Q3 2023 TG Therapeutics Inc Earnings Call

[music].

Greetings and welcome to the TG Therapeutics third quarter earnings update call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.

Once you 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.

Now my pleasure to introduce your host Jenna Bosco. Thank you Journal you may begin.

Thank you welcome everyone and thanks for joining us this morning, I'm, Jenna Bosco and with me today to discuss the third quarter of 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 effort 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 clinical development plans and expectations for our future for our marketed product <unk>.

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 and.

In addition, any forward looking statements made on this call represents our views only as of today and should not be relied upon as representing our views as of any later date.

Specifically disclaim any obligation to update or revise any forward looking statements. This conference call is being recorded for audio rebroadcast on Tg's web site Www Dot TG therapeutics Dot com, where it will be available for the next 30 days now I'd like to turn the call over to Mike Weiss our CEO.

Thanks, Jana and good morning, everyone and thanks for joining us on today's call.

It was another good quarter for T G and I'm happy to share that our net revenue for the third quarter was $166 million, which includes 140 million that we received as an upfront licensing fee from our ex U S partner and also includes over $25 million up ramping that sales in the U S to say I'm pleased with the launch of our teams.

<unk> of our launch strategy would be an understatement.

Continue to outperform our internal expectations and all external revenue expectations set at or prior to our launch.

I believe we're in a great position to close out the year strong and I'm excited for further next year and for the future, but M D and T J.

Yeah.

Just to remind everybody.

<unk> is the first and only anti CD 20, monoclonal antibody approved to treat patients with relapsing forms of multiple sclerosis that can be administered in a one hour infusion twice per year following the starting dose.

In clinical trials for M. B provide a robust efficacy with a safety profile consistent with what is expected of the CD 20 class, it's worth noting that while all anti CD twenty's target the same protein.

They're not all created the same.

The top binding and potency of that finding as well as their ability to engage immune effector cells are different and we're seeing these differences begin to resonate amongst health care providers.

But in the whole package together, we see free onvia as a differentiated anti CD 20 with best in class attributes I believe its differentiated profile has supported our early and meaningful market share gains I don't need to remind you that were only in our second full quarter ourselves. So it's still very early days here for our brand relaunch and we.

Leave that we are well positioned for future share gains ultimately driving us toward our goal to be the number one prescribed anti CD 20 based on dynamic market share.

Okay.

I'd like to spend a few minutes talking about the recent <unk> conference in Milan at terms as the Premier Global Emmis Conference and P. G had a significant presence there and this year for me personally it was great to interact with many health care providers and the real world feedback was overwhelmingly positive.

It was really gratifying to hear anecdotes about the tolerability and convenience people are experiencing but they used to be as bold stories about patients that were earlier leaders on the other hands I see the twenties and are now doing well on three of them.

Okay.

In addition to interacting with the health care providers at the conference we had the opportunity to present additional exploratory analysis from the ultimate one and two phase III trials are biamby in.

Relapsing forms of M S as well as the first data from our enhance phase III trial evaluating patients who switch from another IV anti CD 20 therapy Cipriani.

One of the goals of this trial is to understand the safety profile of a patients switching from another I V. C. D 20, cipriani without the need for the 150 milligram, starting dose as well as to evaluate the speed at which the first infusion the full 450 milligram dose maybe give them safely.

The early data presented was very encouraging demonstrating in 12 patients that we can safely skip the hundred and 50 milligram introductory dose and go straight to the 450 milligram dose and the first cohort that was giving us a two hour infusion.

<unk> demonstrated there were no infusion related reactions reported nor any dose interruptions or delays.

The second cohort is now enrolling and is evaluating the 450 milligram dose administered in the ordinary one hour infusion again without the need for the 150 milligram introductory dose and we look forward to sharing more data from this trial next year.

Interestingly about 60% of the patients who entered the study were reported to have experienced wearing off effect or what some people refer to as the crap gap well on their prior I V. C. D. 'twenty. So that's something we're going to continue to look out for.

While we were in Milan, we also had the opportunity to meet with our colleagues from near X form our ex U S partner as you May recall in June <unk> was approved in the European Union to treat adult patients with relapsing forms of M. S.

Active disease defined by clinical or imaging features.

Our team has been working closely with the <unk> team and we continue to be confident in their ability to bring <unk> to the market in Europe with their extensive experience in the CNS space, they're broad presence in all major European countries, and an extensive and growing team dedicated to the Gorilla V launch. We believe <unk> is positioned for success in Europe.

We are anxiously awaiting the launch which we believe is still on track for early 2024.

We were also happy to share that we just received approval for beyond in the United Kingdom. This is another exciting exciting step forward for brumby.

And for MS patients in the U K looking for a new treatment alternative.

As we look forward, we are evaluating additional potential indications for <unk> and our pipeline candidates as well as new product opportunities and M. S N autoimmune diseases.

Also as I've mentioned before we're evaluating the suitability of bring on me as a subcutaneous injection.

And we expect to be able to provide an update early next year as to whether we believe we have a suitable sub Q formulation that can be brought forward into the clinic.

Based on the current anti CD 20 sub Q landscape. We do believe there is room for a more convenient more tolerable tolerable option.

We continue to view the sub Q market as distinct from the IV market and thus as a potentially attractive expansion opportunity for ground beef.

Finally, let me discuss some financial matters.

CFO, Sean power will join us in a bit to provide more detailed financial update but I just wanted to discuss some revenue expectations and our cash position.

First with respect to revenue expectations.

Many of you have witnessed the market effects associated with analysts changing their revenue forecast for <unk>.

Those changes have been driven by prior quarter sales.

Some have been driven by intra quarter sales reporting from distributors, which despite our warnings about the usefulness of this data has become a source of confusion and price volatility.

To address this beginning on November 1st our distributors will no longer be sharing distributor level data with third party companies.

With that as promised I'd like to provide some guidance for the fourth quarter of 2023.

At this time, we are targeting revenues of approximately 33 to 37 million that should put us on target for approximately $82 million to $86 million for our first partial year ourselves, which is a bit ahead of the current twenty-three consensus of $80 million and well above the consensus of 72 million.

Around the time of our lunch.

Now turning to our cash position as of the end of the third quarter, we had approximately $229 million in cash as I mentioned on our last quarterly call as our revenues grow and we continue to operate with relatively stable opex or cash burn is trending down from here. We believe we have a reasonable line.

On a site to profitability in the near term.

All in all we feel really confident with our cash position and our ability to execute on our business plan.

With that let me turn the call over to our Chief commercialization Officer, Adam Woman, who will provide more detailed information about our brown be launched Adam.

Yeah.

Thank you, Mike and good morning, everyone I'm pleased to be with you today to share another strong quarter of execution for our freedom launch we continue to deliver results that exceed expectations and set the foundation for future success.

Third quarter net sales for brown being were $25 1 million, representing 57% growth quarter over quarter. This growth was primarily driven by increases in new patient infusions reduce logistical barriers and continued steady growth in patient demand as represented by over 900 prescriptions into our hub.

Unknown Executive: Greetings and welcome to the TG Therapeutics third quarter earnings update call. At this time, all participants are in a list and only mode. A brief question and answer session will follow the formal presentation.

That brings our launch to date total to approximately 2200, new patient scripts.

And as we have mentioned in the past. We believe this figure is capturing about 80% to 90% of the total new Breo scripts written.

Unknown Executive: If anyone should require operator systems during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.

As Mike mentioned with approximately 40000 M S patient starting a CD 20, each year in the U S. Our patient accumulation remains on target and based on script store hub. We are now capturing a nice portion of the new anti CD 20 patient share at this early point in our launch and we do believe the C. D towards 20 market is growing.

Jenna Bosco: It is now much pleasure to introduce your host, Jenna Bosco. Thank you, Jenna. We move you in. Thank you. Welcome everyone and thanks for joining us this morning.

Jenna Bosco: I'm Jenna Bosco and with me today to discuss the third quarter of 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, Michael 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.

And we'll continue to expand going forward.

Additionally in Q3, we saw for the first time patients returning for their week 24, infusions and we anticipate the number of week 24, infusions will increase significantly in Q4 as more patients are expected to return.

From an execution perspective, we remain focused on our initial priorities to drive adoption in the high volume targeted accounts provide best in class patient support enable axis and educate patients and we've made great progress across all of these priorities the key.

Jenna Bosco: Before we begin, I'd like to remind everyone that we will be making forward looking statements within the meetings 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, clinical development plans, and expectations for our marketed product. TG questions of these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated.

The facts of what we've accomplished is certainly helping to drive the momentum we saw from Q2 to Q3, and we expect to see that momentum carry forward into Q4 and into next year.

We continue to believe the Brown b profile as best in class and will eventually be the IV therapy of choice for the relapsing Ms market rail means unique one hour infusion every six months delivers on patient convenience reduces health care resource burdens and helps to address the needs of both private practice infusion centers and busy academic centers.

