Earnings Labs

Geron Corporation (GERN)

Q3 2015 Earnings Call· Thu, Nov 5, 2015

$1.52

-0.65%

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Transcript

Operator

Operator

Good day ladies and gentlemen, and welcome to the Geron Third Quarter 2015 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'd now like to turn the conference over to Anna Krassowska, Head of Investor Relations. You may begin.

Anna Krassowska

Analyst

Thank you, Sania. Good afternoon, everyone, and thank you for joining us for the Geron third quarter 2015 earnings call. With me this afternoon are Dr. John Scarlett, our President and Chief Executive Officer; and Olivia Bloom, our Executive Vice President, Finance and Chief Financial Officer. Today we issued a press release that reported results for the third quarter ended September 30, 2015. This release can be found on our website at www.geron.com. Today's call is also being webcast live on our website and will be available for replay through December 05. Before we begin, please note that except for statements of historical facts, 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 potential payments under the Janssen collaboration agreement, the timelines, prospects and plans for imetelstat, including clinical study initiation and enrollment, the therapeutic potential and safety of imetelstat, Geron desire to diversify and financial or operational projections or requirements. These statements include 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 multiple indications, regulatory agencies commence the clinical trials to begin or continue to proceed, clinical trials to proceed without delays and Geron will receive continuation, milestone and royalty payments 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 quarterly reports on Form 10-Q for the quarter ending June 30, 2015. 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 to reflect future information, events and circumstances. We'll begin today's call with a summary of the third quarter operating results from Olivia, and then Chip will review recent events and highlights from upcoming activities through the end of the year. Olivia?

Olivia Bloom

Analyst

Thanks Anna, good afternoon. For the third quarter of 2015, we reported net income of $27.2, or $0.17 per share, compared to a net loss of $9.5 million, or $0.06 per share, for the comparable 2014 period. For the first nine months of 2015 we reported net income of $8.5 million, or $0.05 per share, compared to a net loss of $26.7 million, or $0.18 per share, for the comparable 2014 period. Revenues for the third quarter of 2015 were $35.4 million compared to $160,000 for the comparable 2014 period. Revenues for the first nine months of 2015 were $36.2 million compared to $975,000 for the comparable 2014 period. The increase in revenues for the 2015 period compared to the same period in 2014 was primarily due to recognition of revenue for the $35 million upfront payment from Janssen. We received the upfront cash payment from Janssen in December 2014 upon the effectiveness of the collaboration and license agreement with them, which we recorded as deferred revenue at that time. Under accounting rules to recognize the upfront payment of revenues, we had to deliver imetelstat license rights to Janssen and complete the technology transfer related activities as outlined under the collaboration agreement. In the third quarter of 2015 we completed our performance of the technology transfer related activities to Janssen. Combining this performance, with the delivery of the imetelstat license rights, we were eligible to fully recognize the upfront payment and collaboration revenue in the third quarter of 2015 in accordance with generally accepted accounting principles. Total operating expenses for the third quarter of 2015 were $8.3 million compared to $10.1 million for the comparable 2014 period. Research and development expenses for the third quarter of 2015 were $4.1 million compared to $6 million for the comparable 2014 period. General…

John Scarlett

Analyst

Thanks, Olivia, good afternoon, everyone and thanks for joining. During the third quarter there were two important events for imetelstat that I would like to highlight. First, two papers on imetelstat were published as back to back articles in the September 3 issue of the New England Journal of Medicine. The paper reported results on Geron's proof of concept study in patients with essential thrombocytopenia and the Mayo Clinic pilot study in myelofibrosis where unprecedented molecular and bone marrow responses were observed in the studies. These data suggest imetelstat has disease modifying activity through the selected innovation of the malignant progenitor cell of the malignant clones responsible for the underlying diseases. The papers are available online in the New England Journal of Medicine website. Also in September the first patient was dosed in the IMbark myelofibrosis study. This study is the first to be initiated under the collaboration with Janssen. As we previously described IMbark is a one to one randomized single blind multicenter Phase 2 clinical study to evaluate the activity of two dose levels of imetelstat either 9.4 or 4.7 mgs/kg. Approximately 200 patients a 100 patients per dosing arm, with DIPSS intermediate-2 or high-risk myelofibrosis who have relapsed after or are refractory to a JAK inhibitor are planned to the enrolled in the study. The co-primary efficacy endpoints are spleen response and symptom response rate. The endpoints -- or these endpoints for the basis for the approval of JAK. Secondary efficacy endpoints include the number of patients achieving CR or PR, CI and a linear spleen and symptoms responses as well as an assessment of overall survival. We believe the depth of response captured by the secondary outcomes is clearly unique to imetelstat and is further validated in the trial will enable clear differentiation of imetelstat effects…

Operator

Operator

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

Sarah Weber

Analyst

Hi this is Sarah Weber on for Charles. Congratulations on the progress. Could talk a little bit more about you believe Janssen would like to see in terms of advancing imetelstat from part one to part two of that study.

