Q4 2022 TG Therapeutics Inc Earnings Call
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Speaker 2: Greetings and welcome to the TG therapy of X Ford Quattle and your end 2022 learning calls.ccOT2 ,
Speaker 2: At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.
Speaker 2: If you wish to ask questions, please press star 1. If you'd like, if anyone should require a greater assistance during the conference, please press star 0 on your telephone keypad.
Speaker 2: If you wish to ask questions, please press star one. If you'd like, if anyone should require a greater assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference was being recorded.
Speaker 3: It is now my pleasure to introduce to your host, Jenna Bosco. Thank you and you may begin. Thank you. Welcome everyone and thanks for joining us this morning. I'm Jenna Bosco and with me today to discuss the fourth quarter and year end 2022 financial results.
Speaker 3: and provide a business update, or Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercialization Officer, and Sean Power, our Chief Financial Officer.
Speaker 3: Following our State Harbor statement, Mike will provide an overview of our recent corporate development. Adam will provide an update on our commercialization efforts and Sean will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Security's litigation reform act of 1995.
Speaker 3: These forward-looking statements include statements about our anticipated future operating and financial performance, and a projected regulatory milestones, clinical development plans, and expectations for our marketed product. CG questions 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 CG therapeutic operations include various risk factors.??????????????? May. 2 log-up
Speaker 3: that can be found in our FCC filing. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or advise any forward-looking statements. This conference call is being recorded for audio rebroadcast on TG's website
Speaker 4: 2022 was a mild-summing fatigue as we received FDA approval of Priyambi to treat adult patients with relaxing forms of multiple sclerosis.
Speaker 4: Also referred to as RMS, which includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease. RMS is now the first and only anti-CD-20 monocloral antibody.
Speaker 4: A proof for RMS that can be administered in a one hour fusion twice a year following the starting dose. This approval was based primarily on the results of the ultimate one and two phase through trials, which demonstrated superiority of pre-umvy over tariff glutamide and significantly reducing the annualized relapse rate, which was the primary amp on the studies.
Speaker 4: as well as the number of T1-gadden-hantle lesions and the number of new or enlarged T2 lesions, two important secondary endpoints. Results from the ultimate 1-2 trials were also published last year in the New England Journal of Medicine, marking another major accomplishment for 2022.
Speaker 4: I want to take the time to thank the patients, the families, and the health care providers who are participating on trials and help us get to this point.
Speaker 4: I also want to thank the entire TG team for their hard work and dedication to making ready to become one of the most important ground may have ever done.
Speaker 4: Archive commercialization officer, Adam Walman, which run shortly to talk about the early launch phase, but I also wanted to touch briefly on our B-Lunch. As you can imagine, our team is working hard to introduce B-Lunch to the MS community.
Speaker 4: Key to that effort is educating health care providers on the data as well as the other attributes of Grumpy. The team has received positive feedback thus far and is excited to continue to work with the MS community to make Grumpy available.
Speaker 4: as broadly as possible to RMS patients. As we have discussed in the past, it is estimated that nearly 1 million Americans are living with MS, and roughly 75,000 to 80,000 are seeking a new treatment each year.
Speaker 4: Our internal research suggests that about half of these patients' seeking of nutrition are currently being prescribed an anti-CD-20 therapy. We are excited that Briewambi is now available to these patients as the only anti-CD-20 therapy for RMS that is administered as at one hour of fusion twice a year following the starting dose.
Speaker 4: We do believe that Riyombe can provide an overall enhanced
Speaker 4: and fusion experience for those new to anti-CD20 therapy and also for those currently on the other infused anti-CD20 therapy where infusion times for some patients can be prolonged. Last week I was fortunate enough to attend the Actram's conference in San Diego.
Speaker 4: and had the opportunity to interact with many leading MS health care providers at the meeting. It was nice to hear firsthand the enthusiasm many of them had for Priyambi entering the market, the overall product profile and differentiation of the product label.
