Isoray, Inc.
Q2 2021 Earnings Call Transcript

Published: 9 Feb 2021

[Operator:]

Greetings, welcome to the Isoray's Second Quarter Fiscal Year 2021 Call for the quarter ending December 31, 2020. At this time, all participants will be in a listen-only mode. And the question-and-answer session will follow the formal presentation. Please note, this conference is being recorded. At this time, I'll turn the conference over to Mark Levin, with Isoray's Investor Relations. Please go ahead, Mr. Levin.

[Mark Levin:]

Thank you, Operator. Good afternoon, and thank you for joining us today for Isoray's fiscal second quarter 2021 earnings call for the quarter ended December 31, 2020. Before we get started, I will take a few minutes to read the forward-looking statement. Certain statements in this conference call constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended.

[Lori Woods:]

Thank you, Mark. Good afternoon, and thank you for joining us today for Isoray's fiscal second quarter 2021 earnings conference call for the quarter ended December 31, 2020. Following my prepared remarks, our Chief Financial Officer, Jonathan Hunt will provide a more detailed review of fiscal second quarter financial results. Although our overall business continued to be impacted by the COVID-19 pandemic, I'm pleased that we once again have achieved year-over-year growth in our fiscal second quarter of 2021. Total revenue increased 7% versus the fiscal second quarter of 2020. Similar to the trends we've been experiencing since the onset of the pandemic early last year, our core prostate revenue declined modestly versus the year ago quarter, while our non-prostate revenue increased significantly year-over-year, driven again by treatments for brain cancer, including the sales of Cesium-131 powered GammaTile Therapy, non-prostate revenue increased 92% year-over-year. The ongoing near-term challenges resulting from the pandemic, we continue to be very optimistic about the long-term growth opportunities for Cesium-131.

[Jonathan Hunt:]

Thank you, Lori. I am going to discuss some of the financial information that was contained in our press release for the fiscal second quarter ended December 31, 2020, that we released a short while ago. We anticipate that our Form 10-Q will be filed with the SEC on or around February, 11. Revenue for the second quarter ended December 31, 2020 grew 7%, to $2.36 million versus $2.21 million for the same period last year. Prostate brachytherapy revenues declined 4% versus the second quarter of fiscal 2020, as procedure volumes continued to be impacted by COVID-19. Second quarter 2021 prostate revenue and procedure volumes were in line with the first quarter of fiscal 2021. Second quarter revenue was comprised of 80% the prostate brachytherapy with the balance or 20% of revenue attributed to other brachytherapy. As Lori mentioned earlier, other brachytherapy revenue increased 92% versus the second quarter of fiscal 2020, and was primarily driven by cells to treat brain cancer, which included revenue from GT Medical Technology.

[Operator:]

Thank you. We will now be conducting a question-and-answer session. Thank you. Our first question is from the line of Mike Ott with Oppenheimer. Please proceed with your questions.

[Mike Ott:]

Good afternoon. Thanks for taking my questions. So the quarter was pretty in line with your September quarter. Would you say it's still fair to characterize your revenue trajectory as a gradual improvement from COVID? Spring 2020 low points, or did you like many other med techs feel any pressure in December as COVID cases picked up?

[Lori Woods:]

Hi, Mike, thanks for your question today. So we've been recovering since our low point last April, it has been slow. And I think a lot of that is due to our core business, which is prostate and the demographic of that patient, which is 60 years and older. And, it's been a period of time when it's been difficult to get in, and a lot of people just don't want to get in. So we are encouraged that we continue to see improvement. And we're really at this point in time watching for when this wave of patients who needs to get in to get their prostate cancer diagnosed will be able to get back in the system. And really, we've been feeling this way, I think talking to everyone about this since the COVID pandemic started. And one of the things that really, we feel good about and really backed up what we've been saying and what we've been hearing is that the American Cancer Society just in January released their facts and figures publication, which is a really well-known publication with estimates for the coming years cancer in many areas. And what was very interesting to us is they are estimating that there's going to be a 30% increase in prostate cancer diagnosis in this year, and maybe more next year. So what we feel like is that these patients as the vaccine rolls out and they can become more mobile and feel better about getting into see their doctors will get diagnosed, and we will be able to help them fight their cancers.

[Mike Ott:]

Okay, that's very helpful. Thanks, Lori. And then on the GT registry trial, you mentioned that I know you just started, but do you have any estimate as to when we might start to see some early results from that one?

[Lori Woods:]

I'm sorry, Mike, I don't. I would think, though, that the results would come back certainly a lot quicker than our 10-year data, since prostate or since brain cancer is more aggressive. So I'm hoping that we'll see something over the next year or two definitive on that.

[Mike Ott:]

Okay. That makes sense. And then finally realizing that your sales force certainly had the adapter in COVID. But can you give any additional color on Blu Build traction so far, the early launch? How is it fearing new versus existing accounts? Or higher volume users anything like that you can share, Lori?

