Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) Q4 2022 Earnings Call Transcript

So we’re looking at this one closely. And when we have more data, especially on the adherence side, the long-term persistency, we’ll provide some guidance and steer there. But as we said, since the majority of patients have gone on in the third and fourth quarter of this year to really report out on what three and six months persistency looks like, I don’t think it would be really a good characterization of where we are and where we’re potentially going. So it’s across the board, Maury. And it pretty much maps to what we saw in our clinical trials.

Maury Raycroft: Got it. Okay. And maybe just quick question, in your 10-K, you note that Sun filed an IPR against your 036 patent. And I’m just wondering if you can comment on your latest thoughts on IP positioning and also this particular issue?

Peter Greenleaf: Sure. And let me actually take a minute to address this one. I want to thank you for the question. We did receive notice of an inter partes review, or IPR, petition being filed on February 24 with respect to our patent that has claims directed at LUPKYNIS dosing protocol for lupus nephritis used in our clinical trials. As you all recall, that patent has a term extending out to December of 2037. At this stage, it’s really too preliminary to give a full assessment of this IPR as a position — a petition that was filed from Sun Pharmaceuticals who you all may recall, if you’ve been reading our Ks, we are suing for patent infringement in a separate matter, which I’ll talk about in a second, was really just received.

So we’re looking at it, but we’re confident in our process to prosecute all our patents. This patent in particular, had significant review, as we’ve mentioned previously at the U.S. Patent and Trade Office before being approved as being actual valid patent by that office. We’re putting together our reply. And as I’ve said before, we’ll vigorously defend this patent and other challenges we get, again, from any party that bring any challenge to our patents. With respect to the separate litigation we have with Sun that I just mentioned, and as has been disclosed in our 10-K, in December of 2020, we actually commenced on an action in the U.S. District Court, New Jersey against Sun and certain of their affiliates, and in summary, the action is a claim for patent infringement under U.S. patent laws arising relating to Sun’s CEQUA product, which is a C&I immunosuppressant ophthalmic solution prior to the expiration of our patents relating to voclosporin’s ophthalmic solution.

So basically, in our action, we requested relief in the form of an order confirming that Sun has infringed those patents and injunction preventing Sun for manufacturing, using or selling CEQUA and monetary relief, including costs. Obviously, Sun has responded by denying infringement and/or asserting that the patents here are valid. We and Sun actually have exchanged initial pleadings and patent disclosures, and we’re in the process of what lawyers qualify as claim construction, and that’s all ongoing. Trial action on this one is probably somewhere on or around March of 2023. So that gives the full backgrounder on the previously mentioned Sun litigation and the IPR side of the equation.

Maury Raycroft: Got it. Okay. That’s helpful. Thanks for taking my questions.

Peter Greenleaf: Thanks, Maury.

Operator: Thank you. Our next question comes from the line of Joseph Schwartz with SVB Securities. Please proceed with your question.

Joseph Schwartz: Hi. Thanks very much. I was wondering if you could help us understand the main assumptions underlying your 2022 revenue guidance for LUPKYNIS in terms of things like patient start forms, conversion rates and times and discontinuations, either on an absolute basis or relative to what you’ve been seeing? And then I think, Peter, a couple of weeks ago at our healthcare conference, you had shared some plans to issue aggressive guidance. Are there particular aspects of this revenue guidance that are aggressive or more aggressive than others?