Q4 2024 TG Therapeutics Inc Earnings and Business Update Call
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Speaker Change: It is not my pleasure to turn the call over to Chief Communications Officer, Jenna Bosco. Please go ahead.
Jenna Bosco: Thank you welcome everyone and thanks for joining us this morning.
Speaker Change: And with me today to discuss our fourth quarter and full year 'twenty 'twenty four financial results are Michael Weiss, our chairman and Chief Executive Officer, Adam Waldman, Our Chief commercialization Officer, and Sean Power, our Chief Financial Officer.
Speaker Change: Following our safe Harbor statement, Mike will provide an overview of our corporate development, Adam will share an update on our commercialization efforts and Sean will give a summary of our financial results, but first time before turning the call over to the operator to begin the Q&A session.
Speaker Change: Before we begin I'd like to remind everyone that we will be making forward looking statements within the private group within the meaning of the private Securities Litigation Reform Act of 1995.
Speaker Change: These forward looking statements include statements about our anticipated future operating and financial performance, including sales performance projected milestones revenue guidance development plans and expectations for our marketed product.
Speaker Change: TG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated.
Speaker Change: Factors that may affect TG therapeutics operations include various risk factors that can be found in our SEC filings and.
Speaker Change: In addition, any forward looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date, we specifically disclaim any obligation to update or revise any forward looking statements.
Speaker Change: 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.
Speaker Change: Yeah.
Mike Weiss: Great and thanks, Jenna and thanks, everyone for joining us this morning.
Mike Weiss: I'm really excited to be able to host this call.
Mike Weiss: Just following the Astro conference that was held last week. These meetings are really still energizing for me, they're great venues.
Mike Weiss: We just presented and reviewed data.
Mike Weiss: But as you interact with so many health care providers all in one place and I have to say by and large the feedback.
Mike Weiss: And the T. G team was overwhelmingly positive you don't know how gratifying. It is to hear how our teams can make a real impact on the patient experience.
Mike Weiss: And even more gratifying to hear the stories from health care providers.
Mike Weiss: Hey.
Mike Weiss: Is impacting their patients, especially challenging ones.
Mike Weiss: The anecdotes about patients who are who have challenging times on prior therapies and then followed by a positive experience embryopathy is really.
Mike Weiss: Why we do I myself and everyone at you do do what we do every day.
Mike Weiss: So with that when I turn to the business of today. Our 2024 was an exciting year for T J, mark by outperformance and growth across various aspects of our business.
Mike Weiss: As noted at the JP Morgan Conference, our full year 2024 U S revenues of $310 million far exceeded our target guidance heading into the year, which we believe is reflective of the value brand brings to those living with M. S.
Mike Weiss: The team made significant progress also during the year launching and enrolling clinical trials to prove the patient experience Ambry on V, which led to the presentation of several meaningful data sets during the course of 'twenty 'twenty four.
Mike Weiss: And most recently, we updated our enhance study at the <unk> conference.
Mike Weiss: You may recall in 2024, we presented the first data emerging from the enhance trial, where we demonstrated demonstrated the preliminary safety of a 30 minute maintenance infusion as well as the feasibility of switching individuals from another anti CD 22 <unk>.
Mike Weiss: Without the need for the for our introductory dose at.
Mike Weiss: At <unk>, we updated the 30 minute cohort showing a consistent safety and Tolerability profile. That's pretty was previously presented now with over 80 patients treated with a 30 minute infusion.
Mike Weiss: In addition to our company sponsored studies.
Speaker Change: Presented at Ash from Dr. John Foley from the Rocky Mountain multiple sclerosis clinic presented the first ever real world experience data from his practice from over 160 individuals with MFS treated with <unk>.
Speaker Change: The results seem to be consistent with the overall safety and Tolerability of <unk> as seen in our ultimate one or two clinical trials.
Speaker Change: And interestingly in a subset of patients previously treated with the okra vis who experienced a wearing off effect between their own service infusions did not report.
Speaker Change: This effect, while Ambry on my end.
Speaker Change: In that subset there were 19 patients and 16 of which 85% did not experience wearing off effect after switching to grounding.
Speaker Change: Since this is an independent presentation of externally generated data. It is not included in our publications library, but I'm encourage those who are interested to access to data through the <unk> website.
Speaker Change: Also during 2024 at the actress conference in September.
Speaker Change: The <unk> conference. So very distinguishable one is the European that starts with the <unk> and the <unk>, which was last week starts Tonight.
Speaker Change: We presented the long term follow up data from the open label extension study of the ultimate one and two phase III trials. The data showed after five years of <unk> treatment, 92% of patients were free from disability progression.
And then the fifth year of treatment in annualized relapse rate of <unk>.
Speaker Change: Zero two was observed.
Speaker Change: This is equivalent to one relapse occurring every 50 years of treatment.
Speaker Change: Additionally, the overall safety profile remains consistent over five years of continuous treatment with no new safety signals emerging with prolonged usage.
Speaker Change: With <unk> being the newest entrant into the CD 20 landscape. We believe this data was important to many acp's and individuals with M. S.
Speaker Change: I also wanted to share some clinical progress.
Speaker Change: Which we made during the year as well some of this for these studies, we haven't yet presented the data late in 2024, we started a new cohort to enhance study that combine the starting dose which is 150 milligrams given over four hours.
And the first maintenance dose, which is 450 milligrams given in one hour two weeks later than.
Speaker Change: And we combine that into one single 600 milligram infusion.
Speaker Change: Which effectively eliminates the need to get two infusions in the first two weeks of starting to <unk>.
Speaker Change: While we haven't presented data from this cohort yet from the data we have seen an over 50 patients. We felt confident that this approach is achievable and a four hour infusion, which is the same timeframe as our currently approved starting dose.
We look forward to launching one of more pivotal trials this year with the goal of potentially incorporating all or some of the updates explored in enhance study into the IV program be label as soon as possible.
Speaker Change: Another key effort for us is developing and commercializing a subcutaneous formulation of <unk> as we've discussed in the past.
Speaker Change: Currently the majority of Emmis patients starting on anti CD 20 will choose an IV delivered every six months.
Speaker Change: And the remainder nearly 40% are now choosing to self administer a sub Q at home.
With almost 40% of new starts going on a self administered sub Q, we believe sub cube <unk> would represent a meaningful expansion opportunity for TG and most recently at the JP Morgan Conference. We were pleased to share that we believe in the preliminary data from our bioavailability studies support at least every other.
Speaker Change: Month dosing for sub <unk>.
Speaker Change: The currently self administered subcutaneous taken once per month. So if we are successful we could cut the number of injections per year and half.
Speaker Change: This is an exciting development for us and we look forward to commencing a pivotal trial around the middle of the year and providing additional information on this program later this year.
Speaker Change: Beyond <unk> and M. S. I am pleased to announce that we've started treating individuals with myasthenia gravis or Mg an exploratory study with AMG as a good place for us to begin to explore beyond the outside of M. S and look forward to hopefully sharing some data later this year. We also plan to continue to it.
Speaker Change: Value in other areas outside of events, where we believe <unk> may offer a meaningful treatment option for patients.
Speaker Change: And beyond premium be altogether on the pipeline front, we were pleased to have announced in 2024 that we entered into a partnership with precision biosciences to acquire a worldwide license to develop ease yourself for autoimmune diseases.
Speaker Change: As an allogeneic.
Speaker Change: Which means basically it can be given off the shelf CD 19 car T cell therapy, we believe he's yourself has the potential to be first in class best in class treatment for certain autoimmune diseases, having said that we believe there'll be multiple winners when we see is an extremely large market addressing a significant number of.
This is equivalent to one relapse occurring every 50 years of treatment.
