BioLineRx Ltd【BLRX】株式ニュース

BioLineRx Ltd. (BLRX) Q2 2024 Earnings Call Transcript

Aug. 15, 2024 3:03 PM ETBioLineRx Ltd. (BLRX) Stock

Q2: 2024-08-15 Earnings Summary
EPS of $0.00 beats by $0.14 | Revenue of $5.39M beats by $2.45M
BioLineRx Ltd. (NASDAQ:BLRX) Q2 2024 Earnings Conference Call August 15, 2024 8:30 AM ET

Company Participants

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

Conference Call Participants

John Vandermosten - Zacks

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2024 Financial Results Conference Call. [Operator Instructions]. Following management's formal presentation, instructions will be given for the question-and-answer session.

I would now like to hand 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 second quarter 2024 results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K.

I'd like to remind you that certain statements we make during the call will be forward-looking. Because such statements deal with future events, and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks, and uncertainties, please review our annual report on Form 20-F and our quarterly reports on Form 6-K that are filed with the U.S. Securities and Exchange Commission. On the call today, we will have Phil Serlin, Chief Executive Officer of BioLineRx; 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.

At this time, it is now my pleasure to turn the call over to Phil.

Phil Serlin

Thank you, John, and good morning, everyone, and thank you for joining us on today's call.

Following our strong second quarter 2024 performance and the encouraging progress of APHEXDA to launch to date. I wanted to highlight that today's BioLineRx is a fully integrated leader in stem cell mobilization with promising label expand opportunities. This is a stark change from last year, and we are well positioned to deliver value to all of our stakeholders. I will begin with a brief update on the important progress that we are making on our APHEXDA launch then turn the call over to Holly who'll go into our commercialization and life cycle management progress in more detail.

Mali will review our financial results, and then I will give a brief summary of our upcoming milestones. We will then open up all for your questions. Let me begin with an effect to commercialization update. Last quarter, we set an important goal. We said that among our targeted top 80 transplant centers, by the end of the second quarter, we would secure formulary placement at institutions managing 35% of stem cell transplant procedures.

And I'm happy to say that we surpassed this goal by June 30 with formulary placement at institutions managing 37% of transplant procedures. We continue to make steady progress on this most important launch metric and remain on track to achieve our year-end target of 60%.

Additionally, last quarter, we achieved formulary status at two of the largest transplant centers in the U.S., and we also doubled the number of centers ordering product. We are pleased with this continued positive momentum in only the second full quarter of our commercialization program. Each week, we learn about patients who have failed to collect enough stem cells on other mobilization agents putting their path to transplant at risk.

These patients were then given APHEXDA and they achieved their stem cell mobilization goals, many in a single apheresis session. Transplant centers are seeing the tremendous efficacy that APHEXDA can provide in this new era for multiple myeloma patients, where patients more often are older and increasingly received quad induction therapy which can increase mobilization risk.

In July, the FDA granted approval of an important quad therapy approach for transplant eligible, newly diagnosed multiple myeloma patients, including daratumumab and lenalidomide which can negatively impact stem cell yields. The approval was based on the tremendous efficacy results seen in the PERSEUS trial, which compared the quad therapy to the leading triple therapy. The quad therapy lowered the risk of disease progression or death by 60%.

Physicians have been treating patients with quad therapies prior to this approval. However, we believe that the data from this trial and the subsequent FDA approval will accelerate the process of quad therapy becoming the new standard of care, which, while beneficial to patients has the potential to further increase the need for APHEXDA. Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma in this new era of care for patients.

At this point, I'd like to turn the call over to Holly May, President of BioLineRx U.S., to discuss our commercialization efforts and some of our life cycle management initiatives. Holly, please go ahead.

Holly May

Thank you, Phil.

Last quarter, I discussed APHEXDA benefits on center efficiency and economics, and in conversations with transplant center key decision-makers, including physicians, pharmacists and apheresis unit Managing Directors. These two factors continue to be a significant determinant in transplant center formulary adoption.

We launched effect into a mobilization agent market that included generic plerixafor which had just entered generic status a few months before our approval. At the same time, transplant centers were realizing the impact that new induction therapy approaches have on stem cell collection yields.

