Earnings Labs

BioLineRx Ltd. (BLRX)

Q4 2012 Earnings Call· Tue, Mar 12, 2013

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Transcript

Operator

Operator

Ladies and gentlemen, welcome to the BioLineRx 2012 Year End Conference Call. All lines have been placed on mute to prevent and background noise. After the speakers’ remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, then the number 1 on your telephone keypad. To withdraw your question, press star, and then number 2. Thank you. I would now like to turn the conference over to Mr. Garth Russell of KCSA’s strategic communication. Sir, you may begin your conference.

Garth Russell

Management

Thank you. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call other than historical facts, are forward-looking statements. The words, anticipate, believe, estimate, expect, in time, guidance, confidence, target, project, and other similar expressions, typically are used to identify forward-looking statements. These forward-looking statements are not guarantees of future performances that may involve risks and uncertainties and other factors that may affect BioLine’s business, financial conditions, and other operating results, which include, but not limited to the risk factors and other qualifications contained in BioLine’s annual report on form 20-F quarterly report that will be filled in a 6-K and other reports filed by BioLine with the SEC to which we’re attaching. Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward-looking segments. BioLine expressly disclaims any intent or obligation to update these forward-looking statements. At this time, it’s now my pleasure to return the call over to Dr. Kinneret Savitsky, Chief Executive Officer of BioLine. Kinneret, the floor is yours.

Kinneret Savitsky

Management

Thank you, Garth. Welcome everyone, and thank you for joining our 2012 year end conference call. Joining me on today’s call is Phil Serlin, our Chief Financial and Operating Officer. Today, we will give you an update of the progress of our therapeutic pipeline. After our prepared remarks, Phil and I will be happy to answer any questions you may have. With that said, let’s get started. If we take a look back, 2012 was a very productive year for the company which had carried through into 2013. We have a strong pipeline of programs which continues to extend with promising new therapeutics that address large healthcare concerns and could greatly impact patient’s life. We also have expanded our ability to fund the development of our deep portfolio through 2014 which doesn’t take into account potential out licensing agreements or milestone payments from our existing partner. Today, I’m going to review some of the milestones over the last year, with the majority of my remarks focused on updates for just a select group of our programs. While I’d love to get into each program, we have limited time on this call. For those of you interested in hearing more about a particular program, I recommend visiting our website and listening to the audio from our first analyst day, in December, in New York, along with the slide presentations. During the analyst day, we spend a lot of time covering the details of a number of our programs, and I think you will find it very informative. I am sure you are all aware by now, that we are conducting an interim analysis on our ongoing Phase 2/3 CLARITY study for BL-1020, one of our lead programs for the treatment of schizophrenia. This analysis is being performed on beta from approximately,…

Phil Serlin

Management

Thank you, Kinneret. As Kinneret previously mentioned, I am also very excited by the positive momentum within our pipeline. I also wanted to comment on the fact that 2012 was the first full year of trading for our American depository shares on NASDAQ. We have put in a lot of time and effort in increasing the awareness of BioLineRX among US investors over the last 18 months. In fact, we attend at least one investor conference per quarter. We have held well over 100 investor meetings. We also just held our first analyst and investor day in New York this past December. As a result of these efforts, currently almost 50% of our share holdings are held by North American investors and we now have two US-based analysts covering the company from Roth Capital and Aegis Capital. We hope that as awareness of BioLineRX continues to increase in the US financial market, the valuation placed on our stock will more closely reflect the value we believe exists in our pipeline. Now, turning to the financial for the year ended December 31st, 2012. I would first like to mention that although our primary reporting currency is the Israeli shekel, for the convenience of the listeners on this call, the analysis will be done on a dollar-basis only. The translation into dollar has been done at the representative rate of exchange as of December 31st, 2012 of ILS3.733 to the dollar. Research and development expenses in 2012 were $17.2 million, an increase of $5.8 million or 51% compared to $11.4 million in 2011. The increase resulted primarily from significantly higher expenses in 2012 associated with the CLARITY clinical trial and respective BL-1020, which commenced at the end of June 2011 and was still in its initial ramp-up stages during the third and…

