KORU Medical Systems, Inc. (NASDAQ:KRMD) Q4 2022 Earnings Call Transcript

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Linda Tharby: And maybe the only other thing that I would say, in addition to what Tom had to say is we are confident now in our Q1 Chester site closure. So, we will release all the expenses and headcount related to that. So, you will see the margin as we have guided to ramp up from that 55% level in the first quarter, we will see it ramp up steadily throughout the year. And we have passed all our final validations to our outsourced manufacturing. And so we are confident that will wrap up in the back half as well. As for our margins on our NRE and core, our NRE margins, we are continuing to forecast that to have no meaningful impact on our gross margin at this point.

Caitlin Cronin: Great. Thanks so much.

Operator: Our next question comes from the line of Jason Bednar with Piper Sandler. Please proceed with your question.

Joe Downing: Hey. Thanks for taking the questions. This is Joe Downing on for Jason today. So, one from us on the revenue guide. So, we are curious on what will drive revenue to finish at the low end versus the high end of the guidance today? And can you talk about the assumptions around U.S. market growth versus international market growth? I know you mentioned six new novel therapy partnerships in the 2023 guide. How much growth should we be thinking comes from the novel therapies pipeline this year?

Linda Tharby: Yes. So, you asked what could impact the range of our guidance up or down. And I would point to a couple of things. The first was the first question we got from Alex, which is at the U.S. market, we see that underlying Ig market grow faster, that could bump us up nicely. I think we have international probably in the right place. And then the biggest thing is our novel therapies pipeline. And we start the year, obviously with a number of collaborations and a number of commitments to revenues. And if we get €“ if their trials progress well and they do well, they will order more, if the trials don’t do well, they will order less. Sometimes those trials are canceled, etcetera. So, that’s the biggest variable in our overall pipeline.

However, at this point, obviously, with those broad guidance ranges for U.S. and international, we are expecting significant growth again in our novel therapies overall revenues. And then just then coming back to our U.S. and international, we don’t provide specific guidance. What I would say is that we expect, as we have in the past year to outperform that underlying 10% that we issue for the U.S. market by a couple of points, and we would expect our international business to be on track and maybe a little bit better than our second half performance.

Joe Downing: Great. Thanks Linda. And then one for Tom, just looking at the 2023 margin guidance, what are you looking at in the guidance as it relates to the €“ like further material labor or early OpEx costs? How are you contemplating that in the 2023 margin guidance?

Tom Adams: Yes. So, in terms of labor in the €˜23 guidance. So, as I have mentioned, we are going to be ramping down our Chester location. So, labor will significantly drop as we reduce that footprint and remove that labor. The second part is, as mentioned earlier, our NRE will be slightly improved from last year in terms of overall margin and footprint. And then thirdly, with the outsourcing, that’s the big one. So, the outsourcing will allow us to purchase products at a much lower cost than how we were making them and manufacturing them today. So, I would say with those components, those are the main assumptions that are going to drive lower margin for us this year.

Linda Tharby: And we have built in as well. I mean what Tom is alluding to is, obviously now we have a purchase price that comes from a much lower labor cost environment because our outsources is in Latin America. But on top of that, our costs here, we have built in those inflationary impacts that we saw this year into a much lower base here.

Joe Downing: Very helpful guys. Thank you.

Linda Tharby: Thank you.

Operator: That is all the questions we have for today. I would like to turn the call back to Linda Tharby for closing remarks.

Linda Tharby: I am very proud of our progress in €˜22 against our €˜26 vision. We look forward to continuing to update you in €˜23 and just again, a big thank you to all of our KORU employees.

Operator: Ladies and gentlemen, this does conclude today’s teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.

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