TG Therapeutics Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 1, 2024

Key Takeaways

  • Record Q1 Revenue: U.S. net sales of Briomby exceeded $50.5 million and total revenues topped $63.5 million, exceeding guidance and demonstrating strong demand.
  • VA Contract Award: Briomby was named the preferred anti-CD20 therapy for the VA system at a deep discount, enhancing access for veterans and broadening provider reach.
  • Raised 2024 Outlook: TG lifted its full-year Briomby revenue guidance to $270–290 million, up from $220–260 million, based on robust Q1 momentum.
  • Ongoing Development Initiatives: Initiatives include one-hour 450 mg infusions without a loading dose, subcutaneous Briomby bioequivalence studies, planned autoimmune trials and a new CD19 CAR-T therapy acquisition.
  • Strong Financial Position: Q1 operating expenses were $58 million (including an $8.8 million one-time charge), net loss narrowed to $10.7 million, and cash reserves stood at $209.8 million.
AI Generated. May Contain Errors.
Earnings Conference Call
TG Therapeutics Q1 2024
00:00 / 00:00

There are 12 speakers on the call.

Operator

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. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco.

Operator

Thank you, Jenna. You may begin.

Speaker 1

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the Q1 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 and 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.

Speaker 1

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.

Speaker 1

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.

Speaker 2

Great. Thanks, Jana, 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. Companywide, it feels like we are firing on all cylinders. A prime example was the recent announcement of the award of the VA contract for BrionV as the preferred anti CD20 for the VA system.

Speaker 2

We cannot be more excited to be able to support our veterans with multiple sclerosis by offering Breomby at a deep discount. We see this as a great way to serve our veterans, introduce Breomby 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 Q1, the demand for Briombee was extremely strong, and I'm pleased to report that the U. S. Briombee revenue is in excess of $50,000,000 and total revenues for the quarter were over $63,000,000 which includes milestone payments received from our ex U.

Speaker 2

S. 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 Q1 results.

Speaker 2

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 Briommi has best in class profile that should help us get there. Briomview is the only anti CD20 monoclonal antibody that can be given as a 1 hour infusion every 6 months following the starting dose and is the only anti CD20 monoclonal antibody in Phase III trials to achieve an annualized relapse rate of less than 0.10. Also in Phase 3 trials, the BIOMBIA 1 hour infusion was generally well tolerated with 95% of the 1 hour infusions being delivered on time. Beyond the clinical data, Breomvie is also differentiated by design, having been glyco engineered for enhanced immune effector cell engagement and efficient B cell depletion.

Speaker 2

As previously presented, Ryomvii 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 Brionmi'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 3 newly issued patents of the U. S. Patent and Trademark Office, extending patent protection for BRIONVY through 2,040 2.

Speaker 2

With the extended runway, our development team is focused on potential expansion opportunities for Briomvi both within MS as well as in other autoimmune diseases. To that end, we are focused on 3 Rejumdhi related initiatives this year, which we believe could drive significant future value. First is further improving the convenient dosing of IV viremti. In March at the ACTRIMS conference, we presented updated data from the ENHANCE trial evaluating the safety and efficacy of eliminating the 4 hour Breonvie 150 milligram starting dose for patients who switch from a prior anti CD20. Data presented suggests that Breomdi was well tolerated for patients that skipped the starting dose and went straight to the first full 4 50 milligram dose given as a 1 hour infusion.

Speaker 2

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. 2nd is the development of subcutaneous Breomvie. We believe the subcu CD20 market is distinct from the IV market and believe this could represent a significant additional opportunity for Brionvain. 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 BRYONY in other autoimmune indications.

Speaker 2

The goal is to launch our first autoimmune trial, evaluating Breomby outside of multiple sclerosis later this year. We believe the expansion of Breomby 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 Azercel has the potential to be a 1st in class, best in class treatment for certain autoimmune diseases and look forward to commencing a clinical trial this year.

Speaker 2

I also want to congratulate our partners at NurexPharm on their launch of BREOMBI in Europe, which also occurred in the Q1 with the 1st 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 Pharma 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 TGEers take to ensure the best possible experience for patients with MS.

Speaker 2

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 Breomdi of their positive experiences as well as HCP's anecdotes about their patients' treatment successes with BRONOMY. With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to provide a detailed update on the BRUMENT U. S. Commercial launch. Adam, go ahead.

