Karyopharm Therapeutics Inc. (KPTI) Earnings Call Transcript & Summary

It's my pleasure that I'd like to welcome Richard Paulson, the CEO of Karyopharm. Thanks for joining us today, Richard.

Good morning, Maury. Great to be here.

We're going to do a fireside chat. So maybe to start off, if you want to provide a 1-minute intro to Karyopharm, and maybe talk about some of the key catalysts at.

Sure. I think, Maury, I mean, as you know, and I think as many investors know, Karyopharm is now a fully commercial-stage organization, really founded in science and founded in development of the selective inhibition of nuclear export. And we are the leader in that with selinexor and our next-generation molecule eltanexor, with 3 approved indications now in the U.S. and one in Europe, really moving forward with excitement on what we believe is a real foundational approach, both to hematological blood cancers but also to solid tumors, which we're increasingly excited about as we move forward, really looking at the potential for nuclear export to impact oncogenesis across many different types of cancer. So an area we're very excited about, and I'm excited to have joined as the CEO just a month ago, after being on the Board for over the past year, and helping the organization. And the team is really continuing to move forward and bring to life the number of opportunities we have in front of us.

Got it. And Richard, I think that's kind of a good segue. Maybe talk a little bit about your background. And how you envision the space with XPOVIO as a key player?

Sure. So I mean, I've had an opportunity in the past to be involved in many different types of launches, many types of areas in oncology and hematology and in other therapeutic areas. So most recently with Ipsen, I was the Head of our North American business in oncology, neuroscience and rare disease. And before that, I spent 10 years with Amgen, leading the business in the U.S. and obviously, a number of launches and projects across many different areas. Obviously, in this space, with Kyprolis and multiple myeloma, significant experience in that area. But also as Amgen brought many innovative medicines to life for patients across oncology and hematology. Before the U.S., I spent a lot of years around the world, running the businesses with Amgen in Europe in many different markets. And before that, it's been a decade with Pfizer in Europe, in South Africa, in the U.S. and in Canada and originally started kind of my first decade with Glaxo in Canada, working across a number of different therapeutic areas as well. So a nice range of experiences, I think which really can help us from a Karyopharm perspective about how do we grow really out of, I think, great science and great foundation that might co and strong, put in place as the co-founders. And really I think as an organization now growing and expanding our commercial presence, while we're also continuing to really focus and expand where we want to be in terms of other blood cancers and other solid tumors.

Got it. Very good. And let's see. So with the XPOVIO commercial opportunity, maybe starting with that. So besides script refills, maybe if you can talk a little bit about what you're seeing there and some of the other metrics that investors should be focused on commercially?

Yes. From a commercial perspective, I think as we just shared, I really think in our first quarter post the BOSTON approval, which is obviously moving up into the second line plus from where we were previously with kind of the penta-refractory. I mean, overall, the progress forward to the second line, I think, has happened really quick, which is really positive for us and really talks to the efficacy and the breadth of opportunity we have in multiple myeloma. And in that first quarter post approval, I think our growth is really strong, when you look at our demand growth of 17%. At a time when the market is still moving through the COVID challenges. Actually, we were the only product in multiple myeloma to grow. I think a couple of other products were flat and some other products were negative. And a lot of that impact, obviously, is due to the fact that the patient flow just hasn't gotten back to where it needs to be, and that's progressing well post COVID. So again, when you look at our growth in our first quarter post second line, 17% demand growth, I think prices us kind of well in the bucket of how other products have performed as they've moved up from later lines into earlier lines. And as we continue to move forward, I think some nice indicators of how that evolution is happening, really is around the once-weekly versus a twice-weekly dose. So in quarter 1 of 2020, about 50% of our scripts were in the twice-weekly dose. And as we looked at the data from Q1, post approval, we only have about 15, 1-5, percent of our prescriptions, which are still in that twice weekly. So obviously, that puts 85% in the weekly, which is, I think, a good indication. We're making good progress with the weekly. The lines of therapy, that evolution happens over time. And so when you look at the progress from the later lines in the earlier lines, it is more difficult to kind of parse the data and look at which lines of therapy you're getting. I think as we're starting to see, you're slowly getting some increase in terms of the duration of therapy. And obviously, as that duration moves up from kind of the 2.7, 2.8, 2.9, 3 months, we'll start to see that improve as we move forward with the approval only happening towards the end of December, seeing that data mature. But we're going to see during the second half of this year.

Great. Yes. So the approval for earlier line is still pretty new. And so you mentioned that you're seeing more of the weekly scripts. But it's difficult to parse out whether the weekly is from the earlier line setting or the later line setting. Is that fair? Or do you guys have some additional insight into that?

Exactly. It's quite difficult to get the exact -- you have some different surveys and you're going to have some survey data, but the numbers are quite small. So at such an early stage, it's informative, but it's not really directional.

Got it. And then you talked a little bit about COVID and how that limited 1Q. I guess are you seeing anything in the last couple of weeks in the United States as COVID seems to be opening things out or opening up a lot more?

Yes. I haven't seen the data come through yet, and that it will take some while to get the data. But I think just as all of us are experiencing, we're starting to see the opening of -- the ability to interact more in person with health care professionals. Just myself, I was able to have a dinner last night, and 1 last week, which is great with some of our key thought leaders across the country. So also talking with our field force, they're having increased ability to get in and have those engagements in person, which I think is really important when you're in the launch phase because you're really getting in and also obviously engaging with the physician, but also really with the whole practice with the nurses and others, which really play a key role in helping to make sure the patients get the right kind of therapy and the right kind of support. So I think as we're moving forward, we're seeing that increasingly. Right now, it's anecdotal. And I think we'll start to see those patient flows, hopefully get back to the 100%, which is where they should be because that's really in the best interest of patients.

