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Michael Weiss

Thanks, Jenna, and good morning, everybody, and thanks for joining us on today's call. It's a pleasure to be here with you and to provide an update on TG's continued progress, both in the successful launch of BRIUMVI and in building a company committed to improving the lives of those living with multiple sclerosis.
I'm excited to share that we kicked off 2025 with another strong quarter of performance, underscoring the sustained momentum behind BRIUMVI. As you may have seen in the press release this morning, BRIUMVI US net sales reached nearly $120 million in the first quarter, once again exceeding our expectations.
This growth reflects both the increasing adoption by health care providers and a rising tide of patient interest and confidence in BRIUMVI. Over the past month, I spent a significant amount of time in the field, meeting with prescribers and it's energizing to see firsthand of BRIUMVI's becoming the go-to anti-CD20 therapy for many of them.
But what's even more gratifying is hearing directly from people living with MS. At a recent MS walk, I spoke with two individuals who shared their experiences switching to BRIUMVI from another approved IV anti-CD20 therapy. They both described how they previously felt unwell for days or more after each infusion but not with BRIUMVI.
Their stories echo findings from a recent paper in Frontiers in Immunology which highlighted seven case reports of people with MS who switched to BRIUMVI from a prior anti-CD20 due to issues like tolerability, disease activity, wearing off effects or incomplete B-cell depletion.
In each case, the unwanted effect either resolved or did not recur with BRIUMVI. These real-world experiences support the idea that not all CD20s are the same, and that switching within the class may make a difference.
This point is reinforced by another recent publication in CNS drugs, which explores how structural and mechanistic differences among CD20 therapies may drive variations in efficacy and tolerability. Word of mouth within the MS community is powerful, and we believe these success stories are helping to drive continued growth and enthusiasm.
As I often say, more people who start BRIUMVI, the more people will start BRIUMVI. And even in a highly competitive market, our team and BRIUMVI's unique profile are rising to the challenge, I couldn't be more proud of how our team has executed our multiphase launch strategy and the strong start we've made in 2025 as we pursue our long-term goal of making BRIUMVI the number one prescribed anti-CD20 as measured by dynamic market share.
In a moment, Adam Waldman, our Chief Commercialization Officer, will walk you through the commercial performance in more detail. As well as our investment priorities and updated guidance for Q2 and full year 2025. But first, I'd like to highlight our pipeline and efforts to enhance the BRIUMVI experience.
Our core focus of our innovation strategy is simplifying the patient experience. Our enhanced clinical trial is designed to help us evaluate a number of these strategies and has already yielded some encouraging results.
We previously presented the data from this study, demonstrating the safety and tolerability of a 30-minute maintenance infusion as well as initiating BRIUMVI treatment with a single full dose 450-milligram fusion for patients switching from another CD20 who had low B-cell counts.
And most recently at AAN last month, we shared new data showing the safety and tolerability of starting all patients on BRIUMVI with a single 600-milligram dose on day one effectively eliminating the need for a day 15 dose. Feedback on this streamlined approach has been very positive.
We believe patients will appreciate the simplicity of starting treatment with just one infusion visit, making BRIUMVI a true twice-a-year therapy from day one. We are now preparing to advance this regimen into its registration directed trial.
Another exciting initiative is the development of a self-administered subcu BRIUMVI. While the vast majority of patients continue to prefer to receive their anti-CD20 as an IV infusion, there is a growing minority we're now choosing a self-administered subcutaneous option of which there is only one available today. We see a clear opportunity to expand access and choice with a self-administered subcu BRIUMVI.
Our ongoing Phase 1 safety and bioclobin study is showing promising results. The subcu injection appears to be well tolerated with bioavailability that appears to support every other month or even potentially quarterly dosing. We're pleased with the progress so far and are on track to launch a pivotal trial this year.
We also believe the subcu formulation may open new doors for us in new indications. One area that we are currently exploring is the potential for subcu BRIUMVI and myasthenia gravis, and we're evaluating potential additional indications as well.
Finally, on the pipeline front, we continue to be excited about azer-cel, our allogeneic CD19 CAR-T cell therapy. It's early days for CAR-Ts and autoimmune diseases, but we see great potential across multiple indications. We are excited to launch our Phase 1 for azer-cel in progressive forms of MS a segment of the MS population with limited treatment options and poor prognosis.
In closing, 2025 is off to a very strong start. We're executing on our commercial strategy, advancing our clinical programs after expanding our manufacturing capacity to meet the growing demand. I want to thank the entire TG team for their dedication and hard work is our commitment to our mission that enables us to deliver meaningful progress for individuals with relapsing forms of MS.
And now I'll turn the call over to Adam Waldman, our Chief Commercialization Officer. Adam, go ahead.

