Q2 2024 TG Therapeutics Inc Earnings Call

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Unknown Executive: Welcome to TG Therapeutics, the second quarter of 2024 earnings call. At this time, I'll be dispenser in listen-only mode. The question and answer session will follow the 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 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 0 from your telephone keypad.

Speaker Change: And a confirmation tone will indicate your line is in the question queue.

Speaker Change: You May press Star two if you like to remove your question from the queue.

Speaker Change: For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker Change: If anyone today should require operator assistance. Please press star zero from your telephone keypad.

Unknown Executive: Please note this conference is being recorded. I'll thank you.

Speaker Change: Please note this conference is being recorded.

Speaker Change: I'll now turn the conference over to Jenna Bosco Jenna you may now begin.

Jenna Bosco: 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.

Jenna Bosco: Welcome everyone, and thanks for joining us this morning.

Jenna Bosco: 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, Michael provided an overview of our recent corporate development. 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 and A session.

Speaker Change: Adam <unk>, our chief commercialization officer, and Sean power, our Chief Financial Officer.

Unknown Executive: 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. Factors that may affect TG Therapeutics' operations include various risk factors that can be found in our SEC filing.

Speaker Change: 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 of our financial results before turning the call over to the operator to begin the Q&A session.

Jenna Bosco: 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 political milestones, revenue guidance, development plans, and expectations for our marketed products. TG questions 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 therapeutic operations include various risk factors that can be found in our SEC filing. 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.

Speaker Change: 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 guide.

Speaker Change: <unk> development plans and expectations for our marketed product <unk>.

Jenna Bosco: We specifically display in any obligation to update or revise any forward-looking statements.

Jenna Bosco: 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.

Michael Weiss: 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 the 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, Brieumby, which was approved about 18 months ago for patients with the collapsing forms of multiple sclerosis. The market response has been overwhelmingly positive, and our sales performance has exceeded our initial projections.

Adam Waldman: The market response has been overwhelmingly positive and our sales performance has exceeded our initial projections. 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. The approach is sharing additional data from the enhanced trial in the coming months. Another highlight was that we treated our first MS patients with subcutaneous Briumv in a newly launched phase one study to assess bioequivalence of subq versus IV Briumv.

Michael Weiss: Let me start by highlighting some key achievements to the second quarter of 2024. First on the commercial fund. I'm pleased to share that we achieved 72.6 million in Brieumby 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 270-290 million from last quarter, which was already raised from a preliminary guidance of 220-260 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.

Michael Weiss: This early success reinforces our confidence in Breonna's long-term potential to reach our goal of becoming the leading treatment for relaxing forms of multiple sclerosis on a dynamic market share basis.

Michael Weiss: On the R&D front, we also had a very productive quarter. While commercialization of Breonna remains our core focus, we continue to explore ways to improve upon the delivery of Breonna, explore potentially new indications for Breonna, and advance our newly acquired allogeneic off-the-shelf CD-19 CART-T for all our communities. 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 Breonna from other anti-CD-20s, and continue to grow bust enrollment. We're also able to present preliminary data from the study at the Actram's conference, showing that patients can safely be transitioned from other anti-CD-20s to Breonna 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, with a photo-sharing additional data from the Enhanced Trial in the coming months.

Michael Weiss: Another highlight was that we treated our first MS patients with subcutaneous Breonna and a newly launched Phase I study to assess bio-equivalence of sub-Q versus IV Breonna. 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 CD-20 markets are distinct and believe this could represent a significant additional opportunity for the Breonna B 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 Breonna by May 2025.

Adam Waldman: This was a high priority for the team and I'm proud of their efforts to get the study initiated quickly. As mentioned in the past, we believe the subq and IV CD20 markets are distinct and believe this could represent a significant additional opportunity for the Briumv franchise, and off-the-shelf allogeneic CD19 CAR-T cell therapy for the treatment of autoimmune diseases. The strong launch of Brionvi has positively impacted our financial results, including leading to our first operationally cashflow positive quarter.

Michael Weiss: 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 IND, for ASERCEL. And off the shelf, allogeneic CD-19 part T-cell therapy for the treatment of other patients with Precision Biosciences to acquire a worldwide license to ASERCEL for indications outside of cancer. With an active I&D now in hand, we believe we are on track to launch a Phase I and Automuse diseases initially in patients with progressive MS by the end of this year.

Speaker Change: With an active now in hand, we believe we are on track to launch a phase one in autoimmune diseases initially in patients with progressive Ms.

Speaker Change: At the end of this year.

Michael Weiss: Next, I'd like to highlight our financial position and discuss the share repurchase program we announced this morning. The strong launch of Breonna B has positively impacted our financial results, including leading to our first operationally, Casula positive quarter. Strong power our CFO will do and shortly discuss our financial performance in more detail. Though I wanted to touch on our newly established $5,250,000,000 credit facility with health care, royalty, and blue outcups. 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.

Speaker Change: Next I'd like to highlight our financial position and discuss the share repurchase program, we announced this morning.

Sean Power: The strong launch of <unk> has positively impacted our financial results, including leading to our first operationally cash flow positive quarter Sean.

empower: So empower our CFO will join shortly to discuss our financial performance in more detail.

Adam Waldman: But I wanted to touch on our newly established five-year, $250 million credit facility with healthcare royalty and Blue Owl Capital. Another $100 million of proceeds have 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.

Speaker Change: But I wanted to touch on our newly established five year $250 million credit facility with healthcare royalty and blew out capital.

Speaker Change: The proceeds will first be used to repay essentially refinance or 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 2026.

Speaker Change: 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.

Michael Weiss: We can simply be added to working capital, providing us with additional operational flexibility. We've been talking about the potential for a shared 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.

Michael Weiss: 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.

Adam Waldman: 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. Thank you, Mike, and good morning, everyone. I'm thrilled to share our commercial progress to the second quarter of 2024. Building on the momentum from the first quarter, we have once again delivered strong performance across all key metrics, continuing our commitment to bringing greenery onto the patients with relaxing forms of amounts. As Mike mentioned, we achieved second quarter net sales of $72.6 million, exceeding our target of $65 million and reflecting approximately 45% growth quarter over quarter and 350% growth from the same quarter last year.

Adam Waldman: We saw strong growth in patient enrollments, with over 1,400 new patient scripts processed through the TG hub, marking a 12% increase from the previous quarter. We have now had approximately 5,850 new patient prescriptions written to our hub across 525 centers from over 950 prescribers launched today. We are very pleased with the rate of adoption, but also remember that since not all new prescriptions go to our TG hub, these numbers underestimate the total new patient scripts for branding. For the second quarter, we estimate that the hub captured only about 80 to 85% of total new scripts.

Adam Waldman: And as more and more academic centers and independent infusion centers adopt, these hub capture rates could go down further as these types of centers are less likely to be utilized our TG hub services. Realty continues to gain share in a large and rapidly growing anti-CD20 market in the RMS. Strong share growth and patient adherence is leading to significant revenue growth to the CD20 class overall, year over year. The class now represents an approximately $2 billion quarterly revenue opportunity in the US, with IV therapies capturing approximately 70% of that. We would expect that the class will continue to grow going forward, and Briumbia will continue to grow within it.

