Earnings Labs

BioLineRx Ltd. (BLRX)

Q1 2014 Earnings Call· Tue, May 20, 2014

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2014 Conference Call. All participants are present in listen-only mode. Following the managements formal presentation, instructions will be given for the question-and-answer session. (Operator Instructions) I would now like to turn the call over to Josh Drumm of Tiberend Strategic Advisors to read the Safe Harbor statement. Josh, please go ahead.

Joshua Drumm

Management

Thank you, operator. 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 indeed forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLine’s business, financial condition and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in BioLineRX’s annual report on Form 20-F, quarterly reports that we filed in a 6-K and other reports filed by BioLineRX with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BioLineRx expressly disclaims any intent or obligation to update these forward-looking statements. At this time, it is my pleasure to turn the call over to Mr. Phil Serlin, Chief Financial and Operating Officer of BioLineRx. Phil, please go ahead.

Philip A. Serlin

Management

Thank you, Josh. And thank you all for joining us this morning. Before I begin, I just want to point out that part of our call this morning will be accompanied by a brief slide presentation. We filed the presentation about 15 minutes ago, so you can find on the EDGAR website or in the SEC filings listed in the investors section of our website www.biolinerx.com. Before we address the slide presentation Dr. Kinneret Savitsky, our CEO and I would like to make some general statements regarding our recent progress and discuss our overall strategies for advancing our clinical pipeline. We anticipate this call to be relatively brief, as we have multiple active clinical and pre-clinical programs ongoing with anticipated milestones concentrated in the second half of this year and early next year. This quarter we were focused primarily on advancing our pipeline, particularly on progressing our lead clinical program in oncology and immunology which Kinneret will discuss in greater detail. We are very happy to have the financial flexibility to execute on this more focused, more aggressive clinical strategy which we believe will result in BioLine achieving several potentially transformative milestones in the next quarters. We expect potential success in these high value and orphan drug opportunities to translate into significant partnership interest and added value for our shareholders. While our primary strategic focus is on clinical research and development, we will continue to leverage our deep expertise and extensive academic network to identify promising therapeutic opportunities. Our strength in this area has been proven by our ability to advance handpicked early stage programs into the clinic. And we intend to continue to foster these relationships. There maybe additional opportunities to capitalize on our drug screening capabilities and we will be exploring this as an additional value driver for BioLine. In addition, we’ve continued to seek and secure collaborative and licensing partnerships for our pipeline assets and these efforts will remain at the forefront in parallel with our R&D efforts. With that, I will hand the call over to Kinneret, who will provide a brief overview of our upcoming milestones for our lead clinical programs. And then move into the slide presentation for some additional detail on these and other select programs from our pipeline.

Kinneret Livnat Savitsky

Management

Thanks, Phil, and good morning everyone. As we mentioned we have a great deal of clinical activity ongoing at the moment with several upcoming milestones that I’d like to review for you now. BL-8040 is our most advanced and robust in-house clinical program, which we see as an oncology platform for hematological indications. It is currently being evaluated in three different oncology indications two at BioLine in AML, acute myeloid leukemia and stem cell mobilization as well as an investigator-initiated phase 1/2 study in CML or chronic myeloid leukemia, which we announced following our year-end conference call for 2013. We have received orphan drug status from the FDA for both the AML and stem cell mobilization indication. We anticipate reporting final data from our ongoing Phase 2 study in AML in early 2015 which follows the positive partial data we reported from this study at the end of last year. We also expect to enter the clinic with BL-8040 for stem cell mobilization in the next few months which results in the second half of 2014 and anticipate initiation of the investigator-led phase 1/2 study in CML later this year. Our unique program for celiac disease BL-7010 is also progressing according to plan. In March we reported positive safety and tolerability results from the single administration dose escalation part of our Phase 1/2 study. And we are currently completing the repeated dose stage for which we expect to report results mid 2014. Upon similar favorable results, we would expect to move forward with randomized controlled efficacy study before the end of 2014. We expect this clinical milestone to be the primary value drivers for BioLine over the next six to eight months, which is why we have chosen to focus the majority of our resources on executing on them successfully.…

Philip A. Serlin

Management

Thank you, Kinneret. If you all turn to Slide 9, you can see that we completed a significant financing in early 2014, we raised $24.1 million in underwritten public offering at ADS’s. Roth Capital was the lead and Maxim with co-managers. Our financing included 1.2, almost 1.3 million ADS’s to cover an over-allotment option and it was significantly oversubscribed and we feel it was a very successful offering. This offering broadened our U.S. institutional base our ADS’s were purchased by high caliber institutions. And U.S. investors now hold roughly two-thirds of our outstanding shares. It also has put us in a strong cash position we have $37.5 million at March 31, 2014 this funds our operational capital through the end of 2016. And we also expect to reach several value inflection points during this period. If you all turn to Slide 10, we will now review the expense categories. Research and Development first our total R&D expenses decreased by $2.8 million to a total of $2.7 million in Q1 2014 this results primarily from the termination of the BL-1020 CLARITY trial that we terminated in March 2013. And the decrease was partially offset by a ramp up in spending on a lead clinical stage development programs BL-8040 and BL-7010. As far as sales and marketing is concerned S&M expenses increased by $0.2 million to $0.4 million in Q1 2014, and this increase resulted primarily from professional fees that were connected with increased business development activities. Our G&A expenses were very constant both between Q1 2013 and Q1 2014 and amounted to $1 million for both quarters. Financial income and expenses, net financial income was $0.3 million for Q1 2014, compared to net financial expenses of $0.4 million for Q1 2013 and these changes primarily result from changes in the average…

Operator

Operator

Thank you. Ladies and gentlemen at this time we will begin the question-and-answer session. (Operator Instructions) Your first question is from [Saleem Kashif] (ph). Please go ahead.

