Earnings Labs

Geron Corporation (GERN)

Q2 2018 Earnings Call· Tue, Jul 31, 2018

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Geron Second Quarter 2018 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. As a reminder, this call maybe recorded. I would now like to introduce your host for today’s conference, Ms. Suzanne Messere. Ma’am, you may begin.

Suzanne Messere

Management

Thank you, Skyler, and good afternoon, everyone. Thank you for joining us today for Geron’s second quarter 2018 conference call. I’m joined today by Dr. John Scarlett, Geron’s President and Chief Executive Officer; and Olivia Bloom, the company’s Chief Financial Officer. Please find a copy of our second quarter financial press release issued earlier today on our website under www.geron.com/investors. On today’s call, management will share financial results from the quarter, review recent company events and then we will open it up for questions. A live webcast of the call is available on our website and will be archived for 30 days. 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 expectations, plans, timelines and prospects for the IMbark and IMerge clinical trials, including the Janssen is expected to make it’s Janssen continuation decision by the end of the third quarter of 2018, that Geron would be able to initiate a clinical trial in MDS in the first half of 2019, potential financial payments to Geron under the Janssen collaboration agreement and financial or operating projections or requirements of Geron. 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 whether the imetelstat data shows successful safety and efficacy in both IMbark and IMerge whether Janssen decides to continue developing imetelstat on the terms in the collaboration and license agreement. And if so, informs Geron, by the end of the third quarter 2018, and whether the FDA or other health authorities require that IMbark and/or IMerge be delayed or discontinued. Additional relevant detailed 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 SEC, under the heading Risk Factors, including Geron’s quarterly report on Form 10-Q for the quarter ending June 30, 2018. 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. I will now turn the call over to Dr. John Scarlett, Geron’s President and CEO. Chip?

Dr. John Scarlett

Management

Thanks, Suzanne. I would like to welcome everyone to our second-quarter conference call. By way of an overview since our last update, which we gave at our annual meeting in May, we’ve strengthened our balance sheet and made progress on our plans to address either scenario resulting from Janssen’s upcoming decision whether to continue imetelstat development, which we continue to expect by the end of the third quarter. As a result, we’re confident in our ability to manage our business effectively going forward. I’ll get into specifics on these points later on the call. Now I’d like to turn the call over to Olivia, our CFO, who will provide details on our financial results.

Olivia Bloom

Management

Thank you, Chip, and good afternoon, everyone. For the second quarter of 2018, we reported a net loss of $6.9 million or $0.04 per share, compared to $6.4 million or $0.04 per share for the comparable 2017 period. Net loss for the six months ended June 30, 2018 was $14.1 million or $0.08 per share, compared to $13.6 million or $0.09 per share for the comparable 2017 period. Revenues for the three months and six months ended June 30, 2018, were $208,000 and $526,000, respectively, compared to $174,000 and $711,000 for the comparable 2017 period. Revenues for the three months and six months ended June 30, 2018 and 2017, included royalty and license revenues under various non-imetelstat license agreement. With the adoption of the new revenue recognition accounting standard as of January 1, 2018, using the modified retrospective transition method, revenues for the three months and six months ended June 30, 2018 are presented under the new accounting standard but 2017 amount continue to be reported under accounting standards used historically, which causes a lack of comparability to the prior periods presented. Therefore the decrease in revenues for the six months ended June 30, 2018, compared to the same period in 2017 reflects not only a reduction in the number of active non-imetelstat license agreements and decreased product sales from license fees, but also a change in the counting method. We do not expect the adoption of the new revenue recognition accounting standard to have a material impact on our financial statement on an ongoing basis. Research and development expenses for the three months and six months ended June 30, 2018, were $3.2 million and $5.6 million, respectively, compared to $2.5 million and $5.9 million for the comparable 2017 period. The changes in research and development expenses for the three…

