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TGTX

FY2026 Q1May 6, 2026
CIK: 0001001316ID: TGTX-2026Q1Updated: May 7, 2026

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Operator

Greetings and welcome to the TG Therapeutics first quarter conference call and webcast.

Operator

At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press *0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Jenna Bosco, Chief Communications Officer. Thank you, you may begin.

Operator

Thank you. Welcome everyone, and thank you for joining us this morning.

Operator

I'm Jenna Bosco, and with me to discuss TG Therapeutics' first quarter 2026 financial results are Michael Weiss, our Chairman and Chief Executive Officer,

Operator

Adam Waltman, our Chief Commercial Officer,

Operator

and Sean Power, our Chief Financial Officer.

Operator

Following our safe harbor statement, Mike will begin with an overview of our recent corporate developments

Operator

Adam will provide an update on our commercial efforts,

Operator

and Sean will review our financial results before we open the call for Q&A.

Operator

Before we begin, I'd like to remind everyone that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Operator

These statements may include expectations regarding our future operating and financial performance including sales trends, revenue guidance, projected milestones, development plans, and outlook for our marketed product and our pipeline products. Please note that these statements are subject to risks and uncertainties that can cause our actual results to differ materially from those indicated.

Operator

These risks are detailed in our SEC filings.

Operator

Additionally, any forward-looking statements made today reflect our views only as of this date, and we disclaim any obligation to update or revise them.

Operator

As a reminder, this conference call is being recorded and will be available for replay for the next 30 days on our website at www.tgtherapeutics.com.

Operator

With that, I'll now turn the call over to Mike Weiss, our CEO.

Mike Weiss

Thank you, Jenna, and good morning, everyone. We appreciate you joining us. The first quarter of 2026 was, in my view, exceptional, not because of any single milestone but because of the consistency and durability we're now seeing across the business.

Mike Weiss

Let me start with the commercial side.

Mike Weiss

At a high level, Q1 was a record-setting quarter across nearly every metric we track.

Mike Weiss

Momentum puts us in a very strong position as we move through the rest of the year.

Mike Weiss

From a revenue standpoint, we delivered approximately $195 million in U.S. pre-environmental net product revenue in Q1, ahead of our guidance of $185 to $190 million.

Mike Weiss

On a global basis, revenue exceeded $200 million for the quarter, marking another important milestone.

Mike Weiss

And as we move toward a billion-dollar annualized run rate expected before year-end, we continue to believe we are still early in the Burundi adoption curve,

Mike Weiss

making peak revenue from the IV franchise alone still years ahead of us and multiples of where we are today.

Mike Weiss

Physicians are increasingly recognizing the value of BRINVO-QI, not just on efficacy, but on the overall treatment experience. And that's translating into durable, repeatable growth.

Mike Weiss

And importantly, the data continues to support that differentiation.

Mike Weiss

Earlier this year, we were pleased to see our 5-year follow-up data from the Ultimate I and II open-label extension study published in JAMA Neurology, reinforcing sustained efficacy of BrownV along with a consistent safety and tolerability profile over time.

Mike Weiss

At AAN earlier this month, we continued to build on that story with real-world data demonstrating sustained and rapid B-cell depletion,

Mike Weiss

low annualized relapse rates maintained over time, and continued evidence of a favorable infusion experience and tolerability profile.

Mike Weiss

And for the first time, we we presented prospective data from patients who switched from a prior anti-CD20 therapy to Briomvy, which showed improvement in patient-reported wearing-off symptoms, sometimes referred to as the crap gap, after switching to Briomvy.

Mike Weiss

Given that meaningful number of patients report this wearing-off effect, the potential to address it represents a clear and differentiated use case.

Mike Weiss

Turning to the pipeline. This is where we continue to invest in both strengthen and extend the franchise.

Mike Weiss

First, our Phase 3 ENHANCE study evaluating initiation of Riondi therapy with a single 600-milligram IV infusion as compared to the currently approved schedule of 600 milligrams divided into 2 infusions, one on day 1 and one on day 15.

Mike Weiss

I'm pleased to report that based on current timelines, We expect top-line data from this Phase 3 study in the coming weeks.

Mike Weiss

Assuming a positive outcome and regulatory approval, we believe this positions us to launch the consolidated dosing schedule next year.

Mike Weiss

This is about simplicity. Fewer infusions, same efficacy. And feedback on eliminating the day 15 infusion continues to be very positive from both patients and providers.