Unidentified Analyst

Analyst

Hi, good afternoon. I’m private investor and I invest in the company, but I’m so disappointed and frustrated because there is no correlation between your declaration and your presentation on what you are saying declaration and the reality. All the time you keep changing the dates and for all results of the [clinical phase] (ph) that are occurring. And I would like, as a private investor to know what you are doing to regain the trust of the private investors?

Kinneret Livnat Savitsky

Management

Regarding our AML program the BL-8040 we didn’t have any delay, we announced the partial results sometime by the end of 2013 with encouraging results regarding the end of the escalating stage. We’re still saying that the results will be in mid this year. I have to say that, its bit hard to give a very clear timeline since it’s hard to forecast exactly at what core – which those you’re going to stop and continue to the escalating stage of the study. And therefore, it’s a bit hard to give a very clear timeline regarding the exact timing of when we’ll move to the next phase of the study. The same and also regarding to the celiac program, we mentioned that the final results will be in mid 2014, we are still saying that the top-line results will be at the same timing that we mentioned before. There is no change in the timeline, also we expect to start the next study, if everything will be according to plan and there will be no toxicity issues this year and nothing has changed from this angle as well.

Unidentified Analyst

Analyst

Thank you.

Kinneret Livnat Savitsky

Management

You’re welcome.

Unidentified Analyst

Analyst

I have another question – may I ask another question.

Kinneret Livnat Savitsky

Management

Yes, please.

Unidentified Analyst

Analyst

Kinneret Livnat Savitsky

Management

So this is something that could be changed in – based on the plans that we discussed in the previous calls that we had with investors. And this is because this discussions are advancing and we feel that the direction that our potential partners are taking the compound is into other indications. And therefore we feel that it will be wrong to start this seborrheic keratosis study as we planned. Although, we have all the approval from the German authorities and if something will change we will consider conducting the study as planned. The discussions are advancing as we expected I have to say on the one end and the other end we need to take into account that this discussions takes time and we expect still to reach an agreement hopefully in the next six months or so.

Unidentified Analyst

Analyst

?:

Kinneret Livnat Savitsky

Management

Yes, we do have several channels in Israel in order to be available for Israeli investors as well. Last week we were giving, we were participating in a panel in Tel Aviv from Oppenheimer. Last year we were in another forum that we gave a presentation called sponsor forum. So we do have several conferences and meetings with Israeli investors on a regular base as well.

Unidentified Analyst

Analyst

Thank you a lot. And have a good day.

Kinneret Livnat Savitsky

Management

Thank you.

Unidentified Analyst

Analyst

Thank you a lot.

Operator

Operator

Your next question is from Bert Hazlett of Ladenburg. Please go ahead. Bert C. Hazlett – Ladenburg Thalmann & Co., Inc.: Yes, good morning. My apologies I may have missed some of the commentary, but just regarding BL-8040. As you consider it more broadly as you gain experience with it in the clinic in AML and stem cell mobilization and maybe soon to be CML. Is your experience or instincts telling you to broaden the consideration of this molecule or they telling you to focus it more on let’s says specific indication like AML or stem cell mobilization. Do you have a sense of how you might handle it just given those two scenarios at this point?

Kinneret Livnat Savitsky

Management

Thanks, Bert. Yes, we do feel that the right thing will be to broaden the indications that we are looking at for BL-8040 based on the data that we have so far, the fact that we know that the compound works as a standalone both from mobilization and also for apoptosis do give us positive or do show the potential of the compound in other indications as well. We need remember that we started with very difficult patients here these are reluctant and refractory patients. And we do feel that it will be right to try and look at the activity of the compounds in other indication. In the last ASH conference we showed some pre-clinical data in FLT3 mutations I think this is the one of the directions that you would like to consider, there are other indications that we are discussing internally just too early to talk about it, but once we’ll make our decision of course we will announce it. Bert C. Hazlett – Ladenburg Thalmann & Co., Inc.: Terrific, and then again my apologies I may have missed it. But what are the options that you are considering with Bellerophon broadly, what can you do, what do you think you will do at this point and just kind of the roadmap for your options for the next several months?

Kinneret Livnat Savitsky

Management

So unfortunately I cannot discuss this issue I just have to say that we’re talking to Bellerophon on a constant basis. We do see this study as an important study and we won’t jeopardize it. But I cannot disclose any more information. Bert C. Hazlett – Ladenburg Thalmann & Co., Inc.: Okay, I figured a try. Thank you very much.

Kinneret Livnat Savitsky

Management

You’re welcome.

Operator

Operator

(Operator Instructions) There are no further questions at this time. Before I ask Dr. Kinneret Savitsky to go ahead with her closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1866-276-1485. In Israel, please call, 039-255-945. Internationally, please call 9723-925-5945. Dr. Savitsky, would you like to make your concluding statement?

Kinneret Livnat Savitsky

Management

Yes, thank you. I want to thank all of you for joining us today. We hope we have successfully highlighted the many significant catalyst, we have in the next 12 months or so. We are committed to executing our clinical strategy both for our internal program as well as with our partners. And we are very well funded to achieve our planned clinical milestones. Our primary goal is to demonstrate the clinical value of our lead compounds effectively in well designed human studies in order to drive favorable valuations for these programs among potential partners. We are well on our way in this regard and we look forward to updating the market on our continued progress. We thank you again for joining us today and for your support. Good bye.

Operator

Operator

Thank you. This concludes the BioLineRX first quarter 2014 conference call. Thank you for your participation. You may go ahead and disconnect.