Kinneret Savitsky

Management

Thank you, Phil. We continue to execute our strategy, which remains focused on performing diligence and discipline testing to ensure the utmost success rate for each compound that enters clinical development. We also believe in being opportunistic in this very dynamic and risky industry. For example, over the last two years, we unlicensed two clinical stage assets on an opportunistic basis and entered full force into the oncology scene. We believe that our staff’s diverse experience as well as expertise in the oncology space, among others, allowed us to proactively move on these opportunities and many others that may present themselves in the future. 2012 has been a year of substantial achievement for BioLine. We have made significant progress on multiple fronts, many of which are expected to come to key value inflection points in the near future. The next few weeks are expected to be eventful as we receive the interim analysis of the CLARITY trial for BL-1020, as well as the results of the phase 2 clinical study for BL-7040, our IBD treatment. We also await the beginning of clinical trials for two of our more promising compound in the very near future, including BL-8020 for the treatment of HCV and BL-8040 for the treatment of leukemia. Looking ahead, we will constantly evaluate our pipeline in order to develop the most cost-effective and markable therapeutics for the unmet medical needs that can make a real impact on global healthcare. Our expectation, our eye [ph] for 2013, is we expect certain material events to reach their targets. In closing, we remain focused on building our pipeline and continuing to do our part to commercialize our therapeutic candidates. Operator, we are now ready to open the call for questions.

Operator

Operator

Thank you. Ladies and gentlemen, we will begin the question-and-answer session. (Operator instructions) The first question is from Bert Hazlett of Roth Capital. Please go ahead. Bert Hazlett – Roth Capital Partners: Yes, Kinneret and Phil, thank you very much for the update and congratulations on all the progress during 2012. I have really two questions, first on BL-1020 and then, second, on the BL-8040, the CXCR4 program. First on BL-1020. Just quite frankly a little more clarity, no pun intended, with regard to the completion of that study. You have mentioned if the program continues to its – that study continues to its end, you would finish that up in the second half of 2013. Can you be any more specific with regard to when you might expect to finish? Is it fourth quarter? Or a little bit more information in terms of when that final result for that study might be available if you run it to its full length.

Kinneret Savitsky

Management

Yes. So regarding BL-1020, the study is expected to finish as long as we don’t need to recruit more than 450 patients in the fourth quarter of 2013. But as I mentioned before, it depends also on the number of patients that are needed. If we need to recruit less patients or more patients, that might change. Bert Hazlett – Roth Capital Partners: Okay, so 4Q. And you would expect partnering discussions to ramp up in earnest once the analysis is complete, whether it’s either shorter term or longer term.

Kinneret Savitsky

Management

We are already discussing this target with potential partners. We believe that even based on the interim results if the results will be clear and will show a nice – or a robust signal in cognition, and this is based on the number of patients that are needed to recruit for this study, this will probably accelerate the discussions with those partners. Bert Hazlett – Roth Capital Partners: Thank you for that. I appreciate it. And then with regards to BL-8040, that’s quite an exciting program, the CXCR4 program, how large a trial are you contemplating in AML and can you give us a sense of timing of that trial, the start, and how long it might take?

Kinneret Savitsky

Management

We didn’t disclose the information yet since we’re still in the process of building the protocol, doing all the submissions, and it’s a bit too early. I can just say that it’s going to be a Phase 2 study on several tens of patients, probably resistant patients. I can mention that the first phase of the study will be an acceleration phase, and then second phase of the study will be the highest dose, a bigger number, or bigger group of patients if we continue the highest dose that was tested in the study, that will be tested in the study. Bert Hazlett – Roth Capital Partners: Thank you for that as well. And I know it’s very early days with that program, but at this point, are you contemplating additional indications of beyond AML, or would that be something for a partner to consider with that compound?

Kinneret Savitsky

Management

No, we are planning to start an additional study either one or two, it’s still under discussion, and I assume that we will start with the next study probably in the second half of 2013. Bert Hazlett – Roth Capital Partners: Thank you. Very much looking forward to the results of both programs. Thanks very much.

Kinneret Savitsky

Management

Thank you.

Operator

Operator

The next question is from Robin Davidson of Edison Investment Research. Please go ahead. Robin Davidson – Edison Investment Research: Hello there. Greetings from London. I just wanted, because I can’t remember the exact details, but can you remind me what’s the number of patients, the interim analysis in the CLARITY study will be based upon?

