Veru Inc. (NASDAQ:VERU) Q1 2023 Earnings Call Transcript

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Yi Chen: Got it. My next question is, do you expect the FC2 sales to return to the levels seen in the fiscal first and second quarter of 2022? And if so, how soon do you expect to return to that level?

Mitchell Steiner: It’s a good question. I’ll have Michele, answer that.

Michele Greco: For this quarter, we’re starting to see our revenues coming back to that level that we saw in our quarters, first quarter and second quarter. As we’ve said before, our customers experienced some headwinds as Mitch said, one of them had some issues. They had leadership changes. They had rebranding issues. They’ve rebranded again. And so it’s taken them a while to fix some of their internal issues. Another customer had similar internal changes, and some other problems that they’ve been sorting through and it’s taken them a while. It sounds like, they’ve worked all that out. We stay in close contact with these customers. We’ve pushed through some of the issues as we’ve developed our own portal. We’ve had some issues to tackle.

We’ve been working on those and clearing those up so that we’re starting to see, an increase. But our visibility right now is into the second quarter, where things look good for the third and fourth quarter, but a lot of it is still dependent on how quick that do you see their customers fix their issues but all signs are pointing to it coming back to those levels.

Yi Chen: Thank you. And my last question is just to confirm that Veru, may terminate one of the ongoing breast cancer or prostate cancer trial, due to budgeting priority. Is that, correct?

Mitchell Steiner: Again, we have not made a decision and we’re looking at all options sometimes, one other extreme is just modifications or that kind of stuff. That’s why I said, it’s just too early to say. But what I can tell you, is that we want to decrease our spend, we want to prioritize the ones that are closest to the finish line. We want to ensure that we do everything we can to focus on that, because at the end of the day what matters is data. So we’ve got to get the clinical data. And then we’ll put a strategy in place to do that so that 2023 is sort of the year of enrollment and 2024 will be the year of data. Especially now that COVID-19, even though it’s still around, it really impacted all clinical trials by all companies, because of all the rules that were put in place for COVID-19 management, the lockdowns and all that stuff, it affected everything.

But now, it’s kind of moving the other way. Even though the endemic numbers are pretty high, but we’re definitely seeing that the world is starting to come back. And a lot of these sites were fatigued, because they were pulled to help with the pandemic. And you’ve heard over and over about the craziness that’s going there. But again, that’s kind of passing as well. So let us spend the time to come up with a plan to understand how we want to position our oncology program. What I can say for sure is Sabizabulin and infectious disease is here to stay. We have a real opportunity. Oncology, we’re committed to oncology. That’s our other core asset. We have unique assets that need to make their way through. And as it relates to sexual health business, it’s always been a good source of revenue, so that we can partially fund our clinical development and we’re not beholden to the marketplace.

It feels good after seeing the Q2 numbers, the fiscal year Q2 numbers. As Michele said, it’s kind of moving back to a position where a significant revenue will come in, and so that we can move these trials forward and offset some of that cost with what we bring in ourselves.

Yi Chen: Thank you.

Mitchell Steiner: Okay.

Operator: Thank you. Ladies and gentlemen, this concludes our question-and-answer session. I would like to turn the conference call back over to Dr. Mitchell Steiner for any closing comments.

Mitchell Steiner: Thank you. I appreciate everyone who joined us on today’s call, and I look forward to updating all of you on our progress in our next investor call. Thank you again.

Operator: Thank you. The digital replay of the conference call will be available beginning approximately noon Eastern Time today, February 9, by dialing 1-877-344-7529 in the US and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 9127050. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today’s presentation. You may now disconnect your lines.

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