TG Therapeutics, Inc.

Greetings and welcome to the CG Therapeutics first quarter 2023 earnings call. At this time, all participants are in a listen-only mode. The 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. I would now like to turn the call over to Jenna Bosco. Thank you. 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 2023 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 developments. 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 meanings 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, and expectations for our marketed and pipeline 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. With that, I would like to turn the call over to Mike Weiss, our CEO.

Thanks, Jenna, and good morning, everyone, and thanks for joining us on today's call. 2023 is off to an excellent start for us at TG. With the U.S. approval and commercial launch of Briandvi, and we are excited to be able to offer a patient the first and only anti-CD20 monoclonal antibody approved for relapsing forms of MS that can be administered in a one-hour infusion twice a year following the starting dose. We believe that BrionV's clinical profile has best-in-class potential in the treatment of multiple sclerosis and offers an exciting value proposition for all key constituents, including patients, providers, and payers. Today, we are pleased to share the results of our first partial quarter of sales commencing on January 26, 2023. As such, we are essentially reporting on the first two months of BrionV commercial availability. Our Chief Commercialization Officer, Adam Waldman, will join us shortly to provide some detailed metrics surrounding the first quarter results. Accordingly, I will keep my comments regarding the launch at a high level and touch on a few other topics that may be of interest to investors. With respect to the launch, we have said for some time that the profile of Ryundi has been well received by healthcare providers, and we are pleased to see such enthusiasm carrying through to the launch phase. Early adoption has come from both major academic centers and community practices. Geographically, all of our territories have seen HCPs prescribing BRIUMPI and we have seen nice adoption within our target accounts. In terms of patients, we are also seeing a nice distribution of those that are new to MS treatment, new to CD20 treatment, and also switches from other CD20s, which we believe further underscores the attractiveness of the BRIUMPI profile. Overall, I believe our commercial teams and medical teams are doing a fantastic job introducing BRIOMBI to and educating healthcare providers on the attributes of BRIOMBI as well as building payer access. And I'm very pleased with the launch thus far. With that, I'll move on. I want to briefly talk about our European marketing authorization application and our ex-US launch plans. At the end of March, about a month ago, we announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency, referred to as the EMA, issued a positive opinion recommending the approval of BRIAMDI for the treatment of adult RMS patients with active disease defined by clinical or imaging features. With this opinion, we expect to hear a final decision from the EMA by early June. We continue to evaluate the best commercial pathway for us in Europe, either go-it-alone or partner, and we will seek to answer that question in the coming months to enable a European launch later this year, if approved. Whatever pathway we select, we see Europe as another opportunity to create additional shareholder value by making Brionvia available internationally. Finally, let me discuss TG's cash position. As reported, we ended the quarter with approximately 160 million in cash when you include the 20 million of additional capacity available to us under our Hercules facility. We continue to believe our current cash and associated incremental Hercules capacity, along with modest assumptions of revenue, will be sufficient to take us into mid-2024. Of course, if revenues continue to exceed those in our cash model, our current cash should last even longer. With our growing revenues and relatively stable burn, it is not clear how much, if any amount, we would need to raise prior to cash flow breakeven. Accordingly, we are quite comfortable with our current cash position and with our many options for adding to the balance sheet in non-dilutive or minimally dilutive ways. With that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer to share some additional color on our first quarter of launch. Adam?