Buried within BioXcel Therapeutics' Q1 2024 earnings call lies a fascinating strategic shift. While most analysts are focused on the company's ambitious push into Alzheimer's-related agitation, a closer look reveals a more nuanced play: leveraging their existing, approved sublingual film, IGALMI, to dominate the entire agitation market – both in-care and at-home. This subtle but significant strategy could catapult BioXcel to a dominant position in a market desperately in need of effective therapies.

The company's existing product, IGALMI, is already approved for acute treatment of agitation associated with schizophrenia or bipolar disorder in adults. However, this approval is specifically for the in-care setting, leaving a massive untapped market: agitation episodes occurring in the home. BioXcel is now pursuing two parallel paths to address agitation: TRANQUILITY for Alzheimer's-related agitation and SERENITY for bipolar and schizophrenia-related agitation in the home setting.

What's fascinating, and seemingly overlooked by most, is the potential synergy between these programs. BioXcel isn't simply developing separate treatments; they're building an interconnected "agitation ecosystem" centered around their sublingual film technology.

Consider the evidence: BioXcel is prioritizing the SERENITY At-Home trial, which leverages the existing 120 microgram IGALMI dose. This allows for a faster, less costly development path, potentially leading to an sNDA filing in 2025. A successful outcome could quickly expand the IGALMI label to include at-home use, creating a powerful one-two punch: IGALMI dominating the in-care market for bipolar and schizophrenia-related agitation, and then extending its reach to the home setting.

This "sublingual film strategy" holds several key advantages. First, it leverages existing familiarity with IGALMI amongst healthcare providers, easing the transition to at-home use. Second, the sublingual film format itself is a significant differentiator. In a market dominated by oral medications and injectables, a fast-acting, discreet sublingual film offers unique benefits, particularly in the home setting where patient comfort and caregiver ease-of-administration are paramount.

The numbers further underscore this strategy's potential. While TRANQUILITY promises long-term growth in the vast Alzheimer's market, SERENITY at-home offers a quicker path to market expansion. Imagine this: IGALMI, already gaining traction through volume contracting and new customer acquisitions in Q1 2024 (with net revenue up 55% from the previous quarter), suddenly becomes the only FDA-approved option for managing bipolar and schizophrenia-related agitation at home. This scenario could lead to a dramatic increase in IGALMI utilization, transforming BioXcel's financial trajectory.

This "quiet revolution" is further reinforced by BioXcel's focus on building a robust intellectual property portfolio. With 30 granted patents and over 140 applications in prosecution, the company is fortifying its position. The recent grant of two new patents in the US and Japan is particularly noteworthy, hinting at a long-term vision for global expansion.

Hypothetical IGALMI Sales Growth with At-Home Label Expansion

Assuming SERENITY at-home proves successful and the 120 microgram IGALMI dose receives label expansion for at-home use in 2025, BioXcel could see an exponential increase in IGALMI sales. If only 10% of the estimated 6 million individuals in the US suffering from bipolar or schizophrenia-related agitation experience at least one at-home episode per month, and IGALMI captures even a fraction of this market, the revenue potential is enormous.

BioXcel is playing a long game, patiently building an "agitation empire" centered around its unique sublingual film technology. While the focus remains on TRANQUILITY and Alzheimer's, the SERENITY at-home trial and the broader sublingual film strategy represent a shrewd, potentially game-changing move that could redefine the entire agitation market.

"Fun Fact: BioXcel's sublingual film technology was initially developed for treating chemotherapy-induced nausea and vomiting, demonstrating the versatility of their platform. It wasn't until later that the company pivoted to focus on agitation, recognizing the unmet need and the potential of their technology to revolutionize treatment."