AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) Q4 2022 Earnings Call Transcript

Unidentified Analyst: Got it. Yes. Well, I really appreciate all the details for being so looking forward to — and just as one more question from us regarding the prefilled syringe products. Can you discuss any ongoing commercial path for a potential launch with the NDA closing? And also, just to clarify, PFS-01, so that’s the first NDA to be submitted should we expect commercial launch of both prefilled syringe products or there will be market as soon as approved?

Vincent Angotti: Yes. So the prefilled syringe products are being developed in a staggered fashion. The first one is the ephedrine or PFS-01 product. again, trade name or trademark right now as Fed Sera, ephedrine syringe, as you can imagine. So Fed Sera, something to that effect. So that will be on a 10-month review clock. During that period of time, we’ll be discussing contracting with the IDNs as well as the group purchasing organizations. We’re really encouraged by the uptake we’ve seen in the market of what I’ll call similar, but potentially less advantageous products. And what do I mean by that? We mentioned in the script that and following the most recent launch of an ephedrine ready-to-use vial not in syringe form, but in the vial.

So, they still have to draw it up, having prepared to the table. And if they don’t use it, they’re going to have to discard it, which is significant waste. So it requires time, energy and potential waste is on — or completed $30 million in sales in only its second year of launch. So, there’s clearly a need to advance the efficiency safety and quality of this product, in particular in this market. And so we’re going to try to submit that here in very short order and get on that 10-month clock. The balance of the prefilled syringe that you’re asking would be the phenylephrine. We’re continuing to do work on that with Aguettant. It will be a staggered submission, so it will be delayed to after ephedrine. That will do two things for us, allow us to get a read from the FDA on ephedrine, which we feel very confident in and continue to work on development to fine-tune that submission as well.

Operator: The next question comes from James Molloy with Alliance Global Partners. Please go ahead.

Unidentified Analyst : This is actually Laura calling in for James Mallooy. And also, congratulations on the recent divestment with DSUVIA with Elura Pharma. And with this, do you think you could possibly walk through your expectations for the ramp-up of sales? And then also, I have another question. So, in regard to your Niyad, when do you expect the registrational trial to be commenced and then the expected study design that you’re expecting to hold at this year? Thank you.

Vincent Angotti: Sure, Laura. Thanks for the question. So, we can’t comment on the ramp-up of sales. I think you were referring to DSUVIA on that 1 based off its divestment to elura. What I can tell you is we are in deep transfer mode with them or transition mode between our commercial team, their commercial team. As a matter of fact, they’re absorbing our commercial personnel, all except one to maintain the momentum we have in the procedural suites. I know that they will be expanding and training even further their hospital sales team based off their communication to us and they’ve got deep distribution. So, we’re excited about what they’re going to do. I can’t comment on a forecast from them, I can only comment on their commitment and resources that they’re putting against it, which is impressive.

As it relates to Niyad, again, we mentioned that the study design has been agreed upon with the FDA. The end points have been agreed upon with the FDA. Those endpoints as a primary or activated clotting time. And as a secondary that we didn’t mention are?