Jenna Bosco: Factors that may affect TG therapeutic operations include various risk factors that can be found in our SEC filing. 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 display any application to update or revise any forward looking statements.

The real world experience with Brown B continues to grow and the feedback we're receiving is overwhelmingly positive as we continue to progress towards our goal of making bring them via the go to I V. C. D 20 therapy.

There is nothing more valuable than positive physician nurse and patient experience. We believe theyre growing experience will help reinforce the differentiation of <unk> and lead to expanded utilization in the future.

Unknown Executive: This conference call is being recorded for audio rebroadcasts on TG's website, www.tgceraputics.com, where will be available for the next 30 days.

Michael Weiss: Now, I'd like to turn the call over to Mike Weiss, our CEO. Thanks, Jana, and good morning, everyone, and thanks for joining us on today's call. It was another good quarter for TG, and I'm happy to share that our net revenue for the third quarter was $166 million, which includes $140 million that we received as an upfront licensing fee from our X-US partner, and also includes over 25 million of Brionby Net sales in the US.

Encouragingly, we are seeing increases in both breadth and depth with our prescribers, we're seeing more and more prescribers and centers getting their initial experience with the drug and we are now up to approximately 500 total prescribers at more than 325 centers that have used <unk>.

Importantly.

The adoption rate at top centers of excellence continues to increase.

Now, 90% of the top 50 centers and 80% of the top 100 centers, having utilized brown b.

Michael Weiss: To say I'm pleased with the launch in our team's execution of our launch strategy would be an understatement. We continue to outperform our internal expectations and all external revenue expectations set at our prior to our launch. I believe we're in a great position to close out the year strong and I'm excited for for the next year and for the future of Rihambi and TG.

Depth is also increasing from early adopters with significant increases in physicians that now have multiple patients on brown b.

We view increases in repeat users as an important metric as we believe it likely represents a positive experience using the product.

We've always known that the process of accessing.

Michael Weiss: Just to remind everybody, Rihambi is the first and only anti-CD-20 molecule on a body approved to treat patients with relapsing forms of multiple sclerosis that can be administered into one-hour fusion twice per year, following the starting dose. In clinical trials, Rihambi provided robust efficacy with a safety profile consistent with what is expected of the CD-20 class. It's worth noting that while all anti-CD-20s target the same protein, they are not all created the same.

Accessing Brown V was going to be critical a critical success factor for this launch and we were very pleased with the feedback we received from customers on their interactions with both our people and our patient support services to date.

We are very proud of the patient hub programs that we have built to support patients and our field teams have done a tremendous job engaging with our customers. We believe our efforts here are contributing to the positive experience with brown B and building confidence in our organization in general.

We continue to focus on moving patients from the hub to the infusion as quickly as possible.

Michael Weiss: Epitope binding and potency of that binding, as well as their ability to engage and manufacture cells, are different, and we're seeing these differences begin to resonate among self-care providers. Putting the whole package together, we see Rihambi as a differentiated anti-CD-20 with best-in-class attributes and believe Rihambi's differentiated profile has supported our early and meaningful market share gains. I don't need to remind you that we're only in our second full-quarter of cells, so still very early days here for our Rihambi launch and we believe that we are a well-positioned for future share gains. Ultimately driving us toward our goal to be the number one prescribed anti-CD-20 based on dynamic market share.

Awesome.

And we are seeing improvements year over time continued improvement in payer coverage is facilitating our ability to do that we are now up to 95% coverage for commercial and Medicare lives exceeding our corporate goal for the year.

And we believe this will enhance access to bring him be moving forward. In addition, the permanent J code has now been loaded in the payer systems and our average selling price has been published all of which should help build confidence in reimbursement.

We have made progress we've also made progress in the quarter with major institutions and health systems.

Secured an increased number of institutional formulary wins for beyond for Brown beam and importantly, we have seen our first scripts and infusions this quarter from several of the top academic institutions and highest volume in our centers.

Michael Weiss: I'd like to spend a few minutes talking about the recent Ektrums conference in Milan. Ektrums is the premier global MS conference and TG had a significant presence there this year. From me personally, it was great to interact with many healthcare providers and the real-world feedback was overwhelmed on the positive. It was really gratifying to hear anecdotes about the tolerability and convenience people experiencing with the use of Rihambi, as well as stories about patients that were early repladers on other anti-CD-20s and are now doing well on Rihambi.

We are confident prescribing at these institutions will expand moving forward as they gain more and more experience and fully integrate bring ambience of their systems.

Finally, our research indicates that patients play an important role in selecting their therapy for them and us.

With that in mind and now that we've made great progress on building awareness with their health care providers and gaining broad insurance coverage, we have significantly increased our patient activation tactics and are starting to see the impacts of those efforts.

Michael Weiss: In addition to interacting with the healthcare providers of the conference, we had the opportunity to present additional exploratory analysis from the ultimate one and two phase three trials of Rihambi in relapsing forms of MS, as well as the first data from our enhanced phase three B trial evaluating patients who switched from another IV anti-CD-20 therapy to Rihambi. One of the goals of this trial is to understand the safety profile of a patient switching from another IV CD-20 to Rihambi without the need for the 150 mg starting dose, as well as to evaluate the speed at which the first infusion before 450 mg dose may be given safely.

September and October we generated substantial increases in overall impressions through our digital media efforts and we are already seeing the impact in website visits and increases in patient requests for Brown b.

I can say with certainly with certainty, but our team has built a strong foundation for success and we are determined to build upon this don.

Going into the fourth quarter, we have solid momentum behind us 95% coverage in place decreasing logistical barriers positive growing positive experience with brown b.

And an increasing number of patients coming back for their big twenty-four infusions.

We remain confident in the short run will see deepening utilization with our current base and we'll continue to unlock more and more accounts going forward. We're also confident then in the long term.

Michael Weiss: The early data presented was very encouraging, demonstrating in 12 patients that we could safely skip the 150 mg introductory dose and go straight to the 450 mg dose in the first cohort that was given as a two hour infusion and demonstrated there were no infusion related reactions reported, nor any dose interruptions or delays. The second cohort is now enrolling and is evaluating the 450 mg dose administered in the ordinary one hour infusion, again without the need for the 150 mg introductory dose.

He will become the a b C D 20th choice for <unk>.

Patients with relapsing forms about less.

We certainly have more work to do.

But we continue to make progress and we're ahead of where we thought we'd be at this point and we are extremely motivated to continue to work every day to bring B M. B to those people living with MFS and their families.

With that I'll now turn the call over to Sean power our CFO.

Thank you Adam and thanks, everyone for joining us.

Michael Weiss: We look forward to sharing more data from this trial next year. Interestingly, about 60% of the patients who entered this study and reported to have experienced wearing off effect, or what some people referred to as the Crab Gap, while on their prior IVCD-20. So that's something we're going to continue to look out for. While we're in Milan, we also have the opportunity to move our colleagues from Nurex Farm, our ex-US partner.

Earlier. This morning, we reported our detailed third quarter 2023 financial results, which can be viewed on the investors and media section of our website.

I'll start today's call by recapping some of the financial highlights from this morning's release.

For the third quarter. We are pleased to report total net revenue of approximately $166 million.

It is comprised of $25 1 million and Brie M. B net product sales and $140 million in license revenue stemming from the upfront payment.

Michael Weiss: As you may recall, in June, Riyambi was approved in the European Union to treat adult patients with her lapsing forms of MS, who have active disease defined by clinical or imaging features. Our team has been working closely with the Nurex Farm team, and we continue to be confident in their ability to bring Riyambi to the marketing Europe. With their extensive experience in the CNS space, their broad presence in all major European countries, and an extensive and growing team dedicated to the Riyambi launch, we believe Riyambi is positioned for success in Europe. We are anxiously awaiting the Riyambi launch, which we believe is still on track for early 2024.

Our ex U S commercialization agreement with neuro cause harm.

This brings our total net revenue for the nine months year to date period to approximately $190 million, which includes approximately 49 million embry on the net product sales.

On the back of the reported revenues, we were able to report net income in both the three and nine month periods.

Net income for the three months period was approximately $114 million or 73 cents per share per diluted share.

Michael Weiss: We are also happy to share that we just received approval for Riyambi in the United Kingdom. This is another exciting step forward for Riyambi, and for MS patients in the UK looking for a new treatment alternative.

And net income of $27 million or 19 cents per diluted share for the nine months period.

Our opex during the period has remained well controlled and within our previously guided range range. It.

Michael Weiss: As we look forward, we are evaluating additional potential indications for Riyambi and our pipeline candidates, as well as new product opportunities in MS and autoimmune diseases. Also as I have mentioned before, we are evaluating the suitability of Riyambi as a subcutaneous injection, and we expect to be able to run an update early next year as to whether we believe we have a suitable subcut formulation that could be brought forward into the clinic.

For the third quarter, our R&D and SG&A operating expenses totaled approximately 48 million.

And approximately 38 million when excluding noncash compensation.

