IsoRay, Inc. (ISR) CEO Lori Woods on Q3 2020 Results – Earnings Call Transcript

IsoRay, Inc. (NYSEMKT:ISR) Q3 2020 Earnings Conference Call May 12, 2020 4:30 PM ET

Company Participants

Mark Levin – IR

Lori Woods – CEO

Jonathan Hunt – CFO

Conference Call Participants

Jason Kolbert – Dawson James

Ed Woo – Ascendiant Capital

William Urschel – Accord Partners

Operator

Good day, ladies and gentlemen, and welcome to your IsoRay Inc. Third Quarter 2020 Earnings Conference Call. All lines have been placed in a listen-only mode and the floor will be open for your questions and comments following the presentation.

At this time, it is my pleasure to turn the floor over to your host, Mr. Mark Levin of Investor Relations. Please go ahead sir.

Mark Levin

Thank you, operator. Good afternoon and thank you for joining us today for the IsoRay fiscal third quarter 2020 earnings call for the third quarter ended March 31st, 2020. Before we get started, I will take a few minutes to read the forward-looking statements.

Certain statements in this conference call constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended.

When used in this conference call, words such as will, believe, expect, anticipate, encourage, and similar expressions, as they relate to the company or its management as well as the assumptions made by information currently available to the company’s management, identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements are based on management’s current expectations and beliefs about future events as of today May 12th, 2020. As with any projection or forecast, they are inherently susceptible to uncertainty and changes in circumstances and the company undertakes no obligation to and expressly disclaims any obligation to update or alter its forward-looking statements whether resulting from such changes, new information, subsequent events, or otherwise.

Additional information concerning forward-looking statements is contained under the headings of Safe Harbor statement and risk factors listed from time-to-time in the company’s filings with the Securities and Exchange Commission.

We will begin today’s call with Lori Woods, IsoRay’s Chief Executive Officer; and then Jonathan Hunt, IsoRay’s Chief Financial Officer, who will discuss the fiscal third quarter 2020 financial results. Following their prepared remarks, we will take questions from our analysts and institutional investors.

I will now turn the call over to Lori.

Lori Woods

Thank you, Mark. Good afternoon and thank you for joining us today for IsoRay’s fiscal third quarter 2020 earnings conference call for the quarter ended March 31st, 2020. Following my comments, our Chief Financial Officer, Jonathan Hunt will provide a more detailed review of the fiscal third quarter financial results.

I am very pleased to share with you the considerable progress, we continue to experience at IsoRay and the accelerated growth we realized in the quarter ended March 31st.

Record revenue for the third quarter increased 50% versus the year ago quarter. This quarter comprised the top three single highest revenue months in the company’s history. We continued to see substantial operational improvements in this quarter as gross margin expanded to a record 59.2%. Combine that with moderate operating expense growth, and we significantly decreased our operating loss, which was half of what it was in the fiscal third quarter of 2019.

A central factor in driving strong momentum that is manifested in our financial results is our growing leadership role within the brachytherapy industry. We continue to expand our role as a trusted, valuable partner, enabling more practitioners to better treat their patients.

This is evidenced again this quarter by yet another increase in new customers. As of the trailing 12 months ending March 31st, our net new physician customer count increased 33% versus the previous 12-month period. We continue to gain traction by highlighting the unique benefits of Cesium Blu and our supporting delivery devices. In addition, our best-in-class customer service and support and our expanding digital presence should allow us to continue to grow our leadership position.

As we ended the quarter in March, the world saw a significant shift from the unfortunate implications of the COVID-19 global health pandemic. I am proud to report that from the onset, IsoRay has been proactive in implementing plans to ensure the health and well-being of our employees, while remaining focused on providing uninterrupted product flow to the physicians and patients who count on us.

We seamlessly transitioned many employees to work from home and made other adjustments to ensure the continuity of our business through this time. At the beginning of the pandemic, we moved quickly to ensure that our inventory of non-isotope supplies were appropriate in case our supply chain was disrupted.

In addition, we set in motion our strategy to maintain a continuous and uninterrupted supply of isotope from our suppliers in Russia. Our partners at nuclear facilities in Russia have worked hard to adjust to our needs going above and beyond to support us, which we appreciate immensely.

