TG Therapeutics, Inc. (TGTX) Q4 2016 Earnings Report, Transcript and Summary

Greetings, and welcome to the TG Therapeutics Fourth Quarter 2016 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only-mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded. At this time for opening remarks and introduction I would like to turn the conference over to Ms. Jenna Bosco, Vice President of Investor Relations. Please go ahead Miss Bosco.

Thank you. Good morning, and welcome to our conference call regarding TG Therapeutics fourth quarter 2016 financial results and business update. I’m Jenna Bosco, TG’s VP of Investor Relations, and I welcome you to our conference call today. Following our Safe Harbor statement, Sean Power, TG’s Chief Financial Officer, will provide a brief overview of our financial results and then turn the call over to Michael Weiss, the Company’s Executive Chairman and Chief Executive Officer, who will provide an update on the ongoing development of our novel, glycoengineered anti-CD20 monoclonal antibody, TG-1101, our novel once-daily PI3K delta inhibitor, TGR-1202, as well as a review of our clinical development program. Before we begin, I’d like to remind everyone that various remarks that we make about our future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to risks and uncertainties that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors and uncertainties that can be found in our SEC filings. This conference 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. All participants on this call will be on a listen-only mode. Now, I’d like to turn the call over to Sean Power, our Chief Financial Officer, to briefly discuss the financial results for the fourth quarter of 2016, as well as the Company’s overall financial condition.

Thank you, Jenna, and thanks everyone for joining. As you may be aware, our financial results were released this morning and can be viewed on the Investors and Media section of our website at www.tgtherapeutics.com. I’ll begin with our cash position. At December 31, we had cash, cash equivalents, investment securities and interest receivable of approximately $45 million. As I’m sure everyone is now aware over this past week, we were able to bolster our cash position raising approximately $84 million of net proceeds through our recent public offering and prior to that, the use of our ATM program. We believe our current cash position will be sufficient to fund our operations for approximately the next 24 months. Our net loss for the fourth quarter of 2016 excluding non-cash items was approximately $22.3 million including $9.1 million of manufacturing and CMC expenses for Phase 3 clinical trials and in preparation for potential commercialization. The GAAP net loss for the fourth quarter of 2016 inclusive of non-cash items was $23.7 million or $0.48 per share compared to a net loss of $17.6 million or $0.37 per share during the comparable quarter in 2015. Our net loss for the 12 months ended December 31, 2016 excluding non-cash items was approximately $70.7 million including $27 million of manufacturing and CMC expenses for Phase 3 clinical trials and in preparation of commercialization. The GAAP net loss for the 12 months ended December 31, 2016 inclusive of non-cash items was $78.3 million or a $1.60 per share compared to a net loss of $62.9 million or $1.38 per share during the comparable quarter in 2015. The increases in R&D expenses and net loss for both the three and 12 months ended December 31, 2016 is primarily due to the ongoing clinical development programs and related manufacturing cost for TG-1101 and TGR-1202. I’ll now turn the call over to Mike Weiss our Executive Chairman and CEO.

