TG Therapeutics, Inc.

Greetings and welcome to the TG Therapeutics third quarter earnings update call. 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 third quarter of 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 meetings 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, clinical 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.

Thanks, Jana, and good morning, everyone, and thanks for joining us on today's call. It was another good quarter for TG, and I'm happy to share that our net revenue for the third quarter was $166 million, which includes $140 million that we received as an upfront licensing fee from our ex-U.S. partner, and also includes over $25 million of BrionVNet sales in the U.S. To say I'm pleased with the launch and our team's execution of our launch strategy would be an understatement. We continue to outperform our internal expectations and all external revenue expectations set at or prior to our launch. I believe we're in a great position to close out the year strong, I'm excited for the next year and for the future of BRIOMV and TG. Just to remind everybody, BRIOMV is the first and only anti-CD20 monoclonal antibody approved to treat patients with relapsing forms of multiple sclerosis that can be administered in a one-hour infusion twice per year following a starting dose. In clinical trials, BRIOMV provided robust efficacy with a safety profile consistent with what is expected of the CD20 class. It's worth noting that while all anti-CD20s target the same protein, they are not all created the same. Epitope binding and potency of that binding, as well as their ability to engage immune effector cells, are different. And we're seeing these differences begin to resonate amongst healthcare providers. Putting the whole package together, we see BrionV as a differentiated anti-CD20 with best-in-class attributes I believe Brionvy's differentiated profile has supported our early and meaningful market share gains. I don't need to remind you that we're only in our second full quarter of sales, so still very early days here for our Brionvy launch, and we believe that we are well positioned for future share gains, ultimately driving us toward our goal to be the number one prescribed anti-CD20 based on dynamic market share. I'd like to spend a few minutes talking about the recent ECTRIMS conference in Milan. EDTRMS is the premier global MS conference, and TG had a significant presence there this year. For me personally, it was great to interact with many healthcare providers, and the real-world feedback was overwhelmingly positive. It was really gratifying to hear anecdotes about the tolerability and convenience people are experiencing with the use of Briomv, as well as stories about patients that were early repleters on other anti-CD20s and are now doing well on Briomv. In addition to interacting with the healthcare providers of the conference, we had the opportunity to present additional exploratory analysis from the ultimate one and two phase three trials of BRIOMV in relapsing forms of MS, as well as the first data from our enhanced phase three B trial evaluating patients who switched from another IV anti-CD20 therapy to BRIOMV. One of the goals of this trial is to understand the safety profile of a patient switching from another IV CD20 to BrionV without the need for the 150 milligram starting dose, as well as to evaluate the speed at which the first infusion, the full 450 milligram dose, may be given safely. The early data presented was very encouraging, demonstrating in 12 patients that we could safely skip the 150 milligram introductory dose and go straight to the 450 milligram dose In the first cohort, that was given as a two-hour infusion and demonstrated there were no infusion-related reactions reported, nor any dose interruptions or delays. The second cohort is now enrolling and is evaluating the 450 milligram dose administered in the ordinary one-hour infusion, again, without the need for the 150 milligram introductory dose. And we look forward to sharing more data from this trial next year. Interestingly, About 60% of the patients who entered this study are reported to have experienced a wearing-off effect, or what some people refer to as the crap gap, while on their prior IV CD20. So that's something we're going to continue to look out for. While we were in Milan, we also had the opportunity to meet with our colleagues from NurexPharm, our XUS partner. As you may recall, in June, Rionvi was approved in the European Union to treat adult patients with relapsing forms of MS. who have active disease defined by clinical or imaging features. Our team has been working closely with the NurexPharm team and we continue to be confident in their ability to bring BRIOMV to the market in Europe. With their extensive experience in the CNS space, their broad presence in all major European countries, and an extensive and growing team dedicated to the BRIOMV launch, we believe BRIOMV is positioned for success in Europe. We are anxiously awaiting the BRIOMV launch which we believe is still on track for early 2024. We're also happy to share that we just received approval for BrionV in the United Kingdom. This is another exciting step forward for BrionV and for MS patients in the UK looking for a new treatment alternative. As we look forward, we are evaluating additional potential indications for BrionV and our pipeline candidates, as well as new product opportunities in MS and autoimmune diseases. Also, as I've mentioned before, we're evaluating the suitability of BrionV as a subcutaneous injection. And we expect to be able to provide an update early next year as to whether we believe we have a suitable subcu formulation that could be brought forward into the clinic. Based on the current anti-CD20 subcu landscape, we do believe there is room for a more convenient, more tolerable option. We continue to view the subcu market as distinct from the IV market and thus as a potentially attractive expansion opportunity for Briombe. Finally, let me discuss some financial matters. Our CFO, Sean Power, will join us in a bit to provide a more detailed financial update, but I just wanted to discuss some revenue expectations and our cash position. First, with respect to revenue expectations, many of you have witnessed the market effects associated with analysts changing their revenue forecast for Briombe. Some of those changes have been driven by prior quarter sales, but some have been driven by intra-quarter sales reporting from distributors, which despite our warnings about the usefulness of this data has become a source of confusion and price volatility. To address this, beginning on November 1st, our distributors will no longer be sharing distributor-level data with third-party companies. With that, as promised, I'd like to provide some guidance for the fourth quarter of 2023. At this time, we are targeting revenues of approximately $33 to $37 million. That should put us on target for approximately $82 to $86 million for our first partial year of sales, which is a bit ahead of the current $23 consensus of $80 million and well above the consensus of $72 million set around the time of our launch. Now, turning to our cash position. As of the end of the third quarter, we had approximately $229 million in cash. As I mentioned on our last quarterly call, as our revenues grow and we continue to operate with relatively stable OpEx, our cash burn is trending down. And from here, we believe we have a reasonable line of sight to profitability in the near term. All in all, we feel really confident with our cash position and our ability to execute on our business plan. With that, let me turn the call over to our Chief Commercialization Officer, Adam Waldman, who will provide more detailed information about our Brownbee launch. Adam?