midastouch017
3 weeks ago
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.
midastouch017
3 weeks ago
BioLineRx Reports 2023 Financial Results and Recent Corporate and Portfolio Updates
https://finance.yahoo.com/news/biolinerx-reports-2023-financial-results-110000704.html
- Reported significant commercial progress for APHEXDA® -- secured payer coverage representing ~95% of covered lives in the U.S.; continued progress on formulary approvals at targeted major transplant centers; received Healthcare Common Procedure Coding System (HCPCS) J-Code to facilitate Medicare reimbursement -
- Announced first patient dosed in randomized Phase 2b clinical trial evaluating motixafortide in first-line pancreatic cancer -
- Continued to support partner Gloria Biosciences in plans to execute pivotal bridging study of motixafortide in stem cell mobilization and Phase 2b randomized study in first-line pancreatic cancer in China -
- Management to host conference call today, March 26, at 8:30 am EDT -
TEL AVIV, Israel, March 26, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its financial results for the year ended December 31, 2023, and provided recent corporate and portfolio updates.
"Following FDA approval of APHEXDA® in September, physicians and transplant centers have been very receptive to the value of our strong clinical data, and our commercial team has made substantial progress establishing relationships with transplant centers across the country," said Philip Serlin, Chief Executive Officer of BioLineRx. "This year will continue to be primarily a foundational period for the commercialization of APHEXDA. We are seeing substantial progress on Pharmacy & Therapeutics committee approvals -- the first step toward center adoption -- and are actively supporting centers as they build usage protocols and treat their first patients. Initial feedback on patient experiences has been positive, and we are already seeing repeat purchases. Notably, we have achieved payer coverage representing approximately 95% of covered lives in the U.S. to date, which we believe reflects the value that APHEXDA offers to payers and patients alike, particularly its ability to mobilize the targeted number of stem cells in fewer apheresis sessions.
"Additionally, through a clinical collaboration with Washington University, we are actively evaluating the potential of motixafortide to support gene therapy for patients with sickle cell disease, a treatment process that requires significant quantities of hematopoietic stem cells. We anticipate data from this proof-of-concept Phase 1 study in patients with sickle cell disease in the second half of this year.
"At the same time, we are making significant progress advancing clinical programs evaluating motixafortide in pancreatic cancer, which if ultimately approved in combination with PD-1 inhibitors, would serve a much larger patient population and provide confidence for expanding into additional solid tumors. In pancreatic cancer, our enthusiasm is bolstered by the compelling data presented last fall from the single-arm pilot phase of the Phase 2b trial sponsored by Columbia University. The first patient has now been dosed in the randomized Phase 2b portion of that study, and we are also working with Gloria Biosciences on the design and execution of a similar randomized Phase 2b combination trial of motixafortide and zimberelimab in pancreatic cancer in China.
"Our vision of bringing a best-in-class stem cell mobilization agent to market, as well as advancing development in pancreatic cancer and other solid tumor areas with major unmet needs, is being actively realized. We look forward to the exciting, continued execution progress that our commercial and development teams will make this year," Mr. Serlin concluded.
Corporate Updates
Launched APHEXDA (motixafortide) in the U.S.
Announced closing of exclusive license agreement that includes development and commercialization rights to motixafortide across all indications in the Asia region, as well as a strategic equity investment
Strengthened motixafortide intellectual property estate with notice of allowance for U.S. patent covering method of manufacturing motixafortide suitable for large scale production; the patent supplements existing Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as Orphan Drug market exclusivity for autologous stem cell mobilization in multiple myeloma patients in the U.S. following last year's FDA approval of APHEXDA
APHEXDA Launch Updates
Reported positive coverage decisions by payers representing ~95% of all covered lives in the U.S.
