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BioLineRx Ltd. (BLRX)

Q4 2013 Earnings Call· Mon, Mar 17, 2014

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Fourth Quarter and Year-End 2013 Conference Call. (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.

Josh Drumm

Management

Thank you, Nancy. 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 performances 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 segments. BioLineRx expressly disclaims any intent or obligation to update these forward-looking statements. At this time, it is now my pleasure to turn the call over to Dr. Phil Serlin, Chief Financial and Operating Officer of BioLineRx. Phil, please go ahead.

Phil Serlin

Management

Thank you, Josh. I'd just like to point out to everyone on this call that our quarterly call is in the form of a presentation. And you can find the presentation on the EDGAR website that was filed 15 minutes ago, as well as on BioLine's corporate website in the Investor page under Events. Now I'd like to turn to Slide 3 in the presentation. It's our pipeline slide. One of the things that I think you'll notice is our pipeline slide has changed over the last year and we are now showing specifically two lead development programs, BL-8040 that's indicated for AML and stem cell mobilization. Our AML program is in the Phase 2 at the moment. And stem cell mobilization, we should be starting a Phase 1 some time in the next few months. And also BL-7010 for celiac disease, which is currently in the Phase 1/2, and Kinneret will speak about those momentarily. We also have three additional development programs. These are programs that we are moving forward, but our lead development programs where we're spending the vast majority of our development spend. We also have four programs that are partnered or in co-development, the most important of which is BL-1040 for – to prevent ventricular remodeling post-AMI and that's partnered with Bellerophon, which formerly was Ikaria. And that's in a phase - a pivotal study for CE Mark registration. I'd now like to turn the call over to Kinneret who will go more specifically, more deeply into our pipeline.

Kinneret Savitsky

Management

Thank you, Phil. Today we would like to give a brief summary of how our 2013 major events and I'm turning to Slide 5. Let me start with where we are today. Our current pipeline is focused on oncology and immunology. We have two lead programs in our portfolio, BL-8040 for AML, stem cell mobilization and other hematological indications; and BL-7010 for celiac disease. We are very well financed to achieve our major milestones, especially for these two compounds. Besides the programs, we also have found several partnerships besides BL-1040, the agreement with Bellerophon that as Phil mentioned formerly known as Ikaria. In 2013, we signed three collaboration agreements and I will elaborate on this in a minute. We have two new Board members, Dr. B.J. Bormann and Dr. Sandra Panem, who will give us significant value. Both of them are bringing strategic business development and capital market expertise and it shows our commitment to the US market. I will now turn to Slide 6. In 2013, we moved our key programs. BL-8040, we reported our partial results for the Phase 2, and we also achieved orphan designation by the FDA. Regarding the stem cell mobilization, we've made the regulatory submission for the Phase 1, and we expect to start this study in the next month or two. For this indication, we also achieved an orphan designation from the FDA. Regarding the celiac program, BL-7010, we started the Phase 1/2 study. And a week ago, we announced the completion of a single administration stage. We are now moving to the repeated administration and I will elaborate on this in a few minutes. And regarding the skin lesion projects, BL-5010, we received regulatory approval to commence the pivotal CE Mark registration study. This is a small study of 20 patients [as…

Phil Serlin

Management

Thanks, Kinneret. I'm on Slide 12. So as many of you know, we can see the significant financing. In the last few weeks, we raised a gross amount of $24.1 million in an underwritten public offering of American Depository Shares. Roth Capital was the lead book runner on the deal and the Maxim Group was co-manager. It included $1.3 million in ADSs to cover an over-allotment option. It was also significantly oversubscribed. The financing broadened significantly our US institutional investor base. The ADSs were purchased by high caliber institutions and US investors now hold about two-thirds of our total shares outstanding. This financing puts us in a very good position. It provides us with at least three years of operational capital, and the proceeds will be used primarily to advance our lead programs, BL-8040 and BL-7010 to meaningful inflection points. Now on Slide 13 with a financial overview, this analysis is in US dollars at the December 31, 2013, exchange rate. Our R&D expenses in 2013 decreased from 2012 by $5.8 million. This decrease includes a $1.7 million one-time reversal of a liability of the Office of the Chief Scientist in Israel. So on a normalized basis, our R&D spend decreased by about $4 million. And this decrease primarily resulted from lower expenses in 2013 associated with the CLARITY trial for BL-1020, which as you know we terminated in March 2013. So the expenses in 2012 were much more significant than 2013. And these lower expenses were partially offset by a significant increase in spending on our two lead programs, BL-8040 and BL-7010. Sales and marketing expenses increased by about $300,000 in 2013. This primarily results from increased business development activities and also expenses associated with our JHL collaboration agreement, which Kinneret earlier mentioned. I'm on Slide 14, G&A. It…

Operator

Operator

(Operator Instructions) The first question is from Bert Hazlett of Roth Capital Partners.