Adam Waldman: Strong share growth and patient adherence is leading to significant revenue growth for the CD20 class overall year over year. As previously announced, we successfully expanded our market reach by securing a contract with the Department of Veteran Affairs, making Briambi the preferred anti-CD20 treatment for relapsing forms of MS among veterans. In conclusion, I want to extend my gratitude to our dedicated team for the relentless effort in driving the success of this program. Together, we're making significant strides in improving outcomes for individuals living with unwellness.

Adam Waldman: We have seen our prescriber base continue to expand, adding approximately 150 new prescribers and over 70 new accounts in quarter two. Many of these new prescribers are coming from leading academics on partners, further establishing Briumbia's presence in the MS treatment landscape. Some have also started to come from the VA. As previously announced, we successfully expanded our market reach by securing a contract with the Department of Veterinary Affairs, making Briumbia the preferred anti-CD 20 treatment for relapsing forms of a mass among veterans. This strategic partnership, which went into effect on June 17, not only broadens our patient base, but also reinforces Briumbia's value proposition.

Adam Waldman: We believe this partnership creates access not only to a new group of patients, but also treating physicians in many cases have dual appointments at the VA and in academic. Overall, we continue to see strong new patient accumulations, reflecting our effective commercial strategies and operational excellence. We believe our strategic investments in field force expansion and patient marketing initiatives are yielding high returns contributing to our overall growth trajectory. Patient access to Briumbia remains our top priority. Our comprehensive patient support programs have been instrumental in assisting patients with accessible Briumbia and working to ensure they receive the treatment they need.

Adam Waldman: We have received very positive feedback from both patients and health care providers about the support and resources available to get patients started on therapy, and our patient adherence at week 24 remains strong. The diversity of patient types being treated with Briumbia remains consistent. We continue to see a balanced mix of patients who are treatment naive, those switching from non-CD 20 therapies, and those switching from other CD 20 therapies. This broad adoption is a testament to Briumbia's compelling clinical profile and its differentiation in the marketplace. Looking ahead, we are optimistic about the continued growth and potential of Briumbia based on current trends in both new patient accumulations and persistence.

Adam Waldman: We are raising our full-year guidance, which was 270 to 290 million, to 290 and 300 million for the year. We expect the quarters to continue to build and have considered the seasonality we saw last year in Q3. We, therefore, would expect more modest growth from Q2 to Q3, with stronger growth from Q3 to Q4.

Adam Waldman: In conclusion, I want to extend my gratitude toward dedicated team for the relentless efforts in driving the success of Briumbia. Their hard work and commitment has been crucial on achieving these remarkable results. I also want to thank the health care providers and patients for the trust in Q3 that have put it. Together, we're making significant strides and improving outcomes for individuals withing with our masks. We're excited about the future and remain focused on our mission to bring Briumbia even more patients, helping them live better lives. Thank you.

Sean Power: And with that, I'll hand the call over to Sean Power, RCFO. Sean? Thank you, Adam, and thanks everyone for joining us. Earlier this morning, we reported our detailed second quarter 2024 financial results, which can be viewed on the Investors and Media section of our website.

Sean Power: Before I get into the results for the quarter, I'd like to begin by briefly discussing the county matter we described in 8-K filed earlier this morning. During a second quarter review, we identified an error which was deemed to be immaterial related to the expense recognition of a single restricted stop grant from 2021. This error was isolated to 2021 and 2022 and does not impact results of operations in any other or subsequent period. Although the error was determined to be immaterial to all relevant financial statements, it was determined that this represented a material weakness in the company's internal control over financial reporting related to controls around non-routine stock awards.

Speaker Change: In 2021.

Speaker Change: This error was isolated to 2020, one and 2022 and does not impact results of operations and any other subsequent period.

Speaker Change: Although the error was determined to be immaterial to all relevant financial statements. It was determined that this represented a material weakness in the company's internal control over financial reporting related to controls around non routine stock awards.

Sean Power: Which will require some disclosure in our 10-Q this quarter and an amendment to our 2023 10-K that will be filed later this week.

Speaker Change: Which will require some disclosure in our 10-Q this quarter and an amendment to our 2023 10-K that will be filed later this week.

Sean Power: We are already in the process of updating our internal controls relative to these equity grants and expect the material weakness will be fully remediated before December 31 of this year.

We're already in the process of updating our internal controls relative to these equity grants.

Speaker Change: Expect a material weakness will be fully remediated before December 31 of this year.

Sean Power: Now let's turn to the financial results for the quarter. We are pleased to report that we were both cash flow positive and generated net income in the second quarter of 24. We ended the quarter with approximately 217 million cash, cash equivalence, and investment securities, up $7 million from Q1 and flat from year end. This was of course made possible by the strong quarter of Brambi with 72.6 million of US Brambi net product revenue, which is up more than 350% or the comparable quarter in 23. Our OPEX excluding non-trash items during the second quarter came in below guided ranges at approximately 47 million, roughly in line with Q1-24 when excluding the one-time charges seen during Q1-2024.

Speaker Change: Now, let's turn to the financial results for the quarter.

Speaker Change: We were pleased to report that we were both cash flow positive and generated net income in the second quarter of 'twenty four.

Speaker Change: We ended the quarter with approximately $217 million in cash cash equivalents and investment securities.

Speaker Change: Up $7 million from Q1 and flat from year end.

Speaker Change: This was of course made possible by the strong quarter of Brown B was $72 6 million of U S brand. The net product revenue, which is up more than 350% over the comparable quarter and 23.

Sean Power: Our OPEX for the first six months of 2024 is approximately 105 million, or averaging just over 50 million per quarter, again below our guided range. As discussed briefly earlier, our gap net income for the three months ended with $6.9 million, or $4 per diluted share. When excluding non-trash items, net income for the period was approximately 16.4 million.

Sean Power: Our OPEX for the first six months of 2024 is approximately $105 million. We're averaging just over $50 million per quarter, again, below our guided range.

Sean Power: And finally, I'll close by touching briefly on today's announcement of a new $250 million debt facility with Healthcare Royalty and Blue Al Capital. We were pleased to be able to refinance our existing debt to a facility with a longer term duration and attractive financial terms. As Mike discussed, this will provide us with sufficient resources to execute on our shared purchase program, also announced today, as well as continue to invest in the Brambi commercial opportunity.

Unknown Executive: With that, I will now turn the call back over to the conference operator to begin the Q&A. Thank you. At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, you may press star one from your telephone keypad, and a confirmation tone indicates your line is in the question queue. You may press star two if you like to withdraw your question from the queue.

Operator: At this time, we'll be conducting a question and answer session.

Unknown Executive: For Christmas, using speaker equipment, you may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Thank you.

Roger Song: Thank you, and our first question comes from the line of Roger Song with Jeffries. Let's just use your questions.

Roger Song: Great, congrats for the strong quarter, and thank you for taking all questions. Maybe the first one might give you a comment on the current dynamic market share. As we recall, you have been thinking you're getting around 10%. Just curious about this quarter, and then also what the near turn goal for the dynamic market share and the thing you want to become the number one dynamic market share in the future. Thank you. Yeah, thanks, Roger. Yeah, of course, our goal is to get to that number one position. We're working hard at it. We've got to have goals, so we're going to keep driving at it.

Michael Weiss: Yeah, I mean, look, I don't know, be with 1,400 out of 10,000 apartment. We're using approximate numbers. But, you know, we assume again, about 10,000 patients will start a new therapy. So that's the dynamic share per quarter. We had 1,400 enrollments into the hub, which, as Adam said, probably represents only about 8 to 5% of the total prescriptions. We are tracking towards sort of into that 15 ish percent range, give or take. But again, it's not fully, fully baked. But yeah, I think we're doing great. The team is out there, hustling that working hard; the drug is performing well, and we're going to continue to push toward our goal.