Over the course of the year, we have continued to invest and bring on the inventory with approximately 34 million now on our balance sheet.

Of which 24 million is reflected in the current quarter cash burn.

Michael Weiss: Based on the current anti-CD-20 subcuter landscape, we do believe there is room for a more convenient, more tolerable option. We continue to view the subcube market as distinct from the IV market, and thus as a potentially attractive expansion opportunity for Grownby.

And finally from a cash standpoint, we ended the quarter with approximately $229 million in cash cash equivalents and investment securities.

Mike touched on earlier, we feel comfortable that our existing cash when coupled with modest three on the revenue assumptions.

Michael Weiss: Finally, let me discuss some financial matters. Our CEO of Photoshop and Power will join us in a bit to provide a more detailed financial update, but I just want to discuss some revenue expectations and our cash position. First, with respect to revenue expectations, many of you have witnessed the more market effects associated with analysts changing their revenue forecast for Riyambi. Some of those changes have been driven by prior quarter sales, but some have been driven by intra-quarter sales reporting from distributors, which despite our warnings about the usefulness of this data has become the source of confusion and price volatility. To address this, beginning on November 1st, our distributors will no longer be sharing distributor-level data with third-party companies.

Provides us with sufficient capital to fund our operations to cash flow positivity.

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

Thank you well now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.

A confirmation tone will indicate your line is in the question queue.

Press Star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star Q.

One moment, please while we poll for questions.

Okay.

Thank you. Our first question comes from Ed White with H C. Wainwright. Please proceed with your question.

Michael Weiss: With that, as promised, I'd like to provide some guidance for the fourth quarter of 2023. At this time, we are targeting revenues of approximately 33 to 37 million. That should put us on target for approximately 82 to 86 million for our first partial year of sales, which is a bit ahead of the current 23 consensus of 80 million and well above the consensus of 72 million set around the time of our launch.

Good morning, everyone. Congratulations on a great quarter.

Thanks, Ed.

You're welcome.

So Mike I, just wanted to get your thoughts on the anti CD 20 market penetration within the overall M. S treatment landscape and your thoughts on infusion versus sub Q injection is going forward.

Michael Weiss: Now, it's turning to our cash position. As at the end of the third quarter, we had approximately $229 million in cash. As I mentioned on our last quarterly call, as our revenues grow, and we continue to operate with relatively stable objects, our cash burn is trending down, and from here we believe we have a reasonable line of sight to profitability in the near term. All in all, we feel really confident with our cash position and our ability to execute Plan.

Yeah, So I'll do a little bit about sub Q, let Adam take the first half of that question about the growing city 20 market.

But yeah, I mean, my impression of the infusion versus sub Q market are the infusion market is.

Is growing but the AR, but the overall market is probably growing faster and that's probably because the sub Q market is expanding into areas in which are the IV market never penetrated. So I think we're seeing sub Q penetrating out into more general neurologists again into centers that probably.

Adam Waldman: With that, let me turn the call over to our chief commercialization officer, Adam Waldman, who will write more detailed information about our Brambe launch. Adam? Thank you, Mike, and good morning everyone. I'm pleased to be with you today to share another strong quarter of execution for our Brambe launch. We continue to deliver results that exceed expectations and set the foundation for future success. The third quarter net sales for Brambe were 25.1 million, representing 57% growth quarter over quarter.

We're not already using or very limited use potentially of I V. C. D twenty's. So.

Adam Waldman: This growth was primarily driven by increases in new patient infusions, reduced logistical barriers, and continued steady growth in patient demand, as represented by over 900 prescriptions into our home. That brings our launch to date total to approximately 2,200 new patient scripts. And as we have mentioned in the past, we believe this figure is capturing about 80 to 90% of the total new Brambe scripts written. As Mike mentioned, with approximately 40,000 MS patients starting a CD-20 each year in the US, our patient accumulation remains on target, and based on scripts to our hub, we are now capturing a nice portion of the new anti-CD-20 patient share at this early point in our launch.

We think that the RV market will continue to grow our focus continues to be on centers that are involved in IV therapy.

And I think we're leaving for the bigger players here too to work on the general neurologists.

And as they expand their use and to see the 'twenty and into sub Q and potentially into Ivy. We could then tagalong in and introduced me I'm being more centers.

Adam you want to talk about C D twenties.

Part of the overall and that's treatment landscape.

Sure Yeah. So so Ed we we estimate about 80000 patients is about the dynamic market those are patients that are either.

Initiating a new treatment for the first time or they are switching from another therapy in a given year.

And about 50% of those are about 40000 patients.

Going on a CD 20.

And we believe as Mike said that that market is is the CD 20 market is growing and expanding.

Adam Waldman: And we do believe the CD-20 market is growing, and will continue to expand going forward. Additionally, in Q3, we saw for the first time patients returning for their week 24 infusions, and we anticipate the number of week 24 infusions will increase significantly in Q4, as more patients are expected to return. From an execution perspective, we remain focused on our initial priorities to drive adoption in the high volume targeted accounts, provide best-in-class patient support, enable access, and educate patients.

But that's where we get our that's our assumption for the Ms market, and where CD twenty's play in that market.

Yes.

Okay. Thanks, Adam and perhaps you can comment on you mentioned the enhance trial I'm just wondering if we can get your thoughts on on the real world number of patients that are switching from other CD 22 brianti.

Adam Waldman: And we have made great progress across all these priorities. The cumulative effects of what we've accomplished are certainly helping to drive the momentum we saw from Q2 to Q3, and we expect to see that momentum carry forward into Q4 and into next year. We continue to believe the Brambe profile is besting class, and will eventually be the IV therapy of choice for the relapsing MS market. Brambe is unique one hour infusion every six months, delivers on patient convenience, reduces healthcare resource burdens, and helps to address the needs of both private practice infusion centers and busy academic centers.

Sure Adam I'll take that one.

Adam Waldman: The real world experience with Brambe continues to grow, and the feedback we receive is overwhelmingly positive. As we continue to progress towards our goal of making Brambe to go to IV CD-20 therapy, there is nothing more valuable than positive physician, nurse, and patient experience. We believe their growing experience will help reinforce the differentiation of Brambe and lead to expanded utilization in the future. Encouragingly, we are seeing increases in both breadth and depth with our prescribers.

Adam Waldman: We are seeing more and more prescribers and centers getting their initial experience with the drug, and we are now up to approximately 500 total prescribers at more than 325 centers that have used Brambe. Importantly, the adoption rate at top centers of excellence continues to increase, with now 90 percent of the top 50 centers and 80 percent of the top 100 centers having utilized Brambe.

Dark the quick start program did you see this quarter and see what are your expectations for that I'm going forward.

Sean Power: [inaudible] Thank you, Adam, and thanks everyone for joining us.

Sure Yeah free goods remain.

Around 20% <unk> very similar to last quarter. The majority of that is quick start. So you know we do expect now that we have 95 per cent coverage in place <unk>.

That we will see a drop in free goods going into the fourth quarter.

And you know continuing forward so I I can't exactly tell you how much of a drop but we do think it will be less than what we're seeing in the first three quarters. So far.

Okay, great. Thanks for taking my questions.

Things that.

Our next question is from Roger song with Cafes. Please proceed with your question.

Great, Thanks, and and my Congrats ordered a good contact a couple of questions on that.

Yes.

So.

The first question maybe of Joe down for the patient compensation you have been here for your.

For the patient <unk> <unk>.

<unk> like how many of them are what's the breakdown between and you pay shin versus switch patients.

The new patient because I believe eustacia since then venue patients but.

That may be more interesting is that how <unk>.

Four Q eustacia, some advil patient.

Yeah.

Adam you Wanna.

Tackle that long so, it's you're saying composition of new verses returning patients for their infusions.

Is is that the question Roger or is it is it how many new versus switch patients can you just clarify the cool yeah.

Yeah sure. So basically we have three categories of the patient and your patience you to the to the 20th switch from the 20th and also that venue for that we argumentation.

Qualitatively all you will characterize those three categories. Thank you.

Got it yes, sorry, I misunderstood you go ahead.

So so you know we we see a nice balance between all those three groups right. So so we are seeing a good percentage from new to therapy.

We are seeing a probably the biggest percentage from switches from Nancy the 20th.

And we are seeing a decent amount from as I mentioned before decent and and more than expected from existing CD 20th.

So relatively balanced across those three groups, probably a little bit more than the switching.

From now on C D 20 therapy.

Got it thank you and then.

Also do I needed to that cause I have a new question as to the.

You report the prescription.

Prescription you're getting and also the revenue.

From the prescription to the revenue what what are the key factors to play into the final <unk> because the.

That the prescription get getting are made.

Sean Power: Earlier this morning, we reported our detailed third quarter 2023 financial results, which can be viewed on the Investors and Media section of our website. I'll start today's call by recapping some of the financial highlights from this morning's release. For the third quarter, we are pleased to report total net revenue of approximately 166 million dollars, which is comprised of 25.1 million in Breonvy net product sales and 140 million in license revenue, stemming from the upfront payment for XUS commercialization agreement with Nerox Farm.