Fortunately, we have not experienced any material supply chain issues to-date. As we think about how COVID-19 is impacting IsoRay’s business, it is important to remember the demographics of the patients cancer our customers commonly treat. The majority of the cancers are in prostate.

In general, prostate cancer is a relatively slow progressing form of cancer, and does not often present an imminent life threatening emergency for many of our customers’ patients.

As COVID-19 began to spread, many states implemented new guidelines in an attempt to mitigate spread of the virus and to conserve certain medical supplies, such as PPE. Those guidelines led to the cancellation or postponement of elective and non-emergency surgical procedures including prostate brachytherapy procedures.

Consequently, at the very end of March, we saw some procedures begin to be postponed in many markets we serve. This resulted in preliminary revenue for the month of April declining about 20% versus April in 2019.

In the recent weeks, as states begin to lift restrictions on non-essential surgeries, we’ve received an increasing amount of customer feedback that those implants that had been cancelled in March and April were beginning to be rescheduled. Our order growth has been accelerating since the last week of April.

We firmly believe that most, if not all, treatments in process prior to the outbreak will take place over the next few months. In the meantime, we continue to tightly manage our expenses and make fluid adjustments to isotope orders to meet potential increased treatment demands as restrictions lift.

The COVID-19 pandemic has impacted the sourcing of parts associated with the assembly of our proprietary disposable delivery device Blu Build. This was due to our parts manufacturer temporarily converting their production capacity to making clinical PPE for the battle against the pandemic.

We have enough inventory to support our current customers and new customers in the pipeline until our parts manufacturer is back online. We support their decision and as a result now anticipate Blu Build will see a slower than expected release through the remainder of fiscal 2020. With the expectation that Blu Build will continue contributing revenue in the fiscal fourth quarter of 2020 and deem traction in fiscal 2021.

Turning to GammaTile and our partners at GT Medical Technologies. GT Medical Technologies launched their full market release of GammaTile therapy in January. In support of this launch, they have extended beyond their current distribution partners to include indirect GT Medical Technologies sales team.

For those of you who are not aware of our relationship with GT Medical Technologies, we have a 10-year manufacturing and supply agreement to manufacture GammaTile with Cesium-131 feeds in the tiles to treat both recurrent and primary brain cancers.

We remain optimistic about the prospects for GammaTile and the benefit it can offer to many brain cancer patients and are looking forward to how the salesforce expansion proceeds. Revenue from the sales of GT Medical Technologies were again nominal to IsoRay’s overall revenue in the fiscal third quarter ended March 31st.

On another front, we continue to remain actively engaged with policymakers in Washington D.C. on a number of key items. I am very pleased to report that there is a new development to share with you.

Yesterday evening, we were notified that we had received 64 ICD 10 PCS codes for reimbursement in the inpatient DRG setting. These codes allow hospitals to bill Medicare for specific surgical procedures that would benefit from the addition of Cesium-131.

You will recall that the ICD 10 PCS codes are important for the growing surgical applications of Cesium-131 in treating hard to treat cancers. Just a few of the codes include lung, head and neck, brain, GYN, pelvic, and many others. These codes will take effect on October 1st, 2020.

Another important matter is one you may recall from our fiscal 2019 year in earnings call back in September, I shared with you that CMS had proposed a significant change to the way Medicare currently pays for radiation oncology services in the outpatient setting.

The proposed radiation oncology alternative payment method or ROAPM would provide a single bundled payment for a 90-day episode of radiation therapy, including LDR brachytherapy, IMRT, SPRT, proton therapy, and HDR brachytherapy. 17 disease sites, including the prostate are included in this proposal.

The common period ended September 16th, and after an initial delay this past fall, the final CMS ruling was rescheduled for release on April 1st, 2020. However, with the onslaught of the pandemic in the U.S. in March, the ROAPM was not released on April 1st, and a date has not been set.

We continue to watch for new developments in this matter because we believe that the implementation of this bundle may further level the playing field for brachytherapy over time, given the various radiation treatments available to patients.

We have also been working with policymakers to help them understand the importance of Cesium-131 as they turn their attention to ensuring that everyone can safely access the healthcare services necessary to diagnose and treat life threatening diseases beyond COVID-19. We believe that many aspects of brachytherapy using Cesium-131 supports this process. The procedure is a one-time hospital visit reducing the risk of exposure to threatening diseases like COVID-19 and is supported by long term clinical evidence demonstrating positive patient outcomes.

