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spk12: 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.
spk00: 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.
spk04: 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?
spk10: Yep. Thank you, Mike, and good morning, everybody. Before I jump into the quarter results in the U.S., let me start by saying how excited I am to be partnering with Nurex Farms to launch BreonV in Europe and other markets around the world. They share our entrepreneurial mindset and urgency and will undoubtedly make BreonV a top priority. From a commercial perspective, I'm very impressed with their capabilities, expertise, and presence in the neurology space. And I believe they will do an excellent job accelerating the launch and quickly bringing BreonV to patients around the world. As far as the US performance in the second quarter, which as Mike mentioned is our first full quarter in the market, We are very pleased with the progress we're seeing with Breon B, and we continue to exceed our internal expectations. We have built positive momentum in the first half of the year and encouraged by the launch trajectory to date. With second quarter net sales for Breon B of $16 million, representing over 100% growth quarter over quarter. Key highlights from the quarter include increases in patient demand growth, where we saw daily average hub enrollments nearly double quarter over quarter. with greater than 800 BrionB prescriptions coming through our hub in the second quarter, bringing our launch-to-date total to more than 1,200 new patient scripts. As we have mentioned in the past, we believe this figure is capturing 80 to 90% of the total new scripts written. And while it is challenging to determine the exact number, we saw dramatic increases in new patient infusions in the second quarter. Importantly, patient and physician feedback continues to be overwhelmingly positive. In our market research, the majority of BrionB prescribers report having very positive experience so far, with nearly all patients completing the one-hour infusions as expected. We also continue to increase our breadth of adoption, adding more than 100-plus incremental accounts and over 170 incremental prescribers, bringing the total to over 225 accounts and over 340 prescribers launched to date. This includes both academic and community centers across all regions of the U.S. At this point, we have seen a high percentage of our initially targeted accounts prescribe Briumde, and we intend to broaden our focus in the second half of the year. We also continue to see broad utilization across patient types, including newly diagnosed and switches that are both new to CD20 and from other CD20s. Importantly, the feedback we have received from customers on the unique profile of BreonV continues to be encouraging. We routinely hear that the predictability of the one-hour infusion combined with the annualized relapse rate of less than 0.1 are important differentiators for BreonV. Through our market research, we have also found the vast majority of BreonV prescribers plan to increase their use of BreonV over the next six months. We've launched with a focused strategy to maximize our market opportunity with a nimble and experienced team who are producing early results. Neurologist perceptions of TD rep performance is outstanding and outpaces our competition on almost all attributes. The team is actively engaging with accounts and has shown strong share of voice among customers on par with leading MS therapies. I'm extremely proud of the team's performance to date and their continued commitment to the MS community. Our growing patient demand in the form of enrollment and new patient infusions, increasing breadth of adoption by prescribers and centers, and an effective J-code as of July 1st, we believe puts us in great position going into the second half of the year. I am also very pleased to report that we now have achieved payer coverage for approximately 80% of commercial and Medicare lives, giving us coverage for BrionV at parity with Ocrevus across the vast majority of these plans. If you recall, our corporate goal was to achieve 80% coverage by the end of the year. So accomplishing that by mid-year far exceeds our expectations and is a testament to the attractiveness of Realme to payers and the strong efforts of our market access team. We also made solid progress in the quarter, securing additional institutional formulary coverage. While many of these institutions have been slower moving than we had anticipated, we expect they will increase adoption into the second half of the year. So following a strong start in Q1, this was another very solid quarter for the BRIOMB launch. We continue to make progress across all fronts and believe BRIOMB offers a best-in-class profile. We continue to see MS specialists expand their use of CD20s and anticipate this trend will continue given the therapeutic index of the drugs in this class and further believe IV therapies will continue to lead the market. We now have a permanent J code in effect, which helps on reimbursement. Pair coverage is significantly ahead of schedule and major health systems have added and are continuing to add 3MB to their formularies. While we still have a lot of work to do, we are really pleased with the progress we've made in Q2. With that, I'll now turn the call over to Sean Power, our CFO.