Maybe those patients will have some compliance rate to get two for a few of those and of course, we will have this.

Drug and that goes to that are those are the key factors to.

<unk> from prescription to the revenue thank you.

And I'm gonna keep going you're on a roll here.

Sure Yeah. So those are the factors I would also say you know it's important to to understand that there is a tie.

Time-lag from the hub.

To the infusion right. So there there is time that that goes on from when a patient comes into our hub and when a patient gets infusion. There's also you mentioned compliance, but they're also we we we know that there are some patients that go into the hub that that actually never get to an infusion uhm. So those are the factors in addition to the <unk>.

Sean Power: This brings our total net revenue for the nine month year-to-date period to approximately 190 million, which includes approximately 49 million in Breonvy net product sales. On the back of the reported revenues, we were able to report net income in both the three and nine month periods. Net income for the three month period was approximately 114 million or 73 cents per share per diluted share, and net income of 27 million or 19 cents per diluted share for the nine month period.

That you you mentioned.

Yeah. That's all that's all I can think of is that that answer your question Roger.

Oh, that's great. Okay final question quick one.

You have the the guidance for <unk> Oh.

Over all year.

Maybe.

Sean Power: Our op-ex during the period has remained well controlled and within previously guided range, ranges. For the third quarter, our R&D and SGNA operating expenses totaled approximately 48 million and approximately 38 million when excluding non-cash compensation. Over the course of the year, we have continued to invest in Breonvy inventory with approximately 34 million now on our balance sheet of which 24 million is reflected in the current quarter cash firm. And finally, from cash standpoint, we ended the quarter with approximately 229 million in cash, cash equivalents, and investment securities. As Mike talked on earlier, we feel comfortable that our existing cash went coupled with modest Breonvy revenue assumptions, provides us with sufficient capital to fund our operations to cash flow positivity.

When you will provide that 2024.

And how should we think about <unk> two eight to.

<unk>. Thank you.

Yeah. Thanks, Roger So yeah, we have not we have not given any violence on 24, yet we're still getting our our feet wet here and trying to work on how do we produce guidance. So still early days for us in that standpoint, but I'll go would be to.

Tend to extent possible to try to get some guidance out as early as possible next year again to avoid people trying to guess what it's gonna look like so we are trying to close the information gap. So again people don't use sources of information that we don't believe are as reliable as what at least.

<unk>, we're seeing in looking at is creating the forecasts. So so yeah. So hopefully we can get something out early next year and get some some guidance get people on the right track.

Unknown Executive: With that, I will now turn the call back over to the conference operator to begin the Q&A. Thank you.

Excellent. Thank you. Thank you for taking the question that comes back again.

Unknown Executive: We'll now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your questions from the queue. For participants using speaker equipment, it may be necessary to pick up your hands up before customers start to you. One moment please, while we pull up your questions. Thank you.

Thanks Roger.

Our next question is from my document Menconi with be Riley Securities. Please proceed with your question.

Good morning team Vanguard spelled so strongly application and thanks for being a question. So maybe just continuing on <unk> questions on you know understanding prescription volume revenue. So so Adam you know.

Ed Weiss: Our first question is from Ed Weiss with H. St. Wayne Wright. Please proceed with your question. Good morning, everyone. Congratulations on a great quarter. Except you're welcome.

For a prescription volume you know for example, if you have two loading doses is that.

Basically one prescription volume and then the 24 <unk> is that sort of another prescription number that basically just from a process standpoint that how it works and then sorry, if I missed that did you did you say the number for your new patients Sherry.

Michael Weiss: So Mike, I just wanted to get your thoughts on the anti-CD-20 market penetration within the overall MS-Treatment Landscape and your thoughts on infusion versus sub-Q injections going forward. Yeah, so I'll do a little bit about sub-Q, let Adam take the first half of that question about the growing CD20 market. But yeah, my impression of the infusion versus sub-Q market, the infusion market is growing, but the overall market is probably growing faster, and that's probably because the sub-Q market is expanding into areas in which the IV market never penetrated.

Info within the anti C. D 20 class it looks like you have some mature data now to be able to see what what your market share. It is for mutations.

Yeah, My <unk> just to be clear the only number were reporting is new prescriptions and they're not separate script. So we're not reporting we 24 scripts were not reporting the 15th grips. The the numbers were giving you our new new scripts for new patients coming into our home.

Super helpful. Thank you for <unk>.

Michael Weiss: So I think we're seeing sub-Q penetrating out into more general neurologists. Again, it to centers that probably were not already using or very limited use potentially of IV CD20s. So, you know, we think that the IV market looking to grow, our focus continues to be on centers that are involved in IV therapy. And I think we're leaving for the bigger players here to work on the general neurologist. And as they expand their use into CD20 and into sub-Q and potentially into IV, we could then tag along and introduce probably in those centers.

And then on the market Garcia on the market sure. Yeah. I think we're just we're just taking the calculation of 40000 patients in a year approximately.

It's about 10000, a quarter and if you get 900, new into the into the hub and again were based on that just on folks coming into our hub.

That's that gives you a good sense of the share of the anti seen 20 market that we're doing.

Got it and then you'll find on the hop do infusion dime and and pushing <unk> conversion to infusion like this <unk> how does that involving if you could comment on that and I didn't know if you <unk> if you could comment on that day.

Adam Waldman: Adam, you want to talk about CD20s as a part of the overall MS treatment landscape? Sure. Yeah, so Ed, we estimate about 80,000 patients is about the dynamic market. Those are patients that are either initiating a new treatment for the first time, or they are switching from another therapy in a given year. And about 50% of those are about 40,000 patients are going on the CD20. And we believe, as Mike said, that market is the CD20 market is growing and expanding, but that's where we get that's our assumption for the MS market and where CD20s play in that market. Okay, thanks, Adam.

Sure. So as I mentioned in the prepared remarks, we're seeing improvements in time to you know from home to infusion, which we would expect his insurance coverage catch better so.

So that's good that we're seeing that and we're doing everything we can to decrease that time as as much as possible. There's some things that we can control and there's certainly some things that are outside of our control, but we we think that that's an important thing to focus on and we are we are seeing improvements in that area as far as the.

Gross to Matt question, Yeah, I think what we said was in the first quarter. It was 77 per cent.

And in case, you reset it was in line with that and I think it's a good number to use for a modeling perspective across the year, but we're not going to update the girls to that on a quarterly basis.

Michael Weiss: And perhaps you can comment on, you mentioned the enhanced trial. I'm just wondering if we can get your thoughts on the real world number of patients that are switching from other CD20s to Brigham V. Sure, Adam, let me take that one. Yeah, so we have seen, I think we've said before on this call that we did not expect a lot of patients to be switching from either IV CD20 or sub-Q CD20.

Understood. Thank you and final question about your subtle guidance thinking I I I.

Are you ready to give a little bit more color on Neil verses of dried entice you need 20 switch you know how should let me think about that and then also you know making in the redone patients to 24 Richard M. Patients could you just maybe comment on how to think about it for you in in the first half given what you're saying.

Michael Weiss: That was not part of our initial estimates or a thought process, but we have seen it. And we've said, actually, it surprised us at how much we are seeing. And I will say that a lot of the reasons that we hear from physicians as to why they are doing it is, you know, one is the one-hour shorter infusion. Of course, that's the most often, you know, referred to attribute of Brigham V that causes a switch.

Sure you know I think I covered the the distribution of patience well I'll give a couple of things to think about with with regards to revenue from week 24 infusions.

So just just a couple of things to think about one is that and you mentioned this a patient that starts therapy.

Is going to get that initial Ah loading dose or 150 milligrams, followed by 450 milligrams. So that's four vials right the vials or 150 milligrams. Each so that's four miles a patient coming back for.

Michael Weiss: But we also increasingly hear about this wearing off effect or craft gap that it's called by patients where there's an early wearing off effect with other CD20s and physicians are willing to get Brigham V. A try to see if they can... You'll get a better response with Briumby. So we're seeing that and guess it has surprises of how much we are soon. Thanks, Adam.

<unk> 24.

<unk> is getting three vials alright. So that's that's a 25 per cent reduction if when that patient comes back and just from a revenue standpoint.

The other thing that's important to think about just in terms of revenue from repeat versus new is.

You have to take into into account that not everyone will return from week, one to two week 24.

Adam Waldman: And perhaps my last question would just be how much free drug through a quick start, the quick start program. Did you see this quarter and, you know, what are your expectations for that going forward? Sure, yeah, free goods remains in around 20% with quarter, very similar to last quarter. The majority of that is quick start. So, you know, we do expect now that we have 95% coverage in place that we will see a drop in free goods going into the fourth quarter and, you know, continuing forward. So, I can't exactly tell you how much of a drop. But we do think it will be less than what we're seeing in the first three quarters so far.

