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spk08: Greetings and welcome to the TG Therapeutics Conference call-in webcast. 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, Jenna. You may begin.
spk06: Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the first quarter 2024 financial results are Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercialization Officer, and Sean Power, our Chief Financial Officer. Following our Safe Harbor Statement, Mike will provide an overview of our recent corporate developments, Adam will share an update on our commercialization efforts, and Sean will give an overview of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory or clinical milestones, revenue guidance, development plans, and expectations for our marketed product. TG cautions that these forward-looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG therapeutics operations include various risk factors that can be found in our SEC filings. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on TG's website, .tgtherapeutics.com, where it will be available for the next 30 days. With that, I'd like to turn the call over to Mike Weiss, our CEO.
spk13: Great. Thanks, Jenna. Good morning, everyone, and thanks for joining us on today's call. 2024 is off to an exciting start, and I'm incredibly proud of the accomplishments already achieved this year. Company-wide, it feels like we are firing on all cylinders. A prime example was the recent announcement of the award of the VA contract for Breonvy as the preferred anti-CD20 for the VA system. We cannot be more excited to be able to support our veterans with multiple scholarships by offering Breonvy at a deep discount. We see this as a great way to serve our veterans, introduce Breonvy to additional healthcare providers, many of whom split their time between the VA and their academic appointments, and of course, generate incremental revenue. As for the first quarter, the demand for Breonvy was extremely strong, and I'm pleased to report that the U.S. Breonvy revenue was in excess of $50 million, and total revenues for the first quarter were over $63 million, which includes milestone payments received from our -U.S. partner. By any measure, it was a robust revenue quarter for T.G. As mentioned previously, starting in late 2023 and continuing, we have significantly increased our investment in patient awareness activities and strategically increased the size of our commercial team. I have to believe these investments contributed to the strong first quarter results. More broadly, our team continues to be focused on our long-term goal of becoming the number one prescribed anti-CD20 from a dynamic market share perspective, and the feedback from physicians, patients, nurses, and infusion centers continues to drive our confidence that that is achievable. We believe that Breonvy has -in-class profile that should help us get there. Breonvy is the only anti-CD20 monoclonal antibody that the U.S. has been able to use to help The first quarter of 2015 can be given as a one-hour infusion every six months following the starting dose, and is the only anti-CD20 monoclonal antibody in phase three trials to achieve an annualized relapse rate of less than .10. Also in phase three trials, the Breonvy one-hour infusion was generally well tolerated with 95% of the one-hour infusions being delivered on time. Beyond the clinical data, Breonvy is also differentiated by design, having been glycol engineer for enhanced immune effector cell engagement and efficient B cell depletion. As previously presented, preclinical data demonstrates that compared to the other anti-CD20s approved or used to treat MS, Breonvy has the highest binding affinity to CD20, the target found on the B cells, and through its glycol engineering, has the ability to treat the B cells to induce the highest level of antibody-dependent cellular cytotoxicity. We look forward to evaluating these preclinical differences further to assess what, if any, contribution they may have to Breonvy's differentiated clinical profile, and we will seek to share these data when available. We are also excited to share during the quarter that there were three newly issued patents of the U.S. Patent and Trademark Office extending patent protection for Breonvy through 2042. With the extended runway, our development team is focused on potential expansion opportunities for Breonvy both within MS as well as in other autoimmune diseases. To that end, we are focused on three Breonvy-related initiatives this year, which we believe could drive significant future value. First is further improving the convenient dosing of IV Breonvy. In March, at the Actron's conference, we presented updated data from the enhanced trial evaluating the safety and efficacy of eliminating the four-hour Breonvy 150-milligram starting dose for patients who switch from a prior anti-CD20. Data presented suggests that Breonvy was well tolerated for patients that skipped the starting dose and went straight to the first full 450-milligram dose given as a one-hour infusion. These early results are encouraging, and we look forward to continuing to present additional