spk02: Thank you, Adam. And thanks everyone for joining us. Earlier this morning, we reported our detailed second quarter 2023 financial results, which can be viewed on the investors and media section of our website. I'd like to begin today's call by touching on our cash position. As we released earlier this morning and highlighted by Mike, we are pleased to report that the XUS commercialization agreement with NeuroX Farm contains an upfront cash payment of $140 million and additional near-term cash milestones of approximately $12.5 million. During the second quarter, we were also able to take advantage of favorable market conditions to bolster our balance sheet and raised approximately $46 million in net proceeds from the utilization of our ATM facility at an average price of approximately $34. All told, we ended the second quarter with approximately $145 million in cash. And when accounting for the $140 million upfront payment, have a current pro forma cash balance of approximately $285 million. We believe our current capital, when coupled with modest BRIOMV revenue assumptions, will take us out into the foreseeable future without the need to raise incremental capital. Turning to some of the other key financial metrics for the quarter. First, as Adam previously reported, we are pleased to announce $16 million in BRIOMV net sales in our first full quarter since launch, representing 100% growth over the first quarter of 2023, and $23.8 million in cumulative net sales since launch. As for our broader financial results, our net loss for the second quarter of 2023, excluding non-cash items, was approximately $35.1 million, roughly in line with the first quarter of 2023 where we saw a net loss of $32.4 million when excluding non-cash items. Our gap net loss for the second quarter of 2023 was approximately $47.6 million, or $0.34 per share, compared to a gap net loss of $40.5 million, or $0.30 per share, in the second quarter of 2022. With that, I will now turn the call back over to the conference operator to begin the Q&A.
spk12: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. And our first question is from Eric Joseph with JP Morgan. Please proceed with your question.
spk06: Good morning. Thanks for taking the questions. Can you talk a little bit about the cadence of new prescriptions for Brumby over the course of 2Q and throughout July to date? I'm curious to know whether the demand curve is accelerating, plateauing, is it choppy? Um, and then are you, are you seeing a material impact so far from now having the J code in place?
spk04: Yeah. Thanks, Eric. Uh, I didn't want to go ahead and tackle that.
spk10: Yeah, I would characterize it as, as steady growth. Um, and I, I would say, you know, we saw a little bit of a slowdown in July 4th week, uh, you know, which is a down week, I think across the board. Um, we've seen acceleration since, um, that said, you know, we wouldn't expect, you know, an immediate impact on the J-code. It takes time for this J-code to get loaded into payer systems, loaded into the institutional systems. We do believe it's a net positive. We do believe that it will lead to continued growth and will lead to more pickup or pre-unbeat, but it will take time, as I think I've said in the past.
spk06: Okay, that's helpful. Maybe just to follow up if I could. Just when it comes to your updated cash guidance, right, having been funded through operations for the foreseeable future, can you just talk about what that encompasses, if anything, beyond re-ungreed commercialization in the U.S.? Does it anticipate any further development of the product perhaps for other indications or formulations? Thanks.
spk04: Yeah, thanks Eric. So, uh, yeah, it does mean we are continuing to evaluate, um, the sub-Q formulation of, uh, of BrionV. So that's also included in that. We've got, uh, our eye on potentially additional clinical studies for, for BrionV. We've got, uh, some other, we obviously have the BTK inhibitor in our portfolio that we're evaluating. We're kind of waiting to see what the data looks like from some of the competitive products to see if there's an avenue for us to move forward there. And we've said, and we continue to be active in looking at new opportunities, and all of that would be included in that cash guidance. Yeah, none of it would be so material to impact where we're going, which appears to be quarter over quarter, our net loss should continue to decline.
spk06: Great. Thanks for taking the questions. Thanks, Eric.
spk12: Thank you. And our next question is from Ed White with HC Wainwright. Please proceed with your question.
spk13: Good morning. Congratulations on the second quarter sales and also on the deal announced this morning.
spk04: Thanks, Ed.
spk13: You're welcome, Mike. Just two questions for me. First, Mike, I just wanted to get your thoughts on the Okravis subcutaneous phase three data and the potential impact that will have on the market and, you know, where you are as far as you had just mentioned your subcutaneous formulation. And then the second question I have is just for Sean. You know, the R&D was up dramatically sequentially in the second quarter. I just wanted to get your thoughts on R&D expenses over the second half of the year.