Adam Waldman

Thanks, Mike, and good morning, everyone. I'm excited to share the details of another strong quarter of commercial execution, delivering meaningful growth and further validating our belief in the long-term potential of BRIUMVI in the RMS market.
US net sales for BRIUMVI in the first quarter of 2025 were approximately $119.7 million, exceeding our internal expectations and reflecting a strong start to the year with 137% year over year growth and 16% sequential quarter over quarter growth. Based on this performance and the strength of leading indicators, we are increasing our full year 2025 BRIUMVI US net revenue guidance, which I will detail at the end of my remarks.
We continue to see strength across our key performance drivers. The first three months of the year marked our highest months of total new patient enrollments since launch, a clear indication that demand continues to accelerate. This is despite the headwinds typically seen in the first quarter and an ongoing competitive product launch. Importantly, March was also our highest month ever for repeat prescribers with physicians coming back to prescribe BRIUMVI again, a strong signal of growing prescriber confidence and satisfaction.
Further, we saw continued strength in the hospital setting, which contributed approximately 60% of enrollments in March, the highest percent to date, highlighting our deepening footprint among institutional accounts.
With discontinued growth for the first time repeat prescriptions have now surpassed new prescriptions, a key inflection point in BRIUMVI's life cycle demonstrating strong persistence trends at week 24 and week 48. While we remain in a competitive marketplace, BRIUMVI continues to stand out. Our five year data, consistent real-world safety and efficacy profile combined with our unique one hour twice-a-year infusion, remain highly compelling to both physicians and patients.
Importantly, we are seeing both an expansion of the CD20 market overall and continued dynamic market share gains for BRIUMVI and the anti-CD20 IV segment, driven by both newly diagnosed patient starts and an increasing volume of switch patients.
Additionally, from my point of view, the field team has executed with excellence. We've deepened our reach among high-volume infusion centers, community neurologists and leading academic institutions, and we continue to receive positive feedback on our team from our customers.
As we look ahead to the remainder of 2025, we are focused on several key growth drivers. First, continuing to accelerate uptake among community neurologists, academic and broader practice types. Second, we will be launching our first ever direct-to-patient BRIUMVI television commercial campaign, including full digital surround sound strategy, to educate, inspire and activate eligible patients to seek out BRIUMVI treatment. Third, our teams will continue to build and leverage a real-world evidence to support BRIUMVI's position as a differentiated and trusted anti-CD20 option.
And fourth, we will start preparing for life cycle innovations, including our subcutaneous formulation, which we believe represents a significant long-term growth opportunity. In summary, we are off to a strong start in 2025.
Our Q1 results reflect growing demand, increasing prescriber confidence, growing patient awareness and broad commercial execution. Looking ahead, we are optimistic about the continued growth and potential of BRIUMVI. As I mentioned, based on current trends in both new patient accumulations and persistence, we are raising our full year 2025 US net revenue guidance for $525 million, which we highlighted at JPMorgan in January to $560 million for the full year 2025.
Additionally, Q2 was already off to a strong start with April being another record month for enrollments into our hub. And while we are still early into the quarter, we're currently targeting $135 million for the second quarter.
With a robust foundation in place, multiple catalysts on the horizon and a highly differentiated product, we believe BRIUMVI is well positioned to become a market-leading therapy in RMS. I want to thank our commercial team for their tireless commitment to drive. Your work is making a meaningful impact on the lives of people living with MS. We're proud of the momentum we've built, and I'm more excited than ever about what lies ahead.
And with that, I'll turn the call over to Sean to walk through our financials. Sean?

Sean Power

Thank you, Adam, and good morning, everyone. Earlier this morning, we reported our detailed first quarter 2025 financial results in a press release, which is available on the investors and media section of our website.
I'd like to start today with a quick overview of our first quarter revenue, something Adam and Mike both already touched on briefly. We're very pleased to report US net product revenue of $119.7 million for the first quarter of 2025.
This reflects 137% growth compared to the same period last year and a 16% increase over the fourth quarter of 2024. This continued momentum underscores the strong demand that we're seeing for BRIUMVI.
Turning to operating expenses. Excluding noncash items, our total OpEx for the quarter, which includes both R&D and SG&A expenses came in at approximately $82 million for the quarter. That's tracking slightly ahead of our full year guidance of approximately $300 million. This increase during the quarter was primarily driven by about $20 million in manufacturing investments for subcutaneous BRIUMVI.
We expect these costs charged to R&D to fluctuate from quarter to quarter. But importantly, we remain confident in our full year OpEx guidance of approximately $300 million. On the bottom line, thanks to the continued strong performance of BRIUMVI, we reported GAAP net income of approximately $5 million or $0.03 per diluted share for the quarter ended March 31, 2025.
And finally, a quick note on our balance sheet. We closed the quarter with $276 million in cash, cash equivalents and investment securities. We believe this puts us in a strong financial position to continue executing our commercial strategy, advancing our pipeline and supporting our operations for the foreseeable future.
Before concluding, I'd like to offer some initial perspectives on the recent discussions regarding potential tariffs. As you may know, BRIUMVI is currently manufactured in South Korea. Given our relatively low cost of goods, we do not anticipate that the currently proposed tariffs will have a material impact on our gross margins or overall financial performance. Nonetheless, we are actively monitoring developments and evaluating all of our options.
With that, I will now turn the call over to the conference operator to begin the Q&A.

Question and Answer Session

Operator

(Operator Instructions)
Tara Bancroft, TD Cowen.

Tara Bancroft

Hi, good morning, and thanks for taking the question. So I was hoping maybe you could provide a little bit more color on competitive dynamics, especially with Ocrevus de novo? And like what are you seeing with new patient share there. I asked because Roche had a small but meaningful miss this quarter. So I'm wondering what you're hearing, if anything, on preferred uptake of BRIUMVI in new patients versus other treatments. Thanks so much.

Michael Weiss

Adam, do you want to go ahead and take that one?

Adam Waldman

Yeah, sure. I think, as I mentioned in my comments, Tara, that we saw the highest three months ever on patient enrollments. We saw a really strong month in April. So we believe we'll continue to drive market share gains. We sat back at JPMorgan, we think we're getting about 25% of the IV segment.
We assume that's up from there, and we continue to see good traction in the marketplace. So we're really encouraged by what we're seeing. On the question on de novo, but what we can tell, we've seen zero impact on BRIUMVI.

Tara Bancroft

Great. Thank you so much.

Michael Weiss

Thank you.

Operator

Michael DiFiore, Evercore ISI.

Michael DiFiore

Hey guys, hope all is well. Thanks for taking my question. Just two for me. Just any update on gross to net trends this quarter, a figure in how the Part D redesign that may have affected this. And any comments on how this may affect gross net for the balance of the year.
And also with regards to gross margin, when can we expect you to fully deplete, I guess, the prelaunch reserves in gross margin? And perhaps when could we expect maybe kind of a decrease there. Thank you.

Michael Weiss

Adam, let's take the GTM and maybe, Sean, on the gross margin?

Adam Waldman

Sure. On the gross to net question, no material change in gross to net in the quarter. Part D redesign is not really relevant for our drug, which we look like Part B drugs. Sean?

Sean Power

Yeah, sure. Thanks, Mike. So we fully depleted that pretty that pre-commercial inventory reserve that you're seeking at. So the margins you're seeing this quarter and going forward to be the fully big number and consistent quarter to quarter.

Michael DiFiore

Thanks.

Michael Weiss

Thanks, Michael.

Operator

Roger Song, Jefferies.

Roger Song

Great. Congrats for the quarter and then thank you for taking our questions. So maybe the question related to the subcu of BRIUMVI, you said you will start pivotal this year. So just curious what is current thinking about how many doses you will move forward and then when we will start to see the PK data second half. Thank you.

