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BioLineRx Ltd. (BLRX) Q1 2024 Earnings Call Transcript

May 28, 2024 5:56 PM ETBioLineRx Ltd. (BLRX) Stock1 Comment

Q1: 2024-05-28 Earnings Summary

EPS of $0.00 beats by $0.29 | Revenue of $6.86M beats by $6.52M

BioLineRx Ltd. (NASDAQ:BLRX) Q1 2024 Earnings Call Transcript May 28, 2024 8:30 AM ET

Company Participants

John Lacey - Head of IR and Corporate Communications
Phil Serlin - CEO
Holly May - President of BioLineRx USA
Mali Zeevi - CFO

Conference Call Participants

Joe Pantginis - HC Wainwright
John Vandermosten - Zacks

Operator

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.

John Lacey

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 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 US Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Phil Serlin

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 Zeevi, our Chief Financial Officer. In addition, Ella Sorani, 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 APHEXDA 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 APHEXDA commercialization update. As we've noted previously, transplant centers, the end users of APHEXDA 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 APHEXDA, 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 APHEXDA on more transplant center, formularies and treatment protocols.

Furthermore, feedback from transplant centers on the clinical benefits has been positive. They are experiencing APHEXDA's 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 and transplant centers. Patients are more often older and increasingly received quad induction therapy, which can increase mobilization risk. Additionally, transplant centers are seeing increased competition for APHEXDA chair time while experiencing staffing challenges. Greater certainty is the innovation that APHEXDA is 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 motixafortide across all indication locations in Asia. Gloria's IND for a small stem cell mobilization bridging study, a requirement for commercialization approval in China was recently accepted 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 Bao 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 BioLineRx US, for a more detailed review of our early APHEXDA commercialization progress. Holly, please go ahead.

Holly May

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 US, 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 paradigm set centers. This quarter, we presented two posters that highlighted the innovation benefits of APHEXDA 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 ASPA, which assumed an institution averaging 20 transplants per month showed that switching to GCSF plus APHEXDA 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 plerixafor. Additionally, the analysis presented at ISPOR showed that even with APHEXDA's higher drug costs compared to other mobilization regimens, specifically GCSF alone or GCSF plus generic plerixafor, the combination of GCSF plus APHEXDA 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 health care system overall. They are also seeing the tangible value that APHEXDA 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, APHEXDA is in its foundational period. Our commercial team is making strong and steady progress with centers. And as a result, we continue to see APHEXDA 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 methods 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.

Phil Serlin

Thank you, Holly. Turning now to our second development indication for motixafortide pancreatic cancer. Our randomized Phase 2 study collaboration in first-line pancreatic cancer sponsored by Columbia University and supported equally by BioLineRx and Regeneron is actively enrolling. Data from the 11-patient pilot phase of this trial known as CheMo4METPANC continues to show encouraging findings. We recently announced new data from an abstract accepted at this week's American Society of Clinical Oncology, or ASCO’s 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 motixafortide PD-1 inhibitor zimberelimab and standard of care chemotherapy, gemcitabine and nab-paclitaxel with a p-value of less than 0.007.

These biopsy sample fundings continue to confirm immune cell activation and tumor microenvironment modulation initially observed in the earlier COMBAT Phase 2a clinical trial. PD-1 immunotherapies have previously shown limited to no efficacy in pancreatic cancer, we believe that motixafortide 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 METPANC 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 motixafortide in combination with Gloria's commercial PD-1 inhibitor, zimberelimab, a 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 motixafortide 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 multibillion-dollar opportunity.

Turning now to sickle cell disease. We are also making great progress pursuing motixafortide’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, G-CSF is contraindicated patients with sickle cell disease and the current strategy using celrixafor 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 the early data is expected from our collaboration with Washington University School of Medicine in St. Louis, which is evaluating motixafortide for the mobilization of hematopoietic stem cells in patients with sickle cell disease in the Phase 1 clinical trial.

At this point, I'd now like to turn the call over to Mali, who will review our financials. Mali, please go ahead.

Mali Zeevi

Thank you, Phil. 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 loss and cash. I invite you to review the 6-K filing we made this morning that contains our financials and press release. The revenues for the quarter ended March 31, 2024, were $6.9 million. We did not record any revenues during the first quarter of 2023.

