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Edited Transcript of ISR earnings conference call or presentation 12-Nov-19 9:30pm GMT

Q1 2020 IsoRay Inc Earnings Call

RICHLAND Dec 4, 2019 (Thomson StreetEvents) -- Edited Transcript of IsoRay Inc earnings conference call or presentation Tuesday, November 12, 2019 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jonathan R. Hunt

IsoRay, Inc. - CFO & 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

* Yu He

H.C. Wainwright & Co, LLC, Research Division - 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 your IsoRay First Quarter Fiscal 2020 Call. (Operator Instructions)

At this time, it is my pleasure to turn the floor over to Mark Levin, Investor Relations. 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 first quarter 2020 earnings conference call for the quarter ended September 30, 2019. 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. 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 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, November 12, 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 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 first 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 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 first quarter 2020 earnings conference call for the quarter ended September 30, 2019. Following my remarks, our Chief Financial Officer, Jonathan Hunt, will provide a more detailed review of fiscal first quarter financial results.

These are exciting times for IsoRay. I am very pleased to share with you the continued progress we have made and the accelerated growth we have achieved as we begin fiscal 2020. Revenue for the first quarter increased 48% versus the year ago quarter. This speaks to impressive sales growth. We also saw continued substantial operational improvements in the first quarter, as evidenced by these notable achievements. We attained another record gross margin of 53.4%. We continue to demonstrate gains in shrinking our operating losses. They were reduced by 45% when compared to the fiscal first quarter of 2019. The numbers tell the story, and it is clear that we have made significant progress over the last 12 months.

Once again, the driver of revenue growth this quarter was our core prostate brachytherapy business. It increased 51% versus the fiscal first quarter of 2019. This also represents an increase of 20% sequentially versus the fourth quarter of fiscal 2019. Total company revenue also increased 20% sequentially.

Our sequential sales growth reverses the trend of sales numbers that have been flat to down sequentially from the fiscal fourth to first quarters in past years. This speaks to the momentum we are realizing from the strategic direction and changes we have implemented to chart a new course for IsoRay. Clearly, the strategies we've employed and the steps we have taken to establish IsoRay's leadership role in the prostate brachytherapy industry over the past year are resulting in accelerated organic growth and market share gains.

One initiative that we have undertaken that has had an impact and has yielded incremental revenue for IsoRay has been our brachytherapy training collaboration with Texas Oncology. You may recall our comments when we launched the program in April. We noted that the mission of the collaboration was to develop a program to train the next generation of brachy therapists on how to use Cesium-131. The effort was designed to meet a few strategic objectives. It was aimed at building on our leadership role in prostate brachytherapy, expanding brand awareness and generating potential new revenues.

This education and training program has already yielded incremental customer wins for IsoRay. It has led to expanded adoption of Cesium-131 by more brachy therapists in search of what we believe is the best treatment option available. It is clear that IsoRay's leadership role in training the next generation of prostate brachy therapists is working to grow our share of the market. This is evidenced not only by the accelerated growth this quarter, but by the continued growth in our customer base over the past year.

To put this in context, over the trailing 12 months our net new physician customer count increased 26% versus the previous 12-month period. We have and will continue to do similar ventures in training and education to drive broader adoption. We recently took part in the ABS annual prostate brachytherapy workshop in Denver. This, too, realized more than one objective. The continued education of more physicians on brachytherapy gives us brand awareness. It also allowed us to present the benefits of Cesium-131 versus the other isotopes. In addition, it served to give us a forum for firsthand demonstrations with Blu Build for real-time prostate brachytherapy delivery. We were very pleased to play such a prominent role at the event that had great attendance with more than 100 brachy therapists participating.

I underscore the numbers and attendance at this workshop because in recent years, events like this have drawn few attendees. There was little interest and engagement. This ABS attendance numbers represents a 10-year high. We are also very pleased by the high level of engagement. There was a real focus on understanding brachytherapy and enthusiasm on the part of the attendees. In fact, our team had the opportunity to demonstrate Blu Build to every attendee. In addition, we saw the participation of senior respected physicians as another valuable development. This experience reinforces what we have been saying about the growing interest in the field.

As we did with these training forums, we will continue to take advantage of opportunities to showcase our proprietary products like Blu Build. Blu Build remains a key part of the strategy to fuel market opportunity. We see Blu Build has a value proposition that will become a more meaningful contributor to our prostate brachytherapy business in the second half of fiscal 2020.

On another front, we have seen movement on our submission to CMS for ICD-10 PCS codes for reimbursement in the inpatient DRG setting. CMS staff have recommended that IsoRay be granted these codes. You may recall that the ICD-10 PCS code is important for the growing surgical applications of Cesium-131 in treating hard-to-treat cancers. The code allows hospitals to bill for specific surgical procedures that would benefit from the addition of Cesium-131. We believe that specific coding pathways will further support considerations of these procedures in a hospital inpatient setting. The company hopes to hear this spring of the formal notification of approval with the new codes taking effect on October 1, 2020.

Turning to GT Medical Technologies. In their most recent update, we understand that they are working with the FDA on an expanded indication for GammaTile to include newly diagnosed brain tumors. We are very interested in how this effort for expanded indication proceeds with the FDA because of its implications for Cesium-131 and IsoRay.

At this time, GT Medical Technologies tells us this indication is under active review by the FDA. Revenues from sales to GT Medical Technologies in the fiscal first quarter continued to be nominal as they introduced the GammaTile centers around the country. As you look at where we have been and where we are today, I believe you will agree that we are on a different trajectory than we were when I started. The focus this team brings and how quickly we are implementing change is supported by measurable results that we believe will continue. We remain focused on our goals of growth and profitability and very excited about the future.