Roger Song: Excellent. Thank you.

Roger Song: Excellent. Thank you. And then, in terms of the AlloDB19 CAR, your first indication is progressive MS. Just biologically, can you comment on how you think about the CB19 versus CB20 for this particular population of the MS? And then, also, when you start the trial, what are the target population for the progressive MS if you are targeting certain severity or any baseline characteristics you want to do the initial study? Thank you.

Michael Weiss: And then in terms of the LLBD19 car, your first indication of progressive MS, just about logically can you comment on how you think about the CD19 versus CD20 for this particular population of the MS. And then also when you start a trial, what on the target population for the progressive MS if you're targeting certain severity or any baseline characteristics you want to do the initial study. Thank you. Yeah, thanks, Roger. So yeah, I mean CD20 versus CD19, I don't know that there's a huge difference in MS specifically. I mean, CD19 has a 4 over coverage and pre-V cells and short load plasma cells, which has some advantages in some areas, potential some defensive and others, and that might be this disadvantageous in MS if you were constantly treating these patients, given that we think this will be a one time treatment or if it's not one time, it will be separated by a significant amount of time.

Unknown Executive: Yeah, thanks, Roger. So,

Michael Weiss: I think the CD19 is quite a good approach for MS. And again, the goal for this treatment would be to have a very deep and robust B cell completion across tissues within the systemic system. But of course in the central that would create potentially a best in class treatment. And then I think you're releasing; you hopefully let the B cells come back. Hopefully they're reset to be non, I mean, a genetic B cell and that would be ideal. And of course, you'd be able to then leave long gaps, potentially use it as a one-time treatment or very long gaps between treatment.

Michael Weiss: And so I think generally speaking, CD20 probably, if you're going to be repeating treatments, probably CD20 a little bit better for MS. If you're looking at something that has a one-time treatment to 19, they have some advantages and disadvantages in that case. You had a second part of that question, Roger, which of course I lost myself in the answer. Was there more of that question? Yeah, just curious about the progressive MS, any specific baseline population or baseline patient characteristics you want to target in your initial clinical trial? Not really, no. I mean, we're open to all progressive patients, so that is definitely the unmet medical need in MS right now.

Unknown Executive: Yeah, just curious about the progressive MS, any specific baseline population or baseline patient characteristics you want to target in your initial clinical trial?

Michael Weiss: So, yeah, we are excited to get into those patients. So it could be primer progressive, it could be secondary progressive, it could be secondary progressive that are inactive, secondary progressive that are active. We were sort of agnostic to that group. We just want to make sure we're hitting progressive patients, and hopefully, like I said, these tissue penetration and CNS penetration would be great for that disease.

Speaker Change: The primary progressive it could be secondary progressive to give you a secondary progressive that are inactive secondary progressive that are active.

Speaker Change: We we're sort of agnostic to that group and just wanted to make sure we're hitting progressive patients and hopefully like I said deep tissue penetration.

Speaker Change: In CNS penetration would be great for for that disease.

Roger Song: Got it, thank you. Thanks a lot. Thanks, Roger.

Speaker Change: Got it thank you thanks Bob.

Roger: Thanks Roger.

Matthew Kaplan: Thank you. The next question is from the line of Matt Kaplan, with Larry Fallon. Please just use your question. Hey, good morning guys. Congrats on the quarterly results; strong results. I guess a few questions. First on the pipeline. You mentioned that you started the sub-Q program. Can you give us a little bit more sense in terms of the potential profile of your sub-Q from frequency and delivery point of view? Yeah, so there is one sub-Q on the market; it's currently those, once per month in a relatively elegant auto-injector format, but it still needs to be taken once a month, and you still have to deal with getting that drug to the patient once a month.

Speaker Change: Thank you.

Speaker Change: This is from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Matt Kaplan: Hey, good morning, guys and congrats on the quarterly results our strong results.

Matt Kaplan: I guess a few questions first on on the pipeline.

Speaker Change: And that you started the sub Q program can you give us a little bit more sense in terms of.

Roger: Potential profile of your of your sub Q from.

Unknown Executive: from a frequency and delivery point of view. Okay, that's helpful. Thank you. And then, in your prepared remarks, you mentioned, along with your guidance, increased guidance, some seasonality to expect between second quarter and third quarter versus third to fourth. You talked a little bit about that, and how we should think about that. And then also, congrats on your first.

Speaker Change: From a frequency and delivery point of view.

Speaker Change: Yeah. So you know there there is one sub Q on the market. It's currently dosed once per month, I mean, I'd say railroad relatively elegant.

Speaker Change: Auto injector format.

Michael Weiss: And so there's definitely logistical issues that can arise. The other that is not yet in the market, but potentially could be here in September, is a sub-Q version of Okravis. That one is a bit more clunky; you need to either have it pushed over 10 to 15 minutes by a health care provider, or used with a pump format where they catch a pump. But it will cause some bruising, some swelling, some reaction, so I think that's a bit more clunky than the elegance of a sub-Q auto-injector. Our goal is to find ourselves somewhere in the middle, something that's less frequent than the sub-Q Okravis will be every six months if it's approved.

Michael Weiss: The goal is to have something that's less frequently than once a month, and more elegant than large volume sub-Q that has seen with the Okravis.

Matthew Kaplan: So yeah, we think the elegance of sub-Q auto-injectors is the goal standard, and we'd like to get ourselves there, and we'd just like it to be less frequently than once a month. Ok, that's helpful. Thank you.

Adam Waldman: And then in your prepared remarks, you mentioned, along with your guidance, increased guidance, some seasonality to expect between second quarter to third quarter versus third to fourth. You talk a little bit about that, how we should think about that, and then also congrats on your first quarter in terms of achieving profitability from your underlying business. Is that something we should expect kind of going? for it. Sure, Adam, you want to take that to the reality question, and we'll come back to the property question. Sure, yeah, thanks, Matt. You know, historically we have seen the MS market does tend to slow down clutch in the summer months.

Adam Waldman: You have, you know, both patients and physicians taking vacation. So you have seen that historically, and we saw it last year, so we would expect to see it this year. You know, you also have the added, you know, with this year being a little bit unique in the ectrons, the ectrons confidence is moved into quarter three versus quarter four last year. And we did see some softening on ectrons last year, with a lot of positions from the US attending that conference. So those two things we think will contribute to the guidance that we provided. But overall, we're very confident, obviously, in the long term. We raise our full year guidance, and that's just more of a seasonality that's invented.

Michael Weiss: And thanks, thanks, Adam. And then, on the profitability side, I'll take a crack in Sean's here to help and correct me if I get this wrong. But I think, on an operating basis, we should maintain profitability going forward. Again, those are impacted, you know, on a gap basis that will be impacted or net income will be impacted by things like non-catch comp. Cash flow, profitability will be impacted by things like inventory build. So we're in that sort of fringe area where some of those things will affect. But I assume, you know, as we get further into the year, we'll get closer and closer to both. Regardless of whether we're buying inventory or regardless of the non-GAAP or non-catch stuff, we'll maintain both positive net income and cash flow.