Additionally, the overall safety profile remained consistent over five years of teaching U S. Creon re treatment with no new safety signals emerging with prolonged usage.
Speaker Change: Autoimmune diseases with car Ts.
Speaker Change: We were pleased to receive clearance for phase one study evaluating <unk> in progressive forms of multiple sclerosis, and we look forward to enrolling our first patients into the phase one study hopefully very soon.
With <unk> being the newest entrant into the C V. 'twenty landscape. We believe this data it was important to many hep's and individuals with M. S.
Speaker Change: As you can see we made a lot of progress on all fronts in 2024, and we plan to carry that momentum into 2025.
I just wanted to share some clinical progress.
Speaker Change: One last but very important item.
Which we made during the year as well some of this for these studies, we haven't yet presented the data late in 2024, we started a new cohort to enhance study that combine the starting dose which is 150 milligrams given over four hours.
Speaker Change: Wanted to note Sarah.
Speaker Change: 2024, we were incredibly pleased to have three new patents issued by the U S patent and trademark office, providing patent protection for <unk> through 2042.
Speaker Change: Which included a composition of matter covering the glycol engineered attributes of <unk>.
And the first maintenance dose, which is 450 milligrams given in one hour two weeks later.
Speaker Change: In summary, 2024 was a year of continued strong execution by the <unk> team, including above expectations revenues for <unk>.
And we combine that into one single 600 milligram infusion.
Which effectively eliminates the need to get two infusions in the first two weeks of starting pretty lumpy.
Speaker Change: Expansion of the <unk> patent portfolio with composition of matter patent protection now through 2042.
We haven't presented data from this cohort yet from the data we have seen an over 50 patients. We felt confident that this approach is achievable and a four hour infusion, which is the same timeframe as our currently approved starting dose.
Speaker Change: The launch of <unk> on the outside the U S with our partners and racks Forum.
Speaker Change: The presentation of important data, including five year follow up data from the ultimate one and two trials and data from the enhanced trial, which we plan to use to support the launch of additional pivotal trials in 2025.
We look forward to launching one of more pivotal trials this year with the goal of potentially incorporating all or some of the updates explored in enhance study into the IV Granby label as soon as possible.
Speaker Change: And we also made significant progress with our clinical programs, including preliminary bioavailability of subcutaneous <unk> with <unk>.
Another key effort for us is developing and commercializing a subcutaneous formulation of <unk>.
Speaker Change: Treated individuals with Mg with <unk>, and we opened our phase one evaluating as yourself in progressive forms of M. S.
We've discussed in the past.
Currently the majority of MF patients starting on anti CD 20 will choose an IV delivered every six months.
Speaker Change: With that let me hand, the call over to animal woman to provide a more detailed review of the <unk> on the U S launch in 2020 for our early performance in 'twenty five.
And the remainder nearly 40% are now choosing to self administer a sub Q at home.
Speaker Change: Our plans for the rest of the year.
With almost 40% of new starts going on a self administered subcutaneous we believe sub cube reality would represent a meaningful expansion opportunity for T. G and most recently at the JP Morgan Conference. We were pleased to share that we believe in the preliminary data from our bioavailability studies support at least every other.
Speaker Change: Adam.
Adam Waldman: Thanks, Mark and good morning, everyone. We are pleased to report another quarter of strong commercial performance marketing continuing momentum as we closed out 2024.
Adam Waldman: By the new competitive entrant, we delivered significant quarter over quarter growth reinforcing our confidence in <unk> positioning and long term potential and the relapsing Ms market.
Amongst dosing for sub cube Ramsey.
The currently self administered subcutaneous taken once per month. So if we are successful we could cut the number of injections per year and half.
As reported at the Jpmorgan Conference in January.
Adam Waldman: Fourth quarter U S. Net sales for <unk> were $103 6 million.
Adam Waldman: Representing 24% growth quarter over quarter, and 115% growth versus the same quarter last year.
This is an exciting development for us and we look forward to commencing a pivotal trial around the middle of the year and providing additional information on this program later this year.
Adam Waldman: That brought our full year 2020 for revenues to $310 million approximately 250% growth versus 2023.
Beyond the NMS I am pleased to announce that we've started treating individuals' with myasthenia gravis or M. A G and exploratory study we think MG is a good place for us to begin to explore beyond the outside of M. S and look forward to hopefully sharing some data later this year. We also plan to continue to.
Adam Waldman: The fourth quarter numbers and full year numbers exceeded our guidance and reflect the growing demand we're seeing for <unk>.
Adam Waldman: Revenue bulk of gaining momentum internationally as many of you know we partnered ex North America commercialization of life.
<unk> farm loss reality in Germany in February of 2024.
In other areas outside of them, that's where we believe it may offer a meaningful treatment option for patients.
Adam Waldman: Since then they have lost a number of EU countries and the U K.
And beyond premium movie altogether on the pipeline front, we were pleased to have announced in 2024 that we entered into a partnership with precision biosciences to acquire a worldwide license to develop ease yourself for autoimmune diseases.
Adam Waldman: And overall the feedback from the U S.
Adam Waldman: Been positive and we look forward to that continuing to expand the geographical reach of Brown V in the future.
Adam Waldman: Our differentiation strategy remains strong the confidence that physicians have demonstrated continuing to prescribe reality underscore.
Adam Waldman: <unk> underscores the importance and the adult RMS treatment paradigm, our recent five year data and real world experience continue to reinforce the unique value proposition.
As an allogeneic.
Which means basically can be given off the shelf CD 19 car T cell therapy, we believe he's yourself has the potential to be first in class best in class treatment for certain autoimmune diseases, having said that we believe there'll be multiple winners when we see is an extremely large market addressing a significant number of.
Adam Waldman: And efficient infusion.
Adam Waldman: Bind with proven efficacy and a consistent safety profile.
Adam Waldman: The quarter over quarter growth, we achieved validates an increase in confidence among prescribers and patients and <unk> is a leading anti CD 20 options of Rms.
Autoimmune diseases with car Ts.
We were pleased to receive clearance for phase one study evaluating ease yourself in progressive forms of multiple sclerosis, and we look forward to enrolling our first patients into this phase one study hopefully very soon.
Adam Waldman: Our our dynamic market share in the physician administered anti CD 20 segment is increasing.
Adam Waldman: And we anticipate continued growth as physician experience and comfort with <unk> increases.
Adam Waldman: Additionally, our field teams have been highly effective in educating prescribers on the attributes of brown with.
As you can see we made a lot of progress on all fronts in 2024, and we plan to carry that momentum into 2025.
Adam Waldman: With increasing adoption among high volume infusion centers and academic neurologists, we remain committed to expanding patient education efforts in optimizing the overall treatment experience.
One last but very important item I wanted to note. During 2024, we were incredibly pleased to have three new patents issued by the U S patent and trademark office, providing patent protection for <unk> through 'twenty 42.
Adam Waldman: The foundational work we have done throughout 2024, coupled with the strong adoption trends, we're seeing today.
Set the stage for continued growth in 2025, we will maintain our focus on driving deeper penetration in the IMF market, ensuring that <unk> reaches as many eligible patients as possible.
Which included a composition of matter covering the glycol engineered attributes of brown.
In summary, 2024, it was a year of continued strong execution by the T G team, including above expectations revenues for <unk>.
Adam Waldman: Looking ahead to 2025, we expect multiple drivers to continue fueling our growth.
Expansion of the 300 patent portfolio with composition of matter patent protection now through 2042.
Adam Waldman: Including expansion into additional infusion centers academic and community practices.
Adam Waldman: Direct to patient engagement efforts.
The launch of <unk> on the outside the U S with our partners and racks for them.
Adam Waldman: Increased real world evidence supporting <unk> efficacy safety and Tolerability.
