TG Therapeutics, Inc.

Greetings, and welcome to the TG Therapeutics third quarter conference call and webcast. At this time, all participants are enlisted in 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 be placed into question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to 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 third 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 a summary of our financial results before turning the call over to the operator to begin the Q&A. 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. With that, I'd like to turn the call over to Mike Weiss, our CEO.

Thank you, Jenna, and good morning, everyone, and thank you for joining us for our quarterly earnings call. We're excited to share with you the results of another quarter of growth and execution of our BrionV launch. The positive feedback and uptake for BrionV in the marketplace continues to outpace our expectations, and the strong data presented during the annual experts meeting from the ultimate one and two trials and the enhanced phase 3B trial both evaluating Briomvi in individuals with relaxing forms of MS, continues to strengthen our belief in the long-term value of Briomvi. We remain highly focused on the commercial success of Briomvi, and I'm excited to share with you our current progress, as well as our future plans to continue to grow Briomvi and shareholder value. Let's kick things off with a brief review of the quarterly sales. I'm happy to report that Briomvi third quarter, U.S., Net sales were 83.3 million. Adam Waldman, our chief commercialization officer, will join shortly to write a full commercial update and year-end guidance. But I wanted to say that I'm extremely pleased with the continued commercial launch effort. The team continues to execute on our phased launch plan, setting us on what we believe is a path for continued growth and strong momentum heading into the end of the year and into 2025. And further toward our long-term goal of becoming the number one prescribed anti-CD20 in terms of dynamic market share. To that end, let's discuss some of the brianna data presented at the recent ECTRIMS annual meeting. As I alluded to earlier, we presented two important data sets during the meeting. The first was a long-term follow-up data from our open label extension study from the ultimate one and two phase three trials, which, as a reminder, were the core trials that supported the approval of Realme for individuals with relapsing forms of MS. After five years of Realme 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, which is equivalent to one relapse occurring every 50 years of treatment. And importantly, the overall safety profile remained consistent over five years of continuous pre-OMB treatment, with no new safety signals emerging with prolonged usage. As we've stated previously, we believe we have set the standard for convenience in IV CD20 therapy, and we continue to look for ways to further streamline the patient experience. At ECTRIMS, we updated data previously presented to AN in April from our enhanced study, showing that individuals with relapsing forms of MS who were B-cell depleted on their current anti-CD20 therapy and were switched to BrionV were able to tolerate the one-hour BrionV infusion without first receiving the four-hour introductory dose. Currently, all IV CD20s used to treat MS require two infusions in the first two weeks to initiate therapy. This approach would only require one visit to start BrionV. Additionally, at ECTRIMS, we presented data for the first time on a faster 30-minute BrionV infusion from our enhanced trial. The data presented, while still preliminary, showed that the first maintenance dose of BrionV given as a 30-minute infusion, as opposed to one hour, was well-tolerated, with all infusion-related reactions being mild, grade 1, and resolved completely. We have now treated over 50 individuals with RMS with 30-minute BrionV and look forward to presenting updated data at a future medical conference. As you can imagine, more testing, including randomized trials, will be needed to incorporate these potential updates into our label, but hopefully this highlights our longer-term vision to continually seek to improve the patient journey with BrionV. and maintain what we believe is a best-in-class profile. And further to achieving that goal, I'd like to remind everyone that we are also developing a sub-Q version of BreonV. While the majority of individuals with MS choose IV CD20 delivered every six months, which is how BreonV is currently offered, and we expect that to continue, the at-home self-administered sub-Q market is meaningful. Accordingly, we believe that offering an at-home self-administered sub-Q BRIOMV would open up a new market opportunity for us. We expect to be able to provide an update from our BRIOMV sub-Q bioequivalent study by early next year. And if all goes well, we'd be targeting a pivotal trial commencing in the middle of 2025. And finally, beyond BRIOMV on the R&D front, we previously shared that the US FDA has cleared our investigational new drug application IND for Azercel, and off-the-shelf allogeneic CD19 CART T-cell therapy for the treatment of autoimmune diseases. The team has been working hard to move this forward, and we are targeting launching a phase one study around the end of this year or early next year, starting in individuals with progressive MS. This is an exciting new opportunity that we believe may offer a new treatment for individuals with progressive MS who have few options. Switching gears a little bit, I want to highlight a recent transaction related to manufacturing and supply. As you may be aware from our public filings, we currently manufacture Brionvi at Samsung Biologics in South Korea, who are recognized as the global leaders in biologics manufacturing and who have been and continue to be a great partner to TG. As Brionvi continues to grow, as we continue to believe the blockbuster potential of Brionvi, From a risk management standpoint, we felt it was time to engage a secondary manufacturer of BrionV. Accordingly, we are happy to announce we have secured Fujifilm DioSynth Biotechnologies as a second manufacturer of BrionV at the facility base here in the United States. As we continue to expand our commercialization efforts in MS and think about the future of BrionV, we believe this is an important next step that will continue to support our growth plans and provide additional security for our drug supply. In closing, I want to thank all of our TGers for their hard work and commitment to people living with MS. Our progress is a testament to our collective efforts, and I'm excited about the path forward. Through your efforts, TG is poised to become a new leader in the MS market, focused on developing and delivering innovative therapies for multiple sclerosis. With that, I'll hand the call over to Adam Waldman, our Chief Commercialization Officer, to walk you through a commercial performance in more detail. Thank you. Adam, go ahead.