Speaker 4: It was also gratified to hear that patients are already asking for Brieham to my name. I also have been very impressed with our team's ability to interact with the MS community on all levels, and I know that they will continue to work hard to engage with healthcare providers and other stakeholders during the course of this year.
Speaker 4: with the goal of ensuring that all patients who are walk-free on the, will have access to re-unthe-beat. We continue to be excited by the Grumbry profile that we believe brings the power of the anti-CD-20 class to patients in a convenient one-hour fusion in Minister twice per a year following starting dose.
Speaker 4: At the lowest price of any branded MS treatment, we believe this profile should provide significant benefits across the entire MS community, including to patients, healthcare providers, medical centers, and payers.
Speaker 4: With that, let me turn the call over to Adam Walman, our Chief Commercialization Officer, to share some thoughts on our early days of launch and commercialization in RMS. Adam?
Speaker 5: Yep, thank you Mike and good morning everybody. I'm very happy to be able to share a brief update on the launch of Brion B. We're approximately four weeks post-drug availability, so it's still quite early, but I'm excited to share some initial insights and color around our progress and the reaction we've been seeing of Brion B in the MS community. Thank you.
Speaker 5: Excuse me. Since approval, our teams have been laser focused on executing our strategic launch objectives, a building awareness, driving utilization at our targeted counts, and minimizing access barriers to Briehombi. We are striving for flawless execution on each of these areas.
Speaker 5: which we believe will set the foundation for long-term success for Bionbi. We are so far highly encouraged by the initial feedback and enthusiasm we've received from a wide variety of stakeholders across the MS community.
Speaker 5: and are confident in the potential of Briembi to make a meaningful difference for patients with RMS. Raise awareness of Briembi's profile, we are investing in a mix of both in-person and virtual promotional resources to support our experience field team, while also leveraging peer-to-peer programs, digital marketing, social media, and presence at medical conferences and patient programs.
Speaker 5: executed many highly targeted peer-to-peer programs.
Speaker 5: with key healthcare providers in major MS centers since gaining approval. We are making good early progress in increasing awareness of Brambi throughout the MS community, and we'll continue to increase our efforts here throughout the year.
Speaker 5: Our sales teams are working on driving adoption and utilization at our high potential targeted accounts. Our teams have been very effective so far engaging with our customers to provide education.
Speaker 5: Their deep networks have allowed them to quickly engage with our initial targeted accounts approval. Healthcare providers seem eager to meet with us and learn more about the BREUMB profile. In general, the overall feedback on the product label for BREUMB has been positive.
Speaker 5: With customers consistently pointing to the perceived advantages of the one-hour infusion, the 24-week dosing schedule, the option of using oral pre-meds.
Speaker 5: and limited post-infusion monitoring in patients not experiencing infusion-related reactions with the first two infusions. We also held an advisory board last week at the Actrum's conference with some of the top MS specialists in the country to get their early feedback on the launch.
Speaker 5: The emphasized that Briehambi was a highly effective option with overall safety profile that is in line with expectations for CD20 agent.
Speaker 5: and also felt the tolerability profile, the faster impusion, the lack of breast cancer risk in the label, and the lower pricing strategy.
Speaker 5: was differentiated and potentially meaningful for patients. They also were very complimentary of the early interactions they've had with our field-based teams.
Speaker 5: Based on all the feedback we've received so far, we continue to believe there's significant interest in utilizing BREONV for patients with RMS.
Speaker 5: And many physicians have that we've engaged have expressed their excitement to start using the product. We have already seen a flow of patient enrollments at our hub, and in fact the first patient was infused in Columbus, Ohio on February 1st. Just four business days after the drug was made commercially available. There's actually a really nice article about this patient and Rihambi in US.
Speaker 5: around obtaining P&T committee approvals, working with accounts on miscellaneous J codes, and obtaining coverage for BREOMB. We have built an outstanding patient support program, staff by skilled, dedicated account specific. Thank you, David.
