BioLineRx Ltd. (NASDAQ:BLRX) Q3 2023 Earnings Call Transcript

BioLineRx Ltd. (NASDAQ:BLRX) Q3 2023 Earnings Call Transcript November 20, 2023

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 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. [Operator Instructions] 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, Johnny. Welcome, everyone. Thank you for joining us on our third quarter 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 more risks and uncertainty actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainty, 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 an overview of our Stem Cell Mobilization program, then Holly will provide an update on the effects to launch of activities and progress. I will then provide an update on our other clinical programs, notably the Motixafortide program in PDAC 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. We have made substantial progress since our last quarterly update with our Stem Cell Mobilization program.

We were very pleased to announce in September the U.S. FDA approval of Motixafortide known commercially as APHEXDA in combination with G-CSF to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma. The approval of APHEXDA is the culmination of tireless work by the entire BioLineRx team and transitions us to a commercial stage company that is bringing the patients, physicians and caregivers, the first true advancement in stem cell mobilization in more than a decade. And Holly will detail shortly, we have built out our U.S. commercial infrastructure, which has been engaging in pre-and post-launch activities to support a robust future for APHEXDA. Feedback from our initial outreach to top-tier transplant centers across the U.S. suggest that APHEXDA fills a significant unmet need for a more effective mobilization regimen, conferring benefits to centers, payers and patients alike.

This encouraging feedback gives us great optimism the long-term opportunity that is in front of us. There are many factors driving the need for improved stem cell mobilization regimen several of which we have covered in our prior calls. The population of multiple myeloma patients undergoing autologous Stem Cell Mobilization has expanded to include older patients over the past decade, with 36% of patients aged 65 or over in 2021, older age has been shown to impair Stem Cell Mobilization as stem cell counts decreased with age. In addition, the introduction of stronger induction therapies has further impaired mobilization, including drugs such as lenalidomide and natalizumab (ph), which are often given in combination. As a result, many patients may require multiple apheresis sessions.

Recall that the approval of APHEXDA was based on results from the highly successful GENESIS Phase 3 clinical trial and in this contemporary trial, most patients received lenalidomide containing induction regimen and the median age in the Motixafortide treatment arm was approximately 64 years old. Particularly relevant to the transplant centers in the GENESIS trial affect the plus G-CSF enabled almost 90% of patients who proceed to transplantation after only one apheresis session. Also, as a reminder, multiple myeloma is the second most common hematologic malignancy and autologous stem cell transplantation remains the standard of care treatment and has been shown to prolong the lives of patients with this cancer type. And historically, depending on treatment regimens, up to 47% of patients have faced challenges mobilizing the target number of stem cell after one session.

With APHEXDA as a potential backbone of a new mobilization paradigm, we are optimistic that many more multiple myeloma patients will be candidates for this life extending procedure and will benefit from what we are calling an A-plus transplantation experience. And at this point, I’d like to turn the call over to Holly May, President of BioLineRx USA for a review of our launch activities. Holly, please go ahead.

Holly May: Thank you, Phil. As Phil indicated, the approval of APHEXDA for stem cell mobilization in multiple myeloma patients represents the first true advancement in stems mobilization in over a decade. Our decision to commercialize effects to independently in the U.S. is key to our efforts to make this new mobilization agent available to transplant centers and patients as quickly as possible. I would now like to provide a brief update on our recent and ongoing activity supporting the commercial launch, which we initiated immediately after APHEXDA approval. First, it may be helpful to provide some statistics that support the significant opportunity that is in front of us, not just in terms of potential sales, but also an ability to help thousands of patients who today are having great difficulty mobilizing enough stem cells for transplantation.

As a reminder, there are approximately 35,000 patients diagnosed with multiple myeloma each year in the U.S. And of those, we estimate that about 18,000 are eligible for autologous stem cell transportation. On these eligible patients, approximately 8,000 procedures per annually, a figure that has nearly doubled since 2010. Autologous stem cell transportation remains the preferred first-line treatment for patients with multiple myeloma. However, due to a number of factors, including an aging patient population and the increased use of three and four drug induction therapies, as Phil indicated, up to 47% of patients have had challenges collecting the target number of stem cells in one apheresis session. As we will cover in more detail shortly, the requirements for multiple apheresis session leads to potentially more adverse events, higher costs and tremendous inconvenience and mental hardship for patients.