We still don't know what that obviously, it's still too way too early for us to tell you what we think that that will be for <unk>.

But we do know we we do know that looking at other I D. C V 20th that they lose about 15 per cent of patients from drug initiation to their their their six month dosing.

And then that drop off Ray seems to decrease at a slower rate from there right with with you know that the average duration for an Ivy Sea's 20 seems to be about five years and growing.

But they do lose.

Ah you know about 15% is our understanding of the data about 15% from the first infusions to the second occasion, which is the largest drop off and then as I mentioned that sort of.

Ed Weiss: Okay, great. Thanks for taking my questions. Thanks, Ed. Thank you.

Evens out from there. So those are two two things to think about when you're thinking about return revenue hopefully that answers. The question. Thank you.

Roger Song: Our next question is from Roger Song. Would you please proceed with your question? Great.

Yes very helpful. Thank you for taking my question and come back again.

Thanks Ma'am.

Adam Waldman: Thanks, and my congrats for the good quarter. A couple questions from us. Yes, thank you. So the first question maybe it drove down for the patient compensation. You have been seeing for your, for the patient's use Briumby. So, like how many of them are with the breakdown between the new patient versus switch patient and the new patient because I believe you start to see some new patient. But maybe more interesting is how the recent months in four years you start to see those patients.

Our next question is from Eric Joseph J P. Morgan. Please particular to your question.

Alright, Thank you good morning.

I appreciate the guidance that you guys later fourth quarter and full year can you talk a little bit about your internal targets I guess to delivering on that expectation I'm wondering if the if the charges to.

You know add new centres or expand share with an existing centers or perhaps even a little bit more.

Or to this city 20th switch opportunity.

Is a bit surprising and.

Maybe just one follow up to that to your last comment on them.

On.

Adam Waldman: Yeah, Adam, I want to tackle that one. So it's that you're saying the composition of new versus returning patients for their fusions. Is that the question Roger or is it, is it how many new versus switch patients is clarified by the questions? Yeah, sure. So basically we have three categories of the patient. New patient, new to the TV 20 switch from the TV 20 and also the new for the Briumby patient.

Repeat or re twenty-four infusion expectations.

<unk> 50 per cent drop off that's kind of that's kind of a a hard final number or is that or is it just sort of a time shifted where you might sorta catch the patient, but not quite exactly on a 24 reschedule.

Adam Waldman: Maybe just qualitatively on your world categorize those three categories. Thank you. Sorry, I misunderstood you. Go ahead. Sure. So, you know, we've seen a nice balance between all those three groups, right? So, we are seeing a good percentage from new to therapy. We are seeing a probably the biggest percentage from switches from non CD 20s. And we are seeing a decent amount from, as I mentioned before, decent and more than expected from existing CD 20s.

Adam Waldman: So relatively balanced across those three groups, probably a little bit more in the switching from non CD 23rd. Thank you. And another also related to the revenue question is the new report, the prescription you're getting, and also the revenue from the prescription to the revenue. What are the key factors to you know playing to the final net revenue because the the prescription you're getting are maybe those patients will have some compliance rate to get to fulfill those revenue and of course we have this free drug and growth to net are those are the key factors to convert from prescription to the revenue.

Yeah. So let me <unk> you want me to go <unk>.

Yeah go ahead go ahead, okay. Yeah. So you'll get you. The first part of your question Yeah. As in you know our our strategy is to to continue need to increase enrollments and continue to find.

Adam Waldman: Thank you. Adam, keep going, you're on a roll here. Sure. Yeah, so those are the factors. I would also say you know it's important to to understand that there's a a time lag from the hub to the infusion right. So there's time that that goes on from when a patient comes into our hub and when a patient gets infusion. There's also you mentioned compliance but there are also we know that there are some patients that go into the hub that that actually never get to an infusion. So those are the factors in addition to the ones that you mentioned. Yeah, that's all I can think of. Does that answer your question, Roger?

Roger Song: No, that's great.

Roger Song: Okay, final question, quick one.

No new business, adding new centers of new prescribers, obviously is important but at the same time, you know a deepening experience seems to be you know something that's leading to more experience I will stay in this market that you know as physicians are getting I'm used to the product or they want to try it they want to see how.

It goes they wanted to see how the reimbursement goes even though once they have that experience.

And it goes well then they will continue to add so we're getting to the point here now where many many physicians have have had that experience now.

Gotten reimbursed and now they're they're willing to expand their their base. So I think that's will continue to lean in there, but you know I think there's plenty of opportunity here for us to expand usage and to new centers of new prescribers, we've made great progress, but there's there's plenty of opportunity for us to continue to grow both in.

Nick centers as we've mentioned as a as an area that has been slightly slower to adopt it's increasing but it's it's been slightly slower we think there's plenty of room and.

Academic centers to increase and then just in general I mean, we're we're we're we're getting we're we're making good progress on penetration with our top prescribers, but there's there's a lot of money for us to continue to grow.

And then the second part of your question was the 15 per cent Yeah I'm just what we're doing there is just we don't know obviously with our drop off right is gonna look like but we there is published data out there with the other Ivy C. V 20, we've looked at it and it's about a 15% that they're loose.

<unk> between those one and we are the first dose and in the week or the six month, though.

Okay.

And your heart do you have visibility on week 24 prescriptions versus starting a prescription.

Prescriptions and is that sort of a metric that you anticipate.

Providing it or updating the street on going for it.

Yeah, we don't get those no. We don't we don't Ah, we don't necessarily get those we get the first one to come in.

And then once they're in our hub than we are what we're doing is we're as they come up for their week twenty-four dose, we're reaching out to them. There's no requirement to come back into our home at that point, but will reach out to them to see what we can do to help with the it'll be reverification insurance benefits and so on and so forth but no.

Roger Song: Nice you have the guidance for both you and the overall year for 23 maybe when you will provide the 2024 revenue guidance and the how should we think about the trajectory of 23 to 2024. Thank you. Yeah, thanks, Roger. So yeah, we have not given any guidance on 24 yet. We're still getting our feet wet here and trying to work on how do we produce guidance. So still early days for us in that standpoint, but our goal would be to, you know, again to send possible to try to get some guidance out as early as possible next year, again to avoid people trying to guess what it's going to look like.

We don't have access to visibility till the wee 20th 24 scripts.

Okay, Alright, great. Thanks for taking my questions congrats on the corner.

Hey, Sarah.

Thanks, Sir.

Okay. Our next question is from <unk> with Cantor Fitzgerald. Please proceed with your question.

Hi, good morning, and thanks for taking my question plan Congrats on the corner, maybe first question on the switches from <unk> is this a trend that you'd think persist into next year or.

Roger Song: So we are trying to close the information gap. So again, people don't use sources of information that we don't believe are as reliable as at least what we hope we're seeing and looking at. That's creating the forecast. So yeah, so hopefully we can get something out early next year and give some guidance to get people on the right track.

<unk> Oh cross patients wanting to switch initially maybe digitalin pretty issues any any color for would be appreciated.

Roger Song: Excellent. Thank you. Thank you for taking the question. Come right again. Thanks, Roger.

Yeah, I'll I'll take a crack at that Adam you could join in I mean based on my interactions with health.

Health care providers, and and even with our own uhm folks I would say that that's something that would at least stay constant if not grow over time I think the more patients who go on brownsea. The more patients will be interested in going number Yankees, so if you're reasonably satisfied or or somewhat unsatisfied, but not.

Mayank Mamtani: Thank you. Our next question is from May Young Command, with be Riley Securities. Please proceed with your question. Good morning, Dean. Congrats also on strong education and thanks for taking your question. So maybe just continuing on Roger's sort of flow of questions on, you know, understanding prescription volume to revenues. So Adam, you know, when you report prescription volume, you know, for example, if you have two loading doses, is that basically one prescription volume?

Horribly unsatisfied with with your your current city 20, you still may consider changing you just wanted to see more utilization. So we've heard that from a G. P. S. I'll talk to some other broker patients who are potentially candidates and they'll say hey, you know I just want to wait a little longer see more on market experience you're more more stories from from you and your page.

<unk> and how things are going so I don't think it's it it was about a any sort of bullish I do think it's about organic demand that will occur over time is more and more people see the potential benefits of switching over.

Mayank Mamtani: And then the 24-week return patient is that sort of another prescription number that basically just from a process standpoint, is that how it works? And then sorry if I missed that, did you did you say the number for your new patient share info within the anti-CV20 class? It looks like you have some mature data now to be able to say what your market share is for new patients. Yeah, Mayank just to be clear, the only number we're reporting is new prescriptions.

Any further thoughts on it.

Mayank Mamtani: They're not separate scripts, so we're not reporting week 24 scripts, we're not reporting the 15 scripts. The numbers will give you our new scripts for new patients coming into our hub. Superheasable. Thank you for glad to find that. And then on the market. Yeah, on the market share. Yeah, I think we're just we're just taking the calculation of 40,000 patients in the year approximately. It's about 10,000 a quarter, and if you get 900, you know, new into the into the hub, and again, we're basing that just on folks coming into our hub.

