Q4 2023 TG Therapeutics Inc Earnings Call
Participants
Jenna Bosco; SVP, Corporate Communications; TG Therapeutics, Inc.
Michael Weiss; President & CEO; TG Therapeutics, Inc.
Adam Waldman; Chief Commercialization Officer; TG Therapeutics, Inc.
Sean Power; Chief Financial Officer, Treasurer, Corporate Secretary; TG Therapeutics Inc
Ed White; Analyst; H.C. Wainwright
Kambiz Yazdi; Analyst; Jefferies
Matt Kaplan; Analyst; Ladenburg Thalmann & Co.
Prakhar Agrawal; Analyst; Cantor Fitzgerald
William Wood; Analyst; B. Riley Securities
Presentation
Operator
Greetings and welcome to the TG Therapeutics Fourth Quarter and Year End 2023 financial results and business update call. At this time, all participants are in a listen only mode A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco. Thank you. Please go ahead.
Jenna Bosco
Thank you, and welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco. And with me today to discuss the fourth quarter and year end 2023 financial results are Michael Weiss, our Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercialization Officer; and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate developments. Adam will share an update on our commercialization efforts, and Sean will give an overview of our financial results before turning the call over to the operator to begin the Q&A session.
Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory milestones, revenue guidance, development plans, and expectations for our marketed products. You are cautioned that these forward-looking statements are subject to risks that may cause our actual results to differ or 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.
Now I'd like I'd like to turn the call over to Mike Weiss, our CFO.
Michael Weiss
Thanks, Janet, and good morning, everyone. Thanks for joining us on today's call. 2023 was a transformational year for TJ. We kicked off the year with the launch of VMP for relapsing forms of multiple sclerosis towards the end of January and saw a nice sales momentum carried throughout the year, resulting in approximately $90 million on the net revenue for our first partial year of sales, we believe this 1st year, revenues speak to the high level of early interest and strong underlying demand for B&B. And we look forward to continued carry through 2024, where we are targeting $220 million to 260 million in U.S. sales revenue.
Feedback from physicians, patients, nurses and infusion centers continues to be very positive and drives our confidence in both the short term revenue ramps ramp as well as the long term blockbuster potential beyond our team remains focused on our ultimate goal of becoming the number one prescribed CD. 20 by dynamic market share perspective. And the early uptake supports our belief that that is possible from said that this is a competitive market and reality is the newest entry so differentiation matters. One obvious difference is that round is the only anti-CD20 monoclonal antibody that can be given as a one hour infusion every six months after the starting dose, which may be an attractive profile for both patients want to get back to their daily lives.
Every health care practices C-suite seeking to increase the efficiency with them within their Fusion suites beyond the one hour infusion. We are excited to continue to explore biological base differences that may not be as readily apparent, but are perhaps clinically relevant. As a reminder, for CMV is differentiated by design, having been glyco engineered for enhanced immune effector cell engagement and efficient B-cell depletion. Preclinical data demonstrates that compared to the other anti CD 20s approved for use to treat MS. Three only has the highest binding affinity to CD20 the target for these types of drugs and formed on B-cells as it relates to engineering as the ability to induce the highest level of antibody dependent cellular cytotoxicity regardless of patient specific polymorphisms.
Whether or not these biological attributes of Rayaldee have clinical relevance in patients with MS has not yet been determined, as you know, head to head trials have been conducted for VNB versus the other anti CD 20s. However, what has been well established is that for MB is the only anti-CD20 monoclonal antibody to achieve an annualized relapse rate of less than 0.1 in Phase three trials. Also in clinical trials, BMD rapidly depleted the cells with a median of 96% reduction within 24 hours and 95% on-time infusion completion rate, which we believe speaks to the tolerability profile of BMD.
As we move forward, we are eager to explore to what degree the design attributes of Breyanzi may be contributing to the robust activity seen. We plan to do more work to evaluate some of these unique attributes and to understand whether the molecular and non-clinical differentiation translates into clinical differences, and we look forward to sharing more on that when available.