efficacy, safety, and tolerability data from this study throughout the year. Second is the development of subcutaneous Breonvy. We believe the sub-Q CD20 market is distinct from the IV market and believe this could represent a significant additional opportunity for Breonvy. We are preparing to enter human bioequivalence studies this year and look forward to providing additional updates on this front as we have them throughout the year. And third, we look forward to evaluating Breonvy in other autoimmune indications. The goal is to launch our first autoimmune trial evaluating Breonvy outside of multiple sclerosis later this year. We believe the expansion of Breonvy represents a significant opportunity and we look forward to providing updates throughout the year, but we're not stopping there. The future of TG also lies in the expansion of our portfolio. We recently entered into a partnership with Precision Biosciences to acquire a worldwide license to Precision's Azercell, an allogeneic CD19 CAR-T cell therapy for autoimmune diseases and all other non-oncology indications. We believe the Azercell has the potential to be a -in-class, -in-class treatment for certain autoimmune diseases and we look forward to commencing a clinical trial this year. I also want to congratulate our partners at Nurex Pharm on their launch of Breonvy in Europe, which also occurred in the first quarter with the first commercial sale in Germany. Transitioning the program to enable their timely launch took significant effort from our team and I'm proud of how everyone worked so closely together to make it happen. The Nurex Pharm team is experienced, motivated, and focused and we look forward to hearing more from them as the launch progresses to multiple countries across Europe and then around the globe. Finally, I want to thank and acknowledge the entire TGT. It's amazing to see the focus, attention, and care that TGers take to ensure the best possible experience for patients with MS. While we spent a lot of time on these calls talking about numbers, the most gratifying part of my day is hearing firsthand from patients taking Breonvy of their positive experiences as well as HCP's anecdotes about their patients' treatment successes with Breonvy. With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to write a detailed update on the Breonvy U.S. commercial launch. Adam, go ahead.
spk04: Thank you, Mike, and good morning, everybody. I'm excited to provide insights into our continued commercial progress in the first quarter. This was another very strong quarter of performance, exceeding our revenue guidance and all of our key performance metrics. Our focus on delivering Breonvy to patients remains unwavering, and I'm pleased to share our progress with you today. In the first quarter of 2024, we continue to see strong uptake of Breonvy in the market. As reported in our press release, first quarter net sales in the U.S. for Breonvy were 50.5 million, representing 25% growth quarter over quarter. The first quarter number exceeded our original guidance of 41 to 46 million, providing early January, as well as our updated guidance we provided in late February. The trends we saw early in the quarter continued throughout the quarter, reflecting strong and growing demand for Breonvy. This growth is particularly impressive given the first quarter challenges associated with -the-year payer dynamics. In fact, we were the only CD20 and MS to see revenue growth quarter over quarter in the U.S. market during this time frame. Equally impressive is that we also saw enrollments grow by approximately 25%, with over 1,250 new patient scripts received by the TG Hub in the quarter. I want to congratulate our team on doing an exceptional job preparing for the inherent insurance-related challenges seen in the first quarter and mitigating the potential impact. Since launch, we've implemented a comprehensive commercial strategy that encompasses targeted educational initiatives, engaging healthcare providers both virtually and in person, and leveraging digital marketing channels to reach a broader patient audience. Our efforts have resulted in increasing uptake of Breonvy with healthcare providers recognizing the value Breonvy brings to patients. And currently, ensuring patient access to Breonvy remains a top priority for us. We continue to receive exceptional feedback on the comprehensive patient support programs we have introduced to assist patients in navigating reimbursement challenges and accessing the treatment they need. We also continue to make significant strides in expanding our market presence. Through targeted marketing initiatives and effective Salesforce deployment, we've successfully penetrated new accounts and prescribers, driving sustained growth. We saw both increasing number of repeat prescribers and impressive gains in new prescribers, with approximately 160 new prescribers in the first quarter, the majority of which were from academic centers. We also continue to convert new centers, adding 65 new accounts in the quarter. To date, we have seen broad adoption of Breonvy across the U.S., with new prescriptions coming from over 450 centers and over 800 unique prescribers. Encouragingly, we also continue to see a diverse mix of patient types, including those that are naive to all treatments and those that were previously treated and switched from both non-CD20 and CD20 agents. This makes the patient types continue to be fairly consistent quarter to quarter, with the largest group consisting of patients that were previously treated but naive to anti-CD20 therapy. 