Surmodics, Inc. (NASDAQ:SRDX) Q2 2023 Earnings Call Transcript

Timothy Arens: Gary, well done. I think just Brooks, for everybody on the line, I think there is just a few things that I might add, really, we are seeing that expanding customer base, and that is going to be important into that revenue inflection point that you were asking about for the next 12-months. But keep in mind on the call here, Gary did a nice job of explaining and describing what is going on with limited market evaluations. We have a lot of things that have happened in product development that are coming through the pipeline or getting into the market. And we expect that there will be commercialized here over the coming quarters and certainly in 2024, including Pounce Venous, Pounce Arterial, XL and LP, and of course the Sublime microcatheter. So we will have more, we are filling the bag, we will have more, more products in the bag, have more customers to sell them to. I think these things bode well to that inflection point that you are asking about.

Gary Maharaj: Yes. And, and Brooks, I’m incredibly proud of our marketing and sales commercial team. Remember, we have much less direct field sales, territories than we did three months ago. And even that notwithstanding, they drove incredible revenue performances this quarter. So Tim and I are appropriately bootstrapped with our financial prudence and how we can accelerate that. But I will tell you, the small team we have had, they have driven substantial performance beyond my expectations given the recent cutback in the sales team. So very proud of what they have accomplished.

Brooks O’Neil: Great. That is very helpful. Thank you very much.

Operator: Our next question comes from Mike Petusky with Barrington Research. Please proceed with your question.

Michael Petusky: Hey, good morning. So Gary, I’m wondering, obviously the great update at the end of March on DCB. Has there been, I guess any learning since then that have, you know, made you more confident or just sort of confirmed your confidence in terms of the timing of the, you know, potential regulatory clearance in Q4 and your ability to sort of get a PMA submission, amended submission in Q3. I mean, have you, I guess, have you learned anything in the last four weeks that, you know, might be of interest in this to share in this public forum? Thanks.

Gary Maharaj: You know, the, first of all, the FDA, I have to say, they have responded quickly and I mean this is a compliment more quickly than Tim and I anticipated in our first quarter earnings call, subsequent than our approvable letter. So we want to make sure we can match their speed and readiness at the same time we have a lot of work to do in terms of repurposing the narrative and the amended application. And so getting that in front of them, I don’t want to trivialize that. It is like you hit the send button and you there. And also in terms of discussing and negotiating the appropriate label claims of the product, both with FDA and with our commercial partner Abbott. So that continues to be a work in progress, which is why we gave ourselves through the third quarter to complete all of that.

And so, you know, I think, as we said, you know, the FDA usually guides 180 day turnaround on an amended PMA, but we are confident with our discussions with them that they, the reason we can set this as an expectation in our fiscal fourth quarter is that, two things, they can move quickly on this. And secondarily, the waterfront of things to review is not everything, it is a specific things to get it in an approval format. So, really, the job right now is to work with Abbott, work with agency, and get this file submitted in our whole third quarter. And so we really nose to the grindstone getting it done.

Michael Petusky: Okay. All right. Great. A quick, quick one for Tim, I just want to absolutely make sure I understand the 3.5 to four million of cash utilization is that sort of cash flow from officers that like free cap – like in other words, does that include, CapEx or is that before CapEx?

Timothy Arens: That is right. It is free cash flow. It is all in Mike.

Michael Petusky: Okay. All right, perfect. Helpful. And then just the last one. You know, obviously I think the general view is, you know, the Pounce platform overtime is maybe much – hopefully much bigger opportunity than then Sublime. I’m just wondering what at some point makes sense to talk about those separately and just sort of talk about Pounce customers and Pounce reorder rate and so forth, even just with arterial and then obviously, as you move into Venous. To me, it just seems like that is where the massive opportunity is the home run opportunity, potentially. And I guess I’m just wondering, at some point, you guys start to transition and talk about patents in separately? Thanks.