I also wanted to highlight another recent exciting developments we were pleased to share yesterday then in addition to our current preamble and US Biologics exclusivity, the US Patent and Trademark Office recently issued three additional patents were beyond the including a composition of matter patent related to the glyco engineered attributes of Rayaldee. With these additional patents, our patent protection now extends through 2042, providing us a nice long runway to continue to explore the full potential of rounding, including extending the potential reach of rounding in MS as well as into other autoimmune diseases, which is a good segue to discuss what is next for Brown, the NTG. first, let me say that the US ground the launch and commercialization is and will remain our highest priority. That said, our drug development team is poised and ready to potentially drive additional value through around the lifecycle management activities as well as new drug development. More specifically, we are focused in four key areas.
First, making IV brinci on the even more convenient. Last year, we presented the first data from the ENHANCE Phase three B trial, of which the goal is to evaluate the safety and efficacy of eliminating for our Breyanzi 150 milligrams starting dose for patients who are switching from a prior CD20 and have a prespecified low level of B-cells. Early safety data from this study is encouraging, and we look forward to presenting additional safety and efficacy data this year, including an act at the Aptimus conference, which is happening later this week.
Second key area for us is developing subcu Breyanzi. We have completed our preliminary subcu formulation and are preparing to enter human bioequivalence studies this year. We believe the subcu market could represent a significant new market opportunity for us as the IV and subcu CD20 markets within RMS are rather distinct given the known profile of the currently available subcu and the profile of the other ones under development, we believe there's plenty of room to strive to develop potentially best-in-class subcu CD20 products.
Third, we are looking forward to extend beyond the beyond MS. There are multiple other disease indications where CD 20s have proven to have utility. We'll look forward to launching our first autoimmune trial outside of MS this year and fourth.
And finally, two, we are focused on new drug development and are extremely excited by our recent portfolio expansion. Last month, we entered into a partnership with Precision BioSciences to acquire a worldwide license to Precision's either sell allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications. We believe Asiacell has the potential to be first in class best in class treatment for certain autoimmune diseases. As an allogeneic off-the-shelf products, we think Asiacell may offer benefits over autologous CAR T treatments. Overall, we believe either ourselves a great fit for us and an important addition to our current pipeline. Asiacell has been used to treat over 80 cancer patients, and we look forward to hopefully treating the first autoimmune patients but Asiacell as soon as possible with an IND filing targeted for midyear.
As you can see, we have put together a thoughtful and exciting development plan for 2024 and beyond that we believe can add significant value to our shareholders. We have been we have been and will continue to be measured in our approach to R&D and from a capital allocation perspective, including including included in our approximately $250 million in projected 2024 operating budget of the dollars required to expand our PMB field teams increased our marketing spend as well as new moving forward. All of the current development plans are just discussed.
With that, as I bring my prepared remarks to a close, I think to say I'm incredibly proud I am of the team and the progress we've made in 2023. We built a top-notch M&A focused commercial team that enabled us to rapidly integrate TG. and REMB. into the MS ecosystem. And we will continue to build upon this foundation with TG as a trusted partner to the MS community.
As we strive to serve the patients we treat to the best of our abilities.
Finally, on whilst also want to congratulate our ex U.S. partner, Niraj farm on the official launch of DMD in Europe, which took place this week in Germany. We look forward to hearing more about their progress as they endeavor to commercialize Crown being Europe and the rest of the world with that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to provide a detailed update of their beyond the U.S. commercial launch. Adam?
Adam Waldman
Yes, thank you, Mike. And good morning, everyone. I'm pleased to share with you the results of Q4 and cover the highlights from our BMD commercial launch performance in 2023, launching beyond the last year was a transformational event for our Company. We've built a strong commercial infrastructure that delivered exceptional results, exceeded expectations on the launch and now provides a solid platform for which to build potential blockbuster products in MS and capitalize on other autoimmune disease opportunities going forward. And more importantly, we made a positive difference in the lives of thousands of people living with MS as reported at the JPMorgan conference last month.
Fourth quarter net sales for VNB were $39.9 million, representing 60% growth quarter over quarter and bringing our full year 2023 revenues in at $89 million. The fourth quarter number exceeded our guidance and reflects the growing demand we are seeing for BMD. We saw an increasing number of repeat prescribers in incremental gains in new prescribers and new centers adopting branding. We also started seeing increasing prescribing from major academic centers in the fourth quarter as the logistical barriers at the centers continued to decrease.
