Seamus Fernandez: Yes, I just didn’t name the product.
Frank Watanabe: Yes, that’s okay. I can say that. Go ahead, Todd.
Todd Edwards: Yes. Great. Thank you. So first thing relative to Seb Derm launch. So currently, we’re working on some disease state awareness activity for both patients and dermatologists that’s a targeted education, which will likely be focused, obviously, prelaunch. With the emphasis on the frustration of the condition, the impact on quality of life as well as the polypharmacy that occurs here. We’re talking about five to six treatments per patient. And often, it takes 15 to 30 minutes a day spent with this regimen. So it’s a very frustrating situation for patients. There’s been no innovation branded products within this space for over two decades. And if you think about the number of available patients that you talked about a warehouse of patients, so there is a ready pool of patients that are yearning for a product like ZORYVE that provides a very unique value proposition.
Because this product you can use once-a-day product that you can use, it’s one product versus polypharmacy and delivers long-term disease control. If you think about it, there’s about 10 million patients that are diagnosed with seborrheic dermatitis. Of that, about 7 million of them are treated within Rx. If you continue to break it down, about 4 million are treated within Rx in derm setting, and of that, 3.2 million are treated with the TCS. And if you drop it into our treatment zone, 2.2 million of those are moderate to severe patients that are currently taking to TCS. So there’s significant opportunity here to really bring ZORYVE to life. Furthermore, we’re starting from a position of strength with this formulary position, as mentioned, where two of the three PBMs will cover as a line extension at launch.
And you asked the question about gross to net. So we expect that with the Seb Derm launch, we’re not starting from ground zero, launching a new asset into the market where you have to provide a free goods program is going to have an adverse impact on your gross to net. We’ll have coverage with the two PBMs, those will be reimbursed claims and a positive gross to net. So the gross to net will, for Seb Derm, at launch will be higher relative to the gross to net that we have in psoriasis. But nonetheless, we believe that, that gap will rapidly close over time in 2024 as we bring on that third PBM coverage and maximize our covered claims.
Frank Watanabe: John?
John Smither: Seamus, this is John. To answer your question on the covenants, the 75% applies to the year-end number for 2023 or the year plan number, and then it’s a monthly calculation in 2024 with a six-month lagging average. So, whatever that number is, you apply 75%. If we’re above it, we’re good. And that’s measured each month in 2024.
Seamus Fernandez: Great. Thank you. And maybe just a quick final follow-up. In terms of the stocking necessary to really have this be executed as a robust launch, when should we anticipate the sort of official launch of the foam, regardless of the sort of PDUFA approval timelines? Is this a day of kind of PDUFA hitting the ground running? Or should we think about this as more of a potential sort of stocking the pharmacies event in the last few weeks of the year, followed by maybe a mid-January to kind of February launch timeframe? Just trying to get a little bit of incremental granularity before we get too excited to track the Seb Derm scripts.
Todd Edwards: Yes. Absolutely. So as mentioned, we have the PDUFA December 16, with the full commercial launch anticipated to be mid to late January. So we want to make certain we have ample time to be able to stop the channel, make certain pharmacies have product on shelf as we launch this and drive demand.
Frank Watanabe: Yes. And maybe just to put a fine point on that. Seamus, as you know, with topicals, is a little challenging because of labeling. It’s more challenging than pills or biologics. So I don’t think you should anticipate to see any stocking in Q4.
