Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BXCL501 is being expanded into the home setting for bipolar and schizophrenia-related agitation, as well as a new indication for Alzheimer's-related agitation.
- The SERENITY At-Home trial is nearing initiation, representing a potential near-term value-creation opportunity.
- The TRANQUILITY program for Alzheimer's-associated agitation has received breakthrough therapy designation from the FDA.
- IGALMI has seen growing adoption among psychiatric care clinics and behavioral health facilities, with a 141% increase in net revenue year-over-year.
- The company has substantial patent protection for IGALMI extending to 2043, providing a long-term competitive advantage.
Negative Points
- BioXcel Therapeutics Inc (BTAI, Financial) reported a net loss of $8.3 million for the second quarter of 2024, despite reduced expenses.
- The company used $23.2 million in operating cash during the second quarter of 2024, indicating high cash burn.
- There is uncertainty regarding the timing and cost of the TRANQUILITY In-Care trial, with no specific guidance provided.
- The company is exploring various strategic financing alternatives, indicating potential financial instability.
- The SERENITY At-Home trial, while less complex, still lacks precise timelines for initiation and completion.
Q & A Highlights
Q: On TRANQUILITY In-Care, at what point do you expect to be able to let us know when data might be available? And on that trial, are there any new variables that might make the trial more or less expensive relative to how you characterized the cost previously?
A: This is Vince. For TRANQUILITY In-Care, today we're not in a position to provide specific timing. To your second question in terms of cost, we don't typically give specific cost guidance. But we see no reason to have changed our view on the cost of the study recently. It's essentially as previously thought or planned.
Q: On SERENITY At-Home, how aligned would you say you are with the FDA on that trial and is the child proof packaging the key part of enabling that trial to proceed?
A: This is Vince. I would say we are very aligned with the FDA. As I mentioned in prepared remarks, we did receive feedback from the FDA that has been incorporated into the protocol. Also, as mentioned, CNC work is complete, statement of work with the CRO has also been defined. So essentially the make ready work for that study is complete.
Q: Can you talk about any potential areas of discussion that you might have with the FDA on the specific TRANQUILITY In-Care protocol?
A: This is Vimal. One point I'll make is, obviously, TRANQUILITY versus SERENITY is an efficacy primary endpoint study. It's obviously a little more complicated, a little longer in duration and actually a little bit more expensive. We know that the FDA is very interested in repeat dose efficacy and I think that will be the one point that we want to get right going forward with that protocol.
Q: What are your expectations for the pace of trial execution for the Phase 3 trials upon initiation, maybe specifically SERENITY here? And maybe could you add some additional color on the potential market opportunity for the At-Home population here as well?
A: This is Vince. Not in a position to give precise timelines today, but I'll actually just repeat what I said a moment ago, and that is that SERENITY -- of the two studies, SERENITY is the less complex study, therefore the faster study and the less expensive study.
A: This is Matt. There are 23 million episodes in the at-home market. Patients who experience agitation with bipolar schizophrenia indicated that they would use the BXCL501 in 80% of their episodes, oftentimes at the very beginning or even before those episodes started. So the patients are motivated and rarely we could imagine taking some of the 23 million episodes adding to that as we draw some of those episodes out of the emergency department in the hospital.
Q: What is the company's current cash runway? And for both the SERENITY and TRANQUILITY studies, are you still planning to finance it yourself or are you thinking of partnering with someone to actually run the trials?
A: This is Rich. On the cash runway, we really haven't changed our guidance on cash runway at all. So it remains similar to what we had talked about in the past.
A: This is Vimal. Regarding your question on the financing, our fundraising strategy is based on funding both trial through various alternatives, as I mentioned. So we are exploring all those opportunities in parallel. Both trials are at a point where we already have feedback and SERENITY At-Home can begin shortly, and we are finalizing our plans for the TRANQUILITY In-Care. Both are strategic priorities and we are moving them along. We are looking at strategic partnerships as well as a part of this exercise.
Q: Can you comment on any favorable tailwinds that you see the product experiencing at this juncture and what impact that might have on the cadence of revenue growth and prescription uptake over the course of the second half of 2024?
A: This is Matt. One of the things that we've observed over the last three quarters is an increase in the interest from these community behavioral health centers. There are about 36,000 of these in the United States. Psychiatrists have the highest intent to use the product of all the constituents in a hospital setting. So we think that that translates nicely to this community mental health clinic type setting. The process for acquiring IGALMI does not require the type of administrative hurdles they typically see in a hospital IDN setting. So we feel like this is an opportunity that is near term low hanging fruit, and we'll continue to progress on that over the balance of the year and into next year as well.
Q: With respect to OnkosXcel, can you provide any update with respect to potential spin out of that entity or other ways in which you could conceivably monetize BXCL701?
A: This is Vince. We are committed to monetizing 701. We have initiated partner outreach through a retained firm, a firm that specializes in this area and that's in addition to formally assessing the commercial value or indications. We are pleased with progress so far, and we'll update you in June.
Q: Can you comment on your plans for the neurology pipeline beyond BXCL501 and to what extent that might potentially provide you with additional sources of non-dilutive funding?
A: This is Vimal. Currently, we are very focused on moving two late-stage pivotal trials, but we will continue to look at what are the best options to progress the pipeline which is 502, 503 either through a partnership mechanism or any other ways to move those programs forward.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
