Ken Marshall
Analyst · Bank of Montreal. Your line is open
Thanks, Keith. As Keith mentioned, we received FDA approval on November 1st for SYMPAZAN as the first oral film approved to treat seizures associated with LGS. This is an important milestone for Aquestive and is being very well received by the LGS community. In preparation for the launch of SYMPAZAN, we spent the last 18 months speaking with over 250 health care practitioners, 80 caregivers and select patients with epilepsy. Those conversations have provided clearer insights into the disease's, burden and its management. We’ve aligned our strategy accordingly, built on our commercial team and developed a focus group of tactics, now it's all about execution. We’ve built a 30 person sales team led by three seasoned regional directors. They’ve all completed home study and most recently, live training in Orlando at a national sales meeting. In conjunction with last week's Orlando meeting, we train a faculty of 30 clinicians to support our speaker’s bureau. Our sales teams in the field as we speak, introducing the company, PharmFilm, scheduling appointments and peer meetings. As they sell in SYMPAZAN, they're also educating physicians on PharmFilm technology and its value when addressing challenges with epilepsy treatment. This will help prepare the market for the introduction of Libervant next year, given the strong overlap in target prescribers. We envision both products forming the foundation for a meaningful epilepsy franchise that will establish a questions reputation amongst physicians and patients as an organization that solves therapeutic problems. We’ve built a distribution network to ensure SYMPAZAN supply in pharmacy. SYMPAZAN will be widely available for prescription by the third week of November and we expect the first patients to start dosing by the end of the month. SYMPAZAN will be available as a very flavored strip in 5 milligram, 10 milligram and 20 milligram strings, and packed in boxes of 60s, which is one month's supply. We’ve benchmarked several innovative products in the class and arrived at a wholesale acquisition price for a 10 milligram box of SYMPAZAN of $1560 per month. The 5 milligram and the 20 milligram will be priced linearly. This makes our monthly wholesale acquisition cost competitive with the recently announced generic liquids. This will help ensure healthcare practitioners can prescribe SYMPAZAN when they feel there is a medical need. We've also put a program, we've also put programs in place that will allow patients with commercial insurance to pay as little as $10. To complement those efforts, we've launched a fully integrated multi-channel branded SYMPAZAN campaign, engaged major advocacy associations to help educate and inform their members about SYMPAZAN. We had a significant unbranded presence at the Child Neurology Society annual meeting last month in Chicago, and we plan to have a significant SYMPAZAN presence at the American Epilepsy Society at the end of this month in New Orleans. That will include a full SYMPAZAN branded presence, both the commercial and medical booth, advisory meeting, one-on-one3 meeting, presence in the innovation pavilion, and three posters one of which is specific to SYMPAZAN that were off and running. Now how do we view the market? As we assess a market opportunity, we consider three important areas. First, does the product have clinical utility? Second, does the product fit in the normal course of the clinic and caregivers live. And finally, is the medicine available and cover? First, let's talk about clinical utility. Fundamental to any new product success is the development of deep market insights, tightly aligned strategies and focused programs that clearly connect the market need with your products relevant attributes. As noted earlier, we've conducted numerous interviews with health care practitioners and caregivers. In those interviews, we quickly confirm that Clobazam, the molecule is viewed as one of the most effective and tolerable molecules at a health care practitioner's disposal. Confirming that insight is the fact that it's prescribed approximately 500,000 times a year, but a molecule is only as good as its ability to be delivered. The challenge with Clobazam and the LGS population is ensuring consistent, complete, dosing so patients get the benefits of the treatment. In the LGS population, many caregivers resort to crushing tablets or use liquids that can easily be expelled. SYMPAZAM, Clobazam on our proprietary PharmFilm platform provides an alternative when those approaches proved to be problematic. Now how about fit in the clinic, and with caregiver and patient lives. The Fit in the clinic as well as the point of administration are obvious. Each dose of SYMPAZAM is contained in a child resistant foil pack. It provides the full dose of Clobazam and a strip that sticks to the tongue and quickly dissolves. Our data shows it's easy to apply and effective in delivering the medicine. LGS caregivers who saw or tried our product were quick to tell us its advantages versus other forms of administration. Finally, access and reimbursement. Once the health care practitioner or caregiver agrees that SYMPAZAM is the right medicine, it's critical that the product be available and covered. To that end, we have a seamless distribution pipeline that includes both retail and specialty distribution. In September, we launched the team of six managed care account managers focused on the top 50 payers representing over 280 million lives. As that team works through the process of getting coverage, we've made programs available to help health care practitioners address prior authorizations or step edits that their patients, insurers may have in place. We also have a coupon for commercially insured patients that allows them to pay as little as $10 per prescription. We want to eliminate economics as a barrier and ensure health care practitioners can prescribe and patients are able to receive SYMPAZAM when it's been medically necessary. In conclusion, we understand our market and how SYMPAZAM adds value. We've built, trained and targeted a fully integrated sales organization. We also have a team focused on coverage as well as programs to support access in the early stages of our launch. Thank you. And now I'll transition to Dan Barber.