Cytokinetics, Incorporated (NASDAQ:CYTK) Q3 2023 Earnings Call Transcript

Andrew Callos: Sure. So with our market research when we put an aspirational profile in front of physicians. The things that they mentioned most is excited about are preservation of LVEF function. Obviously, which is the safety element change in New York Heart class or improvement going from a three to a two or three to a one two to a one as an example, change in KCCQ and limited DDIs that really don’t need to be monitored relative to dosing. Those are the things they mentioned that are most would drive their preference for aficamten.

Unidentified Analyst: Okay. Thank you so much.

Robert Blum: Thank you.

Operator: Thank you. Our next question will come from Yasmeen Rahimi from Piper Sandler. Your line is open.

Robert Blum: Good afternoon, Yasmeen.

Yasmeen Rahimi: Hi, Robert. Thank you so much for all your comments. GI guess with data expected late December and you guys entering a quiet period I guess December 4. Like could you maybe highlight to us what is your definition of late December? And then secondly just maybe comment on how has been this data cleaned up as you guys have been collecting it? Or is it just like do you start like cleaning up the data as soon as things get locked out in early December? Thank you. I appreciate if you could taxable to me?

Robert Blum: Sure. So I hope this can be helpful, but please understand as Fady shared with you while nearly all of the patients have completed their maintenance phase not all of them have and there’s still some additional visits that must occur from which data collection still must follow in order to be enabling of database lock. So while we’re in the very late innings of this project it’s not yet done. So we can’t be as precise as you might like in asking the question about what do we mean by late December. What we mean is it’s going to be in December whether that’s towards — if we thought it was early December we would have said so. Late December probably means, it’s as you can imagine weeks into the month and that’s ultimately going to be defined by how quickly, can we get two database lock and the enabling of analysis.

It’s not uncommon where in a study like this it would typically take four to six or more weeks to go from database lock to tables listings and figures from which one could distill, top line results. We’re going to try to do that faster and as fast as we can, subject to what are still data to be collected. To this point in time, we feel very good about where we are with data collection enabling of database lock and analysis. And I hope that’s helpful to your question.

Yasmeen Rahimi: Thanks, Robert.

Operator: Thank you. Our next question will come from Charles Duncan from Cantor. Your line is open

Robert Blum: Hi, Charles.

Q – Charles Duncan: Hi, Robert. Congrats on the progress by you and the team. Thanks for taking our question. I have a couple of quick ones. A lot of great questions asked on SEQUOIA. But I did want to ask about the baseline data, with regard to certain geographies and an interaction. I guess, I’m wondering when you think about all the patients that are from China versus Europe or Israel are there any call it phenotypic or call it behavioral differences that you think may impact, call it the read-through from China versus Israel or Europe in terms of exercise capacity. Thanks.

Robert Blum: Good question. And I’ll say, I’ve been myself engaging with our colleagues to understand what could be accomplished for our making this a truly international registrational study and what can we learn from prior studies and what do we know? So, I’ll ask Fady to speak specifically to your question.

Fady Malik: Hi, Charles. I think with regards to exercise performance you’re an athlete. If you look at our Olympic level athletes, you see they come from all over the world and performance can be seen in all those populations at an extremely high level. So similarly, I think in studies like this we have the opportunity to see improvements in exercise performance across the board. I’m pleased to really buy the quality of the data that we’ve received from all of those regions. We have experience in GALACTIC for instance, in terms of response to omecamtiv mecarbil, in all of those regions. And the response to cancer was quite strong particularly in China, in fact. So I don’t have any concerns at the moment with regards to regional variability. Obviously, we’ll see when the data emerge.

Robert Blum: Charles, just to add if your question is in any way tied to is there additional risk, for the fact that we’re enrolling in some of those regions. I hope you can draw comfort from the fact that as Fady has pointed out, we’re quite comfortable with the integrity of the data, the absence of missing data, the standard deviation and those things that ultimately read on statistics. So those are things that we continually monitor and we’re quite pleased with where we sit.

Q – Charles Duncan: Yes. That actually answers both parts of the question both in terms of at the patient level, but at the clinical site level. Let me ask you one last question. If you could [indiscernible] if you will, Robert. When you think about the vision of becoming a high-growth specialist-focused cardiovascular company, what are the analogs that you look to really be able to define success in the next couple of years?

Robert Blum: I don’t foresee that there’s really an analog in biopharma today a company that is a specialty cardiovascular company. Obviously, there are specialty companies in other therapeutic categories like in the areas of CNS, for instance. But what we are focused towards in the build-out of our pipeline and corporate development strategies are those kinds of opportunities that are directed to concentrated customer segments. Where there would be both pricing and payer leverage, where there’s limited sales and marketing infrastructure required to get to a high yield, high return on investment strategy. And we don’t think the other predecessor cardiology companies in the biopharma space have those advantages in order to be able to compete effectively.

We think they do exist in those markets and for those programs where our science directed to cardiac muscle lends itself to a new business model in the biopharma space and one for which we do believe there are elements that translate to maximizing shareholder value. So I hope that answers your question.

Charles Duncan: Yes it does. You’ve been a good student of the history of the industry. So I appreciate you providing your perspectives. Thanks.