spk04: Great, thanks, Ed. Yeah, so the Okra sub-Q, so a few points on that. Obviously, it's made somewhat of a splash among the investment community, which I find interesting in that it wasn't a surprise, right, that this has been telegraphed for quite some time that this data was coming. I think the data that they presented is in line with what one would expect from a top-line data release. I do think that the details, what's the expression, the devil's in the details, We all look forward to seeing the detailed data presentation. I do know that there's a pain measure, I think it's a co-primary endpoint. So we'll be interested to see what that pain level looks like. Anecdotally, we have heard that pain associated with the sub-Q can be significant in some patients. So I think we're all in a position of waiting to see what the actual profile of that product looks like. I think as we sit here today, Briumvia with its one hour infusion is the gold standard for convenience and efficacy in the CD20 space and I think the fact that folks are excited and potentially interested in the fact that Roche is excited and interested in a faster and more convenient I'll call it a quote unquote infusion option since it's not a rapid infuse you know it's not a simple sub-queue similar to Cosimta, but it's a process which will take 10 to 15 minutes. It will require significant nursing attention to get that in, which we think also will deter from centers getting too excited potentially about using it as a more efficient product. There's nothing more efficient than setting up an hour infusion for multiple patients and sitting there. So we do think that uh, that Brionvy is setting the standard. We're excited that investors and our competitors are excited about it, trying to improve the patient experience and try to compete with us in that patient experience. But for the next year or more, we're going to have a monopoly on that, that part of the market, uh, and potentially longer, and we'll see what their product looks like. So, uh, I think overall to us, it's all net positive. I think it highlights the fact that, uh, there is a need in the marketplace for, a more convenient product, and Briambi is the gold standard today. Sean, do you want to tackle that R&D difference?
spk02: Yeah, sure. Good morning, Ed. Thanks for the question. The increase in R&D over the first quarter of 23 relates primarily to a milestone due to LFB on the EU approval of Briambi, $6 million.
spk13: Great. Thank you for taking my questions. Thanks, Ed.
spk12: Thank you. And our next question is from Roger Song with Jefferies. Please proceed with your question.
spk07: Great. Thanks for taking the question. Maybe, Mike, if you can, to give us a little bit of color around the ex-US deal regarding the buyback options with the term associated For example, what would be the valuation for the buyback, and would that be tied to the commercialization result? Thank you.
spk04: Sure. Thanks for the question, Roger. So, yeah, the buyback option is basically designed to provide Nurex a return essentially on investment. So whatever they pay us, we basically will pay them back that amount plus a return on their investment. So we think it's a very reasonable approach. We think it accounts for the risk that they're taking in building out what they need to build out to commercialize and building out the market for us and then losing that. But it's also not punitive at all that would inhibit our ability to conduct a strategic transaction.
spk07: Got it. Yeah, that's helpful. And then in terms of the sales, we all track Acuvia and the Symphony. Seems the number in terms of dollar value pretty on track from at least from Symphony. So we know you're market this through the specialty and you have your own hub. So how should we think about reconsolidation of multiple third party database versus your Q and Q sales numbers. Thank you.
spk04: Yeah, so I'll take a quick crack at this and I'll let Adam speak on this as well. But, you know, we've been cautioning all along that trying to create some sort of reconciliation between Symphony Artivia and our numbers at this point is not a useful endeavor. We have said that we believe that over time, once we have several quarters to maybe more than several quarters of utilization that will reach what I've described as steady state. And at that point, I think people can probably take that data and try to use a multiplier effect or some sort of algorithm to calculate what the sales are going to be. But since we're so early in the launch, I think that's a pretty dangerous game to play, and we've warned everyone multiple times publicly in every setting we can that that's not a good idea at this point to try to gauge. Having said that, the net sales for the quarter were ahead of our expectations. We're ahead of all of Wall Street's expectations, honestly, until about two days ago. So we think it was a very good quarter. We're obviously super excited about it. We're right on track of where we want to be. So it's obviously a little disheartening when folks somehow change the consensus two days before the reporting and then assume that it was a bad quarter. And similarly, to use symphony numbers to try to gauge what that sales number is going to be, again, I just, like I said, we find that to be a very dangerous game to play, and we've said that multiple times. On that note, I'll let Adam add some more color there.
