Earnings Labs

XBiotech Inc. (XBIT)

Q4 2016 Earnings Call· Thu, Mar 16, 2017

$2.58

+0.20%

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the XBiotech Inc. Q4 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to turn the call over to Meg Lewis, executive assistant. Please go ahead.

Meg Lewis

Analyst

Thank you, operator. Before turning the call over to our CEO, John Simard, I would like to make the following remarks. During this call, forward-looking statements including declarations regarding management’s beliefs and expectations will be made. In some cases you can identify forward-looking statements by terminologies such as may, will, should, would, could, expects, plans, contemplates, anticipates, believes, estimates, predicts, projects, intends, or continue or the negative of such terms or other comparable terminology although not all forward-looking statements contain these identifying words.

John Simard

Analyst

Thanks Meg. Thank you all for joining us for our Q4 2016 update. After the update we will provide an opportunity for Q&A from the audience. I will first say a few words on our oncology programs. We were pleased to have our [pivotal] Phase III data from our European study, recently published in The Lancet Oncology. The Lancet Oncology is one of the world’s most prestigious oncology journals, and the publication [Indiscernible] your attention to our remarkable findings for our antibody to treat colorectal cancer. There are really so many important issues raised and addressed in this study. There isn’t time here to discuss them adequately. But in brief the published findings show that we have developed a new way to measure activity for cancer drugs in advanced cancer, and that the product of the natural human immune response our therapeutic antibody can be used in a way to fight cancer. These findings are the tip of the iceberg for a new approach to treat and evaluate cancer therapies. The data featured in the publication is the basis for the company’s marketing authorization application in Europe. We reported in December of last year that we had received our Day 180 List of Outstanding Issues from the EMA’s committee for Medicinal Products for Human Use. On the [quality] side, objections pertain primarily to benefit dose justification of the therapy and its pharmacokinetics. Pharmacokinetics are really a measure of the half life of the molecule in the blood. They wanted further clarification of these measures that we had provided. The quality objections related to qualification of the [line] that we used to produce the antibody and [Indiscernible] systems used to demonstrate robustness in the purification process as well as the clarification of critical process controls. There were no remaining objections for…

Operator

Operator

Thank you. [Operator Instruction] Our first question comes from Kumar Raja with Noble Capital Markets. Your line is now open.

Kumar Raja

Analyst

Thank you for taking my questions. Congratulations for all the progress. For the phase 3 trials you recently released the data from the 50% event. What is the expectation when you will have 75% event and what is the expectation from that analysis [indiscernible] I think that you will be able to stop the trail at that point or will you need to go forward and have the overall survival data? And how can this data be used for the approval process in Europe and in terms of hydra data it is supportive, it looks like it support 300,000 patient market in U.S., how big of a market opportunities subset there you are looking at basically the patient who are not eligible for that [indiscernible]? Thank you.

John Simard

Analyst

Kumar thanks for going into the question. I appreciate that. I will get Mike Stecher, our Medical Director here to respond first and --

Mike Stecher

Analyst

First, on your question regarding the PT23 trial, the FDA trial so we achieved the milestone of 50% of events in January or actually in December, so the 75% of event milestone we have achieved now is we will have the interim analysis in June. It's not possible for us to say right now whether or not we will be further after that so we have the independent data monitoring committee but we are hopeful that we could achieve efficacy at that end point if we at that time. If we don't then the final 100% events will be probably for the end of the year. So it's at this point we are hopeful we can hit efficacy at the next end point or over the next time point but we may have to go end of the year to get to the final analysis. Regarding how this data can be used for the EMA submission, so the EMA submission is next week and there are way of course that we had our first interim analysis. But if we have to get to second interim evaluate efficacy again then the process the marketing authorization process decision will be rendered prior to that next analysis. So it's not going to factor in I would say into this decision. Regarding [indiscernible] you mentioned the incidents in United States so at this point we are still making decisions on how we would move forward. [indiscernible] designation however we can also apply for [indiscernible] designation without having to go head to head against -- because we are different molecule with the different target. So we could choose to go against them before them, after them, so those kind of decisions in terms of what the market size would be have not been made yet but that's something that we will be discussing over the next few months.

John Simard

Analyst

I would add to the question about the importance of the U.S. study findings. I think arguably the results that we already have from this first interim analysis I think could be viewed positively from the perspective of European application because what the go forward result means is that we in fact did have survival effect we just wouldn't have met the stringent requirements for statistical evidence of that that interim but if there was those survival benefits the study would have been stopped for futility. So I think the fact that we travel through that end point successfully means that we have got some positive signals there in support of the European application.

Kumar Raja

Analyst

Thank you for taking my questions.

Operator

Operator

Our next question comes from Monish Bahl with MHB Capital. Your line is now open.

Monish Bahl

Analyst · MHB Capital. Your line is now open.

Thank you. Good morning. John, you said a lot going on so I may have missed did you cover staff inspection program where -- I may have missed that talking.

John Simard

Analyst · MHB Capital. Your line is now open.

Yes. We did Monish. Thanks for calling in. Yes we have all that data together and database is lot, it's as I mentioned we got a lot going on like you pointed out and we are giving some priority right now and we will get to that analysis shortly. It's a lot of – it's a complex population, its data that has to be looked at carefully and we need little time to sort of queue and get it out so we are on that very soon.

Monish Bahl

Analyst · MHB Capital. Your line is now open.

[indiscernible] that event from reporting perspective?

John Simard

Analyst · MHB Capital. Your line is now open.

Well, we plan to focus on these stuff data after we had this package after the EMA which is next week. So we are hoping to have the analysis done by the end of the month and reported sooner after.

Monish Bahl

Analyst · MHB Capital. Your line is now open.

Okay. Got it. Sounds good and then with regard to collaboration partnerships of the company given the burn, the company there is lot going on are you looking to potentially partner some of your programs late stage development I am just wondering about it?

John Simard

Analyst · MHB Capital. Your line is now open.

Yes, I mean, [indiscernible] partnering.

Monish Bahl

Analyst · MHB Capital. Your line is now open.

Is there any partnering -- that makes more sense?

John Simard

Analyst · MHB Capital. Your line is now open.

No. There is so many different ways to potentially do things. It's conceivable for any given – when you look at indication wise, so there is particular program that is more sensible than another. It's just driven by the opportunity is.

Monish Bahl

Analyst · MHB Capital. Your line is now open.

Okay. Got it. Okay thanks a lot. Appreciate it. Take care.

John Simard

Analyst · MHB Capital. Your line is now open.

My pleasure. Thank you for calling again.

Operator

Operator

Thank you and I am showing no further questions. Ladies and gentlemen thank you for participating in today's conference. You may all disconnect. Everyone have a great day.