COMPASS Pathways Plc American Depository Shares 2026 Q2 Earnings Call

You may begin. Thank you, operator.

Welcome all of you, and thank you for joining us today for this conference call. Again, my name's Steve Schultz, Senior Vice President of Investor Relations at COMPASS Pathways. Today I'm joined by Kabir Nath, our Chief Executive Officer, and Lori Englebert, our Chief Commercial Officer. Teri Loxam, our Chief Financial Officer, will also be available for the Q&A. The call is being recorded and will be available on the COMPASS Pathways investor relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward-looking statements.

Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement, including those risks and uncertainties described under the heading Risk Factors in our most recent filings with the U.S. Securities and Exchange Commission. These forward-looking statements represent our views only as of today, and we specifically disclaim any obligation to update or revise any forward-looking statements, even if our estimates or assumptions change. I'll now hand the call to Kabir Nath.

Thank you, Steve, and thank you all for joining us today. The first half of this year has been an exciting time for COMPASS. Now that we have highly statistically significant positive phase III primary endpoint readouts, as well as demonstrated durability through 6 months from both our trials, we believe we have largely de-risked the clinical and regulatory profile of COMP360. In addition to confirming its rapid onset and durability, the totality of data from the program so far shows it has a generally well-tolerated and safe profile. Taken together, these data reinforce our belief that COMP360 has the potential to fundamentally change how mental health is managed. With these data sets in hand, we continue to make significant progress towards our NDA filing for the treatment of TRD.

Our rolling submission and review process allows us to submit data in waves to the FDA, and they have started to review some modules that we've already submitted. We continue to expect to complete the NDA filing in the fourth quarter. With the potential for an accelerated approval following our final submission, we are advancing our commercial readiness. We've built a fantastic commercial team with incredible experience, and we're executing on all fronts to be prepared to get COMP360 to the millions of patients living with TRD who urgently need new treatment options. We're also well positioned with our strong balance sheet, with $433 million of cash on hand as of June the 30th, which carries us well through launch and into 2028. Let me now hand the call to Lori to talk through in more detail how we're preparing to transform treatment options for these patients.

Thanks, Kabir. Hi, everyone. Thank you for joining. As Kabir outlined, we have achieved significant milestones in the first half of the year. Notably, advanced important commercial readiness initiatives across organizational capabilities, strategic collaboration, policy and payer engagement, and distribution. All significant steps towards being launch ready. Earlier this year, we rounded out hiring of the commercial leadership team, attracting highly experienced, energized leaders who immediately started to build out their functions. My direct reports come from companies like J&J, Gilead, Otsuka, and Axsome, and between them have led over 70 product launches. The prospect of launching the first psychedelic in history with a medicine that has the potential to fundamentally change the way mental health is treated is a very powerful attractor of talent, and we are bringing in outstanding professionals from across the pharma industry. I am incredibly proud of the team we are building at Compass.

In the first half of this year, we also announced additional strategic collaborations with Radial and Osmind, taking the total to eight, each with their own distinct capabilities. These collaborations played a critical role in helping to inform our priority focus at launch of ensuring optimal site and patient experience. With the final submission of our NDA expected in the fourth quarter, our focus in the second half of this year is on operationalizing launch plans and ensuring launch readiness. This includes advancing everything from training, education, access and reimbursement, and patient support mechanisms. Importantly, we have also already initiated recruiting for the sales force. Our timelines for launch remain fluid, given the National Priority Review Voucher and executive order in April, and the need for federal DEA and state rescheduling. We remain focused on being ready to launch, which we anticipate being in the first half of 2027.

At launch, we will leverage the well-established existing interventional psychiatry treatment center infrastructure. These treatment sites are specifically designed to support in-office treatment for products that require multi-hour monitoring, such as SPRAVATO, TMS, and ECT. The established infrastructure has existing capacity, and importantly, is already equipped with the staff and operational know-how needed to support additional multi-hour treatments like COMP360. Seven years ago, when SPRAVATO launched, this infrastructure did not exist. Today, there are more than 8,000 established sites across the U.S., and this continues to grow rapidly. COMP360 is poised to lead a profound shift in mental health care, moving beyond daily or frequent dosing toward an option potentially involving just a few treatments a year, which could be life-changing for patients.

Across two highly statistically significant and positive Phase III trials, COMP360 demonstrated extremely rapid onset of action with deep and clinically meaningful reduction in depressive symptoms as quickly as one day, unprecedented durability sustained through at least six months, and notably, reproducibility of effect in a chronic treatment-resistant patient population, one of the most difficult psychiatric conditions in which to demonstrate efficacy. The data are strong, and both patients and prescribers are excited about the potential for a new treatment option. In recent prescriber-focused market research, approximately 90% of interventional psychiatrists stated that they would prescribe COMP360 within the first year of being available. In my experience, this is the highest willingness to prescribe percentage I have ever seen in pre-launch market research.

With the COMP360 emerging profile and continued interest and excitement around the class, we are eager to bring a new treatment option to the 4 million patients living with TRD today who have limited treatment options. We are confident in the blockbuster opportunity. COMP360 has the potential to fundamentally change the way that patients living with depression are cared for. COMPASS is committed to helping as many patients as possible. We are making significant progress towards being launch-ready. I look forward to discussing more with you throughout the rest of this very exciting year. Thank you. Let me hand the call back to Kabir.

Thank you, Lori. Our progress in the first half of the year has meaningfully de-risked the path towards potential approval and launch and reinforces our confidence in the strength, consistency, and robustness of the COMP360 data package that we are submitting to the FDA. With the regulatory process underway, our focus is on disciplined execution, completing our filing activities and preparing for a first-pass approval and ensuring we are poised to deliver COMP360 to patients with TRD as quickly as possible following approval. As you just heard from Lori, we will be ready. With that, let me pass the call to the operator for Q&A.