Received inclusion of APHEXDA in the National Comprehensive Cancer Network (NCCN) guidelines for Hematopoietic Cell Transplantation
Achieved "on formulary" status for APHEXDA within targeted top 80 transplantation centers (which perform 85% of all U.S. transplants) managing ~20% of stem cell transplant procedures at these institutions; anticipate similar on formulary status of ~35% at end of Q2 2024 and ~60% at year-end 2024
Received Healthcare Common Procedure Coding System (HCPCS) J-Code to facilitate Medicare reimbursement for APHEXDA to transplant centers treating Medicare beneficiaries
Clinical Portfolio Updates
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
Presented posters at both the American Society of Hematology (ASH) 65th Annual Meeting on December 10, 2023, and the 2024 Tandem Meetings on February 21-24, 2024. The posters reviewed combination premedication benefits in the Phase 3 GENESIS trial, extended PD effect of elevated CD34+ cells in peripheral blood, and a post-hoc subgroup analysis of impaired HSC mobilization patients that demonstrated a consistent benefit of motixafortide + G-CSF over placebo + G-CSF mobilization for all patients
Supported collaboration partner Gloria Biosciences with stem cell mobilization bridging study IND filing in February with the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate regulatory action in May 2024 and initiation of pivotal clinical trial in 2H 2024
Pancreatic Ductal Adenocarcinoma (mPDAC)
Announced first patient dosed in a randomized, investigator-initiated Phase 2b clinical trial in collaboration with Columbia University assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer
Advanced plans with collaboration partner Gloria Biosciences on a Phase 2b randomized clinical trial in China assessing motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. Anticipate clinical trial initiation in 2025
Sickle Cell Disease (SCD) & Gene Therapy
Continued to enroll patients into a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. Anticipate data in 2H 2024
Financial Results for Year Ended December 31, 2023
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 recognized 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 reflects a $3.0 million sub-license fee to the upstream licensor of motixafortide payable on closing of the exclusive license agreement in Asia, as well as amortization of an intangible asset in respect of these license revenues in the amount of $0.5 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, compared to $17.6 million for the year ended December 31, 2022. The decrease resulted primarily from lower expenses related to motixafortide NDA supporting activities, as well as lower expenses associated with completion of the AGI-134 study
Sales and marketing expenses for the year ended December 31, 2023, were $25.3 million, 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
General and administrative expenses for the year ended December 31, 2023, were $6.3 million, compared to $5.1 million for the year ended December 31, 2022. The increase resulted primarily from an increase in payroll and related expenses associated with a small headcount increase during the 2022 period, as well as an increase in professional services and legal expenses
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 relate 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 $25.0 million for the year ended December 31, 2022. The net loss for 2023 included $17.8 million in non-cash expenses, specifically an expense of $11.1 million for the revaluation of warrants 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 in non-cash income specifically related to the revaluation of warrants.
As of December 31, 2023, the Company had cash, cash equivalents, and short-term bank deposits of $43.0 million. The Company anticipates that this amount and other available resources, including amounts available under a debt facility with Kreos Capital, will be sufficient to fund operations, as currently planned, into 2025
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2023 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at https://ir.biolinerx.com.The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at IR@BioLineRx.com.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 28, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
midastouch017
1 month ago
BioLineRx Strengthens Intellectual Property Estate with Notice of Allowance for U.S. Patent Covering Method of Manufacturing Motixafortide (BL-8040) Suitable for Large Scale Production
https://finance.yahoo.com/news/biolinerx-strengthens-intellectual-property-estate-120000297.html
- New patent, when issued, will be valid until December 2041 -
- Additional IP complements U.S. market exclusivity awarded to BioLineRx upon FDA approval of APHEXDA® (motixafortide) in September 2023 as a result of its Orphan Drug and New Chemical Entity designations -
TEL AVIV, Israel, March 4, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent, "Process for Manufacturing Peptide," covering a method of manufacturing motixafortide (BL-8040) that is suitable for large scale production.
In addition to a broad range of U.S. and international patents covering various aspects of motixafortide, including composition of matter, methods of synthesis, methods of use and combinations, BioLineRx was granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA® (motixafortide) was approved by the FDA, in combination with G-CSF, for use by multiple myeloma patients undergoing autologous stem cell transplantation. Additionally, motixafortide was granted five years of market exclusivity across all indications as a New Chemical Entity (NCE). The NCE exclusivity also commenced on September 8, 2023.