Michael Weiss: But certainly, on an operations basis, as you can see, the expenses, as Sean mentioned, are even lower than expected. We're trying to spend it. We added to our team. We're increasing our marketing budget. We're continuing to do that. We will continue to do that.

Sean Power: But, you know, certainly we don't expect that the expenses could pay, could outpace the revenue growth at this point. Sean, anything to add on top of that? Nope. I think you nailed it, Mike. I think that's perfect. Thanks, Mike. Thanks, Matt.

Unknown Executive: Thanks, Mike.

Michael DiFiore: Our next questions come from the line of Michael D. Fior with Evercore ISI. Please just use your questions. Hi guys. Thanks so much for taking my question, and congrats on such a strong quarter. A few questions from me.

Adam Waldman: Number one, like, how do you foresee the initial launch of sub-cue ochrebus impacting account penetration for the balance of the year? I mean, you've obviously increased guidance, but was wondering if you're hearing anything from the field that may have helped boost your outlook in this regard, and I had two follow-ups. Thanks. Sure.

Adam Waldman: Adam, you want to go ahead and talk a little about what we're expecting from the launch of Sub-Cue Ochrebus? Sure. Thanks, Mike, for the questions. You know, our teams are obviously, we'll be crafting ready for the launch of the product extension and for Ochrebus. But honestly, we haven't detected a lot of enthusiasm for this product with our customer base. We've heard concerns about complex administration, their training required, the venture side effect co-found. So, you know, our interpretation today is we don't think it will have a significant impact in the U.S. market, but that's, you know, that's, that's today the adhering and that's, that's a view from often to many many customers.

Unknown Executive: But honestly, we haven't detected a lot of enthusiasm for this product among our customer base. We've heard concerns around, you know, complex administration, nurse training required, and potential side effect profile.

Michael DiFiore: Got it. Okay, that's helpful.

Unknown Executive: Okay, that's helpful. The second question is just any update on growth to net dynamics in Q2, any outlook for the balance of the year, as well as if you could comment on any inventory dynamics in Q2.

Sean Power: Second question is just any update on growth to net dynamics in Q2 and the outlook for the bounds of the year, as well as if you could comment on any inventory dynamics in Q2. Sorry, Mike, could you repeat the first part of the question? Yeah, I was wondering if you could just clarify any growth to net dynamics in Q2 and the outlook on growth to net for the bounds of the year, as well as comment on whether there was any inventory dynamics to be noted into Q. Yeah, gross and net was was similar to previous quarters and material change and inventory and nothing, nothing to note, nothing that we're going to expect it.

Unknown Executive: I was wondering if you could just clarify any growth-to-net dynamics in Q2 and the outlook on growth-to-net for the balance of the year, as well as comment on whether there was any inventory dynamics to be noted in Q2.

Unknown Executive: Yeah, gross net was was similar to previous quarters and no material change in inventory. Nothing, nothing to note, nothing that was unexpected. Got it.

Speaker Change: No material change.

Speaker Change: And then inventory nothing nothing to note nothing that was unexpected.

Sean Power: Got it.

Speaker Change: Got it.

Unknown Executive: My final question to you, any update on the EU launch? I mean, any feedback from large academic centers there and have you noticed any notable differences compared to the initial rollout of pre-MV in the U.S.?

Michael DiFiore: My final question to any update on the E launch, I mean, any feedback from large academic centers there and have you noticed any notable differences compared to the initial rollout of Bremby in the U.S.? Yeah, Mike, do you want to take that one out of your, Adam? You're in a role. So, as you know, Mike, they launched it in Germany. They're still preparing for the launch, waiting for the investment in several countries, but the feedback has been very positive. They are getting momentum both in the academic centers, but also, interestingly, in the community centers as well, who they're getting feedback that the one hour infusion is particularly attractive in those centers from an efficiency standpoint.

Speaker Change: My final question to any update on the EU launch I mean any feedback from large academic centers, there and have you noticed any notable differences compared to the initial rollout of <unk> in the U S.

Speaker Change: Yeah, Mike you want to take that one Adam your Atomy, you're on a roll once lateral keep volatile okay.

Unknown Executive: Yeah, Mike, you want to take that one?

Speaker Change: So as you know Mike.

Mike: We launched it in Germany.

Speaker Change: Still preparing for the launch with incremental investment and several other countries.

Speaker Change: But the feedback has been very positive.

Speaker Change: They are gaining momentum both in the academic centers, but also interestingly in the community centers as well.

Speaker Change: Who theyre getting feedback that the one hour infusion.

Speaker Change: Particularly attractive and those centers come.

Speaker Change: From an efficiency standpoint.

Adam Waldman: So overall, I think going well, as far as the comparison to the U.S. launch, I think similar in that there is good uptake and enthusiasm for the product profile, and we'll see how they continue to go there. and we're going forward to seeing more countries launching in later this year or early next year. That is very helpful. Thank you. Thanks, Michael.

Speaker Change: So overall, it's been going well.

Speaker Change: As far as the comparison to the U S launch.

Speaker Change: You know I think somewhere in that there is good.

Speaker Change: Uptake and enthusiasm for the product profile and well see how they continue to go there and we're looking forward to seeing you know more countries launching in later this year early next year.

Speaker Change: Got it very helpful. Thank you.

Michael: Thanks, Michael.

Eric Joseph: Our next questions are from the line of Eric Joseph with J.V. Morgan. Please just use your questions.

Speaker Change: Our next questions are from the line of Eric Joseph with Jpmorgan. Please proceed with your question.

Eric Joseph: Alright, good morning, Congrats on a great quarter and thanks for taking my questions I.

Eric Joseph: Good morning. You grabbed some of your recorder, and that's for taking the questions. I guess just first on the updated guidance, I guess, what is that in this particular terms of pull through via the PA contract? I guess any sort of range you can kind of put around that. And then I'm also curious to know what kind of increment of visibility you had this quarter on inter CD20 switching to R&B. How much switches contributed to. Reumbria take and also where you think that might go with additional. Data from the Enhanced Trial. And then secondly, Mike, he kind of commented on sort of additional expenditure to support the launch here.

Eric Joseph: I guess just first on the updated guidance I guess, what does that anticipate terms.

Speaker Change: Paul.

Paul: Uh huh.

Speaker Change: Contract I guess any sort of.

Paul: The range you could kind of put around that.

Speaker Change: And then I'm also curious to know what kind of incremental visibility you had this quarter on insurer CD 20 switching to bnb.

Speaker Change: How much switches contributed to them.

Speaker Change: Remember you have taken and also where do you think that might go with additional.

Paul: Data from the enhance trial.

Paul: And then secondly, Mike you kind of commented on sort of additional expenditure to support the launch here I guess, how should we be thinking about sort of.

Adam Waldman: I guess how should we be thinking about sort of the build and SGNA, the next couple of quarters? And I guess ultimately, looking long-term, I guess how should we be thinking about sort of the commercial margin, the probability of the European franchise. Thanks. Great. Thanks for the three-part question, Eric. I think Adam, if you want, maybe the first one was an updated guidance, how it may be impacted by the VA. I don't start there. Yeah. So the guidance includes the VA, but I would say that the VA, as we mentioned on the call last time, would not be a material impact in 2024.

Paul:

Mike: To build an SG&A are the next couple of quarters and I guess ultimately looking long term I guess, how should we be thinking about sort of the the commercial.

Speaker Change: <unk> margin and the profitability of our franchise.

Speaker Change: Franchise. Thanks.