Revenues for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license agreement and the milestone payment achieved under same license agreement, which collectively amounted to $5.9 million as well as $0.9 million of net revenues from product sales of APHEXDA in the US. 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 reflect sublicense fees on a milestone payment received under the Gloria Biosciences license agreement and royalties on net product sales of APHEXDA in the U, 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 as compared to $3.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide supporting activities as well as termination of the development of AGI-134.

Sales and marketing expenses for the quarter ended March 31, 2024, were $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 motixafortide, including headcount costs associated with fully hired field teams.

Net loss for the quarter ended March 31, 2024, was $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 nonoperating 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-dilutive debt financing under our previously announced agreement with BlackRock, formerly Quellos 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.

Phil Serlin

Thank you, Mali. 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 APHEXDA in the US. Next, initiation of a bridging study by Gloria Biosciences to support approval of APHEXDA in stem-cell mobilization for multiple myeloma in China. Then completion of recruitment in the Phase 1 pilot study of motixafortide for gene therapies and 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 2b randomized clinical trial in first-line metastatic pancreatic cancer sponsored by Columbia University and supported by BioLineRx and Regeneron. And lastly, preparation activities with Gloria Biosciences on a Phase 2b combination study evaluating motixafortide 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.

Question-and-Answer Session

Operator

[Operator Instructions] The first question is from Joe Pantginis of HC Wainwright. Please go ahead.

Joe Pantginis

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 APHEXDA. So a couple of 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 first off, 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 seeing are truly differentiated even if it's as simple as access to chairs quicker?

Phil Serlin

Okay. First of all, Joe, good morning. It's a pleasure to hear your voice. I think this one, I will turn it over to Holly. Holly, can you take this?

Holly May

Yes. Yeah. Thanks, Phil, and thank you, Joe, for the question. So certainly, it's the chair time. We've -- 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 APHEXDA plus G-CSF 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 center, increased efficiencies, chair time, et cetera. But I think the thing that unequivocally resonates across all of the institutions that are using APHEXDA is the number of stem cells that are being able to be harvested in a single session. Exactly what we saw it in Phase 3 data, which is very encouraging. Did that answer the question?

Operator

The next question is from John Vandermosten of Zacks. Please go ahead.

John Vandermosten

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

Phil Serlin

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

Holly May

Yeah, sure. Thanks. Thanks, John, for your question. No, not really. There is 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 up-ramp in that. 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 at a phasing of end of a quarter under the year, that's not necessarily a true statement. They happen every month. And so our field teams are hard at work 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.

John Vandermosten

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

Phil Serlin

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

John Vandermosten

Great. And there are -- I think I calculated spots tracking that are there about 132 transplant centers that aren't in your target group. Have any of those picked up the use of APHEXDA? And how do you anticipate those other centers, I guess, [indiscernible] centers. And 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?

Phil Serlin

Holly, did you get that?

Holly May

Yeah, I did. So I'm happy to answer that question. So first of all, as I think we've stated before, the 86% of all transplants in multiple myeloma occur in those 80 centers. So your math is pretty good there. Those -- 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 [indiscernible] like APHEXDA. 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, as we move through the process that there isn't value in that remaining -- 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.

John Vandermosten

Okay. That's helpful. And another question on the gene therapy side, again, I know I was asking this. But, Phil, you and I have talked in the past and, Holly too, maybe, on just how part of the goal of the current trial that's going on in 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 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?

Phil Serlin

Yeah. So, John, that's a really good question. And I can also ask perhaps Holly and Ella to chime in as well. But we are actively speaking with a number of 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?

John Vandermosten

No, that's helpful. And unless you have anything else that elaborate on that. I do have one more on the finance side. I mean, that doesn't answer it. I didn't want to leave Mali out as looking at gross margin, and I 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.

Phil Serlin

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.

John Vandermosten

Okay. All right. Thank you for taking my questions.

Phil Serlin

You’re welcome. Have a great day.

Operator

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

Joe Pantginis

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.

Phil Serlin

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

Holly May

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. And 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 a team 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 APHEXDA. Now, did I answer your question? I'm not exactly sure.

