Jack Khattar
Chief Executive Officer
I’ll start with the migraine question, Ken. The marketplace continues with the same trends that we saw back in 2018, meaning of course the CGRPs are getting penetration and growth as everybody has seen in the IMS numbers, but the great news so far and continues to be the fact is that if you look at the topiramate market, which was the one relevant to us, obviously, in the first quarter it basically went down by only 2%, so the topiramate market continues to hold up very nicely, although now you have the two other CGRPs that launched later in the fall of 2018 getting more and more traction this year, as you would expect. Topiramate still holds up pretty good, and of course Trokendi XR, per se, on its own managed to also grow another 11% this quarter, first quarter 2019 versus last year. So, we continue to watch it pretty closely. As I made reference in our remarks, the 1Q effect on Trokendi XR was actually a little bit worse this year than it was in previous years, so that is something that we watched closely. Obviously, that’s why also Greg made reference to some of the enhancements we put in place on the co-pay program just to make sure we don’t get hit too--you know, even worse than that. So, we are pleased with what we’ve seen so far and continue to be so, specifically with the market and so forth. As I mentioned also in my remarks, the sequential growth in the second quarter, we have seen already the prescription trends recovering and hopefully as it was in previous years. Typically, the recovery accelerates as the quarters progress through the year. As far as the question on BD and the cash that we have on the balance sheet, there is really no significant change in our strategy, first of all, which continues to be looking at neurology and psychiatry assets. Also, no change in the level of activity and intensity in pursuing these opportunities, so we continue to be very, very active looking at very selective assets that could really make a big difference for us moving forward. Regarding 812, we really don’t like to make specific comments on pricing at this point. First of all, it is a little bit premature, other than what we provided back at the investor day where we gave people at least where the market is as far as branded stimulants and branded non-stimulants, as far as the range of the wholesaler acquisition costs of those two segments of the market. We are in the middle of doing pricing research and so forth, so we don’t even have the answer yet ourselves, and it would be premature to make any specific comments on the pricing. Regarding the 812 profile, again as we strongly emphasized in our investor day, we continue to believe and specifically as we continue to gather more and more data and as we share the profile with the real audience who really matters at the end of the day, which is the physicians and KOLs, they continue to be very excited about the profile and what 812 can represent in therapy as far as the great alternative option not only versus the current non-stimulants but even versus stimulants. Very, very briefly, if you have a product that is not a controlled substance, it’s not a stimulant, it works well and very consistently as the data have shown across all the trials and the data that we have already shared with everyone. It also works on the two subscales in a very meaningful way and consistent way in hyperactivity and in the inattention subscale. It has a fast onset of action - in a week, basically, and a great safety and tolerability profile. If you present that option and tell a parent about this potential new treatment, there is no reason for a parent to go and choose a stimulant that has all the other issues that we’re all very aware of and know about. We think the chances for SPN-812 to even be a first line treatment are fairly high, and we certainly--you know, our plans and our execution will be targeted towards making SPN-812 available to every patient out there, because we believe it’s a product that works, works fast, is tolerable and safe, and if that is the case and it is proven in the marketplace as it has been proven already with more than 1,000 patients in our trials, there is no reason whatsoever for a parent to choose to put their kid on a stimulant, a controlled substance that presents all kinds of issues for them.