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Edited Transcript of ISR earnings conference call or presentation 24-Sep-19 8:30pm GMT

Q4 2019 IsoRay Inc Earnings Call

RICHLAND Sep 30, 2019 (Thomson StreetEvents) -- Edited Transcript of IsoRay Inc earnings conference call or presentation Tuesday, September 24, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jonathan R. Hunt

IsoRay, Inc. - Co-Principal Financial Officer

* Lori A. Holmes-Woods

IsoRay, Inc. - CEO & Director

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Conference Call Participants

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* Edward Moon Woo

Ascendiant Capital Markets LLC, Research Division - Director of Research and Senior Research Analyst of Internet & Digital Media

* Jason Howard Kolbert

Dawson James Securities, Inc., Research Division - Director of Research

* Swayampakula Ramakanth

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Mark Levin

Global Ir Group - Senior MD

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Presentation

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Operator [1]

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Good day, ladies and gentlemen, and welcome to the IsoRay Fourth Quarter Fiscal 2019 Conference Call. (Operator Instructions)

At this time, it is my pleasure to turn the floor over to your host, Mark Levin. Sir, the floor is yours.

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Mark Levin, Global Ir Group - Senior MD [2]

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Thank you, operator. Good afternoon and thank you for joining us today for the IsoRay fiscal fourth quarter and full year-end 2019 earnings call for the quarter and year ended June 30, 2019. 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 assumptions made by and 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, September 24, 2019. 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 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 fourth quarter and fiscal 2019 full year 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 Woods.

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [3]

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Thank you, Mark. Good afternoon, and thank you for joining us today for IsoRay's fiscal fourth quarter and full year 2019 earnings conference call for the quarter ended June 30, 2019. My comments today will include highlights from the fourth quarter and the full year financial results. Following my comments, you will hear from our Chief Financial Officer, Jonathan Hunt, who will provide a more detailed review of the fiscal fourth quarter and full year 2019 financial results.

Our fiscal year 2019 and fiscal fourth quarter 2019 can be summed up in one word, progress. This growth is attributable to our strong core business and the products that support that business. Revenue for the fourth quarter increased 20% over the year ago quarter. Once again, the key driver of growth this quarter was IsoRay's core prostate brachytherapy revenue.

Prostate brachytherapy revenue increased 24% versus the fiscal fourth quarter of 2018. We attribute this growth to the continued positive response to our sales and marketing strategies as well as the introduction of Blu Build delivery system that began its rollout in our fiscal second quarter. These efforts have contributed to increased sales penetration with our existing customers and the addition of new customers.

Fiscal year 2019 was a year of great progress for IsoRay as we continue to take share of the total prostate brachytherapy market. Total revenue increased 23% for the full fiscal year. Gross profit increased 65%, with the gross margin expanding by over 10 percentage points to a record 41.7%. When combined with a 3% decrease in total operating expenses, our net loss declined 23%. Although we have moved each of these key metrics in their respective right directions, we know we have much more to do.

One of the highlights of fiscal 2019 was the introduction of Blu Build. It is the first internally developed proprietary delivery device product in the company's history. We remain very excited about the opportunity that our proprietary Blu Build loader presents for IsoRay to further increase our market share in the prostate brachytherapy market.

We launched Blu Build in a limited capacity in our fiscal second quarter, which ended December 31, 2018. We intentionally limited the release to just a handful of physicians. We did this to gain invaluable feedback that has served us well. It has allowed us to incorporate some minor but key tweaks and adjustments to the product. As has been the case for much of the year, physician interest in general buzz around Blu Build at last week's ASTRO Conference in Chicago was substantial. Now that Blu Build is coming up to full commercial availability, we expect that it will be a more meaningful contributor to our core prostate brachytherapy business in the third and fourth fiscal quarters of 2020. That time line takes into account the time necessary to set up new accounts and all that goes into the process of working with new clients who have not used Cesium-131 before.

