Greetings, and welcome to the TG Therapeutics Fourth Quarter and Year-End 2022 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco. Thank you and you may begin.

Thank you. Welcome, everyone, and thanks for joining us this morning. I’m Jenna Bosco, and with me today to discuss the fourth quarter and year-end 2022 financial results and provide a business update are Michael Weiss, our Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercialization Officer; and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate developments, Adam will provide an update on our commercialization efforts, and Sean will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I’d like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, projected regulatory milestones, clinical development plans and expectations for our marketed products. TG cautions 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 as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on TG’s website, www.tgtherapeutics.com, where it will be available for the next 30 days. Now, I’d like to turn the call over to Mike Weiss, our CEO.

Great. Thanks, Jenna, and good morning, everyone and thanks for joining us on today’s call. The fourth quarter of 2022 was a milestone movement for TG as we received FDA approval of BRIUMVI to treat adult patients with relapsing forms of multiple sclerosis, also referred to as RMS, which includes clinically isolated syndrome, relapsing remitting disease, an active secondary progressive disease. BRIUMVI is now the first and only anti-CD20 monoclonal antibody approved for RMS that can be administered in a one hour fusion twice a year following the starting dose. This approval was based primarily on the results of the ULTIMATE I & II Phase 3 trials, which demonstrated superiority of BRIUMVI over teriflunomide and significantly reducing the annualized relapse rate, which was the primary endpoint of the studies, as well as the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions. Two important secondary endpoints, results from the ULTIMATE I & II trials were also published last year in The New England Journal of Medicine, marking another major accomplishment for 2022. I want to take the time to thank the patients, their families, and the healthcare providers who participated in our trials and helped us get to this point. I also want to thank the entire TG team for their hardworking dedication to making BRIUMVI available to patients. Our Chief Commercialization Officer, Adam Waldman will join us shortly to talk about the early launch phase. But I also wanted to touch briefly on our BRIUMVI launch. As you can imagine, our team is working hard to introduce BRIUMVI to the MS community. Key to that effort is educating healthcare providers on the data as well as the other attributes of BRIUMVI. The team has received positive feedback thus far and is excited to continue…

Yes. Thank you, Mike, and good morning, everybody. I’m very happy to be able to share a brief update on the launch of BRIUMVI. We’re approximately four weeks post-drug availability, so it’s still quite early, but I’m excited to share some initial insights and color around our progress and the reaction we’ve been seeing at BRIUMVI in the MS community. Excuse me. Since approval, our teams have been laser focused on executing our strategic launch objectives of building awareness, driving utilization at our targeted accounts, and minimizing access barriers to BRIUMVI. We are striving for flawless execution on each of these areas, which we believe will set the foundation for long-term success for BRIUMVI. We are so far highly encouraged by the initial feedback and enthusiasm we’ve received from a wide variety of stakeholders across the MS community and are confident in the potential of BRIUMVI to make a meaningful difference for patients with RMS. Raise awareness of BRIUMVI’s profile, we are investing in a mix of both in-person and virtual promotional resources to support our experience field team, while also leveraging peer-to-peer programs, digital marketing, social media, and presence at medical conferences and patient programs to ensure optimal coverage and appropriate education. In the weeks following our approval, we successfully executed multiple national webcasts with attendance that exceeded all of our internal expectations. We also have already trained several of the top MS specialists across the country to speak on our behalf and have executed many highly targeted peer-to-peer programs with key healthcare providers in major MS centers since gaining approval. We are making good early progress and increasing awareness of BRIUMVI throughout the MS community and will continue to increase our efforts here throughout the year. Our sales teams are working on driving adoption and utilization at our…

Thank you, Adam, and thanks everyone for joining us. Earlier this morning, we reported our detailed financial results, which can be viewed on the Investors & Media section of our website. For today’s call, I’ll begin with our fourth quarter burn, which we are pleased to report came in at approximately $25 million for the quarter, well below our previously guided range. In terms of what that means for our cash position, we ended 2022 with approximately $220 million in cash, cash equivalents and investment securities. With that total, including $45 million of available capacity under our Hercules facility, which became contractually accessible to us upon the approval of BRIUMVI. Our GAAP net loss for the fourth quarter of 2022 was approximately $53 million or $0.39 per share, which was down sharply from the comparable quarter in 2021, where we saw a net loss of approximately $93 million or $0.70 per share. With the decrease driven by our disciplined and focused approach to spending ahead of the BRIUMVI approval last December. Our $53 million net loss in the fourth quarter of 2022 was an increase of $17 million quarter-over-quarter from Q3 of 2022, where we saw a GAAP net loss of approximately $36 million, which was primarily the result of a one-time milestone payment triggered by the FDA approval of BRIUMVI, which was expensed in Q4 of 2022. Our GAAP net loss for the year ended December 31, 2022 was $198 million or a $1.46 per share compared to a GAAP net loss for the year ended December 31, 2021 of $348 million or $2.63 per share. The year-over-year decrease in net loss of approximately $150 million, as discussed earlier, is the result of our streamlined and focused efforts in 2022. In terms of what we expect in the quarters ahead, during 2023, we expect our operating expenses, the exclusive of BRIUMVI inventory build will average approximately $40 million to $50 million per quarter. And when coupled with relatively modest assumptions on incoming revenue from the launch of BRIUMVI, we feel we are well positioned from a capital standpoint into mid-2024. With that, I will now turn the call back over to the conference operator to begin the Q&A.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] We have a first question from the line of Eric Joseph with JPMorgan. Please go ahead.