spk10: Sure. I mean, Roger, thanks for the question. If you look at other IV products, including in the MS space, you know, you'll see the ratio between Symphony and IQVIA and reported net sales is often highest in the launch quarter. You know, I think it can be, and it does come down often. As we said, it can be perhaps helpful in understanding directional trends, but it does a poor job capturing launch dynamics that all new products experience. And as I said, and I think Mike has said, it doesn't capture sales through our direct channel. We've also said that that's going to be highly variable quarter to quarter, especially in the beginning as people figure out how they want to purchase. And that will also impact the ratio between symphony sales and net sales. So again, we recommend not using symphony or IQV as a way to estimate our quarterly net sales going forward. And I hope that helps.
spk07: Excellent. Thank you. That's it from us. Thanks, Roger.
spk12: Thank you. And our next question is from Mayank Mamthani with B. Reilly Securities. Please proceed with your question.
spk08: Good morning, team. Thanks for taking your questions. Just to quickly follow up on questions previously asked, if you could comment on inventory on average held by distributors and offices and also on some of those launch metrics, what percentage you're tracking for, you know, free drug sampling. And lastly, if you could comment on, you know, the TRX volume split between newly diagnosed versus switched patients, that would be super helpful.
spk04: Adam, you want to tackle this one?
spk10: Sure. I mean, inventory is within, you know, industry standards. There's no surprises there and pretty much what you would expect. Um, as far as the free goods, um, you know, we, we had free goods of about 20% in the quarter. The majority of that is through our quick start program. And as we said before, that, that is a program to get patients started. And, uh, eventually our hope is that they would convert to commercial product at some point in the future. Um, and then as far as the, you know, patient mix. We haven't said, we're still not in a position yet, I don't think, to comment on the percentages, but what we have said is we've seen a nice distribution across all three segments, both, you know, newly diagnosed and switches, both from CD20s and non-CD20s. I think that covered the question.
spk08: Thank you. Great. Thank you for that comprehensive answer. And maybe Mike, if you could comment on, you know, the bidding process for the XUS deal and would be, you know, would be really helpful to understand how much, you know, the sort of competitive nature of MS marketplace, you know, especially in context of, you know, BTK inhibitors coming down the pipe and also obviously you commented on SubQ, like how much of that is sort of, you know, part of that discussion, because obviously, you know, your partners or future even strategics would want to, you know, incorporate that as part of the long range planning. Thanks for taking our questions.
spk04: Yeah, thanks. So, so yeah, so, you know, look, we we've said for quite a while that we're going to do the analysis on whether we should go it alone in Europe, or we should seek a partner to help us evaluate that. and make that decision. We engaged with JP Morgan to run what I think was a very professional, very competitive process to see what kind of economics we can get on an ex-US deal. It was a competitive process. Nurex Farm was clearly the most eager in Hungary and provided us with the best economic terms, but also we felt the best overall terms, especially with respect to the strategic flexibility that the deal offers us. So the combination of the deal terms, the economic terms, plus the buyback option really made the Nurex farm the top choice. And I think culturally they're a great fit with us. You know, I think we'll be able to work closely with them. I think we can help them with what we've learned in the U.S. And I think, you know, in terms of their ability to execute on this plan, we're feeling very confident and very good about it. So really, to us, the deal kind of offered us everything we wanted. It's almost a hybrid way of getting BrionV to the market as quickly as possible without cutting off our strategic options. So that was the process, and like I said, it was very competitive. In terms of the BTKs or the sub-Q, I think most folks are quite comfortable with what that competitive landscape is going to look like in the future in terms of the real risk of BTK and the real risk of sub-Q. So I don't think that was a major consideration in the process.
spk08: Maybe just one more question, Mike. You know, on the guidance, at some point, I think you had mentioned, you know, you might be one, two, three quarters away from maybe, you know, having a good idea of what demand looks like to be able to, you know, put out a guidance number. Like, would love to hear your most recent thoughts on that and if that could come into the picture at some point.
