TG Therapeutics, Inc. (TGTX) Q3 2022 Earnings Report, Transcript and Summary

Greetings and welcome to the TG Therapeutics Third Quarter Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco. Thank you, Jenna. 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 third quarter 2022 financial results and provide a business update are Michael Weiss, our Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercialization 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 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 Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory milestones, clinical development plans and expectations for our marketed and pipeline products. TG 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 subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This call is being recorded for audio rebroadcast on TG’s website at www.tgtherapeutics.com, where it will be available for the next 30 days. Now, I’d like to turn the call over to Mike Weiss, our CEO.

Thanks, Jenna and good morning, everyone and thanks for joining us on the call. The third quarter of 2022 was a very productive time for TG as the team really came together to execute on our pre-launch commercialization plans. As we have mentioned previously, our goals for this year are to work toward an FDA approval for ublituximab in relapsing forms of multiple sclerosis and to be prepared if approved, to launch early next year. We’ve guided that our goal was to dedicate the resources necessary to achieve these goals and minimize or eliminate all other expenses. I am pleased to report that our streamlining and focusing efforts have been extremely successful in reducing our overall burn while reserving our resources to support the potential approval and launch of ublituximab. Sean Power, our CFO, will join us shortly I’ll provide some additional details, but our burn for the third quarter was approximately $34 million, down substantially from prior quarters. I am proud of the hard work and team effort that was required to realize these cost savings while ensuring we were all well positioned financially for the potential launch of ublituximab. Also in just a few minutes, Adam Waldman, our Chief Commercialization Officer, will join us provide more details around our launch planning and progress which from my vantage point seems to be moving along quite nicely. We believe that if approved, ublituximab has the potential to play a meaningful role in the treatment of multiple sclerosis, and we remain committed to offering patients a highly active treatment option with the convenience of a 1-hour infusion administered every 6 months following the first dose. With that, let me remind everyone of our Phase 3 program that is supporting our BLA submission for ublituximab in relapsing forms of MS, also referred to as RMS. The ultimate 1 and 2 Phase 3 trials evaluated ublituximab compared to teriflunomide, enrolling approximately 1,100 patients across 10 countries and were led by Dr. Lawrence Steinman of Stanford University. As noted in the past, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction an annualized relapse rate, also referred to as ARR, compared to teriflunomide. In addition to the positive primary endpoint results, we’ve had the opportunity over the past year to present several different sub analysis of this data set, which we believe continues to show an encouraging profile for ublituximab for the treatment of patients with RMS. Most recently, we had the opportunity to present 5 additional exploratory data sets at the 2022 Annual Congress of the European Committee for the Treatment and Research in Multiple Sclerosis I am going to refer to as ECTRIMS. The team engaged with numerous KOLs during this meeting and the feedback we received around the profile, ublituximab was highly encouraging, and we believe the data presented further support the potential for ublituximab to treat patients with RMS, if approved. On the regulatory front, as in the past, we will not provide color on any interactions with the FDA but we would like to provide an update on where we are in the process, with less than 2 months of the target PDUFA action date of December 28, 2022. We can confirm that we have completed the late cycle meeting and labeling discussions have recently commenced. We remain hopeful that ublituximab will be approved. And if approved, we’ll be excited to make ublituximab available to the many patients with RMS that are in need of additional treatment options. I will also mention that our efforts with the EMA for EU approval are moving along from a timing perspective, potential approval could occur in the second half of ‘23. We are still assessing the go-to-market strategy in Europe, and we continue to evaluate whether to go it alone or whether to partner ex U.S. So with that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, to share some thoughts on our preparation of the quarter past quarter as well as his thoughts on the potential commercial opportunity and plans for ublituximab in RMS. Adam?