Adam: Great. Thanks for thanks for the three part question, Eric I think Adam if you want maybe the first one was updated guidance how it may be.

Speaker Change: Be impacted by the V a.

Unknown Executive: I'm going to start there.

Adam: And I'll start there.

Adam: Yes. So the guidance includes the VA, but I would say that.

VA: The VA.

VA: I think we mentioned on the call last time would.

Speaker Change: It would not be a material impact in 2024.

Adam Waldman: You know, we're in the early stages of the launch of the VA. It's been about a month since the contract went into place. You know, at this point, I would say 10 to 15 percent, perhaps, of the VA Centers of Excellence have utilized the MD. It's for the contract is specifically for new patients. And so, you know, I don't expect; although our guidance includes it, it's not a major driver of the overall guidance. And then your second question was on switches from CD20. Switches from CD20 remain consistent quarter to quarter. We've seen a good amount of our overall patient populations being switched from CD20s.

VA: We're in the early stages of the launch of the VA its been about a month since the contract went into place.

Speaker Change: Well at this point I would say, 10% to 15% perhaps of the VA centers of excellence that have utilized the AMD.

Paul: For the contract specifically for new patients.

Speaker Change: And so I don't I don't expect although it in our guidance include the it's not a major driver of the overall guidance.

Speaker Change: And then your second question was on.

Speaker Change: Switches from some of the 20th switches from CD 20 remain.

Paul: Consistent quarter to quarter, we've seen.

Paul: A good amount of our overall patient population being switched from June 'twenty and yeah, we would expect with more data and the enhance trial and making it easier to switch.

Michael Weiss: And yeah, we would expect with, you know, more data and enhanced trial and making it easier to switch patients. We know that there are many patients that can point out a crap gap and other issues around polarity of other CD20s. And we believe it's an attractive market, and it's been nice to see it stay consistent and launch in terms of percentage of patients switching over from CD20s. And then I don't remember the third part. Yeah, I've got that one. That one was directed at me. So, although you could help and switch on, probably. But so the question was on the launch build in SG&A and then sort of long-term where we see that going.

Speaker Change: Patients, we know that there are many patients that complaint of crap gap and and.

Paul: In other issues around tolerability of others through to 'twenty.

Paul: And we believe it.

Speaker Change: Practice marketing and it's been nice to see it stay consistent with launch.

Speaker Change: In terms of percentage of patients switching over from city point.

Paul: And then I don't remember the third part.

Speaker Change: Yeah, I've got that one that one was directed at me so although you could helping supercharge, our but yeah. So.

Speaker Change: So the question was on the launch build and SG&A and then sort of long term, where we see that going so.

Michael Weiss: So, yeah, I mean, look, we had a very focused strategy when we started the launch, and we sized the team for that strategy. And we always said that we will grow the team and basically reinvest the revenues to build out the team. The SG&A and total outbacks for this year of 250 million baked in a growth of the team. Over the course of the year, we've, I think, since the launch, is certainly in the core field teams themselves versus our management level position. We've close to double, I think, our field force, or at least grown more than 50% the field force.

Speaker Change: Yeah, I mean look we we had a very focused strategy when we started the launch.

Paul: And we sized the team for that strategy.

Michael Weiss: And that continues to grow. I mean, I get requests for new highers in the field nearly every day, certainly once or twice a week. So the team is growing, but that's again all baked into that, that Outbacks number of, again, it's about 250. I'm going to say exactly, and obviously, we've been running a little bit below. for the year so far, but I think we're just going to still stick with approximately 250 in optics for the year. As we move into next year, I'm confident the optics that we target will be higher. I think incrementally higher; we're certainly, like I said, the team will continue to grow, our marketing budget.

Unknown Executive: Nearly every day, certainly once, once or twice a week. So the team is growing. But that's, again, all baked into that OPEX number of about 250. I'm not going to say exact, and obviously, we've been running a little bit below.

Michael Weiss: We were very specific early on that we wanted to focus on clinician awareness, HTTP awareness, and that was really a field-based endeavor. We're going to obviously continue to do that, and as we said, we're growing that. But things to the launch, we've talked about this a bit, and we've already increased, again, which is already in this year's budget, our online direct to patients marketing efforts, and we're going to continue to grow that budget as we get into next year. A long term, again, I can see we'll continue to incrementally, at some point, the team is probably folding maxed out, so that will cap that out, and then the marketing budget will be the marketing budget that we think is appropriate.

Michael Weiss: But like I said, my hope and expectation is that our incremental spend in FX and SGNA over time is measured and incremental, whereas the revenue should be relatively gapping up every year, and we have a really nice accumulation effect as we continue, hopefully, to build our market share and grow that out. The new starts will continue to build as well, so all of that on top of itself is why I quoted earlier that I could potentially see significant cash flows as we move forward. But yeah, I mean, I think long-term, the margins should be solid.

Michael Weiss: I've looked at some of the best operating margins in biotech out there. I've seen, I think, Vertex or Generon have done an amazing job in keeping their off XI. There's a few other companies out there; I think we could be in a leading position in terms of off X to revenue, so off X margins.

Eric Joseph: All right, great, thanks for taking all the questions, and I can correct the rest of my quarter. Thanks. I appreciate it.

Maya Cbontani: Our next question is from the line of Maya Cbontani with B. Riley's Curities. This is your question. Good morning, team. Congrats on a solid quarter, and thanks for taking our question. So, quick two part on commercial metrics.

Adam Waldman: I don't know if you could update on the persistence rate you're seeing, and if you guys can qualitatively talk to an ear end market share target, be it within new to class, or interact class sort of switch segments, and then I have a quick follow-up. Yeah, thanks, Maya. The persistence rate, yeah, the persistence rate that we 24 continues to be solid, and as expected, you know, what we've said before, we expected it to be around, you know, AD, high AD, and that's what we saw with Oakervis on, and we're waiting in that ballpark, so it rains very strong there.

Adam Waldman: In terms of market share, you know, I'm not going to give us specific market share that we think we're going to hit by the end of the year. I just think to reiterate what Michael said and what we said in the call, we're going to continue to add more and more prescribers, and we're going to continue to grow in a growing market, and you know, that's what we're focused on every day, and we continue to see that we're getting traction, and we'll continue to focus on I'm doing that, and you know, like I said, our goal is to be the number one prescribed MS therapy in terms of gun image sharing.

Speaker Change: M S therapy in terms of then your mature.

Speaker Change: Got it. Thank you and then it trends I see are presenting an update to enhance study results, maybe just talk to what's new and incremental bed in and.

Adam Waldman: Thank you.

Adam Waldman: And then at Ekrems, I see you're presenting an update to enhance study results. Maybe just talk to what's new and incremental there. And what's sort of the healthcare provider feedback to, you know, the data you've generated to date. And also, I noticed there's the collaborative phase three, lead breaker, Gemini, and how curious to program data. Coming also at Ekrems, would love to hear your latest thoughts on how you're thinking, you know, the BTK draft class impact on your sort of long range plan. You know, recognizing the results have been relatively mixed recently. Thanks again for taking a question.

Speaker Change: What's sort of the health care provider feedback to you know the data you've generated debate and also I noticed that the.

Speaker Change: Deliberate phase.

Paul: Phase III late breaker, Gemini and Hercules program data coming also in a trend.

Speaker Change: We'd love to hear your latest thoughts on how Youre thinking you know the <unk> drug class impact on your sort of long range plan.

