Earnings Labs

Xenon Pharmaceuticals Inc. (XENE)

Q2 2015 Earnings Call· Mon, Aug 10, 2015

$54.53

+0.50%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-4.78%

1 Week

+14.35%

1 Month

-6.44%

vs S&P

+0.55%

Transcript

Operator

Operator

Good day ladies and gentlemen, and welcome to the Xenon Pharmaceuticals Inc. Second Quarter 2015 Earnings Conference Call. At this time all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Mr. Ian Mortimer, Chief Financial Officer and Chief Operating Officer. Sir, please begin.

Ian Mortimer

Analyst

Thanks operator, and thanks everyone for joining us on our call and webcast today to discuss our financial and operating results for the second quarter of 2015. Joining me on today's call is Simon Pimstone, Xenon's President and CEO. Following the introduction Simon will provide perspective on Xenon's progress and then I'll review the financial results for the quarter, after that we'll open up the call for your questions. Please be advised that during this call we'll make a number of statements that are forward-looking, including statements about discrepancy of our capital position executed on our business objectives, the timing of IND or IND equivalent submissions with regulatory agencies, the initiation of future clinical trials, the timing of and results from ongoing clinical trials and preclinical development activities, the commercial launch of Glybera in the European Union, our chief administered milestones under our collaboration agreement, the plans of our collaboration partners and their interactions with regulatory agencies and the status and timing of additional product candidates and related development activities. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control including the risks and uncertainties described from time-to-time in our SEC filings. Our results may differ materially from those projected on today's call, we undertake no obligation to publicly update any forward-looking statements. So now I'll turn the call over to Simon.

Simon Pimstone

Analyst

Thank you, Ian and good afternoon everyone, and thanks for joining Xenon on our conference call and webcast today to go through our progress in Q2. I'd like to focus my comments on looking forward to our key potential milestones as we continue to advance our partnered and proprietary pipeline programs, and also leverage the potential of our extreme genetics platform and expertise in ion channel drug discovery. We anticipate continued progress across our product candidate pipeline and believe that it's diversity and therapeutic indications, diversity and drug targets as well as in stage of development is the major strength that helps us to continue to balance the risks and the opportunities inherent in the drug discovery and development process. Since announcing the results of the Phase 2b trial of TV-45070 in patients with single knee osteoarthritis in the beginning of July and the decision we made with our partner Teva, not to continue to pursue this indication further, we have continued to focus on advancing our overall portfolio and general corporate strategy with the exception of removing OA as a target indication for TV-45070 there will be no changes in our companies fundamental areas of focus and we look forward to continued advancement of our product candidate pipeline. Our interest in the Nav1.7 target remain strong and is at the core of our collaborations with both Teva and Genentech, Nav1.7 appears to play a critical role in pain signaling and our focus with Teva remains in developing TV-45070, the targets both Nav1.7 and other sodium channels to treat conditions of chronic pain. As we discussed several weeks ago, our analysis of the results of the Phase 2b trial with TV-45070 conducted in patients with Co-A suggested that the Teva that the lack of observed efficacy in that trial maybe…

Ian Mortimer

Analyst

Thanks, Simon. I'll provide a high level of review of the second quarter 2015 financial statements and finish off with a review of the upcoming milestones. For the quarter ended June 30, 2015, we reported total revenue of $4 million compared to $5.3 million for the same period in 2014. Revenue in both periods was primarily derived from Xenon's collaboration agreement with Teva and Genentech. The decrease of $1.3 million was primarily attributable to revenue recognized in the second quarter of 2014 relating to the upfront payment from our December 2011 Genentech agreement. No such amounts were recognized in the current quarter as the upfront payment was fully recognized by December 2014. The remaining decrease was due to less FTE funding from both Genentech and Teva, and a change in foreign exchange rate between the U.S. and Canadian dollar. Research and development expenses for the quarter ended June 30, 2015 were $3.7 million compared to $2.6 million for the same period in 2014. The increase of $1.1 million was primarily attributable to an increase in spending on our XEN801 and Nav1.6 sodium channel inhibitor programs, partially offset by decreases in Teva and Genentech collaboration expenses. General and administrative expenses for the quarter ended June 30, 2015, were $2.1 million compared to $1.2 million in the same period in 2014. The increase was primarily attributable to additional expenses incurred as the public company. On the financial statements you will also that we've now broken out general and administrative stock-based compensation expense with our functional currency changed to U.S. dollars on January 1 of this year, certain options granted to Directors and certain consultants are subject to liability accounting with fair value calculated using the Black-Scholes option-pricing model. So prior to January 1, these options were subject to equity accounting. Because of…

