NASDAQ:TGTX TG Therapeutics Q2 2025 Earnings Report $27.90 +0.79 (+2.89%) As of 02:28 PM Eastern This is a fair market value price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast TG Therapeutics EPS ResultsActual EPS$0.17Consensus EPS $0.32Beat/MissMissed by -$0.15One Year Ago EPS$0.04TG Therapeutics Revenue ResultsActual Revenue$141.15 millionExpected Revenue$147.76 millionBeat/MissMissed by -$6.61 millionYoY Revenue Growth+92.10%TG Therapeutics Announcement DetailsQuarterQ2 2025Date8/4/2025TimeBefore Market OpensConference Call DateMonday, August 4, 2025Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by TG Therapeutics Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 4, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: In Q2, TG Therapeutics reported U.S. net product revenue of $138.8 million for BREONVY, up 91% year-over-year and 16% sequentially, resulting in GAAP net income of $28.2 million. Positive Sentiment: The company raised its full-year U.S. net revenue guidance for BREONVY from $560–570 million to $575 million, reflecting stronger-than-expected commercial momentum. Positive Sentiment: Enrollment is set to begin soon in the pivotal Phase III trial of subcutaneous BRIONVY, with a BLA filing targeted for 2027 and potential launch in 2028 to capture patients preferring self-administration. Positive Sentiment: The ENHANCE trial has started a Phase III cohort to test consolidating two initial infusions into a single 600 mg dose, with pivotal data expected in 2026 and a label update goal of 2027. Neutral Sentiment: TG closed Q2 with approximately $279 million in cash, cash equivalents and investments, and reiterated full-year operating expense guidance of ~$300 million to fund R&D and commercial activities. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallTG Therapeutics Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Greetings. Welcome to TG Therapeutics Second Quarter Earnings Call and Webcast. At this time, participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. Operator00:00:20At this time, I'll turn the conference call over to Jenna Bosco, Chief Communications Officer. Jenna, you may now begin. Jenna BoscoChief Communication Officer at TG Therapeutics00:00:27Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second quarter twenty twenty five financial results are Michael Weiss, our Chairman and Chief Executive Officer Adam Waldman, our Chief Commercial Officer and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate developments, Adam will share an update on our commercial efforts, and Sean will give a summary of our financial results before turning the call over to the operator to begin the Q and A session. Before we begin, I would like to remind everyone that we will be making forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Jenna BoscoChief Communication Officer at TG Therapeutics00:01:12These 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 products. Cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors that can be found in our SEC filings. 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. Jenna BoscoChief Communication Officer at TG Therapeutics00:01:58This conference call is being recorded for audio rebroadcast on TG's website at www.tgtherapeutics.com, where we'll be available for the next thirty days. Now I would like to turn the call over to Mike Weiss, our CEO. Michael WeissChairman, CEO & President at TG Therapeutics00:02:14Thank you, Jenna, and good morning, everyone, and thank you for joining us on today's call. I'm pleased to share that we delivered another strong quarter with solid performance across all aspects of our business, highlighted by the continued momentum of our flagship product, BREONVY. The ongoing enthusiasm from the MS community has been both gratifying and energizing, and our commercial performance has exceeded expectations. At TG, our mission is to bring forward therapies that truly improve the lives of those living with multiple sclerosis. Hearing real world stories from individuals on BRIUMVI is both validating and deeply inspiring. Michael WeissChairman, CEO & President at TG Therapeutics00:02:53I encourage you to visit briumvi.com to hear some of these patient experiences firsthand. Our commercial team remains disciplined and highly effective in executing our multi year launch strategy. As a result, adoption continues to grow. Now approximately two point five years into launch, we estimate that nearly one in every three new IV anti CD20 patients are prescribed BRIONVY. This represents meaningful progress toward our long term goal of making BRIONVY the most prescribed anti CD20 therapy for relapsing MS as measured by dynamic market share. Michael WeissChairman, CEO & President at TG Therapeutics00:03:35And as adoption continues to grow, we remain focused on expanding choice and flexibility for patients and providers through the development of subcu BRIONVI and our ENHANCE study. The development of subcu BRIONVI represents a strategic opportunity to further build a leadership role in the anti CD20 space. If approved, subcu Briohnvi would significantly expand our addressable market by unlocking access to the 35% to 40% of the anti CD20 dynamic market segment that currently prefers a self administered option, of which only one is available today. We believe subcu Buryumbe has the potential to offer a highly valued alternative for both patients and providers. Moreover, it would uniquely position PG as the only company offering both an IV and a self administered option, potentially simplifying the treatment decision for patients and providers and positioning Breonvi as the anti CD20 therapy of choice. Michael WeissChairman, CEO & President at TG Therapeutics00:04:40Supporting this vision, the team has executed exceptionally well on our clinical development goals this quarter, putting us on track to initiate patient enrollment into our pivotal Phase III trial for subcu Reumvi in the coming weeks. This study will evaluate two dosing schedules every other month and quarterly compared to IV BRIONVY in patients with relapsing forms of MS. The primary endpoint is to demonstrate non inferior exposure between subcu dosing and our approved IV dosing. We anticipate completing enrollment in 2026, filing a BLA in 2027, and pending approval launching a subcu BRIONVY in 2028. At the same time, we're focused on enhancing the patient experience with IV BRIONVY. Michael WeissChairman, CEO & President at TG Therapeutics00:05:36I'm pleased to report that within the ENHANCE trial, we have begun enrollment into a randomized, double blind Phase III cohort evaluating the potential to consolidate the day one and day fifteen infusions into a single six hundred milligram infusion on day one. The goal of this study is to establish comparable exposure between the two dosing schedules. If successful, this simplified approach would eliminate the need for a second infusion in the first two weeks, offering what we believe would be a meaningful convenience benefit for patients and infusion centers. We look forward to pivotal data in 2026 with the goal of an updated label in 2027. Turning briefly to our pipeline. Michael WeissChairman, CEO & President at TG Therapeutics00:06:27We are also pleased to share that we have dosed our first patient with progressive MS using azurecel, on investigational allogeneic CD19 directed CAR T therapy. In parallel, we continue to explore the use of BRIUMVY in myasthenia gravis as we consider additional opportunities to expand the uses of BRIONVY. This is an exciting time at TG. Our results this quarter reflect strong execution across both commercial and clinical fronts and a growing confidence in Voriyomvi from physicians and patients alike. With continued progress on our subcu program, enhancements to the IV experience and the advancement of our CD19 CAR T into the clinic, we're laying the groundwork for sustained leadership in the MS space. Michael WeissChairman, CEO & President at TG Therapeutics00:07:20With that, I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, who will provide additional insights into our commercial performance and updated guidance for the second half of the year. Adam, go ahead. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:07:35Thank you, Mike, and good morning, everyone. I'm excited to report that Q2 twenty twenty five was another strong quarter for TG Therapeutics, marked by continued commercial momentum, executional excellence and the highest number of new patient enrollments into our hub since launch. We're now seeing the tangible results of our strategic investments as the foundation we've built continues to scale. U. S. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:07:59Net sales for Breomby in Q2 totaled approximately $139,000,000 ahead of our internal expectations and building on the robust growth we achieved in Q1, positioning us for a strong 2025. Several key performance drivers reinforce our confidence in the brand's continued trajectory. We saw meaningful increase in both new prescribers and new accounts, reflecting deeper penetration across academic institutions and community neurology practices. Q2 marked our highest volume of new patient enrollments to date, a clear indicator that our reach is expanding and that awareness among providers and patients is accelerating. We also continue to observe strong persistence and repeat prescribing, which we view as a validation of Breomby's differentiated clinical profile and its value in real world practice. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:08:51Today, the CD20 class generates over $8,000,000,000 in annual U. S. MS sales and continues to grow. BREONVY is steadily increasing its share within this expanding market. As Mike mentioned earlier, we estimate that nearly one third of new patients initiating IV anti CD20 therapy are being prescribed BREONVY. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:09:13We believe there remains significant headroom for continued growth for the class and for BRIONVI within it. Our competitive advantage remains clear, a convenient twice a year one hour infusion combined with five year safety and efficacy data collectively offers a compelling treatment option for RMS patients. These differentiators continue to resonate strongly across care settings from large academic centers to private practices to the VA system where we continue to be the preferred anti CD20 therapy. A major milestone this quarter was the launch of our first ever national television campaign. This initiative is part of a broader multichannel strategy that will ramp throughout the second half of the year with the goal of driving patient awareness. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:10:00While it's still early, we're seeing promising signs that the investment is having an impact. Our latest market research shows a measurable uptick in patient awareness of BREONVY. Website traffic, branded organic search impressions, branded paid search impressions and qualified visitors to the website have all increased meaningfully. And importantly, physicians are reporting more patients requesting BREONVY by name. We are closely tracking key performance indicators across media channels and will continue to monitor performance, but early signals are encouraging. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:10:34I also want to highlight the efforts of our commercial team. We believe we have a highly effective field team and our recent surveys back that up with consistently high ratings when compared to our peers in the MS space. Their ability to clearly and credibly communicate BRIMBI's value proposition is a key part of our strategy and their daily commitment is making a real difference. Looking ahead, we are confident in the continued growth of Briumby revenues. Based on current trends in both new patient prescriptions and persistence of existing patients, we are again raising our full year U. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:11:06S. BREYUNBI net revenue guidance, which was $560,000,000 to $570,000,000 to $575,000,000 for the full year 2025. Similar to last year, given expected Q3 seasonality, we would expect stronger growth Q3 to Q4 than Q2 to Q3. With multiple growth drivers in place, expanding patient and prescriber bases, increasing brand recognition and the momentum of our media investments, we believe Breonvi is on track to become a multibillion dollar brand in relapsing MS. To summarize, Q2 was another quarter of commercial strength, execution and strategic progress. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:11:50We expect a strong second half of the year. With that, I'll turn it over to Sean to walk through the financials. Sean PowerCFO at TG Therapeutics00:11:57Thank you, Adam, and good morning, everyone. Earlier this morning, we reported our detailed second quarter twenty twenty five financial results via press release, which is available on the Investors and Media section of our website. Let's start by taking a closer look at our revenue performance, which continues to demonstrate strong growth and commercial momentum. We're very pleased to report total revenue of $141,100,000 for the 2025, which includes U. S. Sean PowerCFO at TG Therapeutics00:12:29Net product revenue of $138,800,000 representing a 91% increase compared to the same period last year and 16% growth over the first quarter of this year. This strong performance reflects the continued uptake and demand for BREONVY and highlights our team's success and execution across the commercial landscape. Additionally, we recorded $2,300,000 in license, milestone and royalty revenue this quarter. Turning to our expenses. Our total OpEx defined as R and D and SG and A costs excluding non cash compensation totaled approximately $71,000,000 for the 2025. Sean PowerCFO at TG Therapeutics00:13:17This represents an increase from $46,900,000 in 2024, but a decrease of about $10,000,000 compared to the first quarter of this year. The year over year increase was primarily driven by ongoing investments in R and D, particularly related to the development of a subcutaneous formulation of BREYMVY, as well as our continued commercial efforts on the SG and A side. In contrast, the sequential decline from Q1 was largely due to the timing of subcutaneous BRIONVI development activities, which we expect will continue to have some quarter to quarter variability. With all that said, we continue to expect full year operating expenses to be in the range of approximately $300,000,000 in line with our prior guidance. On the bottom line, we're pleased to report GAAP net income of $28,200,000 or $0.17 per diluted share for the quarter ended 06/30/2025, as compared to $6,900,000 in net income or $04 per diluted share for the 2024. Sean PowerCFO at TG Therapeutics00:14:29And finally, a quick note on our balance sheet. We closed the quarter with approximately $279,000,000 in cash, cash equivalents and investment securities, which is essentially flat from the first quarter. We believe this strong capital position enables us to continue executing on our long term strategy, while preserving flexibility for future investments in our pipeline and operations. In summary, the second quarter was a success on multiple fronts with strong results both operationally and financially. With that, I will now turn the call over to the conference operator to begin the Q and A. Operator00:15:10Thank you. At this time, we'll be conducting a question and answer session. Thank you. And our first questions are from the line of Tara Bancroft with TD Cowen. Please proceed with your questions. Tara BancroftDirector, Senior Analyst, Biotech Equity Research at TD Cowen00:15:43Hi, good morning and thanks for taking the questions. So I'm curious about guidance. It applies a little bit of leveling off of growth in the back half of the year. So I'm curious to get your thoughts a little bit more elaboration on what various headwinds and tailwinds that we could expect in Q3 and Q4 to get a better idea of cadence for the rest of the year? Thanks so much. Michael WeissChairman, CEO & President at TG Therapeutics00:16:08Sure. Adam, you want to take that one? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:16:13Sure. Thanks for the question, Tara. We're raising guidance here. And as I mentioned in the prepared remarks, we do see seasonality in the summer. We accounted for that in the guidance, and we expect stronger growth from Q3 to Q4. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:16:29And I think the success we've had in the first year with increased enrollments and persistence in week twenty four and week '48 are driving our need to increase the overall guidance for the year. Operator00:16:50Our next questions are from the line of Michael DeFeort with Evercore ISI. Please proceed with your questions. Michael DifioreManaging Director at Evercore00:16:57Hey, guys. Thanks so much for taking my questions and congrats on the strong quarter. Just two for me. I was wondering if you could expand upon comments you recently made at a broker conference where you said that 40% of CD20 new starts now opt for an at home sub queue. Question is how would you say the remaining 60% is broken down in terms of those opting for BRIONVI versus the other competitors IV and subcu formulations? Michael DifioreManaging Director at Evercore00:17:26And second question is just given the growing payer push for lower cost at home therapies, like are you seeing any early signs that the demand for subcu could actually outpace IV? And do you think that payers could accelerate that shift in the next year or two? Thank you. Michael WeissChairman, CEO & President at TG Therapeutics00:17:46Thanks, Mike. Adam, do want to give a crack here? And I could always add on, but I think this one's right in your wheelhouse. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:17:53Yes, sure. Thanks for the question, Michael. So the first question on the 60% that are IV, as I mentioned, we believe in the IV segment or physician administered segment, we're capturing about one out of every three patients today. And the other competitors are getting the other part of that market. As far as the payer questions, we're not seeing it today, but certainly we could see it. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:18:20It's certainly possible. Hence, the reason we are actively developing our own subcu to participate in that segment of the market. Michael DifioreManaging Director at Evercore00:18:31Thank you. Operator00:18:34The next question is from the line of Karin Jenkins with Goldman Sachs. Please proceed with your question. Corinne JenkinsVice President at Goldman Sachs00:18:42Good morning. Maybe could you talk a little bit more about the administration of the subcutaneous product you're developing with the auto injector or prefilled syringe and what additional work do you need to do on the device side in terms of getting that the development through to approval? Thanks. Michael WeissChairman, CEO & President at TG Therapeutics00:19:00Yes, sure. Thanks for the question. So, yes, so as typical for these kinds of programs, main study will be conducted with basically a syringe pulled from a vial to get the bioequivalence and then there's usually a bridging study to either a prefilled syringe and or to an auto injector. I think our plan is probably just go straight to the auto injector and so there'll be a bridging study that's part of the program. But that's all sort of in the timelines that we provided in terms of our target for a filing in 2027 and hopefully an approval in 2028. Michael WeissChairman, CEO & President at TG Therapeutics00:19:38But yes, it starts off as injections from a vial and then bridges to the auto injector. The auto injector we're using is a call it relatively standard. It's been in tens of thousands of patients and multiple drug launches, multiple major drug launches. So it's a pretty well known, well accepted auto injector. And I think there's the basic development that goes along with that, but I don't think we're expecting any technical challenges with the auto injector. Corinne JenkinsVice President at Goldman Sachs00:20:13Thank you. Michael WeissChairman, CEO & President at TG Therapeutics00:20:15Got it. Operator00:20:18Our next question is from the line of Mayank Wontani with B. Riley Securities. Please proceed with your questions. Mayank MamtaniSenior MD & Group Head - Healthcare at B. Riley Securities00:20:25Yes. Thanks for taking my questions and congrats on the progress. One more on the second half revenue guidance. Could you touch on how you're assuming the anti CD20 IV overall market trends, including your belief on how new patient starts might be trending for ZENOVO OCREVIUS? And then I have a quick follow-up. Michael WeissChairman, CEO & President at TG Therapeutics00:20:48Adam, you want to go ahead on this one too? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:20:52Sure. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:20:53Yes, thanks for the question, Mike. We're seeing a lot of enthusiasm for the ZENOVO product in The U. S. We continue I think the biggest point here is that we continue to grow new patient enrollments. We've continued to grow through the launch. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:21:10We've continued to grow through the ASP or the I'm sorry, the J code, the permanent J code that was granted in April. So we're not really seeing any impact on us in terms of the Xenovo product. And we're seeing overall limited enthusiasm for that drug. Mayank MamtaniSenior MD & Group Head - Healthcare at B. Riley Securities00:21:32And the overall market, do you think is stable for IV and steadily growing or it's just flat? Can you comment on that, Adam? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:21:41Yes, sure. It's about I think it's leveled out here at about 60%, 60%, 40%, 65, thirty five percent. Mayank MamtaniSenior MD & Group Head - Healthcare at B. Riley Securities00:21:48Okay. Thank you. And then on ECTRIMS, I believe in the same session, we are getting the six year ULTIPATE one and two trial data set. We are also getting the anti CD19 CAR T, I believe a single center primary progressive early data set. Mike, any thoughts on what your expectations are with some of the early human data that could inform your own azacel development? Michael WeissChairman, CEO & President at TG Therapeutics00:22:15Probably not so much. Mean, think all the data is going be extremely early and we'll see. But I think those programs and our program are early. There's a lot of time to develop them and I think in MS, it's not going to be a short term kind of development program. So anyone thinks they're going to do something relatively quickly there, they're probably maybe off base, but we'll see. Michael WeissChairman, CEO & President at TG Therapeutics00:22:42But anyway, yes, I don't think there's going to be too much. It's going to change how we think about how we're developing the drug. I think we've got a pretty clear focus on what we want to achieve and we'll see if we can get there. Mayank MamtaniSenior MD & Group Head - Healthcare at B. Riley Securities00:22:55Thank you, Mike. Michael WeissChairman, CEO & President at TG Therapeutics00:22:57Thank you. Operator00:23:00Our next question is from the line of Roger Sange with Jefferies. Please proceed with your question. Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:23:07Hi, this is Chachi Yang on for Roger. I had a question about whether you could touch on product adherence versus the biannual infusions? And then my second question is, and maybe I missed this, if you could give 3Q guidance, perhaps I missed that in the beginning of your call. Michael WeissChairman, CEO & President at TG Therapeutics00:23:24Adam, go ahead. Think we'll see you there. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:23:26Sure. Can you please repeat the second half of that question? Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:23:32So about 3Q guidance? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:23:36Yes. Sorry, I didn't hear the last part of it. Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:23:38I was just wondering, potentially I missed it, but did you guys give 3Q guidance? If not, could you give some color on that? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:23:46Yes. No, we did not give 3Q guidance or guidance. We are giving full year guidance similar to what we did last year. We gave you insight into what we feel is the growth trends from Q2 to Q3 and Q3 to Q4, but we're not giving specific Q3 guidance here. Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:24:05Okay. Thanks. And then can you give some color on the product adherence part of it in between the infusions? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:24:12Sure. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:24:14I mean, what we've seen is that our persistence continues to be good both at week 24 and we're getting preliminary data here at week 48, continues to be above our expectations and slightly above where we would expect it to be based on published data that's out there for other CD20s that is. Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:24:36Okay. Thank you. Operator00:24:40Thank you. The next question is from the line of Prakhar Agarwal with Cantor Fitzgerald. Please proceed with your question. Prakhar AgrawalManaging Director at Cantor Fitzgerald00:24:48Hi. Thanks for taking my questions and congrats on the quarter again. So firstly on the subcu BREOMBI, it seems that you're also comfortable with the quarterly dosing here. Maybe if you can comment what you saw in Phase one for the quarterly dosing frequency? And what will be injection volume for both quarterly and every other month dosing? Prakhar AgrawalManaging Director at Cantor Fitzgerald00:25:08Also when can we see the subcu Phase one data? And I had a follow-up. Michael WeissChairman, CEO & President at TG Therapeutics00:25:13Angelo, I have a follow-up. Okay. Thanks, Prakhar, for the question. On the subcu dosing, yes, I mean, look, in terms of quarterly dosing and monthly and every other monthly dosing, we've got preliminary bioavailability information that leads us to believe that both are achievable, certainly every other month and quarterly as well. We haven't provided that information just yet. Michael WeissChairman, CEO & President at TG Therapeutics00:25:42In terms of volume, typical auto injectors max, basically two mls of volume. So we'll probably be pretty close to that. But yes, I think for the moment, what we've said is we're comfortable that what we've seen with the bioavailability should support every other month and as I said in the prepared remarks, potentially quarterly as well. And you have a follow-up you offered? Prakhar AgrawalManaging Director at Cantor Fitzgerald00:26:06Yes. Got it. Thanks. Thanks, Mike. So on the second quarter sequential growth of 16%, how much is volume versus pricing? Prakhar AgrawalManaging Director at Cantor Fitzgerald00:26:17And if you can comment on the gross to net trends for the rest for the year? Thank you so much. Michael WeissChairman, CEO & President at TG Therapeutics00:26:22You got it. Think that's one over to Adam. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:26:27Sure. Thanks for the question, Proctor. On the gross to net, I'll take that first. We've guided 70% to 75% for the year, and that still remains intact. I would say this quarter, it was probably closer to 70 And the reason for that is that we our fastest growing segment is the hospital segment. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:26:47And we continue to see growth in that segment of the market. And with that comes mandated government discounting or more exposure to government mandated discounting like 340B discounting, which can affect your gross to net. So we did see gross to net probably closer to 70% in this quarter, but the guidance that I've given for the year between 7075% is still accurate. But in this quarter, was probably closer to 70%. And was that the was there any what was the second part of that question? Prakhar AgrawalManaging Director at Cantor Fitzgerald00:27:21Yes. How much of the 16% sequential growth is volume versus price? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:27:28Yes. I don't have that exactly broken down, but mostly volume. Prakhar AgrawalManaging Director at Cantor Fitzgerald00:27:32Thank you. Operator00:27:36Thank you. At this time, we've reached the end of the question and answer session. I'll turn the call over to Mike Weiss for closing remarks. Michael WeissChairman, CEO & President at TG Therapeutics00:27:44Thank you very much operator and thank you all again for joining us today. As you've heard this quarter highlights the strength of our commercial execution, the growing demand for BRYONVY and significant opportunity ahead as we continue to expand our presence in MS. We believe TG is well positioned to drive meaningful near term growth while also shaping the future of MS Care through differentiated options across IV, subcu and potentially cell therapy, laying the foundation for sustained growth and long term shareholder value. Most importantly, our focus remains firmly on delivering for patients. And we look forward to keeping you updated on our continued progress in the quarters ahead. Michael WeissChairman, CEO & President at TG Therapeutics00:28:25Thanks again for joining us and have a great day. Operator00:28:29Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.Read moreParticipantsExecutivesJenna BoscoChief Communication OfficerMichael WeissChairman, CEO & PresidentAdam WaldmanChief Commercialization OfficerSean PowerCFOAnalystsTara BancroftDirector, Senior Analyst, Biotech Equity Research at TD CowenMichael DifioreManaging Director at EvercoreCorinne JenkinsVice President at Goldman SachsMayank MamtaniSenior MD & Group Head - Healthcare at B. Riley SecuritiesCha Cha YangSenior Associate, Biotech Equity Research at JefferiesPrakhar AgrawalManaging Director at Cantor FitzgeraldPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) TG Therapeutics Earnings HeadlinesWhat is B. Riley's Estimate for TG Therapeutics Q3 Earnings?August 9, 2025 | americanbankingnews.comTG Therapeutics files automatic mixed securities shelfAugust 9, 2025 | msn.comREVEALED FREE: Our top 3 stocks to own in 2025 and beyondEvery time Weiss Ratings flashed green like this, the average gain on each and every stock has been 303% (including the losers!).August 13 at 2:00 AM | Weiss Ratings (Ad)Beyond the Balance Sheet: What SWOT Reveals About TG Therapeutics Inc (TGTX)August 8, 2025 | gurufocus.comWhat is B. Riley's Forecast for TG Therapeutics Q4 Earnings?August 8, 2025 | americanbankingnews.comFY2025 EPS Estimate