Hi. This is Noah on for Eric. Thanks for taking our question. Just a quick one from us. How have the discussions been going with dedicated fusion centers versus those in hospitals to zip the access to BRIUMVI is vastly different at this stage given the pre J code nature of the launch in the two settings of infusion centers versus hospitals.

Adam, you want to go ahead and answer that one?

Yes. So I think – if I understood the question about the J code, I’m not sure there’s a difference between academic and the infusion centers. I believe, it’s the same issue across both. I think the obstacle at the academic centers is just getting on formulary and institutional formularies, whereas the independent centers are more of a streamlined process. So we’re seeing earlier access there than we are seeing at the academic centers where there’s a formulary process to go through.

Great. Thank you.

Thank you. We’ll take the next question from the line of Josh Schimmer with Evercore ISI. Please go ahead.

Thanks for taking the questions. So for patients who are switching from other anti-CD20 antibody therapy, do they need to go through the same initial dosing protocols or is there an opportunity to move right to the one hour infusion or are there any studies that are contemplated to enable that? And then on the 2023 quarterly OpEx guidance, just confirming that was GAAP and non-GAAP? Thank you.

Sure. Thanks, Josh. Yes. So as per label, folks switching over, we’ll go through the four-hour starting dose. We do have a switch study that we’re printing together that should launch soon to perhaps educate folks on whether that is necessary. But as per label right now, and I assume for some period of time, the rule would be go through the four-hour infusion. Sean, do you have coming on the OpEx?

Yes. Sure. On the OpEx side, that is a GAAP number, but it excludes non-cash compensation.

And then to follow-up, Mike, if patients do have to go through those first two infusions, including a four-hour infusion, do you see that being an obstacle to switch it?

So far, that does not appear to be an obstacle. I think early indications are that the folks are perfectly comfortable switching from one to the other and using the four-hour fusion. I mean, we – again, we’ve heard chatter that people would love to just skip the dose, but it doesn’t seem to be an issue and it certainly at the early days here. Remember, a lot of these folks that are switching over from OCREVUS are still on four-hour infusions plus one hour before, one hour after, and a lot of them are still even having trouble getting into four hours. So it’s a little bit of investment in one extra dose, no doubt. And if we can run a trial that could help people understand the risks of skipping that dose we’re going to do that. And that’s on the way. We think, we’ll have those results relatively quickly once we get that trial started, which is – and I guess, about three months away from commencing. But you’re looking at a one dose trial essentially. I mean, the study will have more in it, but that piece of information will be understood early and we can get that out into a conference setting. Again, we won’t be, obviously, pitching that as something, but we are worried that folks will try to do to get the four-hour, and we just want to make sure it’s safe just in case. And if it’s not, make sure we get that data out there to educate folks that that’s not a good idea, if in fact that’s a problem.

Would that lead to a potential label amendment as well to include simplified transition dosing?

It’s possible. We can – we’ve talked about that internally and we’re trying to see if that would be possible, but I couldn’t promise that today.

Okay. Got it. Thanks very much.

Thank you. We’ll take next question from the line of Ed White with H. C. Wainwright. Please go ahead.

Good morning. Thanks for taking my questions. So I was just wondering if you can give us perhaps an idea of the percentage of patients currently on drugs that are taking advantage of the patient assistance programs. And how should we be thinking about the number of patients or percentage of patients on the free drug programs perhaps in the first half of this year versus the second half?

Yes. Adam, you want to go ahead that one?

Yes. Ed, I don’t have precise numbers in front of me. It’s still pretty early. We do – what I can say is that – we do expect a higher percent of free goods in the first half of the year and a higher engagement with our programs in the first half of the year as we continue to work through the coverage issues. We’re making good progress, as I mentioned gaining coverage, but it’s still a process. And so we expect a higher percentage in the beginning of the year and that should decrease over time.

Okay. Thanks, Adam. And just a question on your sales force. Is your sales force right size now or do you expect to be adding to your footprint?

Yes. We feel good about where we are right now. Of course, we will continue to monitor and see what we need as we kind of continue to engage. I would say it’s an – it’s something that we would consider if we felt that would help us, but right now we feel like we’re right size for the opportunity and where we’re focused.

Yes, I’ll just add to that, Ed, at ACTRIMS, I had a chance to meet with our two business managers that had the east and west coast business and ask them that same question, and everyone feels very comfortable with the size of the team right now.

