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TG Therapeutics, Inc. (TGTX)

Q4 2013 Earnings Call· Thu, Mar 6, 2014

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Transcript

Operator

Operator

Greetings and welcome to the TG Therapeutics Fourth Quarter and Year End 2013 Financial Results and Business Update Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder this conference is being recorded. It is now my pleasure to introduce your host Ms. Jenna Bosco, Director of Investor Relations for TG Therapeutics. Thank you, Ms. Bosco. You may begin.

Jenna Bosco

Management

Thank you. Good morning and welcome to our conference call, regarding TG Therapeutics fourth quarter 2013 financial results and business update. I am Jenna Bosco, TG’s Director of Investor Relations and I welcome you to our conference call today. Following our Safe Harbor statements, 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 Interim Chief Executive Officer, who will provide an update on the ongoing development of our novel glycoengineered anti-CD20 monoclonal antibody, TG-1101 and our novel once daily PI3K delta inhibitor, TGR-1202. Before we begin, I would like to remind everyone that various remarks that we make about our future expectations, plans and prospects constitute forward-looking statements for the purpose of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to certain 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, www.tgtherapuetics.com, where it will be available for the next 30 days. All participants on this call will be on listen-only mode. Now, I would like to turn the call over to Sean Power, our Chief Financial Officer to briefly discuss the financial results for the fourth quarter of 2013 as well as the Company’s overall financial condition.

Sean A. Power

Management

Thank you, Jenna and thanks everyone for joining us. As you may be aware, our financial results were released yesterday evening and can be viewed on the Investors and Media section of our website at www.tgtherapeutics.com. As of December 31, 2013, the Company had cash, cash equivalents, investment securities and interest receivable of $45.4 million, as compared to $16.5 million at December 31, 2012. Turning to the financial results for the quarter. The consolidated net loss for the fourth quarter ended December 31, 2013 was $5.7 million, or $0.19 per diluted share, compared to a consolidated net loss of $3.5 million during the comparable quarter in 2012, representing an increase in consolidated net loss of $2.2 million. The consolidated net loss for the fourth quarter ended December 31, 2013 included an increase in other research and development expenses of $2.7 million, principally related to the TG-1101 and TGR-1202 clinical development programs and drug supply costs. Also, included in the consolidated net loss for the fourth quarter ended December 31, 2013 are the following non-cash items: $2.8 million for the impairment of in-process research and development expenses; and $0.9 million of non-cash compensation expense related to equity incentive grants; partially offset by non-cash income of $2.4 million related to the change in fair value of notes payable. The consolidated net loss for the year ended December 31, 2013 was $20.5 million, or $0.81 per diluted share, compared to a consolidated net loss of $26.2 million for the year ended December 31, 2012, representing a decrease in consolidated net loss of $5.7 million. Included in the consolidated net loss for the year ended December 31, 2012 was $16.6 million in non-cash stock expense recorded in conjunction with the license for TG-1101, which is partially offset by an increase in other research and development expenses in 2013 of $8.6 million principally related to the TG-1101 and TGR-1202 clinical development programs and drug supply costs. Also, included in the consolidated net loss for the year ended December 31, 2013 are the following non-cash items: $2.8 million for the impairment of in-process research and development expenses; and $5.2 million of non-cash compensation expense related to equity incentive grants, both of which are partially offset by non-cash income of $3.3 million related to the change in fair value of notes payable. I will now turn the call over to Mike Weiss, our Executive Chairman and Interim CEO.

Michael S. Weiss

Management

Thank you, Sean, and thanks to all of you for joining us on this call today. 2013 was an extremely productive and exciting year for us at TG. In less than two years since inception we’ve been able to build an aggressively developed and impressive pipeline, driving us closer to your ultimate goal of developing novel, next-generation, non-chemotherapy based combination treatment for B cell malignancies. Some specific achievements for 2013, I would like to highlight are for 1101, our novel glycoengineered anti-CD20 monoclonal antibody. We’ve presented preliminary data from our first U.S. dose escalation trial of 1101 as a single agent at ASCO and at the European Hematology Association meetings, both occurring in the middle of the year. Around the same time we presented via an oral presentation preclinical data demonstrating the synergy of 1101 plus 1202 at the International Conference on Malignant Lymphoma in Lugano. Later in the year we completed enrollment in the 1101 single-agent study, including expansion cohorts, the final enrollment of approximately 30 patients with the expectation that final data from that study will be presented sometime in the middle of this year. And finally, at the end of the year, we commenced combination trials of 1101 plus ibrutinib and 1101 plus 1202, launching our most anticipated combination program. And for 1202, our novel once daily PI3K delta inhibitor, we made significant progress in our first-in-human Phase 1 dose escalation trial and although we have not yet hit a maximum tolerated dose or an MTD, we have reached therapeutic dose levels. As a result, we opened and nearly completed enrollment into our first expansion cohort at 800 milligrams and plan to shortly launch a 1200 milligram an additional expansion cohort. As discussed earlier, we also opened the 1101 plus 1202 combination study and at the end…

