TG Therapeutics - Q1 2024

Transcript

Operator (participant)

Greetings and welcome to the TG Therapeutics conference call and 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.

Jenna Bosco (Chief Communications Officer)

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, Michael 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, www.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.

Michael Weiss (Chairman and CEO)

Great. Thanks, Jenna. And 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 BRIUMVI as the preferred anti-CD20 for the VA system. We cannot be more excited to be able to support our veterans with multiple sclerosis by offering BRIUMVI at a deep discount. We see this as a great way to serve our veterans, introduce BRIUMVI 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 BRIUMVI was extremely strong, and I'm pleased to report that the US BRIUMVI revenue was in excess of $50 million, and total revenues for the quarter were over $63 million, which includes milestone payments received from our ex-US partner. By any measure, it was a robust revenue quarter for TG. 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 BRIUMVI has best-in-class profile that should help us get there. BRIUMVI is the only anti-CD20 monoclonal antibody that 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 0.10. Also in phase three trials, the BRIUMVI one-hour infusion was generally well tolerated, with 95% of the one-hour infusions being delivered on time. Beyond the clinical data, BRIUMVI is also differentiated by design, having been glycoengineered 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, BRIUMVI has the highest binding affinity to CD20, the target found on the B-cells, and through its glycoengineering, has the ability 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 BRIUMVI's differentiated clinical profile, and we will seek to share these data when available. We're also excited to share during the quarter that there were three newly issued patents by the U.S. Patent and Trademark Office extending patent protection for BRIUMVI through 2042. With the extended runway, our development team is focused on potential expansion opportunities for BRIUMVI both within MS as well as in other autoimmune diseases. To that end, we are focused on three BRIUMVI-related initiatives this year, which we believe could drive significant future value. First is further improving the convenient dosing of IV BRIUMVI.

In March at the ACTRIMS conference, we presented updated data from the ENHANCE trial evaluating the safety and efficacy of eliminating the four-hour BRIUMVI 150 milligram starting dose for patients who switch from a prior anti-CD20. Data presented suggests that BRIUMVI 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 BRIUMVI. We believe the subcu CD20 market is distinct from the IV market and believe this could represent a significant additional opportunity for BRIUMVI. 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 BRIUMVI in other autoimmune indications. The goal is to launch our first autoimmune trial evaluating BRIUMVI outside of multiple sclerosis later this year. We believe the expansion of BRIUMVI 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've recently entered into a partnership with Precision BioSciences to acquire a worldwide license to Precision's azer-cel, an allogeneic CD19 CAR-T cell therapy for autoimmune diseases and all other non-oncology indications. We believe azer-cel has the potential to be a first-in-class, best-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 Neuraxpharm on their launch of BRIUMVI 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 Neuraxpharm 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 TG team. 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 spend a lot of time on these calls talking about numbers, the most gratifying part of my day is hearing firsthand from patients taking BRIUMVI of their positive experiences as well as HCPs' anecdotes about their patients' treatment successes with BRIUMVI. With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to provide a detailed update on the BRIUMVI U.S. commercial launch. Adam, go ahead.

Adam Waldman (Chief Commercialization Officer)

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 BRIUMVI 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 BRIUMVI in the market. As reported in our press release, first quarter net sales in the U.S. for BRIUMVI were $50.5 million, representing 25% growth quarter-over-quarter. The first quarter number exceeded our original guidance of $41 million-$46 million provided in 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 BRIUMVI.

This growth is particularly impressive given the first quarter challenges associated with beginning-of-the-year payer dynamics. In fact, we were the only CD20 in 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 BRIUMVI, with healthcare providers recognizing the value BRIUMVI brings to their patients.

Concurrently, ensuring patient access to BRIUMVI 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 sales force deployment, we've successfully penetrated new accounts and prescribers, driving sustained growth. We saw both an 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 BRIUMVI 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 mix of patient types continues 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 BRIUMVI 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 BRIUMVI net revenue of approximately $65 million for the second quarter.

In terms of the full year, we continue to feel confident about the BRIUMVI trajectory. Based on current trends, we believe we are tracking above the top end of our original guidance of $220 million-$260 million and are therefore raising our full-year guidance to $270 million-$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 BRIUMVI'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 BRIUMVI 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 BRIUMVI to those people living with MS and their families. With that, I'll turn the call over to Sean Power, our CFO. Sean?

Sean Power (CFO)

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 the 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 US BRIUMVI net product revenue. Also included in our Q1 2024 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 ex-U.S. partner for the first commercial launch of BRIUMVI in the E.U. 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 unlicensed azer-cel 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 ublutuximab 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, cash equivalents, 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.

