Dew - thanks for posting CC transcript. I just read through it with a focus on CD indication.
My thoughts:
1. Although, the time from FDA approval to launch has been extended. I do like that they waited to get the J code. No neurologist is going to use a drug that they will not get reimbursed. Also, what I found when I was a clinician and in medical sales was that neurologists that treat movement disorders are conservative. They are very measured in utilization of new products. These patients have been seeing their neurologist for years and have a relationship with them. The neurologist wants to make sure that they provide the best outcomes for their patient. CD can be quite debilitating so they don’t want a new product to cause any decrease in outcomes. They will appreciate the study, but want to see for themselves. So the PreVu program was probably a good way to go as now these MDs have one cycle of injections with which to base outcomes.
2. I love that their focus is not strictly on duration beyond 12 weeks, but more on quality of outcomes/effect during 12 weeks. If patients, can just feel solid symptom relief for 12 then that is a huge win. Frankly, per the data from patient interviews/polls - many patients claim that their treatment effects wane in week 9 to 10. many patients could get 20-25% better symptom relief with a toxin that has a 12 week duration of effect. The key factor is that insurances will only reimburse every 12 weeks so if the toxin wears off before the 12 week mark then the patient just has to live with it.
3. I like that their revenue projections are conservative. They had 17 MDs in the PreVu. It was not disclosed on what % of the overall CD patient population these MDs see. Large University movement disorder centers see the majority of these patients. Now, when they are approaching new MDs and centers, they will sample them so that the MDs can get their impression of outcomes. So, for a new prescribing center, it can take 3 to 6 months to see revenue.
4. This was not mentioned in CC, but the number 2 question that skilled neurologists (who inject the scalenes which are the most difficult to inject with potential for side effects that include swallowing difficulties) ask is “is there much spread”. What they are asking is what is your safety profile relative to swallowing difficulty. Daxxify has the best safety profile related to this by a pretty good margin. This is huge for the notoriously conservative neurologists.
5. Lastly, I do like that they are going for the currently treated patient vs the naive to neurotoxin patient. Patients whom have never been injected can have a wider effect as the MD has no base for dosing. With current patients, they know their dosing and will just do a unit conversion (which reps can not discuss). Also, a good number of patients can produces antibodies to their current toxin thus decreasing effects. Those patients are prime for converting to a new toxin.
Just some thoughts. If they were able to get the right reps who have Roledexes of relationships with neurologists then the CD indication could go quite well. Don’t forget for every CD patient there is about 7 to 10x or more toxin utilized than in a cosmetic application. For upper limb spasticity patients which they alluded to that some insurances will cover - there is typically 15 to 20x more toxin utilized than cosmetic.