The presentation of important data, including five year follow up data from the ultimate one and two trials and data from the enhance trial, which we plan to use to support the launch of additional pivotal trials in 2025.
Adam Waldman: And strengthening perceptions around payer coverage and access.
Adam Waldman: We are off to a strong start in 2025.
Adam Waldman: The typical challenges inherent in Q1 enrollments and overall demand has been robust with January and February being our highest month of total new patients into our hub since launch.
We also made significant progress with our clinical programs, including preliminary bioavailability of subcutaneous brownsea.
Adam Waldman: We feel confident in how the year has started and are now estimating a $115 million in U S. <unk> net revenue in Q1.
We treated individuals with Mg with pre envy and we opened our phase one evaluating as yourself in progressive forms of M. S.
Adam Waldman: And believe we are on track to meet or exceed our full year U S guidance of $525 million.
animal woman: With that let me hand, the call over to animal woman to provide a more detailed review of the brand in the U S launch in 2020 for our early performance in 'twenty five and our plans for the rest of the year.
Adam Waldman: In closing I want to thank our dedicated team for their relentless efforts in bringing <unk> to people with Rms.
Adam Waldman: Over the past two years, we have built a strong foundational commercial infrastructure.
Adam.
animal woman: Thanks, Mark and good morning, everyone. We are pleased to report another quarter of strong commercial performance, marking continuing momentum as we closed out 2024.
Adam Waldman: That has delivered exceptional results exceeding all expectations of loss.
Adam Waldman: This success now provides a solid platform from which to build potential blockbuster products.
animal woman: Despite a new competitive entrant, we delivered significant quarter over quarter growth reinforcing our confidence in <unk> positioning and long term potential and the relapsing Ms market.
Adam Waldman: NMS and capitalize on other autoimmune disease opportunities going forward.
Adam Waldman: The team, we have the capabilities and the leverage to drive future growth, including the opportunity to further strengthen our position in the RMS market.
animal woman: As reported at the Jpmorgan Conference in January.
Adam Waldman: With enhanced IV administration options.
animal woman: Fourth quarter U S. Net sales for Brown B were $103 6 million.
Adam Waldman: And the development of a patient administered subcutaneously formulation of rounding.
animal woman: Representing 24% growth quarter over quarter, and 116% growth versus the same quarter last year.
Adam Waldman: We believe this new option has the potential to significantly expand our market opportunity.
animal woman: That brought our full year 2020 for revenues to $310 million approximately 250% growth versus 2023.
Adam Waldman: Allowing us to compete more broadly across the RMS space with.
Adam Waldman: With potentially best in class products, and both the IV and subcutaneous markets.
Adam Waldman: These advancements will help drive sustained growth for years to come.
animal woman: Fourth quarter numbers and full year numbers exceeded our guidance and reflects the growing demand we are seeing from reality.
Adam Waldman: We remain very excited about the future and look forward to updating you on our progress in the quarters ahead.
animal woman: Revenue is also gaining momentum internationally as many of you know we partnered ex North America commercialization rights to <unk>.
Adam Waldman: With that I'll turn it over to Sean to discuss our financials. Thank you.
animal woman: <unk> farm, who launched <unk> in Germany in February of 2024.
Sean Power: Thank you Adam and thanks, everyone for joining us.
Sean Power: Earlier. This morning, we reported our detailed fourth quarter and full year 2024 financial results press release, which is available on the investors and media section of our website.
animal woman: Since then they have lots of number of EU countries and the U K and overall the feedback from the EU has been positive and we look forward to that continuing to expand the geographical reach of Brown V in the future.
Sean Power: Yeah.
animal woman: Our differentiation strategy remains strong confidence that physicians have demonstrated continuing to prescribe reality underscores the importance and the adult RMS treatment paradigm. Our recent five year data and real world experience continue to reinforce the unique value proposition.
Speaker Change: This morning, I'll start with a discussion of our revenue for the fourth quarter and full year of 2024, which Adam had briefly touched on.
Speaker Change: We are pleased to report <unk> net product revenue of $103 6 million during the fourth quarter.
Speaker Change: Our total net product revenue for the fourth quarter was $107 3 million.
animal woman: And efficient infusion combined with the proven efficacy and a consistent safety profile.
Speaker Change: And in addition to U S. Net revenue includes approximately $3 7 million of revenue from products sold to <unk>.
animal woman: The quarter over quarter growth, we achieved validates an increase in confidence among prescribers and patients and <unk> is a leading anti CD 20 option of RMS are done our dynamic market share in the physician administered anti CD 20 segment is increasing and.
Speaker Change: <unk> farm.
Speaker Change: In support of the ex U S commercial launch.
Speaker Change: For the full year, we reported total global revenue of approximately 329 million, which is predominantly comprised of $310 million and U S. <unk> net product sales and.
And we anticipate continued growth as physician experience and comfort with <unk> increases.
animal woman: Additionally, our field teams have been highly effective in educating prescribers on the attributes of brown with.
Speaker Change: In the $12 $5 million milestone from our partner for the ex U S commercial launch of branding.
animal woman: With increasing adoption among high volume infusion centers and academic neurologists, we remain committed to expanding patient education efforts in optimizing the overall treatment experience.
Speaker Change: As mentioned a moment ago during the quarter, we recognized revenue for products sold to our partner <unk>.
Speaker Change: It is worth noting that when looking at our Cogs margin in the fourth quarter. It includes the cost of goods sold through our partner, which are of course sold at a margin significantly less than what we see commercially here in the U S.
animal woman: The foundational work we have done throughout 2024, coupled with the strong adoption trends, we're seeing today.
animal woman: At the stage for continued growth in 2025, we will maintain our focus on driving deeper penetration in the RMS market, ensuring that <unk> reaches as many eligible patients as possible.
Speaker Change: Thereby giving the appearance of having an unfavorable impact on our gross margin.
Speaker Change: Absent this infrequent occurrence when we recognize.
animal woman: Looking ahead to 2025, we expect multiple drivers to continue fueling our growth.
Speaker Change: Revenue related to the sale of goods through our partner our gross margin has and should remain relatively consistent.
animal woman: Including expansion into additional infusion centers academic and community practices.
animal woman: Direct to patient engagement efforts.
Speaker Change: On the expense side of the ledger, we commenced the year with <unk> with 2024, Opex guidance, excluding noncash items of approximately $250 million.
animal woman: Increased real world evidence supporting <unk> efficacy safety and Tolerability.
animal woman: And strengthening perceptions around payer coverage and access.
animal woman: We are off to a strong start in 2025.
Speaker Change: And we're pleased to report that during the quarter and full year 2024, our operating expenses have remained well controlled and below our guided ranges.
animal woman: The typical challenges inherent in Q1 enrollments and overall demand has been robust with January and February being our highest month of total new patients into our hub since launch.
Speaker Change: For the fourth quarter and full year 2024, our opex was approximately $51 million and $206 million respectively.
animal woman: We feel confident in how the year has started and are now estimating $115 million in U S. <unk> net revenue in Q1.
Speaker Change: Earlier this year at the Jpmorgan conference, we guided that we expect our operating expenses to be approximately $300 million for the full year 2025.
animal woman: And believe we are on track to meet or exceed our full year U S guidance of $525 million.
animal woman: In closing I want to thank our dedicated team for their relentless efforts in bringing <unk> to people with Rms.
Speaker Change: As a result of the continued strong bring them relaunch in a strategic and disciplined approach to spending.
animal woman: Over the past two years, we have built a strong foundational commercial infrastructure.
Speaker Change: We are pleased to report GAAP net income of approximately $23 million.
animal woman: That has delivered exceptional results exceeding all expectations for the launch.
