Earnings Labs

TG Therapeutics, Inc. (TGTX)

Q2 2015 Earnings Call· Mon, Aug 10, 2015

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Transcript

Operator

Operator

Greetings, and welcome to the TG Therapeutics' Second Quarter 2015 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. It is now my pleasure to introduce your host, Mr. Jenna Bosco, Director of Investor Relations. Thank you, you may begin.

Jenna Bosco

Analyst

Thank you. Good morning and welcome to our conference call regarding TG Therapeutics second quarter 2015 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 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 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, as well as a review of our preclinical program. 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 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, 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 would like to turn the call over to Sean Power,

Sean A. Power

Analyst · ROTH Capital Partners. Please proceed with your question

Thank you, Jenna. And thanks, everyone for joining us. 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’d like to begin by providing an update on our cash position. At June 30, 2015, we had cash, cash equivalents, investment securities and interest receivable of $110.6 million, as compared to $78.9 million at December 31, 2014. Included in our June 30th cash balance is approximately $51.2 million of net proceeds from the utilization of our aftermarket or ATM sales facility during 2015, $42 million of which had been discussed on our fourth quarter conference call. During the third quarter we continued to opportunistically utilize the ATM facility raising an additional $15.8 million in net proceeds at an average price of $18.38, providing us with a June 30, 2015 pro forma cash position of more than $126 million. As of today we have approximately 52.5 million shares outstanding. Turning to the financial results for the quarter; our consolidated net loss for the second quarter ended June 30, 2015, excluding non-cash items, was approximately $10.9 million which included approximately $4.8 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the second quarter ended June 30, 2015, inclusive of non-cash items, was $17.1 million or $0.38 per diluted share, compared to a consolidated net loss of $12 million during the comparable quarter in 2014, representing an increase in consolidated net loss of $5.1 million. The increase in consolidated net loss during the second quarter was primarily the result of other research and development expenses for TG-1101 and TGR-1202, increasing approximately $5.8 million and $1.3 million respectively over the comparable period in 2014. The increase…

Michael S. Weiss

Analyst · ROTH Capital Partners. Please proceed with your question

Thank you, Sean, and thank you Jenna and thanks to all of you for joining us on this call today. The second quarter of 2015 has been an action packed few months with updated data from all of our key Phase 1 and 2 clinical trials having been presented at several major medical conferences, including five oral presentations and four poster sessions. The data presented continues to fuel our excitement and reinforces our belief that the safety and efficacy profiles of TG-1101 and TGR-1202 are well suited to form a backbone for multi-drug combinations. Accordingly we remained focused on commencing before year-end one or more Phase 3 registration trials for our proprietary combination of TG-1101 and TGR-1202, what we refer to as 1303. Additionally we are focused on continuing to broaden our clinical development program to include additional triple therapy combination trials, launching our first trial in autoimmune diseases as well as continuing to evaluate opportunities to enhance our product pipeline to enable further proprietary combinations. Well that as a quick overview of the quarter and our goals for the remainder of the year let me do a quick update on our ongoing GENUINE Phase 3 trial. During the quarter we were excited to announce that we now have over 120 sites open to enrollment into this Phase 3 clinical trial. Driving enrollment into our GENUINE trial is our top priority and to already have so many sites on board is an incredible accomplishment. From the design standpoint the GENUINE Phase 3 study is a randomized trial where patients will receive either 1101 in combination with ibrutinib or ibrutinib alone. The population for this study is patients with high risk chronic lymphocytic leukemia or CLL, while the primary endpoint of the study is progression free survival. Approximately the first few…

Operator

Operator

Thank you. At this time we will be conducting a question-and-answer session. [Operator Instructions]. Our first question is coming from the line of Joe Pantginis with ROTH Capital Partners. Please proceed with your question.

