BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first quarter 2024 financial results conference call. All participants are presently in a listen-only mode. Following management's formal presentation, instructions will be given for the question and answer session. I would now like to turn over the call to John Lacey, head of investor relations and corporate communications. John, please go ahead.

Thank you, operator. Welcome, everyone. Thank you for joining us on our first 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 6K. 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 20F and our quarterly reports on Form 6K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Terland, Chief Executive Officer of BioLineRx.

Thank you, John, and good morning, everyone. And thank you for joining us on today's call. Joining me today are Holly May, President of BioLineRx USA, and Mali Zevi, our Chief Financial Officer. In addition, Ella Serrani, our Chief Development Officer, will be joining the call for Q&A. I will begin with a brief update on the significant progress that we are making on our effects to launch, then turn the call over to Holly, who will go into our commercialization progress in more detail. I will then provide an update on our very promising pancreatic cancer and sickle cell disease programs. Finally, Mali will review our financial results. We will then open up the call to your questions. Let me begin with an Effecsta commercialization update. As we've noted previously, transplant centers, the end users of Effecsta are a well-defined group in the US. Approximately 80 of the 212 centers in the US perform roughly 85% of all transplant procedures. In this foundational year for Effecsta, we focused our efforts on these top centers and are making strong progress. To date, we have established formulary placement at centers that manage approximately 26% of all multiple myeloma-related transplant procedures in the top 80 centers, up from 20% last quarter. Importantly, we remain on track to achieve our 35% target by the end of the second quarter and 60% by the end of this year. As a result of this work, we saw steady growth in adoption in this, the first full quarter since launch. While it is very early in the launch, we are nonetheless pleased, not only with the sales trajectory that we are on, but on the progress that we continue to make, getting effects on more transplant center formularies and treatment protocols. Furthermore, feedback from transplant centers on the clinical benefits has been positive. They are experiencing effects as value firsthand, which simply put, is greater certainty. Greater certainty in collection, time to collection, and scheduling. This is a new era for multiple myeloma patients in transplant centers. Patients are more often older and increasingly receive quad induction therapy, which can increase mobilization risk. Additionally, transplant centers are seeing increased competition for aporesis chair time while experiencing staffing challenges. Greater certainty is the innovation that affects us providing this new era, and it is having a positive impact on patients as well as nursing and technical staffing. Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma patients. Staying on the topic of stem cell mobilization, recall that last October we closed an exclusive license agreement with Gloria Biosciences for the development and commercialization of metixoportide across all indications in Asia. Gloria's IND for a small stem cell mobilization bridging study, a requirement for commercialization approval in China, by the Center for Drug Evaluation of the National Medical Products Administration in China. We expect that this study will commence with the first patient dosed in the second half of this year. Additionally, for countries in Asia that do not require a bridging study, Gloria is making great progress. We anticipate commercialization to begin in the Boao region of China, in Singapore, and in Macau over the next few quarters. We estimate that Asia had over 51,000 reported cases of multiple myeloma, the largest number of cases globally. Stem cell mobilization is therefore a significant opportunity for both companies in the region. At this point, I'd like to turn the call over to Holly May, President of BioLine RxUS, for a more detailed review of our early effects to commercialization progress. Holly, please go ahead.

Thank you, Phil. As mentioned, this is a new era for patients with multiple myeloma planning for a stem cell transplant. Patients are receiving transplants at increased age, and in the U.S., they are now often treated with quadruplet induction therapy, which leads to the highest rate of complete responses and prolonged progression-free survival. These are both great achievements with strong benefits for patients. However, Increased age and the combination of drugs used in quad therapy are both known to contribute to poor stem cell mobilization. As a result, the number of patients categorized as predicted poor mobilizers is increasing. This outcome is impacting, in real time, long-held mobilization treatment paradigms at centers. This quarter, we presented two posters that highlighted the innovation benefits of AFEXTA on center efficiency and economics. This data, which was presented at the American Society for Apheresis Annual Meeting, or ASFA, and at the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, is supporting decision makers at centers as they consider new mobilization strategies. Results from the analysis presented at ASFA, which assumed an institution averaging 20 transplants per month showed that switching to GCSF plus Afeksta could increase apheresis capacity by 52 patient days per month versus GCSF alone, or by 12.3 patient days per month versus GCSF in combination with Plurixifor. Additionally, the analysis presented at ISPOR showed that even with Afeksta's higher drug cost compared to other mobilization regimens, specifically GCSF alone or GCSF plus generic cloroxifor, the combination of GCSF plus Afexta may confer a similar or better overall financial impact. Early adopting centers understand how this efficiency can offer a better economic outcome to them and to the healthcare system overall. They are also seeing the tangible value that Afexta is bringing to their patients. and this knowledge is being shared peer-to-peer at other transplant centers. Like any newly launched drug in a hospital setting where there can be a longer ramp-up cycle, Afexta is in its foundational period. Our commercial team is making strong and steady progress with centers, and as a result, we continue to see Afexta added to the formularies at the top centers, and we predict continued growth. In summary, I'm very pleased with our momentum since launch and the powerful messages of innovation, efficiency, and value that we are able to convey to patients, physicians, and transplant center leaders. Now, let me turn the call back over to Phil.

