TG Therapeutics, Inc.

Greetings and welcome to the TG Therapeutics second quarter 2023 financial results and business 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, Ms. Bosco. You may begin.

Thank you. Welcome, everyone, and thanks for joining us this morning. I am Jenna Bosco, and with me today to discuss this morning's news of our XUS commercialization partner, as well as the results for the second quarter of 2023, are Michael Weiss, our Chairman and Chief Executive Officer, Adam Walden, our Chief Commercialization Officer, and Shawn Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of today's news as well as our recent corporate developments. Adam will give an update on our commercialization efforts, and Shawn 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, including sales performance, projected 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. Now, 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. We are excited to present to you our second quarter 2023 financial results, representing the first full quarter of Brumby sales. which, like the first quarter of 2023, exceeded our expectations. But before I do, I want to kick off today's call by highlighting this morning's news relating to our agreement for ex-U.S. commercialization of Briomvi. As you may recall, in June, Briomvi 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. Today, we are very happy to announce that we've entered into an ex-US commercialization agreement for Briomvy with Neurex Pharm, a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders or CNS disorders. We're very excited to be partnering with them to launch Briomvy in Europe. Their neurology-focused approach, broad European platform, and entrepreneurial organization really resonated with us as an attractive partner for Briomvy and TG. NurexFarm has over 35 years of experience in the CNS space, a direct presence in 20 European countries, and an extensive commercial CNS team. And in addition, they have committed to add over 100 additional field-based commercial and medical MS specialists dedicated to Brionvi. Moreover, they have the backing of one of the preeminent global private equity firms, Premiera. For all of these reasons, we are confident in their ability to succeed and making Breonvia a leading treatment for patients with RMS worldwide. From a deal perspective, the terms provide us with many important benefits that we were seeking when evaluating potential ex-US partnerships, including a meaningful upfront payment, which together with a near-term milestone total over $150 million, solidifying our balance sheet. We're also eligible to receive up to an additional $500 million in milestone payments based on the achievement of certain launch and commercial objectives for a total deal value at up to approximately $650 million. We will also receive tiered double-digit royalties on net product sales up to 30%, which we think provides significant participation in the success of Breon V in Europe and the rest of the world. And lastly, and very importantly, as part of the deal, we retain strategic flexibility in the event of an acquisition of TG within the next two years with an option to buy back all rights under the commercialization agreement. As we noted previously, retaining this type of strategic flexibility was core to our considering an ex-U.S. transaction, and Nurexpharm and their backers appreciated that need. In exchange, Nurexpharm will have the exclusive right to commercialize Brionvi in territories outside the United States, Canada, and Mexico, which we have retained, and excluding certain Asian countries, which we had previously partnered. As I said earlier, we are very excited to partner with NurexPharm and believe they are well-positioned to successfully launch Rionvi in Europe, which we expect to commence in Germany in the next six months. With that, let me touch upon the U.S. Rionvi launch efforts, which remains our primary focus. As a reminder, Briombe received U.S. FDA approval late last year and officially launched at the end of January of this year as the first and only anti-CD20 monoclonal antibody to treat patients with relapsing forms of MS that can be administered in a one-hour infusion twice per year following the starting dose. I'm delighted to share that we experienced significant growth in revenues and prescriptions over the first quarter of this year, illustrating what we believe is strong early demand for Briombe. Equally noteworthy is the breadth of centers and providers willing to embrace this new treatment option, demonstrating the trust and confidence they have in Briomvi and TG. Our early performance is a testament to the dedication and passion of our entire TG team, who have relentlessly worked to bring Briomvi to patients with RMS. The enthusiasm for Briomvi continues to build, and the feedback we have received continues to encourage us that the unique attributes of Brionvy are supportive of its best-in-class potential, including its glycoengineering for efficient B-cell depletion, lowest reported annualized relapse rates of any CD20 monoclonal antibody in MS Phase III trials, and a rapid and reliable one-hour infusion. As we move into the third quarter, we believe we are building a solid foundation for future Brionvy growth. We continue to see adoption from both major academic centers and community centers and believe that that adoption will continue to grow, especially now that we have a permanent J code in place and improving insurance coverage for BrionV. All of these factors, along with the continuing growth of the CD20 market within the overall MS treatment landscape, further strengthen our confidence in the future potential of BrionV. I'll stop there as our Chief Commercialization Officer, Adam Waldman, will join us shortly to provide more detailed launch metrics But as you can hear, I'm extremely impressed with the progress the team has made to date and look forward to an impactful second half of 2023. Before I turn the call over to Adam, I just want to touch briefly on TG's cash position. Following the NurexFarm transaction, we have pro forma cash balance of approximately $285 million. Given our relatively stable OpEx and growing revenues, we believe we now have sufficient capital to fund our operations into the foreseeable future without the need to raise additional capital. Of course, this projection is subject to many variables, but suffice to say, as of today, we are confident with our cash position. With that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, to share some additional color on our first full quarter of launch. Adam?