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spk01: Greetings and welcome to the TG Therapeutics Second Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Please press star 1 on your telephone keypad to enter the queue. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Ms. Jenna Bosco.
spk00: Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second quarter of 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 to 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 conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where we'll be available for the next 30 days. Now I'd like to turn the call over to Mike Weiss, our CEO.
spk06: Thanks, Jenna, and good morning, everyone, and thank you for joining us. No doubt, the second quarter of 2022 was a challenging one for us at TG, but one also that has provided us with a renewed sense of purpose and focus. Nearly all our efforts are now directed toward gaining FDA approval for lituximab and relapsing forms of multiple sclerosis, which has a target PDUFA goal dated December 28, 2022, and if approved, being prepared to successfully launch. We are dedicated to MS patients and the entire MS community, Levobituximab has the potential to offer a valuable treatment alternative with an added convenience of a one-hour infusion after the first dose. So while 2022 has not gone as expected, we believe there's an exciting opportunity ahead of us that can provide great value to our shareholders. Let me get started off here by providing a brief regulatory update. As many of you know, a couple of months ago at the end of May, we announced that the FDA extended our BDUFA goal date to December 28, 2022. As we shared at the time, the FDA extended the BDUFA goal date to allow time to review a submission provided by us in response to an information request from the FDA. The submission comprised an integration summary of certain existing clinical information that was previously provided to the FDA. Since this submission, as is customary during a BLA review process, we have continued to respond to additional FDA information requests, none to my knowledge specifically related to the submission that resulted in the delay. Generally speaking, my team tells me that they believe the process is moving forward as expected. With that, let's talk a little bit about the commercial opportunity and some market dynamics. It's estimated that nearly one million Americans are currently living with MS, and approximately 70 to 75,000 of them are relapsing MS patients that will be seeking a new treatment each year. Currently, about half of those seeking a new treatment are receiving CD20-based therapy. We do recognize that we are competing against some larger competitors in this marketplace, but we believe our smaller size and nimbleness will play to our advantage. And most importantly, given the size of the market, there's room for all three CD20s to participate at meaningful levels. as each offers patients and physicians unique attributes, which we see as only enhancing the patient experience. In our discussions with MS-focused healthcare providers, we almost uniformly hear that they believe early treatment with CD20s will dramatically change the long-term outcome for these patients, which we see as enhancing the future demand for CD20s. Accordingly, we are optimistic that if Lubitoxibab is approved, we'll competitive in the CD20 RMS marketplace. Adam Waldman, our Chief Commercial Officer, will join us shortly to share his thoughts on the commercial opportunity as well as our plans for commercialization. We will also be joined by Sean Power, our Chief Financial Officer, to discuss our financial position. However, I wanted to highlight that the efforts we have taken as an organization to reduce our burn and ensure our current cash position will take us through the potential launch of Rubituximab have thus far been very successful. Our Q2 burn was even lower than we had projected, coming in around 48 million for the quarter. This was truly a company-wide effort, and I commend the entire TG team for tightening their belts, rolling up their sleeves, and rallying around our near-term goal of approval and launch of Ubitoximab and RMX. To get there, we closed or paused nearly all our oncology programs in order to focus our resources and energy on Ubitoximab and RMX. We expect to revisit our pipeline and the potential for our drug candidates across a variety of B-cell diseases, including oncology, in the first half of next year, ideally on the heels of an ubutuximab approval and launch in RMS. So with that, let me turn the call over to Adam Wallman, our chief commercialization officer, to share some insights on our commercialization plans for ubutuximab. Adam?
