Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA) Q4 2022 Earnings Call Transcript

Operator: And our next question comes from Liisa Bayko from Evercore ISI.

Liisa Bayko: I’m just curious on how you’re thinking about growth to net for 2023. You’d guided to around 10% for 2022. I know it came in more at 9%. What do you think for this year?

Sanj Patel: That sounds like a fantastic question for Mark Ragosa, Chief Financial Officer.

Mark Ragosa: So as Ross mentioned, gross to net was 9% for the year-to-date. And I don’t think while there’s always some quarterly fluctuations we do not expect big swings at this point in gross to net going forward, but certainly have not provided formal guidance.

Liisa Bayko: So wait, so 9% was for year-to-date or was for

Mark Ragosa: Yes, 2022. Yes, exactly. So year-to-date 2022

Liisa Bayko: And then just back to the patients who restarted, I want to clarify to make sure I understand. What percentage of patients I guess discontinued therapy? Are you saying 45% of those who discontinued restarted or 45 — like what is the 45%? And I’m trying to understand does that represent patients who discontinued or those are the restarts of the patients who discontinued? And if so, what was the discontinuation?

Ross Moat: So maybe I can clarify that Liisa. The 45% is 45% of all of those patients who discontinued ARCALYST treatments for recurrent pericarditis throughout 2022. So regardless of when they stopped, so even if they stopped therapy after one month worth or the 12 months or been on therapy for longer. Out of all of those who started aggregating when we look at those all those have stopped aggregated when we look at those that restart therapy that number is 45%. So a stop means that they’ve gone more than 28 days beyond when their prescription ran out or their latest refill ran out. So they’re kind of two months on from having their last script. So that is having stopped therapy and then, yes, 45% restart.

Liisa Bayko: And so what is the discontinuation rate then that you see?

Ross Moat: So we haven’t provided an actual number of the discontinuation rate aside from saying that the average approximate discontinuation time was 12 months across all of the patients that started. In our investors slide deck as well we do have a graph, which shows that kind of discontinuation distribution in broad terms without specifics on it. So that gives you a little bit of a flavor there. But yes, the average is 12 months.

Liisa Bayko: And then can you discuss this valuation release a little bit more? I know you quantitated it, I just missed it.

Mark Ragosa: So it happened in the third quarter of this year. So if you kind of go back and go back a little bit in the second quarter, we had a full evaluation allowance against our deferred tax assets as we were in a three year cumulative tax loss position in both the US and the UK. And then with the proceeds from the Vixa license agreement plus sort of actual and forecasted ARCALYST sales, we reached the three year cumulative tax gain position in the UK. And as such, we were required to release the valuation allowance on our UK deferred non-tax — non-cash deferred tax assets. And that was the main driver of the reported $172 million net income tax benefit in 2022.

Liisa Bayko: And you’ve had 85% compliance so far. Is that pretty stable do you think or do you think that’s going to shift around from here?

Mark Ragosa: The 85% compliance rate is on ARCALYST. We just said in totality across 2022, it was greater than 85% is a compliance rate. And we put a lot of efforts into our touchpoints with patients to make sure that they’re kind of helped all the way along the journey, and that they also understand the high importance of compliance and adherence to therapy driven from our data showing that continuous treatment duration results in continuous response. So we have adherence cause and various other touchpoints with patients that are on therapy as appropriate. So that was greater than 85% across the totality of 2022.