Earnings Labs

Geron Corporation (GERN)

Q4 2016 Earnings Call· Wed, Mar 1, 2017

$1.52

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the Q4 2016 Geron Earnings 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] I would now like to introduce your host for today's conference Ms. Anna Krassowska, Head of Investor Relations. Your line is now open.

Anna Krassowska

Analyst

Thank you, Sandra. Good afternoon, everyone, and thank you for joining us for the Geron fourth quarter and year end 2016 earnings call. With me this afternoon are Dr. John Scarlett, our President and Chief Executive Officer; and Olivia Bloom, our Executive Vice President of Finance and Chief Financial Officer. Today we issued a press release that reported results for the fourth quarter and year ended December 31, 2016. This release can be found on our website at geron.com. Today’s call is also being webcast live on our website and will be available for replay through April 1. Before we begin, please note that except for statements of historical fact, the statements during this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, without limitations, statements regarding, the timeline, milestones, prospects and plans for imetelstat, including the timing and current of additional data reviews and the outcome of those reviews related to IMbark and IMerge, the therapeutic potential and safety of imetelstat, Geron's desire to diversify patent coverage, potential payments under the Janssen collaboration agreement and financial or operating projections or requirements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties include without limitation that imetelstat is safe and efficacious in IMbark and IMerge, whether IMbark and IMerge continue to proceed without any delays caused by health authorities or IRB's or any other factors or that one or both of the trials are discontinued. Janssen is able to timely collect the requisite data from IMbark and IMerge, imetelstat will overcome clinical safety and efficacy technical, scientific manufacturing and regulatory challenges. Geron patterns maintain their validly and whether Geron will actually receive continuation milestone and royalty payment from Janssen. Additional information and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron's periodic reports filed with the Securities and Exchange Commission under the heading Risk Factors, including Geron's Annual Report on Form 10-K for the year ending December 31, 2016. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements reflect future information events or circumstances. We will begin today's call with the summary of the 2016 fourth quarter and annual operating results from Olivia, and then Chip will review recent events and discuss ongoing activities with the imetelstat clinical trials being conducted by Janssen. Olivia?

Olivia Bloom

Analyst

Thanks, Anna. Good afternoon. For the year ended December 31, 2016 we are reporting a net loss of $29.5 million or $0.19 per share compared to net income of $46,000 or $0.00 per share for the year ended December 31, 2015. For each of the fourth quarters of 2016 and 2015, we are reporting a net loss of $8.5 million or $0.05 per share. In the fourth quarter of 2016 revenues were $94,000 compared to revenues of $220,000 for the comparable 2015 period. For the year ended December 31, 2016 revenues were $6.2 million compared to $36.4 million for the year ended December 31, 2015. Revenues for 2016 included the full recognition of an upfront payment of $5 million from Janssen Pharmaceuticals Inc. under our license agreement for certain rights to specialize oligonucleotide backbone chemistry and novel amidates. Revenues for 2015 included the full recognition of the $35 million upfront payment from Janssen Biotech Inc. our collaboration revenue upon transfer of the imetelstat license rate and completion of technology transfer related activities outlined under the imetelstat collaboration agreement with Janssen. Total operating expenses for each of the fourth quarters of 2016 and 2015 were $8.9 million. Total operating expenses for the year ended December 31, 2016 were $36.8 million compared to $36.9 million for the year ended December 31, 2015. Operating expenses for 2015 included restructuring charges of $1.3 million in connection with the Company's organizational resizing announced in March 2015. Research and development expenses for the fourth quarter of 2016 were $4.1 million compared to $4 million for the comparable 2015 period. Research and development expenses for the year ended December 31, 2016 were $18 million compared to $17.8 million for the year ended December 31, 2015. The increase in research and development expenses in 2016 compared to 2015…

John Scarlett

Analyst

Thanks, Olivia. Good afternoon, everyone, and thanks for joining. As this is our 2016 year-end call I'd like to take a moment to reflect on some of the important events occurred during the year. We believe the activities in 2016 provided a foundation on which further development of imetelstat can be evaluated. We remain very pleased with Janssen's continued steady engagement to broadly assess the potential development past very strong. First on the translational research site, Janssen has continued to sponsor and conduct numerous pre-clinical studies. In 2016 at the Annual Meetings of both the American Association for Cancer Research or AACR and the American Society of Hematology or ASH, there were several presentations that describe data from such ongoing work. These studies explored the activity of imetelstat and other hematologic myeloid malignancies such as acute myeloid leukemia both as a single agent and in combination with drugs currently used in clinical practice. Janssen have also sponsored academic research investigating the mechanisms to which telomerase in addition by imetelstat might inhibit the malignant progenitor cell clones in the bone marrow and exert the effects that have been observed in patients. All of these presentations can be found on our website. A new abstract from the Janssen translational research group was recently accepted for poster presentation at the upcoming 2017 AACR Annual Meeting which will occur in April. This abstract summarizes preclinical data on the effects of combining imetelstat with the Bcl-2 inhibitor venetoclax for which both in vitro and animal models of acute myeloid leukemia or AML. The AACR abstract is expected to be published online at AACR.org later today. While promising pre-clinical data have suggested the potential imetelstat and other hem myeloid malignancy such as AML, in the future there is still substantial work to be done before any…

Operator

Operator

[Operator Instructions] And our first question comes from the line of Charles Duncan with Piper Jaffray. Your line is now open.