Speaker 5: Peace managers with deep experience in access and reimbursement, offering patients high-touch support throughout the reimbursement process.
Speaker 5: As part of this comprehensive program, we provide robust financial assistance program for eligible patients, including copay assistance.
Speaker 5: Quick start and coverage interruption programs. And we're appropriate, a program that will provide Breonvy at no cost to eligible patients who may have challenging, who may have challenges accessing Breonvy. The date this team has been very successful working with centers and patients to help Breonvy.
Speaker 5: while we continue to work on gaining coverage. Most importantly, we have already secured early payer coverage at several national and regional plans. In fact, we are ahead of our internal goals and very much on track to meet our goal to have coverage for the majority of covered lives in the US by the first half of the year.
Speaker 5: I'm very happy to share that we now have coverage policies in place for approximately 35% of covered lines across the US.
Speaker 5: We are extremely pleased by these early covers decisions and we believe it validates our pricing strategy and reflects beyond the strong clinical profile and value proposition and of course the hard work of our pair and national account teams.
Speaker 5: It is still very early, but I am proud of the progress our commercial teams have made across the launch objectives to date.
Speaker 5: We're seeing very positive signs so far that reinforce our confidence about the road ahead. We look forward to working with providers, patients, payers, and advocates to continue to broaden access to pre-unvy for patients with relapsing forms of MS. And given that we're only a few weeks into the launch.
Speaker 5: I will not go into a lot more detail at this point, but I'm very pleased with where we are to date and look forward to sharing more progress at the next quarterly call.
Speaker 5: detail at this point, but I'm very pleased with where we are to date and look forward to sharing more progress at the next quarterly call. Done?
Speaker 4: Thank you, Adam, and thanks everyone for joining us. Earlier this morning, we reported our detailed financial results which can be viewed on the investors and media section of our website. For today's call, I'll begin with our fourth quarter burn, which we are pleased to report came in at approximately $25 million for the quarter, well below our previously guided range. In terms of what that means for our task position,
Speaker 4: We ended 2022 with approximately 220 million in cash, cash equivalents and investment securities.
Speaker 4: With that total, including 45 million of available capacity under our Hercules facility, which became contractually accessible to us upon the approval of Ramvi.
Speaker 4: Our GapNet loss for the fourth quarter of 2022 was approximately 53 million or 39 cents per share, which was down sharply from the comparable quarter in 2021, where we saw a net loss of approximately 93 million or 70 cents per share.
Speaker 4: With the decrease driven by our discipline and focused approach to spending, ahead of the grand the approval last December . Our $53 million net loss in the fourth quarter of 2022 was an increase of 17 million quarter over quarter from Q3 of 22, where we saw a gap net loss of approximately 36 million.
Speaker 4: which was primarily the result of a one-time milestone payment triggered by the FDA approval of R&B, which was expense in Q4 of 2022. Our GapNet loss for the year-end of December 31st, 2022 was $198 million for a $1.46 per share, compared to a GapNet loss for the year-end of December 31st.
Speaker 4: of $348 million for $2.63 per share. The year-over-year decrease in net loss of approximately 150 million, as discussed earlier, is the result of our streamlined and focused efforts in 2022. In terms of what we expect in the quarter of the head,
Speaker 4: During 2023, we expect our operating expenses exclusive of Brieum v Inventory Build will average approximately 40 to 50 million per quarter.
Speaker 4: And when coupled with relatively modest assumptions on incoming revenue from the launch of Bremdi.
Speaker 4: We feel we are well positioned from a capital standpoint.
Speaker 4: we are well positioned from a capital standpoint into mid-2024.
Speaker 2: With that, I will now turn the call back over to the ComFIMS operator to begin the Q&A. Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question, Q.
Speaker 2: You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we pull for questions. We have a first question from the line of Eric Joseph with JP Morgan, please go ahead. Hi, this is Noah Unfererick.
Speaker 4: versus hospital. Adam, you want to go ahead and mention that one?
Speaker 4: Adam wanted to go ahead and mention it. Yeah so...