"This is a very meaningful addition to our IP portfolio as we look to scale up the production of motixafortide to support both the commercial demand for APHEXDA for stem cell mobilization in multiple myeloma patients as well as the numerous ongoing clinical trials underway in other indications, including metastatic pancreatic cancer and for gene therapies in sickle cell disease," stated Philip Serlin, Chief Executive Officer of BioLineRx. "When combined with the seven years of Orphan Drug Designation market exclusivity that we were granted upon FDA approval of APHEXDA beginning last September, and five years of exclusivity across all indications as a New Chemical Entity, we have a broad set of IP protections that we believe will allow us to maximize the value of this important molecule for our company and shareholders for years to come."
Motixafortide has also been granted Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as in the U.S. for the treatment of acute myeloid leukemia (AML).
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
Forward Looking Statement
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether BioLineRx's collaboration partners will be able to execute on collaboration goals in a timely manner; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, operationalize and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic, the Russian invasion of Ukraine, the declared war by Israel against Hamas and the military campaigns against Hamas and other terrorist organizations, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contacts:
United States
John Lacey
BioLineRx
IR@biolinerx.com
Israel
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
Logo - https://mma.prnewswire.com/media/2154863/4165445/BioLineRx_Ltd_Logo.jpg
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-strengthens-intellectual-property-estate-with-notice-of-allowance-for-us-patent-covering-method-of-manufacturing-motixafortide-bl-8040-suitable-for-large-scale-production-302078254.html
SOURCE BioLineRx Ltd.
midastouch017
2 months ago
BioLineRx Announces First Patient Dosed in Randomized Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC)
https://finance.yahoo.com/news/biolinerx-announces-first-patient-dosed-120000825.html
- Conducted in Collaboration with Columbia University, the CheMo4METPANC Phase 2 trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies compared to chemo alone -
- Gulam Manji, MD, PhD, of Columbia University to present encore pilot phase data at the Immuno-Oncology (IO) 360° Summit on February 29 -
TEL AVIV, Israel, Feb. 28, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the first patient has been dosed in the randomized CheMo4METPANC Phase 2 combination clinical trial evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC). The investigator-initiated trial is being conducted in collaboration with Columbia University and is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.
"Pancreatic ductal adenocarcinoma (PDAC) has had limited responses to traditional immunotherapy, resulting in a poor prognosis for patients and an urgent need for new treatment approaches," said Philip Serlin, Chief Executive Officer of BioLineRx. "We are encouraged by our early pilot data and look forward to continuing to advance the expanded, randomized Phase 2 CheMo4METPANC trial for patients living with this cancer."
Findings from the single-arm pilot phase of the CheMo4METPANC trial will be shared by Dr. Manji at the 10th Annual Immuno-Oncology (IO) 360° Summit in Brooklyn, New York on Thursday, February 29, 2024. The findings were previously presented during an oral presentation at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer in Boston, Massachusetts, September 28, 2023. As of July 2023, 7 of the 11 patients (64%) in the pilot phase experienced a partial response (PR) of which 5 (45%) were confirmed PRs at the time of the data cut; one patient experienced resolution of the hepatic (liver) metastatic lesion; and three patients (27%) experienced stable disease, resulting in a disease control rate of 91%.
Motixafortide, BioLineRx's lead therapeutic candidate, was approved by the U.S. Food & Drug Administration (FDA) in September 2023, in combination with filgrastim (G-CSF), to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma, under the brand name APHEXDA®. Motixafortide is also being evaluated in a Phase 1 clinical trial evaluating motixafortide as a monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD).
About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04543071) is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, and supported equally by BioLineRx and Regeneron, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in 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.
About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2024, an estimated 66,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths.1 Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.2 In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.
About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.
Register for streaming realtime charts, analysis tools, and prices.
Monksdream
5 days ago
murocman
6 days ago
Bayguy
6 days ago
Hot Features
Premium