Thank you Sean and thanks to all of you for joining us this morning. It’s been a bit of crazy week here at the company and certainly a gratifying one. We were very excited to report positive top line data from our Phase 3 GENUINE study followed by financings which strengthened our balance sheet significantly, providing us the resources needed to aggressively push our cancer and MS programs forward toward commercialization. It is very satisfying to see the strong support of many new large institutional shareholders. The deal is many times oversubscribed and priced extremely well at $9.75 representing less than 4% discount to the closing price the previous day. Let me now spend just a moment recapping some of the highlights for 2016. We had the issuance of composition of matter patents for both TG-1101 and TGR-1202 providing protection through 2029 and 2033, respectively in both cases exclusive of additional potential patent term extensions. We launched and also completed enrolment in the first part of our Phase 2 trial in Multiple Sclerosis for TG-1101. We launched our UNITY-CLL study under special protocol assessment and enrolled the first 140 patients beyond year end. We also launched our UNITY-Diffuse Large B-Cell Phase 2b registration direct to clinical trial on the heels of our ASCO presentation which described compelling, Phase 1, 2 data showing greater than 30% overall response rate for our 1303 combination. Later in the year at ASH, we reported a greater than 75% overall response for the combination of 1303 plus bendamustine in patients with relapsed/refractory Diffuse Large B-Cell, which is a regimen we plan to incorporate into the UNITY Diffuse Large B-Cell program. We announced two publications in prestigious journals, first in BLOOD describing a novel mechanism of action for TGR-1202 with potential significance and c-Myc driven tumors and a second, in the British Journal of Hematology with data from our Phase 2 study of TG-1101 plus ibrutinib and CLL which is the data that originally supported our initiating our GENUINE study. One highlight that we believe is largely overlooked was the announcement of the positive outcome of our UNITY-CLL Phase 3 DSMB safety review meeting. Here the DSMB after the reviewing the safety data from patients treated with TGR-1202 alone or in combination with TG-1101 recommended no changes to the study. We and investigators alike view it as a major milestone given that the first generation will promiscuous PI3K delta inhibitors such as idelalisib have observed major safety issues in the treatment of naïve CLL patients. Then towards the end of the year, we had a solid ASH with three oral presentations and three poster presentations and last but certainly not least, we completed enrolment in our Phase 3 GENUINE trial in mid-December which as many of you are aware resulted in the positive top line data released earlier this week. As you can see, 2016 was a year spent building the critical pieces necessary to ensure successful data read outs in 2017, 2018 and beyond. So despite the challenges, our stock price faced in 2016 it was really an important and productive foundation building year for the company. And those efforts in 2016 have already started paying dividends with the announcement earlier this week of the results from the Phase 3 GENUINE trial. As a recap on Monday, we announced that the study had met its primary endpoint demonstrating a significant improvement in overall response in both the attempt to treat population with a P value equal to 0.001 and in the treated population with a P value of less than 0.001. In the protocol, we designated the primary analysis to be overall response in both the ITT population and treated population, the latter of which reported in overall response rate of 80% in the 1101 combination arm compared to an overall response of 47% for single agent ibrutinib, notably all assessments were confirmed by a blinded independent Center [ph] of Radiology and Hematology review. These results performed perfectly in line with our expectations. The overall response rates historically reported for single agent ibrutinib down to the ibrutinib prescribing information showing 47.6% overall response rate for high risk 17P deleted [ph] relapsed or refractory CLL patients. We believe these data are compelling and accordingly our plan is to seek to meet with the FDA to discuss the potential to file the data for accelerated approval in the second half of the year. Prior to that, we look forward to presenting the full data set at a major medical conference in the June timeframe. With that, let’s switch gears and quickly review our ongoing UNITY program which includes two additional registration directed cancer trial. As you may recall, the UNITY program is evaluating the combination of our lead assets TG-1101 which is also in the GENUINE study which is our glycoengineered anti-CD20 monoclonal antibody and TGR-1202 which is our novel once-daily PI3K delta inhibitor, collectively referred the combination as TG-1303. So ever hear me mention 1303, I’m talking 