Speaker 5: So, you know, I think if I understood the question about the J code, I'm not sure there's a difference between academic and the infusion centers. I believe, you know, it's the same issue across both. You know, I think the obstacle at the academic centers is just getting on formulary and institutional formularies.
Speaker 5: Whereas the independent centers are more of a streamlined process. So we're seeing, you know, earlier access there than we are seeing at the academic centers where there's a form of process to go through. Okay, thank you.
Speaker 2: Thank you. We'll take an next question from the line of Josh Schimmer with Evercore ISI. Please go ahead. Thanks for taking the questions. So for patients who are switching from other anti-CD-20 antibody therapy, do they need to go through the same initial?
Speaker 6: Do same protocols, or is there an opportunity to move right to the one-hour infusion, or are there any studies that are contemplated to enable that, and then on the 2023 quarterly op-ex guidance just confirming that was gap and non-gap? Thank you.
Speaker 4: Sure, thanks, Josh. Yeah, so, you know, as per label, folks switching over will go through the four-hour starting dose.
Speaker 4: We do have a switch study that we're putting together that should launch soon to perhaps educate folks on whether that is necessary, but as per labeled right now, and I assume for some period of time the rule would be go through the other four-ounce fusion. With Shawn, you have a ...
Speaker 4: But we do have a switch study that we're putting together that should launch soon to perhaps educate folks on whether that is necessary, but as per labeled right now, and I assume for some period of time, the rule would be go through the other four-out fusion. Sean, do you have someone on the up-back? Yep.
Speaker 4: Sure. On the OPX, that is a gap number, but it excludes non-cash compensation. Then to follow up, Mike, if patients do have to go through those first two infusions, including a four-hour infusion, do you see that being an obstacle to switch it? So far, that does not appear to be an obstacle. I think early indications are that carefully comfortable switching from one to the other in user to the four-hour infusion, really.
And we've heard chatter that people would love to just skip the dose, but it doesn't seem to be an issue. It's certainly at the early days here. Remember, a lot of these folks that are switching over from Okervis are still on four-hour infusions plus one hour before, one hour after.
And a lot of them are still even having trouble getting them in the four hours. So it's a little bit of investment of what extra does, no doubt. And if we can run a trial, that could help people understand the risks.
of skipping that dose, we're going to do that. And that's on the way. And we think we'll get out of those results relatively quickly once we get that trial started, which is, I might guess about three months away from commencing, but you're looking at a one dose.
trial essentially, when the study will have more in it, but that piece of information will be understood early. And we can get that out into a conference setting. Again, we won't be obviously pitching that as something, but we are worried that folks will try to do to give the four hour, and we just want to make sure it's safe just in case. And if it's not...
Make sure we get that data out there to educate folks if that's not a good idea, if in fact that's a problem. Would that lead to a potential label amendment as well to include simplified transition dose? It's possible. We were talking about that internally and we're trying to see if that would be possible, but I couldn't promise that today. Okay, got it. Thanks very much. Thank you. We'll take next question from the line up, add white with HCWN, please call it.
Good morning. Thanks for taking my questions. So I was just wondering if you can give us perhaps an idea of the percentage of patients currently on drugs that are taking advantage of the patient assistance programs and how should we be thinking about
the number of patients or percentage of patients on the free drug programs, perhaps in the first half of this year versus the second half.
number of patients or percentage of patients on the free drug programs, perhaps in the first half of this year versus the second half. Yeah, Adam, you want to go ahead?
Yeah, and I don't have precise numbers in front of me. It's still pretty early. You know, we do what I could can say is that, you know, we do expect a higher percent of free goods in the first half of the year and a higher engagement with our programs in the first half of the year as we continue to work through the coverage issues. We're making good progress, as I mentioned, you know, gaining coverage, but
It's still a process and so we expect a higher percentage in the beginning of the year and that should decrease over time. Okay, thanks Adam. And just a question on your Salesforce. Is your Salesforce right size now or do you expect to be adding to your footprint? Yeah, we feel good about where we are right now.