Joe Pantginis

You did, Holly. You did. Thank you.

Phil Serlin

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.

Joe Pantginis

Great. Thanks for the follow-up.

Phil Serlin

You’re welcome.

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 US, 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

Yes. Thank you, operator. In closing, we are progressing through 2024 with significant momentum both with the ongoing commercial ramp of APHEXDA as well as the advancement of our development programs in pancreatic cancer and sickle cell disease. I'm 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.

Operator

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

BioLineRx Ltd. (NASDAQ:BLRX) Q4 2023 Earnings Call Transcript March 26, 2024

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Fourth Quarter and Full Year 2023 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 the call over to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.

John Lacey: Thank you, Operator. Welcome, everyone. Thank you for joining us on our fourth quarter and full year 2023 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. If have such statements due to future events and are subject to many risks and uncertainty, 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 report on Form 6-K 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 Serlin, Chief Executive Officer of BioLineRx.

Phil Serlin: 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 Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A. I will begin with a brief update on our APHEXDA launch then turn the call over to Holly who will go into the Stem Cell Mobilization opportunity in more detail. I will then provide an update on our clinical programs in pancreatic cancer and sickle cell disease. Finally, Mali will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. Following the launch of our product in stem cell mobilization just a few months ago in Q4, we expect substantially all of 2024 to continue to be a foundational period for the commercialization of APHEXDA, the first advancement in stem cell mobilization in over a decade.

Since FDA approval in September and the subsequent launch of APHEXDA in U.S. in Q4 early signs among payers and top tier stem cell transplant centers suggest that the APHEXDA value proposition is resonating very well and evolving the stem cell mobilization treatment paradigm for patients with multiple myeloma. Recall that a key consideration when we elected to commercialize APHEXDA independently in the U.S. was that end users of APHEXDA transplant centers are well defined with approximately 80 of 212 transplant centers performing the vast majority approximately 85% of all procedures. Among this defined population, we have already secured formulary placement within these top 80 transplant centers managing approximately 20% of all stem cell transplant procedures at these institutions.

Those familiar with commercial launches know that institutional pharmacy and therapeutic committees or P&Ts determine formulary status, the first step in center adoption and we anticipate that by year-end we will have secured formulary placement within these top 80 transplant centers managing approximately 60% of all stem cell transplant procedures at these institutions. We are pleased with this progress and momentum which is right in line with our expectations. Our customer facing teams have done a fantastic job working with centers to support them in developing protocols following P&T approvals and we are very pleased by the number of clinical champions we are gaining every day. We have also received several repeat orders from multiple institutions.

These centers were early adopters and moved quickly through the formulary process and subsequent design and adoption of new treatment protocols. Importantly, one highly regarded transplant center has already transitioned to all of its patients to APHEXDA, as it recognizes the value of greater apheresis certainty. We are pleased by this early momentum despite the fact that some customers have benefited from lower acquisition costs for generic mozobil or plerixafor relative to reimbursement rates. This cost recovery advantage has been diminishing with time as reimbursement rates adjust to having generic plerixafor in the landscape. Meanwhile, transplantation centers are gaining the opportunity to experience the value APHEXDA can bring to their centers that extend beyond drug cost, including the overall economic benefit of reducing apheresis days and the predictability regarding the number of apheresis days and the impact this reduction has on patients as well as nursing and technical staffing for apheresis, particularly in today's difficult hiring environment and the competition for apheresis tier time.

Staying on the topic stem cell mobilization, recall that in October, we closed an exclusive license agreement with Gloria Biosciences for the development and commercialization of motixafortide across all indications in Asia. In order to receive market authorization for APHEXDA in China, a small bridging study is required. I'm pleased to share that the IND for this bridging study was filed in February with the Center for Drug Evaluation of the National Medical Products Administration and we anticipate regulatory action in May. First patient dosed in this study is expected 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 Bao region of China in Singapore and in Macau over the next few quarters.