1101 plus 1202. We’re particularly impressed with the speed at which the UNITY-CLL Phase 3 trial is enrolling. The UNITY-CLL study is designed to support full approval for both TG-1101 and TGR-1202, with potentially broad label across front line and relapsed/refractory CLL including high risk and ordinary risk patients. The basic study design for the global UNITY-CLL Phase 3 trial was is being conducted under a special protocol assessment is a randomized controlled clinical trial, which is initially randomizing patients into 104 treatment arms. TG-1101 plus TGR-1202, 1101 alone, 1202 alone and an active controlled arm of obinutuzumab plus chlorambucil. A planned interim analysis will assess contribution of each single agent to the combination which if successful, will allow early termination of both single agent arms. Assuming an early termination of the 1101 and 1202 single agent arms, the study will enrol approximately 450 patients. A second interim analysis will be conducted following full enrolment into the study which if positive we plan to utilize for accelerated approval, while we wait for the PFS outcome for full approval. Enrolment into this study began in February 2016 and as mentioned previously, we have extremely pleased with rapid enrolment seem to-date and believe we’re on track for full enrolment to be completed by the first quarter of 2018, which was updated from our previous guidance of first half of 2018. We’ve recently reported that we expected to have at least 200 patients enrolled into the trial by the end of February and based on that, we believe we’ll be able complete the first interim assessment of the contribution of single agent arms by mid-year 2017. So in a few months from now. We’re pleased with the status also of our UNITY Diffuse Large B-Cell program which is a registration directed Phase 2b study evaluating TG-1101 in combination with TGR-1202 as well as 1202 alone in patients with previously treated Diffuse Large B-Cell. The study is being read by Dr. Owen O’Connor at Columbia University Medical Center. The primary goal of this study is to assess the efficacy as measured by overall response rate of the combination of 1303 and 1202 alone with the goal of dropping the single agent 1202 arm after approximately 20 to 40 patients, which we expect to occur in mid-2017. As a reminder, we believe that 1303 combination is a more active regimen for Diffuse Large B-Cell patients, so the goal here is to knockout the 1202 single agent arm. Once the single agent arm is complete, we plan to replace that arm with 1303 plus bendamustine permitting us to then compare 1303 to 1303 plus benda, assuming positive results after approximately 200 patients are enrolled in the total for all arms, we’d like to transition study into a Phase 3 trial and ideally file 1303 alone and or in combination with bendamustine for accelerated approval. Finally, let me mention our MS program which is also moving forward quite rapidly. We plan to announce our pivotal program in the coming months and launch this program in the summer. We see MS as a major and straightforward opportunity for us. Ocrelizumab should be approved soon and our program will be powered based on their successful Phase 3 Ocre program. During 2017 and 2018 we plan to present data from our ongoing Phase 2 MS study and we’re very pleased with the performance of TG-1101 thus far in patients with MS. As you can see, 2017 is shaping up to be data rich year that we believe will drive significant value for our shareholders and get us closer to bringing much needed treatments to patients with B-Cell malignancies. With that, let me give you a quick review of our major goals for 2017. First next month, we’ll present for the first time preliminary data from our Phase 2 MS trial at the American Academy of Neurology Meeting in Boston, then we have an action pact summer, where we plan to present updated clinical data, most importantly the full Phase 3 GENUINE trial data at one-on-one major medical meetings. We plan to complete the first plan interim assessment in the UNITY-CLL trial which will assess contribution of the single agent arms, similarly we should be able to complete the first interim analysis in the UNITY Diffuse Large B-Cell trial, which will compare the efficacy as measured by overall response rate of the combination of 1303 as compared to 1202 alone with the goal of dropping the single agent 1202 arm and replacing it with 1303 plus bendamustine. And then back to the MS run, we plan to initiate our global Phase 3 trial in MS. And it doesn’t slow down for us in the second half of the year, we plan to meet with the FDA to review the GENUINE data and discuss filing for accelerate approval. We’ll report additional clinical data from our Phase 2 MS study. And lastly, we’ll present new and updated data for the ongoing CLL and NHL studies at ASH in December. So again quite a busy and data rich year. With that I’ll pause, turn the call back over to the conference operator to begin the Q&A session. Afterwards I will return to make some concluding remarks.