Olivia Bloom

Analyst

I think it’s a little hard to really comment on that today other than to make the comments directly about having a favorable benefit risk ratio. The specifics of that obviously are going to depend on the data and I think we're not really in a position to comment to strongly about that. Obviously, we would have to believe that a double blind placebo controlled phase 3 study would be likely to be successfully, but beyond that I don’t think we have any specific targets right now that we've established.

Sarah Weber

Analyst

Okay. And then just one additional question in terms of endlicensing and additional asset what kind of attributes are you looking for in an ideal asset?

Olivia Bloom

Analyst

Well, I think we've talked about that previously a bit. It has to make business sense to. so one of the criteria that we have commented on previously is that it would need to be oncology focused and we certainly have been looking predominantly and hematology-oncology focus because we really know that space pretty well and of course with imetelstat were deeply meshed in the myeloid side of the hem-malignancies. Beyond that we have been pretty open about whether it would be an in-licence or whether it would be a platform that we would acquire or even potential a company, but beyond that we haven’t made any further characterizations.

Sarah Weber

Analyst

Thank you for taking my question.

Operator

Operator

Our next question comes from Thomas Yip of FBR & Company. Your line is now open.

Thomas Yip

Analyst

Hi, guys, congrats on the progress on imetelstat and look for very much to ASH in the month. The first question about the new MD as an occasion, can you perhaps outline how you see imetelstat to set into the current MDS driven landscaped.

Olivia Bloom

Analyst

We can’t think Thomas for the question. The big problem with low risk MDS is anemia, severe anemia and in particular anemia that requires transfusions and as we commented on the call and I just elaborated a bit, transfusions although they are relatively inexpensive they really not entirely benign by any means. A side from issues of actually getting into transfusions, which we all know can carry some degree of infectious disease risk in the like. The real issue with repeated transfusion is accumulation of the iron in internal organs and the blood and bone marrow for that matter and that causes toxicity, which causes actually a diminished long term survival. So that’s why transfusion independent is really a well-established regulatory outcome. Current therapies beyond transfusion are really pretty much related to ESAs or erythrocyte stimulating agents EPO, but as we commented they don’t ordinarily give a very prolonged improvement and in patients who have relatively high levels of EPO already, obviously they don’t have a lot of -- they are actually not indicated or don’t have a lot of utility. The hypomethylating agents are used in some cases in the United States they're on level for low risk. But in Europe, they're actually not but again they have a relatively limited period of time that they usually improve this. Now Lenalidomide Revlimid is approved for use in the relatively small number of patients with 5Q delete syndrome as it’s called and it's certainly we know that there is some data out there that I sighted that there is a 27%, they have 27% transfusion independence rate and in a study of Lenalidomide in non-type 2 delete syndrome patients. And just that that will be filed eventually as a SNDA but I think the point is that this really would fit very nicely into that space, into that low risk space because we believe that the malignant progenitor cell clones that are responsible for MDS have a lot of similarities to the same type of mechanism of action in MS. And so we have a lot of hope that we'll actually be improving the underlying disease characteristic of MDS. That’s still to be proven, but I think we would see it sitting in certainly in lieu of transfusions and if ESAs have either not worked or patients have become resistant to it. That's sort of where it's aimed at the moment.

Thomas Yip

Analyst

Okay. That sounds good. Thanks for the details. That makes a lot of sense. Since one of the topic of ASH I see that one of the ASH abstracts are focused on genetic mutation, can you just perhaps quickly align what is the significance of specific G mutations and either MF or may be MDS or even AML?

