Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS) Q3 2022 Earnings Call Transcript

Thirdly Joe and the medical team has been out on the road meeting with key sites, and so we feel as though all those things together, we really now have a significant number of sites that can be important contributors to the study. We’re seeing an increased number of sites enrolling patients in the study. This is always a tricky one because it is an incident study, and so we have €“ we don’t want to get too ahead of ourselves in terms of our timing and what we talk about publicly, but we certainly are enthusiastic about where we are today. I feel like the teams made great progress. Joe is really taking a lot of this on his own and working closely with sites and making sure we’re getting them through the mechanics of what we knew would be a complex study.

So, I feel as though we’re in a better place than we’ve been in a very long time, probably the early days of COVID and we have more site engagement than we’ve had, we continue to see encouraging signs on enrollment, and we’re confident about ending this study later this later this year. Joe, any other comments you want to make that I missed?

Joe Hulihan: No, I mean, I think, the investigators are very positive about this amendment. And universally this is going to allow especially the patients who come in from other hospitals or emergency departments that were excluded before to come into the study. So we’ve gotten great feedback on it and we’re really optimistic about the impact it’s going to have.

Unidentified Analyst : Great. And Chris, do you want to a talk a little bit about the reimbursement process?

Christy Shafer: Absolutely. Just taking a quick step back here, Steve mentioned that we could take up to three months or more to get through the enrollment process, and we mapped that out just based on a couple of typical payer hurdles early in launches such as NDC blocks and really lack of published payer policies and coverage. What I would like to say is that we’re super proud that we’ve been able to accelerate this payer access and drive an efficient payer adjudication process that we’re already seeing approximately half of our scripts covered within 30 days or less. So with an ultra-rare disease population, sometimes there are medical necessity requests, and all of this takes a little bit of time, but we’re proud of the current access that we have and the speed at which we’ve been able to get to them.

Scott Braunstein: Chris, I’m just going to add on, I think, it’s really been a great relationship with not only our payer team, our medical science leagues liaison team, but the payers and our advocacy groups. I think the payers really understand that in these ultra-orphan conditions that have genetic diagnoses or other DEEs, there are not a lot of options for patients. And I think that we’ve done a lot on the education side, our advocacy groups have, other advocacy groups like the TSC Alliance as well. And so we really think this is a business that has sustainability given the unmet need. So I think the early days have taught us a lot of different things, not only about CDD, but the viability for us as a really differentiated orphan treatment for these genetic disorders and more refractory encephalopathies. Next question, operator.

Operator: Thank you. We will take our next question from Brian Skorney with Baird. Your line is open.