Kinneret Savitsky

Management

Yes, it’s going to be on 235 patients. Robin Davidson – Edison Investment Research: Right. Okay. What I was wondering, I’m looking at the inclusion criteria, I mean, these patients, are they likely to have been treated for a long period of time on Risperidone at the point of enrolment in the study? Is that correct?

Kinneret Savitsky

Management

Sorry. Can you repeat the question? Robin Davidson – Edison Investment Research: Yes. Are these patients likely to have been treated with Risperidone for a long period of time? Did they have to have the symptoms for at least a year? And possibly for more? That’s right, isn’t it?

Kinneret Savitsky

Management

Prior to the study? Robin Davidson – Edison Investment Research: Prior the study, as one entry.

Kinneret Savitsky

Management

These are acoustic reservation [ph] patients, so they are actually either after a washout period, but they will start getting both, either Risperidone or a BL-1020 for six months. Robin Davidson – Edison Investment Research: Right. Okay, I think that helps. The other thing as well, just on the – subscribe to the study, it’s a relatively small study and it’s a single arm. What we’ll see the sort of success in that trial for you?

Kinneret Savitsky

Management

So all together it’s, right now, plan to be a 450 patient study. I’m sorry, 7040, sorry, yes. Because proof-of-concept study, before we enter a bigger study, up to 30 patients, it’s an open label study, and what we would like to see is whether we can see signs of activity, and this is based on sigmoidoscopy. So it’s not just a subjective parameter, but also – not histology, but you get some samples of the inflammation in the Mayo score, based on the endoscopy that we are using in the study. And this is after five weeks of treatment. Robin Davidson – Edison Investment Research: Right. You haven’t set a particular target in your mind of the level of benefit or the number of patients...

Kinneret Savitsky

Management

We would like to see a reduction of three points in the Mayo score. Robin Davidson – Edison Investment Research: I see, all right. Okay, excellent. Thank you very much.

Kinneret Savitsky

Management

You’re welcome.

Operator

Operator

The next question is from Steven Tepper of Harel Finance. Please go ahead. Steven Tepper – Harel Finance: Hi Phil and Kinneret. Just a small question on the BL-1020. I understand next week will be the week where you reveal the interim analysis but [inaudible], trying to think of what kind of figures we could see there. What would be the amount of patients that the interim analysis lets you do in large, the sample group? Like what would be the figure where you would have to say this is too large of a sample group, and therefore I have to terminate the project?

Kinneret Savitsky

Management

So if I understand correctly, you’re asking what is the number of patients that we want to consider to continue with the study? And this is the more complex answer since the data that we will receive, the number of patients is not just on six weeks. We will also get the information on the three month and the six month. So we cannot decide a threshold at this point. We would like to see the full picture because if in six weeks, the signal won’t be as strong as in three months, or six months, it is still something that we would like to consider looking at since we would like to see the cognition effect is stable, and we expect the regulatory authorities to look at this longer time plot as well. Steven Tepper – Harel Finance: Okay. One additional question. In the past, of course you discussed the psychotic effects of the drug, so are we looking on a drug that will be used standalone and to treat cognition while we have also the anti-psychotic effect, or for some reason, the drug will have to be combined with other anti-psychotic drugs?

Kinneret Savitsky

Management

Yes. So it’s going to be a standalone drug. It’s not going to be combined with additional anti-psychotic. This is why we’re starting the study with acoustic reservation [ph] patient. The first phase of the study is six weeks in which we’re stabilizing the patient either on BL-1020, or Risperidone. And once the patients are stabilized, we can continue measuring the cognition at longer time points, three months, and six months. So we have all the information on the patients. The study also – the PANSS data, so we can know about the psychotic level of the patient. Steven Tepper – Harel Finance: Thank you.

Kinneret Savitsky

Management

You’re welcome.

Operator

Operator

(Operator instructions) To go ahead after closing statement, I would like to remind participants, that a replay of this call 774560009, in Israel, please call, 039255927, internationally, please call 97239255927. Dr. Savitsky, would you like to make your concluding statement?

Kinneret Savitsky

Management

Thank you all for joining us today. We are excited about the continued development of the company’s program. We appreciate your support and commitment to BioLineRx. And we will continue to update you of our progress. Thank you very much.

Operator

Operator

Thank you. This concludes the BioLineRx fourth quarter 2012 conference call. Thank you for your participation. You may go ahead and disconnect.