Joseph Pantginis

Analyst · ROTH Capital Partners. Please proceed with your question

Hey guys good morning. Thanks for taking the question. Michael you have been pretty consistent with regard to your data presentations and the what appears to be the differentiated safety profile, but there even at your KOL [ph] events at ASCO and subsequent to that there still seems to be some underlying trepidation by some of the investment community. So I guess is there anything you can -- about the potential for emerging AE even though you are seeing any colitis and liver tox to-date. Subsequent to ASCO and EHA can you add anything further with regard to the safety profile?

Michael S. Weiss

Analyst · ROTH Capital Partners. Please proceed with your question

Thanks Joe. Yeah I don’t know that I could really add too much we haven’t been to data updates after the big events. But I think the drugs we presented at the event a pretty good overview of the toxicity profile seen to-date. We have plenty of patients on I think we generally believe that the drug, if it has any signs of liver toxicity is very low. We saw the incidents in the low single-digit percentage in that presentation. Again we’ve never said we won’t ever see colitis but again given the numbers we are seeing, that number will also be quite low relative to the other. So again I think as we add more data overtime, again we’ve never said we were going to devoid of colitis we are not devoid completely of liver tox but it’s just a totally different toxicity profile. And again some of the tox of some of these other drugs maybe again just a function of partially mechanism, partially the toxicity of backbone, possibly a combination of the two and again we believe that we are on a different platform, a different backbone provides a different toxicity profile and I guess I think we’ve presented plenty of patients to get comfort that it’s different. We think reasonably dramatically different.

Joseph Pantginis

Analyst · ROTH Capital Partners. Please proceed with your question

No, that’s very helpful, thank you. And then maybe just two other quick questions, while one housekeeping question one maybe a little philosophical, one for Sean, can you just comment on how much is left on your existing ATM and then the somewhat philosophical question is when you are looking at these triple combos obviously over the last several medical conferences there has been increasing push back with regard to the drug cost today. So if you are going to be putting together the potential for three different drugs with 1101 and 1202 as part of that do you have any comments to -- forward-looking comments with regard to potential pricing and types of pressures you might or might not experience based on having these multiple drugs as a regiment? Thanks.

Sean A. Power

Analyst · ROTH Capital Partners. Please proceed with your question

Hi, Joe this is Sean. I will start and then hand it over to Mike for the second question. So we have about $7 million remaining under the ATM as of today.

Michael S. Weiss

Analyst · ROTH Capital Partners. Please proceed with your question

So I will hit on the second point Joe, so in terms of pricing and obviously as you start to think about two and three drugs, I think everyone is acutely aware of the concern that the drug cost will get out of control if you were to pay for all two drugs, right alone three drugs it could upwards the cost of what $200,000 to $300,000. Clearly we believe and part of the reason why we are doing all of this to make sure we have as many pieces in house as possible is we believe that, that’s not practical so in fact access to the patients will be limited by cost, if you had to pay of each of these drugs individually. Our plan has been and continues to be and to be able to come up with a package pricing for the treatment option that we are providing to the patients and we believe that would be highly competitive in a way that it would be very challenging for other companies to come along and add two, three maybe even four pieces and try to compete with us on price. I think we’ll be the lowest cost provider for treatment option that includes multiple drugs.

Joseph Pantginis

Analyst · ROTH Capital Partners. Please proceed with your question

Very helpful, guys. Thanks a lot.

Michael S. Weiss

Analyst · ROTH Capital Partners. Please proceed with your question

Thank you Joe.

Operator

Operator

Thank you. [Operator Instructions]. Our next question is coming from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions.

Matthew Kaplan

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

Hello, can you hear me?

Michael S. Weiss

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

Hi Matt. I can hear you.

Matthew Kaplan

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

Great, perfect. Congrats on the progress during the quarter. Looking forward in terms of the launch of additional Phase 3 studies. Could you give us a little bit of color what you’re thinking at this point in terms of the 1303 combination studies?

