Arbutus Biopharma Corporation (ABUS) Q2 2013 Earnings Call Transcript
Published at 2013-08-12 20:20:06
Jodi Regts - Director, Investor Relations Mark Murray - President, Chief Executive Officer Ian Mortimer - Chief Financial Officer, Executive Vice President-Finance
Jason Kolbert - Maxim Doug Loe - Euro Pacific Shaukat Khan - Maxim
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.
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.
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 exhibited a significant reduction in tumor burden. We have also completed the Phase I expansion cohort study further examining the safety of the established maximum tolerated dose for TKM-PLK1. Today, four out of 12 patients are evaluable having received two cycles of TKM-PLK. Of those four patients one with Adrenocortical Carcinoma or ACC achieved stable disease. No GI-NET patients were enrolled in this expansion cohort. We are now looking forward to focusing on patients with GI-NET or ACC tumors in our next trial, which we outlined earlier today. This trial will enroll approximately 20 patients with either advanced GI-NET or ACC. With the current lack of available therapy for patients with GI-NET and ACC these indications represent areas of high unmet need and could support an accelerated development strategy. Specifically, we expect to have data from this GI-NET, ACC trial by mid next year and if supported by the data, we believe we could be in a position to initiate a pivotal clinical study in GI-NET in 2014. Now, in addition to the GI-NET, ACC trial in the first half of 2014, we anticipate initiating Phase I/II TKM-PLK1 clinical trial that we will enroll patients with Hepatocellular Carcinoma or HCC, which represents another area of high unmet need. The incidence of ACC has increased 300% in the U.S. from 1975 to 2005, supported by strong pre-clinical data evidence that PLK1 is needed for HCC proliferation and very efficient LNP delivery to the liver, we believe it is appropriate to pursue a clinical trial in HCC with PLK1. In summary, we believe as the promising data generated to-date supports the further advancement of TKM-PLK1 in these indications GI-NET, HCC and ACC, which represent true unmet needs and high value to Tekmira. So to conclude, I’m pleased with the promising clinical data obtained thus far with TKM-PLK1 and believe a strategy of initiating Phase I/II trials looking for efficacy and targeted indications represents an important next step in the development and if supported by the data, we could be in a position to initiate a pivotal trial in GI-NET next year. Looking at the breadth of our plans for PLK1, it is indeed great timing to announce today that Dr. Mark Kowalski has joined us as Tekmira’s new Chief Medical Officer. Mark joins us most recently from Gilead, where he joined its oncology and inflammation group following Gilead’s $510 million acquisition of YM BioSciences. As Tekmira’s business grows, we have a strong commitment to expand our product and clinical development capabilities by recruiting where we can find the very best talent. Mark will have responsibilities for all clinical development functions at Tekmira including clinical operations and regulatory affairs. I’m confident that Mark’s oncology background and extensive clinical development expertise are great fit with Tekmira in our current goals namely to advance the proprietary products within our pipeline while leveraging our LNP technology to enable the clinical programs as strategic partners. We are pleased to welcome Mark to our team and you can expect to hear from him on future calls. Turning now to TKM-Ebola, which is an anti-Ebola viral therapeutic being developed under $140 million contract with the U.S. Department of Defenses joint project manager transformational medical technologies or JMP-TMT. Our contract with the JMP-TMT was recently modified to support development plans that integrate a more potent LNP formulations and advancements in manufacturing technology including lyophilization as well as provide for $6.9 million in additional funding. We anticipate completion of the remaining preclinical studies and submission to the FDA by the end of the year in order to support the use of the more potent product in the Phase I clinical trial. One of the benefits of the TKM-Ebola TMT collaboration is that it supports ongoing innovations to our technology platform that can be applied to other product development programs. New data generated from TKM-Ebola program and other LNP innovations were presented at the 15th Annual TIDES Summit held in Boston in May. Some highlights of this presentation include; the new LNP formulation that’s being incorporated into the TKM-Ebola program is more potent than any LNP currently in clinical development and it has demonstrated significant increased potency in non-human primates infected with the Ebola virus. At 0.5 mg/kg 100% of the infected animals survived after receiving TKM-Ebola daily for seven days. The previous LNP formulation provided that same level of protection 100% survival at 2 mg/kg. Our scientists have also developed a lyophilized a freeze-dried LNP in order to eliminate cold-chain shipping and storage requirements for the product. Importantly, the lyophilized LNP formulation also provided 100% survival in non-human primates infected with Ebola virus with no loss in potency at 0.5 mg/kg. Tekmira is also continuing work on LNP formulations that provide potent activity when administered subcutaneously. The data we have generated indicates that LNP is more potent when compared to other published data using conjugate delivery systems. LNP administers subcutaneously in a rodent model can knockdown a liver target by 96% at 1.0 mg/kg with a single administration. We continue these innovations in order to expand Tekmira’s opportunities to products into our pipeline as well as to license them and to enable our partners’ products. On the business development front, we are aggressively pursuing new partnerships with pharmaceutical biotechnology and