Speaker 3

Thank you, Mike, and good morning, everybody. I'm excited to provide insights into our continued commercial progress in the Q1. This was another very strong quarter of performance, exceeding our revenue guidance and all of our key performance metrics. Our focus on delivering Breomby to patients remains unwavering, and I'm pleased to share our progress with you today. In the Q1 of 2024, we continue to see strong

Speaker 2

uptake of BRYOMBI in the market.

Speaker 3

As reported in our press release, 1st quarter net sales in the U. S. For BRYOMBI were $50,500,000 representing 25% growth quarter over quarter. The first quarter number exceeded our original guidance of $41,000,000 to $46,000,000 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 Breonidine.

Speaker 3

This growth is particularly impressive given the Q1 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 timeframe. Equally impressive is that we also saw enrollments grow by approximately 25% with over 12 50 new patient scripts received by the TG Hub in the quarter.

Speaker 3

I want to congratulate our team on doing an exceptional job preparing for the inherent insurance related challenges seen in the Q1 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 BRYAN B with healthcare providers recognizing the value BRYAN B brings to their patients. Concurrently, ensuring patient access to Breomby 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.

Speaker 3

We also continue to make significant strides in expanding our market presence. Through targeted marketing initiatives and effective sales force deployment, we successfully penetrated new accounts and prescribers driving sustained growth. We saw both increasing number of repeat prescribers gains in new prescribers with approximately 160 new prescribers in the Q1, the majority of which were from academic centers. We also continued to convert new centers, adding 65 new accounts in the quarter. To date, we have seen broad adoption of Briomby across the U.

Speaker 3

S. With new prescriptions coming from over 4 50 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 switch 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.

Speaker 3

We achieved record BRAM B new patient enrollments into our HUB in the Q1 and far exceeded our Q1 revenue guidance and continued to show strong quarter to quarter growth despite the Q1 insurance headwinds. We continue to see momentum building into the 2nd quarter. And based on the information we have available at this time, we are targeting Briombee net revenue of approximately $65,000,000

Speaker 2

for the

Speaker 3

Q2. In terms of the full year, we continue to feel confident about the Brown Beach trajectory. Based on current trends, we believe we are tracking above the top end of our original guidance of $220,000,000 to $260,000,000 and are therefore raising our full year guidance to $270,000,000 to $290,000,000 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 Briohn B's profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market.

Speaker 3

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 Breomdi and confidence in our organization. Also want to thank the healthcare providers and their patients for their trust in TD 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 Briombe to those people living with MS and their families. With that, I'll turn the call over to Sean Power, our CFO.

Speaker 3

Sean?

Speaker 4

Thank you, Adam, and thanks everyone for joining us. Earlier this morning, we reported our detailed Q1 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 $63,500,000 during the Q1 of 2024, which as previously mentioned includes $50,500,000 of U. S.

Speaker 4

BriomVe net product revenue. Also included in our Q1 'twenty four revenue total is approximately $13,000,000 of license, milestone, royalty and other revenue, which consists primarily of the $12,500,000 milestone we received from our ex U. S. Partner for the first commercial launch of Breomby in the EU. Our OpEx during the Q1 of 'twenty four, despite some one time charges, has remained well controlled and in line with previously discussed ranges.

Speaker 4

For the Q1 of 'twenty four, our operating expenses were approximately $58,000,000 which includes one time charges to research and development expenses of approximately $8,800,000 related to our agreement with Precision Biosciences for the in licensed AzerCell program. During the Q1 of 'twenty four, we also saw a modest increase in R and 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 Q1 of 'twenty four, we reported a modest net loss of approximately $10,700,000 or $0.07 per share compared to a net loss of approximately $39,200,000 or $0.28 per share during the comparable quarter in 2023. From a cash standpoint, we ended the Q1 with $209,800,000 in cash, cash equivalents and investment securities, down less than $10,000,000 from Q4 of 'twenty three. 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.

Speaker 4

With that, I will now turn the call over to the conference operator to begin the Q and A.

Operator

Thank you. We will now be conducting a question and answer session. Thank you. Our first question comes from the line of Michael DiFiori with Evercore. Please proceed with your question.

Speaker 5

Hi, good morning guys. Thanks so much for taking my question and congrats on all the great projects this quarter. A couple for me. Regarding sales in the EU, I know it's very early, but when could we expect Nurex Pharm to begin offering details? And I have two follow ups.

Speaker 5

Thank you.

Speaker 2

Yes. So in terms of Neurex Farm 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?

Speaker 3

No, no, nothing to add

Speaker 5

there. Okay. Okay, fair enough. And my other two questions are, how much of Bramby's fiscal year 'twenty four 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?