In fact, the fourth quarter was the first time we saw more scripts from academic centers than in the private practice setting, which we view as positive progress, given that 60% to 65% of patients are being seen by MS specialists in the academic setting. And this has been a focus for our team as we headed into the end of the year. Overall, in 2023, we saw approximately 3,200 new patient prescriptions come through our hub which we believe translates into about 3,500 total new patient scripts. As not all new prescriptions will come into our home. We're also pleased to see a wide distribution of use with new prescriptions coming from over 400 centers and 640 unique prescribers.
Encouragingly, we also saw a diverse mix of patient types, including those that were naive to all treatments and those that were previously treated and switch from both non CD. 20 and CD. 20 agent. This mix of patient types remain fairly consistent throughout the year with the largest group consisting of patients that were previously treated but naive to anti-CD20 therapy kind of. We were also highly encouraged by the persistence of returning patients, which so far appears to be consistent with our assumptions, which was based on what had been seen with the other anti IV anti 20 on the market.
From an execution perspective, our teams did an exceptional job delivering on our launch plan in 2023, and we had a well designed and targeted launch strategy efficiently focusing our resources on driving adoption at high volume targeted accounts where we sell the vast majority of our business at this point, approximately 90% of the top 100 centers in the U.S. and utilize Breyanzi and with the lowest price of any branded medicine for MS. We price to reprioritize gaining early access and coverage, and we're able to achieve coverage for 95% of commercial and Medicare lives. Within the first nine months of launch, we built a best-in-class patient support team and our highly experienced and well network field teams have done an incredible job establishing TG. as a respected partner in the MS community.
We are very proud of our teams and believe their outstanding efforts are contributing to the positive experience with BMD and continue to build confidence in our organization. The cumulative effects of what we've accomplished certainly helped to drive momentum that we saw in 2023, and we expect to see that momentum carry forward this year. And looking forward, we see the CD20 market continuing to grow. This class of drugs has transformed the way that that MS has treated over the last five years with the CD20 share continuing to grow and now capturing approximately 50% to 55% share of new patients every year. And we would expect that that will that will expand even further going forward, we believe this is a continued tailwind for our business.
We also expect that most patients and centers will continue to prefer and six and a every six month IV dosing schedule where patients don't have to think about their disease every day or every month and providers have the confidence that their patients are being compliant receiving their medication We estimate there are approximately 40,000 patients going on a CD20 therapy each year or about 10,000 patients per quarter. In the fourth quarter of 2023, we had approximately 1,000 prescriptions come into the TG. hub, which would reflect approximately a 10% market share as if all these patients were infused since not all these patients prescribed per MB will actually be infuse. These prescriptions through the hub will not translate precisely in the market share. But nevertheless, we do believe this is an indicator of strong early demand for B&B, especially in our 1st year of launch.
We also believe we have significant room to grow in what is a large and growing and expanding market based on our market research and extensive interaction with neurologists. We continue to believe Roundy's profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market. This will of course, take us time to achieve, but that's very much what we're focused on doing in 2024. We'll expand our targets and continue to work on educating our customers on the brand, the difference. We'll also continue to ramp up our efforts to increase patient awareness, which we believe can be an important driver in this market. So far this year is off to a really strong start.
We have seen record enrollments into our hub in January, and we believe we are tracking towards the upper end of our first quarter guidance range of $41 million to $46 million and potentially higher if cement demand trends persist over the next month. We also feel very good about our full year guidance of $220 million to $260 million, which we provided at JPMorgan. We certainly have work to do, but we are we are focused and extremely motivated to continue to work every day to bring B&B to those people living with MS and their family.
With that, I'll call I'll turn the call over to Sean Power, our CFO.
Sean Power
Thank you, Adam, and thanks again to everyone for joining us earlier earlier this morning, we reported our detailed fourth quarter and full year 2023 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 for the fourth quarter and full year of 2023. As previously mentioned, we are pleased to report US PMD net product revenue of $39.9 million during the fourth quarter. Also included in our total net product revenue for the fourth quarter is approximately $3.2 million of revenue for products of generics farm in support of the ex U.S. commercial launch and $800,000 of other revenue. Taking total revenue for the fourth quarter to approximately $44 million as reported.