Mike Weiss

Now turning to our subcutaneous program. We're developing a self-administered at-home version of Brionvi expected to be delivered via an autoinjector and a pen-like device.

Mike Weiss

This program is designed to expand optionality and importantly expand the number of patients we can reach.

Mike Weiss

The program began with a Phase 1 dose escalation bioavailability study evaluating subcu dosing relative to our approved IV schedule.

Mike Weiss

Based on encouraging preliminary results, we advanced directly into our Phase 3 program.

Mike Weiss

In Phase 3, we are evaluating two subacute dosing schedules, every 2 months and quarterly dosing, with the primary endpoint being non-inferiority to IV based on drug exposure over 24 weeks.

Mike Weiss

We were pleased to report in April that the study is now fully enrolled, and we expect top-line data around year-end or early next year.

Mike Weiss

Putting us on track for a potential 2028 launch of SUBQ-BRIOMPHY, assuming a positive outcome and regulatory approval.

Mike Weiss

And I know many of you have been waiting for the Phase 1 bioavailability data. We now expect to share those results in the coming weeks. Strategically, it's important to understand what SUBQ represents. This is not about incremental growth, and it's not about building a new infrastructure or entering a new indication. This is about expanding our reach within the same disease with largely the same physicians and commercial footprint,

Mike Weiss

creating significant operating leverage. By enabling us to compete across both infusion and self-administered settings, we move from participating in a portion of the market to potentially participating across the entire anti-CD20 landscape. And as a result, we believe this has the potential to nearly double our addressable market with relatively limited incremental operating expense.

Mike Weiss

Beyond relapsing MS, we are expanding the reach of Briamvi in additional autoimmune indications.

Mike Weiss

We view Briamvi as a pipeline within a product with a long runway supported by patent protection into the 2040s.

Mike Weiss

In myasthenia gravis, we've completed our Phase 1 work and expect to initiate a Phase 2 potentially registration-directed study this quarter. We're also initiating an exploratory study in treatment-resistant schizophrenia.

Mike Weiss

There is emerging evidence suggesting an autoimmune component in a subset of these patients. It's early, but if validated, the implications could be significant.

Mike Weiss

And finally, Azacel, our allogeneic anti-CD19 CAR-T, continues to advance in progressive MS. Importantly, trial sites are identifying more patients than we currently have slots available, and additional sites continue to express interest in participating.

Mike Weiss

This further highlights the unmet medical need in progressive MS.

Mike Weiss

We look forward to sharing updates from this study later this year.

Mike Weiss

Finally, I'd like to make a few remarks on our capital allocation. During the quarter, we extended our relationship with Blue Owl, enhancing our financial flexibility. This gives us the ability to continue repurchasing shares and pursue strategic business development opportunities.

Mike Weiss

We've been clear. We view our stock as undervalued, and we're acting on that. This quarter alone, we repurchased $100 million of our stock.

Mike Weiss

At the same time, our approach to capital allocation is straightforward. We will continue to deploy capital where we see the best risk-adjusted long-term return,

Mike Weiss

whether that's in business, repurchasing shares, or pursuing external opportunities or investments.

Mike Weiss

With that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, for more detailed commercial update. Adam, please go ahead.

Adam Waldman

Thanks, Mike, and good morning, everyone. I'll pick up on a few themes Mike just laid out, particularly around consistency, durability, and execution, because that's exactly what we're seeing on the commercial side of the business.

Adam Waldman

We delivered approximately $195 million in U.S. net revenue in Q1, exceeding our guidance range and growing 63% year over year, our 12th consecutive quarter of sequential growth since launch.

Adam Waldman

We saw record new patient enrollments in the quarter, and March was our highest month ever.

Adam Waldman

As a result of the strong first quarter, we're raising full-year U.S. revenue guidance to $885 to $900 million,

Adam Waldman

and we're providing Q2 guidance targeting approximately $220 million in U.S. Briambi net revenue.

Adam Waldman

And importantly, we've now reached a meaningful milestone.

Adam Waldman

More than 25,000 patients have been prescribed BriMD globally.

Adam Waldman

That's important because at this point we're no longer talking about early adoption. We're talking about a growing installed base of patients being treated in the real world.

Adam Waldman

At its core, this is a recurring treatment model. Patients who start BriMD are typically treated every 6 months, and we continue to see strong persistence over time. Stronger than what we originally modeled.

Adam Waldman

That means our revenue base doesn't reset each year, it builds.