Charles Duncan

Analyst

Hi guys, thanks for taking the questions and congrats in the progress in the quarter. Chip hope you're feeling - doing well, and wanted to ask you specifically about the imetelstat program thanks for the update and thorough update, sounds like Janssen may have some additional information in the second quarter, I guess I'm wondering if you could see a scenario whereby say that clinical data seems positive but for strategic reasons or other considerations Janssen doesn’t decide to move forward and therefore you would have this asset back in your hands, completely in your hands?

John Scarlett

Analyst

Thanks Charles. Sure, that is always a possibility, they have right to actually terminate the program at any time for any reason that they would deem appropriate, it's very kind in these types of agreements. So it maybe - the potential is always there for them to make that decision on really just about any basis and I wouldn't want to speculate on whether it would be on the basis of clinical data or their own internal thoughts about, other programs that they might have or what happens there is always complicated with large sophisticated companies and that certainly what they are.

Charles Duncan

Analyst

Yes. So your team is involved I know to some extent but I'm wondering if your team has ongoing interaction with investigators and if so, what the recent feedback has been on - from investigators not necessarily on patient disposition because I know you really can't provide much information and investigators probably can't either but really on the imetelstat value proposition and mechanism of action what's your sense of that?

John Scarlett

Analyst

So first of all we do not have specified what we don't have investigator interaction. Janssen's really responsible for all of the activities of the clinical trials. So we really don’t have those interactions. And I really don’t think that I can really make any comments about that in the absence of good interactions.

Charles Duncan

Analyst

And that makes sense. And then last thing is you mentioned your efforts to possibly identifying licensing candidates, is it the case that if Janssen moves forward into later stages of development for imetelstat, you may realize some milestone payments and would those milestone payments be useful to in-licensing any candidate, is it that you haven’t found anything yet that is attractive to you or under the current circumstances in which you are not certain about that collaboration you just haven't pulled the trigger?

John Scarlett

Analyst

You know Charles first of all, I'd comment that we have always said that the collaboration agreement was in effect self-funding assuming everything went forward because of the milestone payments with in essence cover or it would be expected to cover the additional cost that we would be responsible for as part of that program. So, I don’t think we would be counting on any revenues if you will in excess of what we would be spending from the collaboration agreement and certainly not in the early years. Essentially so it might turn out to be very cash flow positive situation but certainly not in early years. So I think that – that's not really the tree we have been barking up but we have a substantial amount of cash available today as Olivia described and I think we would anticipate having to consider how to use that cash going forward with another program as opposed to keeping it in our back pocket at the moment.

Charles Duncan

Analyst

Okay. And I guess my question is if not found anything or you feel like maybe strategically you might want to wait until, you just wait until you hear something for Janssen or both.

John Scarlett

Analyst

Yes, I think both but honestly first of all, I would say that we have a evaluated quite a few opportunities and for one reason or another we haven't found the right opportunity for us and that as you can imagine Charles is a very wide range of different possibilities from things didn't seem to work out when we did our due-diligence to, we didn’t eventually conclude that it was a business that we wanted to gain et cetera. But I would also say that you're quite right that now we have - we're on the cost of learning more about the imetelstat program and I think it's a would be quite wise for us to keep our powder dry and see how that plays out.

Charles Duncan

Analyst

Okay. Thank you for taking my questions and for the added color.

Operator

Operator

And our next question comes from the line of Thomas Yip with FBR & Company. Your line is now open.

Thomas Yip

Analyst · FBR & Company. Your line is now open.

Hi everyone, thank you for taking my questions and Chip I hope you're feeling better as well. First question that I have is regarding going IMbark. Can you tell us how many patients so far have switched from the low dose arm to the high dose arm and can you remind us also do those patients come towards the enrollment target of 100 patients that you're looking for the primary analysis?

John Scarlett

Analyst · FBR & Company. Your line is now open.