Yeah, I'll just thank you.
I'll just add to that. At Act terms, I have a chance to meet with our two business managers that had the use in West Coast Business and ask on that same question and everyone feels very comfortable with the size of the team right now.
Great, thanks Mike. And my last question, if I'm any, you know, I always ask this, but can you give us an update on Europe ? What do you expect the timing that will be the six to nine months behind in any thoughts on strategy there? Thanks. Thanks Ed. Appreciate you always asking that question. Thanks.
partner or do it ourselves. We have a little bit of time here, but we're getting close. Probably have some more to say after we have our quarterly conference call, which I assume will be made time for them the first quarter call. So we'll keep you posted on that, but
or do it ourselves. We have a little bit of time here, but we're getting close. Probably have some more to say after we have our quarterly conference call, which I assume will be made time for the first quarter call. We'll keep you posted on that, but stay tuned. Great. Thanks for taking my questions. Thank you.
Thanks, Ash. Thank you. Take an next question from the line of Prokhar Agrawal with Cantor Fist Gerald. Please go ahead. Hi. Good morning, everyone, and thanks for hearing my questions. So number one, until the ESP is established for B&V, are there specific MS center types that might find it economically more attractive to use B&V over Acrous? Or do you think that the discounts may not be meaningful enough?
I had a couple of follow ups. Adam, did you get that? Yeah, I mean, we think that, you know, for Breelby,
There is a good economic story in advance of ASP, but even when we have ASP, we feel good about where we are with the pricing strategy and how physicians will be reimbursed.
So, you know, in the early stage, I'm trying to understand your question about the ASP. I'm not that I'm aware of that there would be an, you know, in advance of ASP, there would be an economic advantage.
Okay, and on the of the patients who have been treated so far, I think it's only four weeks. If you could provide more details on the profile of these patients, are these treatment knives or mostly switching patients? And it seems that you are seeing some switches from workers, but any color you could provide would be helpful.
Mike, do you want me to take that question? Yep, go ahead. Yeah, we're seeing both. We're seeing some switches from CD20. We're seeing switches from to Sabri. We're seeing newly diagnosed. So we're seeing an array of patient types. Okay.
at this point. But of course still early, but we're encouraged that we're seeing all types of patients come up. Okay, thank you very much.
Thank you. We take an next question from the line up, my young Montani, with B. Riley, security, please go ahead. This is the Sahoakaz me on from IHEC. Thanks for the really comprehensive update here and congrats on the early launch metrics. Just one question, I know there's a...
switching study that's going to get started here in the background. Can you also help us understand what might be sort of the internal decision tree to consider investing behind a higher dose subcutaneous or perhaps even expanding into the primary setting? Sure, so higher dose subcutaneous.
And I was like, things other competitors are doing to try to compete with us. And I'm going to promise that I'll do that. So look, higher dose.
We certainly don't need a higher dose. I think it's very clear to us that our competitor has chosen the higher dose study to try to compete with our more efficient, like engineered anti-CD20 monoclonal antibody. So, you know.
There's nothing else to do that we're already You know in theory the highest dose because of our ability to deplete itself at the Most efficient rate so I don't see any any any reason we want to do that. I think Their efforts in that area are fantastic for us. I think it shows one the insight the inside that shows me whether it's true or not Is that they believe that our data probably is better than theirs and then you'd hire dose to try to compete
in a way that can compare to what we've seen in our clinical trials. Again, across trial comparison, our ARR is just significantly lower, and I think that's what they're trying to go for. So we'll see how that turns out for them.