These factors quite naturally created many questions for centers, centers that have, for many years, had long-standing protocols. It is within this changing landscape that institutions have also come to understand effective innovative benefits for patients and are actively studying how our product can benefit their center and members of our field force are supporting them in this effort with our efficiency modeling tools.

Additionally, we are publishing important health economic data and continues to work on additional research. Our health economic presentations in April at the American Society for Apheresis Annual Meeting and at the International Society for Pharmacoeconomics and Outcomes Research demonstrated the economic advantages for centers using G-CSF plus APHEXDA over G-CSF alone or G-CSF plus plerixafor. Given the efficacy, efficiency and economic benefits that APHEXDA provides, we believe that key decision-makers will continue to move toward our best-in-class mobilizer.

Let me transition now to our life cycle management efforts. Our vision is to maximize the potential of APHEXDA in its current indication and to expand into key areas with high unmet need. There is significant interest by independent investigators to evaluate APHEXDA across a number of areas associated with myeloma, including mobilization studies in patients treated with quad therapies or for post-CAR T cytopenia management.

We are also actively speaking with physician researchers across a number of additional disease states that have high unmet need in the area of stem cell mobilization. One critical area that continues to make progress is evaluating APHEXDA's stem cell mobilization potential in patients with sickle cell disease undergoing gene therapy.

This type of gene therapy is an area where I have significant experience based on my prior roles. The two currently approved gene therapies for sickle cell disease require significant quantities of stem cells to produce the therapies. And in speaking with leaders in the field using a mobilization agent that could speed the collection process would be a great advantage for patients. Our two ongoing sickle cell disease Phase 1 investigator-initiated studies with Washington University in St. Louis and St.

Jude's Children's Research Hospital in Memphis, were designed by significant key opinion leaders in this research area. We anticipate early data from the Washington collaboration in the second half of this year and the first patient dosed in the St. Jude study in September. Overall, in the next 12 months, we anticipate several independent investigators to initiate studies that will provide BioLine with critical data and insights to aid our ongoing life cycle management efforts.

Now let me turn the call over to Mali to provide a financial update.

Mali Zeevi

Thank you, Holly.

As is our practice, I will only go over the most significant items in our financial statements. Revenues, cost of revenues research and development expenses, sales and marketing expenses, net profit and cash. I invite you to review the filings we made this morning, which contain our financials and press release.

Total revenue for the three months ended June 30, 2024, was $5.4 million. We did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million as well as $1.8 million of net revenue from product sales of APHEXDA in the U.S. Cost of revenue for the three months ended June 30, 2024, was $0.9 million. We did not record any cost of revenue during the second quarter of 2023.

Cost of revenue for the quarter primarily reflects the amortization of intangible assets royalties on net product sales of APHEXDA in the U.S. and cost of goods sold on product sales. Research and development expenses for the three months ended June 30, 2024, were $2.2 million compared to $3 million for the same period in 2023.

The decrease resulted primarily from lower expenses related to motixafortide activities the termination of the development of AGI-134 and the decrease in share-based compensation. Sales and marketing expenses for the three months ended June 30, 2024, were $6.4 million compared to $5.6 million for the same period in 2023.

The increase resulted primarily from the ramp-up in head count costs associated with fully hired field team. Net income for the three months ended June 30, 2024, was $0.5 million compared to a net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in nonoperating income compared to nonoperating expenses of $7.7 million for the same period in 2023, both mainly related to the noncash revaluation of warrants.

As of June 30, 2024, the company had cash, cash equivalents and short-term bank deposits of $40.1 million. The company anticipates that this amount will be sufficient to fund operations as currently planned into 2025.

And with that, I'll turn the call over to Phil.

Phil Serlin

Thank you, Mali.

In closing, as is our custom, I would like to take a few moments to summarize our upcoming milestones. We anticipate first patient dosed in the St. Jude sickle cell disease gene therapy Phase 1 trial in September. The Phase 1 clinical trial is an open-label multicenter study evaluating the safety, tolerability and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ hematopoietic stem cells in 12 patients, aged 18 and older with sickle cell disease.

We anticipate the initiation of the bridging study by collaboration partner, Gloria Biosciences to support approval of APHEXDA in stem cell mobilization for multiple myeloma in China in the second half of this year. Also in the second half of this year, as Holly mentioned, we anticipate a presentation on early data from the wash use sickle cell disease gene therapy Phase 1 trial, evaluating motixafortide as a monotherapy and in combination with natalizumab for stem cell mobilization.