Speaker Change: <unk> 15 cents per diluted share in both the three and 12 months 12 month periods ending December 31, two.
animal woman: This success now provides a solid platform from which to build potential blockbuster products.
animal woman: And that math and capitalize on other autoimmune disease opportunities going forward.
Speaker Change: 2024.
Speaker Change: And last but not least <unk>.
Speaker Change: Close by touching on our cash position.
animal woman: The team, we have the capabilities and the leverage to drive future growth, including the opportunity to further strengthen our position in the RMS market.
Speaker Change: We ended the fourth quarter with approximately $311 million in cash cash equivalents and investment securities.
animal woman: With enhanced IV administration options and the development of a patient administered subcutaneously formulation of around it.
Speaker Change: When excluding investments in inventory and share repurchases, we generated cash flow from operations in 2024.
animal woman: We believe this new option has the potential to significantly expand our market opportunity.
Trend, which we expect to continue in 2025.
animal woman: Allowing us to compete more broadly across the RMS space with.
Speaker Change: We believe our existing cash provides us with a strong financial position to continue to support the <unk> commercialization.
With potentially best in class products, and both the IV and subcutaneous markets.
Speaker Change: And invest in our research and development efforts and our business operations for the foreseeable future.
animal woman: These advancements will help drive sustained growth for years to come.
animal woman: We remain very excited about the future and look forward to updating you on our progress in the quarters ahead.
Speaker Change: With that I will now turn the call back over to the conference conference operator to begin the Q&A.
With that I'll turn it over to Sean to discuss our financials. Thank you.
Speaker Change: Thank you well now be conducting a question and answer session, if you'd like to be placed into the question queue. Please press star one on your telephone keypad as a reminder, we ask that you. Please ask one question and one follow up then return to the queue. If you would like to remove your question from the queue. Please press star two once again Thats star one to be placed in the question queue.
Sean: Thank you Adam and thanks, everyone for joining us.
Sean: Earlier. This morning, we reported our detailed fourth quarter and full year 2024 financial results press release, which is available on the investors and media section of our website.
Sean: Yeah.
This morning, I'll start with a discussion of our revenue for the fourth quarter and full year 2024, which Adam had briefly touched on.
Speaker Change: Our first question is coming from <unk> <unk> from Cantor Fitzgerald. Your line is that life.
Speaker Change: Hi, Good morning, and thank you for taking my questions and congrats on all the progress so maybe firstly.
Sean: We are pleased to report U S net product revenue of $103 6 million during the fourth quarter.
Speaker Change: You mentioned about January and February being a strong growth and Duane Duane if I am going to meaningfully exceed the 425 million that you gave so maybe just give more color around that what are you seeing what are the biggest segment of <unk>.
Sean: Our total net product revenue for the fourth quarter was $107 3 million and in it and in addition to U S. Net revenue includes approximately $3 7 million of revenue from products sold to narrow ex farm.
Speaker Change: Growth.
Speaker Change: As you look towards the rest of the year and secondly.
Sean: In support of the ex U S commercial launch.
Speaker Change: <unk> has a hydro's readout this year.
Sean: For the full year, we reported total global revenue of approximately 329 million, which is predominantly comprised of $310 million in U S. <unk> net product sales.
Speaker Change: Maybe if you can talk about where you see that product linger on in the market that would be super helpful. Thank you.
Sean: And the $12 $5 million milestone from our partner for the ex U S commercial launch of a branding.
Mike Weiss: Mike you already think that perhaps your phone is on mute.
Speaker Change: Oh, Yeah, sorry about that Yeah go ahead, Adam once you go ahead.
Sean: As mentioned a moment ago during the quarter, we recognized revenue for products sold to our partner neurons from.
Speaker Change: Yes, <unk>. Thanks for the question our growth.
Speaker Change: First question about the growth our growth come from it's coming from a broad set of customers.
Sean: It is worth noting that when looking at our Cogs margin in the fourth quarter. It includes the cost of goods sold through our partner, which are of course sold at a margin significantly less than what we see commercially here in the U S.
Speaker Change: With enrolment so far in both.
Speaker Change: The academic and.
Speaker Change: Private clinic, setting a little bit more on an academic knowledge.
Thereby giving the appearance of having an unfavorable impact on our gross margin.
Speaker Change: I mentioned I think in previous calls.
Speaker Change: Academic hospitals now account for the majority of where we're seeing growth in our overall enrollments.
Sean: Absent this infrequent occurrence when we recognize.
Sean: Revenue related to the sale of goods through our partner our gross margin has and should remain relatively consistent.
Speaker Change: I think that's being driven by a lot of things a number of things that we talked about in the call. The five year data the real world experience our expansion strategy of course with with more people in the field versus.
Sean: On the expense side of the Ledger, we commenced the year with two with 2024 opex guidance, excluding noncash items of approximately $250 million.
Speaker Change: We did have we did a pretty significant expansion in 2024. So all of those things are driving are driving our growth that we're seeing and as I said January and February were our best months in terms of new.
Sean: And we're pleased to report that during the quarter and full year 2024, our operating expenses have remained well controlled and below our guided ranges.
Enrollments into our hub.
Sean: For the fourth quarter and full year 2024, our opex was approximately $51 million and $206 million respectively.
Speaker Change: And then for the high dose.
Speaker Change: <unk>.
Speaker Change: I'll start and I'll hand, it over to Mike.
Speaker Change: It really depends on the.
Sean: Earlier this year at the Jpmorgan conference, we guided that we expect our operating expenses to be approximately $300 million for the full year 2025.
Speaker Change: The profile.
Speaker Change: We haven't seen much.
Speaker Change: In terms of what the profile looks like what the safety profile will look like what the infusion experience so really hard to comment until we know more.
Sean: As a result of the continued strong bring them relaunch in a strategic and disciplined approach to spending.
Speaker Change: Yeah, I'll just add to that I think that's a fair point and we have very little to go on for the moment, we imagine it will be a relatively long infusions.
Sean: We are pleased to report GAAP net income of approximately $23 million.
Sean: <unk> 15 cents per diluted share in both the three and 12 months 12 month periods ending December 31 2024.
Speaker Change: I assume they'll figure out they'll try to put it into some sort of a sub Q to try to limit the timeframe, but the volume will be pretty dramatic. So yes until we know more I think we just have to wait and see.
And last but not least I'll close by touching on our cash position.
We ended the fourth quarter with approximately $311 million in cash cash equivalents and investment securities.
Speaker Change: Thank you. Your next question today is coming from Michael <unk> from Evercore ISI. Your line is now live.
Sean: Excluding investments in inventory and share repurchases, we generated cash flow from operations in 2020 for a trend, which we expect to continue in 2025.
Speaker Change: Hey, guys. Thanks for taking my call and congrats on all the progress two for me.
Speaker Change: Obviously that would be it seems like the pivotal phase III subcutaneous trial for pre M&A come around the middle of the year to the extent that you can I mean has the sub Q trial design being finalized and can you confirm whether Q2 months or where Q3 months.
Sean: We believe our existing cash provides us with a strong financial position to continue to support the breed on the commercialization.
Sean: And invest in our research and development efforts and our business operations for the foreseeable future.
Speaker Change: Remains the target regimen and.
With that I will now turn the call back over to the conference conference operator to begin the Q&A.
Speaker Change: Finally, just a follow up to expectations on gross to net for the balance of the year. Thank you.
Sean: Thank you well now be conducting a question and answer session, if you'd like to be placed into questions. Two please press star one on your telephone keypad. As a reminder, we ask you. Please ask one question and one follow up then return to the queue. If you like to remove your question from the queue. Please press star two once again Thats star one to be placed in the question queue.
Adam Once you go ahead and do the gross to net and I'll come back and do the sub Q.
Speaker Change: Yeah.
