TG Therapeutics, Inc.

Greetings. Welcome to TG Therapeutics' second quarter 2024 earnings call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If you'd like to ask a question, please press star 1 from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. If anyone today should require operator assistance, please press star zero from your telephone keypad. Please note this conference is being recorded. I'll now turn the conference over to Jenna Bosco. Jenna, you may now begin.

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second 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.

Thank you, Jenna, and good morning, everyone, and thank you for joining us for our quarterly earnings call. I'm pleased to report that we had another quarter of outperformance across all aspects of our business, marked by the continued successful launch of our flagship drug, Briumvi, which was approved about 18 months ago for patients with relapsing forms of multiple sclerosis. The market response has been overwhelmingly positive, and our sales performance has exceeded our initial projections. Let me start by highlighting some key achievements for the second quarter of 2024. First, on the commercial front, I'm pleased to share that we achieved 72.6 million in BrionB net sales in the United States, exceeding our target of approximately 65 million, leading us to raise our full year guidance to approximately 290 million to 300 million. That's up from 270 to 290 million from last quarter, which was already raised from our preliminary guidance of $220 to $260 million provided at the beginning of the year. Our commercial team has done an outstanding job in executing our launch strategy, resulting in strong initial adoption. This early success reinforces our confidence in Briombe's long-term potential to reach our goal of becoming the leading treatment for relapsing forms of multiple sclerosis on a dynamic market share basis. On the R&D front, we also had a very productive quarter. While commercialization of Briombe remains our core focus, we continue to explore ways to improve upon the delivery of BrionV, explore potentially new indications for BrionV, and advance our newly acquired allogeneic off-the-shelf CD19 CART-T for autoimmune diseases. At the same time, we continue to evaluate opportunities to expand our pipeline. Specifically, some R&D highlights for the quarter included our enhanced study, which is evaluating ways to streamline the switch to BrionV from other anti-CD20s continued its robust enrollment. We were also able to present preliminary data from the study at the ACTRMS conference, showing that patients can safely be transitioned from other anti-CD20s to BrionV without the need for the first dose of 150 milligrams over four hours in those patients that enter the study with low B-cell counts. We look forward to sharing additional data from the enhanced trial in the coming months. Another highlight was that we treated our first MS patients with subcutaneous BrionV and a newly launched phase one study to assess bioequivalence of sub-Q versus IV BrionV. This was a high priority for the team and I'm proud of their efforts to get this study initiated quickly. As mentioned in the past, we believe the sub-Q and IV CD20 markets are distinct and believe this could represent a significant additional opportunity for the BrionV franchise. We believe we'll be in a position to share data from this study early next year, and we are still targeting starting a pivotal trial for subcutaneous BrionV by mid-2025. And finally, related to another high-priority R&D program, we were excited to report that the US FDA has cleared our Investigational New Drug Application, or IMD, for Azercel, an off-the-shelf allogeneic CD19 CAR T-cell therapy for the treatment of autoimmune diseases. As a reminder, earlier this year, we entered into a partnership with Precision Biosciences to acquire a worldwide license to age yourself for indications outside of cancer. With an active IND now in hand, we believe we are on track to launch a phase one in autoimmune diseases, initially in patients with progressive MS by the end of this year. Next, I'd like to highlight our financial position and discuss the share repurchase program we announced this morning. The strong launch of Breonvi has positively impacted our financial results, including leading to our first operationally cash flow positive quarter. Sean Power, our CFO, will join shortly to discuss our financial performance in more detail. But I wanted to touch on our newly established five-year $250 million credit facility with healthcare royalty and blew out capital. The proceeds will first be used to repay essentially refinance our approximately $107 million of indebtedness and accrued interest owed to Hercules Capital Partners, which was set to mature in tranches from mid-2025 to January of 2026. Another $100 million of proceeds has been allocated to fund up to a $100 million share repurchase plan, which was recently authorized by our Board of Directors. The remainder will simply be added to working capital providing us with additional operational flexibility. We've been talking about the potential for a share buyback publicly, and we're excited to establish this credit facility, which allows us to accelerate our ability to repurchase shares. We see TG as a growth story, setting up for possible significant cash flows in the future, and we're committed to sharing that value with our shareholders. This repurchase program is just the first step in that process. Importantly, this new credit facility enables us to repurchase shares without utilizing our current cash, which is dedicated to continuing to build out our commercial infrastructure and footprint, growing our marketing efforts, including growing our direct to patient initiatives, and finally investing in our R&D programs. In closing, I want to thank the entire TG team for their dedication and hard work in making this quarter a success. We're excited about the positive impact we're making in patients' lives and the value we're creating for our shareholders. With that, I'll hand the call over to Adam Wallman, our Chief Commercialization Officer, to walk you through our commercial performance in more detail. Adam, go ahead, please.