Adam Waldman

Each cohort of new patients adds to an expanding base of recurring demand.

Adam Waldman

As that base grows, we're developing greater visibility into underlying demand, and growth becomes more predictable over time.

Adam Waldman

The outperformance we saw in Q1 and the raise in guidance reflects both that growing base, including better than expected persistence,

Adam Waldman

and stronger than expected new patient demand. Importantly,

Adam Waldman

we guide conservatively on that new patient growth layer, and we raise when the data supports it. That combination is what's driving the business today. And as we said before, the more patients that go on Briambi, the more patients will go on Briambi.

Adam Waldman

And we're seeing that dynamic take hold.

Adam Waldman

Let me be direct about the competitive environment.

Adam Waldman

We compete against established products with— backed by large organizations. And we don't underestimate that.

Adam Waldman

At the same time, in Q1, we continued to grow sequentially while outpacing both competitors and the broader MS market.

Adam Waldman

We've been growing IV share consistently, and we're now the number one CD20 by dynamic share in private practices with infusion capabilities.

Adam Waldman

Why is that happening? Because we're delivering on the factors that matter most to physicians:

Adam Waldman

a compelling clinical profile, operational simplicity, and a consistent treatment experience.

Adam Waldman

The 1-hour infusion, twice-yearly dosing, and long-term data all contribute to that.

Adam Waldman

And when physicians put a patient on Briambi and that patient has a positive outcome,

Adam Waldman

that physician becomes a repeat prescriber. Since November, we've seen consistent increases in total monthly prescribers, with March setting a new high.

Adam Waldman

And most importantly, we're increasing uptake with treatment-naive patients, patients starting their CD20 journey on BriiLVY, not switching to it.

Adam Waldman

The share of naive patients in our mix continues to rise, which we view as the strongest leading indicator of long-term market position.

Adam Waldman

The momentum we're seeing comes down to execution and doing a few things consistently well. We've reduced friction across the treatment journey, improving time to start and conversion rates. We've expanded our reach and deepened our presence across accounts,

Adam Waldman

and our DTC efforts are helping to increase patient awareness,

Adam Waldman

with more patients entering the office already informed about Briumdi.

Adam Waldman

This is exactly what we set out to build: a commercial engine that can deliver consistent execution, support long-term growth, and scale over time. And importantly, we're doing this while still early in the lifecycle.

Adam Waldman

As Mike outlined, we have two programs that help explain why we believe the long-term opportunity

Adam Waldman

is meaningfully larger than what is reflected today. First, ENHANCE.

Adam Waldman

This is about simplifying the initiation process by eliminating the day 15 infusion.

Adam Waldman

If successful, we would expect it to enhance operational efficiency and make it easier for physicians and infusion centers to get patients started on bryonbine.

Adam Waldman

We view this as an incremental improvement to an already strong IV offering, one that can further support adoption.

Adam Waldman

Second, our subcutaneous patient administrate— administered formulation. This is a much more significant strategic opportunity. Today, the subcutaneous patient administered segment represents roughly 35% of the anti-CD20 market, a segment we are not participating in today.

Adam Waldman

So this is not about taking share within our existing IV business. This is about opening up a new segment of the market. If successful, SubQbriumby would allow us to reach patients who prefer or require at-home self-administration, compete directly in a large and growing segment of the market, and meaningfully expand the overall addressable opportunity.

Adam Waldman

And when you look at this holistically, IV plus sub-q is not just incremental expansion. It has the potential to redefine the scale of the BrioMD franchise over time.

Adam Waldman

Importantly, the current business is already performing at a high level. We don't need these programs to deliver on our near-term expectations, but over time they have the potential to meaningfully expand both the reach and long-term value of BrioMD.

Adam Waldman

So to summarize, we've outperformed expectations in Q1,

Adam Waldman

driven by strong underlying demand. We're seeing continued expansion in both patients and prescribers.

Adam Waldman

Our execution is translating into durable, increasingly predictable growth,

Adam Waldman

and we're significantly raising our 2026 outlook.

Adam Waldman

We now have over 25,000 patients globally, and that base continues to grow. We're approaching a $1 billion annualized run rate, supported by a model that is becoming more scalable over time.

Adam Waldman

And with IV and subcu, we're building a franchise that has the potential to compete across the full spectrum of the anti-CD20 market.

