Earnings Labs

Geron Corporation (GERN)

Q4 2015 Earnings Call· Thu, Feb 25, 2016

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Geron Fourth 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]. As a reminder, the conference is being recorded. I'd now like to introduce your host for today's conference Ms. Anna Krassowska, Head of Investor Relations. Ma’am, you may begin.

Anna Krassowska

Analyst

Thank you. Good morning, everyone. And thank you for joining us for the Geron fourth quarter and year end 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 fourth quarter and year ended December 31, 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 until March 26. 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 payment under the Janssen collaboration agreement. The timeline, milestones, prospects and plans for Imetelstat, including patient enrollment and planned internal data reviews and analysis. The therapeutic potential and safety of Imetelstat, Geron desire to diversify and financial or operating projection or requirement. 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 multiple indications, regulatory agencies permit the clinical trials to begin or continue to proceed, clinical trials can proceed without delays due to slow enrollment or other factors and Geron will receive continuation milestone and royalty payments of 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 report on Form 10-Q for the quarter ending September 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 or circumstances. We will begin today’s call with a summary of the 2015 fourth quarter and full year operating results from Olivia, and then Chip will review recent events and discuss the ongoing activities with Imetelstat clinical trials being conducted by Janssen. Olivia?

Olivia Bloom

Analyst

Thanks, Anna. Good afternoon. For the year ended December 31, 2015 we are reporting Net income of $46,000 or zero cents per share, compared to a net loss of $35.7 million or $0.23 per share for the year ended December 31, 2014. For the fourth quarter of 2015 we are reporting a net loss of $8.5 million or $0.05 per share, compared to a net loss of $8.9 million or $0.06 per share for the comparable 2014 period. Revenues for 2015 were $36.4 million compared to $1.2 million for 2014. Revenues for the fourth quarter of 2015 were $220,000 compared to $178,000 for the comparable 2014 period. The increase in revenues in 2015 compared to 2014 was primarily due to the recognition of collaboration revenue for the $35 million upfront payment from Janssen. We received the cash upfront 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 as revenue we had to deliver the Imetelstat license rights to Janssen and complete the technology transfer related activities as outlined under the collaboration agreement, which we completed in the third quarter of 2015. Combining this performance with the delivery of the Imetelstat license rights we fully recognize the upfront payment as collaboration revenue and in accordance with generally accepted accounting principles in the third quarter 2015. Future milestone payments under the collaboration agreement with Janssen are not expected unless and until an affirmative continuation decision is made by Janssen. Total operating expenses for 2015 were $36.9 million compared to $37.5 million for 2014. Total operating expenses for the fourth quarter of 2015 were $8.9 million compared to $9.2 million for the comparable 2014 period. Operating expenses for…

John Scarlett

Analyst

Thanks, Olivia, good afternoon everyone and thank you for joining. Before I discuss the ongoing IMbark and emerge studies I’d like to acknowledge several recent Imetelstat publications and scientific presentations. In September Imetelstat clinical data were published in two back-to-back papers in the New England Journal of Medicine. These two papers reported the unprecedented molecular responses that were observed in Geron’s proof of concept study in essential thromocytemia or ET and bone marrow responses in the male clinic pilot study in mylofibrosis. These data suggest Imetelstat may have disease modifying activity. In December, at the American Society of Hematology Annual Meeting, there were two oral presentations describing Imetelstat clinical data. The first presentation was given by the investigators of the completed ET study and described further mutation analogy showing that in addition to reductions in allele burdens of primary JAK2, CALR and MPL mutations, Imetelstat also suppress the allele burdens of multiple other gene mutations. These data provide additional evidence to suggest that Imetelstat suppresses the malignant clones driving the disease. The second presentation given by Dr. Tefferi reported clinical data from the first testing of Imetelstat in a cohort of nine patients of MBS from the male clinic pilot study. Eight of whom had transfusion dependent disease. He observed three of those eight or 38% of patients became transfusion independent during treatment with Imetelstat. In November of 2014, we entered into an exclusive collaboration agreement with Janseen to develop and commercialize Imetelstat worldwide. Under the collaboration they are responsible for development, manufacturing, regulatory and commercialization activities for Imetelstat worldwide. During 2015, they advanced the clinical development of Imetelstat with the launch of two large global clinical studies. The first study refer to as IMbark, is a Phase 2 clinical trial in patient with intermediate-2 and high risk mylofibrosis or…