Another important development was the subject of the press release we distributed last week. The results of the study of the 10-year data on the impact of Cesium-131 in treating prostate cancer represents an important milestone. The study results published in the journal, Brachytherapy, are drawing attention due to its positive findings. Since effective prostate follow-up requires 10-year results, we feel we have effectively joined other more mature therapies that have reached this landmark. We believe that this data will have a positive impact on the expanded adoption of Cesium-131 brachytherapy. We are also building on our efforts to support the growing surgical applications of Cesium-131.

To that end, we recently submitted an application for an ICD-10 PCS billing code to the Centers of Medicare & Medicaid Services, CMS, for the intraoperative use of Cesium-131. The code will cover a range of a difficult-to-treat cancers, including head and neck, GYN, lung and colorectal cancers. The ICD-10-PCS code is important because it allows hospitals and facilities to bill for specific surgical procedures that would benefit from the addition of Cesium-131.

We believe that with the growing experiences of our customers in treating these difficult cancer tumors with Cesium-131, specific coding pathways will support further consideration of these procedures in a hospital inpatient setting.

There has been another recent reimbursement development that has led to our active involvement with CMS. Recently, CMS proposed a significant change to the way Medicare currently pays for radiation oncology services. As proposed, these changes carry the potential for both positives and negatives. The proposed radiation oncology alternative payment method, RO-APM, would provide for a single bundled payment for a 90-day episode of radiation therapy, including LDR brachytherapy, IMRT, SBRT, proton therapy and HDR brachytherapy. 17 disease sites, including the prostate, are part of the bundle.

On the one hand, we are happy to be included in the bundling and believe that over time this may level the playing field for brachytherapy, given the various radiation treatment options available for patients. On the other hand, we have some concerns. The proposed payment includes brachytherapy sources, which goes against the current congressional mandate. That mandate provides separate payment for these sources. This is a cost-effective reimbursement process that has supported the physician and patient choice for over 15 years. This proposal would create undue pressures on clinicians regarding their treatment choices.

IsoRay has taken an active role in providing comments and in seeking active involvement from professional societies, various companies, congressional members and physicians who have commented in support of IsoRay and brachytherapy. The comment period ended September 16, and we await the final rule later this fall. We believe that in all likelihood, the rule will become effective for part or all of calendar year 2020, depending on when the ruling is released to the public.

Turning to GammaTile and our partners at GT Medical Technologies. We continue to believe in the great potential of GammaTile. We are confident that brachytherapy can offer great benefits to many brain cancer patients, who oftentimes exhaust treatment options. For the full fiscal year 2019, revenues from sales to GT Medical were nominal due to the limited market release.

As their manufacturer and supplier, we remain optimistic about GammaTile's future. We hope that adoption will pick up as evidenced by the recent increase in the number of radioactive material license requests we have received.

During fiscal 2020, we are dedicating resources to the exploration of other revenue-generating opportunities, in addition to our current prostate and surgical offerings as well as our relationship with GT Medical Technologies. Such opportunities would be complementary to our current product portfolio and would build upon company core competencies.

In summary, it is clear to me that our advances are the results of changes we have made on many fronts, including operations, our sales and marketing strategies and our renewed focus on gross margins and navigating the fine line between growth and managing costs. We intend to capitalize on our momentum and continue to evaluate, make course corrections where needed and build on our commitment to achieve continuing success.

Now I will turn the call over to Jonathan to review the results of our fiscal fourth quarter and full year.

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Jonathan R. Hunt, IsoRay, Inc. - Co-Principal Financial Officer [4]

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Thank you, Lori. I'm going to discuss some of the financial information that was contained in our press release for the fiscal fourth quarter and fiscal year ended June 30, 2019, that we released a short while ago. We anticipate that our Form 10-K will be filed with the SEC on or around September 27.

Revenue for the fourth quarter ended June 30, 2019, grew 20% to $1.92 million versus $1.6 million for the same period last year. As Lori mentioned earlier, the primary driver of revenue growth for the quarter was the company's core prostate brachytherapy business, which increased 24% versus the fourth quarter of 2018.