Speaker Change: Recognizing the results had been relatively mixed recently, thanks again for taking my questions.

Michael Weiss: Yeah, sure. Thanks for the questions. So obviously we can't talk anything about Ekrems. The notifications and abstracts have not been released yet. So can't say anything about that. But I can't answer your second question about HTTP feedback to the results we have presented previously. And, you know, I think the feedback has been extremely positive. I think people, you know, intuitively, they're, if they have a CD20 patient that walks in the door who's already relatively well be felt depleted, but it's having some other issue, whether it's crap, crap, or had some relapse. They don't feel that there's a need to go through the 150 milligram dose, which is, in some respects, a B bulking dose; it will be taken down the B cells, so we can give a full proper dose two weeks later at 450 milligrams in one hour.

Speaker Change: Yeah sure Mike.

Speaker Change: Thanks for the questions.

Speaker Change: So obviously, we can't talk anything about ekstrom of the notification.

Paul: <unk> and <unk> have not been released yet so cant say anything about that but I can ask answer your second part of your question about HCP feedback too.

Speaker Change: The results we have presented previously.

Paul: And I think the.

Paul: The feedback has been extremely positive I think people.

Speaker Change: Intuitively are there because they have a CD 20 patient that walks in the door who's already.

Speaker Change: Relatively well b cell depleting, but its having some other issue whether it's crap graph or had some relapse.

Paul: They don't feel that there's a need to go through the 150 milligram dose which is in.

Unknown Executive: In some respects, a debulking dose where we take down the B cells so we can give a full proper dose two weeks later at 450 milligrams. In terms of BTK, I mean, look, I think, you know, I think most folks would believe at this point, regardless of whether one or several of the BTKs are successful in relapsing forms of MS. On the other hand, I do think that there's a lot of excitement about the potential for these drugs in progressive forms of MS.

Paul: In some respects a T bulking dose will be take down the b cells that we can give a full proper dose.

Paul: Two weeks later at 450 milligrams.

Paul: In one hour so yeah, I think that the.

Michael Weiss: So, yeah, I think that the people, you know, are happy to see that happy and not surprised to see that you can safely transition those patients to do that. So, yeah, I think that's a net positive thus far.

Speaker Change: People are happy to see that happen.

Paul: Happy and not surprised to see that you can safely transition those patients.

Paul:

Paul: To do that so yeah, I think thats, a net net positive thus far and like I said it in the coming months, we'd like to present more data from that trial.

Michael Weiss: And like I said, in the coming months, we'd like to present more data from that trial. In terms of BTK, I mean, look, I think, you know, I think most folks would believe at this point, regardless of whether one or one or several of the BTKs are successful in our lapsing forms of MS, it's more likely than not to be an inferior profile to CD20s. I don't think anyone believes that they are the BTKs in our lapsing forms of MS will be more active, more convenient, less side effects than the CD20, gives it this point.

Speaker Change: In terms of the BT Kay and then look I think.

Speaker Change: Think most folks would believe at this point, regardless of whether one or one or several of the beat the guys are successful in relapsing forms of M. S.

Paul: More likely than not to be an inferior profile to see the 20th I don't think anyone believes that they are.

Paul: <unk> in relapsing forms of MFS will will be.

Speaker Change: More active more convenient less side effects.

Paul: Then the CD 20.

Paul: It gives at this point so.

Michael Weiss: So, you know, again, I think that's probably now a foregone conclusion, assuming that the study is in the lapsing forms of MS are successful. Obviously, we've had some failures and some toxicity that can seem along the way. So we sit and we'll see what the data looks like. But again, I think optimism is relatively low for these drugs in the lapsing forms of MS. On the other side, I do think that there's a lot of excitement for the potential for these drugs in progressive forms of MS. I think, in theory, if they would work in progressive MS, that would be phenomenal, right?

Paul: Again, I think thats, probably now a foregone conclusion.

Speaker Change: I mean that the studies in relapsing forms of MS are successful obviously, we've had some failures and some toxicity that's been seen along the way.

Paul: So we sit and wait and we'll see what the data looks like but again I think optimism is relatively low for these drugs in relapsing forms of Ms.

Paul: On the other side I do think that there is a lot of excitement.

Paul: The potential for these drugs in progressive forms of MS. I think in theory.

Unknown Executive: I think, in theory, if they would work in progressive MS, that would be phenomenal, right? As I mentioned earlier, we're looking at azacel and progressive forms of MS because that is the unmet medical need. That's the area that is most concerning and is least, you know, well-treated at this point. So I think there's excitement and enthusiasm for it to, if it works. I think there's certainly a fair amount of pessimism that it will work. But again, anytime you have an unmet medical need, people are enthusiastic about the potential. So we shall see.

Paul: If they would work in progressive Ms that would be phenomenal right and as I mentioned earlier, we're looking at either selling progressive forms of MMS because that is the unmet medical need that is the area that is most concerning and as the least.

Michael Weiss: As I mentioned earlier, we're looking at easier selling progressive forms of MS because that is the unmet medical need, that's the area that is most concerning and is at least well treated at this point. So I think there's excitement and enthusiasm for it to, if it works, I think there's certainly a fair amount of pessimism that it will work. But again, anytime you have an unmet medical need, people are enthusiastic about the potential. So we shall see, again, would be a very nice thing for patients if these work in progressive forms of MS. I think in the lapsing forms of MS, it's not a concern.

Paul: Well treated at this point, so I think there is excitement and enthusiasm for it for it to if it works I think there's certainly a fair amount of pessimism that it will work.

Paul: But again anytime you have an unmet medical need people arent susiana stick about the potential so we shall see.

Paul: It would be a very nice thing for patients. If there's work in progressive forms of MS. I think in relapsing forms if I mess it's not.

Paul: Concern of ours.

Michael Weiss: Vars.

Maya Cbontani: I understood my thanks for that comprehensive answer, and congrats again on all the problems. Thanks very much. Appreciate it.

Paul: Understood Thanks for that answer.

Paul: The answer and congrats again on the progress.

Paul: Thanks, Ryan I appreciate it.

Prakhar Agrawal: Our next question is different from the line of Prakhar Agrawal with Kenneth Sheryl. Please use your question. Hi, good morning, and thanks for being my questions, and congrats on the quarter. So, following up on the sub-Kyto crores of take based on your conversations on the field, do you expect the update to be similar or different between academic and community centers? And for the thousand or so physicians who have prescribed Brunei, do you know whether the split of their IV versus sub-Kyto CD20 is similar or different than the overall market? I had a follow. Adam, do you want to start on the first one?

Speaker Change: Our next questions are from the line of <unk> <unk> with Cantor Fitzgerald. Please proceed with your question.

Speaker Change: Hi, good morning, and thanks for taking my questions and congrats on the quarter, so pulling up on the subcutaneous <unk> uptake based on your conversations in the field do you expect the uptick to be.

Speaker Change: Similar or different between Academy and community centers.

Speaker Change: And for the cows, so physicians who have prescribed <unk>.

Speaker Change: Do you know what are the split of their IV versus sub acute C. The 20th similar or different than the overall market.

Speaker Change: Had a follow up.

Speaker Change: Yeah, Adam do you want to start on the first one.

Adam: Yeah. So the first one thanks for the question per car. The first one is where do we think the sub Q pick.