Thank you, Mike, and good morning, everyone. I am excited to provide an update on our commercial activities, as we have made considerable progress over the last several months, on our preparation for the anticipated ublituximab launch in relapsing forms of multiple sclerosis. MS is a debilitating chronic disease that can have a significant impact on the quality of life of patients and their families. The CD20 class has truly transformed the way MS is treated and physicians believe that using these agents early may significantly impact the natural course of the disease. Today, approximately 1 of every 2 patients starting a new therapy will go on to CD20. In fact, market data shows that in the second quarter of 2022, there was the highest share of CD20 usage we have seen since these agents were launched. This is a large and growing market. And based on our market research, we believe ublituximab has the potential to capture meaningful market share. We understood from the moment we started working in this space that one of the keys to success would be to hire a team of MS experienced professionals with a deep knowledge of the landscape and strong relationships across the MS community. To that end, we have been methodical in how we have hired our commercial field teams and have hand-selected people that fit our target profile. Over the last several months, we have significantly ramped up our hiring adding critical field-based customer-facing roles in sales, sales leadership and access and reimbursement support. Our hires on average have 12 plus years of MS industry experience. They joined our previously hired field-based regional marketing team as well as our payer and medical teams, which have been engaging providers and payers for the last 12 months. At this point, we have met our internal hiring goals for our field-based team members, and we will be working over the next several weeks to finalize the hiring and training of these teams to be prepared for launch. Our team also knows how important it is to get this drug to the patient community and is working hard to ensure we do everything we can to provide access to ublituximab, once approved. One of the biggest frustrations from physicians and practices in general is navigating the process of access and reimbursement for therapies. We have, therefore, placed a significant emphasis on ensuring that the process to access ublituximab will be as seamless as possible. I am extremely proud of the progress our team has made last several months building our capabilities in this area. First, from a payer perspective, our national account teams are doing a great job engaging with national regional payers for over the last year. Feedback on the clinical profile of ublituximab has been positive, and we do not foresee any major issues with reimbursement. However, with any new product, payers will need to work through their processes over the first 90 to 180 days post launch. Second, we have made considerable progress understanding the institutional formulary process and have plans in place to work with the key MS centers of excellence to include ublituximab on their formularies as soon as possible. Third, we know the majority of MS patients will opt into patient support programs. And that this is another critical component of ensuring access. We have worked very closely with key customers to build what we what we believe will be a best-in-class patient support program. And we are on track to be ready to launch this program alongside ublituximab, once approved. Lastly, we have now hired an experienced field-based access and reimbursement team that will work with accounts to facilitate access to ublituximab. In summary, we have made tremendous progress on building and strengthening our commercial capabilities over the last 12 months, which has accelerated over the last few months as we ready the organization for the possibility of ublituximab launch. We have built an incredible team, which we believe is as experienced, if not more so, on a pound-for-pound basis than any MS team in the industry. These teams are ramping up their activities, actively engaging key participants in the MS community, KOLs, community neurologists, payers and advocacy groups at conferences, advisory boards and other engagements. Our confidence continues to grow as the feedback on ublituximab’s profile and the way we have built our commercial team has been very positive across the board. We believe this launch represents a significant commercial opportunity and all of our attention, focus and commercial resources are aimed at making this a success. We continue to move forward with a sense of urgency and purpose as we know ublituximab, if approved, will be an important new option for patients managing this debilitating disease. And with that, I’m going to hand it over to Sean.