Speaker Change: Yes, Michael we expect gross to net in the 70% to 75% range.
Speaker Change: With with some fluctuation quarter to quarter, but that's that's what we're expecting.
Speaker Change: Okay.
Speaker Change: First question is coming from a car or a walk from Cantor Fitzgerald. Your line is that life.
Speaker Change: And in the sub two yes. So the target is to get this going hopefully by the middle of the year.
Sean: Yeah.
Speaker Change: Hi, Good morning, and thank you for taking my questions and congrats on all the progress so maybe firstly.
Speaker Change: In terms of the exact design that is has not been finalized we're still we're still gathering more violence.
Speaker Change: You mentioned about January and February being a strong growth and trained 25 guy too.
Speaker Change: We're still looking at stuff.
The study design.
Speaker Change: And in terms of whether it's gonna be every two months every three months I think thats.
Speaker Change: Meaning fully exceed the 525 million that you gave so maybe just give more color around that what are you seeing what are the biggest segment of <unk>.
Speaker Change: Still yet to be determined.
Speaker Change: And it is plausible.
Speaker Change: Growth.
Speaker Change: That we could end up with.
Speaker Change: As you look towards the rest of the year and secondly, Oh of course has a higher dose read out this year.
Speaker Change: With potentially.
Speaker Change: Studying two doses in the phase III.
Speaker Change: Maybe if you can talk about where you see that product linger on in the market that release a personal thank you.
Speaker Change: Got it thanks, so much.
Speaker Change: Got it.
Speaker Change: Thank you next question is coming from Ed White from H C. Wainwright. Your line is that a lot.
Ed White: Great. Thanks for taking my questions. So just a follow up question on the sub Q potential how are you thinking about the size of that trial.
Speaker Change: Mike do you want me to take that perhaps your phone is on mute.
Mike: Oh, Yeah, sorry about that Yeah go ahead, Adam once you go ahead.
Speaker Change: And.
Speaker Change: The timing for enrollment sing is that its.
Speaker Change: Yes, <unk>. Thanks for the question our growth.
Speaker Change: Competitive market that's already penetrated.
Speaker Change: First question about the growth our growth come from it's coming from a broad set of customers.
Speaker Change: Yeah. Thanks, Thanks for the question.
Speaker Change: With enrollment so far in both.
Speaker Change: So the size of the trial.
Speaker Change:
Speaker Change: The academic and and private clinic setting a little bit more on an academic now as I mentioned I think in previous calls.
Speaker Change: Is most likely going to be similar to the studies that <unk> did for their sub Q I think we're talking about somewhere around 200 per arm, probably a little bit less trying to remember exactly what the army is there like 150 per arm. So it's not an incredibly large study it's a it's not a small study either.
Speaker Change: Academic hospitals now account for the majority of where we're seeing growth in our overall enrollments.
Speaker Change: I think that's being driven by a lot of things a number of things that we talked about in the call. The five year data the real world experience our expansion strategy of course with more people in the field versus we.
Speaker Change:
But in terms of enrollment I mean, we enrolled in the pivotal studies.
Speaker Change: For for Brown V. A thousand patients in 12 months or so so I don't know that enrollment is going to be the challenge.
Speaker Change: We did a we did a pretty significant expansion in 2024. So all of those things are driving are driving our growth that we're seeing and as I said January and February were our best months in terms of new.
Speaker Change: Here I just think we just got to get ourselves in a position to get it going but yes, we're projecting about a 12 month enrollment period.
Speaker Change: Enrollments into our hub.
Speaker Change: It could be I think it would be the one that can be a little shorter, but give or take many years, yes, you got it okay.
Speaker Change: And then for the high dose.
Speaker Change: Oh, I'll, just I'll start and then I'll hand, it over to Mike and it really it really depends on the.
Speaker Change: Thanks, and then just.
Speaker Change: The profile I mean, we haven't seen much.
Speaker Change: I appreciate the Opex guidance, how should we be thinking about that regarding SG&A.
Speaker Change: In terms of what the profile looks like what the safety profile will look like what the infusion experience so really hard to comment until we know more.
Speaker Change: SG&A versus R&D. The question on SG&A, it's just as the Salesforce right sized now or continue to add there and are there any.
Speaker Change: Yeah, I'll just add to that I think thats, a fair claim and we have very little to go on for the moment.
Speaker Change: Marketing schemes going forward that might.
Speaker Change: Imagine, it's it will be a relatively long infusion.
Speaker Change: Lead to increased SG&A costs.
Speaker Change: And they'll figure out they will try to put it into some sort of a sub Q to try to limit the timeframe, but the volume will be pretty dramatic. So yes until we know more I think we just have to wait and see.
Speaker Change: Yeah.
Speaker Change: Adam go ahead.
Speaker Change: Yes sure. Thanks.
Speaker Change: Yeah.
Speaker Change: On the sales force.
Speaker Change: I think we will look to strategically.
Speaker Change: Continue to add people slowly over over time, where we see opportunity.
Speaker Change: Thank you next question today is coming from Michael <unk> from Evercore ISI. Your line is now live.
Speaker Change: So I think there could be but I don't think those would be material expansions to SG&A.
Michael: Hey, guys. Thanks for taking my call and congrats on all the progress.
Speaker Change: For me.
Speaker Change: Obviously, it seems like the pivotal phase III subcutaneous trial for being able to make it come around the middle of the year to the extent that you can I mean has the sub Q trial design being finalized and can you confirm whether Q2 months or where Q3 months remains the target regimen.
Speaker Change: And then we do expect to do some patient as we said in the past, where we are and we said this morning.
Speaker Change: We'll be doing some things on the patient side, but I'll, let I'll, let sean or my comment to the materiality of that.
Speaker Change: And.
Sean Power: Yeah, I don't have any further comment Sean do you know.
Speaker Change: Finally, just a follow up to expectations on gross to net for the balance of the year. Thank you.
Speaker Change: No nothing nothing further.
Sean Power: Not at this time.
Adam: Adam Once you go ahead into the grocery and then I'll come back and do the sub Q.
Ed White: Ed just a just a quick my crack staff was.
Speaker Change: Yeah.
Ed White: Was it was ready to go with a better answer than mine. So I will tell you that we're probably looking at somewhere about 125 to $1 50 per arm, which is in line with the reopening of sub two study for the <unk>.
Speaker Change: Yes, Mike we expect gross to net in the 70% to 75% range.
Speaker Change: With some fluctuation quarter to quarter.
Speaker Change: That's what we're expecting.
Speaker Change: Okay.
Speaker Change: Q arms.
Ed White: Yeah.
Speaker Change: And in the sub two yes. So the target is to get this going hopefully by the middle of the year.
Ed White: Okay, great. Thanks, Mike Thanks for taking my questions.
Ed White: Thank you.
Thank you next question is coming from Eric Joseph from Jpmorgan. Your line is that life.
Speaker Change: In terms of the exact design that has has not been finalized we're still we're still gathering more by.
Eric Joseph: Hi, good morning, Thanks for taking the questions.
Speaker Change: Got it.
Speaker Change: We're still looking at.
Eric Joseph: Just on your feedback and actions I'm wondering what the reception has been like to enhance.
Speaker Change: The study design.
Speaker Change: And in terms of whether it's going to be every two months every three months I think thats still yet to be determined.
Eric Joseph: The enhanced trial data.
Eric Joseph: Dan.
Eric Joseph: <unk> app to modify.
Speaker Change: And it is plausible.
Speaker Change: That we could end up with.
Eric Joseph: Use today based on the data that <unk> seen so far and how much more would a formal label expansion drive utilization based on the feedback we're getting so far and then.
Speaker Change: With potentially.
Speaker Change: Studying two doses in the phase III.
Speaker Change: Got it thanks, so much.