Thank you, Holly. Turning now to our second development indication for Metixa fortnight pancreatic cancer. Our randomized phase two study collaboration in first line pancreatic cancer sponsored by Columbia University and supported equally by BioLine RX and Regeneron is actively enrolling. Data from the 11-patient pilot phase of this trial, known as CUMO4METPANC, continues to show encouraging findings. We recently announced new data from an abstract accepted at this week's American Society of Clinical Oncology, or ASCOs, 2024 annual meeting. The new analysis of paired pre- and on-treatment biopsy samples demonstrated a significant increase in CD8-positive T-cell density in tumors from all 11 patients treated with the combination of metixifortide, PD-1 inhibitor simiplimab, and standard-of-care chemotherapies gemcitabine and napaclitaxel, with a p-value of less than 0.007. These biopsy sample findings continue to confirm immune cell activation and tumor microenvironment modulation initially observed in the earlier combat Phase IIa clinical trial. PD-1 immunotherapies have previously shown limited to no efficacy in pancreatic cancer. We believe that metixifordide can alter tumor resistance in pancreatic cancer and potentially other solid tumor types, helping to overcome a significant obstacle for immunotherapies, including PD-1s. In addition to the chemo for METPANK trial, as part of our license agreement with Gloria Biosciences, we are working with them on the design of an additional randomized phase 2B clinical trial, evaluating martixiportide in combination with Gloria's commercial PD-1 inhibitor, Zimbarilumab, and standard of care combination chemotherapy in first-line pancreatic cancer. That trial in China is expected to commence in the first half of 2025. In summary, we believe the combination potential of metixifortide and PD-1 inhibitors in pancreatic cancer, as well as over 20 other solid tumor types with high levels of CXCR4 expression, could be a significant multi-billion dollar opportunity. Turning now to sickle cell disease, We are also making great progress pursuing Metixifortite's potential to support gene therapy for patients with sickle cell disease, which requires significant quantities of hematopoietic stem cells for genetic manipulation, manufacturing, and transplant success. The most commonly used drug for collection of stem cells, GCSF, is contraindicated in patients with sickle cell disease, and the current strategy using Clorixifor has shown limitations. including the need for multiple collection cycles to achieve the necessary hematopoietic stem cell yields. For some, gene therapy may be prohibitive by the failure to obtain adequate numbers of hematopoietic stem cells. We are actively working with leaders in the gene therapy field and look forward to the second half of this year when early data is expected from our collaboration with Washington University School of Medicine in St. Louis. which is evaluating metixoportide for the mobilization of hematopoietic stem cells in patients with sickle cell disease in a phase one clinical trial. At this point, I'd now like to turn the call over to Molly, who will review our financials. Molly, please go ahead.

Thank you, Phil. As is our practice, I will only go over the most significant items in our financial statement. Revenues, cost of revenues, research and development expenses, sales and marketing expenses, net loss, and cash. I invite you to review the 6K filing we made this morning that contains our financials and press release. The revenues for the quarter ended March 31st, 2024, worth $6.9 million. We did not record any revenues during the first quarter of 2023. Revenues for the quarter reflect a portion of the upfront payment from the Gloria Biosciences License Agreement and a milestone payment achieved under the same license agreement, which collectively amounted to $5.9 million, as well as $0.9 million of net revenues from product sales of Afexa in the U.S. Cost of revenues for the quarter ended March 31, 2024, was $1.5 million. We did not record any cost of revenues during the first quarter of 2023. The cost of revenues for the quarter primarily reflects sub-license fees on a milestone payment received under the Global Biosciences License Agreement and royalties on net product sales of Afeksta in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales. Research and development expenses for the quarter ended March 31, 2024, were $2.5 million dollars, as compared to $3.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to MOTIC-supported NDA supporting activities, as well as termination of the development of AGI-134. Sales and marketing expenses for the quarter ended March 31, 2024, with $6.3 million as compared to $3.9 million for the same period in 2023. The increase resulted primarily from the ramp-up of commercialization activities related to Nutixa Fortide, including headcount costs associated with fully hired field teams. Net loss for the quarter ended March 31, 2024, with $0.7 million compared to $12.2 million for the same period in 2023. The net loss for the 2024 period included $4.5 million in non-cash income compared to non-operating expenses of $2.9 million for the same period in 2023, both specifically related to the revaluation of warrants. As of March 31, 2024, the company had cash, cash equivalents, and short-term bank deposits of $28.2 million. Subsequent to the end of the quarter, we accessed an additional $20 million in non-diluted debt financing under our previously announced agreement with BlackRock, formerly Krius Capital. We also completed a $6 million registered direct equity offering. We anticipate that this amount will be sufficient to fund operations as currently planned into 2025. And with that, I'll turn the call back over to Phil.

