Abeona Therapeutics Inc Q3 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Dae Gon Ha - Stifel - Analyst : Congrats on all the progress. It's remarkable. Two questions from me. One is for Vish. As we think about the resubmission and the acceptance, given that the CRL was primarily CMC related, I guess, which aspect at this point since it is more of a review issue, which aspect do you think keeps you up at night? Or do you find to be the most question-bearing going forward? And second, for Madhav, as we think about the commercial rollout, thanks for the insights on your market research there. How should we think about or how are you guys thinking about the rollout strategy as we think Vyjuvek as well as Filsuvez that's already available. Polypharmacy-wise, what's been your respective comment that you've received from payer discussions? And how are you strategizing around getting patients back into the centers?

Question: Maurice Raycroft - Jefferies - Analyst : Congrats on the progress. I was wondering if the favorable Medicare reimbursement designation, how that impacts conversations with payers related to commercial reimbursement plans. And can you talk more about payer conversations and what pricing strategy could look like? Maybe remind me if the first treatment will be a flat price and then subsequent treatments would also be a flat price or variable price per number of sheets? Or how are you thinking about that?

Question: Maurice Raycroft - Jefferies - Analyst : Yes, that's really helpful. And maybe one other question. Just wondering if you have a line of sight into how many patients you could treat commercially potentially by the end of 2025, assuming approval and then the two to three months launching after the approval? And then can you talk more about what needs to be done to make the new facility operational that you're leasing and when that could happen as well?

Question: James Molloy - Alliance Global Partners - Analyst : And actually a little more on the question from before or the answer from before. When you say the 10 patient runs per month, what does that translate into the per year of that 225 patients in the target that you walked through the 30% of the 750 that are eligible should you get approval? How should we, on the outside looking and be thinking about when you guys could be able to potentially supply that 225 or potentially even expand that going forward? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 14, 2024 / 1:30PM, ABEO.OQ - Q3 2024 Abeona Therapeutics Inc Earnings Call

Question: James Molloy - Alliance Global Partners - Analyst : Probably the best you can do at this point, of course. Then given the demand versus supply, you guys will be facing and you guys are very good at giving ideas on pricing, you obviously see Vyjuvek's pricing. What do you guys think on pricing power to raise pricing going forward as you're expanding capacity?

Question: James Molloy - Alliance Global Partners - Analyst : Yes. Yes, of course.

Question: James Molloy - Alliance Global Partners - Analyst : It certainly seems a pretty straightforward calculation to show the value of the treatment you're helping these patients avoid. Did I hear correctly, $1.5 million a year annual cost of therapy roughly?

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Congrats on the resubmission and I appreciate all the transparency you've shared with us over the last few months. It's been very helpful. So as you think about potential conversations with surgeons and doctors if you are approved, I mean, I think the data and the durability really speak for themselves. But can you share with us how you're going to talk to them about the actual surgical procedure, including how the patients in the trial experienced in the past have responded from it? Do you see this as a potential barrier?

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : And then when you resubmitted the BLA and the resubmission was accepted for review, did you get any sense from the agency whether the focus during the time from now to the PDUFA is solely going to be on those red line items that were new essentially from the first time? Or are they going to be looking at everything holistically?