TG Therapeutics, Inc.

Greetings and welcome to the TG Therapeutics fourth quarter and year-end 2023 financial results and business update call. At this time, all participants are on a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco. Thank you. 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 year-end 2023 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 recent corporate developments, Adam will share an update on our commercialization efforts, and Sean will give an 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, including sales performance, projected regulatory milestones, revenue guidance, 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 filing. 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 we'll be available for the next 30 days. Now, I'd like to turn the call over to Mike White, our CEO.

Thanks, Jana, and good morning, everyone. Thanks for joining us on today's call. 2023 was a transformational year for TG. We kicked off the year with the launch of Brionvi for relapsing forms of multiple sclerosis toward the end of January and saw a nice sales momentum carried throughout the year, resulting in approximately $90 million in U.S. Brionvi net revenue for our first partial year of sales. We believe these first-year revenues speak to the high level of early interest and strong underlying demand for Brionvi, and we look forward to continued carry-through in 2024 where we are targeting $220 to $260 million in U.S. sales revenue. The feedback from physicians, patients, nurses, and infusion centers continues to be very positive and drives our confidence in both the short-term revenue ramp as well as the long-term blockbuster potential of BrionV. Our team remains focused on our ultimate goal of becoming the number one prescribed CD20 from a dynamic market share perspective and the early uptake supports our belief that that is possible. Having said that, this is a competitive market and BrionV is the newest entry, so differentiation matters. One obvious difference is that BrionV is the only anti-CD20 monoclonal antibody that can be given as a one-hour infusion every six months after the starting dose, which may be an attractive profile for both patients who want to get back to their daily lives and for healthcare practices seeking to increase the efficiency within their infusion suites. Beyond the one-hour infusion, we are excited to continue to explore biological-based differences that may not be as readily apparent, but are perhaps clinically relevant. As a reminder, BrionV is differentiated by design, having been glycoengineered for enhanced immune effector cell engagement and efficient B-cell depletion. Preclinical data demonstrates that compared to the other anti-CV20s approved or used to treat MS. BrionV has the highest binding affinity to CV20, the target for these types of drugs found on B cells, and through its glycoengineering has the ability to induce the highest level of antibody-dependent cellular cytotoxicity, regardless of patient-specific polymorphisms. Whether or not these biological attributes of BrionV have clinical relevance in patients with MS has not yet been determined, as no head-to-head trials have been conducted for BrionV versus the other anti-CD20s. However, what has been well established is that BrionV is the only anti-CD20 monoclonal antibody to achieve an annualized relapse rate of less than 0.1 in Phase III trials. Also, in clinical trials, BrionV rapidly depleted B cells with a median of 96% reduction within 24 hours and 95% on-time infusion completion rate, which we believe speaks to the tolerability profile of BrionV. As we move forward, we are eager to explore to what degree the design attributes of BrionV may be contributing to the robust activity scene. We plan to do more work to evaluate some of these unique attributes and to understand whether the molecular and non-clinical differentiation translates into clinical differences. And we look forward to sharing more on that when available. I also wanted to highlight another recent exciting development. We were pleased to share yesterday that in addition to our current BrionV patent and U.S. biologics exclusivity, the U.S. Patent and Trademark Office recently issued three additional patents for BrionV including a composition of matter patent related to the glycoengineered attributes of BrionV. With these additional patents, our patent protection now extends through 2042, providing us a nice long runway to continue to explore the full potential of BrionV, including expanding the potential reach of BrionV in MS, as well as into other autoimmune diseases, which is a good segue to discuss what is next for BrionV and TG. First, let me say that the U.S. BrionV launch and commercialization is and will remain our highest priority. That said, our drug development team is poised and ready to potentially drive additional value through BrionV lifecycle management activities, as well as new drug development. More specifically, we are focused in four key areas. First, in making IV BrionV even more convenient. Last year, we presented the first data from the enhanced Phase IIIb trial, of which the goal is to evaluate the safety and efficacy of eliminating the 4-hour BrionV 150 mg starting dose for patients who are switching from a prior CD20 and have a pre-specified low level of B cells. Early safety data from this study is encouraging, and we look forward to presenting additional safety and efficacy data this year, including at the Actions Conference which is happening later this week. A second key area for us is developing sub-Q pre-OMD. We have completed our preliminary sub-Q formulation and are preparing to enter human bioequivalent studies this year. We believe the sub-Q market could represent a significant new market opportunity for us, as the IV and sub-Q CD20 markets within RMS are rather distinct. Given the known profile of the currently available sub-Q, and the profile of the other one under development, we believe there is plenty of room to strive to develop a potentially best-in-class sub-Q CD20 product. Third, we are looking forward to expanding the realm beyond MS. There are multiple other disease indications where CD20s have proven to have utility. We'll look forward to launching our first autoimmune trial outside of MS this year. And fourth and finally, excuse me, We are focused on new drug development and are extremely excited by our recent portfolio expansion. Last month, we entered into a partnership with Precision Biosciences to acquire a worldwide license to Precision's AcerCell Allogeneic CD19 CAR-T Cell Therapy Program for autoimmune diseases and all other non-oncology indications. We believe AcerCell has the potential to be a first in class, best in class treatment for certain autoimmune diseases. As an allogeneic off-the-shelf product, we think Azercel may offer benefits over autologous CAR T treatments. Overall, we believe Azercel is a great fit for us and an important addition to our current pipeline. Azercel has been used to treat over 80 cancer patients, and we look forward to hopefully treating the first autoimmune patients with Azercel as soon as possible with an IMD filing targeted for mid-year. As you can see, we have put together a thoughtful and exciting development plan for 2024 and beyond that we believe can add significant value to our shareholders. We have been and will continue to be measured in our approach to R&D from a capital allocation perspective, including in our approximately $250 million in projected 2024 operating budget are the dollars required to expand our pre-MV field teams, increase our marketing spend, as well as moving forward all of the current development plans we've just discussed. With that, as I bring my prepared remarks to a close, I'd like to say how incredibly proud I am of the team and the progress we've made in 2023. We built a top-notch MS-focused commercial team that enabled us to rapidly integrate TG and Brionvi into the MS ecosystem. And we will continue to build upon this foundation with TG as a trusted partner to the MS community as we strive to serve the patients we treat to the best of our ability. Finally, I also want to congratulate our ex-U.S. partner, NurexPharm, on the official launch of BrionV in Europe, which took place this week in Germany. We look forward to hearing more about their progress as they endeavor to commercialize BrionV in Europe and the rest of the world. With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to provide a detailed update of the BrionV commercial launch.