Gary Maharaj: Mike, it is a fair question and a good one. At the appropriate time, we will start to tease out more about that intervention, product portfolio by itself separately. And also, at that time, consider that not breaking these apart so we can give more specific information about the growth opportunities there. I think it is a fair question and in the future, we absolutely are considering that. One thing I will say about the platform, it is not asleep to us, but a reset – I don’t know, another mechanical thrombectomy system that is on the market currently. I mean, there are other devices, suction based or break it up base. But Pounce really is clearly something that has this capability. Though, as I said, we are bootstrapped by a limited field presence, but even within that that you can do the multiplication of if we had a major field presence, I’m not saying we are going to have that.

But it gives you an indication of the power of the product with such a limited field presence compared to that and so very, very happy for that. As to Sublime it is asleep of a different magnitude meaning Pounce very high A SP and as you said, thrombectomy is a very hot market, and a hot opportunity right now. Sublime is really changing the face of healthcare. And now that we have, we will talk about when we intend to commercialize the microcatheter platform. At this point, it will be sometime in fiscal 2024 after the LME. But that was one of the remaining things such as how do you get through a tough lesion all the way from the wrist. And taking a cue from the coronary world of face this may be a decade and a half ago and was successfully able to get microcatheter products to go through the coronary vessels that could really open up the supply market, because now a physician doesn’t have to worry about gosh, I started radially hit some crud on the way down, I just can’t get the guide wire across.

And remember if you can’t cross you can treat. Now I have to go open up a femoral access point a fever or pedal access points. Now I can cross and so I would stay tuned for Sublime it is while ESPs may be low up, that product is going to be used in a cath lab many times a day. Pounce is a very high ASP and a lot of opportunity. But that will depend on the cases of thrombectomy coming in. So eventually Sublime is a product which I have faith in, but it will take some patience to get the market developments there. So hope that answers your question and we are looking forward to sharing and as you said uncovering more in future earnings.

Michael Petusky: Alright. Sounds good thanks guys.

Gary Maharaj: Sure.

Operator: Our next question comes from Jim Sidoti, Sidoti & Company. Please proceed with your question.

James Sidoti: Hi, good morning. Thanks for taking the questions. The first one on the revenue guidance. If your revenue stays flat, Q3 and Q4 was what you did in Q2, you are already at the high end of that guidance. So does that mean there was something in Q2 that might have been unusually high that you think might come down in the third and fourth quarters?

Timothy Arens: Yes, it is a great question. Let me help you understand what is going on with the second half of the year. You heard me and my prepared remarks highlight that our SurVeil revenue is going to be about 4 million to 4.5 million. And that compares to about 5.2 million that we generated last year. I think that headwinds about 1.5 million around the midpoint, that pretty much all is occurring the second half of the year, and you maybe have 100,000 of it that kind of occurred in Q2, but the vast majority is going to be occurring in the second half of the year. So take that into the calculus.

James Sidoti: Okay. So while the licensee is likely to come down to it often in the back half of the year, is that what I’m hearing?

Timothy Arens: Yes. When you combine the licensees and the milestone, it is probably a good way to think about it.

James Sidoti: Right. Okay and then, of course, I had his inventory levels are up about a million dollars from the previous quarter, is that finished goods and is that related to Sublime and Pounce or is that related to Sublime – or something else?

Timothy Arens: Another great question. There is up about a million – it is predominantly raw materials, you will find you will see that in the 10-Q. So take a look there. Notably, Q2 product revenue was significantly higher than it was a prior year, and significantly higher than what you saw in Q1, I think we had both $1.1 million, $1.2 million in sequential product revenue growth in the quarter. So yes, of course, we are doing some replenishment in terms of some of the raw materials to support those products that we have been selling. I think there is a little bit of the growth in the inventory this quarter, as a relates to some products that were in wet and finished goods that have yet to be shipped to customers at the end of the quarter.

But those I think, are going out the door if they haven’t already. But you should be thinking about inventory somewhere around the levels that we are currently having the math. A lot of that is going to be dependent upon how we continue to progress with the product sales, but all-in-all, it is a good sign of what is going on in the revenue line.