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Arbutus Biopharma Corporation (ABUS)

Q2 2013 Earnings Call· Mon, Aug 12, 2013

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Transcript

Operator

Operator

Good day ladies and gentlemen and welcome to the Tekmira Corporate Update and Second Quarter 2013 Results 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 be given at that time. (Operator Instructions) As a reminder, today’s conference is being recorded. I would now like to turn the call over to Jodi Regts. Please go ahead, ma’am.

Jodi Regts

Management

Thank you, Jamie. Good afternoon, and thank you for joining us today on this conference call and webcast to provide a corporate update for Tekmira Pharmaceuticals Corporation and report its results for the second quarter ended June 30, 2013. Joining me on the call is Dr. Mark Murray, Tekmira’s President and CEO along with Ian Mortimer Executive Vice President and Chief Financial Officer. I would like to remind everyone that certain statements made on today's call will be forward-looking and 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. We do not expect to update forward-looking statements continually as conditions change. A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s Form 20-F for the year-ended December 31, 2012 which was filed on EDGAR and SEDAR and is available online under the Investors section of our website. This conference call is being webcast live and the archive will be available on our website at www.tekmirapharm.com following our call today. Just to provide a brief overview of the format for today's call, Mark will provide a corporate update and Ian will then outline the key financial highlights. And Mark will then provide some closing remarks before we open up the call for your questions. So, now over to Mark.

Mark Murray

Management

Good afternoon, everyone, and thank you for joining us today. Let me start by saying that I’m enthusiastic about the development plans that we outlined for TKM-PLK1 today. We anticipate conducting two separate Phase I/II clinical trials targeting patient groups in need of new therapies. As most of you know TKM-PLK1, is our lead oncology product that targets polo-like kinase 1 or PLK1, a protein involved in tumor cell proliferation and a validated oncology target. Just briefly, we know that inhibition of PLK1 expression prevents the tumor cell from completing cell division resulting in self-cycle arrest and death of the cancer cell. PLK1 has been a drug target of interest for years and evidence that patients with elevated levels of PLK1 in their tumors exhibit poor prognosis and survival rates as documented in the medical literature. We believe that by using an RNAi approach and exploiting its naturally occurring mechanism of action that Tekmira can overcome the limitations of other approaches and effectively silence PLK1 and bring new therapies to patients in need. By way of background, in April, we released results from the Phase I portion of our TKM-PLK1 clinical trial and we reported that several objectives were achieved including establishing that PLK1 is generally well-tolerated, establishing a maximum tolerated dose of 0.5, 0.75 mg/kg, observing encouraging signs of drug activity and confirming that RNAi activity occurred in tumor biopsies from these patients. Importantly, despite a heavily pre-treated patient population, we did see evidence of clinical activity in our Phase I trial. We are very pleased and encouraged that four out of nine or 44% of evaluable patients treated at doses in ranges consistent with pre-clinical efficacy showed clinical benefit. Of note, two patients enrolled with gastrointestinal neuroendocrine cancer or GI-NET both responded to treatment with TKM-PLK1. And one…

Ian Mortimer

Management

Thanks Mark. I just wanted to also take a moment to thank you and the rest of the team for giving me the opportunities to a challenging and meaningful work here at Tekmira. As the search begins for my replacement, I do want to reiterate that I’m fully committed to doing whatever I can to support a smooth transition over the coming months. I believe, I’m leaving the company in a strong position as the leading company in the RNAi therapeutics field. So now, I will turn over to the financial highlights. I will place our Q2 2013 results in the context by comparing them to our Q1 2013 results. Tekmira’s net loss for Q2 2013 was $3.1 million that’s compared to a net loss of $2.6 million for the Q1 2013. Looking at revenue, in Q2 2013 revenue was $2.9 million as compared to $2.2 million in Q1 2013. Most of our revenues so far in 2013 is from our U.S. Department of Defense contract to develop TKM-Ebola. Under the contract, we are being reimbursed for costs incurred and we are in an incentive fee. Expenses incurred on the contract are presented on a gross basis on our financial payments that is both as expenses and as revenue. Q2 2013, TKM-Ebola revenue and expenses increased over Q1 as there were some significant non-clinical studies ongoing. Turning now to expenses, total research development collaborations and contract expenses increased from $4.2 million in Q1 2013 to $5.1 million in Q2 2013. Some of this increase relates to the TKM-Ebola contract but we saw also increase spending on our TKM-PLK1 program as we made a new drug batch for our ongoing clinical development. General and administrative expenses were $0.9 million in Q2 2013 and the same $0.9 million in Q1 2013. Now…