Operator

Operator

[Operator Instructions] Our first question comes from the line of Tom Shrader with Stifel. Your line is now open. Tom Shredder if your phone is on mute please unmute if your phone is on speaker phone.

Unidentified Analyst

Analyst

Okay sorry. Here is [indiscernible] for Tom Shrader. I have a question regarding the interim look for the impact as I understand you won’t communicate the data to us, but does the efficacy really has to be as good as the higher dose or will there be some trade-off for a lower efficacy, but a better safety profile?

John Scarlett

Analyst

It’s an interesting question it’s a little hard to answer in the abstract. I think that the goal certainly is to find the right dose and these doses as you might recall are quite different right one is literally half of -- the 4.7 is literally half of the 9.4. The lower dose was defined on the basis of sort of the lowest dose that we’d be expected to have full target engagement of [indiscernible] activity. But I think that at the end of the day the real question is going to simply be is it better to have two doses or one and more importantly what would be the right dose and I don’t think I could comment a whole beyond that right now.

Unidentified Analyst

Analyst

Okay, thank you. And I have another question if I may. At the ASH presentation the presenter spoke about how physicians are still learning to use this product and that the common practice is to have dosing after the emergence of adverse events and that may be counterproductive through the treatment so how will you treat that in the trial and what dosing adjustments are allowed?

John Scarlett

Analyst

Well there are dosing adjustments that are allowed and they are allowed in principally with regard to adverse events right. And so downward dosing adjustments can take place. And that’s been the history of the drug actually. Most patients or many patients who have started off at a given dose if they have significant cytopenias than their dose is reduced or held and then reduced, which is actually more common. So I think that we’re really following with the existing the current studies I think we’re actually following on a path that’s been very well trialed previously in the previous studies.

Unidentified Analyst

Analyst

Okay, thank you very much.

John Scarlett

Analyst

Sure.

Operator

Operator

Our next question comes from the line of [indiscernible] with Janney Capital Market. Your line is now open. If your phone is mute please unmute, if your phone is on speaker phone please lift your handset.

Unidentified Analyst

Analyst

Okay, thank you. And then I had a question on [indiscernible] they are talking about [indiscernible] traffic I am not sure I totally get that. Do you guys have any thoughts on that. I wonder if you can differentiate your approach to HIV versus what the other companies are looking at how you are defining that? Thanks.

John Scarlett

Analyst

I think we have some cross lines here. You’re on the Geron call and we are not engaged with [indiscernible].

Anna Krassowska

Analyst

Operator, could you directly prompt please.

Operator

Operator

[Operator Instructions] Our next question comes from the line of Raymond Bolivi [ph], a private investor. Your line is now open.

Unidentified Analyst

Analyst

In the New England Journal of Medicine article, there was some question raised in terms of the mechanism of action of Imetelstat and the question was raised with regard to how accurate your measurements of the telomeres were? How confident are you that the mechanism of action is actually telomerase inhibition?

