Q1 2024 TG Therapeutics Inc Earnings Call

Participants

Jenna Bosco; Senior Vice President, Corporate Communications; TG Therapeutics Inc

Michael Weiss; Chairman, President, and Chief Executive Officer; TG Therapeutics Inc

Adam Waldman; Chief Commercialization Officer; TG Therapeutics Inc

Sean Power; Chief Financial Officer, Treasurer, Corporate Secretary; TG Therapeutics Inc

Michael Difiore; Analyst; Evercore ISI

Edward White; Analyst; H.C. Wainwright & Co., LLC

Roger Song; Analyst; Jefferies

Matthew Kaplan; Analyst; Ladenburg Thalmann & Co. Inc.

Mayank Mamtani; Analyst; B. Riley Securities

Prakhar Agrawal; Analyst; Cantor Fitzgerald

Corinne Jenkins; Analyst; Goldman Sachs

Presentation

Operator

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

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 I talk 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 1990. 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 market. You're cautioned 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. We specifically disclaim any obligation to update or revise any forward looking statements in this conference call is being recorded for audio rebroadcast on TG's website, w. w. w. dot TG. therapeutics.com, where it will be available for the next 30.
With that, I'd like to turn the call over to Mike Weiss, our CEO.

Michael Weiss

Great. Thanks, Joanna, 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 branding 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 free Onvia at a deep discount. We see this as a great way to serve our veterans, introduce Breon v. two additional health care providers, many of who split their time between the VA and their academic appointments and of course, generate incremental revenue.
As for the first quarter, the demand for B&B was extremely strong, and I'm pleased to report that the US bring on the 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-U.S. partner by any measure. It was a robust revenue quarter for TGS, 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 BME has best-in-class profile that should help us get there. Beyond these, the only anti-CD20 monoclonal antibody setting 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 beyond the one hour infusion was generally well tolerated, with 95% of the one-off fusions being delivered on time beyond the clinical data for AMD is also differentiated by design haven't been glyco engineered for enhanced immune effector cell engagement and efficiency cell depletion. As previously presented, preclinical data demonstrates that compared to the other anti-CD20 is approved for use to treat MS. Cme has the highest binding affinity CD20. The target shown on the B-cells and through its clinical engineering 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 than they have to bring on these 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, U.S. Patent and Trademark Office extending patent protection for ground rate through 2042 with the extended runway. And our development team is focused on potential expansion opportunities for BMD, both within MS as well as in other autoimmune diseases. To that end, we are focused on BMD3 related initiatives this year, which we believe could drive significant future value. First is further improving the convenience dosing of IV therapy in March at the actions conference, we presented updated data from the ENHANCE trial, evaluating the safety and efficacy of eliminating the four hour free on the 150 milligram starting dose for patients who switch from a prior anti-CD20 data presented suggests that beyond the was well-tolerated for patients that skipped the starting dose and went straight to the first full 450 milligram dose, giving us 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 OEMV. We believe the subcu CD20 market is distinct from the IV market and believe this could represent a significant additional opportunity for Breyanzi. We are preparing to enter human bioequivalence studies in 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 beyond the in other autoimmune indications. The goal is to launch our first autoimmune trial evaluating bring on the outside of multiple sclerosis later this year. We believe the expansion of Graham Reeve represents a significant opportunity and we look forward to providing updates throughout the year, but we are 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 worldwide license to Precision's either cell and allogeneic CD19 CAR T-cell therapy for autoimmune diseases and all other non-oncology indications. We believe Asiacell 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 Murex form the launch of Ryoncil in Europe, which also occurred in the first quarter with the first commercial sale in Germany. Transitioning transition the program to enable their timely launch significant effort from our team, and I'm proud of how everyone worked so closely together to make it happen sooner. Ex-foreign teams experienced motivated and focused, and we'll 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 TGS take to ensure the best possible experience for M&A for patients with MS.
Well, we spent a lot of time on these calls, talking about numbers, the most gratifying part of my day hearing firsthand from patients taken beyond the of the positive experiences as well as HCP's anecdotes about their patient's treatment successes with Breyanzi.
With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, for a detailed update on the bromine U.S. commercialization commercial launch. Adam, go ahead.