Fourth quarter revenue was comprised of 89% for prostate brachytherapy, with the balance or 11% of revenue attributed to other brachytherapy. Gross profit as a percentage of revenues for the fourth quarter ended June 30, 2019, increased to 45.7% compared to 27.3% for the quarter ended June 30, 2018. The gross margin increase was primarily driven by higher sales as well as decreased isotope unit cost, primarily resulting from the adjustments to our isotope supply chain that we made at the end of calendar year 2018.

Fourth quarter gross profit dollars of $879,000 increased 101% when compared to the same period last year. Total operating expenses, consisting of research and development, sales and marketing and general and administrative, decreased 28% or almost $800,000 to $2.02 million in the quarter versus $2.81 million in the fiscal fourth quarter 2018.

Total R&D expense decreased 40% versus the comparable prior year quarter to $341,000. Collaborative research expenses related to GammaTile Therapy totaled $135,000 in the fiscal fourth quarter of 2018, which preceded the July 2018 FDA 510(K) approval of GammaTile Therapy, and those expenses declined to $0 this quarter. This along with the decline in proprietary research expenses primarily related to declines in R&D expenses for Blu Build, protocol and travel expenses accounted for the majority of the year-on-year decline in total R&D expense in the quarter.

Sales and marketing expenses were $683,000 in the fiscal fourth quarter of 2019 and were flat versus the comparable prior year period. G&A expenses of $1 million represented a decrease of 36% versus $1.56 million in the fiscal fourth quarter of 2018.

Recall that G&A expenses in the fiscal fourth quarter of 2018 included $360,000 attributable to the executive severance agreement of the former CEO and $200,000 of public company-related expenses. IsoRay posted a net loss of $1.1 million for the fourth quarter ended June 30, 2019, compared to a net loss of $2.36 million for the quarter ended June 30, 2018. The net loss per basic and diluted share was $0.02 versus the net loss of $0.04 for the quarter ended June 30, 2018. Basic and diluted share results are based on weighted average shares outstanding of approximately 67.4 million at fiscal year-end 2019 versus 55.5 million for the prior year period.

Turning now to our full year 2019 results. Revenue for the year ended June 30, 2019, increased 23% to a record $7.31 million compared to $5.92 million for the prior year. The company's core prostate brachytherapy revenue increased 27% versus the full year ended June 30, 2018. This included sales of Blu Build, which began in the fiscal second quarter of 2019 but was primarily the result of increased sales to existing customers as well as sales to new customers. Prostate brachytherapy revenue represented 89% of total revenue at fiscal year-end 2019 versus 86% for the prior fiscal year. Gross profit as a percentage of revenues for the full year ended June 30, 2019, was 41.7% versus 31.1% for the full year ended June 30, 2018.

In addition to higher sales, gross margin benefited from the aforementioned decrease in isotope unit cost, primarily resulting from the adjustments to our isotope supply chain we made at the end of calendar year 2018. As Lori said at the beginning of the call, full year gross profit dollars of $3.05 million increased 65% when compared to the fiscal year 2018.

Total operating expenses of $8.3 million for the year ended June 30, 2019, decreased 3% from $8.57 million in fiscal year 2018.

Total R&D expenses decreased 16% to $1.47 million from $1.75 million in fiscal 2018, largely due to the aforementioned year-over-year decline in collaborative research related to GammaTile Therapy. Sales and marketing expenses and general and administrative expenses each increased less than 1% versus the prior year comparable period to $2.68 million and $4.17 million, respectively.

The company had a net loss of $5.14 million for the fiscal year ended June 30, 2019. This compares to a net loss of $6.7 million in fiscal year 2018. The net loss per basic and diluted share was $0.08 versus $0.12 in the prior year period. Basic and diluted share results are based on weighted average shares outstanding of approximately 67.0 million at fiscal year-end 2019 versus 55.2 million for the prior year period.

