TG Therapeutics, Inc.

Greetings and welcome to the TG Therapeutics conference call and webcast. At this time, all participants are in 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, Jenna. 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 first quarter 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 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 or clinical 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. With that, 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. 2024 is off to an exciting start, and I'm incredibly proud of the accomplishments already achieved this year. Company-wide, it feels like we are firing on all cylinders. A prime example was the recent announcement of the award of the VA contract for BrionV as the preferred anti-CD20 for the VA system. We cannot be more excited to be able to support our veterans with multiple sclerosis by offering BrionV at a deep discount. We see this as a great way to serve our veterans, introduce BrionV to additional healthcare providers, many of whom split their time between the VA and their academic appointments, and of course, generate incremental revenue. As for the first quarter, the demand for BrionV was extremely strong, and I'm pleased to report that the U.S. BrionV revenue was in excess of $50 million, and total revenues for the quarter were over $63 million, which includes milestone payments received from our ex-U.S. partner. By any measure, it was a robust revenue quarter for TG. As mentioned previously, starting in late 2023 and continuing, we have significantly increased our investment in patient awareness activities and strategically increased the size of our commercial team. I have to believe these investments contributed to the strong first quarter results. More broadly, our team continues to be focused on our long-term goal of becoming the number one prescribed anti-CD20 from a dynamic market share perspective and the feedback from physicians, patients, nurses, and infusion centers continues to drive our confidence that that is achievable. We believe that BrionV has best-in-class profile that should help us get there. BrionV is the only anti-CD20 monoclonal antibody that can be given as a one-hour infusion every six months following the starting dose and is the only anti-CD20 monoclonal antibody in phase three trials to achieve an annualized relapse rate of less than 0.10. Also in phase 3 trials, the Brionvia one-hour infusion was generally well tolerated with 95% of the one-hour infusions being delivered on time. Beyond the clinical data, Brionvia is also differentiated by design, having been glycoengineered for enhanced immune effector cell engagement and efficient B-cell depletion. As previously presented, preclinical data demonstrates that compared to the other anti-CD20s-approved were used to treat MS. Brionvy has the highest binding affinity to CD20, the target found on the B cells, and through its glycoengineering, has the ability to induce the highest level of antibody-dependent cellular cytotoxicity. We look forward to evaluating these preclinical differences further to assess what, if any, contribution they may have to Brionvy's differentiated clinical profile, and we will seek to share these data when available. We're also excited to share during the quarter that there were three newly issued patents of the U.S. Patent and Trademark Office extending patent protection for Brionvy through 2042. With the extended runway, our development team is focused on potential expansion opportunities for Brionvy both within MS as well as in other autoimmune diseases. To that end, we are focused on three Brionvy-related initiatives this year, which we believe could drive significant future value. First is further improving the convenient dosing of IV BrionV. In March, at the ATTRMS conference, we presented updated data from the enhanced trial, evaluating the safety and efficacy of eliminating the four-hour BrionV 150 milligram starting dose for patients who switch from a prior anti-CD20. Data presented suggests that BrionV was well-tolerated for patients that skipped the starting dose. and went straight to the first full 450 milligram dose given as a one-hour infusion. These early results are encouraging, and we look forward to continuing to present additional efficacy, safety, and tolerability data from this study throughout the year. Second is the development of subcutaneous pre-OMV. We believe the sub-Q CD20 market is distinct from the IV market and believe this could represent a significant additional opportunity for BrionV. We are preparing to enter human bioequivalence studies this year and look forward to providing additional updates on this front as we have them throughout the year. And third, we look forward to evaluating BrionV in other autoimmune indications. The goal is to launch our first autoimmune trial evaluating BrionV outside of multiple sclerosis later this year. We believe the expansion of Realme represents a significant opportunity, and we look forward to providing updates throughout the year, but we're not stopping there. The future of TG also lies in the expansion of our portfolio. We recently entered into a partnership with Precision Biosciences to acquire a worldwide license to Precision's AcerCell, an allogeneic CD19 CAR T-cell therapy for autoimmune diseases and all other non-oncology indications. We believe the AZER cell has the potential to be a first-in-class, best-in-class treatment for certain autoimmune diseases, and we look forward to commencing a clinical trial this year. I also want to congratulate our partners at NurexPharm on their launch of REARM in Europe, which also occurred in the first quarter with the first commercial sale in Germany. Transitioning the program to enable their timely launch took significant effort from our team and I'm proud of how everyone worked so closely together to make it happen. The InterX Pharm team is experienced, motivated, and focused, and we look forward to hearing more from them as the launch progresses to multiple countries across Europe and then around the globe. Finally, I want to thank and acknowledge the entire TG team. It's amazing to see the focus, attention, and care that TGers take to ensure the best possible experience for patients with MS. While we spend a lot of time on these calls talking about numbers, the most gratifying part of my day is hearing firsthand from patients taking Brionvy of their positive experiences, as well as HCP's anecdotes about their patients' treatment successes with Brionvy. With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to write a detailed update on the Brionvy U.S. commercial launch. Adam, go ahead.