Adam Waldman

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 real value 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 BMD in the market. As reported in our press release, first quarter net sales in the US for ground beef were $50.5 million, representing 25% growth quarter over quarter. The first quarter number exceeded our original guidance of $41 million to $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 grounding. This growth is particularly impressive given the first quarter challenges associated with beginning of the year payer dynamics. In fact, we were the only CD. 20 and I'm asked to see revenue growth quarter over quarter in the US market during this timeframe. Equally impressive is that we also saw enrollments grow by approximately 25% with over 1,250 new patient scripts received by the TV 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 health care 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 brown V with health care providers, recognizing the value BMD brings. So patients concurrently, ensuring patient access to Breon B remains a top priority for us. We continue to receive exceptional feedback on the comprehensive patient support program 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 successfully penetrated new accounts and prescribers driving sustained growth. We saw both increasing number of repeat prescribers and impressive gains in new 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 brown B across the US with new prescriptions coming from over 450 centers and over 800 unique prescribers.
Encouragingly, encouragingly, we also continue to see a diverse mix of patient types, including those that are naïve to all treatments and those that were previously treated and switched from both non-CD 20 and CD. 20 agents This makes the patient types continue to be fairly consistent quarter to quarter with the largest group group, consisting of patients that were previously treated by naive to anti-CD20 therapy 2024 is off to a really strong start. We achieved record brand. The new patient enrollments into our hub in the first quarter and far exceeded our first quarter revenue guidance and continued 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 beyond being net revenue of approximately $65 million for the second quarter.
In terms of the substance of the full year, we continue to feel confident about the Brand B trajectory. Based on current trends, we believe we are tracking tracking above the top end of our original guidance of $220 million to $260 million and are therefore raising our full year guidance to $270 million 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 Rambus' 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 health care providers. And we believe their outstanding efforts are contributing to the positive experience with PMB and confidence in our organization.
I also want to thank the health care 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 beyond PMB to those people living with MS and their families.
With that I'll turn the call over to Sean Power, our CFO. Tom?

Sean Power

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 US BMD net product revenue also included in our Q1 '24 revenue. Total is approximately $13 million of license milestone royalty and other revenue, which consist primarily of the $12.5 million milestone we received from our ex-US partner for the first commercial launch of Breyanzi in the EU, our OpEx during the first quarter of '24, despite some one-time charges has remained well-controlled and in line with previously discussed ranges. For the first quarter of '24, 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-license either cell program. During the first quarter of '24, we also saw a modest increase in R&D expenses driven by manufacturing and development costs associated with our move to tuck Samad subcutaneous development arm on the back of the reported revenues and well-controlled OpEx. During the first quarter of '24, 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 for $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 2013. 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 begin the Q&A. Thank you.

Question and Answer Session

Operator

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 Sarkis. One moment, please while we poll for questions.
Thank you. Our first question comes from the line of Michael G. Fiori with Evercore. Please proceed with your question.

Michael Difiore

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

Michael Weiss

Yes. So in terms of numerics firm, providing public details, I think we're a long way off their 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

No, no, nothing to add there.

Michael Difiore

Okay. Okay. Fair enough. And so the two questions are how much of BMV's fiscal year '24 guidance raise was due to the recently announced VA contract and any color that you can provide on pricing or increased rebating in the segment? I know you said it's heavily discounted.

Michael Weiss

Yes, and one go ahead.

Adam Waldman

Sure. Yes, the revenue raise was really the VA was not really factored in for a couple of reasons. One, some, you know, 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 the 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 at about a 72% discount, roughly about 29 hundred a vial.

Michael Difiore

Okay, great. And my last question is, is this on the most recent cut of the enhanced data presented actions, three patients in Cohort two had to have their infusion slowed down or interrupted. Any color on these patients? Like how long would these infusions flow down to or interrupted for? And were there any unique clinical features of these patients that could explain this.

Michael Weiss

And so no, I don't think there was anything particular about the patients, but the the infusions slowed, we're pretty modest. And I think all were done reasonably close to the one hour anyway. So no, I think it was just yes, the basic stuff, there's no typical one for other infusions, but I don't think there's anything to be worried about there is there was well tolerated overall and those patients to that, it did well.

Michael Difiore

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.

Edward White

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?

Adam Waldman

Yes.

Edward White

Okay. Thank you. And I know this has been brought up before, but I just wanted to address it again. I'm thinking about the potential opportunity, you know, the so-called crap get with Oprah this? And is this something that you think you'll be able to produce data on or somehow address this and with your sales force?

Michael Weiss

Yes. So in terms of Krabbe gap and be able to show and we'll we're trying to capture as much data as we can through through the ENHANCE study, I think the number is about 52, 60 ish percent, maybe a third two-thirds report crack at as they're coming into the ENHANCE trial. So we're trying to capture some of that information on the back end, which we'll have at least some anecdotal information about patient reported, whether they're on are not seeing a crack at it hard. And there's no, there's no scale to objectively measure crop got there's no point. So it is a challenging thing to measure, but we'll do the best we can within the ENHANCE study and whenever our studies were conducted, we are certainly trying to parse out the effect and whether we've changed that for patients.

Edward White

Okay. Thanks, Mike. And just on when thinking about other potential indications? And how do you prioritize outside of MSOE.? I'm sure you have plenty of factors in there, but where does time to potential approval come in for the size of the potential market? How are you sort of ranking that?