Speaker 5

I know you said it's heavily discounted.

Speaker 2

Yes. Adam, you can go ahead.

Speaker 3

Sure. Yes, the revenue raise was really the VA was not really factored in for a couple of reasons. 1, this won't go into effect until June. 2nd, 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 two infusions at best.

Speaker 3

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. As far as pricing, I think that's out there and public. We offered about a 72% discount, roughly about $2,900 a vial.

Speaker 5

Okay. Great. And my last question is this. In the most recent cut of the ENHANZE data presented at XTRIMS, 3 patients in Cohort 2 had to have their infusion slowed down or interrupted. Any color on these patients?

Speaker 5

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?

Speaker 2

So, no, I don't think there was anything particular about the patients, but the infusion slows 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. Was well tolerated overall and those patients too did well.

Speaker 5

Got it. Thanks so much. Congrats again.

Operator

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

Speaker 6

Good morning. Congratulations on the results and thanks for taking my questions. So just to clarify what you just said on the VA contract, Adam, was it a 72% discount?

Speaker 7

Yes.

Speaker 6

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 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?

Speaker 2

Yes. So in terms of Crab GAAP and being able to show, I mean, we trying to capture as much data as we can through the ENHANCE study. I think the number is about 60% to 60 ish percent, maybe a third, 2 thirds, report Kratzcat as they're coming into the ENHANZE 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 crop gap.

Speaker 2

It's hard. There's no scale to objectively measure crop gap. There's no so it is a challenging thing to measure, but we'll do the best we can within the ENHANCE study and whatever studies that we conduct, we will certainly try to parse out the effect and whether we've changed that for patients.

Speaker 6

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?

Speaker 2

Yes. I mean, I think, look, we're probably focused on things like RA and lupus for Briamvie outside of MS, sort of larger indications. And as we've said previously, in some more niche indications we would be looking at Azercel.

Speaker 6

Okay, Mike. Thanks for taking my questions.

Speaker 2

Thanks, Ed.

Operator

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

Speaker 8

Great. And my congrats to the 1Q results. And then so just a couple questions on 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

Speaker 2

been seeing? Yes. Adam, you want to go ahead on that one?

Speaker 3

Yes. 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.

Speaker 3

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.

Speaker 8

Excellent. Thank you. 85% is good. And then so you are having now 800 health provider at around 4 50 centers. So understanding where you start to where you plan to launch, you are targeting top 550 accounts covering 70% to 80% of the MS patients.

Speaker 8

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 $550,000,000 from $450,000,000

Speaker 3

Yes. 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.

Speaker 3

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.

Speaker 8

Great. Thank you. One last question relates to the financials. So I think earlier this year, you're guiding the OpEx is $250,000,000 for the year. Just want to confirm if that's still the guidance for now?

Speaker 8

And then also curious about the expectation for the coming years given your continued to launch and expanding your pipeline? Thank you.

Speaker 2

Yes. I'll take a first crack and Sean jump in. But yes, I mean, I think we're well on track to I mean, we said approximately $250,000,000 in OpEx, so it gives us a little wiggle room there. But if you look at even the Q1, we had 58 and change and we had 8 and change, which was the one time to Precision. So the base OpEx was still only around 50 for the quarter.

Speaker 2

So you multiply that times 4, 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?

Speaker 4

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

Speaker 8

Great. Thank you. That's it for me.

Speaker 2

Roger.

Operator

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

Speaker 2

Hey, good morning, guys. Good morning. 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?

Speaker 3

Yes. 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 OCREVUS or KASIMTA.

Speaker 3

So we're getting encouragingly, we think we're getting a nice diverse group of patients and importantly, staying consistent quarter to quarter. There's no 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.

Speaker 2

Okay. That's helpful. Thanks. And then I guess in terms of the subcutaneous opportunity for the Breyomby formulation, I guess recently on the Roche call, they said they see the subcutaneous opportunity as more than $2,000,000,000 I guess, question is with your potential differentiation differentiated profile, what's your assessment of the subcu opportunity? Yes, I'll speak broadly and I'll let Adam chime in.

Speaker 2

I mean, look, the folks at Novartis have done a really nice job of carving out a subcu market. They created it. And I think as Rajesh probably mentioned, Novartis is probably over $2,000,000,000 and growing today. So there's a nice market there. And yes, I mean, our goal is to come into that market with a very competitive profile product.

Speaker 2

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 6 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?

Speaker 3

Nothing else to really add there, Mike.