For the full year, we reported total revenue of approximately $234 million, which is predominantly predominantly comprised of $88.8 million in U.S. BMD net product sales, $140 million in license revenue stemming from the upfront payment for ex U.S. commercialization agreement with Murex farm and $3.2 million in product revenue for products sold to new routes farm. As Melissa mentioned, our OpEx during the fourth quarter and full year has remained well controlled and in line with previously discussed ranges for the fourth quarter and full year 2023, our operating expenses were $56 million and $213 million, respectively, which includes COGS of $7.8 million and $14.1 million in the respective period.
When excluding noncash compensation, our cash operating expenditures during the fourth quarter and full year 2023 were approximately $47 million and $175 million, respectively. On the back of the reported revenues and well-controlled OpEx, we were able to report net income of $12.7 million or $0.09 per diluted share during the full year of 2023 for the fourth quarter of 2023, we reported a net loss of $14.4 million or $0.09 per diluted share.
And finally, from a cash standpoint, we ended the year with approximately $217.5 million in cash, cash equivalents and investment securities. And 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.
Question and Answer Session
Operator
Thank you. The floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad. At this time. A confirmation tone will indicate your line is in the question queue, you may press star two. If you would like to remove your question from the queue. Participants using speaker equipment it may be necessary to pick up the handset before pressing the star keys. Again, that's star one to register question at this time. Today's first question is coming from Michael. Before I have EverQ. Please go ahead.
Hi, this is Jessica on for Mike. My first question is in the past you guys have said that you've heard anecdotal reports of patients not petering out in the days and weeks, leading up to others and subsequent BRIAN B. dose, which is always the case with competitor anti CD 20s.
So what's been the feedback on this front? And how much do you see brand these consistent treatment duration as a key differentiating factor? And then also, if I can sneak in another question, what can we expect on gross-to-net cadence for the balance of the year.
Michael Weiss
Thank you. Got it. Thanks for the question. Adam, you want to field the first one, and then I have Sean take the second?
Adam Waldman
I assume you mean the discontinuation rate from for patients going from first or second infusion to third parties. And as you know, it's still it's still still early, but what I said in my remarks is to so far the trends seem positive around what we expected based on what we saw with the other IBCD. 20. So it's right in that range.
Sean Power
I don't have any information right now to say that it's better. I certainly don't have any information to say that's worth, but it's right where we expected and we'll continue to look at it. Certainly if it's more positive than we think certainly that would be accelerated going forward.
And then on the gross-to-net front, we have not provided going forward. Any forward guidance on what to expect?
Michael Weiss
There will be some variability quarter to quarter, but again, we haven't provided precise guidance on 2024 go.
Great. Thank you, and thank you.
Operator
The next question is coming from Ed White of H.C. Wainwright. Please go ahead.
Ed White
Good morning. Thanks for taking my question. So I'm just wondering if you have any numbers on the switches from prior therapies and how that's impacting your your sales for it?
Michael Weiss
Yes, I'll start there and Adam can jump in. We haven't read anything new. I mean what we've said previously, and it still holds true is that in terms of distribution of patients, we see about our repo. There are three buckets. Just to be clear, there's patients that are naive to all treatment. These patients that switch from non CD 20 some products to CD20. So there's the non-CON, there's the CD 20s, which is what we said is that the largest group coming on separately on the are those that are naïve to to CD20, but it were pretreated with something else.
And then the other two buckets, while they're not equal to each other at relatively similar, and they're they're reasonably close to the first bucket. So usually there's a nice distribution across all all the buckets.
Ed White
Okay. Thanks, Mike. And on the Europe, congratulations on getting the launch in Germany. Can you give us your thoughts on the launch in Germany and, you know, in other countries and perhaps the cadence of future milestone payment?
Michael Weiss
Yes. Adam, you've been I suppose you want to take a crack?
Adam Waldman
Sure. And so yes, as you know, and as we've spoken about before, getting we're going to launch in Germany was a really important. It's the biggest market by far in Europe. So getting that going out of the start was important. And we're right on track with that, which is great. The other country or the other countries will start to come in the later part of this year into next year, including the UK, France, Spain, Italy and they're continuing to work with the reimbursement authorities and getting through the process they need to on and making sure the drug and can be accessed there, working diligent diligently on that they have a lot of experience doing it and we'll continue to work through the process.
