LumiraDx Limited (NASDAQ:LMDX) Q2 2023 Earnings Call Transcript

Mark Massaro: Hey guys, uh, thank you for the questions. Ron, the first question is for you. I’m curious as to your degree of confidence around the duration of the NIH ITAP program. Obviously, you submitted your COVID ultra test to the, as a 510-K, but your COVID flu is the EUA through the ITAP. I’m just curious, if you have visibility, how long the EUA pathway through ITAP will be available as opposed to submitting regular way 510-Ks. And any thoughts on timing expectations for the COVID flu test?

Ron Zwanziger : Well, on your first question, there’s been tremendous engagement and the continues to be, probably, we don’t know this for sure, but probably because ours is the only multiplex high-performance test available. And so, we suspect that’s the reason. And of course, there’s a lot of anxiety around because of the flu season. So, yes, so the ITAP program continued to interact with us even though that in general, there’s obviously a sharp reduction in U.S., but for this particular application still seems to be there. And so hence our comments before that we’re hoping. Well, there’s no assurance, but we’re hoping to be able to get it in time for the flu season, and we’re working with the customers who are being patient know the situation for that to happen.

Your other comment, your other question about our first 510-K, I think that will follow the regular path and it’s always very hard to estimate 510-K, particularly the first one on an acute new platform where you are submitting and the review process includes a great deal of focus both on the instruments as well as the particular stripping question. So, it’s a much greater amount of work than the second test you submit. But we submitted a very detailed and complete package. And so, I think that there’ll be a back and forth with the FDA and I think the optimistic view might be before the end of the year, otherwise into next year. But I think it’s not far away. It’s not too far away.

Mark Massaro : Okay, great. And then maybe one for you, Dorian. You’re now tracking low $20 million in the first two quarters of the year. Q3 is typically seasonally lighter, I don’t think, I heard you guide for Q3, but can you give us a sense for ballpark, do you think it will be down a little bit sequentially, primarily due to seasonality or are there other offsets that could keep you flattish?

Dorian LeBlanc: Well, it’s a tricky question to answer mark, because such a material impact around the timing of the flu-COVID approval potentially in the U.S. and customers waiting on purchases on the timing of that, on whether they’ll utilize the 12-minute COVID antigen test in the U.S. or the flu-COVID test. So tricky to guide to exactly what Q3 will land just because of such a material impact from the timing. Outside of that, we continue to see the non-COVID portfolio grow. And as we talk to the number of customers that are taking multiple tests and continue to go quarter-on-quarter. We see that trend to, and will carry us through the rest of the year as the menu expansion really plays well in Europe and that will drive the non-respiratory growth. Because respiratory is such a big contributor, hard to guide with the uncertainty around timing.

Mark Massaro: And then on the balance sheet, Dorian, I think you expect to draw $16 million by the end of next week. I think that’ll take you to $41 million of cash. Is that cash sufficient in your view to get through the end of September and just maybe how should we think about cash runway?