for TG Therapeutics Reduced by AnalystAugust 8, 2025 | americanbankingnews.comSee More TG Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like TG Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on TG Therapeutics and other key companies, straight to your email. Email Address About TG TherapeuticsTG Therapeutics (NASDAQ:TGTX), a commercial stage biopharmaceutical company, focuses on the acquisition, development, and commercialization of novel treatments for B-cell mediated diseases in the United States and internationally. It provides BRIUMVI, an anti-CD20 monoclonal antibody for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. The company's development pipeline comprises Umbralisib, an oral inhibitor of PI3K-delta inhibitor for the treatment of adult patients with relapsed or refractory marginal zone lymphoma and follicular lymphoma; TG-1701 is an orally available and covalently bound Bruton's tyrosine kinase (BTK) inhibitor that exhibits selectivity to BTK in vitro kinase screening; and TG-1801, a bispecific CD47 and CD19 antibody. Its research pipeline includes various investigational medicines. The company has license agreements with LFB Biotechnologies S.A.S; GTC Biotherapeutics; LFB/GTC LLC; Ildong Pharmaceutical Co. Ltd.; Rhizen Pharmaceuticals, S A. for the development and commercialization of umbralisib; Jiangsu Hengrui Medicine Co.; and Novimmune SA, as well as collaboration agreement with Checkpoint Therapeutics, Inc. for the development and commercialization of anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. TG Therapeutics, Inc. was incorporated in 1993 and is based in Morrisville, North Carolina.View TG Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles CrowdStrike Faces Valuation Test Before Key Earnings ReportPost-Earnings, How Does D-Wave Stack Up Against Quantum Rivals?Why SoundHound AI's Earnings Show the Stock Can Move HigherAirbnb Beats Earnings, But the Growth Story Is Losing AltitudeDutch Bros Just Flipped the Script With a Massive Earnings BeatIs Eli Lilly’s 14% Post-Earnings Slide a Buy-the-Dip Opportunity?Constellation Energy’s Earnings Beat Signals a New Era Upcoming Earnings Applied Materials (8/14/2025)NetEase (8/14/2025)Deere & Company (8/14/2025)NU (8/14/2025)Petroleo Brasileiro S.A.- Petrobras (8/14/2025)Palo Alto Networks (8/18/2025)Home Depot (8/19/2025)Medtronic (8/19/2025)Analog Devices (8/20/2025)Synopsys (8/20/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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PresentationSkip to Participants Operator00:00:00Greetings. Welcome to TG Therapeutics Second Quarter Earnings Call and Webcast. At this time, participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. Operator00:00:20At this time, I'll turn the conference call over to Jenna Bosco, Chief Communications Officer. Jenna, you may now begin. Jenna BoscoChief Communication Officer at TG Therapeutics00:00:27Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second quarter twenty twenty five financial results are Michael Weiss, our Chairman and Chief Executive Officer Adam Waldman, our Chief Commercial Officer and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate developments, Adam will share an update on our commercial efforts, and Sean will give a summary of our financial results before turning the call over to the operator to begin the Q and A session. Before we begin, I would like to remind everyone that we will be making forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Jenna BoscoChief Communication Officer at TG Therapeutics00:01:12These 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 products. Cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors that can be found in our SEC filings. 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. Jenna BoscoChief Communication Officer at TG Therapeutics00:01:58This conference call is being recorded for audio rebroadcast on TG's website at www.tgtherapeutics.com, where we'll be available for the next thirty days. Now I would like to turn the call over to Mike Weiss, our CEO. Michael WeissChairman, CEO & President at TG Therapeutics00:02:14Thank you, Jenna, and good morning, everyone, and thank you for joining us on today's call. I'm pleased to share that we delivered another strong quarter with solid performance across all aspects of our business, highlighted by the continued momentum of our flagship product, BREONVY. The ongoing enthusiasm from the MS community has been both gratifying and energizing, and our commercial performance has exceeded expectations. At TG, our mission is to bring forward therapies that truly improve the lives of those living with multiple sclerosis. Hearing real world stories from individuals on BRIUMVI is both validating and deeply inspiring. Michael WeissChairman, CEO & President at TG Therapeutics00:02:53I encourage you to visit briumvi.com to hear some of these patient experiences firsthand. Our commercial team remains disciplined and highly effective in executing our multi year launch strategy. As a result, adoption continues to grow. Now approximately two point five years into launch, we estimate that nearly one in every three new IV anti CD20 patients are prescribed BRIONVY. This represents meaningful progress toward our long term goal of making BRIONVY the most prescribed anti CD20 therapy for relapsing MS as measured by dynamic market share. Michael WeissChairman, CEO & President at TG Therapeutics00:03:35And as adoption continues to grow, we remain focused on expanding choice and flexibility for patients and providers through the development of subcu BRIONVI and our ENHANCE study. The development of subcu BRIONVI represents a strategic opportunity to further build a leadership role in the anti CD20 space. If approved, subcu Briohnvi would significantly expand our addressable market by unlocking access to the 35% to 40% of the anti CD20 dynamic market segment that currently prefers a self administered option, of which only one is available today. We believe subcu Buryumbe has the potential to offer a highly valued alternative for both patients and providers. Moreover, it would uniquely position PG as the only company offering both an IV and a self administered option, potentially simplifying the treatment decision for patients and providers and positioning Breonvi as the anti CD20 therapy of choice. Michael WeissChairman, CEO & President at TG Therapeutics00:04:40Supporting this vision, the team has executed exceptionally well on our clinical development goals this quarter, putting us on track to initiate patient enrollment into our pivotal Phase III trial for subcu Reumvi in the coming weeks. This study will evaluate two dosing schedules every other month and quarterly compared to IV BRIONVY in patients with relapsing forms of MS. The primary endpoint is to demonstrate non inferior exposure between subcu dosing and our approved IV dosing. We anticipate completing enrollment in 2026, filing a BLA in 2027, and pending approval launching a subcu BRIONVY in 2028. At the same time, we're focused on enhancing the patient experience with IV BRIONVY. Michael WeissChairman, CEO & President at TG Therapeutics00:05:36I'm pleased to report that within the ENHANCE trial, we have begun enrollment into a randomized, double blind Phase III cohort evaluating the potential to consolidate the day one and day fifteen infusions into a single six hundred milligram infusion on day one. The goal of this study is to establish comparable exposure between the two dosing schedules. If successful, this simplified approach would eliminate the need for a second infusion in the first two weeks, offering what we believe would be a meaningful convenience benefit for patients and infusion