BioLineRx Q2 2024 Earnings Report

BioLineRx EPS Results

• Actual EPS: $0.40
• Consensus EPS: -$3.20
• Beat/Miss: Beat by +$3.60
• One Year Ago EPS: N/A

BioLineRx Revenue Results

• Actual Revenue: $5.39 million
• Expected Revenue: $3.93 million
• Beat/Miss: Beat by +$1.46 million
• YoY Revenue Growth: N/A

BioLineRx Announcement Details

• Quarter: Q2 2024
• Date: 8/15/2024
• Time: N/A
• Conference Call Date: Thursday, August 15, 2024
• Conference Call Time: 8:30AM ET

BioLineRx (NASDAQ:BLRX) (NASDAQ: BLRX) is a clinical-stage biopharmaceutical company that discovers and develops novel small-molecule therapies to address unmet medical needs. The company focuses on identifying promising drug candidates through licensing and collaboration agreements with academic institutions and biotech innovators, then advancing these candidates through preclinical and clinical development stages. BioLineRx’s pipeline spans oncology, immunology and inflammatory diseases, central nervous system disorders and pain management.

Among its clinical programs, BioLineRx is advancing targeted cancer therapies designed to improve outcomes for patients with difficult-to-treat tumors. In immunology and inflammatory diseases, the company is developing novel agents that modulate key biological pathways to reduce disease activity with minimal side effects. BioLineRx also explores treatments for neuropathic pain and other central nervous system conditions, seeking to offer new therapeutic options where few effective treatments exist.

Headquartered in Modi’in, Israel, BioLineRx maintains strategic partnerships and licensing arrangements across North America, Europe and Asia to support its global development efforts. By leveraging a business model that combines in-licensing, co-development and out-licensing of assets, the company aims to maximize the value of its pipeline while managing development risk. BioLineRx collaborates with contract research organizations and clinical centers worldwide to conduct multi-site trials and accelerate the advancement of its drug candidates.

BioLineRx Q2 2024 Earnings Call Transcript

Key Takeaways

• BioLineRx surpassed its Q2 target by securing formulary placement at centers managing 37% of stem cell transplants (versus a 35% goal), doubled the number of ordering institutions, and remains on track for a 60% year-end target.
• Following the FDA’s approval of daratumumab- and lenalidomide-based quad induction therapy, which reduces progression risk by 60%, demand for Effexxa is expected to grow as this regimen becomes the new standard for multiple myeloma mobilization.
• Presentations at ASH and ISPOR highlighted that G-CSF plus Effexxa delivers superior efficacy, greater collection efficiency, and lower overall costs compared to G-CSF alone or G-CSF plus plerixafor.
• Two Phase 1 investigator-initiated sickle cell disease gene therapy trials (Washington University and St. Jude) are underway, with early WashU data anticipated in H2 2024 and the first St. Jude dosing expected in September.
• Q2 2024 financials featured $5.4 million in revenue (including $1.8 million from product sales), a $0.5 million net income versus last year’s $18.5 million loss, and a $40.1 million cash position funding operations into 2025.

Presentation

[Operator]

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx second quarter 2024 financial results conference call. All participants are presently in listen-only mode. Following management's formal presentation, instructions will be given for the question and answer session. I would now like to hand the call over to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.

[John Lacey, Head of Investor Relations and Corporate Communications at BioLineRx]

Thank you, operator. Welcome, everyone. Thank you for joining us on our second quarter 2024 results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K. I'd like to remind you that certain statements we make during the call will be forward-looking. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20-F and our quarterly reports on Form 6-K that are filed with the U.S. Securities and Exchange Commission.

[John Lacey, Head of Investor Relations and Corporate Communications at BioLineRx]

On the call today, we will have Phil Serlin, Chief Executive Officer of BioLineRx, Holly May, President of BioLineRx USA, and Mali Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A. At this time, it is now my pleasure to turn the call over to Phil.

[Phil Serlin, CEO at BioLineRx]

Thank you, John, and good morning, everyone, and thank you for joining us on today's call. Following our strong second quarter 2024 performance and the encouraging progress of our APHEXDA launch to date, I wanted to highlight that today's BioLineRx is a fully integrated leader in stem cell mobilization with promising label expansion opportunities. This is a stark change from last year, and we are well-positioned to deliver value to all of our stakeholders. I will begin with a brief update on the important progress that we are making on our APHEXDA launch, then turn the call over to Holly, who will go into our commercialization and lifecycle management progress in more detail. Mali will review our financial results, and then I will give a brief summary of our upcoming milestones. We will then open up the call for your questions. Let me begin with an APHEXDA commercialization update.