Adam Waldman

When you consider the size of the IV market, the portion we'll be able to access with subcutaneous,

Adam Waldman

and the trajectory we're seeing today,

Adam Waldman

we believe the long-term opportunity for Briumbi is well above where consensus peak estimate sales sit today. And ultimately more consistent with the leading assets in the category.

Adam Waldman

Let me now turn the call over to Sean Power, our CFO, for a detailed financial update.

Sean Power

Thanks, Adam. A few things to highlight on the financial side.

Sean Power

As Mike and Adam highlighted, we came in ahead of expectations.

Sean Power

US net product revenue in Q1 was approximately $195 million. Up 63% versus the same quarter last year.

Sean Power

Total net product revenue was $201 million when including product sales to NeuroRxPharm, our ex-US partner.

Sean Power

Add in $3.6 million of license, royalty, and other revenue, and total revenue for the quarter was $205 million.

Sean Power

On the expense side, OpEx, which we define as R&D and SG&A, excluding stock-based comp, was approximately $117 million for the quarter.

Sean Power

That year-over-year increase reflects continued investment across the business.

Sean Power

On the R&D side, a milestone expense under our Precision Biosciences agreement

Sean Power

and higher clinical costs partially offset by lower subcutaneous manufacturing and development spend.

Sean Power

And on the SG&A side, expanded marketing and media investment supporting Briambi's continued growth.

Sean Power

Even with that investment, revenue growth continues to outpace expense growth, and that dynamic drove operating income of $34.8 million compared to $8.6 million in Q1 of last year.

Sean Power

One item worth flagging below the operating line was a one-time $9.2 million charge related to the refinancing of our Blue Owl facility, of which approximately 50% was noncash.

Sean Power

All that nets to net income for the quarter of $19.8 million or $0.12 per diluted share compared to $5.1 million or $0.03 per diluted share a year ago.

Sean Power

On the balance sheet, We ended the quarter with approximately $573 million in cash, cash equivalents, and investment securities,

Sean Power

up from roughly $200 million at year-end,

Sean Power

reflecting primarily the proceeds from the expanded Blue Owl facility.

Sean Power

From a capital allocation standpoint, we repurchased over 3 million shares during the quarter at an average price of roughly $30.

Sean Power

Since launching the program, we've bought back approximately 6.8 million shares at an average price of approximately $29,

Sean Power

nearly 5% of shares outstanding,

Sean Power

leaving us with 153 million shares outstanding today.

Sean Power

Turning to guidance, we're raising our full-year total global revenue guidance to approximately $925 million.

Sean Power

On expenses, we continue to expect full-year operating costs of approximately $350 million excluding stock-based comp, plus approximately $100 million for subcutaneous manufacturing and secondary manufacturer startup activities.

Sean Power

As we've noted previously, those manufacturing costs are expensed through R&D as incurred,

Sean Power

So if the programs are successful, the related inventory would be sold in future periods with little to no associated cost of

Sean Power

goods. All in all, it was a strong quarter. Revenue ahead of expectations,

Sean Power

operating income up meaningfully year over year, and a balance sheet that gives us real flexibility going forward.

Sean Power

With that, I'll turn the call back over to the conference operator to begin the Q&A.

Operator

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Operator

You may press star 2 to remove yourself from the queue.

Operator

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator

One moment while we poll for questions.

Operator

First question comes from Corinne Johnson with Goldman Sachs. Please go ahead.

Operator

Thanks and good morning, guys. Maybe could you just speak to the market opportunity for the subcutaneous product? If you're able to bring a 12-week versus 8-week formulation to the market, do you see that as kind of meaningfully different in terms of your ability to gain share in that? Currently untapped population? Thanks.

Mike Weiss

Sure. Adam, you want to tackle that one?

Adam Waldman

Sure. Yeah, thanks for the question, Corinne. You know, as we mentioned, that segment represents about 35% of the CD20 market today, one we do not compete in.

Adam Waldman

And, you know, our perspective is this is expanding into a new patient population rather than, you know, shifting patients within our existing base.

Adam Waldman

We think of these as largely these distinct segments with different patients and physician preferences.

Adam Waldman

And it importantly, I think, as Mike mentioned, you know, puts us in position to compete across both the IV and sub-Q space,

Adam Waldman

you know, across the entire CD20 landscape. We think that Q3, to your question about dosing, we think Q3 obviously would be better than

Adam Waldman

incrementally better. I think both are going to be great, you know, but, you know, I think we subscribe to less is more.