Well, first of all Tom thanks for the well wishes and these patients do not - first of all, we have not released the actual numbers of patients who have gone from 4.7 to 9.4 and are not planning to do so at least at this time. Second of all, they will be a separate analysis cohort right because they are been treated differently than the patients who were initially started on for example 9.4, and have always been on 9.4 as opposed to those who stood on 4.7 and stayed on 4.7 so it’s sort of an intermediate cohort. So it’s an interesting cohort, since I'm sure there won't be ultimately analysis done on them but they're really not part of the fundamental analysis that was envisioned and is envisioned in the protocol.

Thomas Yip

Analyst · FBR & Company. Your line is now open.

Okay. Thanks for the clarification. My other question regarding IMbark as well is the 24-week interim review that we should expect in the second quarter that’s on target. Should we expect to learn more about the protocol defined criteria that you guys opted at 12 week and if not when should we expect to see that in term criteria.

John Scarlett

Analyst · FBR & Company. Your line is now open.

You're asking me to predict exactly the course of what Janssen and others are planning to say. I mean here's what I can tell you today Tom, as was the case with the first interim review there are protocol to find efficacy criteria for the second interim review and that interim review will include a very comprehensive set of analysis that I alluded to in the other comments. Janssen has substantial latitude in making decisions about the future conduct of the trial and of course about the future development program of the drug in MS and will undoubtedly be related to that. When exactly the actual analysis and the results of those analysis will be publicly disclosed, I don't know the answer to that and certainly that's - that is a something that will need to be past for the Janssen lease, that will be – it's important that we don’t know the answer today.

Thomas Yip

Analyst · FBR & Company. Your line is now open.

Okay, that’s reasonable. Thank you again for taking my questions and looking forward to the announcement of the two interim review.

Operator

Operator

And our next question comes from the line of Thomas Shrader with Stifel. Your line is now open.

Alexander Schwartz

Analyst · Stifel. Your line is now open.

Hi Chip and team, this is Alex Schwartz going in for Tom Shrader. I had two questions. The first is can you talk about and tell us that potential and different myelofibrosis mutations. And in your pilot study you presented some interesting data segmenting by different mutations, just was potentially different mutations can you talk about the sequencing work done to identify them and then is it possible to launch a Phase 3 trial and certain mutations or exclude certain mutations any comments around that that would be excellent.

John Scarlett

Analyst · Stifel. Your line is now open.

Sure, well I think as you know Alex and others on the call know, this is the whole mutation analysis of responders, non-responders - the hoped for ability to use these mutational analysis for patient selection is a very hot topic in the field as a whole not just what with we're doing. We’re doing exactly what you'd expect a sophisticated program to do there's an assessment of both cytogenetics and also mutational and molecular changes in these patients both before and after treatment with imetelstat that's going across both studies and I couldn't tell you the precise nature of that but I think we would all conclude that it will be quite comprehensive. The challenge with all of this is that we know from many studies done by multiple investigators in these patient population, so there is no single phenotype for - associated with in general particularly good or particularly bad outcomes much less associated to date with imetelstat responses. We know that there is some mutations that across the board appear to be generally correlated with poor prognosis and perhaps a few correlated with better but this is going to be a major effort by anyone in the field because the results are quietly atrophic it's not as if every single patient winds up. It's not if there's a single mutation that appears to confer a particular clinical phenotype. So, I think that while we are very actively looking at that or I should say Janssen are very actively looking at that, I don't know that we're going to have any aha moments in the near future with it, we'll have to wait and see. We will be looking at that data will be included in the second analysis.

Alexander Schwartz

Analyst · Stifel. Your line is now open.

Okay, very good. Thanks for additional color. And just a more administrative question if I can. Just how will the next interim update be communicated to us, will it be press release followed by a call like the last one or how is it going to be communicated to us?

John Scarlett

Analyst · Stifel. Your line is now open.

Well I guess kind of all depends doesn't it. I mean it's a - generally speaking we are - generally speaking we are committed to doing the - making sure that you know when appropriate level of detail but I don't really think we can pre-specify today whether it’s going to be by press release, conference call or what have you, we’ll have to see. Do have any other comments?

Olivia Bloom

Analyst · Stifel. Your line is now open.

I think that - I also think one thing to look through is how the first review with handle, I think that we talked about how that wasn't necessarily any specific data that was being disclosed but obviously any material and actions in connection with the studies and would definitely be something to be discussed. So I think you want to look towards how we treated the first review and there is obviously a lot of similarity between the two.

Alexander Schwartz

Analyst · Stifel. Your line is now open.

Okay, very good. Well thanks for the additional color and looking forward to future update.

Operator

Operator

And this does conclude today's Q&A session. I’d now like to turn the call back over to Dr. Scarlett for any further remarks.

John Scarlett

Analyst

Thanks very much everyone for dialing in and we look forward to future communications. Bye, bye.