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