This — done advantage means vulnerable cancer patients do not need to keep returning for multiple in hospital treatments as typically required by other forms of radiation therapy.

This also lowers the overall use of personal protective equipment, and even the aggregate cost of the treatment is lower. We look forward to continuing our dialogue with policymakers and their staff to ensure that cancer patients have meaningful and timely access to brachytherapy.

Before I turn the call over to Jonathan, I want to take this opportunity to thank all IsoRay employees. Words seem inadequate to describe how proud I am of this incredibly dedicated team.

They remained singularly focused on the company mission even as this unprecedented time of uncertainty has impacted all of us seeing this latest demonstration of commitment, and how successfully we adapted during this pandemic, gives me even more confidence in the future success of IsoRay.

Now, I will turn the call over to Jonathan to review the results of our fiscal third quarter.

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 third quarter ended March 31st 2020 that we released a short while ago. We anticipate that our Form 10-Q will be filed with the SEC on or around May 14th.

Revenue for the third quarter ended March 31st, 2020 grew 50% to $2.9 million versus $1.9 million for the same period last year. The third quarter revenue was comprised of 84% for prostate brachytherapy, which grew 42% versus the fiscal third quarter of 2018.

With the balance or 60% of revenue attributed to other brachytherapy, primarily sales to treat brain, which included normal revenue and GammaTile related sales to GT Medical Technologies.

Gross profit as a percentage of revenues for the third quarter ended March 31st, 2020 increased to a record 59.2% compared to 45.7% for the quarter ended March 31st, 2019. The gross margin increase was primarily driven by higher sales and lower isotope unit costs when compared to the prior year comparable period. Third quarter gross profit dollars of $1.7 million increased 94% when compared to the same period last year.

Total operating expenses consisting of research and development, sales and marketing, and general and administrative increased 10% from the prior year comparable period to $2.3 million from third quarter 2020 revenue growth 50%.

Total R&D expense decreased slightly to $294,000 compared to $299,000 in the comparable prior year quarter. Going forward, we continue to expect proprietary R&D expense to increase back to or above levels in prior recent quarters or to roughly $300,000 to $400,000 per quarter as we are continuing to have discussions with institutions looking at the expanded use of Cesium-131.

Sales and marketing expenses increased 25% versus the comparable prior year quarter to $805,000. The increase in sales and marketing expenses was driven primarily by increased incentive compensation related to the 50% increase in revenue as well as an increase in physician-led training expenses. These increases were partially offset by a decrease in travel costs due to COVID-19.

G&A expenses of $1.16 million represented an increase of 5% versus $1.1 million in the fiscal third quarter 2019. Year-over-year increase was driven primarily by increased incentive compensation related to the 50% year-over-year increase in revenue in company’s financial performance, headcount insurance premium, and public company related expenses. These increases were partially offset by a decrease in our Washington State hazardous substance pack and reduced legal, travel, and employee hiring expenses.

IsoRay posted a net loss of $545,000 for the third quarter ended March 31st, 2020, a significant improvement compared to a net loss of $1.1 million for the quarter ended March 31st, 2019. The net loss per basic and diluted share was $0.01 versus a net loss of $0.02 for the quarter ended March 31st, 2019.

Basic and diluted shares results are based on weighted average shares outstanding of approximately 67.6 million at fiscal third quarter 2020 versus 67.3 million for the prior year period.

As of March 31st, 2020, the company had cash, cash equivalents, and certificates of deposits that totaled $2.4 million compared to $5.3 million at the end of fiscal 2019 ended June 30th, 2019. The company has zero long-term debt. Shareholders’ equity at the end of fiscal third quarter 2020 totaled $5.8 million versus $7.7 million at the end of fiscal 2019.

I will now turn the call over to the operator to take questions from our analysts and institutional investors.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions]

We’ll go first to Jason Kolbert at Dawson James.