[Phil Serlin, CEO at BioLineRx]

Last quarter, we set an important goal. We said that among our targeted top 80 transplant centers, by the end of the second quarter, we would secure formulary placement at institutions managing 35% of stem cell transplant procedures. I'm happy to say that we surpassed this goal by June 30th, with formulary placement at institutions managing 37% of transplant procedures. We continue to make steady progress on this most important launch metric and remain on track to achieve our year-end target of 60%. Additionally, last quarter, we achieved formulary status at two of the largest transplant centers in the U.S., and we also doubled the number of centers ordering product. We are pleased with this continued positive momentum in only the second full quarter of our commercialization program.

[Phil Serlin, CEO at BioLineRx]

Each week, we learn about patients who have failed to collect enough stem cells on other mobilization agents, putting their path to transplant at risk. These patients were then given APHEXDA, and they achieved their stem cell mobilization goals, many in a single apheresis session. Transplant centers are seeing the tremendous efficacy that APHEXDA can provide in this new era for multiple myeloma patients, where patients more often are older and increasingly receive quad induction therapy, which can increase mobilization risk. In July, the FDA granted approval of an important quad therapy approach for transplant-eligible, newly diagnosed multiple myeloma patients, including daratumumab and lenalidomide, which can negatively impact stem cell yield. The approval was based on the tremendous efficacy results seen in the PERSEUS trial, which compared the quad therapy to the leading triple therapy. The quad therapy lowered the risk of disease progression or death by 60%.

[Phil Serlin, CEO at BioLineRx]

Physicians have been treating patients with quad therapies prior to this approval. However, we believe that the data from this trial and the subsequent FDA approval will accelerate the process of quad therapy becoming the new standard of care, which, while beneficial to patients, has the potential to further increase the need for APHEXDA. Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma in this new era of care for patients. At this point, I'd like to turn the call over to Holly May, President of BioLineRx USA, to discuss our commercialization efforts and some of our lifecycle management initiatives. Holly, please go ahead.

[Holly May, President of BioLineRx USA at BioLineRx]

Thank you, Phil. Last quarter, I discussed APHEXDA's benefits on center efficiency and economics, and in conversations with transplant center key decision-makers, including physicians, pharmacists, and apheresis unit managing directors, these two factors continue to be a significant determinant in transplant center formulary adoption. We launched APHEXDA into a mobilization agent market that included generic plerixafor, which had just entered generic status a few months before our approval. At the same time, transplant centers were realizing the impact that new induction therapy approaches have on stem cell collection yields. These factors quite naturally created many questions for centers, centers that have for many years had long-standing protocols.

[Holly May, President of BioLineRx USA at BioLineRx]

It is within this changing landscape that institutions have also come to understand APHEXDA's innovative benefits for patients and are actively studying how our product can benefit their center, and members of our field force are supporting them in this effort with our efficiency modeling tools. Additionally, we are publishing important health economics data and continue to work on additional research. Our health economics presentations in April at the American Society for Apheresis Annual Meeting and at the International Society for Pharmacoeconomics and Outcomes Research demonstrated the economic advantages for centers using G-CSF plus APHEXDA over G-CSF alone or G-CSF plus plerixafor. Given the efficacy, efficiency and economic benefits that APHEXDA provides, we believe that key decision-makers will continue to move toward our best-in-class mobilizer. Let me transition now to our lifecycle management efforts.

[Holly May, President of BioLineRx USA at BioLineRx]

Our vision is to maximize the potential of APHEXDA in its current indication and to expand into key areas with high unmet need. There is significant interest by independent investigators to evaluate APHEXDA across a number of areas associated with myeloma, including mobilization studies in patients treated with quad therapies or for post-CAR T cytopenia management. We are also actively speaking with physician researchers across a number of additional disease states that have a high unmet need in the area of stem cell mobilization. One critical area that continues to make progress is evaluating APHEXDA's stem cell mobilization potential in patients with sickle cell disease undergoing gene therapy. This type of gene therapy is an area where I have significant experience based on my prior roles.