Operator (participant)

Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue, and you may press star two 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. Our first question comes from the line of Michael DiFiore with Evercore. Please proceed with your question.

Michael DiFiore (Managing Director)

Hi, good morning, guys. Thanks so much for taking my question, and congrats 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 Neuraxpharm to begin offering details? And I have two follow-ups. Thank you.

Sean Power (CFO)

Yeah. So in terms of Neuraxpharm providing public details, I think we're a long way off. They're a private company, private equity backed, so I don't anticipate they'll be providing any public guidance or information, to my knowledge. Adam, anything different from your side?

Adam Waldman (Chief Commercialization Officer)

No, nothing to add there.

Michael DiFiore (Managing Director)

Okay, okay, fair enough. And my other two questions are: how much of BRIUMVI'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.

Sean Power (CFO)

Yeah, Adam, you want to go ahead?

Adam Waldman (Chief Commercialization Officer)

Sure. Yeah, the revenue raise was really, the VA was not really factored in for a couple of reasons. One, this won't go into effect until June. Second, it will be a gradual sort of increase as new patients get on. Patients will only really have the opportunity in this year to have their first 2 infusions at best. So it'll 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. As far as pricing, I think that's out there and public. We offered about a 72% discount, roughly about $2,900 a vial.

Michael DiFiore (Managing Director)

Okay, great. My last question is this: in the most recent cut of the ENHANCE data presented at ACTRIMS, three patients in cohort two had to have their infusion slowed down or interrupted. Any color on these patients? 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?

Sean Power (CFO)

So no, I don't think there was anything particular about the patients, but the infusion rates were pretty modest, and I think all were done reasonably close to the 1 hour anyway. So no, I think it was just basic stuff that was typical of infusions, but I don't think there's anything to be worried about there. It was well tolerated overall, and those patients, too, did well.

Michael DiFiore (Managing Director)

Got it. Thanks so much. Congrats again.

Operator (participant)

Our next question comes from the line of Ed White with H.C. Wainwright. Please proceed with your question.

Ed White (Managing Director and Senior Biotechnology Analyst)

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?

Adam Waldman (Chief Commercialization Officer)

Yes.

Ed White (Managing Director and Senior Biotechnology Analyst)

Okay, thank you. This has been brought up before, but I just wanted to address it again. Thinking about the potential opportunity in the so-called crap gap with OCREVUS, is this something that you think you'll be able to produce data on or somehow address this with your sales force?

Michael Weiss (Chairman and CEO)

Yeah. So in terms of crap gap and being able to show it, I mean, we're trying to capture as much data as we can through the enhanced study. I think the number is about 60-ish%, maybe two-thirds report crap gap 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 patient-reported, whether they are or not seeing the crap gap. It's hard. There's no scale to objectively measure crap gap. There's no 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.

Ed White (Managing Director and Senior Biotechnology Analyst)

Okay, thanks, Mike. 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?

Michael Weiss (Chairman and CEO)

Yeah, I mean, I think, look, we're probably focused on things like RA and lupus for BRIUMVI outside of MS, sort of larger indications. As we've said previously, in some more niche indications, we would be looking at azer-cel.

Ed White (Managing Director and Senior Biotechnology Analyst)

Okay, Mike, thanks for taking my questions.

Michael Weiss (Chairman and CEO)

Thanks, Ed.

Operator (participant)

Our next question comes from the line of Roger Song with Jefferies. Please proceed with your question.

Roger Song (Stock Analyst)

Great, and my congrats to the Q1 results. And then so just a couple of questions from us. One is understanding your hub is capturing mostly 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?

Sean Power (CFO)

Yeah, Adam, you want to go ahead on that one?

Adam Waldman (Chief Commercialization Officer)

Yeah. So yes, just to reconfirm here, the patient hub numbers that we're giving you are new patients only. So just to I think that was your question there. And then as far as persistence, we would say we're still early in the 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.

Roger Song (Stock Analyst)

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 through when you plan the launch, you are targeting top 550 accounts covering 70%-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 the 450?

Adam Waldman (Chief Commercialization Officer)

Yeah, yeah. So I think if I understand the question, it's 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're continuing to make progress every day and certainly have opportunity, but feel good about where we're at right now.

Roger Song (Stock Analyst)

Great, thank you. One last question related to the financials. So I think earlier this year, you guided 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 continue to launch and expanding your pipeline. Thank you.