No I think you've covered in my place.

Okay got it and second question on expenses. So the expenses for three Q were at the lower end of your <unk> guidance, excluding share company, an inventory build so any one else for this corner, we should be aware of has been one of those four Q and as a follow up any initial thoughts whether you expect a significant.

Infection and expensive <unk> more about study good thank you.

Yeah, I'll I'll take the the second part of that and Shawn maybe hit the expense question in terms of any inflection and expenses now I think the the short answer there is no. We do anticipate that the burn will creep up a bit.

We've talked about that we've always had a plan to modestly expand our team are doing more what I prefer it to his air support or or advertising initiatives, mostly online and social. So we are we are definitely creeping up on the burn, but nothing too dramatic.

Mayank Mamtani: That's the in that gives you a good sense of the share of the anti-CD 20 market that we're doing. Got it. And then you're point on the hub to infusion time and percent rate conversion to infusion, like this trend wise, how is that evolving? If you could comment on that, and I don't know if you commented on gross demand, if you could comment on that too. Sure, so as I mentioned in the prepared remarks, we're seeing improvements in time to, you know, from hub to infusion, which we would expect is, you know, insurance coverage gets better.

<unk> at all and we've also talked about getting more aggressive on the R&D side, but again, nothing that will dramatically change or show any sort of major inflection and expenses. We've been we've been saying that are operating burn is between 40 and 50 million, but in fact, it's been slack.

<unk> on that over the last two questions since I'm true operating so we have room to be within the 40 to 50 <unk>.

Mayank Mamtani: So that's good that we're seeing that, and we're doing everything we can to, you know, decrease that time as much as possible. There's some things that we can control, and there's certainly some things that are outside of our control, but we think that that's an important thing to focus on, and we are seeing improvements in that area. As far as the gross to net question, yeah, I think what we said was in the first quarter, it was 77 percent.

And and it should be pretty unnoticeable from.

For my financial standpoint, Sean when I answer the question on the expense side.

Yeah, <unk> would you mind just clarifying your your question is it really right. So yeah. It <unk>. It was at the lower end of your <unk> for you to confirm <unk> for the quarter. So maybe any color on.

There were any one offs are you <unk> and how should we think about the phone number.

Mayank Mamtani: And in QQ, we said it was in line with that, and I think it's a good number to use from a modeling perspective across the year, but we're not going to update the gross demand on a quarter of the basis. I understand. Thank you. And final question about your sort of guidance, thinking, are you ready to give a little bit more color on Neo versus prior anti-CV20 switch? You know, how should we think about that, and then also, you know, making in the return patients, the 24-week return patients, could you just maybe comment on how to think about 4Q, and into first half, given what you're seeing?

Yeah, No no one else in the corner and I think I think my covered it pretty well as it relates to sort of the fourth quarter of next year. So no one else in the quarter that don't really.

I drove things being.

On the lower end at the ranch.

Okay.

And last question, there's some interesting data from the B T K drugs and M. S. So how.

How do you feed the those drugs impacting the city 20 class and I know you had a b T. K in the pipeline is there any plan to take that forward into M. S. Thank you.

Sure so yeah.

Yeah, the B T K as look interesting.

Mayank Mamtani: Sure. You know, I think I covered the distribution of patients. I'll give a couple things to think about with regards to revenue from week 24 infusions. So just a couple of things to think about. One is that and you mentioned this, a patient that starts therapy is going to get that initial loading dose, or 150 milligrams, followed by 450 milligrams. So that's four vials, right? The vials are 150 milligrams. Each of that's four vials.

I'd say at this point from afar until we get the the phase three data, which I think is possible we may see some first.

Mayank Mamtani: A patient coming back for week 24 is getting three vials, right? So that's a 25% reduction when that patient comes back in just from a revenue standpoint. The other thing that's important to think about just in terms of revenue from repeat versus new is you have to take into account that not everyone will return from week one to week 24. We still don't know what that obviously, it's still too way too early for us to tell you what we think that that will be for Briandi, but we do know that looking at other IBC 20s that they lose about 15% of patients from drug initiation to their their six month dosing.

Phase three data before the end of this year, we won't really have a good sense of the.

That profile so.

I think I'm, a reserve too much judgment other than I'll I'll save from a market standpoint, what we do here. His folks are more excited about the potential for P. T. K as in primary progressive M. S, where you know glial cell activation, maybe or an activation through B T K.

Could be a really nice mechanism for slowing the progression in the absence of active disease. RMS is primarily characterized by active disease, which is well served by the city 20 class and the convenience of once every six months.

Doesn't seem to fit most people's high end of convenience factor. So you know and let somebody get a remarkable happens in the in the RMS patience I think most people are looking at it firm S. Patience is another option, which will compete with the current oil therapies, but shouldn't really compete very <unk>.

Much with the CD 20th for primary Progressive again on the other hand that could be a potential competitor to to see the 20th if it performs at a at a high level. So yeah.

Mayank Mamtani: And then that drop off rate seems to decrease at a slower rate from there with with the average duration for an IBC 20 seems to be about, you know, about five years and growing, but they do lose, you know, about 15% is our, you know, understanding of the data about 15% from, you know, the first infusions to the second infusion, which is the largest drop off. And then, as I mentioned, it's sort of even felt from there. So those are two, two things to think about when you're thinking about return revenue. Hopefully that answers the question. Thank you. Yes. Thank you for taking that question and come back again. Thanks, ma'am.

Yeah, It's all day to dependent we'll see how it looks so I'm certainly going to reserve judgment, we do have our own B T. K, we've been hanging back we have a lot of information and cancer patients about the profile of our drug. So we know what it looks like we can move pretty quickly once we decided to pull the trigger.

But we're gonna sit back and let's see some data come out let's identify if there's an opportunity.

To fit in to the space.

And and we'll go from there so.

We're all waiting on the data for the moment.

Thanks Parker.

Thank you and come back again.

Mayank Mamtani: Thank you.

Thank you.

Thank you. Our next question is from that Katherine with Ladenburg Thalmann. Please proceed with your question.

Eric Joseph: Our next question is from Eric Joseph with KP Morgan. Please proceed with your question. Thank you. Good morning. I appreciate the guidance that you guys lead up for quarter and full year.

Thank you and good morning, guys and congrats on the on the strong quarter Uhm.

Adam Waldman: Can you talk a little bit about your internal targets, I guess, to delivering on that expectation and wondering sort of if the, if the charge is to, you know, add new centers or expand share with an existing centers or perhaps even lean a little bit more to this CD 20 switch opportunity that, you know, is a bit surprising. And maybe just one follow up to that to your last comment, Adam, on repeat or read 24 infusion expectations.

Maybe.

Can you give us a little bit more color you said that momentum you seen him on line can continue past the end of the third quarter can you give us a little bit my car in terms of what you're seeing in October and I guess, maybe more Broadway to you expect to see any seasonality to the business at all.

Adam Waldman: That 15% drop off, that's kind of a hard final number or is it just sort of a time shifted or you might sort of catch the patient, but not quite exactly on a 24 week schedule. Yeah, so let me, I guess I can take you want me to go might. Yeah, go ahead, go ahead. Yeah, okay. Yeah. So, you know, to the first party of question. Yeah, you know, our strategy is to continue to increase in moments and continue to find, you know, new business, adding new centers and new prescribers.

Sure I didn't want to go ahead and take that one.

Sure Yeah. Thanks Man I. Appreciate the question you know I think we've we've given guidance for the quarter and you know at this point that I'm not gonna get into any fourthquarter trends I think the the guidance it will speak for itself there in terms of seasonality.

Yeah, I mean, you know we did see some seasonality and you know we talked about this a little bit on the last call. We did see some seasonality over the summer months.

In fact, you know we when we looked at it there is a you know sort of a dampening across the entire M. S market in the summer months.

You know you know we saw you know a slower July followed by stronger months in August and September.

Adam Waldman: This is important. But at the same time, you know, deepening experience seems to be. You know, something that's leading to more experience. I will say in this market that, you know, as physicians are getting used to the product or they want to try it, they want to see how it goes, they want to see how reimbursement goes, and then they'll once they have that experience, the, and it goes well, then they will continue to add.

But we do see you know at least we saw it in in early July and into July a slow slowdown and I think you know if people go on vacations people go out of the office, it's natural especially for infusion based therapies and we are seeing that again with other I B C 20th as well so we did see that seasonality.

Adam Waldman: So, you know, we're getting to the point here now where many many physicians have had that experience now, they've gotten reimbursed and now they're willing to expand their base. So, I think that's where we'll continue to lean in there. But, you know, I think there's plenty of opportunity here for us to expand usage into new centers and new prescribers. We've made great progress, but there's there's plenty of opportunity for us to continue to grow.

There were just launching so we're continuing to look at the at the trends and trying to figure out what we what we might see from season to season, so hard to say what the future will bring of course around the holidays.