Operator

Operator

Thank you. (Operator Instructions) Our first question is from Jonathan Aschoff of Brean Capital. Please go ahead. Jonathan Aschoff – Brean Capital LLC: Thanks a lot. I have a couple of questions. I asked a couple of times by some clients about 1202 potency, just given the relatively high doses in which you’re seeing pretty solid efficacy. And if I recall correctly, didn’t Clovis have an oral bioavailability issue that they were able to subsequently formulate around and I was wondering if any such reformulation efforts are going on at the TG.

Michael S. Weiss

Management

Hey, Jonathan. Thanks. So, yes we internally don’t think there is anything related to potency with our compound. When we look at giving the drug at certain levels of milligrams what’s on the other side is an exposure level in the serum and clearly we were having low bio oral availability, very similar to, I guess what Clovis has been seeing. We have several programs underway, looking at ways to improve the oral bioavailability so that we can bring down the actual milligram dosage utilized to get the similar or even better exposure. We haven’t been specific about. We’ve mentioned in a few times and a few different settings, but we think that by middle of the year for sure we should be able to talk about what we’re looking at in terms of savings, I’d say, in terms of where we’ll take the dosing from where we are. Right now I guess we’re about 1,800 milligram in the dose escalation trial. We think we’ll certainly be able to get similar exposure to those levels at lower, potentially much lower levels although that’s the FTC. So we’re working on it. We’re not doing anything material and major that will require new clinical trials or anything like that. We think we have some very subtle changes that can make actually a very big impact. So I think going forward we may end up with milligram quantities that are somewhat similar at least to achieve blood concentrations similar like idelalisib. We’re predicting that we’ll be pretty close to similar milligram quantities that they’re using, but again think we’re going to have the bit fortune to be able to push the dose. We won’t know how much higher, but we think will be higher and we’ll be able to get higher concentrations in idelalisib. Jonathan Aschoff – Brean Capital LLC: Okay. And just two more. Can you give some color what you think is your best dose at present? And the other part of that question was, how fit or flexible – I’m kind of forgetting is the dosing in the 1101 plus 1202, how exploratory or fixed is that?

Michael S. Weiss

Management

Yes, so we’re in a very tight range at this moment. In non-Hodgkin’s lymphoma we safely dosed up to 1,200 milligrams, but we think for convenience sake we’re probably going to settle in at 900 milligrams. With CLL, we’ve dosed now at 600 and 900 both safely. To be conservative, we started the combination with 1202 on the CLL side at 600, but it’s just one step up back to 900 and so we think there’s going to be basically one standard dose for both. NHL and CLL looks to be the 900 milligram dose of 1101. With respect to 1202 in those studies, the plan is to basically dose escalate 1202 as we safely learn more about higher doses on the dose escalation of 1202. So we’ll have a fixed 1101. Again one step up from 600 to 900 on the CLL side. That will be done soon. As soon as we get through that, we’ll continue with dose escalation of the 1202, again as we learn more from that dose escalation trial. Jonathan Aschoff – Brean Capital LLC: Thanks a lot, Mike.

Michael S. Weiss

Management

Thank you, Jonathan.

Operator

Operator

Thank you. The next question is from Matt Kaplan of Ladenburg Thalmann. Please go ahead. Matthew L. Kaplan – Ladenburg Thalmann & Co., Inc.: Hi, good morning, guys.

Michael S. Weiss

Management

Good morning, Matt. Matthew L. Kaplan – Ladenburg Thalmann & Co., Inc.: First, I guess little bit of a housekeeping question. In terms of guidance, your clinical development activities may have been up this year, potentially starting, as you said, Phase 1 study. Do you think it’s best in terms of R&D spend that you’ve backed in 2014?