Thank you, Adam, and thanks, everyone, for joining us this morning. Earlier, we reported our detailed Third quarter 2022 Financial Results, which can be viewed on the Investors & Media section of our corporate website. For today’s call, I’ll focus on a few highlights from the quarter, beginning with our cash position. We ended the third quarter with approximately $198 million in cash, cash equivalents and investment securities. That, coupled with the additional capacity available under our Hercules facility upon ublituximab approval, we believe will be sufficient to us into 2024. We are pleased to report that our burn for the third quarter of 2022 and under our previously guided range of $45 million to $50 million, landing at approximately $34 million for the quarter, also well below prior quarters, which as Mike said, is the result of our determined cost savings measured and our focused preparations for the upcoming launch of ublituximab, along with some timing differences, which we will incur in future quarters. Our GAAP net loss for the third quarter of 2022 was approximately $36 million or $0.26 per share, which was a decrease of almost $50 million from Q3 of ‘21, where we saw a net loss of approximately $86 million or $0.65 per share. As compared to the prior year quarter, the decrease was driven by across-the-board decreases in R&D and SG&A, primarily due to a streamlining of our oncology operations and a shift in focus to our MS development and launch preparation efforts. The GAAP net loss for the 9 months ended September 30, 2022, was $145.3 million or $1.08 per share compared to a net loss of $254.8 million or $1.93 per share for the comparable quarter in 2021, representing a decrease in net loss of more than $100 million period-over-period. In terms of what we expect moving forward, we project our burn for the fourth quarter of 2022 to be between $40 million and $50 million, which we believe leaves us well positioned through the anticipated MS PDUFA at the end of the year. With that, I will now turn the call back over to the conference operator to begin the Q&A.

Thank you. [Operator Instructions] Our first question is from Ed White with H. C. Wainwright. Please proceed with your question.

Good morning. Thanks for taking my questions. So just on the – you had mentioned the EMA timing is the second half of ‘23, how do you describe – can you describe the opportunity in Europe? What is the market like? What are your expectations for it? And then as far as partnering, if you’re going to partner, when should we expect to hear something like that? Would that be prior to approval? Or do you think? Or that would be something that would come after approval?

Hey, Ed, thanks for the question. So the EU opportunity is interesting. I think the EU currently [indiscernible] about 20%ish of the overall market opportunity for CD20s, so that’s – so it’s a reasonable size piece of the market, but it’s not obviously a large portion. So it’s not a high focus for us. Most of that in terms of dollars is in Germany. The other countries, obviously, they are in there, but it’s a lot less. So as we think about the opportunity and we think about potentially setting up an organization in Europe, I think it probably would be Germany focused and then we spread out from there, if we get on our own. In terms of timing of a partnership, we’re not running any timing, but it could happen before after we launch there, it’s always very speculative. But I would say again, if our ultimate decision is to partner to launch, then invariably would have been in advance.

Okay, thanks, Mike. And you’ve done an incredible job on cost cutting. I’m just thinking about how should we consider R&D expenses going forward? You gave some guidance on SG&A being up in the quarter. What are the R&D opportunities? How should we be thinking about that? And how should we be thinking of the expense for that line?

Yes, I would expect that the R&D expenses will continue to go down. Again, we still have oncology trials that are just hard to completely shut down. So we’re carrying some of those expenses still. But as they continue to go down, we will probably – not probably, we will be starting additional studies around ublituximab in MS and potentially outside of that. So I think it continues to go down for the next quarter or two, but maybe Sean wants to chime in, and then it probably starts to creep back up in the second half of next year. Sean, is that about, right or any other color?

Yes. No, I think that’s fair, Mike.

Great. Thanks for taking my question.

Thanks, Ed.

Thank you. Our next question is from Chris Howerton with Jefferies. Please proceed with your question.

Great. Thank you so much. I just wanted to ask a couple of questions on kind of the expected commercial dynamics ofatumumab has been doing a little bit better in the launch. So I was curious how you were thinking about the differences between dosage forms in CD20s, and maybe if there would be some differential patient or physician targeting between those two. So that would be one question. And then the second question I have is just a kind of housekeeping thing as I was looking at our model. What is the latest kind of IP expiry that you’re expecting might continue. Thank you so much.