You know when people don't Wanna get infused that's that's a natural time, where you'll you'll see slowdowns, but you know other than that I think <unk> remains to be seen as we as we continue to move forward.

Adam Waldman: Both in academic centers, as we've mentioned, as an area that has been slightly slower to adopt. It's increasing, but it's, but it's slightly slower. We think there's plenty of room in, in, in, in academic centers to increase. And then just in general, I mean, we're, we're, we're, again, we're, we're making good progress on penetration with our top prescribers, but there's, there's a lot of room for us to continue to grow.

Thanks, Adam that's really helpful and then Micah thank you.

Commented on this in terms of in your prepared remarks, but can you talk a little bit more about the anticipated impact of the sub Q, specifically set up to your <unk> and two are on the anti C. D 20 spacing and M S N and.

How important it is is it for you to have a sub Q offer.

Adam Waldman: [inaudible] And then the second part of your question was the 15%. Yeah, I'm just what we're doing there is just we don't know obviously what our drop off rate is going to look like. But we there is published data out there with the other IV CD 20. In your hub, do you have visibility on week 24 prescriptions versus starting prescriptions and is that sort of a metric that you anticipate. You know, providing and rough getting the street on going forward.

Sure. Thanks, Matt So so yeah. So.

If if you Kate.

The developers of sub Q at their word and the last teleconference. They made it I felt pretty clear that they were gonna use up cue to expand.

The market for for the drug so I don't think that it's a major competitive threat to I V. C. D 20, I think their primary goal again I can only base it on what I, what I heard and when I guess, how I interpreted but they said so I don't think it's going to have a major impact I think.

They are going after that part of the market that has been reserved for Subcu. One company has a monopoly in that area today and I think the new Subcu, we'll we'll try to compete.

Adam Waldman: Yeah, we don't get those know we don't we don't we don't necessarily get those we get the first ones to come in. And then once they're in our hub that we are what we're doing is we're as they come up for their week 24 dose. We're reaching out to them. There's no requirement to come back into our hub at that point, but we're reaching out to them to feel we can do to help with the.

For the extra convenience of of a one one in every six months infusion. So I do think that it's gonna have limited.

Impact on the on the Ivy marketplace in terms of the importance of of us having a a said Q.

Adam Waldman: You know, the re verification insurance benefits and so on so forth, but know that we don't have access or visibility to the week 20 24 scripts. Okay. All right. Great. Thanks for taking the questions. We can grab some of the quarter. Thanks, Eric. Thank you.

Again, it's not important from a primary.

Gold for US right. So our primary goal is to make Briand V. The number one prescribed dynamic sure I V. C D 20.

Prakhar Agrawal: Our next question is from prop our other wall with cancer for Cheryl. Please proceed with your question. Hi.

That's what everyone in the company is working toward so that's and and I don't think a sub too I sent to your professor's gonna impact the overall I can mark and our ability to potentially cheese that call.

Michael Weiss: Good morning and thanks for taking my questions and congrats on the quarter. Maybe first question on the switches from Oak River. Is this a trend that you think versus into next year or is there some sort of a bowlers of Okra was patients wanting to switch initially, maybe due to all the British issues. Any any color for would be appreciated. Yeah, I'll take a crack at that Adam could join in and then based on my interactions with health care providers and even with our own folks.

Is it a potential area for us to expand and create a new market for being on the shore and if we if we get to a point, where we think we can develop a H R. Q that has been a profile.

That is competitive with what's out there and available would you think that began to suck to market is growing we think they're building into general neurologist and other neurology practices that have not historically used a lot of I V. C. D. Twenties. So yeah. I mean do you think there's a market opportunity we think there's.

Michael Weiss: I would say that that's something that would at least stay constant. If not grow over time, I think the more patients who go on reality, the more patients will be interested in going on. So if you're reasonably satisfied or somewhat unsatisfied, but not horribly unsatisfied with your current CD 20. You still may consider changing. You just want to see more utilization. So we've heard that from ACPs. I'll talk to some of the Okra patients who are potentially candidates and they'll say, hey, you know, just want to wait a little longer.

Something there when you look at the two products that are available.

Sorry, one products available in one product that we expect will be available at some point you know we think there is room for a more tolerable more convenient product opportunity. So I'm not sure that will get there, but we think there's an opening will just have to see if we can we can fit the gap.

Michael Weiss: See more on market experience. You're more more stories from from viewing your patients and how things are going. So I don't think it was about any sort of bowlers. I do think it's about organic demand that will occur over time. And as more and more people see the potential benefits of switching over. Adam, any further thoughts on that? No, I think you covered it by thanks. Got it.

<unk> <unk> and <unk>.

Yep. Thank you.

Thank you.

The last question is from like D Fiore with Evercore ISI.

Please proceed with your question.

Hi, guys. Thanks, so much for taking my question and grabbed from the great quarter two for me.

Sean Power: And second question on expenses. So the expenses for 3Q, where are the lower end of your. Opex guidance, excluding share comp and inventory build. So any one offs for this quarter, we should be aware of have been more about 4Q. And as a follow up, any initial thoughts, whether you expect a significant. Infection and expense go to the 3Q for next year or is it more about study go. Thank you. Yeah, I'll take the second part of that and Sean maybe hit the expense question.

And I may have missed this but regarding the the J code now that is fully established at most intuitions.

Can we expect more of a gradual ramp or have we hit.

Like maximum establishment as far as the J code goes.

And then I have a follow up thank you.

Adam I Wanna go ahead with that one.

Yeah, I mean, you know I think the the J code is is a positive thing you know I think we're gonna continue to see a steady steady growth and.

Sean Power: In terms of any inflection and expenses, no, I think the short answer there is no. We do anticipate that the burn will creep up a bit. We've talked about that we've always had a plan to honestly expand our team. We're doing more what I prefer to is air support or advertising initiatives mostly online and social. So we are, you know, we are definitely creeping up on the burn but nothing too dramatic at all.

Continued ads, but in general it's a it's a it's a good thing <unk>.

Provides the confidence in reimbursement and you know, it's it's a positive.

A milestone to reach in and now it has been fully.

A loaded into Payor system, and and you know a S. P has been established though.

Going good shape, there and we would expect to see continued study gross.

Got it got it and then just to go back to the whole B T. K competitive. This question I thought your comments are interesting it in on how based on your research so far physicians.

Sean Power: And we've also talked about getting more aggressive on the, we are on D side. But again, nothing that will dramatically change or show any sort of major inflection and expenses. We've been, you know, we've been saying that our operating burn is between 40 and 50 million. But in fact, it's been slightly lower than that over the last two quarters in terms of true operating. So we have room to be within the 40 to 50.

Sean Power: And should be pretty unnoticeable from a financial standpoint. Sean, you want to answer the question on the expansion sign? Yeah, Parker, would you mind just clarifying your question as it relates? Right. So, yeah, for three, it was at the lower end of your opics guidance of 40 to 50 million for three, for the quarter. So maybe any color on whether there were any one ops or UX and how should we think about the 4Q number?

They seem like they view B T kayes as.

Another oral option for relapsing Remitting M S.

But if the first if phase three data pans out in in in there you have it cause he is really good.

Either equal or on par to the anti C. D 20 therapies why wouldn't K.

K well use.

These all V D k's options instead I mean.

Color would be would be helpful. There.

Yeah, I mean look I think they will give them as options for patience.

I think what we've well we've heard and seen in research is that patients do resonate Jordan every six month treatment option when I've talked to.

Sean Power: Yeah, no, no one ops in the quarter. And I think I think Mike covered it pretty well as it relates to sort of the fourth quarter in next year. So no one else in the quarter that really drove things being on the lower end of the range. Okay, go ahead.

Clinicians about R V T K in particular, and I've said look let's say, it's just as good as the C. V 20, they say so what.

Then they have to take a pill every day or twice a day, that's not as attractive as in every six months infusion. The other thing is compliance alright, orals have historically poor compliance.

Michael Weiss: And last question, there's some interesting data from the BTK drugs and MS. So how do you see that those drugs impacting the CD20 class? And I know you had a BTK in the pipeline. Is there any plan to take that forward into MS?

So in terms of real World experience, a beach case, even if they look phenomenal in clinical trials compliance will be a problem. It's been for every oral drug.

Michael Weiss: Thank you. Sure. So, yeah, the BTKs look interesting. I'd say at this point from afar until we get the Phase 3 data, which I think is possible. We may see some first Phase 3 data before the end of this year. We won't really have a good sense of the exact profile. So, I think I've reserved too much judgment. Other than, I'll say, from a market standpoint, what we do here is folks are more excited about the potential for BTKs in primary progressive MS, where glial cell activation may be or inactivation through BTK could be a really nice mechanism for slowing the progression in the absence of active disease.

There's some some research that's gone on down at U T southwestern with Doctor down Accoutre, whose whose collects.

Unused.

Oral meds for M. S. N I think he's collected I'm gonna make up the number and I could be wrong, but anywhere from 25 to 50 million of unused oral meds.