Adam Waldman: Yeah, so the first one. Thanks for the question, Prakhar. The first one is where do we think the sub-Kyto pickup will be, right? So, you know, at this point, we can go by where Roche has guided, which is in places that don't have IV infrastructure. It's up for us to tell exactly where this will be picked up. You know, I don't know. And, as I said earlier, I just don't detect a lot of overall enthusiasm for the product. So, a cup to say on that. And then we asked about what are the IV versus sub-Kyto; could you just repeat that second part of the question?

Adam: Pickup will be right.

Speaker Change: So at this point, we can we can go by.

Unknown Executive: So, you know, at this point, we can go by where Roche is. Yes.

Roche: Roche is.

Roche: As guided which is in places that don't have the infrastructure.

Speaker Change: It's tough for us to tell exactly where the where this will be picked up.

Speaker Change: I don't know and as I said earlier, just don't detect a lot of overall enthusiasm.

Speaker Change: Gordon.

Gordon: For the products, so tough to say on that.

Speaker Change: And then we're asked about what are.

Gordon: What the IV versus sub.

Speaker Change: <unk>.

Speaker Change: <unk> versus <unk>.

Speaker Change: Can you just repeat the second part of the question make sure I get it right.

Adam Waldman: Let me make sure I get away. Yes, for the thousand physicians who have prescribed Brunei so far, what's their share of IV versus sub-Kyto CD20? Yeah, I don't know, Prakhar, I don't know that, you know, but we are focused on prescribers that, you know, have significant IV share. So, I don't know the exact answer to the question, but, you know, I guess that upper scrubbers have a higher IV share than sub-Kyto. Good.

Speaker Change: For 2000 physicians, who have prescribed really so far what's their share of IV versus subcutaneous <unk> to 'twenty.

Speaker Change: Yes.

Speaker Change: I don't know that.

Speaker Change: But we are focused on prescribers that have significant IV sure.

Speaker Change: So I don't know the exact answer your question, but.

Speaker Change: Guests that are prescribers of a higher Ivy.

Speaker Change: Sure then.

Speaker Change: Then sub Q.

Speaker Change: Got it and just as a follow up on bringing the uptake on maybe mixed by Academy and community centers. If we can provide more details.

Adam Waldman: And just to follow up on Brunei uptake and maybe mixed by academic and community centers, if you can provide more details around the uptake by these segments. And maybe which segments are seeing the most growth right now for Brunei and which segments are starting to moderate? Thank you. Sure. Yeah, as we've said in previous calls, we've seen the initial uptake was in the private practices as academic centers took longer from a form of a perspective and logistics. But we've seen significant growth in all segments. And, you know, particularly in the academic centers, we continue recently and last two quarters to add, you know, to see more and more ads from the prescriber perspective.

Speaker Change: On the uptake by the segments, maybe which segments are seeing the most growth right now for BMD and which segments are starting to moderate thank you.

Speaker Change: Sure Yes.

Speaker Change: As we've said in previous calls we have seen the initial uptake within wasn't the private practices academic centers.

Speaker Change: Took longer from a formulary perspective in logistics.

Speaker Change: But we've seen significant growth in all segments.

Speaker Change: Particularly in the academic centers.

Speaker Change: We continue recently in the last two quarters the C more and more ads from a prescriber.

Speaker Change: Perspective within the hospital segment.

Adam Waldman: Within the hospital segment, you know, in Q2, the Brunei and the hospital segment thought highest, you know, ever quarter over quarter growth in terms of absolute files. And now, you know, the hospital segment is the largest segment of our business today. And so, but we're still seeing growth in both segments. You know, and I think that's a testament to the profile of the drug and, you know, the success that we're seeing. Thank you.

Speaker Change: Q2.

Speaker Change: <unk> Hospital segment, both highest ever quarter over quarter growth in terms of absolute vials.

Speaker Change: And now the hospital segment.

Speaker Change: Is the largest segment of our business today.

Speaker Change: And so, but we're still seeing growth in both segments.

Speaker Change: And I think that's a testament to the.

Speaker Change: The profile of the drug.

Speaker Change: And the.

Speaker Change: The success that we're seeing.

Speaker Change: Thank you.

Speaker Change: Yeah.

Edward White: Any questions in the line of Edward White with AT Wayne, right? Please see with your questions.

Speaker Change: Our next question is from the line of endpoint with H C. Wainwright. Please proceed with your question.

Edward White: Good morning. Thanks for taking my questions, and congratulations on a great quarter. So I just wanted to come back to the question on the VA contract. Adam had mentioned that it's not going to be really material in 2024. I was just wondering if you can give us your thoughts on the opportunity it represents, you know, in 2012. It's going to be 25 and beyond.

Speaker Change: Good morning, Thanks for taking my questions and congratulations on a great quarter.

Unknown Executive: So, I just wanted to come back to the question on the VA contract. Adam had mentioned that it's not going to be really material in 2024. I was just wondering if you can give us your thoughts on the opportunity it represents, you know, in 2025 and beyond.

Speaker Change: So I just wanted to come back to the question on the VA contract Adam had mentioned that it's not going be really material. In 2024 I was just wondering if you can give us your thoughts on the opportunity it represents in 2025 and beyond.

Edward White: Sure, Ed. Thanks for the question. Yeah. I got it. So thanks for the question. Yeah, I mean, you know, what we said was, you know, this is the contract is for new patients. And that will grow over time. You know, I think the contract overall value was estimated about 187 million for the five-year contract. I think it will see, you know, I think we're determined to try to get every new patient that is available, and we'll continue to see how that will grow over time. We don't think compared to our overall business. We don't think it's a huge percentage.

Speaker Change: Sure Ed Thanks for the thanks for the question yes.

Speaker Change: Got it so thanks for the question Yeah, I mean, what we said was this.

Speaker Change: This is the contract is for.

Speaker Change: New new.

Speaker Change: New patients.

Speaker Change: And that will grow over time.

Speaker Change: I think yeah.

Speaker Change: The contract overall value was estimated at about $187 million for the five year contract.

Speaker Change: We'll see.

Speaker Change: We are determined to try to get every new patient that that is available and we will continue to see how that.

Speaker Change: Will will grow over time, we don't think compared to our overall business, we don't visit with a huge percentage, but as I mentioned the value. There is there are a lot of physicians that are in the VA that also.

Adam Waldman: But, as I mentioned, the value there is, you know, there are a lot of positions that are in the VA that also work in academia. I hope is that that will help to have a table effect overall in the academic setting and also reinforce the overall profile of brandy and the value proposition will be raised.

Speaker Change: Work in academia, our hope is that that will help to have a halo effect overall in the academic setting.

Speaker Change: And also reinforce the overall profile of <unk> and the value proposition that <unk> brings.

Adam Waldman: In Adam, as the size of that business grows over the next couple of years, is there any impact to gross to net? Sure, there will be an impact to gross in that for sure. Given that we're public, what we're, what we offered the drug that exists out, so that will affect the gross. Okay, thanks.

Speaker Change: And Adam is the size of that business grows over the next couple of years.

Speaker Change: Is there any impact to.

Speaker Change: Gross to net.

Speaker Change: Sure there'll be an impact to gross to net.

Speaker Change: For sure given that it's public what were.

Speaker Change: What we offer.

Speaker Change: The drug at a discount so that will affect our personnel.

Speaker Change: Okay. Thanks, and perhaps my last question is just on the share repurchase program.