Thank you. The floor is now open for questions. [Operator Instructions] our first question is coming from Matt Kaplan of Ladenburg Thalmann. Please proceed with your question.

Four questions, I guess. First for Sean, just wanted to dig into the R&D expense line a little bit in terms of the last quarter, came in at about $22 million. How does that break down in terms of charges for manufacturing I guess during the quarter and what do you expect to see kind of going forward from that line?

Yes, so as I said in the remarks $22 million in the fourth quarter, $9 million of that was related to manufacturing in CMC expenses and we expect that to be somewhat consistent over 2017. As we’ve disclosed in prior calls, there is a component of that, that’s hung up on the balance sheet as a prepaid and flows through the P&L as different manufacturing activities occur, so it’s not necessarily fuller [ph] representative cash burn relative to manufacturing expenses.

Okay, that’s helpful. Thank you. I guess one question for Mike. One of the questions I’ve been getting a lot over the week after following your announcement of the GENUINE data, was how does this data compare with ibrutinib plus Rituxan, that we’ve seen.

Sure, yes we’ve also heard that question Matt. So yes, so I guess one there is not a lot of data existing on ibrutinib plus Rituxan which is interesting because you think there might be a lot of it, but there’s actually to my knowledge one singular publication which was single center study at MD Anderson it included “high risk patient population” different definition of high risk included some front line patients and relapsed/refractory patients. But most importantly it was a Phase 2 study conducted at the single center response rates were high, north of 90% which one might expect in a small study particularly when you have just one center involved, where you don’t have central review of data. So for all the caveat, I’d say that Phase 2 study was conducted I think three years ago and more. I don’t know when the publication came out, but the actual study was run a while back and certainly one would look at that and say that’s hypothesis generating and you might want to move into Phase 3 and in fact, my understanding is that MD Anderson is running a single center Phase 3 trial, so non-registration quality trial of the combination, but certainly worth exploring to know a little bit more about, but after that study the good kind folks at Pharmacyclics, now AbbVie ran their own study of ibrutinib plus bendamustine plus Rituxan. That was a 500 patient study, it was all relapsed/refractory patients with CLL so it wasn’t restricted to high risk, but they did have a good population of 17p patients and other high risk patients. And in that study, the response rates were for the triple combination of ibrutinib plus bendamustine plus Rituxan, all three drugs together the response rate was 82.5% and 82.7%, so just under 83%. So to me, while the MD Anderson study is interesting and in a hypothesis generating kind of way, we already have a more definitive answer in a much larger registration quality trial that was audited by the FDA and what made it into the label from that study was that 82% response rate of the triple combination. So unless you believe, that bendamustine is hurting the Rituxan, ibrutinib responses which I don’t think you’ll find anyone believes that, then we have to believe that while the MD Anderson study exists, it’s not really instructive anymore as to what you might expect in a registration quality trial of ibrutinib plus Rituxan. It almost in essence pass to be below ibrutinib, bendamustine, Rituxan. So we think that the nice part about our study is we’ve now shown that, you can take our agent, our CD20 which we believe is more potent than Rituxan and put it with ibrutinib and nearly match, I mean there is not statistical difference between 80% and 82.7% or whatever so, we basically matched the best you could expect of any Rituxan based regimen with ibrutinib, we matched it without using chemotherapy. So I think anyone who points to that in the Anderson study is being somewhat disingenuous, since we already have the answer. It’s like joining to look back at preclinical data, when we already have your Phase 3 trial done in showing that, there is contradict [ph] reaction when we put ibrutinib with CD20, well pre-clinically we saw that, but we’re now clinically, it works great. So it’s not really relevant and those are things interesting when you have them at first, their hypothesis is generating you need to figure it out, we already have the answer, we already know that CD20 plus ibrutinib work well, ours seems to work as good as anything if not better, as far as we could tell. And we already know that ibrutinib plus bendamustine, Rituxan is a low 80% response rate and the ibrutinib-Rituxan data that came out of MD Anderson while interesting is really not appropriately used to compare in the setting.

That’s helpful. Well that’s the HELIOS study that you’re referring to.

Correct, thank you. That’s the HELIOS study. And again, just to be clear the HELIOS study was published and then also made it into the label. I’d start with the label and then you can go look at the publication.

Great, that’s helpful perspective. Thank you. And then just going back to your ongoing clinical programs. You went to this little bit in your prepared remarks, but what should we look for I guess on the interim analysis from the CLL study in UNITY-DLBCL studies. Will we be seeing any data or it just kind of blinded situation?

Yes, so the UNITY-CLL will be blinded, so we won’t have any data to report. We’ll get a DSMB report to us that says, you can now eliminate the two arms or/and the alternative you cannot eliminate the two arms. Will be able to announce that then the study will continue as either two arm or four arm study. If it continues as a two arm study, we are going to check with our statisticians and possibly if necessary, check with the FDA to see if once we’ve completed full enrolment could we then present this single agent arm, so that will be potentially earlier data point, but we’re not mucking around with that, until we confirm you with statisticians and more likely I don’t think we’ll probably touch it without, at least having some conversation with the FDA to confirm that, they would have no problem with that. From the UNITY Diffuse Large B-Cell side that is achieved B study, it’s essentially open label, if not blinded in the same way as the CLL trial. So by hopefully mid-summer we would like to be able to say that, one of the two arms hopefully one of two arms is moving forward, I guess it wouldn’t be tragedy, if both arms move forward, but the goal is to move forward with 1303 arm, knock out the 1202 arm and move in with 1303 plus benda in replacing the 1202. In that case, I do believe if that all works out, we’ll be able to present that data perhaps at ASH and that data is not blinded, so we can do something with it. I don’t think we PR, the PR whether the arm is moving forward and it’s meant the threshold, but we preserve the actual presentation for conferencing again, [indiscernible] that would be at ASH.