We believe that commercialization in these territories will provide nine U.S. revenue in the second half of the year or early next year subject to regulatory approval. We estimate that Asia had over 51,000 reported cases of multiple myeloma to largest number of cases globally and stem cell mobilization for autologous transplantation represents a significant opportunity for both companies in the region. Needless to say, we are very pleased with how our Gloria collaboration is progressing. We are also pleased by the progress that we have made since our last quarterly update on our other motixafortide programs, notably, pancreatic cancer and sickle cell disease. I will provide updates on those programs in a moment. But at this point, I'd like to turn the call over to Holly May, President of BioLineRx U.S. for a more detailed review of our early launch progress.

Holly, please go ahead.

Holly May : Thank you, Phil. As Phil indicated, patients, physicians and transplant center teams have begun experiencing strong stem cell mobilization results with APHEXDA. We call this the A-plus A for apheresis experience. Importantly, each positive experience resonates within institutions already using APHEXDA and supports strong peer-to-peer conversations between physicians at other institutions. As Phil said earlier, last quarter and this full year is foundational for APHEXDA commercialization. The pathway to adoption of any new drug of this type is roughly the same. P&T committee scheduling and review, institutional protocol development and staff training, first patient scheduled and use, experience assessment, reorder.

This cycle will happen across our top 80 centers and is occurring at a pace that we anticipated. We have a very strong value proposition for patients, transplant centers and payers and it is resonating. Our goal is to significantly reduce patient and caregiver burden by providing increased assurance in individual apheresis journeys. Additionally, for transplant centers with significant apheresis volume, we can show the advantages that APHEXDA provides for scheduling and use of chair time. Remember that patients with multiple myeloma in the United States are now often treated with quadruplet induction therapy, which includes lenalidomide and bortezomib. Quad therapy leads to the highest rate of complete responses and prolonged progression free survival.

However, this combination is known to contribute to poor stem cell mobilization collection experiences, which leads to an increase in the amount of apheresis session needed to collect the targeted number of CD34+ positive stem cells stem cells required by institutional protocols. With treatment for multiple myeloma moving to quad therapy, we believe this further strengthens our value proposition. Our targeted field force which was hired based on their significant and relevant experience is educating transplant center and apheresis' leadership team on the benefits of APHEXDA. Physician reactions from our meetings at ASH 2023 and more recently at Tandem 2024 have demonstrated a strong belief in our clinical data. Our poster session at both congresses further bolstered our clinical story.

Since launch, we have successfully made in-person contact with all top tier centers. Overall, we estimate the top 80 transplant centers in the U.S. manage approximately 85% of all transplants annually. To date, we have been granted formulary approval by institutions which manage approximately 20% of all stem cell transplant procedures within these institutions. By the end of quarter two, we anticipate that this will increase to approximately 35% of transplant procedures at these top 80 centers. And as stated, by the end of the year, we anticipate formulary status in those managing 60% of the transplants in these centers. Now regarding the entrance of generic mozobil or plerixafor into the market. As we've said, while we consider plerixafor to be the same overall market basket as APHEXDA, we do not see the generic plerixafor as comparable to our drug.

APHEXDA is a second generation CXCR4 inhibitor and has a highly differentiated product profile based on stronger and more predictable mobilization outcome. Furthermore, our early discussions have showed a central to appreciate the innovation as they look to address their need for a better mobilizer. Turning now to payers. Payers view the APHEXDA clinical data very favorably and as a result, we have to date established access for 95% of covered lives across a mix of both commercial and government payers. We continue to work to increase this number so that APHEXDA is as broadly accessible to patients as possible. Additionally, the centers for Medicare and Medicaid services issued us a unique J-Code for APHEXDA, which is critical for obtaining timely reimbursement from all commercial and government payers.

Another way we provide reimbursement confidence is through BioLineRx Connect, our provider and patient services hub. Through this hub, providers can enroll patients to obtain assistance in benefits verification and prior authorization. If coverage issues arise, the hub can step in and help resolve issues. Additionally, payers can enroll their patients in the patient assistance program if they cannot afford the cost of APHEXDA. Those who qualify can receive drug at no cost. In summary, I'm very pleased with our launch progress to date. Our commercial and medical affairs teams are generating results in the early stages of this launch, as we continue to engage with top transplant centers, physician leaders and payers on this exciting new treatment option.

A pharmacist preparing a dose of an immuno-oncology agent for research use.
A pharmacist preparing a dose of an immuno-oncology agent for research use.
Now let me turn the call back over to Phil.