Michael Weiss
But Germany is by far the largest opportunity in the one that we prioritize first, yes, and then just on the cadence of future milestones, as we're not expecting any additional milestones this year, there's a chance we would see a milestone towards the end of next year. An additional milestone, but we'll give more more on that later. But I wouldn't expect any additional milestones this year.
And as we reported at JPMorgan, obviously to launch here for the first, and we're not expecting that and also a lot of royalty revenues as well.
Ed White
Okay. Thanks, Mike. And just lastly, Adam had mentioned adding to the sales force and expanding your reach, how should we be thinking about that as far as the growth or the ramp of SG&A expenses are you currently adding is something that we should see in the second half of the year. Just any guidance that you can give a sign of time how you expanding your sales force?
Michael Weiss
Yes. I'll I'll chime in and Adam can Sean can jump in afterwards. So yes, so as it stands today, even in the fourth quarter and some of that expansion, actually, most of that expansion is already included of the current expansion process. So it's already probably built-in most of it into the fourth quarter and then probably a little bit more that trickles into the first quarter. And then it's possible over the course of the year, it will be slow additional build, but most of it's already incorporated and for sure, it's incorporated in our OpEx estimate of approximately $250 million for the year. So that's all that's all built in to what we're what we are guiding already. It's really the unlimited plan.
Ed White
Okay. Got it. Thanks.
Operator
Thank you. The next question is coming from Roger Song of Jefferies.
Kambiz Yazdi
Please, I this is Kambiz on for Roger. Hi, Mike and team.
Good morning. On what timeframe do you think it's possible to achieve the number one prescribed IBCV. 20 for BMD by dynamic share? And as a second question, are there any remaining gating factors for you to enter the human bioequivalence studies for subcu formulations of remdesivir.
Michael Weiss
You broke up a little bit at the end there, but I think I got it in terms of timeframe to be number one, we haven't set a timeframe yet. So I can't share one. It's a goal that we have and we're going to keep working toward it. But certainly, as we get further along, I don't anticipate 24 will be the year that we do that. So I think that that's pretty sure about that. But we are working toward that and we'll keep you posted in terms of the the subcu development. We do have our preliminary subcu formulation that we want to take into into the into the clinic. We don't think there's anything in our way to do that with data, there are some filings to do, but should be pretty straightforward and we're hoping to have patients on. Yes, hopefully by midyear.
Kambiz Yazdi
And then maybe as a couple follow-up questions either. Is there any preparatory work required to enter B&B into studies outside of China? And the last question, we've noticed there's still a small number of scripts and third-party trackers some investors are still curious about the trends. Maybe we could put this topic to bed for once and all. And do you see any value assessment in the third party escrow packet data system?
Michael Weiss
Yes, I would certainly love that, Adam, you want to hit that one? And the third part answer?
Adam Waldman
Yes, or from wonderful from what I understand, Roger or Roger but I'd cite so what I understand is on yes, the data you're seeing is SP. data, which is a very small portion of our business, less than 10%. So yes, to put it to bed, I would say it is absolutely not something that I would look at.
Michael Weiss
Thank you. And then your last question about moving outside of MS. I don't think there's any any pre-work that we need to do. I think it's just the logistics of getting it done within the context of all the other things that we have on our plate for this year. So that's probably a later later in the year event than in earlier year. I think we've got a higher priority projects will be and the of it. The stuff I talked about, we're trying to make IV. We have even more coming in the subcu and the easier sell stuff. It's probably a higher priority setting for them for the early part of the year. But yes, I don't see any barriers to going outside of MS.
Kambiz Yazdi
Thanks, Mike. Appreciate it.
Michael Weiss
Thank you.
Operator
Thank you. The next question is coming from Matt Kaplan of Ladenburg Thalmann. Please go ahead.
Matt Kaplan
Hey, good morning, guys, and congrats on the progress. Just to stay on the enhanced. Yes, can we just assume ENHANCE Phase three be a switching trial? And can you provide a little bit more information in terms of what we should be looking for from that data assets as it's released after backfilling of spectrums and greater conferences this year.
