Owlet, Inc. (NYSE:OWLT) Q4 2022 Earnings Call Transcript

Allen Lutz: Very helpful. Thank you very much.

Operator: Thank you for your question. That is all the questions that we have registered in the queue.

Mike Cavanaugh: Thank you, Matt. We’d also like to take this time to answer a few questions that we’ve been getting from investors during recent conversations that are probably on everybody’s mind. So I’d like to hand a couple over to Kurt and Kate right now. So the first one, this is for Kate, and you did address this a little bit, but maybe for everybody’s – refreshing everybody’s memory, what is outlet exposure to Silicon Valley Bank? And do you have access to all of your cash? And what happens to the latest LSA?

Kate Scolnick: Yes. Sure. So as I mentioned in the prepared remarks, we were impacted along with everybody else, given this week’s past events. We have been customers of Silicon Valley Bank for a long time. So we do have access to our deposits and we are confirming that our loan agreement and credit facility do remain in place, and we are in the process of amending our loan agreement and line of credit with them as previously disclosed.

Mike Cavanaugh: Okay. Great. And then a couple for Kurt. Kurt, regarding the FDA submissions, you previously mentioned on earlier calls, a 90-day FDA window that starts after submission and pauses as questions come in with the average decision coming around the 6-month mark since we’re coming up on 5 – we’re coming up now in 5 months since submission. Can you share any personal thoughts on how you feel the process is going? And potentially some of the color around some of the questions that the FDA is asking during the process. And then finally, regarding the de novo submission, can you share what the FDA time line typically looks like? And would that be similar to the 510(k) submission?

Kurt Workman: Yes. So just kind of as a quick refresher, we have the two submissions with the FDA. The first is our prescription device called BabySat, which is a 510(k) that will address Baby’s who are sick and need a prescribed medical monitor. That submission is subject to the typical 510(k) rules, which is a 90-day clock that stops when FDA asks questions. The company then has 180 days to gather information and provide a response. So we are currently working through our response to questions from the FDA. I’m not going to comment on the specific details of that submission. We are really confident in our products. In December, we filed a second submission to the FDA for a software-as-a-medical device, as an over-the-counter product that offers the heart rate and oxygen notifications in conjunction with the existing Dream Sock, fleet monitoring capabilities.

The de novo application includes both the display of heart rate and oxygen currently in the Dream Sock and the additional notification features as software-as-a-medical device. So de novo applications with FDA, FDA has 150 days to review and then the company has 180 days to respond. So I would just comment, I’m really proud of our team for getting both submissions in during 2022 while launching Dream Sock, CAM 2 and our new Predictive Sleep features and passing the two audits, the MDSAP audit and ISO 1345. So it’s a very busy year, and I’m really proud of everything they’ve accomplished. I’m also very confident in our products and their ability to meet FDA standards.

Mike Cavanaugh: Okay. Great. And then one final question on international regulatory clearances. How many international regulatory clearance submission is Owlet currently working on? And when can we expect to see each of those submitted?