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TG Therapeutics Inc
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Greetings and welcome to the TG Therapeutics Second Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.
I would now like to turn this conference over to your host, Ms. Jenna Bosco.
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 providing 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 it will be available for the next 30 days.
Now, I’d like to turn the call over to Mike Weiss, our Chief Executive Officer.
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 towards gaining FDA approval for ublituximab in 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 believe ublituximab has the potential to offer a valuable treatment alternative with an added convenience of a 1-hour infusion after the first dose. So while 2022 has not gone as expected, we believe there is 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 PDUFA goal date to December 28, 2022. As we shared at the time, the FDA extended the PDUFA 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 and 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 70,000 to 75,000 of them are relapsing MS patients that will be seeking a new treatment each year. Currently, about half of those seeking 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 [ph] and most importantly, given the size of the market, there is room for all three CD20s to participate in the meaningful levels as each offers patients and physicians unique attributes which we see is only enhancing the patient experience.
In our discussions with MS-focused health care providers, we almost uniformly hear that they believe early treatment with CD20 will dramatically change the long-term outcome for these patients which we see as enhancing the future demand for CD20. Accordingly, we are optimistic that if ublituximab is approved [indiscernible] 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 ublituximab 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 is 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 ublituximab in RMS. To get there, we closed or paused nearly all our oncology programs in order to focus our resources and energy on ublituximab in MS. 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 a new ublituximab approval and launch in RMS.
So with that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, to share some insights on our commercial plans for ublituximab. Adam?
Yes. 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 ublituximab launch in relapsing forms of MS. Our objectives through the launch of ublituximab 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 ublituximab for patients and providers and three, drive demand for ublituximab at approval with MS specialists based on its differentiated profile.
Over the last several months, we have significantly strengthened our core capabilities and 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 joined 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 ublituximab 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 and exceptionally talented and experienced people that truly care about patients.
In terms of the market, CD20, 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 ublituximab 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 ublituximab profile has been very positive. And our belief is that there is a very compelling commercial opportunity for this product. Ublituximab's profile with the 1-hour infusion time and flexibility and administration will allow for potentially enhanced 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 ublituximab launch. We believe this launch represents a significant commercial opportunity and all of our attention, focus and commercial resources are aimed at making the 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 will 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. Now thank you for your time. Sean?
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 & 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 million 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 GAAP net loss for the second quarter of '22 was approximately $40 million or $0.30 per share which was a decrease of $38 million from Q2 of '21 and where we saw a net loss of approximately $78 million or $0.59 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 six months ended June 30, '22, was $109.5 million or $0.81 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 million 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.
[Operator Instructions] Our first question comes from the line of Ed White with H.C. Wainwright.
First, on the sales, just Adam, I was wondering if you could tell us how you're positioned with the sales team? Were you able to leverage any of the oncology sales team? Or are the MS sales force going to be your own new hires?
Ed, yes, 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. And just on...
Ed, I'll just add to that. I'll just add to that. While the end of the [indiscernible] is the sales force, much of the other teams will have a lot of overlap. So our access team is the same and their field basis. So there's some overlap but the actual salesforce themselves will be different.
Okay. And 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?
Yes. At this point, we don't have a lot to share. Yes, sorry. 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.
Okay. 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?
Yes. Thanks, Ed. So I think most importantly, strategically, we are in a holding pattern and preparing ourselves to look at those programs on the other side of the ubli 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 what's going on, some of the studies we are continuing to follow patients. And 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.
Our next question comes from the line of Eric Joseph with JPMorgan.
So first, just hoping to get a better sense of where things are in the review cycle for ubli MS. 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 the point of [indiscernible] discussions? And then secondarily, just wanted to get your current thoughts as to the importance of a subcu formulation to being competitive in the CD20 MS space? And to the extent ubli is amenable to a subcu formulation, are there any plans in your term to explore that clinically?