Mark Murray

Management

Thanks Ian. In summary, the whole team at Tekmira feels a strong sense of urgency to bring innovative new therapeutics to patients and to maximize value for our shareholders. In the second half of 2013 and into next year, is shaping up to be a very busy time at Tekmira. TKM-PLK1 is moving into two separate Phase I/II clinical trials which will generate important data points in 2014 and could put us in a position to initiate a pivotal trial in GI-NET next year. In addition, we expect that TKM-Ebola human Phase I should be completed in 2014. We also expect to nominate our next target for clinical development. Looking at revenues from our partners, we will be paid royalties on commercial sales of Marqibo and received milestone payments from Alnylam. We remain focused on developing our proprietary pipeline of RNAi products in therapeutically important commercially attractive markets, supported by a strong balance sheet and newly recruited talent, I believe we have the resources and the expertise to drive a number of product candidates through various stages of clinical development by 2015. I appreciate your participation on this conference call today. And will now turn things over to the operator, who will open up the call for questions. Operator?

Operator

Operator

(Operator Instructions) The first question comes from Jason Kolbert from Maxim.

Jason Kolbert - Maxim

Analyst · Maxim

Hi, guys. Thanks for the update. Couple of questions, help me understand Ian, your resigning, help me understand you had a pivotal role in building this company this far. Can you give us some insights into what drove this decision?

Ian Mortimer

Management

Sure. I have been at the company a long time and Mark and I have worked with each other since 2008. And I think the company is in really good shape right now both from a financial point of view as well, an exciting time in terms of product development and the milestones of the company is going to ahead as we intend to move forward. So, I think the company is in really good shape and in terms of my own career development this is just kind of my next (wagon) in development in my own career.

Jason Kolbert - Maxim

Analyst · Maxim

Okay. Can we talk a little bit in terms of products, it sounds fantastic that Marqibo is going to get a lot of traction with a great partner, have you have any idea what the estimates are – have they sat down and kind of said what they think they can achieve with this product. And when do you think the first royalties could be rolling in?

Ian Mortimer

Management

Yes. So Jason, I think Spectrum as you said is a really good fit for Marqibo. They have an existing hematology sales force. And they have guided that they will be looking to launch the product later this year. We are excited for them to get out and help the patients. So we receive a royalty based on sales so that royalty we expect depending on exact launch dates would start to flow to us, starting next year, if not before.

Jason Kolbert - Maxim

Analyst · Maxim

Okay. And can you give us some insight, two more questions, then I will jump back in the queue. I’m looking for some insights around the dispute with Alnylam on the milestone payment, is it just a dispute about timing or is it a dispute about what triggers it or is it just of the entire payment is in dispute.

Mark Murray

Management

Jason, this is Mark. I think I would summarize it by saying that we believe the milestone has been achieved and therefore, the milestone is due and they take a different view. They don’t believe the milestone has been achieved. And so the agreements between the companies call for arbitration to sort out disagreements like this.

Jason Kolbert - Maxim

Analyst · Maxim

It’s kind of like déjà vu though, it seems like both you and Alnylam would not want to repeat the arbitration process every time there is a disagreement. But, I’m sure its relatively costly and time consuming. But, I guess you have no choice. Can you talk a little bit about hepatocellular carcinoma and PLK1? I mean that’s a really exciting opportunity. Now, you are moving into not just this kind of niche area; what’s the standard of care right now in HCC and what’s the expected longevity of a newly diagnosed HCC patient, so we can get some idea of where you find proof of concept in the Phase I/II HCC trial?

Mark Murray

Management

So the approved product in the area at the moment is Sorafenib, which doesn’t work very well. And the – I think the expected life, I really, it will depend up on kind of the status of the diagnosis and the genetic underlying components of the patients. So it’s not a simple yes/no answer. But, I think if you look at Sorafenib, we would certainly hope to outperform that.

Jason Kolbert - Maxim

Analyst · Maxim

So, are there slices of patients that you would go for, whether its people that are very advanced stage IV multiple metastasis or is it, maybe there is a particular slice, we know that liver cancer is typically pretty fast. So if you are having an impact, you probably see this relatively quickly and hopefully in a conservative or small number of patients. Am I on the right track in terms of my thinking?

Mark Murray

Management

I think, keep in mind here, we are going to approach this in step wise, right? So initially here what we want to do is, all of these patients will have advanced disease, but we are not selecting patients or powering the study with product approval in mind, right? So we want to see what we can achieve with HCC in a limited set of patients and then we will address I think more specifically your questions, which is how do we identify a population and design an approval strategy.

Jason Kolbert - Maxim

Analyst · Maxim

Okay. Just very early on, very much an exploratory trial established dosing, safety and what patients respond better than other?

Mark Murray

Management

We have a rationale supporting this decision but we haven’t treated patients with HCC yet. So, I just can’t tell you.

Jason Kolbert - Maxim

Analyst · Maxim

Yes. I know it’s really exciting because you have pointed to the fact that PLK opens up multiple other potential large markets. Thanks very much guys. We will look forward to chatting with you more later on.