Phil Serlin : Thank you, Holly. Turning now to our second development indication for motixafortide pancreatic cancer. Remember that motixafortide has been shown to leverage the expression of CXCR4 on different immune cells and can increase the effectiveness of immune system treatments for solid tumors. CXCR4 is highly expressed in over 20 solid tumor types and correlates with poor patient prognosis. In studies with PD-1 inhibitors and chemotherapy in pancreatic cancer, PD-1 inhibitors, a major background of immune therapy today have shown almost no therapeutic advantage. However, in several preclinical studies and more importantly in an 80 patient Phase 2 study with two cohorts that we completed a few years ago, we demonstrated that motixafortide is synergistic with PD-1 inhibitors in the treatment of pancreatic cancer.

This Phase 2 study showed proof of mechanism of synergistic effect with PD-1 in multiple late stage treatment lines as well as promising efficacy when motixafortide is combined with both a PD-1 inhibitor and chemotherapy in second line pancreatic cancer patients. Based on this promising data, we entered into a Phase 2 study collaboration in first line pancreatic cancer sponsored by Columbia University and supported equally by BioLineRx and Regeneron. Recall that the trial known as Chemo for met panc originally had an initial pilot phase and based on the results of this pilot phase an assessment would be made on advancing to an expansion phase of the study. As we presented at the AACR Special Conference on Pancreatic Cancer last September, the data in the pilot phase of the study was quite compelling.

7 of 11 patients were 64% experienced a partial response of which five were confirmed PRs as of the July 2023 cutoff date, with one patient experiencing complete resolution of the metastatic lesion in the liver. Along with the three patients are 27% experiencing stable disease, this resulted in a disease control rate of 91%. These findings compare favorably to historic partial response and disease control rates of 23% and 48% respectively, reported with the current standard of care. Based on these compelling data, the collaboration partners in this study Columbia, Regeneron and BioLineRx agreed to amend the original expansion phase of the study from a single arm expansion study with a target enrollment of 30 patients to a much larger randomized Phase 2b study of a 108 patients with two arms.

Motixafortide, the PD-1 inhibitors, zimberelimab and standard of care chemotherapy versus standard of care chemotherapy alone. The trial's primary endpoint is progression free survival. Secondary objectives include safety, response rates, disease control rate, duration of clinical benefit and overall survival. And last month, we announced that the first patient was dosed in this randomized Phase 2b study. We believe the combination potential of motixafortide and PD-1 inhibitors in pancreatic cancer and other solid tumors could be a significant multibillion dollar opportunity and our work in pancreatic cancer, one of the most difficult to treat cancers is the starting point. Also in pancreatic cancer, a license agreement with Gloria Biosciences covers pancreatic cancer as well and we are working with them on the design of a randomized Phase 2b clinical trial evaluating motixafortide in combination with commercially approved PD-1 inhibitor, zimberelimab and standard of care combination chemotherapy in first line pancreatic cancer.

Zimberalimab is approved in the Asia region for relapsed or refractory classical Hodgkin's lymphoma and for recurrent or metastatic cervical cancer. Gloria Biosciences went from IND to commercialization of zimberalumab and its first indication in China within four years. So we believe they are uniquely positioned to explore the potential utility of motixafortide in combination trials against this difficult to treat cancer. Their Phase 2b trial in China is expected to commence in the first half of 2025. We are also evaluating motixafortide as a mobilization engines in autologous hematopoietic stem cell based gene therapy patients suffering from sickle cell disease, one of the most common generic diseases globally. Hematopoietic stem cell transplantation after genetic modification is potentially cured for patients with sickle cell disease.

However, significant quantities of hematopoietic stem cells are required for genetic manipulation and transplant success and the most commonly used drug for collection of stem cells G-CSF is contraindicated in patients with sickle cell disease. Therefore, peripheral blood mobilization of stem cells using plerixafor is the current strategy to collect hematopoietic stem cells for sickle cell disease gene therapies. As with multiple myeloma patients in many cases, the current mobilization treatment fails to reliably yield after the number of stem cell and sickle cell disease patients often require two to four mobilization cycles with each cycle including two or more apheresis sessions with a minimum 14-day washout period between each cycle to collect an adequate number, as such this patient population is very much in need of an effective new mobilization regimen.