Thank you, Molly. In closing, as is our custom, I would like to take a few moments to summarize our upcoming milestones. The first is continued commercialization ramp-up of Aphexta in the U.S. Next, initiation of a bridging study by Gloria Biosciences to support approval of Aphexta in stem cell mobilization for multiple myeloma in China. Then, completion of recruitment in the phase one pilot study of impetixoportide for gene therapies in sickle cell disease. led by Washington University School of Medicine, with initial data expected in the second half of this year. Also, continued recruitment in the chemo for METPANC Phase IIb randomized clinical trial in first-line metastatic pancreatic cancer sponsored by Columbia University and supported by BioLine Rx and Regeneron. And lastly, preparation activities with Gloria Biosciences on a Phase IIb combination study evaluating metixoportype in first-line pancreatic cancer. With that, we have now concluded the formal part of our presentation. Operator, we will be happy now to open the call to questions.

Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star 1. If you want to withdraw, please press star 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Your questions will be polled in the order they are received. Please stand by while we poll for your questions. The first question is from Joe Pantgenus of H.C. Wainwright. Please go ahead.

Hey, everybody. Good morning and good afternoon. Thanks for taking the questions. Very nice to hear all the early factors contributing to the potential strong launch of Effexa. So a couple questions there, if you don't mind. So first, I realize obviously there ahead of time there might be a lot of noise around your answers here because it's still early in the launch but you know first off you know Phil you mentioned a few different things but I guess for you and Holly what would you say are the top one or two early factors that centers are saying are truly differentiated even if it's as simple as you know access to chairs quicker okay first of all Joe good morning it's it's a pleasure to hear your voice

I think this one I will turn over to Holly. Holly, can you take this?

Yeah. Yeah, thanks, Bill, and thanks, Joe, for the question. So certainly it's the chair time. And I think as I spoke in my comments, we had two very interesting posters that talk about the efficiencies that institutions can see using FECSA plus GCSF over whatever their standard mobilization regimen was. But I think the other thing, and I know we've talked in this forum before about the three legs or the three pillars of our value proposition. I think one of the things that is resonating with every center is the clinical benefit and that is the increased number of CD34 stem cells mobilized in a single apheresis. So the rest of the story is certainly what that means to the center Increased efficiencies, chair time, et cetera, but I think the thing that inequivocally resonates across all of the institutions that are using Effecsta is the number of stem cells that are being able to be harvested in a single session. Exactly what we saw in our phase three data, which is very encouraging.

Does that answer the question? The next question is from John Vondermosten of Zacks. Please go ahead.

Thank you. So let me go on some of the questions about just the effects of rollout. And based on your observations of the formulary committee meetings, do they bunch up around certain parts of the year? I mean, maybe at the end of the semester for academic institutions or just at the end of the quarter, you know, when you see a lot of those come through. Can you give me any color on that?

Yeah, sure. Hi, John. First of all, thanks for dialing in. Holly, you want to take that?

Yeah, sure. Thanks. Thanks, John, for your question. No, not really. There's no kind of phasing by quarter or by year. Most institutions have P&T committee meetings on a monthly basis, so there is a little bit of kind of stickiness on the upramp in that you know, we need to talk to the P&T members, get on the schedule for P&T after P&T approval, after the approval of that committee, then there are protocols that need to be in place and then order sets. So it is a little bit of a longer ramp up, but to say that these P&T meetings where these decisions are being made happen you know, at a phasing of end of a quarter, end of a year, that's not necessarily a true statement. They happen every month. And so our field teams are hard at work, you know, center by center to get them the information that they need in order to move forward with those P&T committee meetings and hopefully positive decisions.

Okay. And so I guess that suggests that you'd see a steady increase increase in penetration as we move towards your target for the end of the year.

I think that that's a correct statement. Yes, John.