2024 is off to a really strong start. We achieved record Breonvy new patient enrollments into our hub in the first quarter and far exceeded our first quarter revenue guidance and continue to show strong quarter to quarter growth, despite the first quarter insurance headwinds. We continue to see momentum building into the second quarter, and based on the information we have available at this time, we are targeting Breonvy net revenue of approximately 65 million for the second quarter. In terms of the full year, we continue to feel confident about the Breonvy trajectory. Based on current trends, we believe we are tracking above the top end of our original guidance of 220 to 260 million, and are therefore raising our full year guidance to 270 to 290 million. Looking ahead, we see promising opportunities for further growth and expansion. We believe we are poised to broaden our reach and make an even greater impact on the MS patient community. We continue to believe Breonvy's profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market. In conclusion, I want to thank our team for their dedication and hard work. They have executed the launch plan with precision, driving awareness and adoption among our targeted healthcare providers, and we believe their outstanding efforts are contributing to the positive experience with Breonvy and confidence in our organization. I also want to thank the healthcare providers and their patients for their trust in TG therapeutics. Together, we will continue to improve outcomes for those in need, and we certainly have more work to do, but we are focused and extremely motivated to continue to work every day to bring Breonvy to those people living with MS and their families. With that, I'll turn the call over to Sean Power, our CFO. Sean?
spk02: Thank you, Adam, and thanks everyone for joining us. Earlier this morning, we reported our detailed first quarter 2024 financial results, which can be viewed on the Investors and Media section of our website. This morning, I'll start with a discussion of our revenue. We are pleased to report total revenue of approximately $63.5 million during the first quarter of 2024, which, as previously mentioned, includes $50.5 million of U.S. Breonvy net product revenue. Also included in our Q124 revenue total is approximately $13 million of license, milestone, royalty, and other revenue, which consists primarily of the $12.5 million milestone we received from our -U.S. partner for the first commercial launch of Breonvy in the EU. Our OPEX during the first quarter of 2024, despite some one-time charges, has remained well-controlled and in line with previously discussed ranges. For the first quarter of 2024, our operating expenses were approximately $58 million, which includes one-time charges to research and development expenses of approximately $8.8 million related to our agreement with Precision Biosciences for the in-licensed Acer cell program. During the first quarter of 2024, we also saw a modest increase in R&D expenses driven by manufacturing and development costs associated with our ublituximab subcutaneous development work. On the back of the reported revenues and well-controlled OPEX, during the first quarter of 2024, we reported a modest net loss of approximately $10.7 million, or $0.07 per share, compared to a net loss of approximately $39.2 million, or $0.28 per share, during the comparable quarter in 2023. From a cash standpoint, we ended the first quarter with $209.8 million in cash, equivalent and investment securities, down less than $10 million from Q4 of 2023. We believe our current cash position, coupled with our previously guided revenue and expense guidance, provides us with sufficient capital to fund our operations to cash flow positivity. With that, I will now turn the call over to the conference operator to begin the Q&A.
spk08: 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. And 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 pull for questions. Thank you. Our first question comes from the line of Michael DiFiori with Evercore. Please proceed with your question.
spk03: Hi, good morning guys. Thanks so much for taking my question. And grats on all the great progress this quarter. A couple from me. Regarding sales in the EU, I know it's very early, but when could we expect NeurAx Farm to begin offering details? And I have two follow-ups. Thank you.
spk13: Yeah, so in terms of NeurAx Farm providing public details, I think we are a long way off. They are a private company, private equity backed. So I don't anticipate they will be providing any public guidance or information to my knowledge. Adam, anything different from your side?
spk04: No, nothing to add there.
spk03: Okay,
spk04: fair enough.
