Earnings Labs

BioLineRx Ltd. (BLRX)

Q4 2017 Earnings Call· Tue, Mar 6, 2018

$2.69

+20.41%

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Fourth Quarter and Full Year 2017 Conference Call. All participants are at present in listen-only mode. Following the management's formal presentation, instructions will be given for the question-and-answer session. [Operator Instructions]. I would now like to turn the call over to Ms. Vivian Cervantes of PCG Advisory to read the Safe Harbor statement. Vivian, please go ahead.

Vivian Cervantes

Analyst

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 BioLineRx'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 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 now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Philip Serlin

Analyst

Thank you, Vivian, and good morning, everyone. Thank you for joining us on our fourth quarter and year-end 2017 earnings conference call. We issued our year-end earnings results earlier this morning and you will find a copy of the press release in the Investor Relations section of our Web site. Our results were also filed as a 6-K this morning along with our annual report on Form 20-F. Our agenda today is as follows. We will begin with a review of our programs and activities following by a discussion of our financial results. We will also enumerate our major target milestones for 2018 and open up the call to your questions. Joining me on today's call are Mali Zeevi, Chief Financial Officer; as well as Abi Vainstein, Vice President, Clinical and Medical Affairs; and Ella Sorani, Vice President, Development who will be available for Q&A at the end of the call. To begin, 2017 was a significant year for the company as we made important advancements in our principal clinical development programs. In this respect, we made key strides in three areas. First, our development of BL-8040 in stem cell mobilization where we recently initiated our first Phase 3 registrational study; second, the study progress on our immuno-oncology programs with both Merck and Genentech. This includes our recently announced partial monotherapy results in pancreatic cancer in combination with Keytruda as well as the initiation of several Phase 1b/2 studies with Tecentriq. And third, execution of our growth strategy which included the acquisition of our second novel oncology drug AGI-134. To support these advancements, we strengthened our balance sheet during 2017 with financing transactions led by BVF Partners. I would also like to point out the very encouraging ongoing long-term survival results which we announced in December relating to our previously…

Mali Zeevi

Analyst

Thank you, Phil. Before I begin, let me invite you to review the filings we made this morning, which contain our financials, operating and financial review and press release for additional information. I will only go over two significant items on this call; research and development expenses and cash. Research and development expenses in 2017 were $19.5 million, an increase of $8.3 million, or 75%, compared to $11.2 million for 2016. The increase resulted primarily from higher expenses in 2017 associated with new BL-8040 clinical studies commenced during the third quarter of 2016 and during 2017, as well as spending on our new AGI-134 near-clinical project. Turning to cash. The company held $49.5 million in cash, cash equivalents and short-term bank deposits as of December 31, 2017. Our financial footing remains solid and provides us with the resources necessary to fully execute on our operational plans into 2020. With that, we have now concluded the formal part of our presentation. Operator, we are now opening up the call to questions.

Operator

Operator

Thank you. Ladies and gentlemen, at this time we will begin the question-and-answer session. [Operator Instructions]. The first question is from Jason McCarthy of Maxim. Please go ahead.

Jason McCarthy

Analyst

Hi. Good morning, Phil. Just a couple of questions. You showed really good data with T-cell infiltration on the pancreatic study there’s a small number of patients, but as we look forward to the top line data later this year and not just pancreatic, gastric and AML as well, for the combination study, what would you expect the response rate to be for a checkpoint monotherapy in these indications just to get a sense of what kind of data we might be looking for? And my second question is around the AML Phase 2b study. I know you haven’t publicly disclosed where enrollment is, but could you give us a sense of what would prompt you? What factors to do an interim analysis this year? Thank you.

Philip Serlin

Analyst

Okay. Hi, Jason. Thanks for asking. So let me answer the second question first. This study will probably complete enrollment of the Phase 2b or the BLAST study in consolidation AML. It will probably complete enrollment sometime towards the end of 2019 or into 2020 and we’ve noted that the top line results will probably be in 2020. We feel that it’s important for us to get a look at the data before 2020. And so we’re looking for enough events that will give us enough confidence in the data that we would like to show towards the end of this year. So we don’t know exactly when that will be. We’re working right now with our statisticians and we’ll have more information later in the year. But I believe that we’re looking at something towards the end of this year for the top line results – I’m sorry, for the interim results. Abi, would you like to answer the first question.

Abi Vainstein-Haras

Analyst

Yes. About the study tumor trial, as you know, we have several solid tumors trial in collaboration with Merck and with Genentech and basically in the area of pancreatic cancer, the expected response to the majority of the population of pancreatic cancer is what we know and publishers that written no response at all. In the area of gastric cancer, the data published is more with the Keytruda [indiscernible] and also the response rate in this group is very low. It’s around 13% of the patient responding. Then we have here a place to improve both the pancreatic treatment with immunotherapy as well as the gastric cancer.

Jason McCarthy

Analyst

Great. Thank you for taking the questions.

Philip Serlin

Analyst

Thanks, Jason.

Operator

Operator

[Operator Instructions]. There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his 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 1-888-326-9310. In Israel, please call 03-925-5901. Internationally, call 972-3-925-5901. Mr. Serlin, would you like to make your concluding statement?

Philip Serlin

Analyst

Yes. Thank you. I would like to thank all of you for joining us on today's call. We are excited about the potential of our therapeutic pipeline and encouraged by the data demonstrated to-date. We look forward to providing you with progress reports on our important milestones ahead. We appreciate your support and we thank you again for joining us this morning. Have a great day.

Operator

Operator

Thank you. This concludes the BioLineRx fourth quarter 2017 conference call. Thank you for your participation. You may go ahead and disconnect.