Eric Joseph: I guess looking to that and I guess when.
Speaker Change: You bet.
Speaker Change: Thank you next question is coming from Ed White from H C. Wainwright Your line is that right.
Eric Joseph: All said and done would you expect to file an S BLA for a consolidated certain.
Ed White: Great. Thanks for taking my questions. So just a follow up question on the sub Q potential how are you thinking about the size of that trial.
Eric Joseph: Enhance it.
Eric Joseph: Infusion.
Eric Joseph: Regiment.
Eric Joseph: Yeah sure. Thanks.
Eric Joseph: Thanks, Eric.
Speaker Change: And the.
Speaker Change: Yes, so we actually did do some Poland, while we're there.
Ed White: The timing for enrollment sing is that its.
Speaker Change: Competitive market that's already penetrated.
Eric Joseph: <unk> asked a number of folks about that.
Eric Joseph: What's interesting is if you recall when we started the enhance study for the <unk> switches.
Speaker Change: Yeah. Thanks, Thanks for the question.
Speaker Change: So the size of the trial.
Eric Joseph: We did it because in large part because we had seen in the market that people were already taken.
Speaker Change: <unk> is most likely it's going to be similar to the studies that oak revisited for their sub Q I think we're talking about somewhere around 200 per arm, probably a little bit less trying to remember exactly what the army is there like $1 50 per arm. So it's not an incredibly large study.
Eric Joseph: Folks on another CD 20, and switching them to.
Eric Joseph: Two the <unk> without going through the introductory dose and.
Eric Joseph: To be honest, we had no experience with that whatsoever, and we really will.
Speaker Change: It's not a small study either.
Eric Joseph: Wanted to make sure there was.
Eric Joseph: Safety information around that in case, we needed to give any further guidance for folks.
Speaker Change:
Speaker Change: But in terms of enrollment.
Speaker Change: We enrolled in the pivotal studies for for Brown V. A thousand patients in 12 months or so so I don't know that enrollment is going to be the challenge.
Eric Joseph: So we've got that going rather quickly.
Eric Joseph: Able to enroll obviously.
Eric Joseph: The number of patients then.
Eric Joseph: What we've seen is that.
Eric Joseph: Switching the patients without the 150 milligram dose doesn't appear to cause any safety concerns. So that was our biggest worry was safety of our folks that were already in the field doing it.
Here I just think we just got to get ourselves in a position to get it going but yeah, we're projecting about a 12 months enrollment period.
Eric Joseph: We did ask.
Speaker Change: So do you think it would be a little longer it can be a little shorter, but give or take about a year. Yes, you got it okay.
Eric Joseph: People about that than most.
Eric Joseph: Most people.
Eric Joseph: We had spoken to are already switching.
Speaker Change: Thanks, and then just.
Eric Joseph: Using the first introductory dose again, so that's that's out of our hands, obviously, we don't.
Speaker Change: I appreciate the Opex guidance, how should we be thinking about that regarding.
We certainly don't.
Eric Joseph: Don't talk about that in terms of commercially.
Speaker Change: SG&A versus R&D. The question on SG&A, it's just that the salesforce right sized now or continue to add there and are there any.
Eric Joseph: Commercially talking about it but we did ask that question.
Eric Joseph: So that one seems to be something that the community of <unk>.
Eric Joseph: It seems very comfortable with I'd say the other the other stuff that we're working on including a 30 minute infusion.
Speaker Change: You know marketing schemes going forward that might.
Eric Joseph: Less likely that people will use a 30 minute infusion until those proper instructions in the label.
Speaker Change: Lead to increased SG&A costs.
Eric Joseph: So that's something we'll be working on as well and then in terms of the.
Adam: Adam on the go ahead.
Eric Joseph: The front end consolidating the two doses into one dose that we give.
Adam: Yeah sure. Thanks, so on the sales force.
Eric Joseph: On day, one and we avoid having to come back.
Adam: I think we will look to strategically.
Eric Joseph: That's something I think we can get started on rather quickly we would hope to have.
Adam: You need to add people slowly over over time, where we see opportunity.
Eric Joseph: Uh huh.
Eric Joseph: A BLA potentially of the <unk>.
Adam: So I think there could be.
Eric Joseph: <unk> date for something like that by mid 'twenty seven.
Adam: I don't think those would be material expansions to SG&A.
Eric Joseph: So we'll keep you posted but yes, I think thats, probably the one that could happen fastest second within a 30 minute and we've stated previously that.
Adam: And then we do expect to do some patient as we said in the past we are we and we said this morning.
Adam: We will be doing some things on the patient side, but I'll, let I'll, let sean or my comment to the materiality of that.
Eric Joseph: Our full efficacy trial would be required to remove.
Eric Joseph: That switch dose.
Eric Joseph: But for the moment I think we feel comfortable providing safety information.
Eric Joseph: Throw medical but I don't know that that's going to go into a pivotal trial at this time.
Speaker Change: Yeah, I don't have any further comment Sean again on that.
Adam: No nothing nothing further.
Speaker Change: Okay, Great and maybe one follow up if I could just thinking about the.
Speaker Change: At this time.
Ed White: Ed just a just a quick my crack staff was.
Eric Joseph: Myasthenia gravis expansion opportunity.
Ed White: It was ready to go with a better answer than mine. So I will tell you that we're probably looking at somewhere about 125 to $1 50 per arm, which is in line with the reopening of sub two study for the <unk> arms.
Eric Joseph: Can you talk neurologists, I'm really thinking about sort of how broadly.
Eric Joseph: Any of your CD 20 approach.
Eric Joseph: Might be adopted.
Eric Joseph: Particularly in relation to the <unk>.
Ed White: Yeah.
Eric Joseph: <unk> and have CRM blockers.
Mike: Okay, great. Thanks, Mike Thanks for taking my questions.
Speaker Change: Yes. Thank you.
Eric Joseph: Yeah I mean.
Speaker Change: Thank you. Your next question is coming from Eric Joseph from JP Morgan. Your line is now life.
Like I said previously I mean, we we are exploring MG was one that we've had on our list for a while it's not.
Eric Joseph: Hi, good morning, Thanks for taking the questions.
Eric Joseph: Just on your feedback and actions I'm wondering what the reception has been like to enhance.
Eric Joseph: Is underserved as it as it used to be but we do think there is room potentially.
Eric Joseph: The enhanced trial data the extent docs are apt to modify.
Eric Joseph: Four.
Eric Joseph: Highly active convenient safe treatment option.
Eric Joseph: Use today based on the data that <unk> seen so far and how much more would a formal label expansion drive utilization based on the feedback youre getting so far and then.
Eric Joseph: That could.
Eric Joseph: Could be potentially providing a cost effective way I mean right now the treatments for Mg are.
Eric Joseph: Paul on the highest highest scale of of of expenses and we know <unk> is quite cost effective and and and how we've priced it. So I think there's I think there's room in MG again, we've said previously we're not yet ready to two two.
Eric Joseph: I guess looking to that and I guess when.
Eric Joseph: Now all sudden done would you expect to file an S BLA for a consolidated certain.
Eric Joseph: Enhance.
Eric Joseph: Infusion.
Eric Joseph: Regimen.
Eric Joseph: Yeah sure. Thanks.
Eric Joseph: Plant, a flag and say Mg as our next.
Eric Joseph: Thanks, Eric.
Eric Joseph: Yeah. So we actually did do some polling while we're there.
Eric Joseph: Development program, but we do think it's interesting we're just doing a lot more work on it.
Eric Joseph: <unk> asked a number of folks about that whats.
Eric Joseph: Maybe James all across this year as we look for other opportunities. We do think there is.
Eric Joseph: This thing is if you recall when we started the enhance study for the <unk> switches, we did it because in large part because we had seen in the market that people were already taking.