Michael Weiss

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

Edward White

Okay, Mike, thanks for taking my questions.

Michael Weiss

Thanks, Ed.

Operator

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

Roger Song

Great. And my congrats to you on the 1Q results. And then so just a couple of questions from us. One is the understanding your hub is capturing most of the new patients in the given you have quite a few quarters since launch. So how would you characterize the repeat infusion rate? You have been slow?

Michael Weiss

Yes. And we want to go have a loan.

Adam Waldman

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

Roger Song

Yes. Excellent. Thank. You're 85%.
That's good. And then so on, you are having now a 100 health provider around around 450 centers. So understanding where you'd start to know where you tend to launch, you are targeting top 50 accounts are covering 70% to 80% of MS patients. I was just curious if that's still the goal for the provider or the center outreach. And then if that's the case through the case? And when do you expect you will achieve that in the 50 found that 450?

Adam Waldman

Yes. Yes. So I think I think if I understand the question is 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.
On the good news in the quarters, 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 are right now.

Roger Song

Great. Thank you. And one last question related to the financials. So I think earlier this year, you're guiding the OpEx is to 50 for the year.
Just wanted to confirm. Is that still the guidance for now? And then also curious about. Yes, the exit for the coming years, given your continued to launch and expanding your pipeline? Thank you.

Michael Weiss

Yes, I'll take a first crack and John jump in. But yes, I mean, I think we're well on track to add approximately 250 in OpEx. 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 eight and change, which was that one-time two to precision. So the base OpEx was still only around 15 for the quarter. So you multiply that times four, you're still well under the two 50. 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.
Shawn, any more details there?

Sean Power

Yes, I think you I think you covered it pretty widely,

Roger Song

But I think you touched upon that, Roger next.

Operator

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

Matthew Kaplan

Hey, good morning, guys. And congrats on the quarter and so it may be 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 and the background here again, it's in the patient's home.

Adam Waldman

Yes, I think, Matt, good morning. So I would say, you know, 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 CD 20s, but we also have good representation from treatment treatment naive patients as well as patients that are switching from from CD 20s like broker Research Center. So we're getting a encouragingly, we think we're getting a nice diverse group of patients and importantly, staying consistent quarter to quarter. There's no there's 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.

Matthew Kaplan

Okay. That's helpful. Thanks.
And then I guess in terms of the subcutaneous opportunity for, let's talk briefly on the formulation I guess recently on the Roche call, they said they see the subcutaneous opportunity is as more than $2 billion. I guess my question is with your potential differentiation, differentiated profile what's your assessment of that, the subcu opportunity?

Michael Weiss

Yes. I'll speak broadly, and I'll let Adam chime in. I mean, look, we the folks at at Novartis have done a really nice job of carving out a subcu market. They created it on. And I think as you Carl mentioned, and the worst is probably over $2 billion growing today. So there's a nice market there. I mean, our goal is to come into that market with a very competitive profile product. As we've said previously, we we understand the parameters are data from the one hand, a relatively elegant auto-injector once and once a month and you've got a relatively bulky on product every six months, somewhere in the middle we think is an optimal product design and we're going to trying 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 Waldman

And nothing else to really add there like.

Michael Weiss

Sorry, sorry about that. Thanks.

Matthew Kaplan

Thanks for taking the question, guys.

Michael Weiss

Okay.

Operator

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

Mayank Mamtani

Good morning and congrats on a strong quarter and thanks for taking our questions. Sorry, I don't know if I missed this, but did you say the revenue split of between new patient starts and maintain inflations. And I was also curious to hear from you how you think that stocking up effect in second half and how we should expect that revenue split could be. And if you can also comment on some other metrics you provided before a free drug percentage gross to net and 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

Yes, we did. 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 they know this is this is a market where duration is a big driver of revenue and there will be a pancake effect that that will as time goes on patients will this is a very sticky. The duration is really good patients on drug, an average of five years. So you will see that pancake effect over time. And so that's 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. I think in the first quarter were about 12% is our right now, I think it was about 12% from earlier in 2023 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 as approximately 75% will go up and down from quarter to quarter, but 75% is probably a good number to use for the for the remainder of 2024.

Mayank Mamtani

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

Adam Waldman

We have Mike up and 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 BMD 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.

Mayank Mamtani

Okay.

Michael Weiss

Yes. My kind of final guidance on the I'm just going to chime in on the on the first question asked about the revenue split new versus old. I 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 new starts in the later years will be driven by we see the ongoing or stacking patients. And so if you look at probably our competitive IV CD20 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 revenues.