Michael S. Weiss

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

So as you know we have not provided too much color other than to say that we’re excited to move 1303 forward across CLL and NHL. We’ve also guided that more likely than not, that a 1303 registration trial in CLL would be first and then we’ll work our way into Non-Hodgkin's lymphoma, both with diffuse large B-cell. So I think if all goes the way we hope the first announcement would be for a CLL trial and then we’ll start layering in additional 1303 studies and possibly we might sneak in some other studies too, just to make it clear.

Matthew Kaplan

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

Okay, sounds good and then one of the things that I’ve consistently heard, as Joe commented on is the tolerability profile, so far especially from KOL, that’s been encouraging. And with the launch of I guess additional triple combination studies where do you think you can take this in terms of the doublet and then going to additional triple combination studies based on the tolerability profile?

Michael S. Weiss

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

Yeah, so what we’ve seen to-date with 1303 it definitely gives us comfort that we can layer in most other third drugs. And when you think about the profile with ibrutinib, there’s no question that another drug can be layered on top of that. So I think what we know today comfortably is that 1303, there’s room for another drug on top of that. We know that if that drug happens to be ibrutinib or maybe another PK inhibitor that’s tolerable in a similar fashion, that easily a fourth drug can be layered on top of that, and again it will depend on what work and the third and fourth drug tolerability profile looks like, but I do feel very comfortable that. 1303 can easily get another drug on top -- almost any third drug should go on top pretty easily. And then the question is what’s the fourth drug potentially that goes on top of that and like you said if we use ibrutinib as the third drug or BTK inhibitor with a similar safety toxicity profile then of course fourth should be quite simple as well, quite achievable.

Matthew Kaplan

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

Okay, great and just to shift gears a little bit in your prepared remarks you started to talk autoimmune disease indications, potentially initiating clinical development later this year. What are you thinking initially, is it monotherapy or is that combination therapy in autoimmune diseases?

Michael S. Weiss

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

I would say we’re going to start as a single agent with 1101. I think that’s the most prudent path. But I think pretty early on we will try to explore a potential to combine the two drugs and see how that may change the activity profile. But I think the base case, the simplest base case is 1101 what’s -- we’re talking, did talk about MS, let’s talk about MS a little bit more, so 1101 in MS, you’ve got Ocre, that’s going to present some data and that comes in the next few months. Again we think that’s going to be, at least the way Roche is talking about, it could be game changing in what they believe will be the care of patients with MS. We think we can be a reasonably fast follower to them. So obviously it’s a huge market opportunity. So we think we have a very competitive simple approach to be a fast follower to Ocre up in MS. And then we’ll start to get fancier when we start to layer in 1202 and see how that works. But I think the base case is just very simply be the fast follower on to Ocre in what could be this pitch by Roche, could be a game changing way to treat these patients by a basically attacking the B-cells.

Matthew Kaplan

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

Great well look forward to more announcements from the autoimmune phase and also your presentations at ASH, so thanks. Mike.

Michael S. Weiss

Analyst · Ladenburg Thalmann. Please proceed with your question. Mr. Kaplan your line is live you may proceed with your questions

Thanks, Matt, appreciate it.

Operator

Operator

Thank you. It appears there are no additional questions at this time. So I’d like to turn the floor back over to Mr. Weiss for any additional concluding comments.

Michael S. Weiss

Analyst · ROTH Capital Partners. Please proceed with your question

Great, thank you. So to conclude let me just say that I couldn’t be more proud of progress made by the team in the first half of this year and we’re all looking forward to achieving our key objectives in the second half. Our mission remains the same as always. We want to bring highly active, well tolerated combination treatment options to patients who need them most. We feel confident from a financial perspective of a $125 million in cash on a pro forma basis we’re well positioned to achieve our goals. On behalf of all of us at TG Therapeutics I’d like to thank our investigators and our patients as well as our shareholders and investors for their continued support. Thanks again for joining us on the call today. Have a great day.

Operator

Operator

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