Additionally, working with Gloria Bio, we completed the study design of the Phase 2b combination study evaluating motixafortide in first-line pancreatic cancer. We anticipate that Gloria will submit the study designed for regulatory review in 2024 with the study initiating in 2025.

Finally, we continue recruitment in the CheMo4METPANC IIb randomized clinical trial in first-line metastatic pancreatic cancer sponsored by Columbia University and in partnership with Regeneron. We anticipate that this trial, which had very encouraging pilot phase data published at ASCO this quarter will be fully enrolled by 2027.

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

Question-and-Answer Session

Operator

[Operator Instructions] The first question is from John Vandermosten of Zacks. Please go ahead.

John Vandermosten

Great. Thank you. So the summer is usually known to have kind of negative seasonal effects for both, I guess, therapy use and with hospital staff, especially in academic settings. And I'm wondering if you could comment on how you expect seasonally the effort to go with sales of APHEXDA. Do you anticipate a strong pickup activity in September? And was this summer, I guess it's not over yet, but I guess was this summer as you had expected?

Phil Serlin

Yes. So John, good morning, and thanks for the question and joining the call. So I'll turn it over to Holly in a moment. But our results are through June 30. So we're talking now about the second quarter, which is really the spring. I would like to, again, mention that we doubled our sales in Q2 from Q1. And so I'm not sure the results at this point really reflect any kind of slowdown -- seasonal slowdown in the summer. We're looking -- things are looking very, very good at the moment. I'll let Holly expand on that, if she'd like.

Holly May

Yes. Thanks, Phil, and good morning John. So we have actually analyzed some of the seasonality on a month-to-month basis. because this is indicated for multiple myeloma, and it's very dependent on patients needing to get timely transplants. We don't necessarily see those same kind of seasonality effects with a product like APHEXDA as you may with others. That's a very general answer, but that is not something that we are terribly concerned about and have huge downturns built into any kind of forecasting for that reason. Does that answer your question?

John Vandermosten

Yes, it does. And how would you characterize the reorder rate? It seems like based on kind of a top-down view that it's fairly good. Would you characterize it that way as well?

Phil Serlin

Holly, you want to take that?

Holly May

Yes, I would love to. So yes, so once -- I think we've spoken about this before. Once a product is on formulary, that's the biggest hurdle to begin utilization -- adoption and utilization and an uptake in sales. And so our field teams are continuing to do both things to onboard institutions that have approved us for formulary through their P&T. So that is a significant part of future growth as well as then working on institutions where we already have formulary acceptance and continuing to do selling efforts in those hospitals to increase the quantities where we are on formulary.

So the team very early on, the field teams very early on were singularly focused on assuring the readiness of P&T committees to put us on formulary. That work continues, but now we are also looking at selling efforts in those institutions that have us on formulary to increase there. So we see revenues from both sources, new accounts and existing accounts as we move throughout the year.

John Vandermosten

Okay. And final question on sickle cell and gene therapy. I guess I was surprised to see two studies in the same gene therapy indication. And I guess that's because -- maybe you can tell me why that is. And then are there any other gene therapy indications that would also be kind of the next place to go for using motixafortide to collect the proper number of cells?

Phil Serlin

Yes. So let me ask Ella, maybe you can talk about the differences between the two studies a little bit.

Ella Sorani

Yes. I'm sorry, but -- the design of the St. Jude study is not -- I don't think that we have disclosed it yet. The design -- there is a difference between the two studies in terms of ...

Phil Serlin

Yes. I guess you're right. Yes, perhaps you can't disclose that yet. I mean are there different -- they're -- I'm wondering if -- I just don't remember whether we've disclosed that. You're sure we haven't disclosed it? Yes. So John, I'm sorry about that.

There are differences in the studies based on whether there are single administrations or multiple administrations and the size of the studies -- but I don't think, like as Ellen said, I don't think that we've spoken about the design yet. There are publication and embargoes and those kind of things that we can't really discuss it at this point. I apologize.

John Vandermosten

Okay. And well -- and then I guess are there any other kind of gene therapy indications that would be equally addressed from sponsors to use motixafortide to collect enough cells? Because I assume that's why the sickle cell was chosen compared to others, they just need more cells.