Eric Joseph: The CD 19 Flash CD 20.
Eric Joseph: Opportunity across autoimmune diseases, as large and whether it's.
Eric Joseph: With something like Ramsay or Theres, some opportunity of course with car T across multiple different.
Eric Joseph: Folks on another CD 20, and switching them.
Eric Joseph: Two the brownsea without going through the introductory dose and.
Eric Joseph: Autoimmune diseases I think theirs is general enthusiasm I think there's a general belief that these work.
Eric Joseph: To be honest, we had no experience with that whatsoever, and we really don't.
Eric Joseph: I mean, they're all between.
Eric Joseph: Wanted to make sure there was.
Eric Joseph: Safety information around that in case, we needed to give any further guidance you folks.
Eric Joseph: Well, let's speak much to the comp on the side of it but certainly between the CD 19, CD 20 landscape and the FTR and I mean, you are working along a certain part of the continuum of.
Eric Joseph: So we've got that going rather quickly.
Eric Joseph: Well to enroll obviously, a significant number of patients and.
Eric Joseph: What we've seen is that.
Eric Joseph: B cell to plasma too to antibodies.
Eric Joseph: Switching to patients without the 150 milligram dose doesn't appear to cause any safety concerns. So that was our biggest worry was safety of folks that were already in the field doing it.
Eric Joseph: <unk> seen some strategies.
Eric Joseph: They're all they're all similarly aligned in ways and just where in that Cascade do you think youre going to have the best effect and the best long lasting effect.
Eric Joseph: We did ask.
Eric Joseph: People about that than most.
Eric Joseph: Most people.
Eric Joseph: We had spoken to are already switching.
Eric Joseph: Great. Thanks for taking my questions.
Eric Joseph: Using the first introductory dose again, so that's that's out of our hands, obviously, we don't serve.
Eric Joseph: Got it.
Ami: Thank you next question is coming from my half months' Ami from B Riley Securities. Your line is now live.
Eric Joseph: Don't know.
Eric Joseph: Ill talk about that in terms of.
Ami: Yes, good morning team, thanks for taking our questions and congrats on a great start deploying 25.
Eric Joseph: Commercially talking about it but we did ask that question.
Eric Joseph: So that one seems to be something that the community.
Ami: Are you able to share the revenue split of <unk> versus medallions nation segment in and just wondering looking forward has there been a change to an internal assumptions amendment in segment revenues exceed that of new patients.
It seems very comfortable with I'd say the other the other stuff that we're working on including 30 minute infusion.
Eric Joseph: Less likely that people will use a 30 minute infusion until those proper instructions in the label.
That's something we'll be working on as well and then in terms of the front end consolidating the two doses into one dose that we give.
Ami: And then just a two part question is the on.
Ami: On a dynamic market share basis.
Day, one and we avoid having to come back.
Comment on what May you stand based on how you look at switch from another <unk> 20.
Eric Joseph: And that's something I think we can get started on rather quickly we would hope to have.
Eric Joseph: <unk>.
Eric Joseph: A BLA potentially of the <unk> date for something like that by mid 2007.
Ami: Adam you want to go ahead, and give a crack and if I can add on top of unnecessary, yes, yes sure. Thanks for the question Mike.
Eric Joseph: So we'll keep you posted but yes, I think thats, probably the one that could happen fastest secondly, the 30 minute and we've stated previously that.
Ami: Further revenue splits I don't I don't have that for you I think what I've said in the past is that early in 2025, we will start to see.
Eric Joseph:
Eric Joseph: <unk> efficacy trial would be required to remove.
Eric Joseph: That switch dose.
Ami: Repeat prescriptions be the majority of the prescriptions.
Eric Joseph: But for the moment I think we feel comfortable providing safety information.
Eric Joseph: Through medical but I don't know that that's going to go into a pivotal trial at this time.
Ami: That debt is forecasted.
Ami: Tap in.
Ami: In the early part of 2025, that's our expectation.
Speaker Change: Okay, Great maybe one follow up if I could just thinking about the.
Ami: To.
Ami: To provide more detail on that in the future and then as far as the dynamic market share.
Eric Joseph: Myasthenia gravis expansion opportunity.
Speaker Change: I guess can you talk to neurologists.
Ami: I think we said this at Jpmorgan, we're getting about one in four.
Eric Joseph: Thinking about sort of.
Eric Joseph: Broadly.
Eric Joseph: Any anti CD 20 approach.
Eric Joseph: Might be adopted.
Ami:
Ami: <unk>.
Eric Joseph: Particularly in relation to the.
Ami: One in four patients on IV <unk>.
Eric Joseph: <unk>.
Ami: <unk> today, which represents about 60% of the market.
Eric Joseph: Have CRM blockers.
Eric Joseph: Yeah, I mean like.
Ami: But that number is increasing and certainly we expect that to increase throughout the year.
Eric Joseph: Like I said previously I mean, we we are exploring MG was one that we've had on our list for a while it's not.
Speaker Change: Great and just on the pipeline front, if you're able to give us some color on the size of the allogeneic.
Eric Joseph: Is underserved as it as it used to be but we do think there is room potentially.
Eric Joseph: Four.
Eric Joseph: Highly active convenient safe treatment option.
Ami: <unk>.
Ami: Study that you just cited enrollment shortly here in Indiana, which would be the timeline and then maybe study objectives I understand this would be dose finding initially but any.
Eric Joseph: That could.
Eric Joseph: It could be potentially providing a cost effective way I mean right now the treatments for Mg are.
Eric Joseph: Paul on the highest highest scale of of expenses and we know <unk> is quite cost effective and and and how we've priced it. So I think there's I think there's room in MG again, we've said previously we're not yet ready to two two.
Ami: Good dynamic data that we could expect.
Ami: It would be helpful to give some color Mike thanks for taking English.
Mike Weiss: Yeah sure so.
Ami: That study is.
Mike Weiss: Ready to launch.
Mike Weiss: Ready to receive patients.
Eric Joseph: <unk>.
Speaker Change: This study is not yet enrolled its first patient so I'd like to say, we're going to have lots and lots of patients Miami, but but so so far a bit of a slow start.
Eric Joseph: Plant, the flag and say Mg as our next.
Eric Joseph: Development program, but we do think it's interesting we're just doing a lot more work on it.
Eric Joseph: Maybe Jim so all across this year as we look for other opportunities and we do think there is.
Mike Weiss: Out of the gate here.
Mike Weiss: The goal as you mentioned is is dose finding so first step is finding the right dose finding the right conditioning regimen that makes the most sense.
Eric Joseph: The CD 19 Flash CD 20.
Eric Joseph: Opportunity across autoimmune diseases, as large and whether it's.
Eric Joseph: With something like Ramsay or Theres, some opportunity of course with car T across multiple different.
Mike Weiss: And these patients in this setting so we've got a little bit of work to do there.
Mike Weiss: And in terms of.
Eric Joseph: Autoimmune diseases. So I think there's general enthusiasm I think there's general belief that these things work.
Mike Weiss: Outcomes for patients with progressive forms of MFS.
Mike Weiss: The ultimate goal as you slow or stop the progression. Unfortunately, that's not a it's not something that you will be able to see easily with with a handful of patients. So I don't think we're in this for some sort of miracle data that.
Eric Joseph: I mean, they're all between.
Eric Joseph: I wont speak much to the comp on the side of it but certainly between the CD 19, CD 20 landscape in the SCR and I mean, you are working along a certain part of the continuum of care.
Mike Weiss: We give it the car T.
Eric Joseph: B cell to plasma too to antibodies.
Mike Weiss: Sure some of the progressive forms of <unk> and all of a sudden you can see some dramatic effect.