spk04: Yep, thank you, Mike, and good morning, everyone. I am pleased to provide an update on our core commercial activities as we continue to accelerate our preparation for the anticipated Ubituximab launch in relapsing forms of MS. Our objectives for the launch of Ubituximab are to, one, build a team of experienced professionals with deep knowledge of the MS landscape and strong relationships across the MS community. Two, ensure we are in a position to facilitate seamless access to Ubituximab for patients and providers. And three, drive demand through Latuximab at approval with MS specialists based on its differentiated profile. Over the last several months, we have significantly strengthened our core capabilities in commercial team, making critical hires in key roles. Recently, we added two general managers for our sales and access teams. Both of these key hires come from major MS companies, each with 10-plus years in field-based execution experience in the MS market. They join our previously hired field-based regional marketing team and medical teams, and we will continue to build up our field teams under their leadership over the next few months as we approach our PDUFA date in December. We currently have approximately half of our field-based team members hired, and we will continue to hire over the coming quarters in the key areas of sales, access, and medical. We have been able to attract exceptional talent, and we continue to receive an incredible amount of interest from people wanting to join our outstanding team as our momentum builds towards this launch. People see the opportunity to make a difference with Ubitoximab and want to work with the high-caliber individuals we have already hired and are eager to be part of what we are building. We are a small biotech company, but we are laser-focused on the MS business and will undoubtedly be able to surround this drug with incredible, exceptionally talented, and experienced people that truly care about patients. In terms of the market, CD20s, as Mike said, now account for approximately 50% of the dynamic market share in the U.S. Physicians have told us that their concerns around using CD20s in the pandemic era have largely dissipated, and they are comfortable using these therapies. We believe B-cell therapy has become the gold standard in efficacy and will continue to grow in the future. This is a significant established and growing market opportunity. that we believe Ubiltuximab is well-positioned to capitalize upon. Our teams continue to ramp up their activities, actively engaging key participants of the MS community. Our confidence continues to grow as the feedback on Ubiltuximab profile has been very positive, and our belief is that there is a very compelling commercial opportunity for this product. Ubiltuximab's profile with the one-hour infusion time and flexibility in administration will allow for potentially enhance patient experience, and improved infusion efficiencies, benefiting patients and providers alike. In summary, we continue to build and strengthen our commercial capabilities as we ready the organization for the Ubletuximab launch. We believe this launch represents a significant commercial opportunity, and all of our attention, focus, and commercial resources are aimed at making this MS launch a success. Everything we have learned from engaging with the MS providers over the last several months only increases our confidence. We remain bullish on the opportunity, and whereas we know we'll need to prove it, we feel very good about our preparations and our ability to execute on the objectives of the launch. With that, I'll hand it over to Sean Power, our Chief Financial Officer, and I'll thank you for your time. Sean?
spk07: Thanks, Adam, and thanks again to everyone for joining us this morning. Earlier, we reported our detailed second quarter 2022 financial results, which can be viewed on the investors and media section of our website. For today's call, I'll touch on a few highlights from the quarter, beginning with our cash position. We ended the second quarter with approximately $231 million in cash, cash equivalents, and investment securities, which we believe will be sufficient to take us into the second half of 2023. As Mike alluded to, we are pleased to report that our burn for the second quarter of 22 came in under our previously guided range of 50 to 55 million, landing at approximately 48 million for the quarter, which is the result of our focused and determined streamlining and cost savings measures. Our gap net loss for the second quarter of 22 was approximately 40 million, or 30 cents per share, which was a decrease of 38 million from Q2 of 21 where we saw a net loss of approximately 78 million, or 59 cents 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 gap net loss for the six months ended June 30th, 22, was 109.5 million or 81 cents per share compared to a net loss of 169.1 million or $1.28 per share for the comparable period in 2021, representing a decrease in net loss of approximately 60 million period over period. In terms of what we expect moving forward, we project our burn for the remaining quarters of 22 to average between 45 and 50 million down rather sharply from where we had been previously trending, which we believe leaves us well positioned through the anticipated MS PDUFA date later this year. With that, I will now turn the call back over to the conference operator to begin the Q&A.
spk01: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation symbol indicate your line is in the question queue. you may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary for you to pick up your handset before pressing the star keys. One moment while we poll for questions. Our first question comes from the line of Ed White with HG Wainwright. You may proceed with your question.
spk08: Good morning. Thanks for taking my questions. First on the sales, just Adam, I was wondering if you could tell us how your position with the sales team, were you able to leverage any of the oncology sales team, or are the MS sales force going to be on new hires?
spk04: Hey, good morning, Ed. Yeah, it's a different customer base, so no, we would have to hire new people for the MS. We will not be using our oncology sales team. Okay.
spk08: And just on, you know, I know... And I'll just add to that. Go ahead.
spk06: And I'll just add to that. While the end of the sphere is the sales force, much of the other teams will have a lot of overlap. So our access team is the same in their field basis. So there's some overlap, but the actual sales force themselves will be different.
spk08: Okay. Thanks, Mike. And, you know, I know you might not be able to say anything for competitive reasons, but I just wanted to get your thoughts on the MS pricing strategy, if there's anything you can share with us.
spk04: Yeah, at this point, we don't have a lot to share yet. At this point, we don't have a lot to share, other than we're actively engaging in payer conversations to inform our strategy, and we will continue to do that as we get closer to launch.
spk08: Okay, thanks. And just a last question, if I may. How should we be thinking about your oncology assets? Are you still enrolling, or excuse me, not enrolling, but are still following patients that have already been enrolled in studies? Will you be producing any data from ongoing studies? And strategically, how are you thinking about this? Are you looking for partners or perhaps outright sales of assets? Thank you.
