Humacyte, Inc. (NASDAQ:HUMA) Q1 2024 Earnings Call Transcript

Heather Prichard: Thanks, Laura. So Josh, as our manufacturing capacity stands now, as you know, at about 8,000 HAVs growth per year. And as far as scaling that out with the LUNA system that we have that manufactures our product, that is just a case of putting in more LUNA lines. Our facility is already ready in a shelled out space that’s already plumbed for electrical and gases and utilities for us to add additional units LUNAs up to about 40,000 HAVs per year annual gross yield. So we’re prepared, and we’re prepared for a launch to be able to produce enough vessels in the first few years. And then we’re also prepared and have begun planning for that expansion within the space. So as demand grows, we can produce enough HAVs for the market.

Josh Jennings: Great. Thank you.

Operator: Thank you. [Operator Instructions]. Our next question is a follow-up from the line of Ryan Zimmerman with BTIG. Please proceed with your question.

Ryan Zimmerman: Hey guys, sorry. I just had one follow-up I want to ask. You did talk about ICD-10s for Humacyte — for the HAV, excuse me. And I’m just wondering if you could speak a little bit to kind of how you’re thinking about that process, any timing that you think you could — you want to put out there in terms of potentially getting a code for implantation of the HAV, be it vascular trauma or AV access or so forth? Thanks for taking the follow-up.

Laura Niklason: Yes, Ryan. So we submitted the application with CMS for the ICD-10 code in trauma, because the ICD-10 code in this case is going to be indication-specific. So we submitted the application in December, and we had a public forum meeting on the ICD-10 code application in March. And this is in the public domain. The CMS recommendation at the time was that the HAV be granted its own ICD-10 code for the implantation of a bioengineered vessel in the upper or lower extremities. CMS doesn’t execute on the final decision on that, I don’t think, until June. But based on the CMS recommendation, which is already in the public domain, we expect that to go through and to have that in hand before approval. And just as a side note, also with respect to CMS, we are planning to apply for a new technology add-on payment with CMS after our projected approval date.

So you can apply for an NTAP once per year, that the application date is typically around October 1st, and we plan on hitting that application date and applying this year.

Ryan Zimmerman: Yes, that makes sense. And appreciate that color, Laura. Thanks for the follow-up.

Operator: Thank you. I’m showing no further questions at this time in queue. This concludes the Humacyte first quarter results conference call. Thank you all for participating. You may now disconnect your lines.