TG Therapeutics, Inc.

Greetings, and welcome to the TG Therapeutics fourth quarter and full year conference call and webcast. At this time, all participants are in listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may press star one at any time to be placed in the question queue. We ask you to please ask one question and one follow-up, then return to the queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Chief Communications Officer Jenna Bosco. Please go ahead.

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 full year 2024 financial results 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 corporate developments, Adam will share an update on our commercialization efforts, and Sean will give a summary 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, including sales performance, projected milestones, revenue guidance, development plans, and expectations for our marketed product. 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 later 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. And thanks, Jenna. And thanks, everyone, for joining us this morning. I'm really excited to be able to host this call. just following the ATRIMS 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 BrionV 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 health care providers of how Briomvi is impacting their patients, especially challenging ones. The anecdotes about patients who have challenging times on prior therapies and then followed by a positive experience on Briomvi is really why we do, I myself and everyone at TG, do what we do every day. So with that, I thought I'd turn to the business of today. 2024 was an exciting year for TG, marked by outperformance and growth across various aspects of our business. As noted at the JP Morgan Conference, our full-year 2024 U.S. revenues of $310 million far exceeded our target guidance heading into the year, which we believe is reflective of the value Bremery brings to those living with MS. The team made significant progress also during the year, launching and enrolling clinical trials to improve the patient experience on BrionV, which led to the presentation of several meaningful data sets during the course of 2024. And most recently, we updated our enhanced study at the Acton Conference. You may recall in 2024, we presented the first data emerging from the enhanced trial where we demonstrated the preliminary safety of a 30-minute maintenance infusion, as well as the feasibility of switching individuals from another anti-CD20 to BrionV without the need for the four-hour introductory dose. At Actrums, we updated the 30-minute cohort, showing consistent safety and tolerability profile as previously presented, now with over 80 patients treated with a 30-minute infusion. In addition to our company-sponsored studies presented at Actrums, Dr. 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 BrionV. The results seemed to be consistent with the overall safety and tolerability of BrionV as seen on our ultimate one and two clinical trials. And interestingly, in a subset of patients previously treated with the Ocrevus who experienced a wearing-off effect between their Ocrevus infusions did not report this effect while on BrionV. In that subset, there were 19 patients and 16 of which, so 85%, did not experience the wearing off effect after switching to BrionV. Since this is an independent presentation of externally generated data, it is not included in our publications library. But I would encourage those who are interested to access the data through the Actron's website. Also during 2024, at the ACTRIMS conference in September, the ECTRIMS conference, so very distinguishable, one is the European, that starts with the E, and the ACTRIMS, which was last week, starts with an A. We presented the long-term follow-up data from the open-label extension study of the ultimate one and two phase three trials. The data showed after five years of BrionV treatment, 92% of patients were free from disability progression, and in the fifth year of treatment, an annualized relapse rate of 0.02 was observed. This is equivalent to one relapse occurring every 50 years of treatment. Additionally, the overall safety profile remained consistent over five years of continuous BrionV treatment with no new safety signals emerging with prolonged usage. With BrionV being the newest entrant into the CD20 landscape, We believe this data was important to many ACPs and individuals with MS. I also wanted to share some clinical progress, which we made during the year as well. 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 150 milligrams given over four hours, and the first maintenance dose, which is 450 milligrams given in one hour, two weeks later, and we combine that into one single 600 milligram infusion, which effectively eliminates the need to get two infusions in the first two weeks of starting BreonV. While we haven't presented data from this cohort yet, from the data we have seen in over 50 patients, we felt 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 hand study into the IV BrionV label as soon as possible. Another key effort for us is developing and commercializing a subcutaneous formulation of BrionV. 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 40%, are now choosing to self-administer a sub-Q at home. With almost 40% of new starts going on a self-administered sub-Q, we believe sub-Q-Briumvi would represent a meaningful expansion opportunity for TG. And most recently, at the J.P. Morgan Conference, we were pleased to share that we believe the preliminary data from our bioavailability studies support at least every other month dosing for sub-Q-Briumvi. The currently self-administered sub-Q 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, and 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 Breon V in MS, I'm pleased to announce that we've started treating individuals with myasthenia gravis, or MG, in exploratory study. We think MG is a good place for us to begin to explore BrionV outside of MS and 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 BrionV may offer a meaningful treatment option for patients. And beyond BrionV 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 Azercel for autoimmune diseases. As an allogeneic, which means basically can be given off the shelf, CD19 CAR T-cell therapy, we believe Azercel 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 with CAR-T's. We were pleased to receive IND clearance for a phase one study, evaluating Azor cell and progressive forms of multiple sclerosis. And we 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 Breon V through 2042, which included a composition of matter covering the glycoengineered attributes of Breon V. In summary, 2024 was a year of continued strong execution by the TG team. including above-expectations revenues for BRIOMV, expansion of the BRIOMV patent portfolio with composition and matter patent protection now through 2042, the launch of BRIOMV outside the U.S. with our partners NurexPharm, the presentation of important data, including five-year follow-up data from the ultimate one and two trials, and data from the enhanced trial, which we plan to use to support the launch of additional pivotal trials in 2025, and we also made significant progress with our clinical programs, including preliminary bioavailability of subcutaneous BrionV. We treated individuals with MG with BrionV, and we opened our phase one evaluating azure cell in progressive forms of MS. With that, let me hand the call over to Adam Waldman to write a more detailed review of the BrionV US launch in 2024, our early performance in 2025, and our plans for the rest of the year. Adam?