Earnings Labs

Xenon Pharmaceuticals Inc. (XENE)

Q3 2015 Earnings Call· Tue, Nov 10, 2015

$54.53

+0.50%

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Xenon Pharmaceuticals Inc. Q3 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, there will be a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference may be recorded. I will now turn the call over to our host for today’s conference, Mr. Ian Mortimer, Chief Financial Officer. Mr. Mortimer, please go ahead.

Ian Mortimer

Analyst

Great. Thank you. Thanks everyone for joining us today on our call and webcast to discuss our financial and operating results for the third quarter of 2015. Joining me on today’s call is Simon Pimstone, Xenon’s President and CEO. Following this introduction, Simon will provide perspective on Xenon’s progress, and I’ll review the financial results for the quarter, and after that, we’ll open up the call for your questions. Please be advised that during this call we will make a number of statements that are forward-looking, including statements about the sufficiency of our capital position to execute on our business objectives, the timing of IND or IND equivalent submissions with regulatory agencies, the initiation of future clinical trials, potential efficacy, future development plans and commercial potential of our product candidates, 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 agreements, the plans of our collaboration partners and their interactions with regulatory agencies, the results of research and development efforts, 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 I’ll now turn the call over to Simon.

Simon Pimstone

Analyst

Thank you, Ian; and good afternoon, everyone. And thanks so much for joining Xenon on our conference call and webcast today. We’re very pleased with our in this past third quarter in advancing both our proprietary programs, as well as our partnered programs. We’ve achieved important milestones that we believe underscore the therapeutic potential and the breadth of our pipeline and product opportunities, as well as the value of our Extreme Genetics platform. We believe we are well-positioned to continue to build on this momentum, with a number of important milestones throughout our pipeline anticipated over the coming quarters, and we have sufficient resources and capabilities to achieve our near-term goals. I’ll start with our two collaborations with Genentech, in both of which we have made strong progress since our last update. Our partnership with Genentech to develop early-active selective small molecule inhibitors of Nav1.7 for the treatment of pain is progressing well. The lead molecule in this collaboration is GDC-0276. And we expect enrollment to be completed by the end of this year and the expanded Phase 1 single and multi-ascending dose clinical trial in healthy volunteers. We’re also excited that Genentech recently advanced a second Nav1.7 inhibitor into clinical development. GDC-0310 is an orally active selective small molecule inhibitor of Nav1.7, and follows GDC-0276 into clinical development. Genentech has initiated a Phase 1 trial in up to 228 healthy volunteers. We are pleased to note that both GDC-0276 and GDC-0310 were included as key pipeline neuroscience assets in the product development portfolio update which Roche presented to investors on October 3. We believe that having two distinct Nav1.7 inhibitors in clinical development via our partner Genentech underscores the significant potential of this novel class of compounds as a new way to treat pain and the productivity of our…

Ian Mortimer

Analyst

Thanks, Simon. I’ll provide a high level overview of the third quarter 2015 financial statements, and then finish off with a review of upcoming milestones. For the quarter ended September 30, 2015 we reported total revenue of $4.3 million, compared to $13.2 million for the same period in 2014. Revenue in both periods was primarily derived from Xenon’s collaboration agreements with Teva and Genentech. The decrease of $8.9 million was primarily attributable to an $8 million milestone payment received in Q3 2014 from Genentech and revenue recognized related 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 September 30, 2015 were $3.8 million compared to $3.2 million for the same period in 2014. The increase of $0.6 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 September 30, 2015 were $1.3 million compared to the same amount in 2014. For Q3 2015, we recognized a recovery of $1 million due to a change in the fair value of our liability classified stock option grants to directors and certain consultants, until the options were reclassified back to equity in September 2015. This was offset by an increase in expenses incurred as a public company and acceleration of stock-based compensation expense for certain consultants. Other expense was $3 million for the three months ended September 30, 2015 as compared to…

Operator

Operator

Thank you. [Operator Instructions] Our first question comes from the line of John Newman with Canaccord. Your line is now open. Please go ahead.

John Newman

Analyst

Hi, guys. Thank you very much for taking my question. I just wondered – first one I have is when we might receive an update possibly regarding the indication for the program with Genentech. And then, the second question I have was just, what would you like to see from the Phase 1 study for XEN801 in order to move their product forward into Phase 2? Thanks.