Michael Weiss

Sure. Thanks, Roger. Yeah, I mean we're still leaning toward having two dosing regimens in there. So the every other month and the quarterly as part of the pivotal. Obviously got a little time to make a final decision, but that's definitely where we're leaning today.
And in terms of PK data coming out probably later this year, you just haven't been focused and we continue to collect more data. So I think we're continuing to work on that study. It's going to lead us right into the trial, and then we'll figure out when we present some of the data. But again, I think we're being super conservative in having to dosing regimens in the pivotal trial, if we do that. And if we don't do that, it's because we're so confident in one or the other.

Roger Song

Thank you.

Michael Weiss

Thanks, Roger.

Operator

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani

Yes, good morning. Thanks for taking our questions and congrats on the quarter. On the 30-minute infusion data that also we saw at AAN an update, Mike, could you touch on the physician feedback there? And also, how might your data be tracking in depleting -- depleted and non-depleted patients as you obviously try to understand the switch profile in ENHANCE broadly about your Phase 3 trial, scale and scope. If you could comment on that, that would be helpful.

Michael Weiss

Sure. So with respect to the 30-minute infusion, the feedback has been positive. Actually, maybe, Adam, you've talked to a lot of folks about that as well. Maybe you want to touch on the 30-minute infusion, any thoughts there?

Adam Waldman

Yeah. I think there's been very positive feedback on the 30-minute infusion. Physicians think it's a convenience for their busy infusion centers. Patients think it's a much more convenient option. And the data so far is showing that it's well tolerated. So it's been a very positive and physicians have encouraged us to continue to develop.

Michael Weiss

Thanks, Adam. Yeah. So -- sorry, did I cut you off, Mayank?

Mayank Mamtani

No, no, go ahead. You were going to comment on Phase 3. And my question, the second part was actually around the R&D spend also, which seems like it's tracking higher yes, if you could factor in the Phase 3 comments there that would stand this year, for example? And then also, as you thought kind of commented on the SG&A spend, for second half, given the DTC spend commitment if you could comment on how you're thinking about profitability going forward?

Michael Weiss

Yeah, Mayank, you've got a lot in there. So I'll try to take it in a few steps, and you can follow up if you like. But the -- just in terms of the pivotal program, so I'll just be clear, there's two pivotal programs that we're planning.
One is for the combined day 1 and day 15 dose, that study again should simplify the onboarding of patients. So we're looking at the 600-milligram dose on day 1 and day 15, and that study should start hopefully in the next one, two, three months a little late.
So that's ongoing 30-minute infusion is probably something we're going to look at getting going later in the year or early next year. There's a little more logistics involved in that program than the 600 milligram.
In terms of the R&D spend that Sean mentioned, again, I think the only delta is just the materials that we have to produce to make the subcu that hit the R&D line instead of the CMC manufacturing line. So I think in terms of our overall R&D spend, we're right on target to what we thought would be.
And in terms of profitability, I'll let Sean discuss two or three things you can add. But I don't think we're highly focused on profitability this year. And I think in terms of the way we view the world, we're not using cash, we should be driving cash through the business.
But I don't think we're prepared to start targeting profitability and earnings per share on an ongoing basis. I think we'll stick to revenue guidance for now and some OpEx guidance that we do have plans to not use cash during the course of the year, that's for sure. Is there something else I missed in there, Mayank, you had a few points.

Mayank Mamtani

You discovered it all. Thank you, Mike. And lastly, on -- I have to ask a traffic question. How far along is your North Carolina plant in being able to produce commercial scale manufacturing, if you could just update on that. And thanks for taking my questions.

Michael Weiss

Yeah, you got it. Yeah. So moving manufacturing is not an easy task. And so I think we've said only several years before we'd be able to manufacture out of that North Carolina facility. So for the moment, I don't think it's a near-term event. It will take several years, I know the group is he's working processes to get there, including potentially even starting out in Europe to perfect it while they're actually working on the facility here.
So it's a long-term process. It was never really meant that all occurred as everyone may remember before any of this tariff talk. It was not a design program for avoiding tariffs. Or is it a design program to have backup manufacturing. So we're working on it as quickly as we can. But again, as Sean mentioned, I don't think we feel that we're going to be impacted too much from any of the tariff stuff. I don't know what the final outcome is.