Mayank Mamtani

Yes, yes. And that bodes well for that size and that FabricCache and downstream.
Yes. I guess last question last question on the subcu that target product profile. Mike, just would be helpful to understand how you and even from the KOL feedback and now that we know what the subcu profile for previous would look like at launch now that all the data is out there.
I was 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 question.

Michael Weiss

Yes. So you look at the and the curve is sub two is not a true patient is administered at home product today. So that is yet to be created or not created, but to be available or are 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 market share. And then we think there isn't a lot of room to and two to thread the needle here and come up with a product profile that accomplishes the goals of being both to me and and easy to use.

Mayank Mamtani

Got it. And I look forward to some of those updates. Thanks Mike.

Michael Weiss

Thank you.

Operator

Our next question comes from the line of Prakhar auto drywall with Cantor Fitzgerald. Please proceed. Question.

Prakhar Agrawal

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

Michael Weiss

Yes. I mean, I think the bottom line is we probably will, but I don't think that's going to be necessary. So I don't know if that's a scenario that and that is, yes, 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, we'll go forward and certainly once a month could be it 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 in that less stable and less frequency, but I'm not so concerned about finishing here.

Prakhar Agrawal

And when do you expect patients to be dosed for subcu privilege?

Michael Weiss

And we would hope to have the first patient dose within the first half of this year, so hopefully in the next few months here.

Prakhar Agrawal

But And lastly, from my side, are we seeing a lot of data on CD19 antibodies and other autoimmune indications. What's your view on CD. 19 versus the 2010? Obviously, there's a theory that targeting CD19 could achieve broader coverage of the BCO count department compared to, let's say, a CD20. So just wanted to get your perspective there and do you have a CD19 and early stage pipeline Yes.

Michael Weiss

I mean, we do have a CD19 which are either cell CAR T therapy is a CD19. So we think CD19 is a great target. We think it's hard to know if the on the broader coverages are positive in all settings, there are some diseases that are characterized by plasma cells that may be impacted by CD. 19 or maybe expressing CD19 where that may be helpful. Animal is one that 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 you don't need the CD19 when they hit its pre B-cells in addition to B cells of CD20 or it's 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 CV 19 versus 20. But from an activity standpoint in most diseases, I don't believe you're going to see a material difference.

Prakhar Agrawal

Yes, I just Mike one clarification. I was asking about the CD19 antibody, not the CAR-T, but do you have a CD19 antibody in R&D stage in preclinical?

Michael Weiss

We don't we don't I don't I don't find that to be a product of interest to us at this time.

Prakhar Agrawal

Thank you.

Operator

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

Hi, good morning, guys.
This is Nick on for Eric. Thanks for taking our question on. We were just wondering if there were other exclusive procurement opportunities similar to that contract at you just secured with the VA?

Michael Weiss

Yes, Adam?

Adam Waldman

I'm not sure I understand the question. Could you clarify?

Yes, we're just wondering if there are and other opportunities for tiered or exclusive access contracts with the other provider of billing for reduction solution focus that are sit there.

Adam Waldman

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

Got it. Thank you.

Operator

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

Corinne Jenkins

Good morning and 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 and the revenue guidance first, the OpEx spend and how are you thinking through profitability versus kind of like it's 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 is what else is left to do before you're able to enter the clinic?
you're also thinking about profitability?

Michael Weiss

And then from a technical perspective on the subcutaneous formulation is what else is left to do before you're able to enter the clinic, you're also thinking about profitability? you're also thinking about profitability?
The. Yes, I don't think those questions are asked are mutually exclusive or points, right so we have we will continue to invest in the brownfield launch. And we've noted that we've had an increased budget and OpEx to approximately to 50 for the year. So there's some room there to even grow from a product standpoint.
Similarly, are we are interested in continuing to build among the brand, the opportunity, the Asia opportunity. And we've said that we tend 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 that's mutually exclusive. And I do think we plan to continue to and grow our brand. The efforts in our team and I continue with R&D platform, but field as an overall company. Our I think our cost structure versus most other companies, not all but most is pretty modest and we've kept on and we've kept a pretty new chip. So I think the consequence of that is we'll be at profitability probably sooner than most companies would given the circumstances.
And 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 and 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 will all just be filtering into the program. But I don't think there's any technical hurdles right not just getting going.

Corinne Jenkins

Yes.

Operator

Thank you and 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 him. Mike, wait for any closing comments.

Michael Weiss

Great. Thank you, everybody. We cycle here. Yes.
Well, okay. So I just wanted to thank everyone for joining us today and 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 as we were the first quarter was was quite good. In our opinion. We think everything went 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. And again, we thank everyone for their support. And most importantly, we want to thank the clinicians and patients who definitely put their trust in TG. The whole team does appreciated.
With that, I'd like to thank everyone for joining us and have a great day.

Operator

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