John Scarlett

Analyst

Well that’s the 64 gazillion dollar question that a lot of sequence basements of various hematology oncologists hospitals are churning away at. I think we really can’t go outside of the four corners of the abstracts under the embargo rules. So really can’t make any further comments on that particular abstract. But I will just simply say this is a major effort on the part of the community to understand what are driver mutations both in the sense of the first mutations to be seen but also those that are thought to actually be causative of the underlying disease but what we now know is that there are used really numerous clones with numerous mutations involved in most of these Myeloid hematologic malignancies. I think it really is uncertain today other than knowing some mutations have certain prognostic factors associated with them in sort of a statistical arrangement. I think beyond that we really don’t know how individual mutations cause or associated with particular elements of the disease. Understanding that will obviously give us tools for ultimately in the future, may be patient selection and certainly that are prognostic opportunities and may be in the development of new very targeted therapies, but for today we're still very much, the community is still very much in a search and research mode. So I don't think we can say a whole lot more about that moment. Long winded explanation so I am not really sure.

Thomas Yip

Analyst

Okay got it, thanks again for taking my questions and looking forward to ASH.

John Scarlett

Analyst

Thank you.

Operator

Operator

And next question comes from [indiscernible] of Stifel. Your line is now open.

Unidentified Analyst

Analyst

Hey can you hear me now. Okay, thank you taking my question. So you mentioned that you're going to leverage or expand in oncology but you also have extensive experience in endocrinology. Are you looking for in this space as well?

John Scarlett

Analyst

No, good question, it is true for those who don’t know on the call, I am in an endocrinologist and I have a couple of companies previously that were endocrine companies, but no the company as a whole Geron has really been focused from many years now on encology and I would like to say that we are very much in a clinical and regulatory flow associated, the information flow associated with in particular hematologic malignancies because of our continuing collaboration with Jannsen and work with imetelstat. So I think that’s really then natural place for us to be focused. It does not rule out there may be certain types of technology platforms for example or even particular products that might have application outside of oncology, but really our focus has been oncology with hematologic oncology as the principal focus.

Unidentified Analyst

Analyst

Okay. Thank you very much.

Operator

Operator

Our next question comes from Ling Wang of Oppenheimer. Your line is now open.

Ling Wang

Analyst

Thank you. Congratulations on the progress. Couple of questions here so first may be already mentioned that, but I wanted clarify for the phase 2-3 emergency study what are any other patient even if you used the mutation status to as they are on a criteria such as review one mutation.

John Scarlett

Analyst

Yes, we are not, it’s too early to draw conclusions about the applicability of individual mutations or even constellations of mutations as patient selection tools as you undoubtedly know Ling that’s a lengthy development process in and of itself. I don’t think we really have enough information about these mutations to go there especially with such important study. So the purpose of this study is actually are to define the clinical phenotypes that are appropriate and going to be used to define the patients enrolment studies and then with respectively evaluate the apparent associations between certain mutations and outcomes of the study and outcomes of the individual patient outcomes. That hopefully will get us a little bit closer to understanding what are important mutations, what may be bi-standard mutations in the like, but it’s certainly too early to be using anything as patient selection tool.

Ling Wang

Analyst

Got it. And also it looks like Janssen decides to do a pretty small Phase two trial for MDS and then move to Faze three versus myelofibrosis trial a start up pretty big full blown Phase two trial. Can you share maybe with us what are the thoughts and considerations here?

John Scarlett

Analyst

So it’s good observation. I think the observation that obviously we have a Phase 3 component to the MDS study. Certainly suggest that the Janssen has some confidence based on results today to be planning such as significant study. I think that’s a real built of confidence. It has also build confidence in the drug as a whole. On the MF we have always said and would continue to say that a key purpose in the MF study is to really refine the dose and I think that’s really important and that’s a key plan for that study. So that doesn’t lend itself to placebo controlled phase three study and hence the MF study remains a single agent but multi dose finding study.

Ling Wang

Analyst

Okay. And lastly at ASH presentation I just want to clarify we are going to get updated results and this is what have been positive today on that abstract.

John Scarlett

Analyst

Well that’s historically been the fact, but these are academic collaborators and they are going to at the end of the day have the dispositive view as to exactly what they will present. So we don’t have control over that and actually don’t really know for sure, but that has historically been the fact. So I guess we'll all go and see what comes out.

Ling Wang

Analyst

All right. Okay. Thank you. And congratulations again.

John Scarlett

Analyst

Thank you.

Olivia Bloom

Analyst

Thanks Ling.

Operator

Operator

And this concludes our question-and-answer session. I would now like to turn the call back over to Dr. Scarlett for any further remarks.

John Scarlett

Analyst

Well, thanks a lot everybody for this call. I think we're feeling very good about how the program is shaping up and we look forward to further discussions and seeing many of you at ASH. Thank a lot.