3 months remains the target regimen? And Finally, just a follow-up, expectations on gross to net for the balance of the year. Thank you.

Adam, why don't you go ahead and do the gross to net, I'll come back and do the subcu. 70% to 75% range. With some fluctuations quarter to quarter, but that's what we're expecting.

Okay.

And the sub two, yes, the target is to get this going hopefully by the middle of the year. In terms of the exact design, it has not been finalized. We're We're still gathering more we're still looking at the study design. And in terms of whether it's going to be every two months or every three months, I think that's still yet to be determined. And it is plausible that we could end up with [indiscernible] studying two doses in the Phase three.

Got it. Thanks so much. Thank you. Next question is coming from Ed White from H. C. Weynman. Your line is now live.

Great. Thanks for taking my question.

So just a follow-up question on the subQ potential. How are you thinking about the size of that trial and the timing for enrollment seeing is that it's a competitive market that's already penetrated [indiscernible] The question. So the size of the trial is most likely going to be similar to the studies that Okervis did for their sub I think somewhere around 200 per arm probably a little bit less. I remember exactly what they were, maybe they're like 150 per arm. So it's not an incredibly large study. It's not a small study either. [indiscernible] But in terms of enrollment, I mean, we enrolled in the pivotal studies for BRYONVIA 1,000 patients in twelve months or so. So I don't know that enrollment is going to be the challenge Here, I just think we got to get ourselves in a position to get it going. But yes, we're projecting about a twelve month enrollment Could be a little longer, could be a little shorter, but give or take.

You got it. Thanks. And then just I appreciate the OpEx guidance. How should we be thinking about that regarding SG and A versus R and D. The question on SG and A is just, is the sales force right size now or continue to add there?

And are there any marketing schemes going forward that might lead to increased SG and A costs?

Adam, you want to go ahead.

Yes, sure. Thanks.

So on the sales force, I think we'll look to strategically continue to add people slowly over time where we see opportunity. So I think there could be but I don't think those would be material expansions to the SG and A. And then we do expect to do some patient, as we said in the past, we are we and we said this morning, we'll be doing some things on the patient side, but I'll let how much Sean or Mike comment and to the materiality of that.

Yes, I don't have any further comments, Sean, do you?

No, nothing further, right? At this time. Ed, just to click my crack staff was was ready to go with a better answer than mine. So I will tell you that we're probably looking somewhere around 125 to 150 per arm, which is in line with the the open receptor study. For the subcu arms Okay, great. Thanks, Mike. Thanks for taking my questions.

Yes.

Thank you.

Thank you. Next question is coming from Eric Joseph from JPMorgan. Your line is now live.

Hi, good morning. Thanks for taking the questions. Just on your feedback at Actrims, I'm wondering what the reception has been like to the enhanced trial data to the extent docs are apt to modify use today based on the data that we're seeing so far and And how much more would a formal label expansion drive utilization based on the feedback you're getting so far? And then I guess looking to that end, I guess when all said and done, would you expect to file an SBLA for a consolidated certain [indiscernible] infusion [indiscernible] With BMD?

Yes, sure. Thanks. Thanks, Eric. Yes, so we actually did do some polling while we're there. Asked a number of folks about that. What's interesting is, if you recall, when we started the ENHANZE study for the We did it because in large part, because we had seen in the market that people were already taking folks on another CD20 and switching them to the to biryomvie without going through the introductory dose. To be honest, we had no experience with that whatsoever and we really were wanted to make sure there was safety information around that in case we needed to give any further guidance to folks. So we got that going rather quickly. And we're able to enroll obviously significant number of patients and What we've seen is that switching to patients without one hundred and fifty milligram dose doesn't appear to cause any safety concern. So that was our biggest worry was safety of folks that were already in the field doing it. We did ask people about that and Most people that we we had spoken to are already switching without using the first introductory dose again. So that's out of our hands. Obviously, we don't [indiscernible] Don't don't talk about that in terms of commercially talking about it, but we did ask that question.

So that one seems to be something that the community seems very comfortable with. I'd say the other that we're working on including thirty minute infusion, less likely that people will use a thirty minute infusion until there's proper instructions in the label. So it's something we'll be working on as well. And then in terms of the front end consolidating the two doses into one dose that we give on day one and we avoid having to come back That's something I think we can get started on rather quickly. We'd hope to have a BLA potentially a PDUFA date for something like mid-twenty seven. So we'll keep you posted, but yes, I think that's probably the one that could happen the fastest second to the thirty minute. And we've stated previously that a full efficacy trial would be required to remove that switched dose But for the moment, I think we feel comfortable with providing safety information through medical, but I don't know that that's going to go into a pivotal trial this time. Okay.

Great. Maybe one follow-up if I could. Just thinking about the Myasthenia Gravis expansion opportunity, guess when you talk to neurologists, how are they thinking about sort of how broadly an anti CD20 approach might be adopted particularly in relation to the the anti C5 and FCRM blockers?