Jason Kolbert

Well, congratulations. I know there’s a lot of chaos going on across the United States. But you did put up great numbers. I think the best numbers I’ve seen since I’m following IsoRay. So that really is a great accomplishment. If I understand what you said Lori, the majority of those revenues were driven by prostate cancer. But you’re beginning to have a glimmer of hope that GT Medical will come online as GammaTile and their salesforce engages. Is that right?

Lori Woods

Yes, that’s correct Jason. And thank you, we’re very excited about what we did this last quarter. To your question, yes, most of it was from prostate and then we are hopeful that GammaTile will be gaining traction and moving forward now that they’ve done their full market release.

Jason Kolbert

Okay. And I just want to make sure I understood a couple of things. You mentioned that there is going to be some interruptions in COVID, both in terms of Blu Build, the device, and just a lot of other factors, but at the end of the day, procedures that were being lined up are going to be rescheduled. So, we might see a dip in April that might come back to an increase in May or June and quarter may end up being somewhat in line with kind of prior expectations. Is that fair to say?

Lori Woods

Well, I think it is fair to say that we’ve gotten a lot of feedback from our customers that indicates that those cases that were cancelled toward the end of March and maybe didn’t get scheduled at the beginning of April. They all believe that those cases will be back and be scheduled.

And so I can’t speak to exactly how next quarter will turn out. But we’re very hopeful that over the next few months, we’ll get them all back and taken care.

Jason Kolbert

Sure, of course. And one last question, to — I wanted to make sure I understood the acronym ROAPM this single bundle payment, multiple cancers that levels the playing field for brachytherapy, but what this row pan stands for?

Lori Woods

It’s the radiation oncology — Jonathan helped me out here.

Jason Kolbert

Yes, but I did get it right, it is R-O-P-A-N, right?

Lori Woods

It’s R-O-P-A-M. So, it’s radiation oncology–

Jonathan Hunt

Alternative payment method.

Jason Kolbert

Got it, alternative payment method. That’s right, I just wanted to get it right so that we go in print. Listen, one last question Lori, cash is starting to get tight, do you have any thoughts about how you’re going to handle the — your cash capital needs?

Lori Woods

I’m going to turn that question over to Jonathan.

Jason Kolbert

Okay.

Jonathan Hunt

Jason, so, we continue to believe that at our current cash flows and based on our current burn rate that we have sufficient cash to last us throughout the remainder of this calendar year. And as you probably know, we do have an ATM in place which although it’s not an immediate financing, it does give us the flexibility to sell stock at the current market price in the market from time-to-time at our discretion. So, we’ll continue–

Jason Kolbert

Preservation of the balance sheet through an ATM. That makes sense.

Jonathan Hunt

Yes.

Jason Kolbert

Okay. All right. Sounds good. And so, Lori, any — thank you very much for that. I appreciate it. Lori, any particular events or catalysts that we should look at? I mean, you and I have been doing this a long time. And IsoRay is the turtle slow and steady, but really showing some nice progress, is there — but we all love catalysts and events. Is there a catalyst or an event that I could hang my hat on?

Jonathan Hunt

I might have answered that question differently if we weren’t in the middle of a pandemic, but I think right now really, it’s important that we stay focused on our core strategy, which is growing our prostate market and getting new patients in the door, organic growth for those customers that we already have, and keep that moving forward.

And as things clear out and this whole thing with COVID-19, I think we’ll be able to talk to you more about relationships we’re developing with the research centers and some other ongoing things. We’re just — with this popping up in the middle here the last couple months, we’re just not ready to have those discussions.

Jason Kolbert

Sounds very reasonable. Thank you. I guess what I was going to ask one last thing it was at what point do you start to see your ability to expand manufacturing margins or get more leverage out of the cyclotrons that are producing the seeds?

Lori Woods

Actually, we buy our radioisotopes from have facilities in Russia and they constantly work on refining how we’re going to get our isotope and one of the reasons we’re very pleased to partner with them is they’ve done a fantastic job of that and they ship us very, very pure isotope. So, it has been one of the things that has helped drive our gross margins up is the fact that we don’t have to refine the isotope once we get it, we don’t have to spend time and money doing that. We get very, very pure isotope from Russia. So, that’s been very helpful for us.

Jason Kolbert

Thanks Lori. Congratulations, everybody at IsoRay. Really appreciate it. Stay safe. Thank you.

Lori Woods

Thank you, Jason, so much. You too.