[Holly May, President of BioLineRx USA at BioLineRx]

The two currently approved gene therapies for sickle cell disease require significant quantities of stem cells to produce the therapies, and in speaking with leaders in the field, using a mobilization agent that could speed the collection process would be a great advantage for patients. Our two ongoing sickle cell disease phase I investigator-initiated studies with Washington University in St. Louis and St. Jude Children's Research Hospital in Memphis were designed by significant key opinion leaders in this research area. We anticipate early data from the Wash U collaboration in the second half of this year, and the first patient dosed in the St. Jude's study in September. Overall, in the next 12 months, we anticipate several independent investigators to initiate studies that will provide BioLine with critical data and insights to aid our ongoing lifecycle management efforts.

[Holly May, President of BioLineRx USA at BioLineRx]

Now, let me turn the call over to Mali to provide a financial update.

[Mali Zeevi, CFO at BioLineRx]

Thank you, Holly. As is our practice, I will only go over the most significant items in our financial statements: revenues, cost of revenues, research and development expenses, sales and marketing expenses, net profit and cash. I invite you to review the filings we made this morning, which contain our financials and press release. Total revenue for the three months ended June 30, 2024, was $5.4 million. We did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million, as well as $1.8 million of net revenue from product sales of APHEXDA in the U.S. Cost of revenue for the three months ended June 30, 2024, was $0.9 million.

[Mali Zeevi, CFO at BioLineRx]

We did not record any cost of revenue during the second quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S., and cost of goods sold on product sales. Research and development expenses for the three months ended June 30, 2024, were $2.2 million compared to $3 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide NDA supporting activities, the termination of the development of AGI-134, and the decrease in share-based compensation. Sales and marketing expenses for the three months ended June 30, 2024, were $6.4 million compared to $5.6 million for the same period in 2023.

[Mali Zeevi, CFO at BioLineRx]

The increase resulted primarily from the ramp-up in headcount costs associated with fully hired field team. Net income for the three months ended June 30, 2024, was $0.5 million compared to net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in non-operating income, compared to non-operating expenses of $7.7 million for the same period in 2023, both mainly related to the non-cash revaluation of warrants. As of June 30, 2024, the company had cash, cash equivalents and short-term bank deposits of $40.1 million. The company anticipates that this amount will be sufficient to fund operations as currently planned into 2025. And with that, I'll turn the call over to Phil.

[Phil Serlin, CEO at BioLineRx]

Thank you, Mali. In closing, as is our custom, I would like to take a few moments to summarize our upcoming milestones. We anticipate first patient dosed in the St. Jude Sickle Cell Disease Gene Therapy phase I trial in September. The phase I clinical trial is an open-label, multicenter study evaluating the safety, tolerability, and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ hematopoietic stem cells in 12 patients aged 18 and older with sickle cell disease. We anticipate the initiation of the bridging study by collaboration partner Gloria Biosciences, to support approval of APHEXDA in stem cell mobilization for multiple myeloma in China in the second half of this year.

[Phil Serlin, CEO at BioLineRx]

Also, in the second half of this year, as Holly mentioned, we anticipate a presentation on early data from the Wash U sickle cell disease gene therapy phase 1 trial, evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization. Additionally, working with Gloria Bio, we completed the study design of the phase II-b combination study, evaluating motixafortide in first-line pancreatic cancer. We anticipate that Gloria will submit the study design for regulatory review in 2024, with the study initiating in 2025. Finally, we continue recruitment in the CheMo4METPANC phase II-b randomized clinical trial in first-line metastatic pancreatic cancer, sponsored by Columbia University and in partnership with Regeneron. We anticipate that this trial, which had very encouraging pilot phase data published at ASCO this quarter, will be fully enrolled by 2027.

[Phil Serlin, CEO at BioLineRx]

With that, we have now concluded the formal part of our presentation. Operator, we will now open the call up for questions.

[Operator]

Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you would like to ask a question, please press star one. To withdraw your question, please press star two. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Your questions will be pulled in the order that they are received. Please stand by while we call for your questions. The first question is from John Vandermosten of Zacks. Please go ahead.

