Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q4 2022 Earnings Call Transcript

John Butler: Yes. No, it’s a very active process. It’s getting clarity that it’s dialysis versus dialysis and non-dialysis, obviously, it was important to the process. Having the CHMP positive opinion is very value-creating for us and having an authorization creates more value for us, ultimately, as you get to a deal. And creating — we have an active process with multiple parties who are interested. And seeing that process through and maintaining multiple parties usually yields the best outcome for us and for the product and if that takes a little bit more time, that’s time that’s usually very, very well spent. So we’re very pleased with how this process is moving forward.

Robert Hazlett: Thanks for all that. Congrats on the progress. Looking forward to more. Thank you.

John Butler: Thanks, Bert.

David Spellman: Thanks Bert.

Operator: I’m showing no further questions at this time. I will now turn the call back over to Mr. John Butler for any closing remarks.

John Butler: Thanks, operator, and thank you all for your attendance this morning. While we celebrate World Kidney Day today, our commitment to patients drives us forward every day and I hope you got a sense of our excitement from this call. I just want to really summarize very quickly a few of the exciting developments we’re expecting in 2023. We’re going to continue to drive revenue growth for Auryxia and expect to deliver net product revenue of $175 million to $180 million. We received a positive opinion from the CHMP for vadadustat and anticipate marketing authorization in a couple of months. We expect a regulatory decision for the ACCESS Consortium countries. We anticipate engaging a partner to commercialize vadadustat in Europe.

We expect a decision on the FDRR process with the FDA. We anticipate that UTHealth will initiate an ARDS study with vadadustat in a broader patient population. And we look forward to talking much more about our pipeline development for vadadustat and other novel HIF-PHI compounds as the year progresses. So it will be a very, very busy year for us, I think, an exciting year for Akebia, and we look forward to updating you further on it. Thanks again for joining us. Have a great day.

Operator: Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.