Unknown Executive: Thanks. And perhaps my last question is just on the share repurchase program. Are you

Michael Weiss: And perhaps my last question is just on the share repurchase program. Are you, do you have any timelines for that? When are you going to start and, you know, any expectations of how long that program will continue to get to 100 million? Yeah, thanks, Ed. So we expect to get started soon. I think we'll be measured in how we do it. So we'll be in, you know, open market purchases, sort of like a, I think a 10, 5, 1 style of plan. And there's no, there is no fixed duration of time in which we will spend the 100 million in the repurchase.

Speaker Change: Are you do you have any timelines for that when are you going to start and any expectations of how long that program will continue to get to the $100 million.

Speaker Change: Yeah. Thanks, Ed So are we expect to get started soon.

Speaker Change: I think we will be measured in how we do it so it will be.

Speaker Change: Open market purchases sort of like a I think it can be five one style of.

Speaker Change: Of our plan.

Speaker Change: And there's no there is no fixed duration.

Speaker Change: Of time in which we will spend the $100 million and the repurchase.

Michael Weiss: In some of it, you know, we'll probably build in some share price targets so we can, you know, buy more at different levels. So, yeah, I think we're going to just think about it and try to buy it back as many shares as we can with the money we have for the moment. Obviously, we expect it over time. We'll get to reload and buy more shares. So, as the revenue has been, cash flow continues. So I think for the moment, we're going to just start the buying as soon as we can, and we'll see how it goes.

Speaker Change: Some of it will probably build in some some share price targets are so we can.

Speaker Change: By more different level. So yeah, I think we're going to just think about it and try to buy back as many shares as we can with the money we have for the moment.

Speaker Change: Obviously, we expect that overtime, we'll get to reload and buy more shares so.

Speaker Change: As the.

Speaker Change: Revenues and cash flow continues so I think for the moment, we're gonna just die.

Speaker Change: Start the buying as soon as we can and then we'll see how it goes.

Speaker Change: Okay, great. Thanks for taking my questions.

Edward White: Okay, great. Thanks for taking my questions. Thanks, Ed.

Unknown Executive: Okay, great. Thanks for taking my questions. Thanks, guys.

Ed: Thanks, Ed.

Unknown Executive: Thank you.

Speaker Change: Thank you. Our final question is from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your question.

Unknown Executive: Our final question is from the wider of Corinne Jenkins with Goldman Sachs. Who's the easier question? Hi, good morning. This is Palak one for Corinne. Just one question for us here. You touched upon seasonality for the business into the second half of the year, but could you also highlight where you see room for potential outside? Do you have any guidance?

Corinne Jenkins: Hi, Good morning. This is <unk> on for Dan just one question for US you touched about seasonality for the business into the second half of <unk>.

Speaker Change: So how do you see room for potential.

Speaker Change: Pension of safety with revenue guidance.

Adam Waldman: Adam, can you take that one? Yeah, for sure. Yes, seasonality was, as I mentioned, was limited to three. As I mentioned, that is, you know, historically affects the entire MS market and probably disproportionately affects ID therapies, just given the location and so on and so forth. As you, as we've noted also, we've raised the full-year guidance for the year. You know, that shows that we're confident in the overall growth story here. And I think upside would be, you know, continued growth and pick up both, you know, on the new patient side and the patients come back where you're going to start seeing the repeat prescriptions continue to grow as new patients continue to go.

Speaker Change: Adam I'll take that one.

Adam Waldman: Adam, you want to take that one? Yeah, for sure.

Adam: Yeah for sure yes.

Adam Waldman: Yeah, for sure. Yeah, seasonality was, as I mentioned, was limited to Q3. As I mentioned, that is, you know, historically affects the entire MS market and probably disproportionately affects IV therapies, just given vacations and so on and so forth. As you, as we've noted also, we've raised the full year guidance for the year, you know, which shows that we're confident in the overall growth story here. And I think upside would be, you know, continued growth and pickup, both, you know, on the new patient side and as patients come back, we're going to start seeing the repeat prescriptions continue to grow as new patients continue to grow. And if that grows faster than we would expect, I think there's certainly potential upside.

Speaker Change: Seasonality was as I mentioned was was limited to Q3 as I mentioned and that is historically affects the entire unless market.

Speaker Change: And probably.

Speaker Change: Disproportionately affect IV therapies, just given vacations and so forth.

Speaker Change: As you.

Speaker Change: As we've noted also we've raised the full year guidance for the year.

Speaker Change: That which.

Speaker Change: It shows that we are confident in the overall growth story here.

Speaker Change: And I think upside would be continued.

Speaker Change: Growth and pick up both.

Speaker Change: Now on the new patient side and in those patients come back we're going to start doing.

Speaker Change: The repeat prescriptions continue to grow as new patients continue to go and if that grows faster than that we would expect that I think there's certainly potential upside.

Unknown Executive: And if that goes faster than we would expect, I think there's certainly potential upside. Thank you.

Speaker Change: Alright, thank you.

Speaker Change: Thank you we've reached the end of the question and answer session I'll now turn the call over to Mike Weiss for closing remarks.

Operator: Thank you. We've reached the end of the question and answer session. I'll now turn the call over to Mike Weiss for closing remarks.

Unknown Executive: We've reached the end of the question and answer session.

Michael Weiss: I'll turn the call over to my voice for closing remarks. Great. Thank you. And thanks everyone, again, for joining us on today's call. We look forward to continuing the positive momentum into the second half of 2024. And, as discussed today, we'll continue to be focused on several key priorities. First, expanding. Brearmors reach to ensure all eligible patients can benefit from this innovative medicine. That includes building out our commercial footprint and increasing our spending on marketing efforts. Next, advancing our Brearm the expansion initiatives. There are subcutaneous development, our enhanced switch study, and exploring new indications for Brearm B.

Mike Weiss: Great. Thank you.

Mike Weiss: And thanks, everyone again for joining us on today's call. We look forward to continuing the positive momentum into the second half of 'twenty 'twenty four and as discussed today will continue to be focused on several key priorities first expanding <unk> reach to ensure all eligible patients can benefit from this innovative medicine.

Speaker Change: That includes building out our commercial footprint and increasing our spending our marketing efforts.

Speaker Change: Next advancing our pre M. B expansion initiatives there are subcutaneous development, our enhanced switch study and exploring new indications for ground beef.

Speaker Change: Finally, commencing our phase one for as we're selling progressive M S as well as looking at opportunities to extend our pipeline.

Michael Weiss: Finally, commencing our phase one for ASER cell and progressive MS, as well as looking at opportunities to expand our pipeline.

Michael Weiss: With that, I'd like to close by thanking the patients and clinicians that put their trust in TG and Briambi and our loyal shareholders for their support, and once again, the whole TG team for making it happen. Have a nice day.

Michael Weiss: With that, I'd like to close my thank-in to patients and clinicians that put their trust in TG on Brearm B and our loyal shareholders for their support. And once again, the whole TG team for making it happen.

Speaker Change: With that I'd like to close by thanking the patients and clinicians that put their trust in T. G. Embry on V and our loyal shareholders for their support and once again the whole T. G team for making it happen have a nice day.

Unknown Executive: Have a nice day.

Unknown Executive: This will conclude today's conference. Let me disconnect your lines at this time. Thank you for your participation.

Speaker Change: This will conclude today's conference you may disconnect your lines at this time and thank you for your participation.

Operator: This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.