[John Vandermosten, Senior Biotechnology Analyst at Zacks]

Great. Thank you. So the summer is usually known to have kind of negative seasonal effects for both, I guess, therapy use and with hospital staff, especially in academic settings. And I just wonder if you could comment on how you expect seasonally the effort to go with sales of APHEXDA. Do you anticipate a strong pickup activity in September? And was this summer, I guess it's not over yet, but I guess, was this summer as you had expected?

[Phil Serlin, CEO at BioLineRx]

Yeah. So, hi, John. So, good morning, and thanks for the question and joining the call. So I'll turn it over to Holly in a moment, but, you know, our results are through June thirtieth. So, you know, so we're talking now about the second quarter, which is really the spring. I would like to again mention that we doubled our sales from Q1 in Q2, and so I'm not sure the results at this point really reflect any kind of slowdown, you know, seasonal slowdown in the summer. We're looking. You know, things are looking very, very good at the moment. But I'll let Holly expand on that if she'd like.

[Holly May, President of BioLineRx USA at BioLineRx]

Yeah. Thanks, Phil, and good morning, John. So we have actually analyzed some of the seasonality on a month-to-month basis, because this is indicated for multiple myeloma, and it's very dependent on patients needing to get timely transplants. We don't necessarily see those same kind of seasonality effects with a product like APHEXDA, as you may with others. That's a very general answer, but that is not something that we are terribly concerned about and have, you know, huge downturns built into any kind of forecasting for that reason. Did that answer your question?

[John Vandermosten, Senior Biotechnology Analyst at Zacks]

Yes, it does. And how would you characterize the reorder rate? It seems like, you know, based on kind of a top, you know, top-down view, that it, it's fairly good. Would you characterize it that way as well?

[Phil Serlin, CEO at BioLineRx]

Holly, you want to take that?

[Holly May, President of BioLineRx USA at BioLineRx]

Yeah. Yeah, I would love to. So, yes, so once a product is on formulary, that's the biggest hurdle, you know, to begin adopt utilization, adoption, utilization, and an uptake in, in sales. And so our field teams are continuing to do both things to onboard institutions that have approved us for formulary through their P&T. So that is a significant part of future growth, as well as then working on institutions where we already have formulary acceptance and continuing to do selling efforts in those hospitals to increase the quantities, where we are on formulary. So the team, very early on, the field teams very early on, were singularly focused on assuring the readiness of P&T committees to put us on formulary.

[Holly May, President of BioLineRx USA at BioLineRx]

That work continues, but now we are also looking at selling efforts in those institutions that have us on formulary to increase there. So we see revenues from both sources, new accounts and existing accounts as we move throughout the year.

[John Vandermosten, Senior Biotechnology Analyst at Zacks]

Okay. And, final question on, on sickle cell and, and gene therapy. You know, I guess I, I, I guess I was surprised to see, you know, two, two, studies in the same, gene therapy indication. And I guess, I guess that's because, well, maybe, maybe you can tell me why that is. And then are there any other gene therapy indications that would also be kind of the next, place to go for using motixafortide to collect the, the proper number of cells?

[Phil Serlin, CEO at BioLineRx]

Yeah. So, let me ask Ella, maybe you can talk about the differences between the two studies a little bit.

[Ella Sorani, Chief Development Officer at BioLineRx]

Yes. So I'm sorry, but the design of the St. Jude study is not. I don't think that we have disclosed it yet, that the design, there is a difference between the two studies in terms of-

[Phil Serlin, CEO at BioLineRx]

Yeah, I guess you're right. Yeah, perhaps we haven't disclosed that yet. They, I mean, they are, they're different. I'm wondering if I just don't remember whether we've disclosed that. You're sure we haven't disclosed it? Yeah. So, John, I'm sorry about that. There are differences in the studies based on, you know, whether they're single administrations or multiple administrations and the size of the studies. But I don't think, like, as Ella said, I don't think that we've spoken about the design yet. There are, you know, possible publication and embargoes and those kind of things, so we can't really discuss it at this point. I apologize.

[John Vandermosten, Senior Biotechnology Analyst at Zacks]

Okay. And then I guess, you know, are there any other kind of gene therapy indications that would be, you know, equally of interest from sponsors to use motixafortide to collect, you know, enough cells? Because I assume that's why the sickle cell was chosen, 'cause compared to others, they just need more cells.

