CVRx, Inc. (NASDAQ:CVRX) Q3 2023 Earnings Call Transcript

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Alex Nowak: Excellent. Appreciate the update. Thank you.

Operator: And our final question comes from the line Frank Takkinen with Lake Street Capital Markets. Please proceed.

Frank Takkinen: Hi, great. Thanks for taking the questions. Wanted to start with one related to the initial FDA feedback, you spoke to Nadim. I’m assuming you can’t go into great detail, but my assumption being you’ve remained in the 180-day window within 2023. Is it fair to assume that some of the interaction is less impactful or we can say maybe non-crucial to the approvability, or maybe it was more streamlined? Can you comment on that at all or if there was any significant questions that they presented to you?

Nadim Yared: Hi, Frank, how are you? Super smart question. Yes, I would – you are correct. I prefer not to negotiate with FDA in the public eyes in here. That said, you are correct on one thing. When FDA submit a question, irrespective of the difficulty of the question, the clock is stopped, right? And then we have to answer the question and provide the data that we feel comfortable that this additional data or additional analysis answer the question of FDA. And here, kudos to our team and the steering committee, with whom we’re working to be able to get these questions, analyze the data, write the answer and submit the answers to the FDA in a timely fashion that whereby all of the clock stoppage, when added together, they still allow us to hit the 180 days in this year.

But – let me be clear to one thing. You cannot infer from that, any elements on the severity of the question or the nature of the question, the fact that our team has done a fantastic job to respond very quickly.

Frank Takkinen: Got it. Fair enough. Makes sense. And I wanted to theorize a little bit into 2024. Assuming some of these items end up in your favor, understanding you guys are assuming base case, but assuming some of them in your favor. Can you maybe talk about if there would be any material commercial changes, whether that’s headcount accelerations, direct to consumer or anything in that category?

Jared Oasheim: Frank, I love the question, but at this point, I think we’re going to pass on providing any additional color on 2024. I think we’re feeling really positive based on the results we’ve seen so far in 2023 and pretty hopeful based on the non-binding vote that we got from the advisory panel on what we could possibly see for a payment level for 2024. But at this point, I don’t think we’re going to commit any additional adds or additional spend until we actually see the real results come out here from the letter in later November.

Frank Takkinen: Got it. Fair enough. I’ll stop there. Thanks for taking the questions.

Jared Oasheim: Thank you.

Operator: Ladies and gentlemen, we have reached the end of the question-and-answer session. I’d like to turn the call back to Nadim Yared for closing remarks.

Nadim Yared: Thank you, operator, and thanks again to everyone for joining us for our third quarter earnings call. We appreciate your ongoing support, and we look forward to updating you on our progress on our next update.

Operator: Thank you. This concludes today’s conference. You may now disconnect your lines at this time. Have a good day.

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