[Lori Woods:]

Yes, absolutely. So although we're not giving specific guidance on it, I'd love to give you some color on that. We had to adapt when the pandemic hit like everybody else did. And we're getting 6very adaptive to Zoom, and being able to present to new facilities about Blu Build during that period of time. We continue to do that and we're excited about the existing customers we have and the new customers that are looking at Blu Build. We feel like once, really things kind of even out in radiation oncology that we will see several of these customers who have shown interest really be able to, in an easier way, get their hands on and be able to start using it. Like everyone else in this sector, we're having the same issue of actually getting into the hospital physically. So we're starting to see that get a little bit easier. And we're hoping that that will continue in that way.

[Mike Ott:]

Great. That's it to me. Thanks for the update.

[Lori Woods:]

Thanks, Mike.

[Operator:]

Thank you. Our next question is from the line of Frank Takkinen with Lake Street. Please proceed with your question.

[Frank Takkinen:]

Hey, thanks for taking my question. Just a couple from me today. I wanted to start with a little bit more of a big picture idea. So there's a phenomenon of COVID backlog and incoming reimbursement change next year, as well as coming off of some positive 10-year data for Cesium-131 last year. So I was hoping you could kind of help us better understand how you feel about brachytherapy coming back into a standard treatment option. And some, maybe anecdotal feedback you're getting from radiation oncologists about reintroducing and using brachytherapy more frequently with the different tailwinds that are coming together at the same time.

[Lori Woods:]

Well, I think you described it really well. We've got several really positive things that can come together here. Coming to where we get some vaccine out there and hopefully get the pandemic more under control, so patients can feel comfortable going back in. And then the ROAPM which was moved to January 1, 2022, I think we've got several different things here that are going to be very positive for prostate brachytherapy, certainly, hopefully to the rest of our fiscal year and then certainly moving towards the end of this coming calendar year and then right into January. I think we just have things lined up very well. And we are working very hard right now. Our sales force is very focused on making sure that we have a broad base of customers, who win as these things happen and trigger interest in brachytherapy, we can be positioned to help as many people as possible. And I'm sorry, can you repeat your second part of that question?

[Frank Takkinen:]

Just what you're hearing anecdotally from radiation oncologists about the adoption of brachytherapy in the field, if it's an expectation that it could come into more of a regular standard treatment option for prostate cancer patient?

[Lori Woods:]

Yes, absolutely. So we are getting currently inbound calls from radiation oncology departments and institutions where maybe in the past, they had a brachytherapy program and they don't necessarily now or they never had one, wanting to find out if we can help them with setting those up again. And one of the things we're finding is we have this discussion is they're quite aware of the change in reimbursement and how that may affect their institutions. And what's really heartening is that because we have so much clinical data, when you combine clinical data with favorable reimbursement, you really have the opportunity to grow a sector like ours, significantly. So we're looking forward to and we're really happy with what we're hearing from folks about the resurgence and interest in prostate brachytherapy.

[Frank Takkinen:]

Great. And then moving on to your recent 510(k) clearance with the Sirius MRI marker. Could you just take us a little bit deeper on the significance of this milestone? And if there's any opportunity to further improve reimbursement for those radiation oncologists who elect to use these MRI markers?

[Lori Woods:]

Yes, absolutely. So we look at a lot of things like this. And as we're assessing these things, there's different things that jump out to our attention. One of the things that jumped out and made us look more seriously at C4 MRI marker is that a lot of the thought leaders were beginning to look at this and use MRI imaging technology. It's a technology that we haven't used that much in the past. It has typically been CT, an ultrasound base. But as imaging improves and there's more options in imaging, certainly we want to make sure that our seats combine with those imaging options, so that we can make sure that the residents coming out of residency programs and out of medical school that are being taught how to use MRI have that option. So we felt like as we look to the future, we wanted to be well positioned to be able to take care of all physicians and their imaging preferences. I think that going forward, we have some interesting opportunities here to work with C4 and really looking forward to what we can do together.

[Frank Takkinen:]

Perfect. And then last one for me, and thanks for taking all my questions. Just a housekeeping question, where does share count and cash stand after the rays as well as the warrant conversion? I know there's quite a few moving pieces. So I think it'd be useful to level set everybody on where that's standing after all of these transactions.

[Jonathan Hunt:]

You got it, Frank. This is Jonathan. So after this transaction with the 51.75 million gross proceeds plus the warrant exercises that occurred during January, as well as the ending cash position we anticipate be in the neighborhood of about $60 million or so at this time. And then in terms of the shares, there was the 83 that was outstanding at the end of December for some additional 12 or so that were issued as part of the warrants. And then the 41.4 million that were issued through the rays that was completed that closed earlier this week.

[Frank Takkinen:]

Perfect. Thanks again for taking all my questions.

[Lori Woods:]

Thanks, Frank.

[Operator:]

Thank you. Thank you. At this time, there are no additional questions, I'll turn the floor right to Lori Woods, for closing remarks.

[Lori Woods:]

Thank you, everyone for joining our conference today. We appreciate your time. Have a great afternoon. Bye-bye.

[Operator:]

This concludes today's conference. Thank you for your participation. You may now disconnect your lines at this time.