Earnings Labs

Xenon Pharmaceuticals Inc. (XENE)

Q1 2016 Earnings Call· Wed, May 11, 2016

$55.63

+2.02%

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Transcript

Operator

Operator

Welcome to the Xenon Pharmaceuticals Incorporated First Quarter 2016 Earnings Conference Call. [Operator Instructions]. I would now like to introduce your host for today's conference, Ms. Jodi Regts. Ma'am you may begin.

Jodi Regts

Analyst

Thanks, Antwain. Good afternoon. Thank you for joining us on our call and webcast to discuss our financial and operating results for first quarter of 2016. Joining me on today's call is Dr. Simon Pimstone, Xenon's President and Chief Executive Officer; and Ian Mortimer, Xenon's Chief Financial Officer and Chief Operating Officer. Following this introduction, Simon will provide perspective on Xenon's progress, and then Ian will review our financial results for the quarter ended March 31, 2016. After that we will open up the call to 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 and our ability to operate in a capital efficient manner, 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 achievement of certain 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. Today's press release summarizing our first quarter 2016 results and the accompanying quarterly report on Form 10-K will be made available under the Investor Section of our website at www.xenon-pharma.com. Now, I'd like to turn the call over to Simon.

Simon Pimstone

Analyst · Canaccord. Your line is open

Thanks very much Jodi and good afternoon everyone and thank you all for joining Xenon on our conference call and webcast today. I am extremely excited about where we’re at Xenon and what lies ahead. We continue to make very solid progress in this first quarter of the year by advancing our research and development pipeline, supporting our partnerships as well as our proprietary programs and continuing to operate in a capital efficient manner in order to achieve our new term goals and numerous key catalysts. We’re especially pleased to have further expanded our senior leadership team. In February, Dr. James Empfield joined Xenon as Senior Vice President of Drug Discovery and in April Dr. Raymond Winquist as our Head of Translation Research. We believe that these very highly respected researchers and our entire team of R&D professionals emblematic not only of the rigor of our science and the quality of our unique genetic space platform but also the therapeutic promise of our pipeline of differentiated product candidate based on targets with very high relevance to human diseases. We believe that the next 12 to 18 months will be a very exciting period for Xenon as our pipeline advances and expands and as we continue to make progress in developing novel medicines that can potentially address many serious diseases. Our business model of leveraging partnerships to participate in larger market indications such as pain, combined with our focus on rare or orphan neurological indications in our proprietary programs such as severe childhood epilepsy disorders enables us to pursue multiple and diverse therapeutic and commercial opportunities. To review our accomplishments in the first quarter I will start with our proprietary pipeline. Our lead proprietary development program in XEN801 is a promising potential treatment for patients with moderate to severe acne. In…

Ian Mortimer

Analyst · Canaccord. Your line is open

Thank you, Simon and good afternoon everyone. For the quarter-ended March 31, 2016 we reported total revenue of $0.6 million compared to $4 million for the same period in 2015. Revenue in both periods was primarily derived from Xenon's collaboration agreements with Teva and with Genentech. We have received royalties from sales of Glybera under our license to Unicare. However we do not expect this royalty revenue to be significant in the near term, the decrease of $3.4 million was primarily attributable to revenue recognized relating to the upfront payment from the collaborative development in license agreement with Teva which was fully recognized by December 2015. The remaining decrease was due to less full time equivalent funding from Genentech and Teva as we've shifted resources away from our partner programs and to our proprietary programs including XEN801 and our Nav1.6 inhibitor program. Research and development expenses for the quarter ended March 31, 2016 were 4.4 million compared to 3.4 million in the same period last year. The increase was primarily attributable to an increase in spending on our XEN801 program which entered Phase 2 clinical development in February of this year and our Nav1.6 sodium channel inhibitor program. This is partially offset by decreases in Teva and Genentech collaboration expenses. General and administrative expenses for the quarter ended March 31, 2016 were $1.9 million this compared to $6.7 million in 2015. In the quarter ended March 31, 2015 we had a $4.9 million expense which was recognized due to the noncash fair value adjustment upon reclassification of certain stock option awards that were granted to directors and certain consultants to do liability classification. These options were then subsequently reclassified back to equity in September 2015. Other income for the quarter ended March 31, 2016 was $2.4 million and this compared to other expenses of $3 million for the same period last year. The change of $5.4 million was primarily attributable to unrealized foreign exchange gains arising from the translation of Canadian denominated balances to U.S. dollars as compared to unrealized foreign exchange losses for the same period in 2015. We ended March 31, 2016 with $56.1 million in cash and cash equivalents which we believe puts us in a strong financial position to execute on our near term business objectives. And as Simon mentioned we anticipate multiple milestone opportunities from our internal pipeline and from that of our partners over the coming quarters. We continue to manage our financial resources efficiently to support the advancement of our proprietary product pipeline and the successful execution of our corporate goal. So now with our prepared remarks concluded, operator we will open the call up for question. Thank you.

Operator

Operator

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

John Newman

Analyst · Canaccord. Your line is open

I just wondered if you know if you can give us a little bit more detail on what the indication is for the Genentech collaboration and I'm also curious as to whether you might be presenting the Phase 1 data for the acne product, anytime this year. Thanks.

Simon Pimstone

Analyst · Canaccord. Your line is open

John, in terms of the Genentech indication no we don’t have that as of yet, Genentech obviously in the [Technical Difficulty] Phase 2 program, Phase 1 studies are complete, they have selected molecules moving forward. I think they will be in a better position to indicate will they be taking this product. So I don’t expect to have data on the indications in the next couple of months but certainly in the latter part of the year as we advance towards the Phase 2 goal, I'm hopeful that we will be able to disclose more about this. They will certainly in their quarterly updates would typically indicate this study indication and details around the study but we’re certainly are hopeful that we will have some of that information just prior to that disclose. We do think John it would be a substantial Phase 2 but more than that we can't discuss at the moment. In terms of the Phase 1 data for the acne trial, the plan actually is not to disclose that data until we have the Phase 2 read out. We would like -- we will probably have some limits at disclosure later this year but certainly we don’t expect the full Phase 1 presentation this year but I think we can expect over the course of the next six months or so we will look to present some limited data around the selection of the dose from the Phase 1 study so I think it won't be a full-blown Phase 1 report, I think that would be something we will wait to determine off the Phase 2 as read but you will get to see in the coming months a limited data that I think will certainly support the selection of the current dose for the Phase 2 trial.

Ian Mortimer

Analyst · Canaccord. Your line is open

And maybe just to add to Simon's comment, John, this was designed of a Phase 1/2 protocol, so the Phase 1 was in a separate study from Phase 2, it was a protocol where we move from Phase 1 to Phase 2. So to present the data we like the complete study to be finished and obviously that data based locked before we would present it in a scientific form.

Operator

Operator

The next question comes from Hugo Ong from Jefferies. Your line is open.

Hugo Ong

Analyst · Jefferies. Your line is open

Just maybe on the XEN801 program, if you could share your thoughts on the placebo response that you see in acne trials and what you guys have done to mitigate that as much as possible? Thanks.

Simon Pimstone

Analyst · Jefferies. Your line is open

Hugo, yes so the placebo response is obviously real, it's there, if I'm not mistaken the recent [indiscernible] Phase 2b study they announced just today saw a 40% placebo response. I haven't seen all of that data but I think that confirms what numbers are generally cited in this indication. Hugo we have done very extensive modeling around a placebo response in that range in order to come up with our Phase 2 trial design. We actually have selected and hope to randomize 150 subjects to enter into the Phase to 12 week dosing regimen as you know. We have modeled based on a high placebo response rate in the range of that was absorbed in the [indiscernible] Phase 2b trial. So we recognize that placebo response rates can be high and certainly need to take that into account in our statistical modeling which we did. Just as a matter of interest the Phase 2a trial that [indiscernible] had originally conducted was in a 105 subjects randomized. We elected to randomize upto a 150 in the study. So we feel very confident that we take into account the potential placebo response rate which we know is often quite significant in these types of studies. The good thing about starting a company around pain trial Hugo is that you learn those lessons quite quickly as you know and placebo response rates are front and center of our mind.

Operator

Operator

I'm showing no further questions at this time. I would now like to turn the call back over to Mr. Jodi Regts for closing remarks.

Jodi Regts

Analyst

Thanks everyone for joining us today. We look forward to keeping you informed on our progress throughout the year. Operator we will now end the call. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may all disconnect. Everyone have a great day.