Phil Serlin

Yes. Well, it's more complicated than that. I mean, I'll turn it over to Holly, but I'll just say one of the reasons why mobilization is so difficult in sickle cell patients is because the underlying mobilization agent G-CSF is contraindicated in sickle cell patients. And therefore, they can only get what you'd call in air quotes, a booster, plerixafor or like APHEXDA. So they can't get the underlying G-CSF, which is given to patients like multiple myeloma before they're given booster agent, so to speak.

So that's one of the main reasons why this is an area that is extreme that has a clear unmet medical need in mobilization. But Holly, if you'd like to expand on that, please feel free.

Holly May

Yes, I'm happy to talk about that a little bit. So there are different types of gene therapy, some like AV therapy that do not require hematopoietic stem cells and others, like the sickle cell approved therapies right now by Bluebird and Vertex that do require stem cells in order to complete the gene therapy.

And so certainly, sickle cell based on the things that Phil just said is the ideal place to begin using a product like APHEXDA for the mobilization of stem cells to complete that type of gene therapy. But we do see that there could be other types of gene therapies that do require CD34 stem cells, which could very easily benefit from APHEXDA in the future. But currently, we are focused on generating the data in sickle cell because of the high unmet.

John Vandermosten

Understood. Thank you, Holly.

Holly May

Yes. Thanks John.

Operator

[Operator Instructions] The next question is from John Vandermosten of Zacks. Please go ahead.

John Vandermosten

Great. Thanks for allowing me a follow-up. Have there been any inquiries from investigators for use that APHEXDA outside of multiple myeloma, expanding more into some other leukemias?

Phil Serlin

As Holly mentioned, and I think I'll let her expand on it a little bit. We have a number of requests from investigators to perform investigate initiated studies in potentially different indications, et cetera? Holly, do you maybe want to expand on that a little bit?

Holly May

Yes. I guess I'm looking for some guidance here as sort of what I can and can't say. Some we are in the process of these ISSs. We are in the process of signing for what I would call kind of indication enhancing data and other investigators are very interested in other areas of study and investigation where mobilization of stem cells is required.

So I think the easiest way to say this is we have a very active IFS program that we have launched here since that we have initiated since launch, and we continue to review all of those proposals, but there does seem to be a lot of interest in motixafortide to be studied in areas to improve on things like multiple myeloma and then in other indications as well.

John Vandermosten

Okay, great. Thank you.

Holly May

Thanks John.

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 03-925-5904. Internationally, please call 972-3-955-904.

Mr. Serlin, would you like to make your concluding statement?

Phil Serlin

Yes, I would. Thank you, operator. In closing, we are progressing through 2024 with significant momentum both with the ongoing commercial ramp-up of APHEXDA as well as the advancement of our development programs in sickle cell disease and pancreatic cancer. I'm excited to what we are poised to accomplish over the remainder of the year and next.

Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in November. Be safe, and have a good day.

Operator

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

BioLineRx Reports Second Quarter 2024 Financial Results and Recent Corporate and Portfolio Updates

https://finance.yahoo.com/news/biolinerx-reports-second-quarter-2024-110000860.html

- Secured APHEXDA® formulary placement among top 80 transplant centers representing ~37% of stem cell transplant procedures performed, surpassing stated goal for quarter; on-track to reach goal of ~60% by end of Q4 -

- Doubled the number of centers ordering APHEXDA during the second quarter -

- Entered into clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease -

- Management to host conference call today, August 15, at 8:30 am EDT -

TEL AVIV, Israel, Aug. 15, 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 unaudited financial results for the second quarter ended June 30, 2024, and provided recent corporate and portfolio updates.

"We continue to demonstrate positive commercial launch momentum with APHEXDA, our best-in-class stem cell mobilization agent," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, among our targeted top 80 transplant centers, we've secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, surpassing our stated goal. Additionally, we doubled the number of transplant centers ordering APHEXDA during the second quarter, which is a strong leading indicator and, we believe, reflects centers' growing recognition of the value that APHEXDA offers relative to other mobilization agents. Our goal is to achieve formulary placement at institutions representing approximately 60% of procedures by the end of year, which will support continued revenue growth and ease burdens on patients, caregivers, and transplant centers.