Michael Weiss (Chairman and CEO)

Yeah, I'll take a first crack, and Sean, jump in. But yeah, I mean, I think we're well on track. I mean, we said approximately $250 in OpEx, so it 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. So the base OpEx was still only around $50 for the quarter. So you multiply that times 4, you're still well under the $250. That gives us room to grow, and we are growing. Like we 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?

Sean Power (CFO)

No, I think you covered it pretty well, Mike.

Roger Song (Stock Analyst)

Great, thank you. That's it from us.

Sean Power (CFO)

Roger.

Operator (participant)

Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Matt Kaplan (Managing Director and Head of Healthcare Research)

Hey, good morning, guys.

Michael Weiss (Chairman and CEO)

Good morning.

Matt Kaplan (Managing Director and Head of Healthcare Research)

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?

Adam Waldman (Chief Commercialization Officer)

Yeah, thanks, Matt. Good morning. So I would say we have not given out specific percentages of the patients 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 OCREVUS or KESIMPTA. So encouragingly, we think we're getting a nice, diverse group of patients and, importantly, staying consistent quarter to quarter. There wasn't any sort of 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.

Matt Kaplan (Managing Director and Head of Healthcare Research)

Okay, that's helpful. Thanks. And then I guess in terms of the subcutaneous opportunity for the BRIUMVI formulation, I guess recently on the Roche call, they said they see the subcutaneous opportunity as more than $2 billion. I guess the question is, with your potential differentiated profile, what's your assessment of the sub-Q opportunity?

Michael Weiss (Chairman and CEO)

Yeah, I'll speak broadly, and I'll let Adam chime in. I mean, look, the folks at Novartis have done a really nice job of carving out a sub-Q 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, I mean, 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 autoinjector 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?

Adam Waldman (Chief Commercialization Officer)

Nothing else to really add there, Mike.

Michael Weiss (Chairman and CEO)

Sorry about that.

Matt Kaplan (Managing Director and Head of Healthcare Research)

All right. Thanks for taking the question, guys.

Michael Weiss (Chairman and CEO)

Yeah. Thanks, Matt.

Operator (participant)

Our next question comes from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your question.

Mayank Mamtani (Senior Managing Director)

Good morning, team. Congrats on a strong quarter, and thanks for taking our 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: feedback 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.

Adam Waldman (Chief Commercialization Officer)

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, 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've 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% right now. I think it was about 12%. From earlier in 2023, we were about 20%.

12% in the quarter. 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.

Mayank Mamtani (Senior Managing Director)

Thank you. That's helpful. And then in your updated guidance for full year, I was just curious to learn, how are you thinking about that year-end exit market share? Again, 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 how you think about that market share in terms of either total RMS patients or within the anti-CD20 drug class patients. Could you just give us some color on what that $280 million midpoint assumes in terms of market share?

Adam Waldman (Chief Commercialization Officer)

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 BRIUMVI across the market. And we're doing a great job of it. And based on our guidance here, we obviously feel very confident in continued growth going forward.

Mayank Mamtani (Senior Managing Director)

Okay. Yeah, Mayank kind of got Mayank.

Michael Weiss (Chairman and CEO)

Go ahead. Yeah, I'm just going to chime in on the first question you asked about the revenue split, new versus old. I know we're not providing actual numbers, but I think it's worth just to mention that in the early years, we're going to be driven by the new starts, and the later years will be driven by the ongoing or stacking patients. So if you look at probably our competitive IV CD20 that's 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 stacks up.

Mayank Mamtani (Senior Managing Director)

Yeah, and that bodes well for that size of that pancake downstream. I guess last question on the sub-Q target product profile, Mike, just would be helpful to understand how you and even some of the KOL feedback now that we know what the sub-Q profile for OCREVUS would look like at launch, now that all the data is out there. We're just curious, Mike, as you design the human bioequivalent study, what differentiating attributes are in mind as you think about that product profile? And thanks again for taking the question.

Michael Weiss (Chairman and CEO)

Yeah, so I mean, look, the OCREVUS sub-Q 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. I mean, our goal is to have something that is a patient-administered, patient-friendly product, again, more along the lines of what was done with ofatumumab. So I don't know how much more I could say other than we think there's a lot of room to thread the needle here and come up with a product profile that accomplishes the goals of being both convenient and easy to use.

Mayank Mamtani (Senior Managing Director)

Got it. Look forward to some of those updates. Thanks, Mike.

Michael Weiss (Chairman and CEO)

Thank you.

Operator (participant)

Our next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald. Please proceed with your question.