Adam Waldman

But I think both would be a very strong profile. We feel good about the opportunity for both, whichever way it works out.

Operator

Thanks.

Operator

Next question, Brian Chang with JPMorgan. Please go ahead.

Mike Weiss

Hey guys, thanks for taking our questions this morning. Just first, can you talk a little bit about the cadence of data from the ENHANCE trial and the Phase 1 bioavailability data? You know, in your prepared remarks, you said both data will be

Mike Weiss

coming in the coming weeks. So, you know, which one should we expect first? Are both data coming at the same time?

Adam Waldman

And I have a follow-up.

Mike Weiss

Thank you.

Mike Weiss

Yeah, in terms of timing, we don't have the exact timing. We just know that

Mike Weiss

Things are coming in soon,

Mike Weiss

so we just basically thought we'd let people know that that data was coming.

Mike Weiss

Okay.

Mike Weiss

Earlier during, you know, you talk about the dynamics of persistence, and you talk about how persistence is stronger than you have anticipated. Can you provide a little bit more color to that, and how much does the DTC campaign so far in driving patients coming to physician practice and asking for Prionbi? Thanks.

Mike Weiss

Thank you.

Mike Weiss

Thanks for the question, Brian. Adam, you want to tackle this one?

Sean Power

Sure.

Adam Waldman

I mean, on the persistence side, obviously, we're encouraged, given my remarks, we're encouraged by what we're seeing on the persistence,

Adam Waldman

particularly as patients move into the second year of treatment where trends have been better than expected. And we think these patterns that we're seeing, you know, are supportive of the durability of the patient experience,

Adam Waldman

which obviously reflects the tolerability and efficacy of BrownVie. You know, that said, still early and we will continue to monitor it, but, you know, we're growing in confidence as we continue to build, as the data matures.

Adam Waldman

And, you know, it comes down to, you know, sustainability of efficacy and tolerability. And then generally when patients do well, they stay on therapy and that drives persistence.

Adam Waldman

As far as DTC, we're encouraged, you know, we've been putting effort into DTC over the last year or so. We've been encouraged with the

Adam Waldman

markers and indicators of success. We'll continue to invest in the space. We think this is a,

Adam Waldman

you know, a patient-driven— they do have shared decision-making in this market. And so we're going to continue to focus on it, and we're encouraged by what we're seeing so far.

Mike Weiss

Great. Thank you.

Operator

Next question, Tara Bancroft with TD Cowen. Please proceed.

Mike Weiss

Hi, congrats on the quarter and thanks for taking my question.

Adam Waldman

This is Greg on for Tara.

Mike Weiss

So you've reiterated top-line Phase 3 data for the SubQbriumV around year-end 2026 or early next year.

Adam Waldman

Can you provide any additional color on the cadence from data readout to filing?

Mike Weiss

And how quickly the sub-q formulation becomes commercially available, assuming a favorable outcome? Thank you.

Mike Weiss

Sure. So our target is to have

Mike Weiss

the sub-q available sometime in 2028. In terms of the cadence of filing after the completion of that study, you know, our goal is to get that filed as soon as we can. We've got a few other studies we'll need to do in the interim to get the filing package complete, including the bridge to the

Mike Weiss

auto injector. But yeah, I mean, for '28, as soon as— as early as possible '27, we're going to get that filing done. That's the goal

Mike Weiss

for '28 approval. Again, it's— the one thing we can't control is the about a 12-month review process. So

Mike Weiss

that's the timing of that. Was there— The last part of that question? I'm sorry.

Adam Waldman

No, that covers my question.

Mike Weiss

Thank you.

Mike Weiss

Okay.

Mike Weiss

Thank you.

Operator

Next question. Next question, Roger Song with Jefferies. Please go ahead.

Operator

Hi, this is Chaffee Yang on for Roger.

Operator

Thanks for taking my question. So I was wondering if you could speak to what you think the impact of Remi-Burton's potential approval in MS would be on Brionzi, but also on the CD20 class as a whole?

Mike Weiss

Yeah, thanks for the question. So, you know,

Mike Weiss

we continue to await product profiles for all the BTKs as they've come through the clinical trials. Each one in turn has

Mike Weiss

had some difficulties, I would say, in producing data that is

Mike Weiss

convincing of a clinical benefit over risk.