spk06: Yep. Thanks, Chad. So I think most importantly is strategically we are in a holding pattern, and we're preparing ourselves to look at those programs on the other side of the OOGLI, hopefully, approval. So I don't think we made any decisions about how we're going to move forward with those. And in terms of, you know, what's going on, some of the studies were continuing with all the patients. And, you know, we're obviously not looking to present data at this moment. It's not a core focus. It's possible. We do have some collaborators. It's possible some data will come out, but it's not a high priority for us right now.
spk08: Okay. Thanks, Mike, for taking my questions. Yep.
spk01: Our next question comes from the line of Eric Joseph with JPMorgan. You may proceed with your question.
spk03: Hi. Good morning, guys. Thanks for taking the questions. So, first, just hoping to get a better sense of where things are in the review cycle for Google EMS. whether you had specific feedback on the additional information, on the response to the additional information request from FDA, and also whether you've reached a point of labeling discussions. And then secondarily, just wanted to get your current thoughts as to the importance of a sub-Q formulation to being competitive in the CD20 MS space. And to the extent OOBLY is amenable to a sub-Q formulation, are there any plans in the term to explore that clinically? Thanks.
spk06: Sure. In terms of the FDA, I think in our prepared remarks, we mentioned that we have not had any further questions as a follow-up to the submission that we made that caused the delay, and we continue to work back and forth with the FDA on information requests. In terms of thoughts on sub-Q formulation and is Ubley amenable to it? Yes, Ubley is certainly amenable to sub-Q formulation. We just haven't decided if that's a strategic imperative for us where we are evaluating. The landscape, again, getting much below, I mean, getting the sub-Q versus an hour infusion, we're doing research right now to see if there's a difference A number of areas, the sub-Q for the IV to sub-Q switch has not been successful. In certain areas, it has been successful. So I think we're currently evaluating, but yes, it will be committed to a sub-Q. Okay, great.
spk03: Thanks for taking the questions. Thanks, Eric.
spk01: Our next question comes from the line of Matt Kaplan with Lattenberg-Solomon. You may proceed with your question.
spk05: Hi, good morning and thanks for taking the questions. Um, I guess maybe a question for Adam. How should we think about, um, access and, and especially kind of thinking about it for next year, uh, if approved at the end of December, um, how does that, um, access ramp up over the next, uh, for, for 2023 and how do you drive access?
spk04: Yeah, thanks for the question, Matt. So, first and foremost, we've been engaging with payers for over a year at this point. We think early engagement will help in terms of getting coverage as quickly as possible. And those conversations continue to be ongoing. I think, in general, they welcome a new entrant into the market. in the CD20 class. They obviously, from an overall spend perspective, this is an area of focus for them. They believe competition has the potential of decreasing overall net costs in the space. And, you know, in general, we think we can get rapid access into 2023 upon approval. You know, everything we've been doing up into this point is aimed at making sure we can get coverage as quickly as we possibly can. Our, you know, big part of that, another aspect of that is making sure that we have a patient support services. We know that that's really important in this space. And we are, you know, well positioned right now. We not only, and back to Ed's question, We have existing infrastructure on patient support that we're able to leverage for this MS launch. We're in good shape in building a best-in-class patient support services and hub for patients with MS, and we believe that will help with access as well. Okay, that's very helpful.
spk05: And then in terms of driving demand, what's the feedback you've been getting from KOLs and other organizations others in the treatment space in terms of Oble's differentiated profile and what do they see as important characteristics that could help to drive demand there?
spk04: Yeah, I mean, I think first and foremost, it's the one-hour infusion. I think that continuously comes up as being an important differentiator. I also think the overall tolerability profile of the drug and the The infusion experience overall is something that physicians have noted as being very important. You know, obviously a best ARR that's ever been reported in a Phase III study is important, but again, without head-to-head trials, you know, hard to make the claim that it's better from an advocacy perspective, although the ARR is certainly, you know, eye-popping or something that at least gets people's attention. And so, you know, overall, I think with the one-hour infusion, the efficacy and the safety and tolerability profile, I think it's the whole package that makes it a very compelling and value-add, you know, entrant into the market. Okay, great.
spk06: I'll add on top of that, Matt. I'll add on top of that. I've been on the road personally a lot this summer, meeting with physicians and other healthcare providers. And what's interesting to see is that It's not one thing necessarily that gets everyone, but there seems to be something for everyone. So as Adam mentioned, we've had people tell us, look, I look at your data and I see it's one relapse in every 14 years versus one relapse in every seven years for Ocrevus. Why would I use Ocrevus? Present the facts and quickly we'll find what they're most interested in. And as Adam mentioned, sometimes it's the overall tolerability profile. And of course, quite frequently, it's the one-hour infusion. So just to add on top, again, from personal experience out there on the road, we're seeing a lot of big feedback across the board.