Sure. So on the IP side, I think the patents for ublituximab, the basic patents are with a term extension 32, 33 assuming there is an approval, we will be entitled to 12 years market exclusivity for biologics. So, that would actually put us into ‘25 or very, very late ‘24 sorry, ‘34 late ‘34 or early ‘35 for the 12 years, sorry. Sorry about that. So – and then we do have some other patents we haven’t spent much time talking about that could go on for another 5, 10 years plus. So we think we’ve got a pretty good runway with the patents with the biologic relativity and potential with some other patents behind the scenes. I will briefly answer your first question, and I’ll let Adam discuss it. But it’s interesting in terms of the dosage forms. It’s really become somewhat two markets. I think the physicians the prescribers view these products somewhat differently and in different settings in which they might want to use them. Most doctors and most patients actually we heard yesterday in one-on-one engagements that even most patients are just not interested in dealing with their disease once a month. But it does seem that the subcu has a nice role for patients who travel distances to get to their MS provider. And so we had projected early on that subcu probably represents about 30% of the market. And it does feel like that’s whether they are capping out there. Obviously, their overall market share continues to grow because, as you know, there is an accumulation effect as people come on, they stay on. So – but their dynamic share is getting close to cap, and I think it’s between 25% and 30% of the dynamic share. And that’s kind of where we see the market. So I think that’s about how we believe it’s going to continue to shake out. About 70% of the patients will continue to receive an IV CD20 and about 30%, we will go with the subcu. Adam, please add some more color.

I think you pretty much covered it, Mike. The only thing I would add is that it does seem like the market with KESIMPTA launch, it does seem like the market has continued to expand, perhaps outside the centers of excellence in more rural areas and perhaps more general neurologists. But what Mike said is pretty much exactly what I would say.

Okay. And maybe just as a minor kind of follow-up, if you’ll entertain it, Adam, and then Mike to, of course, would you – I guess, how are you thinking about targeting those physicians that would be more likely to prescribe IV versus subcu, I guess, do you have that visibility, do you think?

Yes, I’ll start, Mike, and we can add. I think MS centers of excellence that have infusion capabilities. I think community practices that have infusion capabilities would be a logical place to start and make sense in terms of where we think IV usage will predominantly continue to be. And so that is where we believe the initial focus for us should be – and I think the majority of OCREVUS use is seen is in those large MS centers of excellence and these very large community centers with infusion capabilities.

Yes. I’ll add to that, Chris, that when we think about the best or highest ROI for us, obviously, it’s going after the sites that Adam has referred to. The general neurologist is just been getting into CD20s, and that’s, I think, been a huge effort of both the Roche, Ventec and Novartis teams to get out there. I do think, again, as Adam mentioned, as they are pushing into the more rural environments, I think those are going to be nice areas for something like KESIMPTA where they may be far from their physician. And general neurologists, again, who don’t have infusion capabilities might be an interesting place for something like KESIMPTA. But for us, the vast majority of the business and the vest current OCREVUS business, I think we’re close to 80% is still concentrated in those large centers of excellence in large community practices.

Okay. That sounds excellent. And a more efficient business model, it sounds like, too. So, thanks, guys.

Yes, thanks, Chris.

Thank you. Our next question is from Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Hi, thanks for taking my questions, and congrats on the progress, guys.

Thanks, Matt.

Just wanted to take Chris’ question a little bit more forward, can you comment on, I guess, Roche’s subcutaneous programs and their high dose program as well? And how do you think those will impact the market other than what you said?

Yes. So I’ll go first, Adam, you could chime in. we don’t know a ton about those programs. I mean, we know from certain timing, potentially, I think the subcu could be available in the next 2 years, give or take. And then on the high dose, we don’t really have any good visibility into where they are with that other than to say that I think their high-dose strategy is to try to comp off of our potentially perceived better activity with the more potent CD20. So we will see how that works out for them. But again, I think it’s going to take them a long time to get the material into the patient. So I don’t know that, that’s a strategy that’s going to provide a lot of additional competitive advantages for them. The subcu side, again, I think where the jury is out. I don’t think we’re overly concerned about it and think a 1-hour infusion every 6 months is still an extremely convenient way of delivering the product. The subcu, I think there are issues with that subcu formulation. I mean it’s been used in a number of other products, some of which have been very successful, others have been not so successful. So I think the jury is out on that we will see how it goes for them. Adam, anything further, any color?