With the efficacy demonstrated in Phase 3 GENESIS trial, which supported the approval of effects to indecent indication, we believe we can overcome these challenges. We believe we are highly differentiated as a novel second-generation mobilization agent and that we have a significant value proposition for all stakeholders, that includes centers, patients and payers. Staying on the topic of differentiation for a moment, we have done extensive research on the market and have deep appreciation of the evolving landscape. Since our last earnings call and as expected, multiple abbreviated new drug applications or ANDA have been approved for generic [indiscernible] leading to rapid and significant price erosion for the first-generation mobilization agent.

This is something that we anticipated and what we have incorporated into our model. And why we consider, plerixafor to be in the same overall market basket at APHEXDA, it is not the same as APHEXDA. We have a highly differentiated product profile based on our stronger and more consistent mobilization outcomes. And our early discussions with customers support that the centers appreciate the innovation as we look to address their need for a better mobilizer. As such, we have indicated previously that we have price effects at [indiscernible] per vial. We believe this price adequately reflects the value that APHEXDA adds to the autologous stem cell transplant treatment landscape. Further, notwithstanding the existence of lower-priced generic plerixafor.

We believe the differentiated clinical attributes APHEXDA will drive long-term adoption and allow it to evolve into the new standard of care for mobilization. Over time, we strongly believe that differentiation will outweigh drug price as centers adopt the best treatment paradigm for their patients. As we indicated previously, our first priority has been to educate transplant centers on the unmet need of roughly 8,000 patients who progress to autologous stem cell transplant each year. We estimate the top 80 centers out of the band 212 nationally perform approximately 85% of all stem cell transplant procedures. Since approval, we have established initial contact with all of our top-tier centers and root activity has been extremely high. Increases shares can be in short supply at many transplant center and the potential for APHEXDA to allow for the collection of the targeted number of stem cells quite often in a single apheresis session should allow for the more efficient scheduling and utilization of those tiers.

This is of significant value to transplant centers, particularly those that perform a high number of procedures. We are in ongoing discussions with pharmacy and therapeutics committees at those centers that require positive PMP formulary decision prior to trialing the product and including APHEXDA in their protocols. We are making consistent and steady progress. We believe an important factor driving the future success of APHEXDA is inclusion in clinical treatment guidelines. Shortly after approval, APHEXDA was included in the national clinical practice guidelines in oncology otherwise known as NCCN, for stem cell mobilization broadly, including multiple myeloma. The American Society for transplantation in cellular therapy or ASTCT is also working on updated guidelines, which we anticipate next year.

Currently, ASTCT to [indiscernible] recommendations call for a recommended collection target of 3 million to 5 million cells per program and double that target with multiple transplants are planned. Recall that in the GENESIS trial, the median number of CD34 stem cells collected on the first day of apheresis was $8.5 million in the treatment arm versus $1.5 million in the control arm. As Phil indicated earlier, the addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session compared to 10.8% in the G-CSF, given the demonstrated performance of APHEXDA relative to the current treatment guidelines, we are confident that we will ultimately gain inclusion. Turning now to payers. The success of any new therapeutic launch is contingent upon establishing broad, affordable access from a coverage and reimbursement perspective.

This includes not only national and regional commercial health plans, but also the centers for Medicare and Medicaid services since a significant number of multiple myeloma patients are older and therefore, receive their health care through Medicare. The immediate upfront cost of stem cell collection independent of drug costs is 13,850 per patient and can range from 6,300 (ph) to $48,500 and the cost of one apheresis session is 6,200 to 6,600 again independent of drug costs. For the ability to more predictably and reliably achieve the target number of stem cells required for transplantation and fewer apheresis sessions can result in significant savings to payers over time. Payers view the effects of clinical data very favorably. And as a result, we have already established unrestricted access to over 90% of covered lives.

This represents a mix of both commercial and government payers, and we continue to work to increase this number so that APHEXDA is as broadly accessible to patients as possible. In summary, I am very pleased with our launch progress to date. Both our commercial and medical affairs teams, which include many individuals with decades of experience in both stem cell mobilization and multiple myeloma 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. At this point, I’ll turn the call back to Phil to provide an update on our other programs.