Michael Weiss
Matt, like a day or two away from really what I'm going to give you just give it all the way on Yes, look, so what are we trying to accomplish? I think it's a fair question. So we want to make it as easy as possible for folks to be able to switch seamlessly from another CD. 20 onto PMV. It's again, no Secours doing an extra doing an extra four hour infusion. It's not the ideal situation for that patient population who already are T-cell depleted. So the goal is step one is, can you safely take a patient who is on another drug with other T-cell depleted and put them on another CD20 without sort of this initial conditioning with regimens that we have for the starting dose. And so that's step one.
So safety is the utmost importance, and that's what we wanted to do partly we wanted to go get that done too, because we had heard in the field that people were just switching people straight through to one our VMP. So we wanted to make sure we have safety. The next part is look, I think we would love to get it into the label. We are eliminating 100, 50 milligrams of drug. So there will be an efficacy question. I don't think its material entities and sentiments, sorry, efficacy question, but it has to be answered. So I think as we move forward one, so what are we looking for make sure it's safe and well tolerated to switch people directly to a one-hour for CMV from from another CD. 20.
And there's any signal that we somehow be losing some activity by eliminating 150 milligrams. So I think we're still probably in the safety phase of this trial, so they get action. We'll be looking for more safety information. Probably by the time we get to terms we should be able to have some some additional efficacy against a single arm. So the efficacy information will be pretty straightforward, looking at MRIs and just making sure that there's nothing going on there. It would be surprising again.
Matt Kaplan
That's really helpful. Thank you. And then in terms of your plans for BMD outside of the MS opportunity? And can you help us think about how you prioritize the different indications you are potentially looking?
Michael Weiss
And I think, look, we want to get started on probably somewhere in the RA lupus arena with within. I can't promise that that's what's going to happen, but we do think that there's an interesting opportunity. It also will dovetail nicely as we as we look to get easier sell in some of those indications as well. There's a nice synergy of of clinical resources. So that's a that's an angle that we're looking at, but I can't promise as the year goes on, we may have additional thoughts and we may start someplace else. But we do believe that that brand is designed well for large market indications. And right behind that is are sellers designed for the more and a smaller sicker kind of patient populations potentially within the same indications.
Matt Kaplan
Okay, great. And then lastly, in terms of the recent patents that you announced, can you provide us some more detail in terms of what they cover and providing more protection until it was at 20.3?
Michael Weiss
Yes. I mean, there's a lot of detail on those patents, but I think there's some substance is that in addition to new composition of matter patent, that covers the like echo cancellation profile of CMV plus some use patents within that, we feel good about the 2042 patent protection. So we feel that we've got a really nice runway here, but the bonds are issued, they're out there. People can read them. But the overriding concept is that it's a composition of matter plus some use patents and 2042 is a nice new have to assure exclusivity to Russia our perspective.
Operator
Eric Joseph, JPMorgan.
And this is Noah on for Eric. Thanks for taking our question. And the question is with regard to , have to agree on the fact that how important to drive uptake would it be to demonstrate efficacy, the relapse rate compared to demonstrating comparability of bioequivalence.
Michael Weiss
Thanks that. And so the current competitor that's moving from their IV to subcu did a bioequivalence study. We're hoping that we'll be able to follow a similar similar pathway. So I don't think we're going to need to do a full efficacy study to bring subcu forward, but that will be subject to more conversations with the FDA. But as of now, the competitor subcu that's moving from IV conducted a bioequivalent study. We think that's an appropriate pathway.
Operator
Thank you. The next question is coming from Parker Outerwall of Cantor Fitzgerald. Please go ahead.
Prakhar Agrawal
Hi, good morning and congrats on the progress and thanks for taking my questions. So number one, a Adam, you said, though, 1Q is tracking at the top end of the guidance range. So maybe if you can give some more details on the January and February trends, where is the demand growth coming from in terms of patient segments as well as physician segment Academy courses community?
Michael Weiss
Yes, hi, prepared. Thanks for the question on. I'm not going to get into too many details beyond what I said in the prepared remarks, we got off to a really strong start to the quarter. And as I said, we're feeling really good about our guidance to the higher end of that range. And then any other details we'll discuss on the next quarter call.