spk05: All right. Thanks a lot.
spk01: Our next question comes from the line of Mayank Mandani with B. Riley. You may proceed with your question.
spk09: Good morning, team. Thanks for taking our questions. So just maybe a follow-up on the FDA review discussions. Just curious if anything pertaining to standard of care differences in the U.S. and maybe the geographies that you may have conducted, ultimate one and two, has, you know, come up. And also if you can compare, contrast, you know, with the similar three-month delays we've seen with Ocrevus and Casenta in the past.
spk06: Yeah, so, I mean, look, you know, the delays that Okravis and Cosimta received were also three months. Their review cycle was pushed back by three months. Ours wasn't. I don't think there's any other way for us to compare. Other than that, Okravis specifically said it was a CMC issue, and Cosimta said it was an ordinary issue. review issue or ordinary information request. Other than that, we do not have enough detail to try to compare and contrast the two. And in terms of FDA review, again, prepared remarks, we stated that, you know, we have not heard any follow-up from the, specifically related to the request that caused the delay. and we're continuing to work with the FDA in answering their information requests.
spk09: Great. And just two more quick follow-ups. Any plans for pursuing the primary progressive MS indication? And then please remind us on the filing how that might be proceeding in Europe. And if that's – you know, either of the two – are important to any meaningful interest you may have gotten from a strategic, for example, you know, inbound you may have gotten from a life cycle or a geographical expansion standpoint?
spk06: Yeah, I mean, we continue to socialize the primary progressive area with KOLs. I would say we have not a great demand or interest in studying that area right now. We're continuing those discussions. For the most part, I think most physicians do view primary progression as just an extension of RMS. In many of their opinions, that may not have been picked up earlier, and they're pretty much secondary progressive. But we're continuing to look at ideas, and we keep bouncing ideas off KOLs, and we're inviting ideas on studies for primary progressive that they think will be helpful, interesting, or possibly for registration.
spk09: And then on Europe?
spk06: On Europe, we are continuing to work on the application. Our expectation is that a European approval could be about six to nine months behind the US approval. And in terms of commercialization in Europe, we're going to hopefully come up with our definitive plan early next year.
spk09: Great. Thanks for taking our questions, Mike.
spk06: Sure. Thank you.
spk01: Our next question comes from the line of Prakhar Agrawal with Cancer for Shares. You may proceed with your question.
spk02: Hi. Good morning, and thanks for taking my questions. So firstly, a different follow-up on pricing. How do you plan to thread the needle on pricing discount versus making sure ASP doesn't get too low for the infusion centers, making economics unattractive? Are there specific segments of the MS market that might be more receptive to this lower pricing strategy? And I had a quick follow-up.
spk06: You want to go ahead on that one, Adam?
spk04: Sure. Yeah, I don't think we're prepared right now to say, you know, what our pricing strategy is going to be. That said, we do believe there is a price out there that meets both payers' and providers' needs. And, you know, we're very aware of the dynamics that exist. And so we're working through all the different options, and we'll be ready to price it at launch.
spk02: Got it. And a quick follow-up. If the drug gets approved in December, what's the earliest timeline by when you can get a permanent J-code? Thank you.
spk04: Yeah, I believe that is a six. Oh, sorry, Mike. Go ahead. It's a six-month process on the J-code. So it's a six-month process. It's a six-month process on the J-code. That said, you know, there are, you know, not everyone, but there's a decent amount of physicians that are comfortable using a miscellaneous J-code, and people will use it before the permanent code is in place, based on our conversations with many physicians and offices.
spk02: Okay. Thank you.
spk01: Ladies and gentlemen, we have reached the end of today's question and answer session. I would like to turn this call back over to Mr. Mike Weiss for closing remarks.
spk06: Great. Thank you. And thanks again, everyone, for joining us this morning. As I mentioned throughout the call, our primary focus is on working with the FDA with the goal of getting Lubatoxib approved to treat patients with relapsing forms of multiple sclerosis by the PDUFA goal date of December 28, 2022. We believe we have made the necessary changes to our organization to ensure we have the runway and structure to be commercially successful, if approved, and are excited about the potential for Lubitoximab to be a meaningful treatment option for patients with RMS. Thanks again for joining us this morning, and we look forward to sharing additional exploratory analysis, one and two data sets, at the upcoming ECTRON Congress in October. Thank you. Have a great day.
spk01: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. Enjoy the rest of your day.
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