Bert Hazlett - Roth Capital Partners

Analyst

I have a couple of questions regarding 8040, the CXCR4 program and just one on 5010. First, on 8040, you'll get the initial stem cell mobilization results sometime relatively shortly in the 2014, as you mentioned. Given the data you already have in hand, some of the data with the stem cell mobilization, is there an ability to move rapidly with that specific indication maybe more rapidly than in AML and just a little color on that?

Kinneret Savitsky

Management

We have clinical data on stem cell mobilization from the multiple myeloma studies. With the Phase 1/2 study, that was conducted still by Biokine, the company that we end licensed the product from. Based on this study, they showed robust mobilization in the highest dose that was tested in this study. In one [authorization] [ph], they collected enough stem cells that are needed for the transplantation. So this was encouraging. But right now, the study that we're planning to run is in healthy volunteers, and this is the first time that we are going to check the activity of BL-8040 in healthy volunteers for allogeneic transplantation. And we don't know this activity and it's something that we still need to learn. But of course, we're planning to look for autology and also allogeneic activity of stem cell mobilization. But we believe that we can go and maybe have a [inaudible] development path, but it also depends on the agencies. And since AML is a difficult disease with no medications, new medications in the last three decades or so, we believe that maybe it will be able to seek for a conditional approval. So we still are to know which one will have a faster track.

Bert Hazlett - Roth Capital Partners

Analyst

I guess shifting to 7010, the gliadin polymer for celiac disease, you'll get data with regard to the systemic absorption or the systemic availability of that compound. How important do you think that's going to be in terms of licensing that program ultimately?

Kinneret Savitsky

Management

So in the Phase 1/2 study that we're running in Finland, as you mentioned, we are going to check the systemic absorption, we're going to collect and we are collecting also in the single administration stage urine and blood samples. We believe that based on previous discussions which we had with an (inaudible) body and also with the Finnish authorities, Valvira, that if we show no absorption or limited absorption, we might receive a device designation, meaning that it's a bit different regulatory path, and we believe that this might bring the product earlier to the market, at least in Europe. This designation is unique for the European authorities and we are planning to start also and move toward the US market as well. And our idea is to go to a pre-[IND] [ph] meeting with FDA in Q3 after we have the safety from this study. Now, the chemists are producing the product. So although it can be defined maybe as a device in Europe, we still believe that the companies that are relevant for this product are global drug companies. And therefore, I don't think this matters. And what matters is that since we might see a different regulatory path, we might reach the market earlier and this would count I believe.

Bert Hazlett - Roth Capital Partners

Analyst

And then just a brief one on 5010. You do get pivotal results in seborrheic keratosis. I know you have the additional studies upcoming. But could you just give us a status update with regard to partnering of 5010? Thank you.

Kinneret Savitsky

Management

In the report, we mentioned that we are in meaningful discussions with the companies on this program. I cannot disclose much more about these discussions. They are taking time and it's not something that you are signing in a month or so. But we decided not to wait and till the agreement will be signed, we decided to continue with our development plans and we are going to enter this study as soon as we are ready for this [inaudible].

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 US, please call 1888-269-0005. In Israel, please call, 039-255-938. Internationally, please call 9723-925-5938. Dr. Savitsky, would you like to make your concluding statement?

Kinneret Savitsky

Management

Yes, thank you. I would like to emphasize the fact that 2014 is a significant year for us. We have important studies that will reach significant milestones in the next 12 months. This includes AML, the stem cell mobilization, the celiac and the acute myocardial infarction studies. In addition, we will stay focused on our oncology and immunology indications. We have the funding and expertise to support our lead programs in order to make sure that we can leverage the deals and position BioLine as an important player in this industry. So thank you very much for your time.

Operator

Operator

Thank you. This concludes the BioLineRX fourth quarter and year-end 2013 conference call. Thank you for your participation. You may go ahead and disconnect.