Yes. I mean, like I said previously, I mean, we we are exploring MG. It was one that we've had on our list for a while. It's not as underserved as it it used to be. But we do think there's room potentially for highly active, convenient, safe, treatment option [indiscernible] could be potentially provided in a cost effective way. I mean right now the treatments for MG are all on the highest highest scale of expenses and we know Briaumvy is cost effective in how we've priced it. So I think there's room in MG. Again, we've said we're not yet ready to to plant a flag and say MG is our next development program, but we do think it's interesting. We're just we're doing a lot more work on it.

And we'll be doing so across this year. As we look for other opportunities, we do think there's We do think the CD19CD20 opportunity across autoimmune diseases is large and whether it's with something like Briaumvie or there's some opportunity of course with CAR T across multiple different autoimmune diseases. So I think there's general enthusiasm I think there's general belief that these work I mean, they're all between won't speak much to the complement side of it, but certainly between the CD19, CD20 landscape and the FCRN? I mean, you are working along a certain part of the continuum of B cell to plasma to antibody to do some strategies So they're all similarly aligned in ways and just where in that cascade you think you're going to have the best effect and the best long lasting effect?

Thanks for taking my questions.

You got it.

Thank you. Next question is coming from Mayank Mamtani from B. Riley Securities. Your line is now live. Yes, good morning, Dean. Congrats on a great start to 2025.

Are you able to share the revenue split of new to BMW versus maintenance patient segment? And just wondering, looking forward, has there been a change to an internal assumption when maintenance segment revenues exceed TG that of new patients? And just a two part question here. On a dynamic market share basis, are you able to comment on what where you stand based on how you look at switch from another DMT or CD20 Adam, do you want to go ahead and give a crack and if I can add on top if necessary. [indiscernible] Yes, sure. Thanks for the question, Mike. As far as the revenue splits, I don't have that for you. I think what I've said in the past is that early in 2025, we will start to see repeat prescriptions be the majority of [indiscernible] That is forecasted to happen in the early part of twenty twenty five. That's our expectation. I can provide more detail on that in the future. And then as far as the dynamic market [indiscernible] I think we said this at JPMorgan. We're getting about one in four One in four patients on IV CD20 today, which represents about 60% of the market.

But that number is increasing and certainly we expect that to increase throughout the year.

Great. And just on the pipeline front, if you're able to give us some color on the size of the allogeneic CD20 study that you're starting enrollment shortly here and And kind of what would be the timelines and maybe study objectives? I understand this would be dose finding initially. But any pharmacodynamic data that we could expect would be helpful to get some color Mike.

Yes, sure. So that study is ready to launch. We're ready to receive patients. This study is not yet enrolled its first patient.

So I'd like to say we're going to have lots and lots of patients. Nayank. But so far, a bit of a slow start. Out of the gate here.

The goal as you mentioned, is dose finding. So first step is finding the right dose, finding the right conditioning regimen that makes the most sense in these patients and in the setting. So we've got little bit of work to do there. And in terms of outcomes for patients with progressive forms of MS [indiscernible] slow or stop the progression Unfortunately, that's not a it's not something that you will be able to see easily with a handful of patients. So I don't think we're in this some sort of miracle data that We give it we give the CAR TG person with progressive forms of MS and all of a sudden you can see some dramatic effect Hopefully, we will be able to slow or stop that progression, which would be fantastic. There are biomarkers that could be looked at There's some CNS biomarkers, oligonal bands, would be interesting. Certainly, we'll look at B cell depletion and repletion. So it's some of these biomarkers are out there. We can look at those. But I think at some point, we'd have to [indiscernible] get enough conviction to move forward with a randomized, which is the only way for primary forms of progressive forms of MS.

Having said that, we're also looking to expand into other disease states which I'd call adjacent or ancillary to MS and things we think we could do well to get started. And then we can think about further expansion of that opportunity. But I'd prefer probably at this point TG start slow and let's do some dose finding and let's make sure we can have it safe. Product that at least depletes B cells [indiscernible] folks with autoimmune diseases. Great. Very helpful. Thank you, Mike. Thanks, Mikhail. Appreciate it.

Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to Mike further or closing comments.

Great. Thank you. And thanks again everyone for joining today's call. We've been incredibly pleased with the progress made in 2024.

And of course looking forward to an exciting 2025. I think you heard some really exciting developments both on the the commercial front and the early enrollments that we're seeing have given us a really nice feel for the year. You know, Just to restate some primary goals, for us commencing pivotal programs for subcu commencing one or more pivotal studies to enhance the overall patient experience with BRIOMV rolling participants into the ongoing trials [indiscernible] enrolling hopefully as we discussed in this last question our first patients into the Phase 1A outstanding we'll continue to make presentations during the course of the year And as Adam described in great detail, really continue to push hard to bring Breonvy as far as wide as we can into the into the patient community in The U. S. And our partners ex U. S. So with that, again, I'll just thank everyone for joining us and have a great day.

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day.