BTAI: Data from TRANQUILITY II Trial in Late 2022 or Early 2023…

By David Bautz, PhD

NASDAQ:BTAI

READ THE FULL BTAI RESEARCH REPORT

Business Update

IGALMI™ to Launch May 25th, 2022

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) is a biopharmaceutical company that recently received its first FDA approval for IGALMI (dexmedetomidine) sublingual film for the treatment of acute agitation associated with schizophrenia or bipolar I or II disorder in adults. The company is fully focused on the upcoming commercial launch. The sales team has been hired, is currently undergoing training, and will be deployed nationally on May 23, 2022 across priority regions and customers.

During the first quarter conference call, BioXcel management announced the wholesale acquisition cost (WAC) for IGALMI of $105/film. IGALMI will be packaged as individual films in 10- and 30-count cartons for both 120 μg and 180 μg doses. There will be no difference in WAC for the different doses. According to management, there were a number of factors that went into setting the WAC, which included wanting to maximize market share while ensuring good profitability. In addition, the fact that 15% of patients in the SERENITY trials received a second dose was an important consideration for the price that hospitals were likely to find amenable.

The $105 WAC is approximately 50% of what had been utilized in our model, however we believe that it should result in a greater market share than what we had previously considered. Prescription data will not be available through syndicated outlets, thus we will need to wait for updates from the company to determine how the launch is going. The company is unsure at this point regarding what to expect for gross-to-net numbers, however generally speaking it is typically more favorable in the hospital setting than the retail setting. No guidance was given as far as revenues, market share, or any other launch metrics.

To extend the geographic reach of IGALMI, BioXcel will be filing a marketing authorization application (MAA) with the European Medicines Agency (EMA) in the second quarter of 2022. The package that was filed with the FDA to support the approval of IGALMI in the U.S. was previously shown to EMA officials, who indicated that it was sufficient to file the MAA. Following submission of the MAA, BioXcel will be actively looking for a commercialization partner, particularly one with a neuropsychiatric franchise that will support potential future indications in Alzheimer’s and MDD. The company is also exploring market entry strategies for IGALMI in Japan.

TRANQUILITY II Trial Underway

The company has initiated the TRANQUILITY II trial of BXCL501 for the acute treatment of agitation in Alzheimer’s disease. The first patient has been dosed and topline results should be available late in the fourth quarter of 2022 or early in the first quarter of 2023. This trial will focus on patients in assisted living or residential facilities. The TRANQUILITY III trial is expected to commence in the second half of 2022 and will focus on patients in nursing homes. Both 40 and 60 μg doses are being tested in these trials, which is supported by positive efficacy, safety, and tolerability data in 100 patients in the Phase 1b/2 TRANQUILITY trial along with a recent study of BXCL501 40 μg dose. The following chart shows a rapid, dose dependent decrease in PEC score from baseline in the TRANQUILITY trial that separates from placebo numerically by 30 minutes post-treatment and becomes statistically significantly different by 60 minutes. In addition, 70% of patients in the 60 mg BXCL501 cohort were responders, which was defined as a ≥40% reduction in PEC score.

Financial Update

On May 9, 2022, BioXcel announced financial results for the first quarter of 2022. As expected, the company did not report any revenues in the first quarter of 2022. Net loss in the first quarter of 2022 was $31.5 million, compared to a net loss of $26.4 million in the first quarter of 2021. R&D expenses in the first quarter of 2022 were $18.6 million, compared to $14.7 million for the first quarter of 2021. The increase was primarily due to clinical trial costs related to the TRANQUILITY program. G&A expenses in the first quarter of 2022 were $12.9 million, compared to $11.6 million for the first quarter of 2021. The increase was primarily due to personnel related costs along with costs related to the commercial launch readiness efforts for IGALMI in the U.S.

As of March 31, 2022, BioXcel had approximately $200 million in cash and cash equivalents. In April 2022, the company entered into a $260 million strategic financing with Oaktree and Qatar Investment Authority. The financing includes up to $135 million in a delayed draw term loan, up to $120 million in a capped revenue interest on net sales of IGALMI and any future BXCL501 products, and up to $5 million purchase of BioXcel Therapeutics common stock. Thus far, the company has drawn $70 million of the loan agreement and has met the milestone to receive $30 million of the royalty financing, which is expected to be drawn in the second quarter of 2022. This financing gives the company a cash runway into 2025.

As of May 5, 2021, the company had approximately 24.6 million shares outstanding and when factoring in stock options a fully diluted share count of approximately 28.7 million.

Conclusion

We’re excited for the commercial launch of IGALMI and will be looking forward to updates from the company about how it’s going as the year progresses. We were a little surprised by the final WAC of $105 per film, but are hopeful that the lower than anticipated price will translate to a large market share and acceptance by payers. Based on the announced WAC price we have made some changes to our model, which has lowered our valuation to $90 per share. However, we still view BioXcel as a good long-term holding for investors with a high risk tolerance and are confident that IGALMI will be a commercial success.

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