Okay, that’s helpful. And then last question, with respect to your other ongoing combination studies. When should we look for data updates with respect to this?

Yes, so I think there could be some updates this summer. We’ve got three conferences so I would like to hopefully put out some data there and saying then we’re [ph] updated data at ASH. But I believe this summer there should be some more data coming out, somewhat for the other combinations.

Great, thanks for the detail.

Thank you. Our next question is coming from Jason Wittes of Aegis Capital. Please proceed with your question.

Just first off, in terms of R&D spend this year, how should we be modeling it relative to the fourth quarter?

Yes, so I think our general burden guidance is consistent with what we’ve been saying roughly 15% a quarter over this year, which obviously is heavily focused on R&D, but a component of that will of course be for G&A as well.

Okay and then, you spoke about this earlier but I know that you know, you’re originally looking for at least 20% difference in the GENUINE trial and [indiscernible] as you got much better 33% which obviously was very good. In terms of your discussions with the FDA, can you give us what their impressions have been in the past? I know they might - you might not have specifically asked them about if we do this or we do that, but in terms of whether you thought 20% was enough for approval in accelerated pathway and your confidence that 33% will definitely get you that.

Yes, so we have not dealt with them recently. Their current thinking on the appropriate delta, but as part of the original SPA discussions, the target for approval, the first - for accelerated approval based on overall response was based on in, 80% versus 60% response rate, so the delta of 20% was in wide into the SPA as the target, so that was to us, we feel pretty confident that at least at the time we signed the SPA, that 20% delta was clinically meaningful to them and certainly we’ve met that hurdle with some comfort room. So again, I said all along to investors along the way 20% is certainly, 20% delta gets us in the door because again we noted that was acceptable to them based on our prior discussions, again we don’t know if their thinking is changed over the last two and half years. But our feeling has been and continuous to be but with no further guidance, is that the greater the delta over 20%, the more likely they are to be enthusiastic about moving this forward. So we always felt 20% was certainly good enough to have the conversation because of based on past, 25% would be great and anything above into the 30% would be, does we think quite amazing. So like I said, we - in the past part of the SPA, 20% delta was clearly enough for accelerated approval and we believe, we actually have no reason to believe it’s changed.

Sure of course.

We won’t until we start presenting data to them.

Okay, no that’s good. I understand it. It looks pretty good and just curious about past conversations which you know you’ve only [indiscernible] that’s still pretty comforting. And then last question, I mean the full data is not released but you did basically say for GENUINE that the safety profile looked very similar to your Phase 2 study which was published earlier. I know that during the call, the Dr. [indiscernible] I believe it was, was asking questions about safety and I think, he basically I think he pointed out was infusion side related reaction. So is there any other color you could provide on the safety profile of the drug or is that about it for now.

I mean that’s pretty much it, we see again with the addition I’ll say this more qualitatively, I mean the addition of ublituximab to 1101, to ibrutinib, does not appear to change the safety tolerability profile of ibrutinib generally speaking, the only two that we’d expect to see slightly higher numbers on would be infusionary [ph] reactions which should really be zero with ibrutinib, right because then we didn’t do dummy infusion, so it will be very hard for them to have infusionary [ph] reactions and the profile for infusionary [ph] reaction with ubli, is relatively consistent, very low rates of grade three, four infusionary [ph] reactions and they do grade one, two’s are somewhat prevalent into the 35%, 40%-ish range I guess over different studies. So that’s to us that’s a very clean profile, it’s consistent I think observationally, we believe that the grade three, four infusionary [ph] reactions with ubli are less than Gazyva, obviously we have never done head-to-head study but observationally, we believe it appears less than, that’s been seemingly consistent across all trials. Neutropenia again, you might expect to be slightly higher, but I think as far as Neutropenia goes I would refer to the British Journal of Hematology paper and I think we’re pretty quiet enlightened with that.

Okay, great. That’s helpful. Thank you very much.

Thank you. Our next question is coming from Yatin Suneja of SunTrust Robinson and Humphrey. Please proceed with your question.

Maybe just one on GENUINE, how quickly you can get these data reflected on, in the end NCCN guideline is it possible before the drug gets approved. And then Mike, could you also touch on the market opportunity, I remember there was some recruitment challenges in GENUINE, does that have any read through in terms of the market size?