Yes, I think you covered it, Mike. I think we will wait to see what the actual profile of that looks like and what’s required from a pre-medication post monitoring that all adds time and – but I think what’s interesting is that we do believe convenience streamlining the experience does matter in this market, and it’s an important aspect of the overall experience, both from a patient perspective, from a convenience, but also from an office perspective. So, we believe convenience is important. But we also continue to believe that we will be best positioned for patients who want a quick one hour twice a year B-cell therapy.

Okay. Thank you. And you mentioned that you – plans for continued development of ublituximab. Can you – following approval, can you talk about your plans for PMS, progressive MS in the future?

Yes. So, we are exploring that area. I don’t think we have any plans to discuss today, but we have certainly been engaging with KOLs to understand what the needs are and what they think would be a successful trial design in that area.

Okay. And then last question, I guess maybe for Adam. I guess following approval, what will your commercial team look like in terms of the size, the footprint and from where it is now?

Yes. Thanks Matt. We are pretty much in good position at this point. As I mentioned in our prepared remarks that we have hit our internal timelines for hiring. And I think what I have said in the past is that our footprint from a field-based perspective is about 80 to 100 people. We feel like this is, as we were talking about with Chris there, we think somewhat of a targeted approach. We think we know where we have to go in order to get the business. MS centers of excellence, large community centers is going to be our focus. We think we have a team that will be more than adequate to cover that, and we are in a good position right now, and we will be ready for launch and come early next year.

Great. Thanks a lot and good going to December.

Thanks Matt.

Thank you. Our next question is from Eric Joseph with JPMorgan. Please proceed with your question.

Good morning. Thanks for taking the question. Can you just expand a little bit on your access strategy from the patient perspective? I am just curious to know if there is much opportunity to compete with open risk and can symptom when it comes to co-pays borne by the patient? And then I would also be curious to get your latest sense of how sensitive payers are to price. And then finally, just on cash position. Sean noted being capped through 2024, I am just wondering whether you are considering any financing alternatives to support the launch, perhaps royalty monetization? Thanks.

Thanks. Adam, do you want to take the first question?

Yes. Thanks Eric. I think we are going to compete very well from a patient access perspective. As I mentioned, we have built a best-in-class patient support program. We will have all of the support initiatives that these companies have. You asked specifically about a co-pay program, we will have a co-pay program, and we feel that we are in a good position to support practices and patients. And then your second question was around payers and sensitivity to price. I think what we have heard is that payers are interested in inviting competition into the market. They are looking for lowest net cost. And I think they are sensitive to, I would just say, low net cost, and I think we have gotten feedback from them. We understand where they are at and have developed our – an idea of how we want to price this going into the launch.

Great. And in terms of cash position and alternative financings, I think Eric, we are keeping all the doors open in terms of ideas on how we want to continue to add. But we are not going to be in any rush. We want to get – we have plenty of money to launch on day one, obviously, move money into ‘24. So, not an emergency situation. Obviously, we are not overfunded, but most of that money will be sitting in the bank anyway, while we are getting everything up and running. So, I think we are feeling quite good about the cash position, even though it may not look like a whole lot to others, we are expecting to drive some revenues in the first year, which will also extend by 2024 burn number. And we have plenty of options. And yes, royalty monetizations are on the table, of course, as our other potential financings depending on the market conditions when we get to the launch phase.

Okay. Thanks for taking the questions and good luck going through December.

Thanks Eric.

Thank you. And our next question is from Mayank Mamtani with B. Riley. Please proceed with your question.

Hi. Good morning team. This is Sahil Kazmi asking a couple of questions for Mayank. What are your expectations for the potential labeling interactions as we are getting closer to the PDUFA date? And how the warning section could be differentiated from accretives, for example?

Yes. So, thanks for the question. So, in terms of – we did disclose earlier that the labeling discussions have commenced, but we are not going to provide any further color. So, I don’t know if I have anything more to add and same thing as it goes to the second part of your question.