"Our vision is to maximize the potential of APHEXDA by expanding into key areas with high unmet need. To that end, we announced our second clinical trial collaboration, with St. Jude Children's Research Hospital, evaluating APHEXDA for stem cell mobilization in patients with sickle cell disease (SCD) seeking gene therapy. This new collaboration complements the ongoing SCD stem cell mobilization Phase 1 trial at Washington University in St. Louis (Wash U.). APHEXDA has the potential to support the collection of the immense amount of stem cells needed for these complex gene therapies in a more predictable and condensed timeline for patients. The companies launching these new gene therapies for SCD report continued expansion of authorized treatment centers and increased numbers of patients initiating cell collection. We look forward to seeing early data from the Wash U. Phase 1 trial later this year."

APHEXDA Launch Updates

Among top 80 transplant centers, secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, exceeding the company's stated goal for the quarter; on track to achieve ~60% by year-end 2024

Saw double the number of centers ordering APHEXDA during the second quarter as compared to the first quarter, which contributed to quarter-over-quarter net revenue growth of 100%

Clinical Portfolio Updates

Motixafortide

Multiple Myeloma

Presented a poster at the American Society for Apheresis (ASFA) 2024 Annual Meeting on April 17, 2024, demonstrating that transplant centers (averaging, for example, 20 transplants per month), when switching to G-CSF plus APHEXDA, could increase capacity by 52.0 patient days per month versus G-CSF alone, or by 12.3 patient days per month versus G-CSF in combination with plerixafor

Presented a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on April 6, 2024, showing that even with APHEXDA's higher drug acquisition cost compared to other mobilization regimens, specifically G-CSF alone or G-CSF plus generic plerixafor, the combination of G-CSF plus APHEXDA may confer a similar or better overall financial impact while providing centers and patients with an improved mobilization experience

Collaboration partner Gloria Biosciences' stem cell mobilization bridging study IND was filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate initiation of pivotal clinical trial in 2H 2024

Sickle Cell Disease (SCD) & Gene Therapy

Entered into clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease. The Phase 1 clinical trial is an open-label, multi-center study evaluating the safety, tolerability, and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ HSCs in 12 patients (aged 18 and older) with SCD. Anticipate first patient dosed in September 2024 and initial data in 2025

Reported continuing enrollment of patients into a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial, in collaboration with Washington University School of Medicine in St. Louis, has been expanded from five to 10 patients. Anticipate initial data in 2H 2024

Pancreatic Ductal Adenocarcinoma (mPDAC)

Presented positive biopsy data from the completed pilot phase of the ongoing CheMo4METPANC Phase 2b clinical trial collaboration with Columbia University at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting held on June 1, 2024 in Chicago, IL. New analyses of paired pre- and on-treatment biopsy samples demonstrated a statistically significant increase in CD8+ T-cell density in tumors from all 11 patients treated with the combination therapy approach (P=0.007). Enrollment in the randomized trial targeting 108 patients continues with full enrollment anticipated in 2027

Completed design of Phase 2b randomized clinical trial in China with collaboration partner Gloria Biosciences intended to assess 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

Second Quarter 2024 Financial Results

Total revenue for the three months ended June 30, 2024 was $5.4 million. The Company did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million, as well as $1.8 million of net revenue from product sales of APHEXDA in the U.S.

Cost of revenue for the three months ended June 30, 2024 was $0.9 million. The Company did not record any cost of revenue during the second quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S., and cost of goods sold on product sales

Research and development expenses for the three months ended June 30, 2024 were $2.2 million, compared to $3.0 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide New Drug Application (NDA) supporting activities, termination of the development of AGI-134 and a decrease in share-based compensation

Sales and marketing expenses for the three months ended June 30, 2024 were $6.4 million, compared to $5.6 million for the same period in 2023. The increase resulted primarily from the ramp-up in headcount costs associated with a fully hired field team

General and administrative expenses for the three months ended June 30, 2024 were $1.6 million, compared to $1.3 million for the same period in 2023. The increase resulted primarily from an increase in legal and certain other expenses

Net income for the three months ended June 30, 2024 was $0.5 million, compared to net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in non-operating income, compared to non-operating expenses of $7.7 million for the same period in 2023, both primarily related to the non-cash revaluation of warrants

As of June 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $40.1 million. The Company anticipates that this amount will be sufficient to fund operations, as currently planned, into 2025

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 August 19, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

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