Sure, so in the first instance I’m not sure. We’re actually starting to, when I starting we have one in place waiting to join us in April, who does have some expertise with reimbursement and getting out the guideline and that kind of stuff. My impression is I think prior to approval getting on the NCCN guidelines might be a challenge, but I’ll follow-up, I don’t know the answer to that question. And then part two was related to.

The market opportunity challenges.

Market opportunity enrolment challenges. Yes you know, it’s - so we’re looking for assuming in the label we have high risk CLL which I imagine that’s what we’re going to get because that’s we’re going to ask for that’s possible the FDA would be so generous and offers us a broad label, but our going assumptions is that we’re asking for high risk CLL patients, it’s the unmet medical need despite the fact that ibrutinib has 17p label, will then a year or so after that, then Venetoclax also was approved with 17p label, neither of them have done randomized trials to validate that endpoint, so to in fact to make it non-unmet medical need, so it maintains a high an unmet medical need and so we’re focused right now in the high risk patient and yes, when the enrolment challenges have thought us something about the marketplace for high risk patients, there are estimated to be anywhere to be between 35%, 45% maybe up to 50% of all relapsed/refractory patients, will have high risk features. The problem today is that, in the academics, well not the problem. The academics have no problem, they screen all patients for high risk features and so they’ll know that and today when they do that their matrix is simply lighter [ph] than ibrutinib or Venetoclax. And I’d say from the limited serving done thus far, it looks like it’s almost a shutout in terms of first choice is always going to be ibrutinib and Venetoclax is always going to be a second choice and so I think the academic centers, where ibrutinib is going to be first choice and known that they’re looking at a high risk patient. They’ll have to consider whether they want to use 1101 on top of that, which I think for folks like Dr. [indiscernible] and Dr. [indiscernible] down at Duke who we’ve had extension conversations with, it seems like it’s quite a no brainer for them. The community is a little bit different, they don’t have well before the ibrutinib drill, they never had anything for high risk patient to begin with, everything was the same. So they never really, they didn’t have an ideal curiosity in knowing that information since they had nothing they could do with it. Today, it’s still kind of a novelty to them because they don’t really use Venetoclax. So they’re treating the patient with ibrutinib no matter what the high risk test comes back and says, I think what our job will be to do is, to make sure that they understand that, if they want to use 1101 with ibrutinib, they’re going to have to test those patients because they’re probably not going to get reimbursement without it, so part of our marketing campaign will be a basically a testing campaign, diagnostic campaign where they should be looking at that, it’s a simple blood draw, so it’s not a challenging test to do. So I think the read through from the clinical trial, we’re looking it at a subset of a subset, if you think about, yes and there is super round numbers and I’m sure you and some of the other analysts and probably the buy [ph] side folks have better models than us. But if we assume that, ibrutinib does about $1 billion in CLL cells. We could assume anywhere from $350 million to $450 million or in patients who have high risk features. And then the other question is what percentage will we participate in that. I don’t think we’ve ever said that this is a, this first label is a $1 billion opportunity for us, but it’s a great opportunity for us to get on the market and we do think, we’ll do several hundred millions sales just in this label alone and then that sets up for future use, in all relapsed/refractory CLL which is a bigger opportunity and we think ultimately [indiscernible] ibrutinib will be approved in the front line, we think it’s possible that is part of our commitment to the FDA and it part of [indiscernible] approval, we made [indiscernible] front line study. So I think it’s all these are building blocks in how large the market’s going to be, but the first one we’re looking at targeting somewhere between $350 million and $500 million let’s say of the ibrutinib sales that we’d like to partner with.

Got it, fair enough and then just a couple of questions on the MS front. So obviously you’re going to learn a lot the Ocre experience, but have you requested a meeting with the FDA, what sort of an endpoint are you looking at, will it be two-year, one-year? And then in terms of the profile for TG-1101, I mean what’s the goal there in terms of the infusion duration?

