Karyopharm Therapeutics Inc. (NASDAQ:KPTI) Q3 2023 Earnings Call Transcript

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Colleen Kusy: Great. Thanks. Good morning. And thanks for taking our questions. First one on a multiple myeloma with the elevation of the NCCN guideline recommendation for XVd to category one. Can you help us understand how much of a tailwind that could be through the end of the year? And then I have a follow-up?

Sohanya Cheng: Yeah, thanks Colleen. So, as we think about the evolving competitive landscape and multiple myeloma, XPOVIO has become established as a foundational mechanism. Now this elevation from of XPOVIO from category one, which used to be other recommended regimens to now category one and preferred regimens is meaningful, particularly in the community setting where it’s a large driver of treatment decisions. So, notably, the NCCN guidelines made two updates that were favorable for XPOVIO, as I mentioned, one was recommending class switching against supports a novel class of therapy like XPOVIO as well as the elevation of XPOVIO Velcade, dex into the category one and preferred status. In terms of impact. We are not going to see an impact overnight.

However, with multiple myeloma, it is an area that is highly promotionally sensitive. And we see steady growth over time. So, we are excited that our field team is now able to actively promote this update today and moving forward. And we believe this strengthens our position in the community and in the earlier lines.

Colleen Kusy: That’s helpful, thank you. And then for endometrial given the evolution of the treatment landscape with Dostarlimab and BMMR and you’re really encouraging results in PMMR. Have used pre specified, any sort of analysis and this PMMR P53 wild-type patient population for the ongoing Phase 3 study?

Reshma Rangwala: Yeah, great question Colleen. So similar to SIENDO, in which we had endpoints, looking specifically at the DMMR versus PMMR we’ll continue to do that in our ongoing Phase 3 as well. It’s not a stratification factor, we assume that the vast majority of patients are going to be MMR proficient given the fact that they represent 80% that’ll ensure balance likely. But again, we will be looking specifically at the efficacy across these two MMR subgroups.

Colleen Kusy: Great, thanks for taking our questions.

Operator: The next question comes from Eric Joseph of JP Morgan. Please go ahead.

Unidentified Analyst: Hi, thanks for taking the question. This is [indiscernible] on for Eric. Quick one from us just on the combination with the BMS drug could be [indiscernible]. Just overall thoughts on what the rationale there is, in terms of the combination with [indiscernible]?

Reshma Rangwala: Absolutely a great question. We’re really, really excited about this novel combination. Just to give you a little bit of insight, right, this combination was pushed by some of our key KOLs coming out of Dana Farber Cancer Institute PH], specifically Paul Richardson, he just thought that this builds upon the number of combinations, selinexor has already shown remarkable efficacy in patients with multiple myeloma. The other aspect that is intriguing to him, but also BMS, and of course, us is the fact that both of these drugs XPOVIO1 inhibition with selinexor, as well as this novel cell mod in mezigdomide has individually and potentially in combination, shown that it can reverse T-cell resistance. And this concept of T-cell resistance is of course, becoming more and more important for multiple myeloma traders.

Given the fact that they are now introducing T-cell therapies into the multiple myeloma arsenal, this novel combination potentially gives them a really important tool to help with sequencing of these therapies for their multiple myeloma patients.

Unidentified Analyst: That’s helpful, thank you. And then just wanted to mind quickly on the Patient Assistant Program and how kind of see the impact of the foundation closures going forward? And then kind of a Medicare D design might be effective in 2024?

Sohanya Cheng: Yeah, thank you for the question. I can take that. So, in terms of — as we know, we saw an increase utilization of PAP free drug this year due to foundation closures. Now year-to-date through Q3, the impact of PAP has been roughly $5 million to $6 million, which includes about a $1 million to $2 million PAP impact in Q3. Now in Q3, there were two of the foundations that were open and we — as a result saw new patient starts in PAP, normalized, but the refill impact remained now in Q4 these two of the four foundations remain open to date. And we anticipate the PAP impact being very similar in Q4 as it was in Q3, assuming the foundation dynamic does not change. Now as we move forward into 2024, where we are encouraged by the IRA related change to the design of the Medicare Part D which eliminates the patient burden of the 5% beneficiary coinsurance requirements.

And we expect therefore, significantly less need for these patients to utilize our patient assistance program for copay assistance.

Unidentified Analyst: Great, thanks for taking my question.

Operator: [Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to Richard Paulson for any closing remarks.

Richard Paulson: Thank you, operator. And thank you, everyone for joining us today. As we mentioned, we are well prepared for the next stage of growth as we continue to expand on our foundation of multiple myeloma with our proven commercialization of late-stage development capabilities. And as we continue to rapidly advance our pipeline, concentrating investments in our three Phase 3 programs that are expected to read out through ‘24 and ‘25 as we work to create near and long-term value for all stakeholders. Thank you for joining. And have a wonderful day.

Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

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