spk04: Yeah, I mean, in terms of U.S. revenue guidance, Mike, And when we may be in a position to do that. Yeah, I mean, again, I think we are, and what I've said in the past is probably, you know, going into next year, we'll be in a much better position to give some sort of guidance. I think for the remainder of this year, we're going to keep to ourselves and we're going to keep working on it. But, you know, I think, like I said, this quarter we exceeded expectations Our expectations, we exceeded the street expectations until about two days ago when they changed. But short of that, we feel like we're on track and we're doing great in terms of where we're heading. But yeah, my guess is that we'll probably wait to get this whole year under our belt. We'll get a good sense of how the sales are tracking. One, we'll have At that point, we'll know how many patients we treated in 2023, which will give us a base case for 2024. We'll know where we are in terms of new patient starts in the fourth quarter of 23, which will help us start to think about what the first quarter of 24 will look like in terms of new patient starts. So I think we'll just have a lot more information to be in a better position to do that. We'll also understand the dynamics. We're still so early on in this process. We've We don't have the full dynamics of prescription to the hub to total prescriptions to total infusions, right? So because, you know, at the early phases, it's going to take longer to go from prescription to vein as that compresses over the next few quarters. Then once we have that piece of information also, that will help us give a better sense of, you know, how long and where those rubbing is going to fall. So I just think it's, it's so early. We're literally in our first full quarter. I think, you know, uh, we're, we're quite happy again. You know, we've got a lot of centers that have tried the drug. We've got a lot of physicians that have tried the drug, uh, and things are going quite well. And there's so much untapped potential here. Uh, even within those centers, you know, many of those centers have, multiple providers and perhaps only one or two of those providers are already involved in BrionV and we think that that should grow. And there's still, unfortunately, and I think Adam touched on this, there's still many centers where the internal formulary process just takes much longer than we anticipated. So there's a lot of major centers that are still yet to be able to prescribe BrionV. So we think that's a nice area that we'll see some nice growth going forward. So, again, I think we're on the right trajectory that we expected. And when we get to the end of the year, as we get into next year, I think we'll be in a better position to give some guidance.
spk08: Makes a lot of sense. Again, congrats on the progress and look forward to an equally exciting second half. Thanks, man. Appreciate it.
spk12: Thank you. And our next question is from Michael DeFiore with Evercore. Please proceed with your question.
spk09: Hi, guys. Thanks so much for taking my question, and congrats on all the progress. A few for me. Number one, how should we think about uptake and adoption in the EU, just considering the back-end loaded nature of the deal? I have two follow-ups.
spk04: Yeah. So, Adam, do you want to talk about uptake and adoption in the EU?
spk10: Yeah. Michael, thanks for the question. As you know, Europe is a country-by-country approach, each country having a slightly different reimbursement timeline. And I think Germany is first, and then we will layer in other countries as they come aboard from a reimbursement standpoint. So that process does take some time and will play out over, you know, the next year to two in terms of getting up to full speed in Europe. Hopefully that answers the question.
spk09: Thanks. Okay. Also separately, in the past you said that among MS patients opting for anti-CD20 treatments, roughly 30% prefer sub-Q. My question is, how do you see this changing over the next 12 months as Alzheimer's therapies gradually encroach on the infusion share capacity. Could this 30% figure increase as it gets harder and harder for patients to schedule share time?
spk04: Yeah, I mean, I think that plays, you know, into the Brionvi value proposition. So, again, if you're an infuser, you want to optimize your infusion suite. And so, And I would assume instead of sending out patients for sub-Q, you'd prefer to keep them in-house. Again, there's a lot of good reasons. I hear it all the time. The doctors want to know the patient's getting the infusion. So sending it out for sub-Q, we think, is not the first alternative. We think the first alternative is going to be switching all your patients from Ocrevus to Briamvi to free up the chair time. and see how that goes. But again, we think this is something that will really play into our favor. I mean, I assume there will be some uptick in SubQ as a result, but I also think there'll be a nice uptick in Briamvi use for that same very reason. And again, if you're going to optimize your infusion suite to the best that you can, and certainly moving patients from Ocrevus to Briamvi in that setting, if that's what you're trying to achieve and getting more patients in, then we think that's a nice tailwind for us.
spk09: Finally, just any comments on growth to net metrics during Q2? Has it changed from the 70% to 75% that you cited in Q1?
spk11: No, it was largely in line with Q1.
spk09: Thank you.
spk12: Thank you. Our next question is from Prakhar Agrawal with Cantor Fitzgerald. Please proceed with your question.
spk01: Hi, good morning, and thanks for taking my questions. So I had a question on the quarter. The 800 prescriptions in the BMV hub that you reported in 2Q, so there seems to be a lag between prescriptions and the revenue reported. So could you help us bridge that gap? What is causing the lag? percentage paid Rx's, gross to net seems to be stable. So like any color you could provide on that. And would you expect permanent J code to improve the conversion from prescriptions to patient infusions? And I had a follow up.