Right, so we’ve had, we’ve not been shy about saying that we’ve been engaged in a very productive dialog for some time with the FDA in designing this program, we’re modeling it after the Ocre program for Ocrelizumab, Ocre for short. And the endpoint for MS studies have been and continue to be annualized relapsed rates over a two-year study period. So our study will be exactly the same, I think the only difference is how big do our studies have to be relative to the Ocre studies which ended up having three or four zeros before you got a number. So we know that they were overpowered dramatically overpowered actually. So as part of the discussion with the FDA’s what is the right size for these trials and I think we’ve had really great interactions with them, they’ve been super helpful and super productive, so we plan to get it done and hopefully announce in the next several months, what exactly that program looks like, well we’ve had a lot of guidance and help from the FDA. Similarly, we have scientific guidance from EMA, so we’ve incorporated that and we know what they’re looking for as well, so we do believe this will be a global registration trial. And the profile the 1101 is relatively straightforward, these are anti-CD20 monoclonal antibodies and diseases like autoimmune diseases where the B-cell burden is low to begin with, it must be abhorrent [ph] to be part of the disease process, but it is not necessarily a numbers game so whereas a potency of CD20 in cancer is extremely important, when you have such a large views burdening, you want to get deep into those nodes, as much as possible. In MS it’s a slightly different story, the agents are all quite confident agents that depleting B-cells and depleting B-cells of with a low burden is not very challenging, so it’s the potency for us just gives us that the ability to have flexibility on the dose, the low dosing that we want to use which also translates into what we see as an advantage in terms of infusion times. So ultimately, for MS our profile is pretty straightforward. We’re going to have, we believe we will have a comparable activity, comparable safety profile in a convenient one hour infusion given every six months and we believe our price point will be significantly lower than the competition.

Okay, fair enough just one last question for Sean. I think Sean you addressed the G&A part. I think I missed it. So the G&A was a bit choppy in the last two quarters, can you just help us to, how we should model it for 2017?

Yes, so I think if you look at the table in our earnings release, it becomes a little bit helpful. So the total G&A line becomes a little bit choppy as a result of non-cash compensation. But if you look at the other general administrative line, it’s pretty consistent quarter-to-quarter and if you need any further clarity, happy to take in a little bit.

Got it. Thank you guys. Congrats on all the good news and all the progress you guys are making.

Thank you. Our next question is coming from Reni Benjamin of Raymond James. Please proceed with your question.

Can we talk, I guess sticking with CLL. Can you talk a little bit about what proportion of the community or the market is IBR right now and is that the focus maybe we should we looking at, that could be replaced by ublituximab and ibrutinib and related to that, will we see any preliminary PFS data at the medical conference, where this data will be presented that probably rhymes with BASCO [ph]?

Reni, you’re the best. So yes, hopefully it will be at a conference that rhymes with BASCO [ph]. So we’ll start that, but there is few other good conferences during this summer actually, you know you lost me. What was the question?

Any sort of PFS type data?

Yes, so we should see some PFS data as part of the presentation. Absolutely and then I guess, the first part was about IBR. So the HELIOS data was presented in publication form it was presented at conferences and then it made into the label only about six months ago. So I think one thing that’s worth noting for everyone again even as it relates to the thought that someone is going to use ibrutinib plus Rituxan because it was in a singular paper, here we have HELIOS which is pretty well covered press releases, articles, publications, into the label I think pretty impressive results, they have to be because they’re similar to ours. But not really being used when we do a lot of pulling of our clinical sites, when we do our investigator meetings and it’s pretty rare that they use that it’s just as rare for them to use IR and I think most of it is because, to get folks to use these kind of regimens, one we have to have clear prescribing instructions for them. So IR put on the side because there is nothing available for position, but IBR is there it’s in the label, there is prescribing instructions they know how to do it. But there is no one actually educating them on how to do it. So it’s an interesting market, it is a very educational driven marketplace where you have physicians that are quite busy and those use what’s easiest and what’s known to them and IBR is really not known to them yet and the reason why they’re not being educated on that treatment regimen is nobody has an interest in educating them on that. So the fine folks again at Pharmacyclics plus AbbVie they just care, if you use ibrutinib. They do not care, if you use ibrutinib plus bendamustine, Rituxan. They just care that you use ibrutinib. In theory, they could care because you might get a better PFS, but I don’t think that’s really made it into their sales program yet to start promoting IBR, so they’re not out there educating on IBR. Roche has no interest these days in promoting anything that has Rituxan in it, they’re moving everything in all their marketing educational programs to Gazyva. So without an educational program to support the label, it is not readily used and it’s not out there. Contrast that with what we’re offering, we believe when we’re offering a better more potent treatment that’s going to get more patients to respond and we have an interest in educating physicians about that regimen. So we have a huge network of US based centers. I think HELIOS if I recall correctly, it was very much an Ex-US trial so that’s another reason why you wouldn’t have a lot of educated physicians here on that regimen, but ours is a US based study. We only had I think one or two patients that were in Israel and the rest is at, every other patient was right here in the US and most of them at centers, in community centers where those are the people that were hardest to educate because they’re out and about. So we feel good about the prospect of offering, the same basic activity profile of using IBR which includes chemotherapy, exclude the chemotherapy, get a great outcome for the patient and we have every interest in educating. We’ll be the only ones in the offices with educators we already have, I think six educators on staff. We already have I think eight clinical science liaisons which are basically medical science liaison so it’s all part of high touch educational program, so yes I think I could stop there.