Dr. John Scarlett

Management

Thanks, Olivia. I’m going to first provide updates on the IMerge and IMbark trials. Then I’ll provide our thoughts of the components potentially influencing Janssen’s decision. I’ll finish with how we’ve been preparing to respond to each scenario once we’ve been informed of Janssen’s decision of whether they elect to continue development of imetelstat. First, a few comments on IMerge and myelodysplastic syndrome or MDS. As you, IMerge is a two-part clinical trial evaluating imetelstat in transfusion dependent patients with low or intermediate one risk MDS, who are relapsed after or refractory to prior treatment with an erythropoiesis stimulating agent or ESA. Part 1 of the IMerge is an open-label Phase 2 study. Part 2 is a double blind place controlled Phase 3 study that has not yet begun. The primary endpoint for both parts of IMerge is the rate or percentage of patients who achieved red blood cell transfusion independence or TI for at least an eight week period of time. On June 17th of this year, updated data from Part 1 of IMerge were presented at the 23rd Annual Congress of the European Hematology Association or EHA, in Stockholm. These updated data reflected a longer medium follow-up of 95 weeks as compared to the December 2017 presentation at the American Society of Hematology or ASH Annual Meeting at which time the follow-up was 66 weeks. Because the original inclusion and exclusion criteria for IMerge did not restrict the number or type of other prior MDS treatments of patient received before entering the trial. Part 1 of IMerge originally enrolled a total of 32 patients who had a variety of prior treatments. Among these original cohort of 32 patients, a subset of 13 patients had not received prior treatment with either hypomethylating agents or HMAs or lenalidomide and also…

Operator

Operator

[Operator Instructions] Our first question comes from George Zavoico with B. Riley FBR. Your line is now open.

George Zavoico

Analyst

Hi. Good afternoon, everyone. Hi, Chip. Hi, Olivia. Hi, Suzanne.

Suzanne Messere

Management

Hi.

George Zavoico

Analyst

Just basically two questions. The Phase 2 IMerge trial, the second cohort is still going and the follow-up was guided to be towards the end of the third quarter or fourth quarter for those actually 20 patients, if I’m not mistaken. And if the decision, sounds like the decision is going to be coming before that. If so, I mean, if Janssen decides to continue, they’ll continue to the trial, but what if they don’t, would you keep going with those -- with that cohort, you think?

Dr. John Scarlett

Management

Well, it kind of depends on what we see. We do expect to receive around the time of their decision or in advance of that evidence of how those patients have actually done and I think that we certainly would continue patients in that study if it looks like the data warranted it. But I do think that we will have enough data from the original 13-patient subset and the additional cohort of the 25 patients actually going to end up being enrolled, that hopefully we would be able to make some decisions on our own part based on those data, but we…

George Zavoico

Analyst

Okay.

Dr. John Scarlett

Management

… do expect to get some of that data before they…

George Zavoico

Analyst

Okay.

Dr. John Scarlett

Management

… put out the decision.

George Zavoico

Analyst

And I noticed that your -- thank you for that. I noticed your legal and consulting fees are just a little bit lower, originally unchanged. Is lot of that related to the upcoming Janssen decision? What -- can you provide any guidance as to what legal and consulting fees might be going forward?

Olivia Bloom

Management

Are you referencing in G&A area?

George Zavoico

Analyst

In the G&A area, yeah.

Olivia Bloom

Management

G&A, yeah, no, actually it relates to a number of other corporate activities. So, for example, as you know, we had a new equity in place this year to replace our old ones. So, there’s a lot of paper work surrounding that to put in a new equity plan in place, for example.

George Zavoico

Analyst

Okay. I was just going off the press release. You just said that it was due to higher legal and consulting fees. So, I guess, that is included that category then, I guess.

Olivia Bloom

Management

That’s correct.

George Zavoico

Analyst

I see. Okay. All right. That’s all for me. Thanks.

Dr. John Scarlett

Management

Got it.

Operator

Operator

[Operator Instructions] Our next question comes from Michael Kay with Kay Associates. Your line is now open.

Michael Kay

Analyst · Kay Associates. Your line is now open.

Thank you very much. A few questions. To this point, how much money has Janssen put into the project? And secondly, am I correct that Geron generally is just a one drug company? In other words, if it turns out that the imetelstat is not efficacious or safe or whatever, that will be the end of it? I mean, do you have any other irons in the fire or is everything depended upon the efficacy safety of this one drug?

Dr. John Scarlett

Management

So, I’ll take the latter first and we can address your first comment if we can address it, we’ll do so afterwards. So, you’re quite correct, Michael. Geron has one major asset, which is imetelstat. And I think you’ve laid out the possible outcomes in a case in which the drug doesn’t go forward then it’s not a very happy of them for the company. But we are dependent really on the one asset for the value of the company. I don’t know if we’re prepared to make any comments about Janssen’s.