Michael S. Weiss

Management

Yes, and I think across 2014 the burn should remain reasonably stable. I mean, we’ve been typically in the 4 to 5-ish range of guidance per quarter. My guess is we’ll probably run close to 5 during the course of 2014 even as we ramp up and get involved potentially in some registration trials towards the end of the year. Again, unfortunately you just can’t spend enough money early on those trials. Recruitment ramps up in somewhat of a hockey stick format usually. Then we can’t predict exactly the start time to stay high, but most clinical trials that I have ever been involved in start off pretty modestly. So at the beginning I don’t think we could spend the money as fast as we’d like them through the end of 2014. So I think practically speaking we’ll be concerning to that 5-ish per quarter number through 2014. And, again, as we get into 2015, we’ll evaluate – we’re going to do a lot more. We’re going to be at one, two, six, who knows how many registration trials. Certainly we’re modeling for at least one and with one registration trial even through 2015. Again, when you take away a lot of these other background studies that we’re running, the burn rate for one pivotal trial wouldn’t really change our burn rate through much of 2015 as well. And so that would get us comfortably through 2015 also. Again, it really does stand on how many opportunities we see as we go through this year and how we want to develop the drug, but we see a pretty stable burn rate with a baseline case of, say, one registration trial starting at the end of the year and going through 2015. Matthew L. Kaplan – Ladenburg Thalmann & Co., Inc.: Okay, great. Thanks for the detail. One question I get frequently is, so let’s say, the phase in terms of B-Cell, going to phase has a kind of a little bit crowded, to speak, in terms of the therapies that are in development or available now, and can you talk about how 1101 and 1202 potentially differentiate and why the relative playing the market in future?

Michael S. Weiss

Management

Sure. So, one thing that’s important to note is when you think about 1101, it really stands in a class that’s very small, I mean we look into those two really glycoengineered anti-CD20s. Our view today is based on data received from Xylem [ph] and data received from our drug is that these drugs are differentiated and should perform better than Rituxan, particular in CLL and probably carries forward into most applications in NHL, although, again yet to be determined. We you think about the next level of studies, we’re talking about not just taking CD20 plus cells or ibrutinib, but we’ve actually gone to the next level. We now feel like we are the standard. We are the only one who have been able to combine and exam glycoengineered CD20 with a PI3K delta, which in this case is also 1202 and with ibrutinib. So in terms of differentiating, we’ve always said it’s going to be combinations, but obviously combinations of potentially best-in-class molecules and being the first two best-in-class combinations, we think in and of itself, a differentiator. Going forward, again, it’s going to be a function of clinical and regulatory development. I think for the most part, if you look at the series of Phase 3 trials that underway or have been telegraphed as planned by some of the other companies that are developing drugs in this area, we have a pretty good picture and it’s not as vast as people might think, pretty good picture of where the next approvals are going to occur and they’re not going to occur for two, three or four years, right. So we’ve got this first class of compounds, got ibrutinib now approved from Mantle Cell and CLL and possibly they’ll have long terms approval earlier. The next set of…

Michael S. Weiss

Management

Yes, so the on liver lead abnormalities it’s a tough one. The other deltas particularly, I don’t list it, it’s 145. When they see liver tox, it’s reasonably early onset. It’s typically, I would say, anywhere from two to eight weeks. You would see liver lead abnormalities. In some cases it’s obviously in the week three or four range, which gets kind of scary. You do run the risk of liver failure at that point., patients are taken off the drug. They go on a holiday. Most patients, I think, are able to reinitiate treatment, but again its toxicity and it’s an issue that I think people would rather not have to deal with. And particularly once you start thinking about multi drug combinations it just adds another level of complexity when you look at these together. So, that did we have not seen it yet. We are certainly at therapeutic dose levels. Actually we have not seen it. It all gives us some reasonable level of confidence that we have done a good job in engineering around it, but I don’t think we could definitively say we are devoid of liver tox at this point, but I’d say we’re feeling pretty good about that part of our projected product profile, when we started the program. Again, we need to achieve more patients and potentially even at higher doses and we’ll see what happens there, but we’re feeling pretty good about it. And then again, all of these drugs need to be taken in the context. When I talked earlier about safety and tolerability, I could have easily added new price subjects that would be combinability, right, which is none of these drugs are going to on a simulative basis be the answer for the treatment of CLL or NHL.…

Michael S. Weiss

Management

Thanks Matt, we appreciate it.