As of June 30, 2019, the company had cash, cash equivalents and certificates of deposit that totaled $5.33 million compared to $3.43 million at June 30, 2018. The company has $0 long-term debt. Shareholders' equity at the end of fiscal 2019 totaled $7.68 million versus $5.03 million in the prior year comparable period.

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

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Jason Kolbert from Dawson James.

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - Director of Research [2]

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Lori, congratulations on seeing the growth in the prostate cancer market and on the expanding margins. But my real question today, other than the continuing growth there, which is good and it's positive, where did the breakout revenues come from? And can you give us a more detailed update on how you're going to benefit from GammaTile? And how is GammaTile doing in the GBM field?

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [3]

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Jason, thank you for your question. In regards to your questions regarding to GammaTile, GammaTile, in the period that we're reporting on was in a limited release and as such, the revenues we've seen from them are nominal. However, we are excited about the potential they have for the future. We can't give any guidance on it, because we don't have any idea at this point in time what it's going to look like. And outside of that, I don't have a lot in the way of an answer for you on that particular topic. Can you restate your first part of your question so I can answer it as well?

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - Director of Research [4]

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Yes. I was just talking about the fact that there's been nice but incremental growth in prostate cancer. At this rate, how long does it take for you to get to breakeven?

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [5]

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I'm going to turn that call over to Jonathan.

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Jonathan R. Hunt, IsoRay, Inc. - Co-Principal Financial Officer [6]

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So Jason, we have not provided guidance on when that breakeven points will be. We still continue to see growth in the markets we're in, particularly in the core prostate market, and we're excited by that and what we see there.

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Operator [7]

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And our next question comes from Ed Woo from Ascendiant Capital.

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Edward Moon Woo, Ascendiant Capital Markets LLC, Research Division - Director of Research and Senior Research Analyst of Internet & Digital Media [8]

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You mentioned that Blu Build will be increasing revenues in the third and fourth quarter. Is that the third and fourth of fiscal quarter or third and fourth by calendar quarter 2020?

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [9]

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Thank you for that question, Ed. It is the fiscal quarters, third and fourth fiscal quarters. It takes some time to get new centers, to get their radioactive materials license amended and get them set up to use Cesium. So it will take some time. As it did when we originally got started with prostate, it took a while to get those new customers on board with all the different things you have to do to get them set up. So that gives you some color on why we're saying third and fourth quarter for fiscal 2020.

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Edward Moon Woo, Ascendiant Capital Markets LLC, Research Division - Director of Research and Senior Research Analyst of Internet & Digital Media [10]

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Well, do you have to spend some -- and money to invest to ramp this up? Or has that pretty much been all done and spent during your development?

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [11]

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There may be some additional cost. But we feel like we've, to date, spent most of the money that's going to be required to get this up and running in the development process.

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Edward Moon Woo, Ascendiant Capital Markets LLC, Research Division - Director of Research and Senior Research Analyst of Internet & Digital Media [12]

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Great. And then my other question is going back to the gross margin improvement. You mentioned that it was due to the supplier change. Are you guys pretty much at a relatively stable gross margin rate or will you see continued improvement going forward?

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Jonathan R. Hunt, IsoRay, Inc. - Co-Principal Financial Officer [13]

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So yes, we feel like the gross margin that we're not quite at our potential yet, that as sales continue to rise that we'll be able to continue to increase that margin as well. It's just becoming more efficient in some of our operations.

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Operator [14]

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And our next question comes from Mr. Ramakanth from H.C. Wainwright.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [15]

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You stated that at ASTRO, the last week's ASTRO conference, Blu Build was well received. Could you elaborate what you mean by that? And also, how do you see that impacting sales and growth of your franchise in 2020 and beyond 2020 as well?