John Scarlett

Analyst

Yeah it’s a good question thank you very much. Well we’re very confident that Imetelstat is a telomerase inhibitor that I can tell you for sure. Companies done many, many studies and both preclinically and using clinical materials and we can absolutely be confident that it is a telomerase inhibitor. I think the question of the exact mechanism of action by which it is exerting its effects in clinical trials of course remains open as it often does for many drugs as they progress through clinical development. There may be different mechanisms that come to the floor as both sciences continues on and as we do more work. However on the other hand, I think that all of the indications to-date certainly suggest that an important role is being played by telomerase inhibition. I think we continue to view this drug predominantly as a telomerase inhibitor. Sometimes it’s very difficult in clinical studies to accurately measure given depending on which types of clinical materials you’re using. It can be quite difficult to accurate measure telomerase inhibition. And I think that that’s just again a reflection often of the polytrophic nature of clinical trial materials that you are able to access. But I think overall, we continue to view this very much as a telomerase inhibitor and that’s a very important and critical and differentiating part of its activity. So thank you.

Operator

Operator

Our next question comes from the line of Edward Levy with [indiscernible] Health Wealth management. Your line is now open.

Unidentified Analyst

Analyst

Hi Chip this is Ed Levy and we haven’t talked in a while, but I am excited about the direction of that Geron is going right now and I want to give you a lot of thanks for that. I have a couple of questions; the first question involves the uncertainty of the opt in by Janseen. And it’s understood that a prerequisite for opting in would be continuation. But if Janseen internal reviews later this year are very positive does that prevent Janseen from opting in or do they have to wait for continuation?

John Scarlett

Analyst

So good question thank you very much. First of all we ought to get our terminology right. So the terminology in our collaboration agreement is a continuation decision. So what you’re kind of referring to is as an opt in generically is actually treated in all of our documents and all of our materials that we put out as a positive continuation decision or an affirmative continuation decision. That means that Janseen continues to maintain their license or worldwide exclusive license to the drug and continues to develop the drug worldwide. With regard to your -- the more specifics of your question if I understand it correctly the question was do they have to wait if you will to the end of the conclusion of the primary analysis in the MS study or would it be possible for them to continue to make a positive or from the continuation decision earlier. It is possible however, I don’t -- I think the way the agreement is structured there is really not a very power motivation for them to do that. And so that will probably take us going into the agreement a little more detailed than we have time or the ability to do. But I can simply say it is possible and it is also possible because they hold a fully paid license today. They can start additional studies potentially without having to actually make that continuation decision. So they have a lot of flexibility and I wouldn’t be really thinking too much about the precise timing and nature of that continuation decision. Of course if it does -- if it never comes than it’s very important. But I think they have a lot of flexibility and therefore I wouldn’t be necessarily expecting them to make an early continuation decision. I would watch the space for actual activities that occur and the actual studies and so forth. And I think that's going to give you the most information about the prospects of the drug in their hands.

Unidentified Analyst

Analyst

So Chip what you’re saying basically is that Janseen can advance a Imetelstat forward in other indications like AML for example without opting in is that possible?

John Scarlett

Analyst

Yes that is possible.

Unidentified Analyst

Analyst

Okay, that’s good answer. And one final question, if the internal reviews are good does John or Janseen have any timelines involving application for breakthrough therapy designation?

John Scarlett

Analyst

So we as you probably have gathered by following this for as long as you have Ed. We generally refrained from making predictions or commentary about regulatory matters such as that. We usually just announce them when and if they occur. And I think that we’re going to continue with that. It’s the smart thing to do both for our relationship with regulatory health authorities and also for our competitive situation with other companies. So I think we’re going to have to decline on that one.

Unidentified Analyst

Analyst

Okay good. I do have some ideas about possible diversification strategies. So I’d like to talk to you at some point in the future about that.

John Scarlett

Analyst

Thank you very much for your questions.

Unidentified Analyst

Analyst

I know you don’t need my advice but okay.

John Scarlett

Analyst

Thank you very much alright, bye-bye now.

Unidentified Analyst

Analyst

Bye.

Operator

Operator

This does the Q&A portion of the call. I would now like to turn the call over to Dr. John Scarlett CEO for further remarks.

John Scarlett

Analyst

Well thanks very much everyone for taking the time to listen to the call. We appreciate your continued support and interest in the company. Good evening. Bye-bye.