Got it. And how did the conversations with the thought leaders go?

Great. I mean from one perspective, it was just fantastic to be able to get out and really see people again in person and have the kind of engagements, I think, that are really valuable and insightful. And the conversations we had were with some physicians that are using XPOVIO, in earlier lines of therapy, are using it in our XPd regimen, also using in some of our NCCN regimens, and really positive. They're engaging with us proactively about the data. They're engaging with us proactively. We heard some great stories of all patients who have been on therapy for a long time and doing incredibly well. So that I think is what motivates us and what excites us and seeing their excitement around the product. And also how they're really engaging as we continue to develop the product as we move forward is really promising and exciting.

Got it. And I'm guessing that the thought leaders are primarily from academic institutions, just wondering what the perspective is on academic versus community doctor dynamic with XPOVIO? What your latest thoughts are on convincing community docs to drive earlier line use of the drug?

Yes. I think it's a great question, Maury. Because as we move up into earlier lines, there is a shift in terms of where the patients are. In the later lines of therapy, majority of those patients are still in the academics of the institutions. But as you move up into the earlier lines, probably about 70% of those patients are actually in the community. So ironically, these 2 conversations, I guess, were 50-50. One was with somebody who runs some major community centers and the other was more on the academic and the institution side. So both conversations -- and on the community side, really positive with regard to their experience, positive with regards to some of the experiences they're having with patients and the benefit of the convenience we have with the oral and the ability to really, I think, evolve patients with the appropriate supportive care and as they've gone through a couple of months of tapering off the supportive care and finding the right dose. Those patients doing really well and progressing well. And then on the academic side, we're actually talking about some of the upcoming data, the ASCO data, and kind of the breadth of data that we're starting to uncover, and that's where the academic position was really interested and excited about the real breadth of data that we're generating and kind of how selinexor really does have the potential to be a foundational therapy. When you look at multiple myeloma, I mean, it's great for patients. There's so much innovation. There's a lot of opportunity. And for physicians it's difficult because there's a lot of permutations and combinations in terms of what they can prescribe. So the conversations we're just having yesterday was really, how do you help physicians in that sequencing. And with the breadth of data, I think we're generating it, it really is an opportunity for us to show, having the ability to change mechanism of action or MOA change, which we provide. It was really important, given the number of therapies and kind of the real length of survival of patients can have through their whole multiple myeloma journey.

Makes sense. And that's kind of with my understanding of myeloma, I think prescribers, it can become sort of an art with how they prescribe the different regimens to the treatment paradigm. Is there a way that the process could be more standardized, can carry a farm help with that? And I guess, what are some of the thoughts from the experts on that?

Yes. I think many physicians obviously love to see the data, and they're going to do what their experience shows them. And based on the data, every patient is different. I think that's important. I think our data is, it's evolving. And as you look at some of our ASCO data, with our STORM trial, we have some really strong data across a breadth of different areas we're combining with. So obviously, we have XVd, which is our group regimen. But in the STORM trial, we're seeing XPd with Pomalyst. We're seeing XKd with Kyprolis, XDd with Darzalex. And that's where I think there's some really interesting data across those different areas. And as physicians are increasingly using either kind of an RVd in the frontline or a data-based regimen in the first-line or second line, what physicians are really excited about is kind of the breadth of data we're also showing with selinexor post daratumumab. And that's increasingly being used in earlier lines with potential different combinations based on the patient and the physician's preference. And so for us, I do think having the ability to have the MOA change post daratumumab for your kind of standard risk patients is exciting. And I think something which we'll be able to start bringing to life more as we see the data evolve. And then I think also for your high-risk patients, which are probably about 25% of patients in general multiple myeloma. The kind of data that we're showing is we really go deep into the BOSTON trial and do some analysis is also exciting for physicians. Because for the higher risk patients, they need some other alternatives. And I think the data we're showing is giving them those kinds of alternatives.

Great. Makes sense. And so you've talked about ASCO and EHA a little bit. What else should investors be focused on for these medical conferences? You guys have a lot of data that you're going to be showing there. So how can you help us focus?

Yes. And I think for ASCO or EHA -- I mean for ASCO, we have 16 publications. So a lot of areas I would focus on the kind of the breadth and the depth of the data as we're just talking about in multiple myeloma. So looking at our data with Pomalyst, XPd, I think, is really promising and insightful and obviously is helping us as we've made the decision to move forward and do a registrational trial with Pomalyst. So we're going to be moving forward with that still this year and enabling us to get that registration is important moving forward. I think, again, the data with Kyprolis, the data with Darzalex, the data post EHA, I think, is really important. So that's kind of the breadth and depth of data I would look at in multiple myeloma. The second area I would look at is actually kind of our second-generation opportunity, which is eltanexor in high-risk MDS patients, where we're continuing to see the data move forward really positively there. And I think that's a real opportunity for patients where there's a very high unmet need. And then also, I would look at some of our evolving data with regards to solid tumor. If you look at lung and CRC, I think that's earlier stage, but it's really showing good activity that we can have.

Right. Okay. And for MDS, we're definitely interested in seeing that update. What should we be looking for in the new data cut? And what's the best benchmark for the program on safety and efficacy?