Simon Pimstone

Analyst

John, thank you. It’s Simon. So in terms of the Phase 1 study for XEN801, we obviously like to see a tolerability that’s at least as good, if not, better than what’s currently available. And importantly we’d like to see drug exposure in the skin at drug concentrations well about the predicted IC50 and the predicted efficacy concentration. So, we don’t have a PD read-out in the Phase 1 study. We’re not specifically looking at sebaceous glands, because those studies generally require much longer duration of action. And so, primarily as we outlined, this is a safety tolerability and PK steady. And really those are the key features. So, how well the drug is tolerated, and obviously we’re looking for tolerability that is as good, if not, better than existing drugs. And we’re looking for exposure of the drug in the dermal, epidermal layer. That’s well above the predicted exposure required, the efficacy based on some of our earlier modeling that’s come from early preclinical studies. In terms of the Genentech update, the goal is, as we outlined, to complete enrollment of the Phase 1 for GDC-0276 this year. We’ll continue to make progress with 310 this year through the Phase 1. But it’s likely that that will complete into 2016. As we speak, John, that once the 0276 Phase 1 has completed in both the SAD and MAD phases. We would be in a position to provide some updates to investors in the street regarding the next steps and plans for ongoing development for the program. So we’re not in a position to do that today. As outlined Phase 1 should complete over the next few months and we should be in a position thereafter to provide a more informative update.

John Newman

Analyst

Great, thank you.

Operator

Operator

Thank you. Our next question comes from the line of Hugo Ong with Jefferies. Your line is now open. Please go ahead.

Hugo Ong

Analyst · Jefferies. Your line is now open. Please go ahead.

Hi, guys. Thanks for taking the question. Just one on the acne program, just one is the Phase 2 and maybe subsequent trials, were they all also be performed in Canada like the Phase 1 trial? And second question is on the pain program, just based on your experience with Nav1.7 inhibition, how transferable is success in one neuropathic pain condition to a different neuropathic pain condition in your opinion?

Simon Pimstone

Analyst · Jefferies. Your line is now open. Please go ahead.

Thanks very much. Hugo, that’s an excellent questions. Let me start with the first one. The Phase 2 will likely be a – clearly a multicenter study and we have goals of conducting that in Canada. Beyond the Phase 2 proof-of-concept, as we move into larger development studies which would be Phase 2b effectively, for those range of finding we would likely go beyond Canada. But the first Phase 1, 2 trial for which the protocol is approved is set to be conducted in Canada. We already are setting sites up for the Phase 2. This is a study in terms of numbers of patients that is eminently recruitable in Canada. In fact, Dermira ramdir [ph] ACC inhibitor program for acne in Canada is solely in Canada as well in the initial Phase 2. So, we’re quite confident that the study conducted in Canada will be conducted well. In terms of your next question how transferable is success in one neuropathic pain indication to another for a Nav blocker, I think it’s an outstanding question. And I think the answer at end of the day is we really just don’t know. What I can say, of course, is we do test the molecule in multiple forms of neuropathic pain, in vivo, we’ve looked at a variety of different industry recognized forms of neuropathic pain. We do see efficacy across those models. So, that is certainly our experience in preclinical in vivo models. I think if one goes broadly to pharmacological validation in humans today, not obviously without compound, but in general what we would call dirty our sodium channel blockers, I think it’s tough to say that a given drug is reproducible across all forms of neuropathic pain. We don’t know that’s specifically to be the case, Hugo. But, if we look at a molecule like carbamazepine, for example, it really would be used as a first line treatment, for example, in trigeminal neuralgia. It may not be used as a first line treatment, because of dose limiting AEs in another neuropathic indication like diabetic neuropathic pain. So, I think, it’s going to depend on the molecule. And I think we can make a blanket statement. And obviously, the work we’re doing, the work that others are doing, is this a competitive area – as you know, I think, we’ll certainly start to lucubrate which indications are best suited to this mechanism within the neuropathic timeframe work. So, normal neuropathic pain is equal, we know that. Some have mostly shifted elements. We need to obviously study this drug and others will study their drugs across different indications to identify the best indication. But coming back to our preclinical work, we are encouraged by the breadth of activity we see in our preclinical assays across a broad array of neuropathic models.

Hugo Ong

Analyst · Jefferies. Your line is now open. Please go ahead.

Great. And thanks for taking the questions.

Simon Pimstone

Analyst · Jefferies. Your line is now open. Please go ahead.

Pleasure.

Operator

Operator

Thank you. [Operator Instructions] One moment, while we wait for additional questions. I am showing no additional questions. I will now turn the call back to Ian Mortimer, Chief Financial Officer, for closing remarks.

Ian Mortimer

Analyst

Great. Thanks, operator. And thanks, everyone, for joining us on the call today. We look forward to keeping you informed of our progress throughout the remainder of this year and into 2016. Operator, we’ll now end the call.

Operator

Operator

Ladies and gentlemen, this does conclude today’s program. You may all disconnect. Everybody have a wonderful day.