centers. We look forward to pivotal data in 2026 with the goal of an updated label in 2027. Turning briefly to our pipeline. Michael WeissChairman, CEO & President at TG Therapeutics00:06:27We are also pleased to share that we have dosed our first patient with progressive MS using azurecel, on investigational allogeneic CD19 directed CAR T therapy. In parallel, we continue to explore the use of BRIUMVY in myasthenia gravis as we consider additional opportunities to expand the uses of BRIONVY. This is an exciting time at TG. Our results this quarter reflect strong execution across both commercial and clinical fronts and a growing confidence in Voriyomvi from physicians and patients alike. With continued progress on our subcu program, enhancements to the IV experience and the advancement of our CD19 CAR T into the clinic, we're laying the groundwork for sustained leadership in the MS space. Michael WeissChairman, CEO & President at TG Therapeutics00:07:20With that, I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, who will provide additional insights into our commercial performance and updated guidance for the second half of the year. Adam, go ahead. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:07:35Thank you, Mike, and good morning, everyone. I'm excited to report that Q2 twenty twenty five was another strong quarter for TG Therapeutics, marked by continued commercial momentum, executional excellence and the highest number of new patient enrollments into our hub since launch. We're now seeing the tangible results of our strategic investments as the foundation we've built continues to scale. U. S. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:07:59Net sales for Breomby in Q2 totaled approximately $139,000,000 ahead of our internal expectations and building on the robust growth we achieved in Q1, positioning us for a strong 2025. Several key performance drivers reinforce our confidence in the brand's continued trajectory. We saw meaningful increase in both new prescribers and new accounts, reflecting deeper penetration across academic institutions and community neurology practices. Q2 marked our highest volume of new patient enrollments to date, a clear indicator that our reach is expanding and that awareness among providers and patients is accelerating. We also continue to observe strong persistence and repeat prescribing, which we view as a validation of Breomby's differentiated clinical profile and its value in real world practice. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:08:51Today, the CD20 class generates over $8,000,000,000 in annual U. S. MS sales and continues to grow. BREONVY is steadily increasing its share within this expanding market. As Mike mentioned earlier, we estimate that nearly one third of new patients initiating IV anti CD20 therapy are being prescribed BREONVY. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:09:13We believe there remains significant headroom for continued growth for the class and for BRIONVI within it. Our competitive advantage remains clear, a convenient twice a year one hour infusion combined with five year safety and efficacy data collectively offers a compelling treatment option for RMS patients. These differentiators continue to resonate strongly across care settings from large academic centers to private practices to the VA system where we continue to be the preferred anti CD20 therapy. A major milestone this quarter was the launch of our first ever national television campaign. This initiative is part of a broader multichannel strategy that will ramp throughout the second half of the year with the goal of driving patient awareness. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:10:00While it's still early, we're seeing promising signs that the investment is having an impact. Our latest market research shows a measurable uptick in patient awareness of BREONVY. Website traffic, branded organic search impressions, branded paid search impressions and qualified visitors to the website have all increased meaningfully. And importantly, physicians are reporting more patients requesting BREONVY by name. We are closely tracking key performance indicators across media channels and will continue to monitor performance, but early signals are encouraging. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:10:34I also want to highlight the efforts of our commercial team. We believe we have a highly effective field team and our recent surveys back that up with consistently high ratings when compared to our peers in the MS space. Their ability to clearly and credibly communicate BRIMBI's value proposition is a key part of our strategy and their daily commitment is making a real difference. Looking ahead, we are confident in the continued growth of Briumby revenues. Based on current trends in both new patient prescriptions and persistence of existing patients, we are again raising our full year U. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:11:06S. BREYUNBI net revenue guidance, which was $560,000,000 to $570,000,000 to $575,000,000 for the full year 2025. Similar to last year, given expected Q3 seasonality, we would expect stronger growth Q3 to Q4 than Q2 to Q3. With multiple growth drivers in place, expanding patient and prescriber bases, increasing brand recognition and the momentum of our media investments, we believe Breonvi is on track to become a multibillion dollar brand in relapsing MS. To summarize, Q2 was another quarter of commercial strength, execution and strategic progress. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:11:50We expect a strong second half of the year. With that, I'll turn it over to Sean to walk through the financials. Sean PowerCFO at TG Therapeutics00:11:57Thank you, Adam, and good morning, everyone. Earlier this morning, we reported our detailed second quarter twenty twenty five financial results via press release, which is available on the Investors and Media section of our website. Let's start by taking a closer look at our revenue performance, which continues to demonstrate strong growth and commercial momentum. We're very pleased to report total revenue of $141,100,000 for the 2025, which includes U. S. Sean PowerCFO at TG Therapeutics00:12:29Net product revenue of $138,800,000 representing a 91% increase compared to the same period last year and 16% growth over the first quarter of this year. This strong performance reflects the continued uptake and demand for BREONVY and highlights our team's success and execution across the commercial landscape. Additionally, we recorded $2,300,000 in license, milestone and royalty revenue this quarter. Turning to our expenses. Our total OpEx defined as R and D and SG and A costs excluding non cash compensation totaled approximately $71,000,000 for the 2025. Sean PowerCFO at TG Therapeutics00:13:17This represents an increase from $46,900,000 in 2024, but a decrease of about $10,000,000 compared to the first quarter of this year. The year over year increase was primarily driven by ongoing investments in R and D, particularly related to the development of a subcutaneous formulation of BREYMVY, as well as our continued commercial efforts on the SG and A side. In contrast, the sequential decline from Q1 was largely due to the timing of subcutaneous BRIONVI development activities, which we expect will continue to have some quarter to quarter variability. With all that said, we continue to expect full year operating expenses to be in the range of approximately $300,000,000 in line with our prior guidance. On the bottom line, we're pleased to report GAAP net income of $28,200,000 or $0.17 per diluted share for the quarter ended 06/30/2025, as compared to $6,900,000 in net income or $04 per diluted share for the 2024. Sean PowerCFO at TG Therapeutics00:14:29And finally, a quick note on our balance sheet. We closed the quarter with approximately $279,000,000 in cash, cash equivalents and investment securities, which is essentially flat from the first quarter. We believe this strong capital position enables us to continue executing on our long term strategy, while preserving flexibility for future investments in our pipeline and operations. In summary, the second quarter was a success on multiple fronts with strong results both operationally and financially. With that, I will now turn the call over to the conference operator to begin the Q and A. Operator00:15:10Thank you. At this time, we'll be conducting a question and answer session. Thank you. And our first questions are from the line of Tara Bancroft with TD Cowen. Please proceed with your questions. Tara BancroftDirector, Senior Analyst, Biotech Equity Research at TD Cowen00:15:43Hi, good morning and thanks for taking the questions. So I'm curious about guidance. It applies a little bit of leveling off of growth in the back half of the year. So I'm curious to get your thoughts a little bit more elaboration on what various headwinds and tailwinds that we could expect in Q3 and Q4 to get a better idea of cadence for the rest of the year? Thanks so much. Michael WeissChairman, CEO & President at TG Therapeutics00:16:08Sure. Adam, you want to take that one? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:16:13Sure. Thanks for the question, Tara. We're raising guidance here. And as I mentioned in the prepared remarks, we do see seasonality in the summer. We accounted for that in the guidance, and we expect stronger growth from Q3 to Q4. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:16:29And I think the success we've had in the first year with increased enrollments and persistence in week twenty four and week '48 are driving our need to increase the overall guidance for the year. Operator00:16:50Our next questions are from the line of Michael DeFeort with Evercore ISI. Please proceed with your questions. Michael DifioreManaging Director at Evercore00:16:57Hey, guys. Thanks so much for taking my questions and congrats on the strong quarter. Just two for me. I was wondering if you could expand upon comments you recently made at a broker conference where you said that 40% of CD20 new starts now opt for an at home sub queue. Question is how would you say the remaining 60% is broken down in terms of those opting for BRIONVI versus the other competitors IV and subcu formulations? Michael DifioreManaging Director at Evercore00:17:26And second question is just given the growing payer push for lower cost at home therapies, like are you seeing any early signs that the demand for subcu could actually outpace IV? And do you think that payers could accelerate that shift in the next year or two? Thank you. Michael WeissChairman, CEO & President at TG Therapeutics00:17:46Thanks, Mike. Adam, do want to give a crack here? And I could always add on, but I think this one's right in your wheelhouse. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:17:53Yes, sure. Thanks for the question, Michael. So the first question on the 60% that are IV, as I mentioned, we believe in the IV segment or physician administered segment, we're capturing about one out of every three patients today. And the other competitors are getting the other part of that market. As far as the payer questions, we're not seeing it today, but certainly we could see it. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:18:20It's certainly possible. Hence, the reason we are actively developing our own subcu to participate in that segment of the market. Michael DifioreManaging Director at Evercore00:18:31Thank you. Operator00:18:34The next question is from the line of Karin Jenkins with Goldman Sachs. Please proceed with your question. Corinne JenkinsVice President at Goldman Sachs00:18:42Good morning. Maybe could you talk a little bit more about the administration of the subcutaneous product you're developing with the auto injector or prefilled syringe and what additional work do you need to do on the device side in terms of getting that the development through to approval? Thanks. Michael WeissChairman, CEO & President at TG Therapeutics00:19:00Yes, sure. Thanks for the question. So, yes, so as typical for these kinds of programs, main study will be conducted with basically a syringe pulled from a vial to get the bioequivalence and then there's usually a bridging study to either a prefilled syringe and or to an auto injector. I think our plan is probably just go straight to the auto injector and so there'll be a bridging study that's part of the program. But that's all sort of in the timelines that we provided in terms of our target for a filing in 2027 and hopefully an approval in 2028. Michael WeissChairman, CEO & President at TG Therapeutics00:19:38But yes, it starts off as injections from a vial and then bridges to the auto injector. The auto injector we're using is a call it relatively standard. It's been in tens of thousands of patients and multiple drug launches, multiple major drug launches. So it's a pretty well known, well accepted auto injector. And I think there's the basic development that goes along with that, but I don't think we're expecting any technical challenges with the auto injector. Corinne JenkinsVice President at Goldman Sachs00:20:13Thank you. Michael WeissChairman, CEO & President at TG Therapeutics00:20:15Got it. Operator00:20:18Our next question is from the line of Mayank Wontani with B. Riley Securities. Please proceed with your questions. Mayank MamtaniSenior MD & Group Head - Healthcare at B. Riley Securities00:20:25Yes. Thanks for taking my questions and congrats on the progress. One more on the second half revenue guidance. Could you touch on how you're assuming the anti CD20 IV overall market trends, including your belief on how new patient starts might be trending for ZENOVO OCREVIUS? And then I have a quick follow-up. Michael WeissChairman, CEO & President at TG Therapeutics00:20:48Adam, you want to go ahead on this one too? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:20:52Sure. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:20:53Yes, thanks for the question, Mike. We're seeing a lot of enthusiasm for the ZENOVO product in The U. S. We continue I think the biggest point here is that we continue to grow new patient enrollments. We've continued to grow through the launch. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:21:10We've continued to grow through the ASP or the I'm sorry, the J code, the permanent J code that was granted in April. So we're not really seeing any impact on us in terms of the Xenovo product. And we're seeing overall limited enthusiasm for that drug. Mayank MamtaniSenior MD & Group Head - Healthcare at B. Riley Securities00:21:32And the overall market, do you think is stable for IV and steadily growing or it's just flat? Can you comment on that, Adam? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:21:41Yes, sure. It's about I think it's leveled out here at about 60%, 60%, 40%, 65, thirty five percent. Mayank MamtaniSenior MD & Group Head - Healthcare at B. Riley Securities00:21:48Okay. Thank you. And then on ECTRIMS, I believe in the same session, we are getting the six year ULTIPATE one and two trial data set. We are also getting the anti CD19 CAR T, I believe a single center primary progressive early data set. Mike, any thoughts on what your expectations are with some of the early human data that could inform your own azacel development? Michael WeissChairman, CEO & President at TG Therapeutics00:22:15Probably not so much. Mean, think all the data is going be extremely early and we'll see. But I think those programs and our program are early. There's a lot of time to develop them and I think in MS, it's not going to be a short term kind of development program. So anyone thinks they're going to do something relatively quickly there, they're probably maybe off base, but we'll see. Michael WeissChairman, CEO & President at TG Therapeutics00:22:42But anyway, yes, I don't think there's going to be too much. It's going to change how we think about how we're developing the drug. I think we've got a pretty clear focus on what we want to achieve and we'll see if we can get there. Mayank MamtaniSenior MD & Group Head - Healthcare at B. Riley Securities00:22:55Thank you, Mike. Michael WeissChairman, CEO & President at TG Therapeutics00:22:57Thank you. Operator00:23:00Our next question is from the line of Roger Sange with Jefferies. Please proceed with your question. Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:23:07Hi, this is Chachi Yang on for Roger. I had a question about whether you could touch on product adherence versus the biannual infusions? And then my second question is, and maybe I missed this, if you could give 3Q guidance, perhaps I missed that in the beginning of your call. Michael WeissChairman, CEO & President at TG Therapeutics00:23:24Adam, go ahead. Think we'll see you there. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:23:26Sure. Can you please repeat the second half of that question? Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:23:32So about 3Q guidance? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:23:36Yes. Sorry, I didn't hear the last part of it. Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:23:38I was just wondering, potentially I missed it, but did you guys give 3Q guidance? If not, could you give some color on that? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:23:46Yes. No, we did not give 3Q guidance or guidance. We are giving full year guidance similar to what we did last year. We gave you insight into what we feel is the growth trends from Q2 to Q3 and Q3 to Q4, but we're not giving specific Q3 guidance here. Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:24:05Okay. Thanks. And then can you give some color on the product adherence part of it in between the infusions? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:24:12Sure. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:24:14I mean, what we've seen is that our persistence continues to be good both at week 24 and we're getting preliminary data here at week 48, continues to be above our expectations and slightly above where we would expect it to be based on published data that's out there for other CD20s that is. Cha Cha YangSenior Associate, Biotech Equity Research at Jefferies00:24:36Okay. Thank you. Operator00:24:40Thank you. The next question is from the line of Prakhar Agarwal with Cantor Fitzgerald. Please proceed with your question. Prakhar AgrawalManaging Director at Cantor Fitzgerald00:24:48Hi. Thanks for taking my questions and congrats on the quarter again. So firstly on the subcu BREOMBI, it seems that you're also comfortable with the quarterly dosing here. Maybe if you can comment what you saw in Phase one for the quarterly dosing frequency? And what will be injection volume for both quarterly and every other month dosing? Prakhar AgrawalManaging Director at Cantor Fitzgerald00:25:08Also when can we see the subcu Phase one data? And I had a follow-up. Michael WeissChairman, CEO & President at TG Therapeutics00:25:13Angelo, I have a follow-up. Okay. Thanks, Prakhar, for the question. On the subcu dosing, yes, I mean, look, in terms of quarterly dosing and monthly and every other monthly dosing, we've got preliminary bioavailability information that leads us to believe that both are achievable, certainly every other month and quarterly as well. We haven't provided that information just yet. Michael WeissChairman, CEO & President at TG Therapeutics00:25:42In terms of volume, typical auto injectors max, basically two mls of volume. So we'll probably be pretty close to that. But yes, I think for the moment, what we've said is we're comfortable that what we've seen with the bioavailability should support every other month and as I said in the prepared remarks, potentially quarterly as well. And you have a follow-up you offered? Prakhar AgrawalManaging Director at Cantor Fitzgerald00:26:06Yes. Got it. Thanks. Thanks, Mike. So on the second quarter sequential growth of 16%, how much is volume versus pricing? Prakhar AgrawalManaging Director at Cantor Fitzgerald00:26:17And if you can comment on the gross to net trends for the rest for the year? Thank you so much. Michael WeissChairman, CEO & President at TG Therapeutics00:26:22You got it. Think that's one over to Adam. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:26:27Sure. Thanks for the question, Proctor. On the gross to net, I'll take that first. We've guided 70% to 75% for the year, and that still remains intact. I would say this quarter, it was probably closer to 70 And the reason for that is that we our fastest growing segment is the hospital segment. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:26:47And we continue to see growth in that segment of the market. And with that comes mandated government discounting or more exposure to government mandated discounting like 340B discounting, which can affect your gross to net. So we did see gross to net probably closer to 70% in this quarter, but the guidance that I've given for the year between 7075% is still accurate. But in this quarter, was probably closer to 70%. And was that the was there any what was the second part of that question? Prakhar AgrawalManaging Director at Cantor Fitzgerald00:27:21Yes. How much of the 16% sequential growth is volume versus price? Adam WaldmanChief Commercialization Officer at TG Therapeutics00:27:28Yes. I don't have that exactly broken down, but mostly volume. Prakhar AgrawalManaging Director at Cantor Fitzgerald00:27:32Thank you. Operator00:27:36Thank you. At this time, we've reached the end of the question and answer session. I'll turn the call over to Mike Weiss for closing remarks. Michael WeissChairman, CEO & President at TG Therapeutics00:27:44Thank you very much operator and thank you all again for joining us today. As you've heard this quarter highlights the strength of our commercial execution, the growing demand for BRYONVY and significant opportunity ahead as we continue to expand our presence in MS. We believe TG is well positioned to drive meaningful near term growth while also shaping the future of MS Care through differentiated options across IV, subcu and potentially cell therapy, laying the foundation for sustained growth and long term shareholder value. Most importantly, our focus remains firmly on delivering for patients. And we look forward to keeping you updated on our continued progress in the quarters ahead. Michael WeissChairman, CEO & President at TG Therapeutics00:28:25Thanks again for joining us and have a great day. Operator00:28:29Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.Read moreParticipantsExecutivesJenna BoscoChief Communication OfficerMichael WeissChairman, CEO & PresidentAdam WaldmanChief Commercialization OfficerSean PowerCFOAnalystsTara BancroftDirector, Senior Analyst, Biotech Equity Research at TD CowenMichael DifioreManaging Director at EvercoreCorinne JenkinsVice President at Goldman SachsMayank MamtaniSenior MD & Group Head - Healthcare at B. Riley SecuritiesCha Cha YangSenior Associate, Biotech Equity Research at JefferiesPrakhar AgrawalManaging Director at Cantor FitzgeraldPowered by