Abeona Therapeutics Inc ZEVASKYN FDA Approval Call Transcript

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

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Hi, good morning, everybody, and congratulations on this approval. You should feel extremely proud about getting it over the finish line. And it was clear from Noelle and Giovanna stories, the great impact that this therapy is having for patients, so well done. I had two questions this morning. The first was just on the payer work side of things. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 29, 2025 / 12:00PM, ABEO.OQ - Abeona Therapeutics Inc ZEVASKYN FDA Approval Call We consistently hear from KOLs and I believe you showed the same view that this is intended to be a complementary therapy and not one versus the other. So I'm curious if payers have had any comments about supporting two-plus therapies at the same time.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Okay thanks And then for the five QTCs, I understand that you'll provide the names once they're onboarded, but can you just give us like a big picture sense of the kind of QTCs they are? Are they higher volume centers? Are they specialized in EB in particular? And then have they been communicating that they potentially have patients within their practice that could be potential candidates for this treatment.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Thanks. Congrats again. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 29, 2025 / 12:00PM, ABEO.OQ - Abeona Therapeutics Inc ZEVASKYN FDA Approval Call

Question: Stephen Willey - Stifel - Analyst : Yeah, good morning. Congratulations on the approval. Thanks for taking the questions. Can you provide a little bit more granularity around the outcomes-based agreements that you talked about specifically, I guess, the percentage of costs that would be reimbursed to a payer if a patient required retreatment of a target wound within three years. And then, I guess, the nominal rebate that you would pay if a patient needs to come back to a center within a three year period. And I guess, are there any list of criteria or specifications that kind of characterize that quote unquote coming back process for that patient within that three year window?

Question: Stephen Willey - Stifel - Analyst : Yeah. That's helpful color. And then just curious if this kind of three year surveillance window that's established under the outcome agreement, if you think that will it all impact the kinetics of patients seeking a second treatment for a different wound?

Question: Stephen Willey - Stifel - Analyst : Yeah, Understood. And then maybe just lastly, I think you have previously given kind of soft guidance around a steady-state gross margin in the 85%, 90% range. And I think the gross to net obviously dependent upon patient mix, but kind of in the mid- to upper teens. And just kind of curious if given the clarification now on pricing and the reimbursement protocol if those things have kind of changed at all in a meaningful way?

Question: Stephen Willey - Stifel - Analyst : All right, thanks for taking the questions and congrats again.

Question: Francois Brisebois - - Analyst : All right, thanks for the questions and congrats on the progress here. This is great news. I just wanted to clarify a little bit on the last question. So on the gross to net kind of mid to high teens that was mentioned there. Is that something -- like how do you expect that to ramp up? Or is this something with reimbursement that should be pretty steady right off the get-go here? And then I'll have a follow-up. Thank you.

Question: Francois Brisebois - - Analyst : Okay. Great. And then in terms of the 10 to 14 kind of patients, you talked about supply and demand here, the 10 to 14 patients by end of '25, is that 10 to 14 patients totally with revenue completely recognized kind of soft guidance? Or -- and just on that note, what are the gating factors? Obviously, you -- it seems to be more of a manufacturing thing and the patients are there, but is there anything else that you would consider kind of a gating factor to get to the numbers that you hope to get to?

Question: Francois Brisebois - - Analyst : And also -- and then -- sorry, go ahead.

Question: Francois Brisebois - - Analyst : Understood. And then just the last one here for me is the five centers that you talked about, they seem like they've got serious numbers, you talked about high double digit, low triple digits of patients. But at peak, how many centers do you hope to have?

Question: Francois Brisebois - - Analyst : Okay, that's it for me. Thank you and congrats again.

Question: Ram Selvaraju - H.C. Wainright - Analyst : Thanks very much for taking my questions and congratulations once again on this landmark milestone for the company, very important. Firstly, I was wondering if you could maybe walk us through some of the kinetics of reimbursement and payment under different scenarios. So for example, a situation in which patient is covered by private insurance, what would the negotiation process look like? And what would the kinetics of payment be? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 29, 2025 / 12:00PM, ABEO.OQ - Abeona Therapeutics Inc ZEVASKYN FDA Approval Call Secondly, in the context of patient retreatment. And also if you could give us some sense of at steady state, what you anticipate rebating to look like, not within the context of the three year monitoring period? Thank you.

Question: Ram Selvaraju - H.C. Wainright - Analyst : That's all very helpful. I wanted to ask a couple of other things very quickly. Firstly, in the wake of the FDA approval, can you give us some insights into how you expect to proceed with pursuit of regulatory approvals for pz-cel in territories outside of the United States as well as how the kinetics REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 29, 2025 / 12:00PM, ABEO.OQ - Abeona Therapeutics Inc ZEVASKYN FDA Approval Call and logistics might work if there are patients located internationally who have RDEB who would prefer to be treated at a QTC in the United States. Give us a sense of maybe how might that work? And what sort of patient flows might you see from ex-US demand? And lastly, if you could comment on the current situation with priority review vouchers, generally, latest sale prices as well as the degree to which you expect to see demand, what kind of demand for the PRV that you anticipate receiving and selling, especially in the context of recent FDA upheaval, does that impact demand for these vouchers? Thank you.

Question: Ram Selvaraju - H.C. Wainright - Analyst : Thank you very much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 29, 2025 / 12:00PM, ABEO.OQ - Abeona Therapeutics Inc ZEVASKYN FDA Approval Call

Question: Brett Kopelan - Debra of America - Analyst : Hello Vish, it's Brett Kopelan from Debra of America and father to Rafi, 17-year-old with severe RDEB. I just wanted to say congratulations and thank you for from a very grateful patient community for your dedication and commitment to bringing this product to market through sometimes choppy waters. So I just want to say thank you to your incredible team. And for your willingness to embrace bringing the patient voice into the drug development pathway. So thank you. It's been a pleasure working with you. We look forward to deepening our relationship going forward. And I actually don't have a question.

Question: Brett Kopelan - Debra of America - Analyst : Good data always wins out.