spk03: My other two questions are how much of BreMV's fiscal year 2024 guidance raise was due to the recently announced VA contract? And any color that you could provide on pricing or increased rebating in this segment? I know you said it's heavily discounted. Yeah, Adam,
spk04: go ahead. Sure, yeah. The revenue raise was really, the VA was not really factored in for a couple reasons. One, this won't go into effect until June. Second, it will be a gradual increase as new patients get on. Patients will only really have the opportunity in this year to have their first two infusions at best. So it will be a gradual increase and it wasn't really a factor in the way that we looked at raising our guidance. The guidance was raised based on the demand trends that we're seeing. First, pricing, I think that's out there. And public, we offered about a 72% discount, roughly about $2,900 a vial.
spk03: Okay, great. And my last question is this. In the most recent cut of the enhanced data presented at the X-TRIMS, three patients in cohort two had to have their infusions slowed down or interrupted. Any color on these patients? Like how long were these infusions slowed down to or interrupted for? And were there any unique clinical features of these patients that could explain this?
spk13: So no, I don't think there was anything particular about the patients, but the infusions were pretty modest and I think all were done reasonably close to the one hour anyway. So no, I think it was just basic stuff that was typical of infusions, but I don't think there was anything to be worried about there. It was well tolerated overall and those patients too that did well. Got it. Thanks so much. Congrats again.
spk08: Our next question comes from the line of Ed White with H.C. Wainwright. Please proceed with your question.
spk05: Good morning. Congratulations on the results and thanks for taking my questions. Just to clarify what you just said on the VA contract, Adam, was it a 72% discount? Yes. Okay, thank you. And this has been brought up before, but I just wanted to address it again. Thinking about the potential opportunity in the so-called CrapGat with Okra this. Is this something that you think you'll be able to produce data on or somehow address this with your sales force?
spk13: Yeah, so in terms of CrapGat and being able to show it, we're trying to capture as much data as we can through the enhanced study. I think the number is about 50 to 60-ish percent, maybe a third, two-thirds report CrapGat as they're coming into the enhanced trial. So we'll try to capture some of that information on the back end. Hopefully we'll have at least some anecdotal information about the patient reported, whether they are or are not seeing the CrapGat. It's hard. There's no scale to objectively measure CrapGat. So it is a challenging thing to measure, but we'll do the best we can within the enhanced study and whatever studies we conduct. We will certainly try to parse out the effect and whether we've changed that for patients.
spk05: Okay, thanks Mike. And just when thinking about other potential indications, how do you prioritize outside of MS? I'm sure you have plenty of factors in there, but where does time to potential approval come in or size of the potential market? How are you sort of ranking that?
spk13: Yeah, I think we're probably focused on things like RA and lupus for brionvy outside of MS, sort of larger indications. And as we've said previously, in some more niche indications, we would be looking at an AES or CEL.
spk05: Okay, Mike, thanks for taking my questions. Thanks Ed.
spk08: Our next question comes from the line of Roger Song with Jeffreys. Please proceed with your question.
spk10: Great, and my congrats to the 1Q results. And then just a couple of questions from us. One is understanding your hub is capturing most of the new patients, and given you have quite a few quarters since launch, so how would you characterize the repeat infusion rate you have been seeing?
spk13: Yeah, Adam, you want to go ahead, Anand?
spk04: Yeah, so yes, just to reconfirm here, the patient hub numbers that we're giving you are new patients only. So just to do, I think that was your question there. And then as far as persistence, we would say we're still early with our data, and we continue, but however, the data that we see, we continue to see that the 24-week persistence is in line or maybe slightly better than our expectations of about 85% week 24. So we feel pretty good about it, although the data is early. We'll continue to look at it, but right now it's in line or maybe slightly ahead of what we expected.
spk10: Excellent. Thank you, 85%. That's good. And then so you are having now 800 health providers at around 450 centers. So understanding where you start to, you know, when you plan the launch, you are targeting top 550 accounts covering 70 to 80% of the MS patients. Just curious, is that still the goal for the provider or the center outreach? And then if that's still the case, then when do you expect you will achieve that 550 from 450?
spk04: Yeah, so I think if I understand the question, it's, you know, what's our goal in terms of new accounts and new prescribers? I'll just say that I think we've done really good. We've got broad adoption right now, but we certainly see opportunity for more adoption with even more prescribers and of course deepening the use with our current prescribers. The good news in the quarter is we saw increases in both repeat prescribers and adding new prescribers at a pretty good clip and new accounts at a pretty good clip. So we feel good about it. We'll continue to make progress every day and certainly have opportunity, but feel good about where we're at right now.