But I think that will be an extremely long infusion. And then subcue from that standpoint, we feel that the subcue competition in the main part is not. Oh, Taballan, humans. Now you know that there is always one little bird installed inside. So you know that there is always one little bird installed inside.
our business model, right? So if we have, there's two markets here, right? I think it's pretty clear the two markets have developed. Some patients do want to do a sub-cue, and so those patients right now there's only one option. But it appears that the other IV drug is looking to turn that into a sub-cue to compete in that portion of the market. So it sounds like they're going to have an IV.
competitor to us and they're going to have a sub-Q competitor to the sub-Q product. So we are evaluating whether we can come up with a better product for the sub-Q marketplace and then we know what that's going to cost. If we do a sub-Q, it's going to cost us the 80 or 100 million. So that's again something we'll have to consider and ask about whether it makes sense to do that investment.
We're doing the research now and the numbers to see, but first step is we're doing an evaluation of the Toximab, we're on V to see if the format of that sub-tube would look like. We're at the early stages of understanding that and we'll see how the two markets evolve. I think the same thing goes for PPMS. We know that it's going to cost somewhere in the order of 80 to 100 million and we're just not sure that.
that all market participants viewed PPMS as a distinct indication from the lapsing forms of MS. I think that's something whether there's really a full sum market there for us to invest into. The folks who studied the sub-Q and have approval sub-Q have also chosen not to run that study at this point. So I think there's probably good reasons.
not to do it, but we're evaluating that. Certainly we can consider doing some smaller studies just to understand.
the capabilities of our glycoengineered more efficient to the 20 MPPMS. Hopefully that helps.
Excellent. No, that's very helpful. Thank you for that. And then maybe just one more question for Sean. Could you remind me of the cast position at the end of the quarter and how we should think about the R&D and G&A mix going through 2023?
The cash position at the end of the current quarter? Sorry, at the end of the fourth quarter. Right. So 220 million, which as we stated in the prepared remarks, includes 45 million of available capacity under our fertility facility. Sorry.
And then in terms of the R&D and SGNA mix, you know, the guidance that we provided around OPAC, as I said, is exclusive of Briander Inventory Build. So I think it would be weighted to the SGNA side as opposed to R&D.
Okay, great. Thanks a lot. Thanks for taking our questions. Thank you. We'll take an next question from the line up, Matt Kaplan with Levenburg-Thalman. Please go ahead. Oh, hi. This is Raymond and from Matt. Thanks for taking our question.
Yeah, just to grab some beating or internal goals for coverage. I just want to let you know if you can elaborate on how we should think about the access and coverage over the next 12 to 18 months.
or internal goals for coverage. I just want to let you know if you can elaborate how we should think about the access and coverage over the next 12, 18 months. I'm going to go ahead.
Sure, you know, as we said, our goal is to get the majority of covered lives before the end of the first half of the year. And we're on track to do that. You know, we feel good about where we are to date. You know, what we said, I think in the past was we want to get to, you know, 80 to 90% before the end of the year, which we also feel good about at this point. And, you know, we continue to, we continue to work through all the processes, but, you know, we feel good with where we are at.
Oh, okay, cool. Yeah, and then I guess, just touching on this, you mentioned the switching study, which is very nice. I was wondering, is there any other kind of cadence of maybe postmarking study, the trials, or registries that might help sort of flesh out the commercial opportunity that you plan? Or, yes, thanks. Yeah, we're looking at a number of additional studies and none that we're prepared to talk about. And we do have,
which is probably about we do have some post commitment studies that we have to do so we'll be working on this as well. Okay, thanks.
Thank you. Ladies and gentlemen, we have reached the end of the question and answer session. And I would like to turn the floor back over to Mike Weiss, so closing comments. Over to you, sir. Great. Thank you. Excellent. And thanks, everyone, for joining us this morning. As discussed on today's call, we believe the initial launch activities are progressing well, and in many ways ahead of schedule. Thank you, everyone.
We believe these early successes position us for an exciting year of commercial execution. We believe RUMBIE adds significant values to the treatment landscape in RMS, and we remain committed to supporting the MS community. Thanks again to the patients and their families and healthcare providers who worked with us to get us to this point. And we thank everyone for joining the call. Today have a great day.
Thank you. Ladies and gentlemen, this concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Very good!