To that end, last March, we announced a clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide in this indication. To gather with Wash U, we're conducting a proof-of-concept trial to study motixafortide as both a single agent and in combination with the immunomodulator, natalizumab. The study is evaluating the safety and tolerability of the two regimens as mobilization agents of CD34+ hematopoietic stem cells in patients with sickle cell disease as well as efficacy endpoints. Sickle cell disease is an important lifecycle strategy for APHEXDA and we are in discussions with multiple stakeholders to understand its potential usage in patients who may qualify for the two recently approved gene therapies in the United States.

We were very pleased to have the dose the first patient in this important trial in December and we anticipate data in the second half of this year. In summary, we are very excited by both our pancreatic cancer and sickle cell disease clinical development programs, which may provide incredible value to patients and shareholders. At this point, I'd now like to turn the call over to Mali, who will review our financials. Mali, please go ahead.

Mali Zeevi : Thank you, Phil. As is our practice in our financial discussion on this call, we will go over the most significant items in our financial statements; revenues, sales and marketing expenses, research and development expenses, non-operating expenses, net loss and cash. I invite you to review the filings we made this morning that contain our financials 20-F and press release for additional information. Total revenues for the year ended December 31, 2023 were $4.8 million compared to no revenues for the year ended December 31, 2022. Revenues in 2023, all of which were recorded in the fourth quarter primarily reflect a portion of the upfront payment from the Gloria Biosciences license agreement of which $4.6 million was recorded in 2023 as well as $0.2 million of revenues from product sales of APHEXDA in the U.S. Cost of revenues for the year ended December 31, 2023 amounted to $3.7 million compared to no cost of revenues for the year ended December 31, 2022.

The cost of revenues in 2023, all of which was recorded in the fourth quarter primarily reflect a $3 million sublicense fee to the upstream licensor of APHEXDA for payable on closing of the exclusive license agreement in Asia as well as amortization of an intangible asset in respect of this license revenues in the amount of $5 million. Cost of product sales were insignificant representing approximately 6% of related sales. Research and development expenses for the year ended December 31, 2023 were $12.5 million as compared to $17.6 million for the year ended December 31, 2022. The decrease resulted primarily from lower expenses related to motixafortide as NDA supporting activities as well as lower expenses associated with completion of the AGI-134.

Sales and marketing expenses for the year ended December 31, 2023 were $25.3 million as compared to $6.5 million for the year ended December 31, 2022. The increase resulted primarily from the ramp up of pre-commercialization and commercialization activities related to motixafortide. Non-operating expenses for the year ended December 31, 2023 were $10.8 million compared to non-operating income of $5.7 million for the year ended December 31, 2022. Non-operating expenses and income primarily relates to the non-cash revaluation of outstanding warrants resulting from changes in the company's share price during the respective periods. Net loss for the year ended December 31, 2023 was $60.6 million compared to $25 million for the year ended December 31, 2022.

The net loss for 2023 included $17.8 million of non-cash expenses specifically an expense of $11.1 million for the revaluation of warrant and a one-time $6.7 million impairment of intangible assets associated with discontinuation of the AGI-134 development program. The net loss for 2022 included $6.4 million of non-cash income, specifically related to the reevaluation of warrants. As of December 31, 2023, the company had cash, cash equivalents and short-term bank deposits of $43 million. The company anticipates that this amount and other available resources including amount available under a debt facility with Kreos Capital will be sufficient to fund operations as currently planned into 2025. And with that, I'll turn the call back over to Phil.

Phil Serlin : Thank you, Mali. In closing as is our custom, I would like to take a few moments to summarize our key upcoming milestones. First, continued commercial ramp up of APHEXDA in the U.S. Next, commercial expansion in Asia with collaboration partner Gloria Biosciences, then initiation of bridging study by Gloria Biosciences in 2024 to support approval of APHEXDA in stem cell mobilization for multiple myeloma in China. Next is completion of recruitment in the Phase 1 pilot study of motixafortide for hematopoietic stem cell mobilization 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. Next is continued recruitment in the chemo for med panc Phase 2 randomized clinical trial in first line metastatic pancreatic cancer sponsored by Columbia University.