Operator

Operator

Thank you. The next question is from Joe Pantginis of ROTH Capital Partners. Please go ahead. Joe Pantginis – ROTH Capital Partners LLC: Hey, guys good morning, thanks for taking the question. Couple of question, first, when you are looking at CD20 landscape now. How would you look to interpret at this point? Do you [indiscernible] had on your program and tracking more intermediate just or anything from a potential continued aspect how would you describe its impact …

Michael S. Weiss

Management

For us, I don’t know if it’s had any particularly positive or negative, I think perception wise, it certainly helped us. I think people get what the differences now between Gazyva Rituxan and ideally between plus Rituxan. It’s nice to talk in theory about a class of drug i.e. glycoengineered CD20s and say that, we think they are going to be better than Rituxan, and then to have one of the class members and there is only two members of the class, one of the class members actually demonstrate itself to be better and in randomized control trial. So we think that the physician community that we’ve been interacting with there is a clear change in mindset that yes, you know what? Gazyva’s glycoengineering it matters, it does change the profile for these drugs. It does add to the potency of these drugs, and so I think that’s helped us, and again I think over time as Roche Genentech, who we think are obviously super smart people get out there and tell the story and convince people that the glycoengineering CD20 is better than what they are using currently with Rituxan. That’s a great opportunity for us, that’s where people can be okay. Now we know that there is something better out there. What else is out there looks or acts like that, and we are only the other guys around, so we think that the community is certainly down on board. So I think that’s part of the biggest overall change in terms of competition, again we never viewed this space as a winner take all zero-sum game, we’ve always been of the position that it’s about the novel combination, it’s not about any individual component in a combination, but the more you could push better and more tolerable agents into those combinations, the better off you can be, and there is plenty of room across CLL and NHL to share, and more importantly it help patients in multiple lines of therapy. So we think that being the only other glycoengineered CD20 puts us in a great position, and whether Roche is the dominating first line player, we think as we move into second, third line, and again we’ve always been focused on those later lines, we can actually provide a real valuable product to patients to help improve their survival. Joe Pantginis – ROTH Capital Partners LLC: That’s great, thank you. And then with regard to the 1101 and ibrutinib combination study, what would say will be your base case expectation toward the study in order to consider in success give something beyond the data and safety in combination?

Michael S. Weiss

Management

Yes, so if you look at around the largest studies that have been done, I don’t know if there is a large one with ibrutinib and CD20. But certainly there has been a large study of idelalisib for CD20 Rituxan in that case. And that team in about 85% with long-term follow-up. We are looking at is certainly early on we are going to have maybe two months or four months of data, the response rate for ibrutinib on its own, it’s pretty low at the two month and four month check points. So we are not 100% sure of what to expect at two and four months. We certainly know that as you get to by six or nine months, we will feel comfortable that we should be at peak response for the combination. Peak response ideally would be 90% north. I think we’d be certainly happy again in smaller numbers you can easily end up at 85% north. But as the numbers get larger and larger, our hope would be that we are driving closer to 90%. And then, obviously following that forward new, we soon will like to see even better than that, particularly combinations in CLL, when we look at the ultimate response rate for ibrutinib is a balance of 70% with about another 20% in the nodal responses without clearance of lymphocytosis. So again in base case, we take their 70 plus our 20, we should be pretty close to 90%, since we are pretty close to 100% in clearing the lymphocytosis. In case we are 100%, but pretty darn close to 100% in clearing the lymphocytosis. That doesn’t account for any potential synergies between the two agents. It doesn’t account for the fact that we are seeing on a standalone basis for our drug, even near or close to about 50% response rate in CLL, relapsed refractory patients. So, we think we’ve got a pretty strong rationale to push higher and higher and ideally push higher the CR rates. The CR rates for single-agent ibrutinib were quite low, I think it was 4% or 5%. If that high, the CR rates of idelalisib plus Rituxan were also quite low. I think and maybe in the 10% to 12% range. I have to double check that number, but I remember it was quite low. So, we think there is room to improve the overall response rate. We think there is certainly room to improve the CR rates. And so, we are – that is kind of where what we are thinking about. Joe Pantginis – ROTH Capital Partners LLC: Yes, it’s real great, thank you. And then, my last question is with regard to 1202 in the average this year regarding, and I guess we call it reformulation or how you describe it was, as you are looking to change [indiscernible] structured combination error. Do you have the potential for move your – once for daily dosing or is that factor in?

Michael S. Weiss

Management

Joe, can you ask that question again please? Joe Pantginis – ROTH Capital Partners LLC: Sure, sure. I think based on your reformulation effort for 1202, you’ve the potential to produce your once per day dosing uncharacteristic of the drug.