Prakhar Agrawal (Managing Director)

Hi, good morning, and thanks for taking my question, and congrats on the quarter. So just following up on the sub-Q BRIUMVI question, I'm trying to better understand, what's your base case assumption on where the dosing frequency could land for sub-Q BRIUMVI? I guess the reason I'm asking is if it ends up being once a month, would you still go ahead with the sub-Q development? And I had one more.

Michael Weiss (Chairman and CEO)

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 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 have some impact in the market. Obviously, it probably has less impact than something that has a less duration, and we'll do the math on that, not less duration, less frequency. But I'm not so concerned that that's an issue here.

Prakhar Agrawal (Managing Director)

When do you expect patients to be dosed for sub-Q BRIUMVI?

Michael Weiss (Chairman and CEO)

We would hope to have first patients dosed within the first half of this year, so hopefully in the next few months here.

Prakhar Agrawal (Managing Director)

Got it. 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? Obviously, there's a theory that targeting CD19 could achieve broader coverage of the B-cell compartment compared to, let's say, a CD20. Just wanted to get your perspective there. Do you have a CD19 in early-stage pipeline?

Michael Weiss (Chairman and CEO)

So yeah, I mean, we do have a CD19. Our azer-cel 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 expressing CD19 where that may be helpful. 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 hits mature B cells. So in terms of recovery, you may see a difference there.

I think there's a lot of things to balance when you think about CD19 versus CD20. But from an activity standpoint, in most diseases, I don't know that you're going to see a material difference.

Prakhar Agrawal (Managing Director)

Yeah, I guess, Mike, one clarification. I was asking about the CD19 antibody, not the CAR-T. Do you have a CD19 antibody in early stage, even preclinical?

Michael Weiss (Chairman and CEO)

We don't. We don't. No, I don't find that to be a product of interest to us at this time.

Prakhar Agrawal (Managing Director)

Got it. Thank you.

Operator (participant)

Our next question comes from the line of Eric Joseph with J.P. Morgan. Please proceed with your question.

Noah Ahn (Analyst)

Hi, good morning, guys. This is Noah Ahn 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.

Sean Power (CFO)

Adam?

Adam Waldman (Chief Commercialization Officer)

Not sure I understand the question. Could you clarify?

Noah Ahn (Analyst)

Yeah, we're just wondering if there are other opportunities for tiered or exclusive access contracts with other providers going forward.

Adam Waldman (Chief Commercialization Officer)

Gotcha. Understood. Okay. Understood. I don't have any updates at this time on that question.

Noah Ahn (Analyst)

Got it. Thank you.

Operator (participant)

Our next question comes from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your question.

Corinne Jenkins (VP)

Good morning. So maybe a couple of questions from us. One, it strikes me that you guys are probably close to reaching profitability in the next quarter or two given the revenue guidance, first the OpEx guidance. So how are you thinking through profitability versus kind of ramping or expanding your R&D or SG&A spend to support the launch and future development? And then from a technical perspective on the subcutaneous formulation, I guess, what else is left to do before you're able to enter the clinic? Thanks.

Michael Weiss (Chairman and CEO)

Sure. Thinking about profitability, I don't think those questions you asked are mutually exclusive or points, right? We will continue to invest in the BRIUMVI launch. We've noted that we have an increased budget in OpEx to approximately $250 million for the year. There's some room there to even grow. From a product standpoint, similarly, we are interested and continue to build among the BRIUMVI opportunity, the azer-cel opportunity, and we've said that we will continue to look for additional external opportunities. I don't know that we're fixated on the exact profitability numbers. And I know that maybe 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 BRIUMVI efforts and our team and continue with our R&D platform.

As an overall company, I think our cost structure versus most other companies, not all, but most, is pretty modest. We've kept a pretty lean ship. I think the consequence of that is we'll be at profitability probably sooner than most companies would given the circumstances. In terms of 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. I think there's a continuing effort to make continued improvements in what we're working on, which will all just be filtering into the clinical program. I don't think there's any technical hurdles right now to us getting going.

Corinne Jenkins (VP)

Thank you.

Michael Weiss (Chairman and CEO)

Thank you.

Operator (participant)

Thank you. We have reached the end of our question and answer session. With that, I would like to turn the floor back over to Mike Weiss for any closing comments.

Michael Weiss (Chairman and CEO)

Great. Thank you, everybody. One second here. Well, okay. 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. I think the first quarter was quite good in our opinion. We think everything went extremely well. We look forward to continuing to push forward and achieve even 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.

Operator (participant)

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.