And lastly, preparation activities with Gloria Biosciences on a randomized Phase 2 clinical trial evaluating motixafortide in combination with the PD-1 inhibitors in barilumab and standard of care chemotherapy in first line pancreatic cancer. With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions.

Operator: [Operator Instructions] The first question is from John Vandermosten of Zacks.

John Vandermosten: Just to get a little bit better understanding about how the formularies work and when APHEXDA’s added to the formulary, is it immediately replacing the third support and other alternative or is there it sounds like there’s some education that’s required to get students to on board with it. Is that correct?

Phil Serlin: John, so I just want to make sure I guess the line isn’t that clear. I want to make sure I understand. First of all, good morning. And, second, I think are you asking about the formulary process, how it works and how long the process takes? Is that — did I understand correctly?

John Vandermosten: Yes. And also, are the teams immediately picking up the use of APHEXDA or is there some education required to get them to get on board with it?

Phil Serlin: Holly, would you like to take that?

Holly May: Yes. That would be great. So you’re right. With this type of a product, formulary acceptance is critically important. It behaves while this is an outpatient product, it is sold in transplant centers associated with hospital institutions and therefore does require a P&T approval. So the way that it works is that I mean this is work and that’s exactly why we put the three field teams in place, sales, medical, as well as the payer team. And what required is, always having a clinical champion, an MD clinical champion, and then making sure that the message gets out to those who are associated with making the decision, and then you need to get on the schedule for formulary for the P&T committees. This can take several months.

And then once the decision is made, the formulary decision is made then protocols need to be in place, order sets then need to go in place. So that takes, some time. Some institutions have P&T meetings, monthly. Some are every other month. These are things that the field team knows and understands and we are working critically hard on getting on those formularies. So once on, yes, we have gotten several acceptances, and we are very happy to be selling APHEXDA in many institutions. It’s really very much up to the institution as to what those protocols look like and whether it’s kind of sole formulary or if it’s a shared formulary. I will say that we have had some institutions which have made the full switch over to APHEXDA for multiple myeloma.

But I do want to make sure that, I’ve answered your question clearly and that everyone understands that this cycle does take some time and therefore the uptake ramp for APHEXDA is exactly as we were expecting. It’s a little bit of a slower uptake than something such as like a retail product et cetera. Now does that answer the question?

John Vandermosten: Yes. That does. And then kind of continuing on from there, it sounds like there is somewhat of a standardized process to getting on the formulary, but is there a big level of difference in difficulty? I mean, maybe there’s a lot more hoops you have to jump through for some formularies rather than others? Is it pretty similar or somewhat harder?

Holly May: We have a saying that if you’ve seen one transplant center, you’ve seen one transplant center. So there are ranges of ease or difficulty by center. So it’s not that standard. Getting to know who the decision makers are is always the first challenge, and then being able to get to those individuals is important. You did ask a question that I — part of the question initially that I don’t think I answered. It is really, really important that there is either during and then after the formulary decision that education and in servicing, we call it in servicing with the institutions is in place so that, everyone knows how to dose the product, everybody knows how to administer and have best patient care. So it is definitely a process and it differs most certainly by institutions.

Some are quicker and some have a little bit more of a prolonged formulary process. So we, the field teams understand these differences and then they work center by center on what is required.

John Vandermosten: And second question is on the gene therapy opportunities. I think you suggested that the two approved sickle cell gene therapies, I think it’s Casgevy and Lyfgenia, are being used in the Washington University study. Have you been contacted by other gene therapies to possibly look at other uses of motixafortide in gene therapy processes?

Phil Serlin: So first of all, John, I think there might be a mistake. I don’t know or a misunderstanding because we are doing a Phase 1 trial for mobilization of sickle cell patients, at Wash-U, but these are not patients that are receiving any gene therapy, neither Vertex is nor Bluebirds at this point. So I just wanted to make sure that you understand that and if there was a misunderstanding, I apologize. So how — but we are I mean, I just, I can say that we are speaking with companies and with institutions, et cetera, et cetera. This is an area of real interest to us. I mean, we see this as a huge potential upside for the company. These patients require huge amounts of cells, 15 million to 20 million hematopoietic cells per kilogram and have very a lot of difficulty mobilizing, especially since they can’t get G-CSF.