Got it and then just switching gears to MS. About how many patients worth of data will we be seeing at ARR. Will there be any imaging data that comes along with that? And how important is that kind of data outside of the B-cell depletion in helping you to design your Phase 3? And do you think you might get us a spot for the Phase 3 as well?

Yes, so we don’t need the radiographic information to move into Phase 3. We’re comfortable that if we have a dose that effectively depletes B-cells the mechanism of action is the depletion of B-cells, we have three agents that are proven, that if you deplete B-cells efficiently you will get the reaction and for the patient in the radiographic sense and also in reduction in ARR. So no, so the short answer is, what you’ll see in the first presentation in April will be B-cell depletion data I assume will have summer over 20 patients of data available, at mix durations of time, so all of them will have certainly initial B-cell depletion, so we should have at least one month of data and more on all the patients that are presented and then, or at least on the 20 patients because we’re still enrolling so maybe [indiscernible]. I would say at least 20 patients will have no less than four weeks of B-cell depletion data and then we’ll have some that are out, six months a handful, some that are out interim periods of time and so we can start to see the basic trend in depletion, repletion and that’s really the most important information to us. I again, I imagine things no one really cared about GENUINE until we actually showed the data, that I assume people will be interested in seeing the data for MS on the lesion reductions, but we’re highly confident that mechanistically it is well established, that you deplete B-cell, you get the reaction, so later in this year, we should be able to provide the first glimpse of radiographic reductions, [indiscernible] lesion reductions, but until then we’ll just be dealing with B-cell depletion.

Got it and just one final one from me. How important is getting a partner for you guys for this program, just given the fact that there is likely to be two other anti-CD20s on the market for MS by the time this makes it to market?

Yes, we think we’re offering something that in a lot of ways will be able to sell itself. We think we’ll have the most convenient presentation of anit-CD20 program in terms of one hour every six month infusion and I think there’s no one who’ll be able to match us in price point. So again, we feel very comfortable that in MS, US strategy, we can handle quite well and again it’s a strategy that works great for us and again, if we have 100,000 patients on drug at $30,000, $35,000 a year which is a dramatic discount to what others are charging, that’s $3.5 billion opportunity and I guess, we believe that sells itself with the convenience in cost advantages. So and that may not resonate and we don’t know this for sure because we’ve only really looked for all of our products for outside the US relationships, but we don’t know that will resonate with the US company, our value proposition but we’re committed to that value proposition, we believe that it’s a winning strategy and something that works great for us.

Great, thanks guys and congratulations again.

Thank you at this time. I would like to turn the floor back over to management for any additional or closing comments.

Thank you operator and thank you all for taking the time to join us this morning. As a company we’re extremely excited to have reached our goals with the GENUINE trial and even more excited to potentially bring forward a much needed treatment options for patients with high risk CLL. We’re also quite pleased to have successfully raised almost $90 million this week and appreciate the support of many of you on this call, who participated in the offering. We truly believe the positive Phase 3 GENUINE data and the strengthening of our balance sheet, was a major turning point for our company with so many exciting trials and data readouts coming in the 2017, 2018 timeframe and a healthy cash position to execute on our goals. The company has never been better positioned for success. On behalf of all of us at TG. I’d like to thank our investigators and their patients as well as all of our shareholders for their continued support. Thanks again for joining us and have a great day.

Ladies and gentlemen, today’s conference is now concluded. You may disconnect your lines at this time and have a wonderful day.