Yahoo Finance BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q4 2023 Earnings Call Transcript
BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q4 2023 Earnings Call Transcript March 12, 2024
BioXcel Therapeutics, Inc. beats earnings expectations. Reported EPS is $-0.76, expectations were $-0.98. BioXcel Therapeutics, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good morning, and welcome to the BioXcel Therapeutics Conference Call, which will include an update on the company's late stage clinical programs and the discussion of financial results for the fourth quarter and full-year 2023. At this time, all participants are in listen-only mode. [Operator Instructions] After the formal remarks, there will be a question-and-answer session. [Operator Instructions] Just to remind everyone, certain matters discussed in today's conference call and/or answers that may be given to questions asked are forward-looking statements subject to risks and uncertainties related to future events and/or the future financial or business performance of the company. Actual results could differ materially from those anticipated in those forward-looking statements.
Risk factors that may affect future results are detailed in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2023, which can be found at www.bioxceltherapeutics.com or on www.sec.gov, and which will be updated in its annual report on Form 10-K for the quarter ended December 31, 2023. As a reminder, today's conference is being recorded. Speaking on today's call are Dr. Vimal Mehta, Chief Executive Officer; Dr. Vince O'Neill, Chief of Product Development and Medical Officer; and Richard Steinhart, Chief Financial Officer. They will be joined in the Q&A session by Frank Yocca, Chief Scientific Officer; Matt Wiley, Chief Commercial Officer; and Dr. Rob Risinger, Chief Medical Officer of Neuroscience. It's now my pleasure to turn the call over to Dr. Mehta.
Please go ahead.
Vimal Mehta: Thank you, operator. Good morning and thank you for joining us. This is an exciting time for BioXcel Therapeutics. First, we are very pleased with the progress of our TRANQUILITY program. As I have communicated previously, this is a top priority for capital allocation. Second, we are focused on advancing the SERENITY program. Both programs provide significant opportunities for us to address the unmet needs in treating patients is struggling with episodes of acute agitation. During today's call we will dedicate our prepared remarks to updates on TRANQUILITY and SERENITY. These late-stage clinical programs represent groundbreaking opportunities to advance our goal of bringing new treatment options to patients. As a reminder, there are no currently approved acute treatments for agitation associated with Alzheimer's disease or for bipolar disorder or schizophrenia in the at-home setting.
These conditions represent large untapped markets. All of us at BioXcel Therapeutics are motivated to develop new treatment options for the greatest number of patients and caregivers. Vince will now provide a detailed update on TRANQUILITY and SERENITY. After this, I will briefly discuss several corporate updates. Rich will then review our financial results before we open the call for Q&A. With that, I will turn the call over to Vince.
Vince O'Neill: Thank you, Vimal. So I appreciate the opportunity to speak with all of you this morning and provide an update on our two late stage clinical programs with BioXcel 501. Let me begin with TRANQUILITY, where we are evaluating 501 as an acute treatment for agitation associated with Alzheimer's dementia or for short, AAD. As Vimal said, TRANQUILITY remains a top priority to bring a novel treatment to this large, underserved patient population. Every year, estimates show that millions of Americans with Alzheimer's disease experience agitation. Physicians often aim to address this with neuropsychiatric drugs used off label, because there are no approved treatments specifically for acute agitation episodes. This area of neuroscience drug development for an episodic treatment is novel and uncharted, and we believe we are uniquely positioned in this space.
At BioXcel Therapeutics, we have IGALMI already on the U.S. market as an approved acute treatment for bipolar disorder and schizophrenia-related agitation. This provides us with a strong foundation from which we are expanding into development in AAD in our TRANQUILITY program and into development in different settings in the bipolar and schizophrenia populations through the SERENITY program. For TRANQUILITY, we have completed now a Type B breakthrough therapy designation meeting with the FDA on February 20. This meeting followed the one we had in October of last year. Let me remind you that we are not in a position to provide detailed information about our overall program plans until after we receive and review the FDA's final meeting minutes.
However, we can share now that based on the FDA's feedback, we plan to generate additional Phase 3 efficacy and safety data in care facilities to expand the database beyond the 70 patients, who have been treated with 60 micrograms of 501 in TRANQUILITY 1 and 2 to-date. We plan to generate these data, including repeat efficacy data, in a variety of relevant care settings and to use PEC as the primary measure as used in the prior TRANQUILITY 2 study. To remind everyone, in November 23, we announced that we were planning to conduct a Phase 3 trial in the at-home setting with safety as the primary objective, otherwise known as TRANQUILITY At Home. Given the priority to expand the database to generate additional efficacy data in care facilities, the company is now reevaluating the timing for initiating TRANQUILITY At Home.