spk04: Adam, you want to take a crack?
spk10: Sure. Yeah. I think, thanks for the question. I think as we said in the past, there is a time lag between when a script comes into the hub and when you get the actual infusion. I believe what we said is even Ocrevus that's five years into the market, they're averaging around six weeks. We continue to look at our timeframe and it's in that range and hopefully we'll compress over time as we continue to get more insurance coverage. I don't think the J code will necessarily affect that. It would give people more confidence around reimbursement, but the increased insurance coverage and confidence around insurance coverage should help as we smooth out the process. And so, over time, that number should come down.
spk01: Okay. Thanks, Adam. And secondly, if the subcutaneous ocreverse safety tolerability looks good, do you have any plans for subcutaneous formulation for pre-OMG?
spk04: Yeah, so we've said on multiple calls that we are evaluating the physical, biological properties of our material around a sub-Q and to understand what is feasible with Brion-B in a sub-Q. So that work is ongoing as we speak and we're going to make a determination you know, at some point toward the end of the year, early next year, of what we might do with that, assuming we have a profile that we think makes sense. But, you know, I think to the OCAVIS sub-Q point, I don't know that we've seen all the safety and tolerability data. I think it would be premature to say that it looks good. I think we haven't seen that data, and we're looking forward to seeing it, and I assume we will see that at ECTRM. I think the jury is still out on what's the exact profile of the Ocaris sub-Q and what that will look like and what the patient experience will be. Like I said, anecdotally, we do hear that there's some possibility of pain. And, of course, pain is a co-primary endpoint. So it will really be interesting to see how that pain endpoint stacks up against placebo.
spk01: Thank you.
spk12: Thank you. Thank you. Our next question is from Matt Kaplan with Lattenberg Thalmann. Please proceed with your question.
spk03: Hey, guys. Good morning, and thanks for taking the question. Just wanted to follow up a little bit on the ex-US deal. Can you give us a little bit more color on the $500 million toss-in milestones? What would trigger those and how those could roll out?
spk04: Yeah, absolutely. Sean, do you want to take a crack at that? Yeah, sure.
spk02: Good morning, Matt. So as you may expect, they're mostly tied to sales milestones in the U.S. escalating out to your basis. So beyond that, not providing a whole lot more detail at this point.
spk03: Okay. And then, Sean, similarly for the tiered royalty up to 30%, how should we think about that? How does that work?
spk02: I'd say sort of in a similar fashion, escalating from double digits up to 30% is sort of what we're guiding at the moment. Okay, thanks.
spk03: And then I guess maybe for Adam, can you give us some more detail on the feedback that you're hearing from the different stakeholders, the payers, the doctors, patients, and also infusion centers, current feedback that you're getting for RE-MV?
spk10: Yeah, sure. Thanks for the question, Matt. Yes, from a payer perspective, I think the proof is in the pudding. With 80% coverage now, you know, they're talking with their policies, and I think we're in good shape there. Patient feedback has been very positive in terms of the infusion time and ability to get in and out of the center. Infusion centers have been very impressed with the overall tolerability and the efficiency that BreonV provides. Doctors have given us great feedback in terms of the efficacy of the drug and the one-hour infusion as being attractive, as I mentioned in my remarks. So I would say across the board, we're getting very positive and consistent feedback.
spk03: All right, great. Well, thanks for taking the questions, and congrats on the XUS deal. Thanks, Matt. Appreciate it.
spk12: Thank you. We have reached the end of our question and answer session. And with that, I would like to turn the floor back over to CEO Mike Weiss for closing comments.
spk04: Great. Thank you. So on behalf of all the senior management team on this call today, I want to thank all of our shareholders for their continued support and to the entire TG team for their tireless efforts in support of the MS community. As we've Mentioned a few times today, we do believe that Breonvia has set a high bar for activity and convenience in the treatment of MS with the goal of permitting folks with MS to live their best lives. It's really what we're here for, and we work toward it every day. And I know everyone at the company feels the same way. So with that, we are looking forward to a great and exciting second half. And thanks again for joining us, and have a great day.
spk12: Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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