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 request. In terms of thoughts on subcu formulation and is ubli amenable to it, yes, ubli is certainly amenable to subcu formulation. We just decided if that’s a strategic impact for us where we are evaluating the landscape. Again, getting much below -- I mean, getting the subcu versus a 1-hour infusion, we’re doing research right now to see if there’s a difference. A number of areas the subcu for the IV to subcu switch has not been successful in certain areas, it has been successful. So I think we’re currently evaluating. But yes, ubli can be made into a subcu.
Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann.
I guess maybe a question for Adam. How should we think about access and especially kind of thinking about it for next year, if approved at the end of December, how does that access ramp up over the next -- for 2023 and how do you drive access?
Yes. 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 cost in the space. And in general, we think we can get rapid access into 2023 upon approval. Everything we've been doing up into this point is aimed at making sure we can get coverage as quickly as we possibly can.
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 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 the 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. And then in terms of driving demand. What's the feedback you've been getting from KOLs and others in the treatment space in terms of ubli's differentiated profile? And what do they see as important characteristics that could help to drive demand there?
Yes. I mean, I think, first and foremost, it's the 1-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 infusion experience overall is something that physicians have noted as being very important. Obviously, best ARR that's ever been reported in a Phase III study is important. But again, without head-to-head trials, it is hard to make the claim that it's better from an efficacy perspective, although the ARR is certainly eye-popping or something that at least get people's attention.
And so overall, I think with the 1-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 entering into the market.
I will add on top of that, Matt -- on top of that [indiscernible] I've been on the road personally a lot this summer, meeting with physicians and other health care providers. And what's interesting to see is that it's not one thing necessarily that gets everyone but there seems to be something [ph] for everyone. So as Adam mentioned, we’ve had people -- look at your data and I see it’s one relapse in every 14 years versus one relapse in every 7 years for OCREVUS, why would I use OCREVUS? Present the facts and typically, 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 1-hour infusion. So just to add on top again, some personal experience out there on the road, we’re seeing a lot of big feedback across the board.
Next question comes from the line of Mayank Mamtani with B. Riley.
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 I and II has come up? And also, if you can compare/contrast with the similar 3-month delays we’ve seen with OCREVUS and KESIMPTA in the past?
Yes. So I mean, look, the delays at OCREVUS and KESIMPTA received were also three months, their review cycle was pushed back by three months. Ours was [indiscernible] any other way for us to -- other than that OCREVUS specifically said it was a CMC issue. And KESIMPTA said it was related to an ordinary review issue or ordinary information request. Other than that, we do not have enough to try to compare and contrast the two. And in terms of FDA review, again in the prepared remarks, we stated that we have not heard any follow-up specifically related to the request that have caused the delay and we're continuing to work with the FDA in answering their information request.
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 – either of them to are important to any meaningful interest you may have gotten from a strategic, for example, inbound you have gotten from a life cycle or a geographical expansion standpoint.
Yes. I mean we continue to socialize the primary progressive area with KOLs. I would say we have not a great demand or interest in studies in that area right now. We're continuing those discussions. For the most part, I think most physicians do view primary progressive areas as just an extension of RMS and many of their opinions that may not have been picked up here and they're pretty much secondary progressive. But we're continuing to look at ideas and we keep bouncing ideas of KOLs and we're inviting ideas on studies for primary progressive that they think will be helpful, interesting or possibly for registration.
And then on Europe?
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 U.S. approval. And in terms of commercialization in Europe, we're going to hopefully come up with our definitive plan early next year.
Next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald.
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.
Sorry, do you want to go ahead on that one, Adam.
Sure. Yes, I don't think we're prepared right now to say 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 we're very aware of the dynamics that exist. And so we are working through all the different options and we'll be ready to price it at launch.
Got it. And a quick follow-up. If the drug gets approved in December, what's the earliest time line by when you can get a permanent J code?
Yes. I believe that is – sorry, Mike, go ahead.
No, go ahead.
It’s a 6-month process on the J-code. So it’s a 6-month process on the J code. That said, there are 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.
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.
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 ublituximab 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 the runway and structure to be commercially successful, if approved and are excited about the potential for ublituximab 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 [indiscernible] data sets at the upcoming [indiscernible] congress in October. Thank you. Have a great day.
This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. Enjoy the rest of your day.