And there are, I think I calculated by subtracting that there are about 132 transplant centers that aren't in your target group. Have any of those picked up the use of Effecsta? And how do you anticipate those other centers, I guess like proliferative centers, how do you anticipate those actually picking up the product? I mean, maybe by physicians that used it in one of the primary centers kind of taking it with them or just recognizing the value. How do you see those other guys that you aren't really targeting directly using the product as we move through the quarters?

Holly, did you get that?

Yeah, I did. So I am happy to answer that question. So first of all, as I think we've stated before, the 86% of all transplants and multiple myeloma occur in those 80 centers. So your math is pretty good there. The extended effort that would need to occur in order to get that additional 14% isn't necessarily efficient, especially for a small company like BioLine that's very much focused on those top 80 centers. The other thing that we haven't necessarily talked about is that we also are looking at those institutions that use a booster agent like Plurixifor or like Effexa. And many of those institutions that you're speaking of in that additional 14% still aren't necessarily using a boosting agent to the rate that those top 80 are. So there's many reasons why we are hyper-focused on those top 80. That's not to say that eventually you know, as we move through the process that there isn't value in those remaining institutions. But it will just take a lot more effort from our field teams in order to gain those. So in the first year, we are very much focused on where we can make the greatest impact as quickly as we can.

Okay. That's helpful. And another question on the gene therapy side. Again, I know I always ask one of those. But, you know, Phil, you and I have talked in the past and Holly, too, maybe on just, you know, how part of the goal of the current trial that's going on at Washington University is to establish safety. I guess after you achieve that and the data is made available, do you anticipate that there will be a lot of demand in gene therapy clinical trials for the use of your product? I mean, do you see that that is something that you know, maybe other studies are looking at and kind of waiting to kind of get the validation from the sickle cell trial to kind of use it themselves?

Yes. So, John, that's a really good question. And, you know, and I can also ask perhaps Holly and Ella to chime in as well. But we are, you know, actively speaking with a number of, you know, potential collaboration of partners, both in the industry as well as at academic institutions. And so we certainly do believe, we certainly do see in the future additional clinical trials in this area. Does that answer your question, or do you want any additional information?

No, that's helpful. I mean, unless you have anything else to elaborate on there. I do have one more on the finance side. I mean, that does answer it. Didn't want to leave Molly out. I was looking at gross margin and wanted to see if there's any guidance you could give us in terms of trying to estimate that as we move through the year based on our forecast for product sales.

Yeah, so, I mean, I think that you can see in our financial statements that gross margins are well in excess of 90% and significantly in excess of 90%, and I don't think that that's going to change. Okay.

All right. Thank you for taking my questions.

You're welcome. Have a great day.

The next question is from Joe Pantinus of HC Wainwright. Please go ahead.

Hey there. Thanks for taking the follow-up. I just wanted to ask, look, I don't want to overstate or understate, but I really wanted to get your comments as to the potential importance of the work that you did ahead of time. to be able to get the pass-through status for CMS with regard to hospital bundling. And then second, anything that we need to consider with regard to drug supply and manufacturing efforts for additional ramp-up. Thank you.

Okay, so I will turn that first question over to Holly, and I'll take the second question. Go ahead, Holly.

I don't know if I heard the question in there, but I will attempt to answer this, and if I didn't, If I didn't clearly get to your concern, please ask the question again. So we are quite pleased with the work that our account team has done. We have three different types of field individuals. We have our sales professionals, we have our medical team, and then we also have our account payer team. And they are focused on the payers, both commercial and government payers, to assure that we have access. We are quite pleased where we are right now with about 95% of the lives covered. And as you said, also we are in the first quarter, we have attained that pass-through status. So we feel like we are well-positioned and we have not to date had any issues with any sort of access or denial of patients to receive a FEXTA. Now, did I answer your question? I'm not exactly sure.

You did, Holly. You did. Thank you. And on the supply side, Joe, we are very well positioned from a drug supply perspective, both for all of our commercial needs as well as our clinical needs. So there's really no issue there whatsoever. Great. Thanks for the follow-up. You're welcome.

There are no further questions at this time. Before I ask Mr. Phil Surlin 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 03-9255-904. Internationally, please call 972-39255-904. Mr. Surlin. Would you like to make your concluding statement?

Yes. Thank you, operator. In closing, we are progressing through 2024 with significant momentum, both with the ongoing commercial ramp of Afexa, as well as the advancement of our development programs in pancreatic cancer and sickle cell disease. I am excited for what we are poised to accomplish over the remainder of this 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 August. Be safe and have a great day.

Thank you. This concludes the BioLineRx first quarter 2024 conference call. Thank you for your participation. You may go ahead and disconnect.