So it is a major issue compliance so again.

I just don't see it's gonna it's gonna go on the oral class I assume then I could be wrong.

Based on the conversations that I've had with folks you know unless it's dramatically better than the city 20th.

Comparable activity to see the twenties will just drop it into the oral bucket.

Because for most of them, there's nothing more convenient and nothing more assured then a six months I V infusion.

Michael Weiss: RMS is primarily characterized by active disease, which is well served by the CD20 class and the convenience of once every six months does seem to fit most people's high end of convenience factor. So unless something remarkable happens in the RMS patients, I think most people are looking at it for RMS patients as another oral option, which will compete with the current oral therapies, but shouldn't really compete very much with the CD20s.

Got it thanks, so much.

You got it.

Okay.

So I I believe that was the last question is that correct operator.

There are no further questions at this time.

Excellent well, we've got two minutes till the market open. So I think we should bring this call to a conclusion I just wanted to thank everyone again for joining us today, how we feel really great about the launch and what we've done so far our team is really working super hard they're sincere about really helping folks with M. S. I would say.

Michael Weiss: For primary progressive, again, on the other hand, that could be a potential competitor to CD20s if it performs at a high level. So it's all data dependent. We'll see how it looks. So certainly going to reserve judgment. We do have our own BTK. We've been hanging back. We have a lot of information in cancer patients about the profile of our drug. So we know what it looks like. We can move pretty quickly and once we decide to pull the trigger.

You know the feedback we've gotten from the patient has been really heartwarming and also really provides the fuel for everyone at T. G to do what we do every day I think it's also important that we recognize the H P. As you put their trust in T. G. Embryopathy, we really do believe it is the best in class Madison and can offer real benefit to patients.

As you closed out the year will continue to work hard to drive adoption.

Michael Weiss: But we're going to sit back. Let's see if some data come out. Let's identify if there's an opportunity to fit in to the space and we'll go from there. So we're all waiting on the data for the moment. Thanks, Prakhar. Thank you and come there again.

Matthew Kaplan: Thank you.

The revenue targets me upset and build value and T G for our shareholders in our employees.

That I would like to conclude the call have a great day everybody. Thank you.

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

Adam Waldman: Our next question is from that Kaplan with Leidenberg-Thalman. Please proceed with your question. Thank you and good morning guys and congrats on the strong quarter. Maybe can you give us a little bit more color? You said the momentum. You're seeing the momentum continue past the end of the third quarter. Can you give us a little bit more color in terms of what you're seeing in October? And I want to go ahead and take that one. Sure. Yeah. Thanks, Matt. Appreciate the question.

Adam Waldman: I think we've given guidance for the quarter and at this point that I'm not going to get into any fourth quarter trends. I think the guidance speaks for itself there in terms of seasonality. Yeah. We did see some seasonality and we talked about this a little bit on the last call. We did see some seasonality over the summer months. In fact, you know, when we looked at it, there is a sort of a dampening across the entire MS market in the summer months.

Adam Waldman: You know, we saw a slower July followed by stronger months in August and September. But we do see, you know, at least we saw in early July and into July a slow down. And I think, you know, as people go on vacations, people go out of the office. It's natural, especially for infusion based therapies. And we are seeing that again with other IVC 20s as well. So we did see that seasonality there.

Adam Waldman: You know, we're just launching. So we're continuing to look at the trends and trying to figure out what we might see from season to season. So hard to say what the future will bring. Of course, around holidays. You know, and when people don't want to get confused, that's a natural time where you'll see slowdowns. But, you know, other than that, I think remains to be seen as we continue to move forward. Thanks Adam. It's really helpful. And then Mike, I think you commented on this in terms of in your prepare remarks.

Michael Weiss: But can you talk a little bit more about the anticipated impact of the sub queue, specifically sub queue creatives into or on the anti CD 20 space and NMS. And how important it is. Is it for you to have a sub queue offer? Sure. Thanks Matt. So, so yeah. So, you know, if you Kate. The developers of sub queue at their word in their last teleconference, they made it. I thought pretty clear that they were going to use sub queue to expand the market for the drug.

Michael Weiss: So I don't think that it's a major competitive threat to IV CD 20. I think they're primary goal. Again, I can only base it on what I heard and what I guess how I interpreted what they said. So, I don't think it's going to have a major impact. I think they are going after that part of the market that has been reserved for sub queue. One company has a monopoly in that area today.

Michael Weiss: And I think the new sub queue will try to compete for the extra convenience of one, one every six month infusion. So, I do think that it's going to have limited impact on the on the IP marketplace in terms of the importance of us having a sub queue. Again, it's not important from a primary goal for us, right? So, our primary goal is to make. Priyambi, the number one prescribed dynamic share IV CD 20, that's what everyone in the company is working toward.

Michael Weiss: So, that's, and I think a sub queue, sub queue, this is going to impact the overall market and our ability to potentially achieve that goal. Is it a potential area for us to expand and create a new market for Reumvey? Sure. And if we, you know, if we get to a point where we think we can develop a subcube that has a profile that is competitive with look out there and available, we do think that, again, the subcube market is growing, we think they're building into general neurologist and other neurology practices, that have not historically used a lot of IV CD twins.

Michael Weiss: So, again, we do think there's a market opportunity, we think there's something there. When you look at the two products that are available, sorry, one product is available and one product that we expect will be available at some point, you know, we think there is room for a more tolerable, more convenient and product opportunity. So, not sure that we'll get there, but we think there's an opening. We'll just have to see if we can fit the gap. Thanks. Thanks, we had a pillow mic and grass again. Yep. Thank you.

Michael DiFiore: Our last question is from Mike D. Fiori with Evercore ISI. Please proceed with your question. Hi, guys. Thanks so much for taking my question and gratt from the great quarter.

Adam Waldman: Two for me, and I may have missed this, but regarding the J-code, now that it's fully established at most institutions, can we expect more of a gradual ramp or have we hit like maximal establishment as far as the J-code goes? And then I have a follow-up. Thank you. Adam, you want to go ahead and comment? Yeah, I mean, you know, I think the J-code is a positive thing. You know, I think we're going to continue to see a steady growth and continued ads, but in general, it's a good thing.

Adam Waldman: It provides the confidence in reimbursement, and you know, it's a positive milestone to reach, and now it has been fully loaded into pair systems and, you know, ASP has been established, so we're in good shape there, and we would expect to see continued study growth. Got it.

Michael Weiss: And then just to go back to the whole BTK competitiveness question, I thought your comments were interesting on how, based on your research so far, physicians, they seem like they view BTKs as just another oral option for relapsing remitting MS. But if the first, if phase three data pans out and their efficacy is really good, either equal or on part two, the anti-CD 20 therapies, why wouldn't K-wells use these oral BTKs options instead?

Michael Weiss: I mean, any color would be helpful there. Yeah, I mean, look, I think they will give them as options for patients. I think what we've heard and seen in research is that patients do resonate toward every six month treatment option When I've talked to clinicians about RBTK in particular, and I've said, you know, look, let's say it's just as good as the CD-20 they say, so what? Then they have to take a pill every day or twice a day.

Michael Weiss: That's not as attractive as in every six month infusion. The other thing is compliance. Right. Orals have historically poor compliance. So in terms of real world experience at BTKs, even if they look phenomenal and clinical trials, compliance will be a problem. It's been for every oral drug. There's some some research that's kind of on down at YouTube Southwestern with Dr. Darnakuda who's who's collects unused oral meds for MS and I think he's collected.

Michael Weiss: I'm going to make up a number and I could be wrong. But anywhere from 25 to 50 million of unused oral meds. So it is a major issue compliance. So again, I just don't see it's going to it's going to go on the oral class. I assume again, I could be wrong, but based on the conversations that I've had with folks, you know, unless it's dramatically better than the CD-20s, even comparable activity, CD-20s will just drop it into the oral bucket because for most of them there's nothing more convenient and nothing more short. So I'm going to go forward than a six month IB infusion. Thanks so much. You got it.

Michael Weiss: So I believe that was the last question. Is that correct operator? Yes, there are no further questions at this time. Excellent. Well, we've got two minutes to the market open. So I think we should bring this call to a conclusion. I just want to thank everyone again for joining us today. You know, we feel really great about the launch and what we've done so far. Our team is really working super hard.

Michael Weiss: They're sincere about really helping folks with MS. I would say, you know, the feedback we've gotten from the patients has been really, you know, heartwarming. And also really provides the fuel for everyone at TG to do what we do every day. I think it's also important that we recognize BHEPs who put their trust in TG and Brownv. We really do believe it's the best in class medicine and can offer real benefit to patients. As we close out the year, we'll continue to work hard to drive adoption. Need the revenue target we have set and build value in TG for our shareholders and our employees.

Unknown Executive: With that, I'd like to include the call. Have a great day, everybody. Thank you. This concludes today's call. You may disconnect your lines at this time. Thank you for your participation.