Eric Joseph: <unk> seen some strategies.
Eric Joseph: So they're all they're all similarly aligned in ways, and just where and that Cascades, you think youre going to have the best effect and the best long lasting effect.
We will be able to slow or stop that progression, which would be fantastic.
Mike Weiss: There are biomarkers that could be looked at.
Mike Weiss: There is some CNS biomarkers all the clonal bans would be interesting.
Eric Joseph: Great. Thanks for taking my questions.
Mike Weiss: We will look at it b cell depletion and repletion.
Eric Joseph: Got it.
Amin: Thank you next question is coming from last month's Amin from B Riley Securities. Your line is now live.
Mike Weiss: So it's from some of these biomarkers are out there we can look at those.
Amin: Yes, good morning team, thanks for taking our questions and congrats on a great degree in 'twenty five.
Mike Weiss: But I.
Mike Weiss: I think at some point, we'd have to just get.
Again, good enough conviction to move forward with a randomized which is the only way for primary forms of.
Amin: Are you able to share the revenue split of <unk> versus maintaining vision.
Mike Weiss: Progressive forms of MS. Having said that we're also looking to expand into other.
Amin: <unk> and just wondering looking forward has there been a change do an internal resumption amendment in segment revenues exceed that of new patients.
Speaker Change: Disease States.
Speaker Change: Which I would call it adjacent or ancillary to mess and things. We think we could we could do well to get started and then we can think about further expansion of that opportunity but.
Amin: And just a two part question here on.
Amin: On a dynamic market share basis.
Amin: <unk> to comment on what May you stand based on how you look at switch from another <unk> 20.
Speaker Change: Preferred probably at this point too to start slow and let's let's do some dose finding and let's make sure we can have a safe.
That at least depletes b cells.
Speaker Change: Effectively in folks of autoimmune diseases.
Adam: Adam you want to go ahead, and give a crack and if I can add on top if necessary.
Mike Weiss: Great very helpful. Thank you Mike.
Speaker Change: Yeah sure. Thanks for the question Mike.
Matt: Thanks, Matt appreciate it thank.
Speaker Change: Further revenue splits I don't I don't have that for you I think what I've said in the past is that early in 2025, we will start to see.
Matt: Thank you we reached end of our question and answer session I'd like to turn the floor back over to Mike for any further or closing comments.
Mike Weiss: Great. Thank you and thanks again, everyone for joining today's call.
Speaker Change: Repeat prescriptions.
Mike Weiss: We've been incredibly pleased with the progress made in 'twenty four and of course looking forward to an exciting 25, I think you heard some really exciting developments both on the commercial front in the early.
Speaker Change: The majority of the prescriptions.
Speaker Change: That is forecasted.
Speaker Change: Tap in.
Speaker Change: In the early part of 2025, that's our expectation.
Mike Weiss: Enrollments that were seeing given us a really nice feel for for the year.
Speaker Change: I can provide.
Speaker Change: <unk> provide more detail on that in the future and then as far as the dynamic market share.
Mike Weiss: Just to restate some primary goals.
Speaker Change: I think we said this at Jpmorgan, we're getting about one in four.
Mike Weiss: For us commencing pivotal program for sub Q.
Mike Weiss: <unk> commencing one or more pivotal studies to enhance the overall patient experience with <unk> enrolling participants into the ongoing.
Speaker Change: <unk>.
Speaker Change: One in four patients on IV CD.
Speaker Change: <unk> today, which represents about 60% of the market.
Mike Weiss: Trials for.
For ground in myasthenia gravis enrolling hopefully as we've discussed in this last question our first patients into the phase one as yourself study and will continue to make presentations during the course of the year and as Adam described in great detail really continue to push hard.
Speaker Change: But that number is increasing and certainly we expect that to increase throughout the year.
Speaker Change: Great and just on the pipeline front, if you're able to give us some color on the size of the allogeneic <unk>.
Mike Weiss: To bring Brown V as far as wide as we can into the.
Speaker Change: <unk>.
Speaker Change: Study that youre signing enrollment shortly here in <unk>.
Mike Weiss: And to the patient community and in the U S and our partners ex U S. So with that again I'll just thank everyone for joining us and have a great day.
Speaker Change: What would be the timeline and maybe study objectives I understand this would be dose finding initially but any.
Speaker Change: Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.
Speaker Change: Moving dynamic data that we could expect.
Mike: It would be helpful to give some color Mike thanks for taking my question.
Speaker Change: Yes, sure so that.
Mike: That study is.
Speaker Change: We're ready to launch.
Speaker Change: Ready to receive patients.
Speaker Change: This study is not yet enrolled its first patient so.
Speaker Change: I'd like to say, we're going to have lots and lots of patients.
Speaker Change: But but so so far a bit of a slow start.
Speaker Change: The gain here.
Speaker Change: The goal as you mentioned is is dose finding so first step is finding the right dose finding the right conditioning regimen that makes the most sense.
Speaker Change: And these patients in this setting so we've got a little bit of work to do there.
Speaker Change: In terms of.
Speaker Change: Outcomes for patients with progressive forms of MFS.
Speaker Change: The ultimate goal as you slow or stop the progression. Unfortunately, that's not a it's not something that you will be able to see easily with a handful of patients. So I don't think we're in this for some sort of miracle data that.
Speaker Change: Yeah, we gave it the car T <unk>.
Speaker Change: First on the progressive forms of <unk> and all of a sudden you can see some dramatic effect.
Speaker Change: We will be able to slow or stop that progression, which would be fantastic.
Speaker Change: There are biomarkers that can be looked at.
Speaker Change: There is some CNS biomarkers, all Oklahoma bans would be interesting certainly we'll look at b cell depletion and repletion.
Speaker Change: So it's some some of these biomarkers are out there we can look at those.
Speaker Change: But yes.
Speaker Change: I think at some point, we'd have to just get.
Speaker Change: Again, good enough conviction to move forward with a randomized which is the only way for primary forms of.
Speaker Change: Progressive forms of MS and we said that we're also looking to expand into other disease.
Speaker Change: Disease stage.
Speaker Change: Which I would call it adjacent or ancillary too to IMS and things. We think we could we could do well to get started and then we can think about further expansion of that opportunity but.
Speaker Change: Preferred probably at this point too to start slow and let's let's do some dose finding and let's make sure we can have a safe.
Speaker Change: That at least depletes b cells.
Speaker Change: Effectively in.
Speaker Change: Folks of autoimmune diseases.
Speaker Change: Great very helpful. Thank you Mike.
Speaker Change: Thanks, Matt appreciate it thank.
Speaker Change: Thank you we reached end of our question and answer session I'd like to turn the floor back over to Mike for any further or closing comments.
Speaker Change: Great. Thank you and thanks again, everyone for joining today's call.
Speaker Change: We've been incredibly pleased with the progress made in 'twenty four and of course looking forward to an exciting 25, I think you heard some really exciting developments both on the commercial front and the early.
Speaker Change: Enrollments that were seeing given us a really a nice feel for for the year.
Speaker Change: Just to restate some primary goals.
Speaker Change: For us commencing pivotal program for sub Q.
Speaker Change: Commencing one or more pivotal studies to enhance the overall patient experience with <unk> enrolling participants into the ongoing.
Speaker Change: Trials for.
Speaker Change: For ground the myasthenia gravis enrolling hopefully as we've discussed in this last question our first patients into the phase one as yourself study and will continue to make presentations during the course of the year and as Adam described in great detail really continue to push hard.
Speaker Change: To bring <unk> as far as wide as we can into the.
Speaker Change: And for the patient community in the us and our partners ex U S. So with that again I'll just thank everyone for joining us and have a great day.
Speaker Change: Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.
Speaker Change: Yeah.
Speaker Change: Yeah.