Speaker 2

Sorry about that. All right. Thanks. Thanks for taking the question, guys. Thanks, Matt.

Operator

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

Speaker 7

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 of 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?

Speaker 7

And if you can also comment on some other metrics you provided before, free 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.

Speaker 3

Yes. 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 in average 5 years.

Speaker 3

So you will see that pancaking effect over time. So that's the best that I have for that question. I think your other questions was free drug. As I said before, we did expect free drug rates to come down. We are seeing free drug rates come down.

Speaker 3

I think in the Q1, we're about 12% is right now, I think it is about 12% from earlier in 2023, we're 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.

Speaker 7

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, 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 how you think about that market share in terms of either total RMS patients or within the anti CD20 drug class patient, like could you just give us some color on how what that 280,000,000 midpoint assumes in terms of market share?

Speaker 3

Yes, Mayank. 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.

Speaker 3

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

Speaker 2

Okay. Yes. Mike, I'm trying to go ahead.

Speaker 7

Go ahead.

Speaker 2

I'm just going to chime in on the first question you 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, we're going to be driven by the new starts, in the later years will be driven by the ongoing or stacking patients. So if you look at probably our competitive IV CD21 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. We're still reliant on our new starts, but over time, the continuing patients sort of take the commanding role in how the revenue step up.

Speaker 7

Yes. And that bodes well for that size of that pancake downstream. I guess last question on the subcu 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 subcu 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 bioequivalence study, what differentiating attributes are in mind as you think about that product profile? And thanks again for taking the questions.

Speaker 2

Yes. So I mean, look, the OCREVUS sub Q is not a true patient administered at home product today. 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.

Speaker 2

So I don't know how much market sales and then 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.

Speaker 7

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

Speaker 2

Thank you.

Operator

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

Speaker 9

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

Speaker 2

Yes. 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 if that's a scenario that is likely. But yes, 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, will go forward and certainly once a month could be could have some impact in the market.

Speaker 2

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.

Speaker 9

And when do you expect patients to be dosed for subcuantibular?

Speaker 2

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

Speaker 9

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?

Speaker 2

Yes, I mean, we do have a CD19, it's our azurecell 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 maybe expressing CD19 or that may be helpful. NMO is one that folks talk about quite frequently as more potentially CD19 driven.

Speaker 2

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 they hit it's 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. So 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.

Speaker 9

Yes. Just one clarification. I was asking about the CD19 antibody, not the like do you have a CD19 antibody in early stage even preclinical?

Speaker 2

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

Speaker 9

Got it. Thank you.

Operator

Our next question comes from the line of Eric Joseph with JPMorgan. Please proceed with your question.

Speaker 10

Hi, good morning guys. This is Noah on 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?

Speaker 2

Adam?

Speaker 3

Not sure I understand the question. Could you clarify?

Speaker 10

Yes. We're just wondering if there are other opportunities for tiered or exclusive access contracts with other providers going forward. Okay.

Speaker 3

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

Speaker 2

Got it. Thank you.

Operator

And our next question comes from the line of Corrine Jenkins with Goldman Sachs. Please proceed with your question.

Speaker 11

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 2, given the revenue guidance versus the OpEx guidance. How are you thinking through profitability versus kind of like ramping or expanding your R and D or SG and A spend to support the watch in future development? And then from a technical perspective on the subcutaneous So thinking about

Speaker 2

profitability, So thinking about profitability, I don't think those questions you asked are We've noted that we have an increased budget in OpEx to approximately $250,000,000 for the year. So there's some room there to even grow. From a product standpoint, similarly, we are interested and continue to build among the BRAVIMI opportunity, the AZERCELL opportunity, and we've said that we will continue to look for additional external opportunities. So I don't know that we're fixated on the exact profitability numbers. I know that may as EPS becomes something of interest, But I don't think the future is exclusive and I do think we plan to continue to grow our Brionve efforts and our team and can see with our R and D platform.

Speaker 2

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 it pretty lean shift. So I think the consequence of that is we'll be at profitability probably sooner than most companies would given the circumstances. In terms of the subcu 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 2 months or so. And 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.

Speaker 2

But I don't think there's any technical hurdles right now just getting going.

Speaker 9

Thank you.

Speaker 2

Thank you.

Operator

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.

Speaker 2

Great. Thank you, everybody. 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.

Speaker 2

We were the Q1 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.

Speaker 2

The whole team does appreciate it. With that, I'd like to thank everyone for joining us and have a great day.

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