Lastly, the FDA has indicated that we will need to generate long-term safety data. However, given the lack of any regulatory precedent for episodic treatment of AD in patients, we plan to further engage with the FDA regarding this requirement. We look forward to receiving final meeting minutes from the agency and sharing more details with you later this month. We're extremely motivated by this potential opportunity to bring a much needed acute treatment option to patients. Developing novel episodic treatments with no regulatory precedent comes with new learnings to create an optimal development path. At this time, we believe we have a clear path forward. To that point, we've had multiple meetings with the FDA for this uncharted regulatory path and have greatly appreciated the agency's guidance as we move forward to advancing our clinical program.
Let's now turn to SERENITY, where we are evaluating the potential at-home use of 501 for agitation associated with bipolar disorders or schizophrenia. On March the 6, we completed a Type C meeting with the FDA. This followed the one we conducted last November. Based on FDA feedback, we plan to evaluate the 120 microgram dose of 501 as a reminder and approved dose of IGALMI in the at-home setting in an amendment to our SERENITY 3 Part 2 protocol, which the company had voluntarily paused as we discussed the FDA's proposed changes to the protocol in light of the results of SERENITY 3 Part 1. And our current plan is to move forward with this study as amended, with safety as the primary objective and efficacy measures as exploratory endpoints. Keep in mind the label for IGALMI currently includes a limitation on use, noting the lack of efficacy or safety data beyond 24 hours.
We believe that our ability to seek labeling without the current LOU will depend in part on the number of agitation episodes we observe over the three-month follow-up period. To support our pivotal trial with the 120-microgram dose, we're also planning to conduct a small study, approximately 30 patients, to evaluate the correlation between patient reported or informant reported efficacy with trained rater reported efficacy using PEC scores. We expect to provide additional information about the program plans after receiving and reviewing final meeting minutes from the FDA. And with that, I will turn the call back over to Vimal.
Vimal Mehta: Thank you, Vince. We are also pleased with progress in other areas of the business. On January 1, the permanent J Code for IGALMI became effective, and our commercial [Technical Difficulty] efforts continue to progress. In addition, we continue building a robust intellectual property portfolio and strengthening our long-term patent protection. Finally, we are pleased to have received fast track designation from the FDA for BXCL701. I would like to end my remarks by emphasizing that we remain focused on strengthening the company's balance sheet. To this end, we are actively exploring multiple financial options to extend our cash runway and fund our key clinical programs in order to create maximum value for our shareholders. I would now like to turn the call over to Rich who will review our quarter and full year 2023 financial results. Rich?
Richard Steinhart: Thank you, Vimal. Net revenue from IGALMI was $376,000 for the fourth quarter 2023 compared to $238,000 for the same period in 2022. The net revenue was $1.4 million for the full-year 2023, compared to $375,000 for 2022. Research and development expenses were $9 million for the fourth quarter of 2023, compared to $32.5 million for the same period in 2022. Research and development expenses were $84.3 million for the full-year of 2023 compared to $91.2 million in 2022. The decreased expenses for both fourth quarter and the full-year were primarily attributed to the decrease [Technical Difficulty] productivity associated with the wind down of SERENITY III and TRANQUILITY 2 studies, a decrease in chemicals, manufacturing and control costs and a decrease in personnel related to the company prioritization in August of 2023.
Selling, general and administrative expenses were $9.6 million for the fourth quarter of 2023 compared to $20.7 million for the same period in 2022. SG&A expenses were $83.4 million for the full-year 2023, compared to $68.8 million for 2022. The increased costs for the full-year was primarily attributable to an increase in legal and professional fees costs associated with personnel and related expenses to support the commercialization of the IGALMI in the U.S. prior to the company's reprioritization. BioXcel Therapeutics had a net loss of $22.3 million for the fourth quarter of 2023, compared to a net loss of $54.8 million for the same period in 2022. For the same year -- for the full-year 2023, the company reported a net loss of $179 million, compared to a net loss of $165.8 million for the full-year 2022.
The loss for 2023 includes approximately $18.6 million in noncash stock-based compensation. Total cash expenditures for 2023 totaled approximately $155 million. Cash and cash equivalents totaled $65.2 million as of December 31, 2023, compared to $193.7 million as of December 31, 2022. The company estimates that its current cash and cash equivalents will fund its operations through mid-2024. The estimated cash runway does not include any potential financing activities that may be undertaken by the company. Now I'd like to turn the call back to Vimal.
Vimal Mehta: Thank you, Rich. We would now like to turn the call for questions. Operator?
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