Michael S. Weiss

Management

Absolutely not. Yes, now what we were talking about in terms of reformulation is very, very basic kinds of things. We haven’t even thought about doing anything complicated. We think we can actually bring down the dose pretty dramatically. I mean and I say, we think that we can get two about the concentration level of idelalisib with about the same milligram dosage, through very modest modifications. Again, I won’t say it’s – can be exactly overlapping at that point, but much closer than where we are today and that doesn’t require any sophisticated formulation efforts. So nothing will impact the once a day status. It won’t change, since anything on liver tox, I mean there is nothing complicated about what we’re doing, really simple straightforward stuff. And so, yes, once a day is, we think, pretty well locked up and the half life at steady state is almost incalculable at this point, but somewhere between 1500 hours is the best estimates we have. Joe Pantginis – ROTH Capital Partners LLC: Okay, great. Thanks, a lot Mike.

Michael S. Weiss

Management

Thanks. Joe, just one last point. So let me just – my correct research desk is on the case and apparently in the Rituxan idelalisib pivotal trial. There were no CRs. So I’ve really on its own had about 3% to 4% and Rituxan plus idelalisib had no CRs in the CLL pivotal trial. Joe Pantginis – ROTH Capital Partners LLC: Got it. Thanks again.

Operator

Operator

Thank you. The next question is from Graig Suvannavejh with MLV. Please go ahead. Graig Suvannavejh – MLV & Co. LLC: Thank you. Good morning, guys and let me add my congratulations on a really nice 2013. Couple of questions if I may. What are your current thoughts on the next combination trials? I think in the past you’ve talked about a combination 1101 plus idelalisib and so while the focus remains on the current combination, just if you could help us think about how you are thinking about the next trials going forward?

Michael S. Weiss

Management

Yes. So we haven’t disclosed anything further. I could say that we’re probably internally deemphasizing the idea of working with idelalisib. At this time we have, I’d say, a few other novel combinations that we’re thinking about and planning, and do some serious exploration on, and I think as we announced those trials, we will obviously talk about and I think given the competitive landscape and given we’ve identified some interesting greenfields of opportunity that folks have just decided not to outsource just or not seeing, we’ve decided not to disclose any of those sort of strategy. So I think for the moment we’re keeping investor focused on 1101 plus ibrutinib and 1101 plus 1202. And potentially in the coming months we’ll announce some additional combination trials. Graig Suvannavejh – MLV & Co. LLC: Okay. Thank you. More specifically as it relates to upcoming medical meetings being EHA and ASCO, what kind of data should we investors be expecting you guys to maybe share?

Michael S. Weiss

Management

Yes. So the goal would be to present the final Phase 1 data from the single-agent 1101. We’d like to present an update, the 1202 study. So whatever data we have again are still dose escalating, we’re running some expansion cohorts. So whatever data is available we would like to share that data around that time. We have the combination studies running. So 1101 plus ibrutinib and 1101 plus 1202 and I still think our goal is to have patient data on somewhere between five and 10 patients for each of those studies available for those conferences around mid-year. Graig Suvannavejh – MLV & Co. LLC: Okay. Thank you for that. And meanwhile other questions will be – and Michael you’ve done a really nice job, building value and the company as well building value for shareholders and it’s just now for some reasons struck me that you have a tag of Interim CEO. And so, I’m wondering if you could share with us what your or what the Company’s or what the Board’s thought is on a more permanent CEO person whether to you or someone else?

Michael S. Weiss

Management

Yes. I think for the moment, we actually recently had this conversation with the Board and I have no intention of advocating my position anytime soon and I think my goal has always been to make sure I see TG to a secure place in terms of development and where we are strategically. And at that point I would make a decision of what makes most sense. I think that’s still a year or more away in terms of giving that a hard look. So I think that you could feel very secure for better or worse if I stopped me consistently over 12 months and then we’ll just reevaluate at that point, but I think we’ll get for 12 more months for sure. Graig Suvannavejh – MLV & Co. LLC: Okay, great. Thanks for taking my questions. And, again, congratulation on a great 2013 and also look forward to another great 2014.

Michael S. Weiss

Management

Great. Thanks, Graig.

Operator

Operator

Thank you. We have no further questions in the queue at this time. I’d like to turn the floor back over to Mr. Weiss for any closing remarks.

Michael S. Weiss

Management

Thank you. So let me just conclude then by thanking all of my investigators and their patients and as well as all our shareholders and investors for their continued support. We look forward to most exciting 2014, in which we plan to aggressively accelerate both of our programs towards and ideally into Phase 3 development. Thanks again for joining us and have a great day.

Operator

Operator

Thank you. Ladies and gentlemen, this does conclude today’s teleconference. You may disconnect your lines at this time and thank you for your participation.