Mike Weiss

We'll see how Fenny does at the agency, and Remi is yet to come. So I think we just have to wait. I mean, overall, we've maintained our position

Mike Weiss

that there's certainly a home for these drugs in

Mike Weiss

certain patient populations, particularly

Mike Weiss

patients who are potentially secondary,

Mike Weiss

non-active secondary progressive, where we're not labeled.

Mike Weiss

So

Mike Weiss

I think there's room for it. Remember, there's still a big oral market. I think there's room for

Mike Weiss

a BTK with the right profile to participate in that oral marketplace, but we don't think it's a

Mike Weiss

drug class that will have a material impact on the CD20 class.

Operator

Great. Thank you.

Operator

Next question, Michael DeFiore with Evercore ISI. Please go ahead.

Adam Waldman

Hi, guys. Thanks so much for taking my questions. Just one for me.

Adam Waldman

Given Roche's potential twice-yearly

Adam Waldman

home Ocrevus device and Kasimpta's longer interval

Adam Waldman

work,

Adam Waldman

what dosing profile does subcu pre-emptive need to have in order to be meaningfully

Adam Waldman

differentiated? Is every 2-month dosing enough, or is quarterly dosing really the commercial bar

Adam Waldman

given where we're headed? Thank you.

Mike Weiss

Sure, thanks for the question, Michael.

Mike Weiss

Look, as Adam mentioned, it's a competitive market. Everyone is trying to do their best to improve their product profile

Mike Weiss

to

Mike Weiss

meet the needs and the challenges that these individuals with MS face, and we're certainly doing our part. Obviously, we've said before, we feel that, and Adam said it earlier, The market is large. It can probably get larger on the sub-q side. We'll continue to obviously have a very big presence in the IV sector,

Mike Weiss

whereas I don't think the other— I don't think Okervis' long-term plan is to participate much longer in the IV marketplace. And as you mentioned, they're working on their own at-home,

Mike Weiss

on-body device. So like I said, from the standpoint of the patient, this is all great.

Mike Weiss

And as Adam mentioned earlier, every 2 months or every 3 months will be a really strong offering. Again, it's, it's Briomvy still loaded into

Mike Weiss

the autoinjector, which means that all the differentiation that we have on the IV side on the molecule itself will continue to exist as we go into the marketing effort

Mike Weiss

on the sub-q side. So convenience is one thing, you know, obviously as Adam said, quarterly is going to be incrementally better than every other month.

Mike Weiss

We feel obviously very confident in our ability to deliver a quarterly product, but I think we'll let the data speak for itself as it slowly comes out.

Mike Weiss

But yeah, I think we're going to do great. I mean, we've done quite well in the IV space. Again, Briombia is a molecule and the convenience factors

Mike Weiss

all come together. So I think it's a package of

Mike Weiss

of competitive products. And ours is going to be, I think, highly competitive in this marketplace. And

Mike Weiss

like I said, we think we're going to do really, really well in this space. Thank you.

Operator

Next question, Emily Bodnar with HC Wainwright. Please go ahead.

Operator

Hi, thanks for taking the question. Maybe one on the updated guidance. Obviously quite an uptick from the fourth quarter guidance. So maybe just talk a bit more on your confidence for why you think the growth you saw in Q1 might be sustained for the rest of the year. And also on operating expenses, looks like that was up quite a bit in the first quarter. So maybe just touch on expectations for the rest of the year.

Mike Weiss

Sure. Adam, you want to start on the updated guidance?

Adam Waldman

Yeah, sure. Thanks for the question, Emily. Q1 performance, as I mentioned, was driven by strength across all key drivers, including record number of new

Adam Waldman

patient starts and better than expected persistence.

Adam Waldman

You know, I think we're seeing that momentum continue into Q2. And, you know, as I outlined in my prepared remarks,

Adam Waldman

the model really has two components to it. It's a growing recurring base with continued new patient demand.

Adam Waldman

And so the strength of Q1 reflects both of these working together and gives us confidence in the updated full-year guidance.

Mike Weiss

Sean, you want to talk about the OpEx?

Adam Waldman

Sure.

Sean Power

Thanks, Emily. Yeah, on the OpEx front, as we said in our prepared remarks,

Sean Power

we expect full-year OpEx,

Sean Power

you know, again, which we define as R&D and SG&A excluding stock-based comp, to be roughly $350 million plus an additional $100 million

Sean Power

for subcutaneous manufacturing work and secondary manufacturer preparation. So yeah, Q1 was up a little bit

Sean Power

higher than perhaps that range would guide, but we are still

Sean Power

reiterating that guidance for the full year.

Operator

Thank you.

Operator

Next question, Prakhar Agarwal with Cantor Fitzgerald. Please go ahead.

Operator

Hi, this is Jennifer on behalf of Cantor. Congrats on the quarter. I have two quick questions. One on the capital allocation share buyback versus meaningful BD. Since you have quite a lot of cash, what's the plan on that? And then quickly on the gross-to-net discount for Q1, how do you expect that for the rest of the year?

Mike Weiss

Sure. Adam, why don't you

Mike Weiss

or Sean handle the gross to net and I'll talk about the use of cash.

Mike Weiss

Sure. Yeah.

Adam Waldman

You know, as I mentioned in the Q4 call,

Adam Waldman

we did have gross to net dynamics in Q1, but these were largely in line with our expectations.

Adam Waldman

As I've mentioned before, gross to net can

Adam Waldman

vary from quarter to quarter.

Adam Waldman

But for the year, we expect it

Adam Waldman

to average out around 65%.

Mike Weiss

Thanks, Adam. And then in terms of use of cash and capital allocation and share buybacks versus BD,

Mike Weiss

look, we continue to be highly selective in our BD efforts. We've seen some interesting things. We like some stuff. We're disciplined about what we're willing to pay for.

Mike Weiss

For programs

Mike Weiss

and assets.

Mike Weiss

And of course, we are always happy to buy our shares if others are not willing to value them at fair value. So we will continue to buy back shares. I think that is until we see some significant price

Mike Weiss

reassessment. We will continue to be buying shares back with our cash.

Mike Weiss

And like I said, yeah, we are out there. Looking at new opportunities

Mike Weiss

quite aggressively. And but like I said, we've been disciplined about executing and certainly disciplined about price.

Operator

Great, thank you.

Operator

Next question, William Wood with B. Riley Securities, please go ahead.

Mike Weiss

Hi, yes, thanks for taking our question. I'm just thinking about in terms of sort of apart from Briambi, you know, you've got the earlier stage Azure Cell running in your open label PPMS. I'm just curious with that trial readout coming up later this year if there's anything that you could sort of provide at a top level on what you might be seeing, what gives you confidence with advancing that, and then any— yeah, I'll stop there.

Mike Weiss

Thanks, appreciate

Mike Weiss

it. Yeah, for AzurCell, it's still early. We are excited to be moving up in the dose escalation, but it's a challenging study logistically to get to a point where we we can open up enrollment.

Mike Weiss

So we'll continue to push forward. I think we're just about on the penultimate dose. I think we'll be able to start that in the next 1 to 2 weeks. So we're getting close, we're getting warm, but there's a significant delay between each individual patient while we strive to get to the dose that we're targeting.

Mike Weiss

You know, safety, of course, is going to be the most important piece. Secondarily, of course, is going to be some biomarkers of activity, whether we're deleting B cells, alloclonal— excuse me— alloclonal bands

Mike Weiss

in the CNS.

Mike Weiss

So we are hopeful to be able to present some of that data, but again, it's still early, but we're enthusiastic about it. We think the— again, the rationale for these drugs has not subsided. And we do think that there's a real opportunity, but it's still early.

Adam Waldman

Got it.

Mike Weiss

Thank you.

Mike Weiss

Thank you.

Operator

I would like to turn the floor over to Michael Weiss for closing remarks.

Mike Weiss

Great. Thank you, operator. And thanks again, everyone, for joining us this morning.

Mike Weiss

Let me just briefly recap. We outperformed expectations commercially with strong revenue and record patient starts. We advanced two key life cycle programs, both with the near-term catalyst.

Mike Weiss

We're expanding development efforts beyond MS into new indications,

Mike Weiss

and we are allocating capital with discipline and intent.

Mike Weiss

We've said this before, and it's worth repeating: we do not see Briomvy simply as a successful, successful product. We see it as a multi-billion dollar franchise with a long runway supported by patent protection into the 2040s. And importantly, even as we approach a billion-dollar run rate, we believe we're still early in realizing that full potential.

Mike Weiss

We remain focused on executing the business and maximizing long-term value.

Mike Weiss

I want to thank our shareholders for their continued support, our TG team for their commitment to our mission and the patients we serve, and of course, to the patients and healthcare providers who put their trust in us. We take that responsibility very seriously.

Mike Weiss

Thank you all again for joining us and have a great day.

Operator

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

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