TG Therapeutics, Inc.

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. If you wish to ask questions, please press star 1. If you'd like, if anyone should require operator assistance during a conference, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce to 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 development, 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 for TG as we received FDA approval of Pre-Omvi to treat adult patients with relapsing forms of multiple sclerosis, also referred to as RMS, which includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease. Brionvi is now the first and only anti-CD20 monoclonal antibody approved for RMS that can be administered in a one-hour infusion twice a year following the starting dose. This approval was based primarily on the results of the ultimate one and two phase three trials, which demonstrated superiority of Brionvi over teraflutamide in significantly reducing the annualized relapse rate which was the primary endpoint of the studies, as well as the number of T1 GAD-enhancing lesions and the number of new or enlarging T2 lesions, two important secondary endpoints. Results from the ultimate one in two 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 hard work and dedication to making BrionV available to patients. Our Chief Commercialization Officer, Adam Wallman, will join us shortly to talk about the early launch phase, but I also wanted to touch briefly on our BrionV launch. As you can imagine, our team is working hard to introduce BRIOMV to the MS community. Key to that effort is educating healthcare providers on the data as well as the other attributes of BRIOMV. The team has received positive feedback thus far and is excited to continue to work with the MS community to make BRIOMV available as broadly as possible to RMS patients. As we have discussed in the past, it is estimated that nearly 1 million Americans are living with MS. and roughly 75,000 to 80,000 are seeking a new treatment each year. Our internal research suggests that about half of these patients seeking a new treatment are currently being prescribed an anti-CD20 therapy. We are excited that Briome is now available to these patients as the only anti-CD20 therapy for RMS that is administered as a one-hour fusion twice a year following the starting dose. We do believe that Briomvik can provide an overall enhanced infusion experience for those new to anti-CD20 therapy and also for those currently on the other infused anti-CD20 therapy where infusion times for some patients can be prolonged. Last week, I was fortunate enough to attend the Actrums Conference in San Diego and had the opportunity to interact with many leading MS healthcare providers at the meetings. It was nice to hear firsthand the enthusiasm many of them had for Briamvi entering the market, the overall product profile and differentiation, and the product label. It was also gratifying to hear that patients are already asking for Briamvi by name. I also have been very impressed with our team's ability to interact with the MS community on all levels, and I know that they will continue to work hard to engage with healthcare providers and other stakeholders during the course of this year with the goal of ensuring that all patients who want BrionV will have access to BrionV. We continue to be excited by the BrionV profile that we believe brings the power of the anti-CD20 class to patients in a convenient one-hour fusion administered twice per year following starting dose at the lowest price of any branded MS treatment. We believe this profile should provide significant benefits across the entire MS community, including to patients, healthcare providers, medical centers, and payers. With that, let me turn the call over to Adam Wallman, our Chief Commercialization Officer, to share some thoughts on our early days of launch and commercialization in RMS.