Abeona Therapeutics Inc Q2 2024 Earnings Call Transcript

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

Question: Dae Gon Ha - Stifel Financial Corp - Analyst : Hey, good morning, guys. Thanks for taking our call (technical difficulty) the second half question a little bit more. Was there any direct feedback on additional data or additional assay? I mean it seems like the last time we spoke, everything was on track to be sort of at the end of the Type A meeting, that seemed almost like the rate limiting step before you resubmit. So I'm just wondering if there was anything additional that you need to run or anything additional that needs to be completed to kind of fulfill the dotting of the T's and I guess, dotting on the I's and crossing the T's, if you will. And then one question for Madhav. In your prepared remarks, you were talking about on track for launching about three months after pz-cel approval. Did I hear that correct? And if so, just wondering what additional work needs to get done to get the sites on board. It seems like six months is quite a bit of time, but now you're estimating about three more months beyond that. So any update on that would be great. Thank you so much.

Question: Dae Gon Ha - Stifel Financial Corp - Analyst : Yeah. No, that's very helpful. I guess on that point, on the pricing and reimbursement, you also talked about some payer discussions being fruitful. I was wondering if you could comment on sort of the poly, I guess, combo therapy type of discussions? Have you had that? What are the sort of feedback on payer side about funding both Vyjuvek as well as pz-cel?

Question: Dae Gon Ha - Stifel Financial Corp - Analyst : Great. Thanks for taking my questions. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 12, 2024 / 12:30PM, ABEO.OQ - Q2 2024 Abeona Therapeutics Inc Earnings Call

Question: Ram Selvaraju - H.C. Wainwright & Co LLC - Analyst : Thank you so much for taking my questions and congratulations on all the progress. I just wanted to ask one quick clarificatory point regarding the process via which the FDA will consider the resubmission. What is the statutory timing with which the FDA would need to respond to the BLA resubmission once it is filed and to sign a PDUFA date? Can you just remind us what that time frame is, please?

Question: Ram Selvaraju - H.C. Wainwright & Co LLC - Analyst : Yeah, very much. So and just for a quick other follow-up is, if we just, for a moment, think about the hypothetical scenario in which you receive a PRV and elect to monetize it. In such a context, can you give us a sense of whether strategically you would look to broaden your product offering, specifically in the dermatology space or if you would think strategically about potentially broadening your reach into other rare diseases as you think about the optimal commercial strategy for the company.

Question: Ram Selvaraju - H.C. Wainwright & Co LLC - Analyst : Thank you so much for that thoughtful response and congrats again on all the progress.

Question: Rick Miller - Cantor Fitzgerald LP - Analyst : Hi, this is Rick Miller on for Christian. Thanks for taking our questions. On the SaaS approach that the FDA suggested, are you able to characterize whether this is a more stringent approach? Or what was the motivation do you think for suggesting this specific approach?

Question: Rick Miller - Cantor Fitzgerald LP - Analyst : Yes. So I believe you mentioned a statistical approach that the FDA suggested related to one of the two remaining outstanding items. So just kind of if you're able to characterize whether this approach is a more stringent approach? Or what do you think the motivation there was for suggesting this specific approach?

Question: Rick Miller - Cantor Fitzgerald LP - Analyst : Yeah, that helps a lot. Thank you, that's all for us. Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 12, 2024 / 12:30PM, ABEO.OQ - Q2 2024 Abeona Therapeutics Inc Earnings Call

Question: James Molloy - Alliance Global Partners - Analyst : Hey. guys. Good morning. Thank you very much for taking my questions. I had a quick question on -- in the PRV market, I know that Biogen recently reported they sold their last one for $89 million, down a little from $100 million to sort of have been going. Have you guys seen any softening in the PRV market or anything further -- anything going on there that you guys are noting assuming again, you get the approval and get a PRV and look to monetize it?

Question: James Molloy - Alliance Global Partners - Analyst : Excellent. Absolutely not, no. And then maybe given the competitive -- Vyjuvek selling pretty well, getting off to a nice jump has that impacted? Or has there any change to potential looking at a potential partnership rather than a self-launch or some sort of combination thereof on your end? Should -- again, should you get approval?

Question: James Molloy - Alliance Global Partners - Analyst : And then maybe last question here. Any updates on sort of the earlier state -- early state pipeline? Obviously, you guys hit your hands full and the game is getting it through. But any thoughts on your earlier stage and sort of the next key catalysts we should keep an eye on for?

Question: James Molloy - Alliance Global Partners - Analyst : Great. Thank you for taking the questions.