Mark Murray

Management

All right. Thanks Jason.

Operator

Operator

(Operator Instructions) The next question comes from Doug Loe from Euro Pacific.

Doug Loe - Euro Pacific

Analyst · Euro Pacific

Thanks very much and good afternoon gentlemen. Probably going to ask the same (basket) of questions maybe just a little bit different focus, so I’m kind of intrigued by this eventual dispute with Alnylam again. I was just wondering if whatever is triggering their sense, if you have'nt met obligations on that program would in anyway be relevant to the $5 million you expect to get in the TTR02 program before end of year?

Mark Murray

Management

I don’t think so.

Ian Mortimer

Management

Yes, I think that’s accurate Doug. The milestones were separate and discrete. And we still believe that the $5 million for TTR based on the initiation of a Phase III or pivotal study is – will happen before the end of 2013.

Doug Loe - Euro Pacific

Analyst · Euro Pacific

Okay. In response to the previous question, I’m not sure, you actually specifically said what’s your obligations were in order to trigger the milestone and presumably they are not only separate but distinct in the two circumstances, are you allowed to share with us just what exactly you are required to accomplish in order to schedule the payments?

Mark Murray

Management

Yes. And I think this is probably in the filed documents. So with respect to TTR, the trigger is Alnylam initiating a Phase III or pivotal clinical trial for TTR02. And for the VSP the triggering event is Tekmira providing the technology to enable (inaudible) to produce VSP.

Doug Loe - Euro Pacific

Analyst · Euro Pacific

Got it. Okay. Thank you very much for the clarification Mark. And then just real quick on Marqibo, it is great, but tell on those – as the business development that trigger that should afford partner to commercialize Marqibo here. I was just wondering if, I haven’t see Spectrum provide any update on this maybe you could, are you aware of whether they or not they would still intend to continue funding the larger newly diagnosed ALO study that Talon was funding previously which certainly open up a broader ALO market if they were chose to continue to fund that study probably with that? Thanks.

Mark Murray

Management

Yes. So, Spectrum has guided. There is two ongoing Phase III studies one as you mentioned the nearly diagnosed leukemia patients and the other nearly diagnosed non-Hodgkin’s Lymphoma patients. So both of those studies are ongoing and I agree with your comments that there is an opportunity based on those data to expand the opportunity for Marqibo.

Doug Loe - Euro Pacific

Analyst · Euro Pacific

That’s great. Thank you very much gentlemen.

Operator

Operator

The next question comes from Jason Kolbert from Maxim.

Shaukat Khan - Maxim

Analyst · Maxim

Hi, guys. This is Dr. Shaukat Khan. Actually I have two questions. And they both actually deal with formulations of LNP, the first one is actually regarding sub-Q since Alnylam is really going after sub-Q and you have done some experiments with sub-Q, if you are on LNP formulation. Have you actually gone into primate and shown that it’s as efficacious as what Alnylam is claiming with their sub-Q?

Mark Murray

Management

No, our data is in rodent.

Jason Kolbert - Maxim

Analyst · Maxim

But, do you feel like you are going to be competitive by opening up to sub-Q pathway that you may ultimately end up with a very competitive sub-Q formulation, right because that could really bring Alnylam back to the sub-Q table, if you will?

Mark Murray

Management

Jason, I think what we know at this point is based on the data that we have seen in the public domain. The LNP formulation sub-Q in rodents is considerably more potent. I really can’t speculate how anyone else would think about that or would consider using it or.

Jason Kolbert - Maxim

Analyst · Maxim

Okay. Fair enough. But, so far the preclinical data is very suggestive.

Mark Murray

Management

Yes.

Shaukat Khan - Maxim

Analyst · Maxim

And as far as (inaudible) LNP formulation that you're using for your preclinical, when do you think you will bring that into the cancer side for PLK1 or other indication?

Mark Murray

Management

Well, so, it would probably not be for an oncology application but for other sort of general applications. I think that we would almost very likely incorporate in our next development candidate which we haven’t yet announced. But, I said earlier we expect to do that by the end of the year.

Shaukat Khan - Maxim

Analyst · Maxim

So, does that have something to do with the different chance that you are using that allow TKM-PLK1 to stay in the blood stream longer?

Mark Murray

Management

Yes. So remember that TKM-PLK1 utilizes a formulation that is designed to stay in circulation longer and accumulate at sites of distilled tumor growth. So, the new formulation that we are applying in the Ebola program does not have that feature.

Shaukat Khan - Maxim

Analyst · Maxim

All right. Thank you.

Operator

Operator

I’m showing no further questions. I would now like to turn the call back over to the presenters.

Jodi Regts

Management

Thank you, Jamie. Thanks everyone for joining us on the call today. We look forward to sharing our progress with you in the months ahead.