Mayank Mamtani

Understood. Thank you, Mike.

Operator

Eric Joseph, JP Morgan.

Hi guys. This is Ron on for Eric. Congrats on the quarter. And just wanted to ask, I believe you previously cited expectations with about 20% product adherence between biannual infusions. Do you have a sense of that matter in Q1 and any anticipated fluctuations going forward? Thanks.

Michael Weiss

Sure. Adam, you want to grab that one?

Adam Waldman

Yeah, sure. Can you just clarify the question? I didn't care the first you said -- did you -- what was the percentage you said?

70% adherence between biannual infusions.

Adam Waldman

Yeah. I don't remember saying that. But what I would say is the persistence trends, as I said in my remarks, remain very much very positive and persistence remains strong and above our expectations.

Michael Weiss

Thank you, guys.

Operator

Prakhar Agrawal, Cantor Fitzgerald.

Prakhar Agrawal

Hi, thank you for taking my questions and congrats on the quarter. So firstly, on subcu BRIUMVI, when is the phase pivotal trial expected to start. I think previously, you had mentioned targeting midyear 2025 as the time line. Is that still on track?
And secondly, a question on BRIUMVI outside of MS, what do you need to see for BRIUMVI's profile and indications like myasthenia gravis to make the decision to invest further, especially given you have some income interesting data from the CD19 drugs in this space, especially Amgens.

Michael Weiss

Yeah. Thanks, Prakhar. So in terms of subcu, yeah, still on track, as we said in the prepared remarks, still on track with the subcu timelines. And in terms of MG data. Yeah, I mean, we're definitely moving cautiously forward in that area.
We've been speaking to lots of KOLs, I will keep you here in the data, we'll get a chance to see how the CD19 is received in the marketplace. So I think we're not prepared to go diving into the pool just yet, but we've got more than a toe in, and we'll continue to evaluate.
I don't think it's one piece of information. I think there's an aggregate of information. And I don't think most of that information is necessarily related to our drug and the performance of our drug. I think it's more related to the marketplace and how things evolve. So we are going to stay on top of it, we're going to keep pushing forward. in a moderate basis were an ability to accelerate at any moment, we feel the time is right.

Prakhar Agrawal

Got it. And maybe just one last question. What percentage of BRIUMVI patients right now are switches from Ocrevus? And is this a trend that you're seeing more of an inflection this year? And if so, why is that the case?

Michael Weiss

Adam, you want to go ahead?

Adam Waldman

Yeah. We haven't seen -- I wouldn't say we've seen material changes in the percent of which is we still see a healthy amount of switches from Ocrevus. And that trend has stayed consistent since launch. So no material change, and I'm sorry, I don't remember the second part of the question. (multiple speakers)

Prakhar Agrawal

Okay, thanks.

Operator

At this time, I would like to turn the floor back over to Mr. Weiss for closing comments.

Michael Weiss

Great. Thank you, operator, and everyone, thanks for joining us. As you can see, we're off to a very strong start in 2025. And we're looking forward to keeping that momentum positive going forward into the rest of the year.
We've got a number of key objectives that we're still looking to achieve and we discussed on today's call, of course, meeting our revenue targets that we've set, commencing pivotal trials for a simplified starting dose for IV BRIUMVI and for subcu BRIUMVI as well as executing on our Phase 1 trials for BRIUMVI patients with myasthenia gravis and for azer-cel patients with progressive forms of MS.
Beyond that, we continue to evaluate opportunities to expand our portfolio of product opportunities across autoimmune and autoinflammatory diseases and we'll continue our share buyback program.
In closing, I want to extend a heartfelt thank you to all the individuals living with MS and health care providers to place their trust in TG and BRIUMVI. It their courage that inspires everything that we do here at TG. So we really do appreciate it. And again, thanks, everyone, for joining us today and have a nice day.

Operator

Ladies and gentlemen, this concludes today's event. You may disconnect your lines or log off the webcast at this time, and enjoy the rest of your day.