Prakhar Agrawal
Got it. And do you have a sense of what's the split of Academy courses, community patient segments for BMD? And how do you expect that to trend over time?
Michael Weiss
Sure. So in the beginning of the year, as I mentioned, it was probably 60 40 private practice to academics in the most recent quarters, it's more 50 50 academic to private practice. And we are seeing, as I mentioned in the remarks, growth coming from academic centers in the latter half of the year and especially in the fourth quarter.
Prakhar Agrawal
Got it. And lastly, what percentage of patients who are getting a prescription actually end up getting the infusion Do you have any initial details on the on the trend there? And what's the time lag between getting a prescription? We're getting an infusion right now and how does it track relative to Ocrevus?
Michael Weiss
So the conversion rate we have, it's still it's still pretty early and we have not given a number on that. It's no, it's encouraging, but we haven't given a specific number and that perhaps in future calls, we'll look at it, but we still think it's very early to be giving that number. And then can you repeat the second part of that question?
Prakhar Agrawal
So what's the time lag between a prescription and getting the infusion? And how does that trend versus O'Charleys?
Michael Weiss
Yes. So I think of what I said in the past, it's about six weeks, it timeframe from enrollment into the hub into the first infusion approximately. And from what we understand and from what we it's very similar to what you see with August. There are a lot of things you can control in that process and there's things that are outside your control. We continue to see it trend in the direction, and we continue to shorten it over overtime. And so we'd like to see that trend. And we think it's very much in line with what's on the competitor product.
Prakhar Agrawal
Thank you and congrats on the quarter.
Michael Weiss
Thanks.
Operator
Thank you. Our final question today is coming from Mayank Mamtani of B. Riley Securities. Please go ahead.
William Wood
This is actually William Wood, on from Mayank Mamtani. Congratulations on the past year and thank you for taking our questions on. In terms of the cash and the OpEx burn for 2024, how should we be thinking about the spend allocation between your trials and what's been factored so far into the subcu trial?
And then additionally, on the subcu trial on FX Do you have any view of frequency of administration or the kind of device that you will be using for the formulation?
Michael Weiss
Yes. So on the on the subcu, we don't know yet in terms of the frequency of dosing. I think part of that is just going to be, but let's look at what the conversion is between the two from IV to subcu and from there, we'll be able to design the appropriate dosing interval. Our goal, obviously, we know what the goalposts are. We've got once a month from one of the subcu products. And the other is once every six months with a pretty clunky zone product as far as we can tell. And so somewhere in between we think we'd be very successful. So we're going to trying to get there. We won't know if we can until we put the material into people and she helped us and see how they react to it.
Sean Power
On the OpEx guidance, obviously, we've guided to 50 OpEx for 2014. We haven't provided a detailed breakdown of how that shakes out but everything that Mike and the team discuss today is obviously included in that 250 guidance number.
William Wood
Appreciate that color. And then the one last question on your obviously you reported multiple new patents providing protection into 2042, including Com, I just noted as well as the recent launch and you how should we be thinking about this in terms of potential external parties doing these events and maybe spurring additional interest in TG.?
Michael Weiss
Yes, our goal is to build our business went on to worry about external parties. I think if you're referring to external parties me being investors, I would I would hope they'd be updating their models to understand the significance of patent protection through 2042 and what that means to the overall NPV of the SaaS and other outside parties. I'm not too worried about.
William Wood
Appreciate that, and thank you for taking our questions.
Michael Weiss
Great. Thank you.
Operator
Thank you at this time, I'd like to turn the floor back over to Mr. Weiss closing comments.
Michael Weiss
Great, and thank you, and again, thanks to everyone for joining us this morning. As reported, we had a great launch year and year two well early is taking shape, and we're excited about our target guidance for this year of $220 million to $260 million in US net sales revenue. Our pipeline and lifecycle management activities are in full swing and believe these activities could translate into translate into significant future value for TG and our recent patent issuance will ensure a long runway to explore the full potential of DMD.
Finally, I want to thank again the whole TG. team for their dedication to serving the MS community and for their incredible efforts on behalf of teaching. Everyone has a very nice day.
Operator
Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines at this time or log off the webcast and enjoy the rest of your day.