Operator

We’ll go next to Ed Woo with Ascendiant Capital

Ed Woo

Yes, I also like to say congratulations. This is a very great quarter, especially in this environment. My question is — congratulations also on getting the additional billing codes from Medicare. But just walk them through some of the details, does that mean that you have now have approval for hospitals to bill Medicare for these additional procedures? And what is the reimbursement rates?

Lori Woods

So, I see — the reason you want to have ICD 10 PCS codes is because they play a really important role in communicating claims information. And that really helps ensure the establishment of appropriate groupings. So, in the in-patient setting, it’s going to be a group of codes around a specific type of treatment.

While there’s never been able to be a Cesium portion of that and so it’s been very difficult to set payment levels in relationship to using Cesium. So, it’s very key for us to get these ICD 10 PCS codes, because now that really helps ensure that we get the appropriate group rate — groupings and levels of payments for hospitals in the in-patient setting.

Ed Woo

So, does that mean a hospital today can now use Cesium-131 and get reimbursed for it whereas yesterday, they wouldn’t be able to?

Lori Woods

Well, many hospitals have been using Cesium-131 to-date and they just didn’t have a code to tell Medicare that they were actually using it. And so as of today, they have a code that they will use when they use Cesium-131 to tell to tell Medicare and by extension, other insurers, that they are using Cesium in this particular type of surgery and that it justifies additional payment for that procedure.

And they’ll gather data over time to help determine what the appropriate reimbursement rates will be. But it’s a big step toward working for a strong reimbursement for Cesium in the in-patient setting where we’ve always just been in the out-patient setting before.

Ed Woo

Great. So, the reimbursement rate for in-setting is still a work in process?

Lori Woods

Exactly. And this was this was a key milestone to really make that move forward.

Ed Woo

Great. Is there any timeline on when the next step would be?

Ed Woo

So, that’s something that CMS works on and each year as they set new reimbursement rates, they will take this into account. So, now it’s an evolving process from year-to-year as to how they’re going to set those rates. And we don’t have any control over that. So, there’s not a next step for us to take. We’ve taken the step of making sure we got these codes in place and now Medicare pulls that into their system.

Ed Woo

Okay, but this is definitely a good positive first step — or milestone?

Lori Woods

Yes.

Ed Woo

Great. Another question I have is — obviously, fortunately, lucky your business hasn’t been effective relatively. What about outreach to physicians and getting the word out on Cesium-131, has that been slowed as well with shelter-in-place or do you still see good outreach to new positions?

Lori Woods

That’s a great question Ed. And it’s been very interesting because, of course, our salesforce was being right in front of that physicians and talking to them. So, it has been an adjustment.

It’s been one that we found has been working better than we thought it was going to. We have new patients that have come — sorry, new physicians who have come on board. And we also have had some really great interaction with physicians on conference calls — multiple physicians on conference calls, lots of things that I think we’re all adjusting to, seeing each other on video camera and working day in and day out that way, we’re finding that works with physicians.

And the feedback we’ve gotten is that in many ways, they like that because it allows them to manage their time better, and they can still have good communications with us. So, it’s an adjustment like I think it is for many businesses across many sectors, but so far, it’s been going very well.

Ed Woo

Great. Well, thank you for answering my questions and wish you continued luck going forward. Thank you.

Lori Woods

Thank you so much.

Operator

We’ll go next to Bill Urschel, Accord Partners.

William Urschel

I’d like to echo my congratulations, guys, but my questions were answered by — in the earlier answer, so I’m good to go. Thank you.

Lori Woods

Thank you so much Bill.

Operator

[Operator Instructions]

I have no other questions holding at this time. So, I’ll turn the conference back to Ms. Woods for any additional or closing comments.

Lori Woods

Thank you, everyone, for joining us today. We’re really excited about what we’ve been able to share with you today. And we’re going to work hard to ensure that we get this very valuable treatment out to physicians and their patients and that we really help work with our policymakers in Washington D.C. to understand how important it is that cancer patients have access to treatment during this difficult time and what a great treatment brachytherapy is during this time as well.

Thank you for your time today and have a great evening.

Operator

Ladies and gentlemen, that will conclude today’s conference. We thank you for your participation. You may disconnect at this time and have a great day.

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