Olivia Bloom

Management

We don’t actually have the information to be able to comment.

Dr. John Scarlett

Management

Yeah.

Michael Kay

Analyst · Kay Associates. Your line is now open.

Okay. One -- well, I appreciate your candidness. One more thing, if it turns out that Janssen elects to opt-out, then it wasn’t too clear, then will you try and get other major drug companies to take on the further development of the drug? Is that what you meant in terms of, if that scenario occurs?

Dr. John Scarlett

Management

I don’t think the decision’s really been taken if -- I mean the major point is, we would take the product forward assuming the data warranted, right? So we would move forward with the product, and right now we feel as if the MDS area, again, depending on the data that we see. But assuming that’s good, that looks very favorable for moving into the Phase 3 portion of IMerge study. So, I think that would be our first instinct. What we would do after that at once we have retransferred the drug back in and what the strategic decisions would be, I think, we would wait until we finish that set of activities and then we’ll consider other strategic options, which would include, as you pointed out, the possibility of doing another out license, out license in part of the geographies, no out license in taking the drug forward entirely on our own and so forth.

Michael Kay

Analyst · Kay Associates. Your line is now open.

Now, will that decision be made, I know it’s at the third quarter. Would that be in any time within the third quarter or it means the date ending the third quarter?

Dr. John Scarlett

Management

By the end of the third quarter.

Michael Kay

Analyst · Kay Associates. Your line is now open.

Or by the end roughly so, it could be, that gives some leeway in terms of.

Dr. John Scarlett

Management

That’s correct.

Michael Kay

Analyst · Kay Associates. Your line is now open.

Okay. Thank you very much.

Dr. John Scarlett

Management

You bet.

Operator

Operator

Our next question comes from Chad Messer with Needham and Company. Your line is now open.

Chad Messer

Analyst · Needham and Company. Your line is now open.

Great. Good evening and thanks for taking my question. And thanks for that overview Chip, of sorting out the scenario analysis of what’s -- that was very helpful. With respect to lease time on and if the drug doesn’t look like helping anyone and warrants to take forward I believe, the last call you referred to that as an unhappy event.

Dr. John Scarlett

Management

Indeed.

Chad Messer

Analyst · Needham and Company. Your line is now open.

We should agree there. Presumably though you still have a balance sheet to deploy and…

Dr. John Scarlett

Management

Yeah.

Chad Messer

Analyst · Needham and Company. Your line is now open.

… in the past I know you’ve had -- you’ve been undertaking a search for assets on the side of all this for quite some time. I just wondering if there’s any general comments that you could make about what that BD landscape looks like to you? Should you be back out there kind of comment through it?

Dr. John Scarlett

Management

Sure. Well, I can give you a little bit of history, Chad. Where we ended up last year, we actually evaluated upwards of five different opportunities for platforms of even companies, and I mean, five companies in a very deep way. However, we decided number of months ago that it was getting place enough for Janssen decision, that would make no sense to proceed with any of those transactions, whether any of those transactions would be available to us in the event that we wanted to react to them and whether they would still meet our criteria, I can’t comment on today. That’s total too forward looking. But I think what we can say is that there are interesting opportunities and as you quite rightly point out we do have a fairly healthy balance sheet that would allow us to go and look for some, I would hope, very attractive properties. But I don’t know, I can’t say anything more specifically about what we would do in that event. But thanks for bringing that.

Chad Messer

Analyst · Needham and Company. Your line is now open.

No. Very helpful. And just to hope and we’re looking at one of the other scenarios.

Dr. John Scarlett

Management

Exactly.

Operator

Operator

This does end the Q&A session. I’d like to turn the call back over to Dr. Scarlett for closing remarks.

Dr. John Scarlett

Management

Well, thanks for joining the call today, everybody. We do expect that the next time we speak with you will be after the Janssen decision has been made. And so, I’m personally looking forward to that moment very much. It’s been quite a long story here and I think we’re looking for the clarity that comes with that. Thanks.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This does conclude the program. You may now disconnect. Everyone have a great day.