Phil Serlin: Thank you, Holly. At this point, I would like to provide an update on opportunities that we are pursuing in Stem Cell Mobilization for multiple myeloma outside of the United States. Just a few weeks ago, we closed an exclusive license agreement with the development commercialization of Motixafortide in Asia across multiple indications. As part of the agreement in Stem Cell Mobilization cell mobilization, our partner, Gloria Biosciences plans to execute a 30 to 50 patient bridging study in China to support approval and commercialization of APHEXDA for Stem Cell Mobilization in multiple myeloma. And we’ll also seek approval in other Asian countries. In prior clinical trials, Gloria Biosciences has demonstrated an ability to enroll patients quickly, and we believe they will be able to complete this trial with similar efficiency.

In 2022, it is estimated that Asia had over 51,000 reported cases of multiple myeloma, the largest number of multiple myeloma cases globally. So this is an area of great unmet need in those territories as well. And in China, autologous stem cell translocation for multiple myeloma is already included in medical insurance reimbursement. We continue to evaluate additional commercialization partnership opportunities in significant markets for APHEXDA in stem cell mobilization. Turning now to our second development indication for Motixafortide pancreatic cancer, our license agreement with Gloria Biosciences covers this indication as well. Gloria Biosciences is a leader in the development of cancer immunotherapies in Greater China having developed and commercially launched the anti-PD-1 monoclonal antibody, zimberelimab, which is approved in the region for relapsed or refractory classical Hodgkin lymphoma into a recurrent or metastatic cervical cancer.

Gloria Biosciences went from IND to commercialization of zimberelimab in its first indication in China in only 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. Recapping the terms of the agreement, we received $15 million upfront and are eligible to receive up to approximately $50 million in development milestones based on the achievement of specific development milestones in China and Japan. Additionally, we are eligible to receive up to approximately $200 million in potential commercial milestones and royalties ranging from 10% to 20% of net sales following the approval of Motixafortide in any indication in the Asia region.

In addition, the transaction included an equity investment of $14.6 million in BioLineRx, with the purchase of newly issued American depositary shares and of price at $2.14 per ADS. No warrants were issued in the transaction. In other PDAC developments in July, we announced the initiation of a randomized Phase 2 combination clinical trial of Motixafortide first-line pancreatic cancer. The trial known as CheMo4METPANC is sponsored by Columbia University, and it was recommended to precede the randomized phase of the study based on the very compelling preliminary data in the single-arm pilot phase of the study. Recall that the original pilot study was to enroll approximately 10 patients and was to be expanded to 30 patients if data from the first 10 patients were encouraging which was defined as three or more patients showing the partial response per the RECIST criteria.

As we recently presented at the AACR Special Conference on Pancreatic Cancer in September, seven of 11 patients were 64% experienced a partial response, of which five were confirmed PRs with one patient even experiencing resolution of the metastatic lesion in the liver. Along with the three patients were 27% experiencing stable disease, this resulted in a disease control rate of 91%. These findings compare very favorably to historic partial response and disease control rate of 23% and 48%, respectively, reported with the current standard of care. Based on these compelling data, the original trial design was amended from a single-arm study with a target enrollment of 30 patients is mentioned to a much larger randomized study of 108 patients.

The trial’s primary endpoint is progression-free survival PFS. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival. Enrollment in the study is expected to begin in the next few months. As is well known, PDAC is a tumor type in dire need of new effective treatment options. Neuro immunotherapies have shown promise in other tumor types with limited efficacy in PDAC due to immunosuppressive pathways. On our more optimism for this trial is also based on the success of our COMBAT/KEYNOTE-202 triple combination Phase 2a study for which we announced results in December 2020. Recall that the COMBAT/KEYNOTE study evaluated the combination of motixafortide, KEYTRUDA and chemotherapy as a second-line therapy.

Substantial improvement was observed across all study end points including overall survival, progression fee survival and overall response in the most challenging PDAC patients, those initially diagnosed with stage four cancer. The combination also appeared to be well tolerated with a low incidence of neutropenia and infections in treated patients. Needless to say, we are excited about the potential of Motixafortide to form the backbone of new PDAC treatment regimens giving new hope to patients suffering from this very difficult to treat tumor type, while demonstrating the versatility of Motixafortide across both hematological and solid tumor cancers. It is also worth mentioning that based on the promising data to date in PDAC, we see opportunities to explore Motixafortide as part of exciting new combination therapies to treat other solid tumor types.