[Phil Serlin, CEO at BioLineRx]

Yeah, well, it's more complicated than that. I mean, I'll turn it over to Holly, but I'll just say one of the reasons why mobilization is so difficult in sickle cell patients is because the underlying mobilization agent, G-CSF, is contraindicated in sickle cell patients, and therefore, they can only get what you'd call, you know, in air quotes, a booster, like plerixafor or like APHEXDA. So they can't get the underlying G-CSF, which is given to patients like multiple myeloma before they're given, you know, a booster agent, so to speak. So that's one of the main reasons why this is an area that is extreme, that has a clear unmet medical need in mobilization. But, Holly, if you'd like to expand on that, please feel free.

[Holly May, President of BioLineRx USA at BioLineRx]

Yeah, I'm happy to talk about that a little bit. So there are different types of gene therapy. Some like AAV therapy that do not require hematopoietic stem cells, and others, like the sickle cell-approved therapies right now by Bluebird and Vertex, that do require stem cells in order to complete the gene therapy. And so, certainly sickle cell, based on the things that Phil just said, is the ideal place to begin using a product like APHEXDA for the mobilization of stem cells to complete that type of gene therapy. But we do see that there could be other types of gene therapies that do require stem CD34 stem cells, which could very easily benefit from APHEXDA in the future.

[Holly May, President of BioLineRx USA at BioLineRx]

But currently, we are focused on generating the data in sickle cell because of the high unmet need.

[John Vandermosten, Senior Biotechnology Analyst at Zacks]

Understood. Thank you, Holly.

[Holly May, President of BioLineRx USA at BioLineRx]

Yep.

[Phil Serlin, CEO at BioLineRx]

Thanks, John.

[Operator]

If there are any additional questions, please press star one. To withdraw your question, please press star two. Please stand by while we pull for more questions. The next question is from John Vandermosten of Zacks. Please go ahead.

[John Vandermosten, Senior Biotechnology Analyst at Zacks]

Great. Thanks for allowing me to follow up. Have there been any inquiries from investigators for use of APHEXDA outside of multiple myeloma, you know, extending more into some other leukemias?

[Phil Serlin, CEO at BioLineRx]

As Holly mentioned, and I think I'll, I, you know, I'll let her expand on it a little bit. We have a number of requests from investigators to perform investigator-initiated studies in, you know, in potentially different indications, et cetera. Holly, do you, do you maybe want to expand on that a little bit?

[Holly May, President of BioLineRx USA at BioLineRx]

Yeah. I guess I'm looking for some guidance here as to what I can and can't say. So we are in the process of these ISSs, we are in the process of signing, signing for what I would call, you know, kind of, indication enhancing data. And other investigators are, yes, very interested in other areas of study and investigation where mobilization of stem cells is required. So I think the easiest way to say this is we have a very active ISS program that we have launched here since that we have initiated since launch, and we continue to review all of those proposals. But there does seem to be a lot of interest in motixafortide to be studied in areas to improve on things like multiple myeloma and then in other indications as well.

[John Vandermosten, Senior Biotechnology Analyst at Zacks]

Okay, great. Thank you.

[Phil Serlin, CEO at BioLineRx]

Thanks, John.

[Holly May, President of BioLineRx USA at BioLineRx]

Mm-hmm.

[Operator]

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 1-888-295-2634. In Israel, please call 03-925-5904. Internationally, please call 972-3-925-5904. Mr. Serlin, would you like to make your concluding statement?

[Phil Serlin, CEO at BioLineRx]

Yes, I would. Thank you, operator. In closing, we are progressing through 2024 with significant momentum, both with the ongoing commercial ramp-up of APHEXDA, as well as the advancement of our development programs in sickle cell disease and pancreatic cancer. I'm excited for what we are poised to accomplish over the remainder of the year and next. Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in November. Be safe and have a good day.

[Operator]

Thank you. This concludes BioLineRx's second quarter 2024 conference call. Thank you for your participation. You may now go ahead and disconnect.

Participants

Executives

• Ella Sorani, Chief Development Officer
• Holly May, President of BioLineRx USA
• John Lacey, Head of Investor Relations and Corporate Communications
• Mali Zeevi, CFO
• Phil Serlin, CEO

Analysts

• John Vandermosten, Senior Biotechnology Analyst at Zacks