Okay. Great. And then just on the recent ISO report that came out, just any of your kind of top line thoughts on how you are navigating through some of the payer discussions more broadly maybe for Adam as well.

Yes. I will lead off and I will let Adam take over. But the ISO report, we have obviously are reviewing, continue to review it. We will probably have some comments on it, official comments at some point soon. But generally speaking, with ISO’s role is to try to influence how we price the drug. There was a clear reason why they put the report out before we launched. I mean the whole report was all about, in my opinion, getting us to try to affect how we think about pricing. As you know, we have always been thinking about coming in at a lower price point. So, it’s not for us the concept, but I think some of their analysis are skewed and certainly is just to make a point, but I will let Adam maybe address the overall care access environment.

Yes. I think with regards to the ISO report specifically, I mean our view is we don’t think it’s going to affect our access and payers haven’t really reacted to it. And we feel good about the value proposition we are bringing with ublituximab and feel good about our payer strategy and what we are thinking about from a pricing perspective and feel confident, as I mentioned in the remarks that we don’t foresee major issues with reimbursement and coverage.

Excellent. Thanks for taking our questions and best of luck for PDUFA.

Thank you.

Thank you. Our next question is from Prakhar Agrawal with Cantor. Please proceed with your question.

Hi. Good morning and thanks for taking my questions, and congrats on all the progress. So, firstly, a quick clarification. If you can remind us if there are any inspections left for the FDA? And also if you could talk about your readiness in terms of drug supply at launch, and I had a follow-up.

Yes. So, again, we haven’t provided any color on inspection. So, I am going to pass on that question. And what was the second part.

Readiness in terms of drug supply at launch?

Yes, we have plenty of drug supply for launch. We have a large manufacturing arrangement with Samsung Biologics, and we are comfortable with our launch supply.

Okay. And secondly, Mike, you mentioned you presented the data at several times over the past few months. So, talk about what you are hearing from specialists on what really gets them excited about ubli some of the key factors. And also, what’s their willingness to switch loyalty from Ocrevus? Thank you.

Sure. Thanks for the question. So, when we go around and talk to the physicians, and I think our goal is to just present the data as it exists. We think the data speaks for itself. And what we find is that different clinicians will resonate towards different aspects of the data set. Some folks will look at the annualized relapse rate. And although we don’t compare to other drugs in the class or the drugs outside the class other than teriflunomide. Many physicians will look at and say, well, this is by far the best annualized relapse rate, and I want to have the best for my patient. And they believe that this is the best. Others will look at the data and they will be impressed with the tolerability and speed in which we can deliver the infusion. So, it’s not just about the one-hour infusion. It’s about the consistency to deliver a one-hour infusion and the tolerability. Ocrevus continues to have in later lines of infusion continue to have relatively high rates of infusion reactions, upwards of 20%, 25% even as of the third or fourth infusion. So, where we are down by the third infusion, I think we are around 5% or something. So, it’s I think tolerability is one people have resonated toward. Again, we don’t compare. We don’t make the comparisons, but folks will do their own comparisons in their head. And then the one-hour infusion obviously, from a patient convenience standpoint, a practice convenience standpoint, a lot of folks will resumate towards the one-hour infusion. So, I think it’s a mixed bag. Our job is just to make sure we present the facts and only the fats and folks will do their own internal assessments of how they view the data.

Thank you. I am looking forward to December.

Thank you.

Thank you. There are no further questions at this time. I would like to hand the floor back over to Mike Weiss for any closing comments.

Great. Thank you. And thanks, everyone, again for joining us this morning. As discussed multiple times today on this call, with the target PDUFA action goal date of December 28th, our primary focus is and remains working toward an approval for ublituximab for patients with relapsing forms of multiple sclerosis. And if approved, being prepared to launch early next year. And if approved, we believe ublituximab could be a meaningful treatment option for patients with RMS. We believe treatment options are essential when it comes to treating chronic illnesses like MS and we are committed to supporting the MS community. Thanks again for joining us this morning and have a great day.

This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.