This only adds to our optimism for the long-term potential of this molecule. Another area where we are exploring the potential utility of Motixafortide in autologous hematopoietic stem cell-based gene therapy for patients suffering from sickle cell disease one of the most common genetic diseases globally. To that end, in March, we announced the clinical trial collaboration with Washington University School of Medicine to evaluate Motixafortide in this indication. Unlike multiple myeloma patients, the current standard of care mobilization G-CSF carries significant risks and potential severe side effects for patients suffering from sickle cell disease. Furthermore, in many cases, current mobilization treatments fail to reliably yield optimal number of stem cells to facilitate gene therapy.

As such, this patient population is in need of an effective new mobilization regimen. Through this collaboration, we are 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+ in motixafortide stem cells in patients with sickle cell disease. Study enrollment has recently begun, and we anticipate data in the second half of 2024. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our main financial results. Mali, please go ahead.

Mali Zeevi: Thank you, Phil. As is our practice in our financial discussion on this call, we will only go over the most significant items in our financial statements. Sales and marketing expenses, research and development expenses, non-operating expenses, net loss and cash. Therefore, let me invite you to review the filings we made this morning, which contain our financials, 20-F and press release for additional information. Sales and marketing expenses for the three months ended September 30, 2023 were $8.1 million, an increase of $6.8 million or 517.4% compared to $1.3 million for the corresponding period last year. The increase resulted from the significant launch-related activities for Motixafortide in the U.S. Research and development expenses for the three months ended September 30, 2023 were $2.7 million, a decrease of $1.6 million or 37.6% compared to $4.3 million for the corresponding period last year.

The decrease resulted primarily from lower expenses for NDA supporting activities related to Motixafortide as well as lower expenses associated with the completed AGI-134 clinical trials. Non-operating expenses for the three months ended September 30, 2023 were $3.1 million, an increase of $3.5 million compared to nonoperating income of $0.4 million for the corresponding period last year. The increase relates primarily to a non-cash expense from revaluation of outstanding warrants due to an increase in the company’s share price during the 2023 period. Let me now turn to net loss. Net loss for the three months ended September 30, 2023, was $16 million compared to $6.8 million for the corresponding period last year. Net loss for the nine months ended September 30, 2023, amounted to $46.7 million compared to $19.2 million for the corresponding period last year.

The increases in net loss for both the three and the nine months period in 2023 were primarily due to the significant nonoperating expenses related to revaluation of outstanding warrants as well as the significant increases in sales and marketing expenses related to launch activities which were partially offset by a decrease in research and development expenses. The company emphasizes the non-cash expenses associated with the warrant revaluation did not impact its cash position as of September 30, 2023, note that they affect the company’s projected cash runway going forward. Turning to cash. The company held $26 million of cash, cash equivalents and short-term bank deposits as of September 30, 2023. This does not include the roughly $30 million consideration from the license agreement and the equity investment in the deal with Gloria Biosciences nor does it include the $30 million available to us under our debt agreement with Kreos Capital, which is tied to the attainment of certain milestones.

We believe we are well financed to fund our 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. Commercial ramp-up of effects to U.S. sales and an ongoing evaluation of commercial partnership opportunities for APHEXDA in additional markets. Recruitment in the chemo for met Phase 2 randomized clinical trial in first-line PDAC sponsored by Columbia University. Recruitment in the Phase I pilot study of Motixafortide 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 2024. Initiation by Gloria Biosciences of a 30 to 50 patient bridging study in 2024 to support approval of APHEXDA and Stem Cell Mobilization for multiple myeloma in China in preparation activities with Gloria Biosciences on a randomized Phase II/III clinical trial, evaluating ixaportid in combination with the PD-1 inhibitor zimberelimab and standard of care combination chemotherapy in first-line pancreatic cancer.

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

See also 10 Best Selling Smartphones in the World in 2023 and Top 30 Oil Producing Countries in 2023.

Q&A Session

Operator: Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] The first question is from Joe Pantginis of H.C. Wainright. Please go ahead.