agricultural companies that are seeking access to our industry leading LNP technology. I will provide more detailed updates when these relationships are formally established. We have granted license to Alnylam to use our LNP technology enabling certain of its RNAi therapeutic products including ALN-TTR02, ALN-VSP and ALN-PCS02. We will receive milestone and royalty payments as the LNP enabled products are developed and commercialized. ALN-TTR0-2 is an RNAi therapeutic for the treatment of TTR mediated amyloidosis or ATTR. That is enabled by Tekmira’s LNP technology. This past quarter, Alnylam reported results from 19 patients that demonstrated significant knockdown of up to 93% of circulating a wild type a mutant TTR in a multidose study. Multiple doses of ALN-TTR02 were reported to be generally safe and well-tolerated, importantly Alnylam continue to guide that ALN-TTR02 is expected to enter a Phase III trial by year-end triggering a $5 million milestone payment to us. In July of this year, Talon Therapeutics announced that it’s been acquired by Spectrum Pharmaceuticals. One of Tekmira’s legacy products Marqibo was licensed from Tekmira to Talon in 2006. In August of 2012, Marqibo received accelerated approval from the FDA for treatment of adult patients with acute lymphoblastic leukemia in second or greater relapse whose disease has progressed following two or more anti-leukemia therapies. Spectrum has guided that it expects to commercially launch Marqibo later this year through their existing hematology sales force. The future sales of Marqibo will result in a recurring mid-single digit royalty stream for Tekmira. We are pleased that the commercialization plans for Marqibo continue to advance and that an innovated new treatment based on Tekmira’s technology will soon be available to cancer patients in need. As outlined in my comments today, we are focused on meeting our key milestones over the coming months. At this point, I would like to turn the call over to Ian, who will go over the financial highlights. But before doing that, I would like to thank Ian for his contributions and dedication to Tekmira over the past 5 years. We announced today that Ian will leave Tekmira in mid-October to pursue a new opportunity. As we gear up to recruit a new CFO, Ian will retain his responsibilities as CFO and assist us to ensure we have a smooth and straight forward transition. On behalf of the entire Tekmira team, I’m wishing well in his future endeavors. Ian?
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 that we are at the midpoint of the year, I will also provide updated financial guidance. I will remind you that in our 2012 year-end MD&A, we guided that R&D expenses would be in the range of $24 million to $29 million. We now expect R&D expenses will be closer to the low-end of that range. We also guided that based on continued contract revenue from the U.S. government and U.S. $10 million in milestone payments expected from Alnylam that 2013 revenue would be in the range of $20 million to $25 million. Also, we guided that cash would be greater than $35 million at the end of 2013. And the current funds on hand would be sufficient to continue product development into 2015. But, based on our updated cash projections and considering that payment of the $5 million ALN-VSP milestone is being disputed, we now expect 2013 revenue to be in the range of $15 million to $20 million and year-end 2013 cash and equivalents to be in the range of $30 million to $35 million. Also, we are extending our cash runway and now believe that current funds on hand will be sufficient to last until mid-2015. So, I will now turn things back over to Mark for some concluding comments before we open the call up for your questions. Mark?
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 Instructions) The first question comes from Jason Kolbert from Maxim. Jason Kolbert - 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?
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: 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?
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: 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.
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: 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?
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: 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?
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: Okay. Just very early on, very much an exploratory trial established dosing, safety and what patients respond better than other?
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: 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.
(Operator Instructions) The next question comes from Doug Loe from Euro Pacific. Doug Loe - 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?
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: 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?
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: 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.
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: That’s great. Thank you very much gentlemen.
The next question comes from Jason Kolbert from Maxim. Shaukat Khan - 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?
No, our data is in rodent. Jason Kolbert - 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?
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: Okay. Fair enough. But, so far the preclinical data is very suggestive.
Yes. Shaukat Khan - 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?
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: 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?
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: All right. Thank you.
I’m showing no further questions. I would now like to turn the call back over to the presenters.
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.
Ladies and gentlemen, that does conclude the conference for today. Again, thank you for your participation. You may all disconnect. Have a good day.