Operator

Operator

[Operator Instructions]. Our first question comes from the line of John Newman from Canaccord Genuity. Your line is open.

John Newman

Analyst

Just wondered if you could talk about what you’re looking to see in the current work that you’re doing on the acne asset in order to be confident in moving that forward?

Simon Pimstone

Analyst

I mean obviously the program one we speak a lot more about as the CTAs filed and we expect to be improved and we move into the clinic, I think what's the critical first phase of Phase 1 is obviously to the general tolerability of this topical application. This is a gel based formulation for the drug product. It appears to have appeared performed well in our GOP [ph] toxicology program and so we certainly are hopeful that we will see a good tolerability in setting [ph]. Secondly I think what is also going to be important is to get a sense of the pharmacokinetics of the drug itself John and looking particularly at how much drug gets into the skin which we will be able to through biopsies and obviously what the associated plasma concentration is, that would be the Phase 1 part of the program which we will be focusing on starting this quarter. As we have guided and we continue to be on track for is that goes well and we showed the tolerability and we show appropriately decay, we expect to initiate our Phase 2 programs at the end of the year, this will be a 12 week dosing period, placebo controls and we will be looking at the study in about a 125 to 150 patients with moderate to severe acne and what will be the looking for is the change in the lesion count at the end of the 12 weeks in dosing compared to base line and the difference between response between and active and placebo treated patients. So fairly standard, in fact very standard proof of concept study, well powered study for preliminary Phase 2 and I think we have built into this study, kinds of assumptions that this study should be able to give us an answer whether this drug is working or not John.

John Newman

Analyst

And then one additional question, during the call touched it but you discussed this, I think you mentioned in the printed press release that you filing an IND for Genentech asset if I'm not mistaken and I just wondered if you could give us any sense as to if and when you maybe able to disclose more information about that indication?

Simon Pimstone

Analyst

So I think what we said and our guidance continues to be and we expect to complete enrollments in the Phase 1 towards the end of this year, we will be providing updated guidance later in the John, we’re obviously in discussions with Genentech on next phases that we have not disclosed anything and we’re under confidentiality obligations based on our agreement with them to keep confidential at the moment, the plans we don’t have final plans at this point and so there is really no disclosure for us to make. We should be ironing out the next phase plans with Genentech over the next few months and so our guidance's remained that we will be updating the market in the later part of the year on the plans. What you may have referred to is the second collaboration we have is a genetics collaboration with Genentech. We’re guiding hopeful that we will be identifying another pain target as you may recall, we were studying families that don’t feel pain, well families with excessive forms of spontaneous pain who try and identify new pain targets for drug discovery. Obviously Nav1.7 is a very important one, there maybe others that we can identify in humans that when altered either by a loss or regain of function can really alter human pain perception, we've got some really interesting families that we're studying to hope to identify a novel target or novel targets than and we expect to be able to do this year and that was probably the reference that you were referring to.

Operator

Operator

Thank you. [Operator Instructions] At this time I'm showing no further questions in the queue. I would like to turn the call back over to Mr. Ian Mortimer for further remarks.

Ian Mortimer

Analyst

Great, thanks operator and thanks everyone for joining us on the call today. And, we look forward to keeping you informed of our progress throughout the year. We'll now end the call. Thank you, operator.

Operator

Operator

Thank you. Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect.