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Arbutus Biopharma Corporation (ABUS)

Q4 2014 Earnings Call· Thu, Mar 12, 2015

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Transcript

Operator

Operator

Good day, ladies and gentlemen, thank you for standing by, and welcome to the Tekmira Reports Fourth Quarter and Full-year 2014 Financial Results and Provides Corporate Update 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] As a reminder, this conference call is being recorded. I would now like to turn the conference to our host, Ms. Julie Rezler, Director of Investor Relations and Corporate Communications. Ma’am you may begin.

Julie Rezler

Analyst

Thank you, operator. Good afternoon, everybody, and thank you very much for joining us as we provide our corporate update and report the 2014 financial results for Tekmira Pharmaceuticals Corporation. Talking on today’s call is Dr. Mark Murray, our CEO; and Bruce Cousins, our CFO. Mark will provide a strategic overview of Tekmira post-merger, and Bruce will review the company’s 2014 financials and future outlook. We are also joined by Pat Higgins, Tekmira’s COO, who will participate in the Q&A session following our prepared remarks. I would like to remind everyone that certain statements made on today’s call will be forward-looking and constitute forward-looking statements or forward-looking information under applicable securities laws. Forward-looking statements and information discussed in this conference call include, but are not limited to, our focus on discovering and developing a cure for HBV through a combination strategy, maximizing the value of our non-HBV assets, our competitive advantages, anticipated timing on clinical milestones for both HBV and non-HBV assets, our branding, ticker symbol and office location, planned investment conferences and road shows, the completion of post-merger integration activities and the continuation of our ongoing partnership programs. Forward-looking statements and information are current predictions only, which are based on certain assumptions, which include, but are not limited to, the effectiveness of our products, the ease of integrating the merger and the stability of economic and market conditions. While we consider these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive market, and social uncertainties and contingencies. Forward-looking statements and information involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results expressed or implied by such forward-looking statements. A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s 10-K for the year-ended December 31, 2014, which will be filed on EDGAR and SEDAR shortly, and will be available online under the Investors section of our website. We do not expect to update forward-looking statements continually as conditions change. This conference call is being webcast live and the archive will be available on our website at tekmira.com following today’s call. Please note that we do report in U.S. dollars and we are in compliance with U.S. GAAP. At the end of the prepared comments, we will open the call for your questions. So now, over to you, Mark.

Mark Murray

Analyst

Thanks, Julie. Good afternoon and thank you all for joining us on the call and webcast today. I’d like to focus my remarks today on Tekmira post-merger with OnCore Biopharma and the extraordinary opportunities we believe our new company has, as we aim to cure the millions of patients worldwide with chronic hepatitis B infection. I’ll provide a brief overview of our drug combination HBV strategy, as well as our valuable non-HBV assets and preview the milestones we expect to achieve in the near future as we complete the merger integration and move our pipeline forward. By all measures, 2014 was a transformational year for Tekmira. We believe that 2015 has the potential to be another year of significant progress and accomplishment. Tekmira today is an industry-leading therapeutic solutions company, focused on developing a cure for chronic HBV, by advancing a deep and broad portfolio of clinical and pre-clinical assets toward a combination therapy. Through the merger we have transformed Tekmira from a technology-based development company into a therapeutic solutions company. We plan to mobilize what we believe is an unprecedented portfolio of high-value HBV assets, plus the highly successful former Pharmasset scientific discovery and development expertise to focus on discovering and developing a cure for HBV. We also intend to explore ways to maximize the value of our non-HBV oncology, antiviral and metabolic disease assets, as well as our partnered programs. The foundation of these valuable assets is the leading position we have built in RNAi technology with our proprietary Lipid Nanoparticle or LNP technology. In our press release issued today, we highlighted some of those assets, such as clinical candidates TKM-PLK1 and TKM-Ebola-Guinea, both of which have shown early promise and will yield clinical data later this year. We’ve also highlighted several pre-clinical candidates we believe can become…

Bruce Cousins

Analyst

Thanks Mark. I’ll begin with a recap of recent merger-related activities. Along with Mark, I want to express our appreciation to our investors for your strong support for the merger and helping us to forge an exciting new Tekmira. As we announced last week, the transaction was approved by 99.5% of votes cast by Tekmira’s shareholders, voting at a special meeting held on Tuesday, March 3, and representing 51.2% of shareholders of the company. The transaction has also received all necessary regulatory approvals in the U.S. and Canada. The total shares outstanding on closing of the transaction are 46.6 million shares with fully diluted shares of 49.7 million. The merged companies will continue under the Tekmira brand and will continue to trade under the ticker symbol of TKMR. We are currently undertaking creation of a new corporate identity that we believe will symbolize the promise of our new company, and it will likely result in the change in our ticker system. We hope to have that project completed before the end of the second quarter. Tekmira will continue to be headquartered in Vancouver, Canada, with offices in Doylestown, Pennsylvania. And as Mark has noted, we are well advanced in combining operations, and are confident that full integration will be completed in the upcoming months. Given the extensive asset trove we have in our entire portfolio, including our HBV pipeline, which Mark has summarized, as well as our non-HBV and partnered pipelines as part of the integration process, we are now focusing on program prioritization and resource allocation decisions. In a few minutes, I will summarize Tekmira’s financial performance for 2014, which reflects our business pre-merger. By next quarterly financial report, we’ll reflect our combined company’s investment and allocation strategies and the combination of solutions-based business model that will define Tekmira…

Mark Murray

Analyst

Thanks, Bruce. Everyone on the Tekmira management team is excited by the opportunities that lie ahead. We have the potential to lead the industry in a solutions-based way to develop a complete care for HBV. And that promise motivates us every day. We look forward to keeping you appraised of our progress and to see you at upcoming industry events. Now, we would like to ask the operator to open the call for questions. Operator?

Operator

Operator

Thank you. [Operator Instructions] And our first question comes from Michael Yee of RBC Capital Markets. Please go ahead.

Judy Liu

Analyst

Hi, good afternoon. This is Judy Liu on for Michael Yee. Thanks so much for taking the questions. I’ve got two questions today. First one is on your Ebola program, the study that you just initiated in West Africa. Could you tell us a little bit more about that such as how many patients, what endpoint you’re looking at and what is current percentage survival success for you? So if you could clarify that first, please.

Mark Murray

Analyst

Sure. I’ll do this at a fairly high level. So yes, so the study is underway. We are treating patients who are admitted to treatment centers with the confirmed Ebola viral infection. The endpoint is mortality. They have collective data in the field about the mortality rate that could be achieved with standard of care and we’re looking to improve upon that. So the trial is designed to sort of measure efficacy or lack thereof on a rolling basis. So it will probably require something like 20 or 30 patients, depending upon the results as they unfold.

Judy Liu

Analyst

Okay, great. Thank you so much. And so second question is on your Phase 1 HBV program. So if you could give us a little bit more clarity on, for example, how many doses, what the starting doses you’ll be using and at what point would this trigger some kind of data release like X number of cohorts on roles or what [indiscernible] for the summer this year? Thank you.

Mark Murray

Analyst

Sure. And I’ll give you a high level. I think you can get more detail on clinicaltrials.gov if you’d like. So just remember it’s a healthy volunteer study. It’s a single ascending dose trial. It’s designed to go through approximately five dose cohorts. And you will recall that we are actually running two LNP formulations in parallel comparing their tolerability one to another. We expect to complete the study in the first half of the year, and then we would disclose results and talk about the selection of the go-forward LNP sometime after mid-year when the trial is completed. So did I answer that question?

Judy Liu

Analyst

Yes, thank you.

Mark Murray

Analyst

Okay.

Operator

Operator

Our next question comes from Michael Schmidt of Leerink. Please go ahead.

Michael Schmidt

Analyst

Hi, good afternoon, and thanks for taking my questions. I had one follow-up on the Hepatitis B program. Could you talk about potential plans for some pre-clinical data releases on some of the OnCore assets potentially going forward? Is there anything that you might have for investors for the 030 data likely in ’16, I would assume?

Mark Murray

Analyst

So Michael, good afternoon. We’re of course interested in doing such things. I can't give you a specific target date when we might have that kind of a result. But clearly something we think is interesting, it of course will depend a lot on what activities you’re trying to measure and what combination and is there an appropriate animal model for such thing.

Michael Schmidt

Analyst

So I guess we should stay tuned on that front?

Mark Murray

Analyst

Yes. I think - stay tuned. We’re very interested in it and we know you are as well.

Michael Schmidt

Analyst

Sounds good. And then I guess on your R&D data, you spoke about plans for RNAi drug targeting Delta virus. I was wondering that is still a part of your plan going forward to address that co-infection?

Mark Murray

Analyst

Yes, it is of high interest to us, and there is a couple of strategies. One of course is you know that Delta virus requires B virus surface antigen to package it. So one strategy is just to explore the ability of the current product that we have in the clinic to impact Delta virus co-infection. The other is to develop specific agents targeting the Delta virus sequence. We’re interested in both of those. The limitation with respect to the second is that there is not a lot of Delta virus genomic information available, but we’re continuing to look at it.

Michael Schmidt

Analyst

Great. Sounds good. And then a financial question. I was wondering if you could comment on cash, cash burn post-merger especially with respect to 2015 operating expenses. To what degree should we expect those to increase over 2014?

Bruce Cousins

Analyst

So on closing of the transaction, Michael, we’re in the $100 million range of cash on hand for the combined entity. We’ve not offered any specific guidance on cash burn as of yet. We will have more to say about that at our next call. However, I would expect our burn to be in the $60 million to $80 million range, and we’re working through that asset, that prioritization model as we speak. So, more to say on this at the next call.

Michael Schmidt

Analyst

Sounds good. Great. Thank you so much.

Bruce Cousins

Analyst

Okay.

Operator

Operator

Our next question comes from David Novak of Clarus Securities. Please go ahead.

David Novak

Analyst

Hi guys. Congrats on the exciting developments and thanks for taking the call. There seem to have been a bit of confusion with respect to the future direction of the company with recent statement solely focused on the HBV. So it’s nice to hear you speak on the value of other RNA assets. So with that, just curious if there is any further development with respect to innovating on the rooted delivery with respect to sRNAs? Is this something that the company will continue to look into, for example, assuming TKM-HBV demonstrates some sort of efficacy in the clinic, or with the transition away from IV come more in the form of the OnCore assets, particularly the antigen assets for S-antigen suppression?

Mark Murray

Analyst

Well, I think - so David, you know that our long-term aspiration will of course is to get to an all oral combination therapy. So that’s our ultimate target. Along the way of course we may be using other types of agents that go by IV administration in the meantime as you know. So we continue to be interested in evolving the delivery methodology I would say, and in investing in that technology development.

Bruce Cousins

Analyst

And I would just offer an addition from a funding perspective. We do have a number of collaborations already underway, important source of funding for us and it’s certainly assist us greatly on the technology development front. So we will leverage that fully.

David Novak

Analyst

Okay, perfect. Thanks guys. Just building on RBC’s question as well with respect to TKM-Ebola. I’m trying to get a feel for what the parameters will need to be in order to demonstrate statistical significance in the trial? So I was hoping you could provide a bit of clarity, specifically to how you will benchmark historical survival rates because it’s my understanding that they seem to be slightly fluid at the moment, meaning as time goes on best support of care has been relatively affected that decrease in mortality. So how do you account for this variability when looking at TKM-Ebola efficacy?

Mark Murray

Analyst

Well, David, it’s a challenge. And you’ve identified a challenge. What you really have to do is you have to focus on recent standard of care data in the site in which you are operating. So it’s as close as you can get to a good comparison.

David Novak

Analyst

Perfect. And is there sort of a soft benchmark at which point you decide to transition the current trial into a “Phase 3” trial?

Mark Murray

Analyst

No, I don’t think there is a design like that. The design will yield the result that says the drug is effective or the drug is not effective using the measurements in the statistical parameters that are in the trial design. So there is no plan to do a subsequent Phase 3 like trial in this setting.

David Novak

Analyst

Got you. Perfect. And finally, this doesn’t really move the needle one way or another, but $5 million coming in from the Alnylam arbitration in Q2 of 2015. Just wondering if you can provide any clarity on how that’s progressing? I mean, like I said it doesn’t really move the needle, just curious.

Mark Murray

Analyst

So there is a hearing for the arbitration which will occur in May. And so we really won't know anything until that hearing has been completed.

David Novak

Analyst

Great. That’s it for me, and congratulations once again guys.

Mark Murray

Analyst

Thank you, David.

Bruce Cousins

Analyst

David, good to hear from you.

Operator

Operator

[Operator Instructions] And our next question comes from Stephen Willey of Stifel. Please go ahead.

Stephen Willey

Analyst

Yes, thanks for taking the questions.

Mark Murray

Analyst

Hi, Steve.

Stephen Willey

Analyst

Hi, how is it going? I know that you’re still kind of going through the program and proletarianization [ph] here post-merger and you’ve made comments with respect to kind of the maximizing value around the non-HBV assets. But I’m just kind of wondering without necessarily asking for what the strategic objectives are, but just trying to get a sense as to kind of what you think your flexibility is on the strategic front and I guess how many - what kind of optionality you do have there in a potential monetization of some of these non-HBV assets? And I guess I have to question on the context of some of the recent BD deals in this space were kind of RNAi related targets and IP have been had for relatively low prices.

Mark Murray

Analyst

So Steve, I would say basically all options are on the table, and I just - I would hate to give you a direction one way or another and then be wrong. But we - there is a number of possible ways forward and our focus is really maximizing the value and then at the same time preserving our focus on HBV.

Stephen Willey

Analyst

Okay. So I guess, it does sound like you feel like a few options?

Mark Murray

Analyst

Yes, I think so.

Stephen Willey

Analyst

And I think there was also some pre-clinical work that was supposed to be ongoing this year. I think it was in relation to evaluating the Cytos compound combination I think with TKM-HBV. I’m just wondering if that’s initiated and if you were to be expecting that to complete by year-end?

Mark Murray

Analyst

Yes. So we are expecting to do some pre-clinical work on the Cytos compound, and most likely that will sort of get initiated mid-year and we expect to be able to complete it towards the end of the year.

Stephen Willey

Analyst

Okay. That’s it. Good luck with all the integration.

Mark Murray

Analyst

Thanks Steve.

Bruce Cousins

Analyst

Thanks Steve.

Operator

Operator

And I am showing no further questions at this time. I’ll now like to turn it back to management for closing remarks.

Mark Murray

Analyst

Thank you all for joining us today and we are available if you have further questions.