spk10: Great, thank you. One last question related to the financials. So I think earlier this year, your guiding, the OpEx is 250 for the year. Just want to confirm if that's still the guidance for now and then also curious about the expectations for the coming years given your continued to launch and expanding your pipeline. Thank you.
spk13: Yeah, I'll take a first crack and Sean jump in. But yeah, I think we're well on track to set approximately 250 in OpEx. So that gives us a little wiggle room there. But if you look at even the first quarter, we had 58 and change and we had 8 and change which was that one time to precision. And so the base OpEx was still only around 50 for the quarter. So you multiply that times four, you're still well under the 250. That gives us room to grow and we are growing. Like I said in my prepared remarks, we're strategically adding to our team and we're continuing to spend money on patient awareness programs. But I think from where we sit today, we're in pretty good shape. Sean, any more details there?
spk02: No, I think you covered it pretty well.
spk10: Thank you. That's it Paul.
spk08: Our next question comes from the line of Matt Kaplan with Lattenberg-Falman. Please proceed with your question.
spk12: Hey, good morning guys. Congrats on the quarter. So maybe for Adam, in terms of new patient starts, can you give us a little bit more detail in terms of where they're coming from in terms of naive switch and the background that you're getting these new patients from?
spk04: Yeah, thanks Matt. Good morning. So I would say we have not given out specific percentages of the patient and how it exactly breaks out. What we said is the biggest group is patients switching from non-CD20s, but we also have good representation from treatment-naive patients as well as patients that are switching from CD20s like Ocaris or Casimta. So encouragingly we think we're getting a nice diverse group of patients and importantly staying consistent quarter to quarter. There wasn't any big boluses of a certain patient group that sort of diffused over time, so we're seeing consistently representation from all three of those groups.
spk12: Okay, that's helpful. Thanks. And then I guess in terms of the subcutaneous opportunity for the Bray-Humby formulation, I guess recently on the Roche call they said they see the subcutaneous opportunities as more than $2 billion. I guess the question is with your potential differentiated profile, what's your assessment of the subcue opportunity?
spk13: Yeah, I'll speak broadly and I'll let Adam chime in. I mean the folks at Novartis have done a really nice job of carving out a subcue market. They created it. And I think as Roche probably mentioned, Novartis is probably over $2 billion and growing today, so there's a nice market there. And yeah, our goal is to come into that market with a very competitive profile product. As we've said previously, we understand the parameters. We've got on the one hand a relatively elegant auto-injector once a month and you've got a relatively bulky product every six months. Somewhere in the middle we think is an optimal product design and we're going to try to get there. So I think from just where we sit today, we're seeing opportunity and we're going to take our best crack at it. Adam?
spk04: Nothing else to really add there,
spk13: Mike. Sorry about that.
spk12: All right. Thanks for taking the question, guys.
spk08: Our next question comes from the line of Mayank Montani with B. Riley Securities. Please proceed with your question.
spk09: Good morning, team. Congrats on a strong quarter and thanks for taking your questions. Sorry, Adam, if I missed this. Did you say the revenue split between new patient starts and maintenance patients? And I was also curious to hear from you how you think that stacking up effect in second half, how we should expect that revenue split to be. And if you can also comment on some other metrics you provided before, feed drug percentage, gross to net, anything on that would be helpful as we think about the full year modeling. And then I have a couple of follow-ups.
spk04: Yeah, we didn't share, you didn't miss it. We didn't share any specifics on new versus continuing patients from a revenue perspective. We do continue to feel that this is a market where duration is a big driver of revenue and there will be a pancaking effect that will, as time goes on, patients will, this is a very sticky, the duration is really good. Patients are on drug an average of five years. So you will see that pancaking effect over time. So that's the best that I have for that question. I think your other question was free drug. As I said before, we did expect free drug rates to come down. We are seeing free drug rates come down. I think in the first quarter we're about 12% is right now, I think it is about 12% from earlier in 2023 we were about 20%. So 12% in the quarter and then from a gross to net standpoint, I think what we said previously is our gross to net is approximately 75%. We'll go up and down from quarter to quarter, but 75% is probably a good number to use for the remainder of 2024.
spk09: Thank you. That's helpful. And then in your updated guidance for full year, I was just curious to learn, you know, how are you thinking about that year end exit market share? Again, like, I don't know if you think of the market as total NRX percentage, which Mike, I think you provided, you're tracking at that 10%, but obviously curious to hear, you know, how you think about that market share in terms of either total RMS patients or within the anti CD20 drug class patients. So, like, could you just give us some color on how what that 280 million midpoint assumes in terms of market share?
spk04: Yeah, Mike, I'm probably not going to get into any specifics. I mean, our goal here is to increase the depth of the use and the breadth of the use and continue to add new prescribers. We see continued opportunity for growth. We feel very confident in the trajectory. We feel very confident in the demand trends that we're seeing, and we're going to continue to focus on growing the usage of of the, you know, across the market. And we're doing a great job of it. And, you know, based on our guidance here, we feel obviously feel very confident and continued growth going forward.
spk09: Okay, yeah, my own kind of item.
spk13: Go ahead. Yeah, I'm just going to chime in on the on the first question asked about the revenue split new versus old. Just I know we're not providing actual numbers, but I think it's worth just to mention that in the early years, you know, we're going to be driven by the new starts in the later years will be driven by the the ongoing or stacking patients. So if you look at probably our competitive IV CD 20 has been on the market for a long time. The vast majority of their sales are going to be based on continuing patients, not on new patients in any particular quarter. Whereas I'd say we're probably the opposite still right. We're still reliant on our new starts. But over time, the continuing patients sort of take the commanding role in how the revenue steps up.
spk09: Yeah, and that goes well for that, you know, size of that pancake downstream. Yeah, I guess. Last question. Last question on the subcute target product profile. Mike just would be helpful to understand how you and you know, even some of the KOL feedback. Now that we know what you know the subcute profile for a crevice would look like at at launch. Now that you know all the data is out there with this curious Mike as you design the human bioequivalent study what differentiating attributes are in mind as you think about that product profile. Thanks again for taking my question.
spk13: Yeah, so look, the the ochre risk subcute is not a true patient administered at home product today. So that is yet to be created or not created, but to be available or even studied as far as my knowledge. So that's still yet to come. You know, our goal is to have something that is a patient administered patient friendly product again more along the lines of of what was done with. So for two map, so I don't know how much more I could say other than, you know, we think there's a lot of room to to to thread the needle here and come up with a product profile that accomplishes the goals of being both convenient
spk09: and
spk13: easy to use.
spk09: Got it. Look forward to some of those updates. Thanks Mike. Thank you.
spk08: Our next question comes from the line of Procar Adrawal with Cantor Fitzgerald. Please proceed with your question.
spk01: Hi, good morning and thanks for taking my question and congrats on the quarter. So just following up on the subcute Brium V question, I'm trying to understand like what's your base case assumption on where the dosing frequency could land for subcute Brium V. I guess the reason I'm asking you this ends up being once a month, would you still go ahead with the subcute development and I had one more.
spk13: Yeah, I mean, I think the bottom line is we probably would, but I don't think that's going to be necessary. So I don't know that that's a scenario that that is likely. But yeah, I mean, it's early to tell and again, I think if we feel like we've got something that has a good opportunity to make a dent in the market, we'll go forward and certainly once a month could be, could have some impact in the market. Obviously probably has less impact than something that has a less duration and we'll do the math on that. And that less duration, less frequency, but I'm not so concerned with that's an issue here.
spk01: And when do you expect patients to be dosed for subcute Brium V?
spk13: We would hope to have the first patients dosed within the first half of this year. So hopefully the next few months here.
spk01: And lastly, from my side, we're seeing a lot of data on CD19 antibodies and other autoimmune indications. What's your view on CD19 versus CD20? And obviously there's a theory that targeting CD19 could achieve broader coverage of the B-cell compartment compared to let's say CD20. So just wanted to get your perspective there. And do you have a CD19 in early stage pipeline?