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [16]

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Absolutely. So at ASTRO last week, we had quite a few people come by who had actually heard about Blu Build. But they came by specifically to play with it, touch it, feel it, see how it works, work it themselves with some of the demonstration models we have there and to talk to their sales representative about opportunities for their centers and Blu Build. So that continues to build on our sales force talking about this, the couple of centers we have during the limited market release for us. And we're really happy to see all that continued interest. We have, I think, reported in the past that we feel that about 25% of the prostate brachytherapy market, we don't have access to because we didn't have a loader like this. So we feel like, and I think it's been backed up by the interest that we're seeing, that we will have access to that 25% of the market that we previously haven't had access to. So that gives us quite some good places to go in the coming years.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [17]

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Thank you for that. And I know you got couple of questions on GammaTile already. But in general, in the short commercial life of GammaTile so far, what are you hearing from your partners on -- from your partners in GT Medical about this and in terms of acceptance? And also you were talking about -- that you are seeing more centers trying to get the license for radioactive -- for the use of radioactive material. How good of a correlation is that, the growth that you have seen in the past that you would expect in the future?

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [18]

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So to address the first part of your question, I think -- and if you go to some of the publicly released statements from hospitals who have used GammaTile, there has been a lot of excitement from the centers that have used it. We continue to hear real positive things from GT Medical Technologies about the future and how they view the acceptance of this product going forward.

Can you please restate the second part of your question?

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [19]

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I'm just trying to understand how -- what is the correlation that you are seeing, because you said there was increased number of licenses for facilities to use radioactive material. How does that correlate with your sales that you had seen in the past, that you would expect something like that to happen again, that -- in the future with GammaTile?

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [20]

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Absolutely. So it's a key step in getting a center to be able to use Cesium-131. And in the past, in our prostate business, in our surgical applications, it's been one of the most crucial steps in moving forward. So seeing the increased requests from centers is exciting to us. There is not real good time lines that you can tie to it. And looking back over our prostate business, I can't tell you that somebody got a materials license amended within a month ordered. That's just not the process. There is so many other steps involved in hospital administration and multiple specialties to get through. But seeing that, that volume is increasing is definitely supportive of the interest in GammaTile, and we're excited to see it.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [21]

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And my last question is, you also stated that in the last year, there were quite a few changes within your sales strategy. So what are the learnings from that? And what additional changes do you think you need to be doing so that you can optimize the Cesium product that you have currently in the market?

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [22]

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So some of the things we looked at really closely this last year was doing some more training for prostate brachytherapy. There's been a real lull in the market as there have been other competing modalities out there that were -- that had significant reimbursement. And one of the things that we've identified and are continuing to work through this year is how do we get more physicians interested in doing brachytherapy, and how do they get trained to do it in the best manner possible.

So I think if you go back to one of our press releases, we talked about some training we're doing. We're really excited about that, and we're seeing that we're getting some interest from physicians to get trained in learning how to do brachytherapy and how to do it with Cesium-131 specifically. And that's going to be really important to have more doctors trained as doctors retire. And a lot of the doctors who've been doing prostate brachytherapy for a long time will retire in the next few years, and it will be nice to have a group of people coming up who know how to do the procedure and who can support the procedure.

I think the other thing that we've been really looking at this year is reengaging with the urology community. They are really many times the referral for prostate brachytherapy case, and they are also a competitor in some ways because they do radical prostatectomy. So really engaging them and making sure they understand the appropriateness of brachytherapy for some of these prostate cancer patients has been important. And keeping them involved in prostate brachytherapy, I think, is going to be helpful for us in the long run as well.

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Operator [23]

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(Operator Instructions) And our next question -- they just bounced out of the queue. (Operator Instructions)

At this time, we have no further questions. I'd like to turn the call back to management. Thank you.

Actually, 2 questions -- 2 people just popped in. One second. No, sorry. Again, ladies and gentlemen, thank you. I will now turn the call back to management.

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [24]

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Thank you very much, everyone, for joining us today. We appreciate it. Have a great rest of your day. Bye-bye.

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Operator [25]

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Thank you. This does conclude today's conference. We thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.