Alimera Sciences, Inc. (NASDAQ:ALIM) Q4 2022 Earnings Call Transcript

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Alex Nowak: Got it. And so you put everything together, I mean, how should we be thinking about growth for 2023. I mean you started the call off mentioning we are back to pre-pandemic growth levels. Is that the right way to think about 2023?

Rick Eiswirth: I hope it is, and I think that’s possible, Alex. I will tell you that we think that driving positive EBITDA, right, and cash flow is a critical component of our future as we talked about. So internally, we sort of model for conservatively 10% growth and try to drive EBITDA around that number, and then we hope to positively be surprised throughout the year.

Alex Nowak: Okay, got it. And then last question here just around the NEW DAY readout timing around that. And then you got a couple of years here with Ocumension in China, what’s the sales potential there or at least how to think about it?

Rick Eiswirth: So with respect to the NEW DAY study, we expect to complete enrollment in the second quarter. I hope as early as the end of April. We are getting close to the final stretches there. If we can complete the enrollment in the second quarter, we would expect to have top line data in late 2024, that we could begin talking about both commercially and medical presentations, et cetera, in early 2025. To be honest with you, it’s a little bit too early to give you guidance on the Ocumension — what the Ocumension sales in China might be. But remember, we have a — we took a significant amount of money upfront, a very low margin on those unit sales. And then most of the revenue that would come in from Ocumension in the future would be milestone-based if we get here. So probably a little bit too early to give projections on that.

Alex Nowak: Okay. Understood. Appreciate the update. Thank you.

Rick Eiswirth: Thank you for your support, Alex.

Operator: Our next question comes from Yi Chen from H.C. Wainwright. Please go ahead.

Yi Chen: Hi. Thank you for taking the question. Could you comment on whether there is a change in physicians practices today or at least change in their opinion, of potentially using a steroid based product as a first-line treatment? Thank you.

Rick Eiswirth: I’m not sure if I completely understand the question, Yi, but we do continue to see a shift in — we continue to see a shift in more physicians using steroids in their practice, right? I think there is more and more discussion out there at every industry meeting about the need to address the broader role of inflammation in diabetic macular edema. And that’s something that the anti-VEGF can’t do as more of a mono focused drug, right? The steroids have a broad — very broad mechanism of action addressing multiple cytokines in the pathology of the disease. And frankly, the doctors are seeing the need to get that more under control. That’s evidenced by a study I’ve referenced quite a few times from the DRCR where they used anti-VEGF on a monthly basis for 6 months.

And regardless of what type of anti-VEGF it was, anywhere from 35% to 65% of the patients have persistent edema, right? And everybody believes that’s because of the underlying inflammatory aspect. So I think you’re seeing doctors see that data, see the positive impact, frankly, at both OZURDEX and ILUVIEN in treating these patients more broadly and are starting to shift to steroids earlier, it’s why both OZURDEX and ILUVIEN are growing. We also see a huge desire out there for longer-term, more durable therapy, right? It’s what has talked about with the potential higher dose of Eylea. It’s what’s discussed with the availability of faricimab. And frankly, we think we’re very lucky that we’ve got ILUVIEN, we’ve had ILUVIEN for a while, and it is clearly the most durable therapy by a significant measure compared to all of those alternatives, whether anti-VEGF or steroid.

Yi Chen: Got it. In the European market, would you say DME is the primary driver for user demand, not uveitis?

Rick Eiswirth: Yi, you are hard — I’m sorry, you are hard to understand. I think you asked if DME or uveitis would be the primary driver. Is that correct?

Yi Chen: Yes. I’m asking in the European markets, is DME still the primary driver in growth in user demand, not necessarily the uveitis indication, right?

Rick Eiswirth: It’s — I would say — I mean, I would say it’s both. I think we continue to drive greater usage in the DME segment as well. However, remember, our DME label in Europe is a little bit more restricted. So the expansion of the NIPU or uveitis indication is driving some of that more rapid uptake in these markets. The great thing for us is, though, having a second indication to talk about there, we think, gives us more time with the DME doctors. It gets them experience in uveitis to see the value of the durable therapy that then eventually translates into more usage in DME. So we are able to leverage that rapid growth and uptake in uveitis to then generate more utilization in DME.

Yi Chen: Got it. And lastly, would you expect the operating expenses to remain relatively stable throughout 2023?

Rick Eiswirth: We do. We do. We are not quite down in Q4 at the level we would expect. You still — you will see some additional decreases in Q1 and then they should stay stable over the course of the year.

Yi Chen: Got it. Thank you.

Rick Eiswirth: Okay. Thank you, Yi.

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Rick Eiswirth for any closing remarks.

Rick Eiswirth: I want to thank everyone for participating on today’s call and your continued support and interest in Alimera. We do look forward to sharing additional results as we go through the year, specifically our first quarter results, which we will probably release in early May. Thank you all, and have a wonderful day.

Operator: Conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

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