spk13: So yeah, I mean we do have a CD19. It's our Acer Cell CAR-T therapy is a CD19. So we think CD19 is a great target. We think it's hard to know if the broader coverage is a positive in all settings. There are some diseases that are characterized by plasma cells that may be impacted by CD19 or may be expressed in CD19 or that may be helpful. So NMO is one that folks talk about quite frequently as more potentially CD19 driven. So we think there are areas where CD19 may be helpful, but overall we think the overlap between CD20 and CD19 is going to be hard to distinguish in most diseases. And the CD19 when it hits pre-B cells in addition to B cells, CD20 only gets matured B cells. So in terms of recovery, you may see a difference there. So I think there's a lot of things to balance when you think about CD19 or CD20. But from an activity standpoint in most diseases, I don't know that you're going to see a material difference.
spk01: Yeah, I guess my one clarification. I was asking about the CD19 antibody, not the CAR-T. Do you have a CD19 antibody in early stage even pre-cancer?
spk13: We don't. We don't know. I don't find that to be a product of interest to us at this time.
spk01: Good. Thank you.
spk08: Our next question comes from the line of Eric Joseph with JP Morgan. Please proceed with your question.
spk11: Hi, good morning, guys. This is Noah for Eric. Thanks for taking our question. We were just wondering if there were other exclusive procurement opportunities similar to the contract that you just secured with the VA. Adam?
spk04: Not sure I understand the question. Could you clarify?
spk11: Yeah, we're just wondering if there are other opportunities for tiered or exclusive access contracts with other providers going forward. Gotcha.
spk04: Okay. I don't have any updates at this time on that question.
spk11: Got it.
spk10: Thank you.
spk08: Our next question comes from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your question.
spk07: Good morning. Maybe a couple questions from us. One, it strikes me that you guys are probably close to reaching profitability in the next quarter of two given the revenue guidance versus the OPEX guidance. How are you thinking through profitability versus kind of like ramping or expanding your R&D or SG&A to support the watch in future development? And then from a technical perspective on the subcutaneous formulation, what else is left to do before you're able to enter the clinic? Thanks.
spk13: Sure. So thinking about profitability, I don't think those questions you asked are mutually exclusive or points, right? So we will continue to invest in the Brown V launch. We've noted that we have an increased budget in OPEX to approximately $250 for the year, so there's some room there to even grow. From a product standpoint, similarly, we are interested in continuing to build among the Brown V opportunity, the ASIA saw opportunity, and we've said that we're continuing to look for additional external opportunities. So I don't know that we're fixated on the exact profitability numbers, and I know that may, as EPS becomes something of interest, but I don't think it's mutually exclusive. And I do think we plan to continue to grow our Brown V efforts and our team and continue with our R&D platform. But as an overall company, I think our cost structure versus most other companies, not all, but most, is pretty modest and we've kept a pretty lean shift. So I think the consequence of that is we'll be at profitability probably sooner than most companies would given circumstances. In terms of the sub-q technical aspects before entering the clinic, I think we're pretty much over most of the technical hurdles. I think we'll be able to get into the clinic, I believe, in the next two months or so. And I think there's a continuing effort to make continued improvements in what we're working on, which I'll just be filtering into the clinical program. But I don't think there's any technical hurdles right now to us getting going.
spk07: Thank you.
spk08: 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 Mike Weiss for any closing comments.
spk13: Great. Thank you, everybody. One second here. Well, okay. So I just want to thank everyone for joining us today. Hopefully, everyone has been able to see the excitement and enthusiasm that we have here at TG and what's going on with the company. We were, you know, the first quarter was quite good in our opinion. We think everything went extremely well. And we look forward to continuing to push forward and achieving more as we move forward into the remainder of the year. Again, we thank everyone for their support. Most importantly, we want to thank the clinicians and patients who definitely put their trust into TG. The whole team does appreciate it. With that, I'd like to thank everyone for joining us and have a great day.
spk08: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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