Great, thanks Mike. And my last question, if I may, I always ask this, but can you give us an update on Europe, what you expect the timing will be the six to nine months behind and any thoughts on strategy there? Thanks.

Yes. Thanks, Ed. Appreciate you always asking that question for us. Yes, so nothing has changed. We’re still feeling that we’re about 69 months behind in total time from the approval in the U.S. and in terms of strategy, we’re still working hard to identify whether we want to a partner or do it ourselves. We have a little bit of time here, but we’re getting close, probably have some more to say after we have our quarterly conference call, which I assume will be in May timeframe, the first quarter call. So we’ll keep you posted on that, but stay tuned.

Great. Thanks for taking my questions.

Thanks, Ed.

Thank you. We’ll take a next question from the line of Prakhar Agrawal with Cantor Fitzgerald. Please go ahead.

Hi, good morning, everyone, and thanks for taking my questions. So number one, until the ASP is established for BRIUMVI, are there specific MS center types that might find it economically more attractive to use BRIUMVI over approval, or do you think that it the discounts may not be meaningful enough? You had a couple of follow-ups?

Adam, did you get that?

Yes. I mean we think that for BRIUMVI, there is a good economic story in advance of ASP, but even when we have ASP, we feel good about where we are with the pricing strategy and how physicians will be reimbursed. So in the early stage, I’m trying to understand your question about the ASP – not that I’m aware of that there would be a in advance of ASP, there would be an economic advantage.

Okay. And on the – of the patients who have been treated so far, fully recognizing it’s only four weeks, if you could provide more details on the profile of these patients, are these treatment naïve or mostly switching patients? And it seems that you’re seeing some switches from OCREVUS, but any color you could provide would be helpful.

Mike, you want me to take that question?

Yes. Go ahead.

Okay. Yes. We’re seeing both, right? We’re seeing some switches from CD20. We’re seeing switches from Tysabri, we’re seeing newly diagnosed so we’re seeing an array of patient types at this point. But it’s of course, still early, but we’re encouraged that we’re seeing all types of patients come up.

Okay. Thank you very much.

Thank you. We take a next question from the line of Mayank Mamtani with B. Riley Securities. Please go ahead.

Hi, good morning, team. This is Sahil Kazmi on for Mayank. Thanks for the really comprehensive update here, and congrats on the early launch metrics. Just one question, I know there’s a switching study that’s going to get started here in the background. Can you also help us understand what might be sort of the internal decision tree to consider investing behind higher dose subcutaneous or perhaps even expanding into the primary setting?

Sure. So higher dose subcu, sounds like things that our competitors are doing to try to compete with us and primary progressive, okay. So like higher dose, we certainly don’t need a higher dose. I think it’s very clear to us that our competitor has chosen to a higher dose study to try to compete with our more efficient glycoengineered anti-CD20 monoclonal antibody. So there’s nothing for us to do there. We’re already in theory the highest dose because of our ability to deplete these cells at the most efficient rate. So I don’t see any reason we’d want to do that. I think their efforts in that area are fantastic for us. I think it shows, one, the insight that shows me whether it’s true or not is that they believe that our data probably is better than theirs, and they need a higher dose to try to compete in a way that can compare to what we’ve seen in our clinical trials. Again in a cross-trial comparison, our ARR is just significantly lower, and I think that’s what they’re trying to go for. So we’ll see what – how that turns out for them. But I think that’ll be a extremely long infusion. And then subcu from that standpoint, we feel that the subcu competition is in the main part is not our business model, right? So if we have – there’s two markets here, right? I think it’s pretty clear the two markets have developed. Some patients do want to do a subcu, and for those patients right now, there’s only one option but it appears that the other IV drug is looking to turn that into a subcu to compete in that portion of the market. So it sounds like they’re going to have an IV…

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?

The cash position at the end of the current quarter?

Sorry, at the end of the fourth quarter.

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.

Okay. Great. Thanks a lot. Thanks for taking our questions.

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

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?

Adam, you want to go ahead?

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.

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?

Yes, July 1.

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.

Yes. We’re looking at a number of additional studies, none that we’re prepared to talk about. And we do have, which is probably available. We do have some post commitment studies that we have to do. So we’ll be working on those as well.

Okay. Thanks.

Thank you. Ladies and gentlemen, we have reached the end of the question-and-answer session, and I’d now like to turn the floor back over to Mike Weiss for closing comments. Over to you, sir.

Great. Thank you. Excellent. And thanks everyone for joining us this morning. As discussed on today’s call, we believe the initial launch activities are progressing well and in many ways ahead of schedule. We believe these early successes position us for an exciting year of commercial execution. We believe BRIUMVI add significant value to the treatment landscape in RMS. We remain committed to supporting the MS community. Thanks again to the patients and their families and healthcare providers who worked with us to get us to this point. And we thank everyone for joining the call today. Have a great day.

Thank you. Ladies and gentlemen, this concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.