So we think that we have a great product for them and we’re very much looking forward to getting the safety data and some initial efficacy data so that we can continue to make noise in this area and enter into other collaborations on the way towards being able to sell the product.

Holly May: Can I add on to that? I just want to be clear about the opportunity. This would be for ex-vivo type of approaches or those approaches — those gene therapy approaches which require CD34+ stem cells it would not be applicable for say a gene therapy, like an AAV gene therapy. So in looking at the gene therapy opportunities, our focus obviously would be on those that require stem cells in order to complete the gene therapy. That would be most definitely the focus as is with sickle cell as Phil just spoke of.

Phil Serlin: John, did that answer your question? Is there anything else?

John Vandermosten: No, I appreciate the answers, Phil. Thank you.

Operator: The next question is from Joe Pantginis of H. C. Wainwright.

Unidentified Analyst : This is [Lander] on for Joe. So regarding the Phase 2 study in pancreatic cancer in China with Gloria, I wonder if you could provide some color on the preparations. Do you anticipate any difficulties with the Chinese agency or recruitment or site activation of the trial? And also are there plans to expand to additional Asian territories besides Macau and Singapore?

Ella Sorani: Hi, this is Ella. With regards to the PDAC study in China — we are Gloria is planning to submit it to the regulatory authorities and hopefully the study can be initiated early by the end of this year or by the latest early next year that’s with regards to the PDAC. I think the question you asked of expanding in additional territories, you’re relating to the PDAC, was this related to PDAC or stem cell mobilization?

Unidentified Analyst : Maybe both. It’s Gloria. Are you planning on any agreement with Gloria to expand to additional territories beside China?

Phil Serlin: Yes. So maybe I can take that. So first of all, in PDAC, I also want to answer the second part of your question. We anticipate Gloria being able to recruit the patients quite quickly. As I mentioned in the prepared remarks, they were able to bring a drug in two indications for approval in China within four years, which is on Western terms very, very significant and very quick. And so I think their ability to recruit the patients for the Phase 2b study in PDAC is quite significant and some of the institutions there are quite large in comparison to institutions in the West. As far as where they’re going with the, for in other territories, I guess we can separate that into stem cell mobilization and PDAC. So with regard to stem cell mobilization, there are a number of territories because we have FDA approval, there are a number of territories in the Asia region, mostly in southeast Asia, like Singapore, some areas of China I think Macau, et cetera that have a sort of an early access type of program where you can use a drug, a U.S.-label drug based on FDA approval and sell into the territory to various hospitals, et cetera, et cetera.

And so they are working very diligently to try to start the commercialization very quickly in these smaller areas. But as far as the larger areas of the territory, for example, China, Japan and Korea, our assessment and their assessment as well is that there will probably be a bridging study, one or more bridging studies required that include Asian patients in order to get regulatory approval for stem cell mobilization. So that’s regarding stem cell mobilization. With regard to pancreatic cancer because pancreatic cancer has no approval anywhere, the pathway is obviously much longer. They’re still, they’re going to be starting the trial in China and I think that right now that’s sort of the main focus in pancreatic cancer is to get the trial up and initiated in China and see what the results are and then based on that expand perhaps into other areas.

We would be thinking as well about at some time down the road based on this data, interesting a partner, getting a partner interested in a large registrational Phase 2, 3 global trial but that’s a little bit down the road. But that’s sort of the pathway right now for Gloria in Asia. I hope that answers your question.

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 039-255-0904. Internationally, please call 9723-9255-904. Mr. Serlin, would you like to make your concluding statement?

Phil Serlin : Yes. Thank you, operator. In closing, we are progressing through 2024 with significant momentum both with our ongoing commercial ramp of APHEXDA 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 year and next. Thank you all very much for your continued interest in BioLineRx. We look forward to providing you our next comprehensive quarterly May. Be safe, and have a great day.

Operator: Thank you. This concludes the BioLineRx fourth quarter 2023 conference call. Thank you for your participation. You may go ahead and disconnect.

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