Robert Hazlett: Yes, thank you for taking the questions and congrats on the progress. Looking forward to more. Just a quick question on margins for this quarter. I think you mentioned it in the call, excuse me, in the release. But COGS had a benefit this quarter; I think there was some mention about contract termination fees. Could you go into it a little bit more detail about how we should be thinking about the cost of goods and gross margin? Again, I know you’re not commenting on the expense guidance, but just in general, thinking about the operations of Auryxia and costs and gross margins and things in general? Thanks.
David Spellman: Yes. Thanks for the question, Bert. So as folks are aware, back in December, we AK-ed release on the termination of a supply contract that we had a multiyear supply contract between the different supply agreements that we had back then. We had then each quarter been providing updates on something that we call an excess purchase commitment with the restructuring of the supply chain. We expect that those charges are going away, and we have reversed those charges in the fourth quarter. So what you’ll see going forward within that COGS line, you’ll still see the amortization of intangible that is clearly in there and called out as a noncash expense. But what you’ll see now is you’ll see a much more normal cost of goods line, which would be just our cost to produce and sell Auryxia.
And that will be — again, we’re not providing the specific numbers, but you can go back historically and look at what we’ve disclosed, whether it’s excess purchase or inventory write-offs, take those to the side, and it will just be a much more normal rate. And we’re really, really happy about those contract terminations and reworks because it does save us a real significant amount on the cash flow. And again, a big, big contributor to us having this cash runway that we’re talking about now has been changing of those contracts. It was in excess of $70 million that we reversed for those excess purchase commitments.
Robert Hazlett: Terrific. Looking forward to cleaner numbers moving forward. That’s great. A couple on that — I bet. Only a couple of questions on vadadustat. In the U.S. is Dr. Stein seeking additional data from Akebia at all? Are you interacting with him directly in any way, shape or form?
John Butler: So the focus of the letter is the internal discussions that he is having. If he requests anything from us then obviously we’ll be responsive to that. Part of the FDRR is that you can’t actually give new data into the review, so we couldn’t proactively get him anything new to look at. It’s got to be all things that are included in the NDA. That’s part of the rules of the FDRR. So I mean, I think his initial focus is certainly, I don’t want to speak for him, but coming up to speed, clearly from his letter, he’s come up to speed a long way. I mean he really was quite versed in the issues at hand, but wants to seek that internal guidance. So I think it’s more about that. We are — we will do everything we can to support him in that process and support a positive outcome. So having a direct communication with him on these issues is something we would be clearly welcome.
Robert Hazlett: Okay, terrific. And then just thinking about — again, there’s a little bit of additional data coming up the focus study, the three times weekly data. What does this give you? What should we expect in terms of data release for that study?
John Butler: Yes. So I mean we do expect that we’ll be presenting that data at a scientific session or in a publication to be determined. It’s an important study. It is the study that we feel will be the basis for having a three times weekly dose for vadadustat in our label. And obviously, with the in dialysis patients, right? So even with a negative outcome in the U.S., we have a positive outcome in Europe and having that ability for dialysis providers to deliver the drug when the patient is on dialysis is just another option for them that can be very helpful and ensure compliance for their patients. And so it’s important, and I think it’s important for patients, and it’s important commercially too. It’s giving physicians more of an option. So that study is completing, and we do expect that, that data will be presented this year.
Robert Hazlett: Okay, terrific. And just one more and I think you talked about this to some degree, but I’m sorry to kind of come back to it. But I just, maybe a little bit more formally, what would a label look like in the EU for vadadustat as Vafseo as we’re moving forward? Just any kind of broad characterization you can do, you can provide for the potential authorization would be helpful. Thanks.
John Butler: So obviously, until we have that marketing authorization, we don’t want to kind of get ahead of that. But you obviously are talking about a label as you go through the CHMP and we’re very pleased from kind of at least I’m looking at it with a commercial eye and I think it’s a label that we absolutely can work with. There’s nothing that’s outside of what I would expect in there. And I mean, obviously, focused on dialysis patients alone. But when I look at the concerns expressed by the FDA, those are either, those are all handled in a very appropriate way in the SmPCs. So the anticipated SMPC. So we’ll see the final when we have it, but I have no concerns from a commercial perspective based on what I’ve seen so far.
Robert Hazlett: Terrific. And just one more along those lines, how would you characterize the status of interactions for folks with additional commercial parties in the EU? You said pretty clearly that obviously nothing is going to happen until formal authorization. But I’d just love to get a sense of the temperament out there. Thanks.