Joe Pantginis: Hi, everybody. Good morning. Thank for taking the questions. And first, I just wanted to extend my well wishes to everybody, not only for these difficult and turbulent times, but also for the holidays. So we have all of our best — so I’d like to focus on two things for stem cell transplantation and then one on PANC (ph), if you don’t mind. So first, Holly, I really appreciate all the details that it definitely is encouraging to hear all the details that you shared about the launch. So hopefully, I’m not getting too much into the weeds because it is early. I guess, when you’re early in the launch, I’m just considering what places or areas that you feel the company has had nimble in according to the plans that you had and saying, okay, we learned we might need more emphasis in a particular geography or anything of that such of those details. Yeah.

Phil Serlin: Holly, go ahead.

Holly May: Yeah. Sure. Thanks, Joe. So much of what we’re doing right now is as expected as planned. We have said this previously, I spoke again in my comments this morning about the fact that transplant centers make up about 85% of all of the transplantations in the U.S. And therefore, we are — we have a deployment plan with field individuals, both sales account type people as well as medical affairs type people. And I think we kind of got that one right. The deployment plans and our ability to reach and hit the right frequency with in those institutions is spot on. I think one of the things that’s been interesting for us, I don’t know if it’s a huge shift, but it’s been interesting to speak to some of these decision makers within the centers about the — what we would — we have three pillars of value — and the one I think that maybe not surprising, but we’re finding a lot of interest in is that the efficiency of this product.

And that has to do really around the planning and logistics asset centers as well as the pharmacokinetics. So that’s an area I think that we are spending perhaps a little bit more time than maybe we had originally the strong clinical data, which is our efficacy pillar the Phase 3 GENESIS data is resonating quite well. But I think the thing that we’re spending some more time on is probably the efficiency and what that means. I do want to add, though, you didn’t ask this, but the third, I’ve spoken about the efficacy and the efficiency of the other really important part of our value proposition is the experience that patient experience as well. So we are out there with all of that messaging, but the one I think that we’re really finding to resonate for maybe a few more questions than we initially thought was that efficiency color.

Joe Pantginis: That’s really, really helpful. Thank you for that. And I guess the thing that I’m curious about is because it’s pretty intriguing is the fact that it’s huge that you’re on the NCCN guidelines. And you said for SCM broadly, so I wanted to get a sense of how that impacts your potential development plan. And I know you can’t really talk to off-label use in other indications, but I think this could help drive, I guess, how you develop for other indications. I don’t know if you have any comments on that.

Phil Serlin: Holly, do you want to take that?

Holly May: I can. Yes. So we are very much staying the course on thinking about what we want to do for add-on indications, either things that would be driven within our own clinical planning. We do have an active IS independent sponsored studies that is open and available for various institutions or physicians that have an area of interest [indiscernible] in stem cell mobilization. We are constantly looking at the data that required for making sure that we shore up our label and that. But I’m certainly not going to speak at all to any kind of off-label utilization that the guidelines may or may not afford. Did that answer your question?

Joe Pantginis: It does. I’d like to add something.

Phil Serlin: Joe, I’d like to add something — I just I’m sorry, I sorry to interrupt you. I just wanted to add, first of all, hi, good to speak to you. But I do want to add, we mentioned the gene therapy in the sickle cell disease area. And obviously, that’s an area that we’re putting a lot of focus on in a big way. And so we see that as a very key life cycle management upside for the company.

Joe Pantginis: Great. And then just the last question. I mean, short question, but maybe more elaborate answer. Maybe. The Phase II pilot study being run with Colombia. Obviously, you’re having a nice expansion into a larger set of patients. I guess a question this way. To what extent do data from this study impact or serve as a rate-limiting step for potential business development?

Phil Serlin: Okay. So let me just make sure that I understand. So I mean, I mean I think I do understand. I think we are obviously looking to generate data I think that we’ve made it clear that we are looking to generate data to move this forward. We were — we entered into agreement with Gloria Biosciences. In Asia, part of that deal, a significant part of that deal is for them to generate Phase IIb data in a randomized study, Phase II, III data in a randomized study in PDAC and we’re running this trial or we’re cooperating or collaborating with Columbia University in this IST trial. Depending on the data, we are hoping to be able to take this data and move forward from a business development perspective and speaking with large pharma companies, that would be the idea.