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

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Jonathan R. Hunt, IsoRay, Inc. - CFO & 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 first quarter ended September 30, 2019, that we released a short while ago. We anticipate that our Form 10-Q will be filed with the SEC on or around November 14.

Revenue for the first quarter ended September 30, 2019, grew 48% to $2.315 million versus $1.56 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 51% versus the first quarter of 2019. First quarter revenue was comprised of 90% for prostate brachytherapy with the balance or 10% of revenue attributed to other brachytherapy, primarily sales to treat brain, gynecological, colorectal and other cancers.

Gross profit as a percentage of revenues for the first quarter ended September 30, 2019, increased to a record 53.4% compared to 33.5% for the quarter ended September 30, 2018. The gross margin increase was primarily driven by higher sales and significantly lower isotope unit costs when compared to the prior year comparable period, continued leverage of the fixed cost components within cost of sales and more efficient isotope usage. The lower isotope unit costs are related to our previously discussed change in our supply chain made at the end of calendar year 2018. First quarter gross profit dollars of $1.24 million increased 136% when compared to the same period last year.

Total operating expenses, consisting of research and development, sales and marketing and general and administrative totaled $2.07 million or an increase of 1% compared with the first quarter of 2019 on revenue growth of 48%. Total R&D expense decreased 45% versus the comparable prior year quarter to $233,000. The decrease in total research and development expenses was primarily the result of a mutually agreed termination of a grant agreement, which resulted in a reversal of the accrual as well as the year-over-year decline in collaborative research expenses related to GammaTile Therapy. Going forward, we would expect R&D expense to increase back to or above levels in prior recent quarters. We are currently holding discussions with institutions, looking at the expanded use of Cesium-131.

Sales and marketing expenses increased 26% versus the comparable prior year quarter to $815,000. The increase in sales and marketing expenses was driven primarily by increased headcount and incentive compensation related to the 48% increase in revenue as well as increased travel expenses largely due to a calendar shift of this year's ASTRO conference to September, whereas 2018's conference was in October.

G&A expenses of $1.1 million represented an increase of 13% versus $973,000 in the fiscal first quarter 2019. The year-over-year increase was driven primarily by increased headcount and incentive compensation related to the 48% year-over-year increase in revenue.

Total operating expenses for the first quarter of 2020 included a change in estimate of asset retirement obligation as a result of a lease term extension during the first quarter of fiscal 2020, which decreased total operating expenses by $73,000. Excluding this onetime gain in the change in estimate, operating expenses were $2.15 million or an increase of 5% compared with the first quarter of 2019.

IsoRay posted net loss of $816,000 for the first quarter ended September 30, 2019, a significant improvement compared to a net loss of $1.51 million for the quarter ended September 30, 2018. Excluding the onetime gain and change in estimate of the asset retirement obligation, IsoRay's net loss was $889,000 for the quarter ended September 30, 2019. The net loss per basic and diluted share was $0.01 versus the net loss of $0.02 for the quarter ended September 30, 2018. Basic and diluted share results are based on weighted average shares outstanding of approximately 67.4 million at fiscal first quarter 2020 versus 66.1 million for the prior year period.

As of September 30, 2019, the company had cash, cash equivalents and certificates of deposit that totaled $4.58 million compared to $5.33 million at the end of fiscal 2019 ended June 30, 2019. The company has 0 long-term debt. Shareholders' equity at the end of fiscal first quarter 2020 totaled $6.96 million versus $7.68 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.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And we'll take our first question from Ed Woo with 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 [2]

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Yes, congratulations on the quarter. I had a question, you said that R&D levels will creep up a little bit in the next couple of quarters. What are you going to be investing in?

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

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We really can't comment on that at this point in time, but we are always looking for new ways to partner with folks on the use of Cesium-131. And at this point in time, we can't comment, but we will as soon as we can. And thank you for your...

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Edward Moon Woo, Ascendiant Capital Markets LLC, Research Division - Director of Research and Senior Research Analyst of Internet & Digital Media [4]

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Sure. Then my next question is going on to Blu Build and GammaTile, which one do you think is going to be more incremental in the back half of this fiscal year?

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

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Well, I really can't comment on GammaTile because I'm not privy to what their market strategy is. But we're really excited to what -- about what we think Blu Build can do for us.

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Edward Moon Woo, Ascendiant Capital Markets LLC, Research Division - Director of Research and Senior Research Analyst of Internet & Digital Media [6]

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Great. And then you mentioned the gross margin improvement because you guys changed your supply earlier this year. Will we continue to see incremental improvement going forward? Or has most of the benefit been recognized?

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Jonathan R. Hunt, IsoRay, Inc. - CFO & Co-Principal Financial Officer [7]

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We're actually not providing guidance on that right now at this time. There's just a lot of moving pieces that we're currently dealing with.

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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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Sure. Then just one general question. Have you guys noticed any change in your competition out there? Have you guys really seen any changes by either other competitors or other providers out there?

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

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I can tell you that I really feel like we're taking the leadership role in the industry. We see less and less engagement from some of our competitors. Some of them like Bard have kind of slowed down in their participation in the industry, and we have a great sales team who's well trained and fully engaged. And I really feel like they are helping represent us to potential customers out there and our customers as the industry leader.

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Operator [10]

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And our next question comes from Arthur He with H.C. Wainwright.

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Yu He, H.C. Wainwright & Co, LLC, Research Division - Analyst [11]

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This is Arthur for RK, and congratulations on another strong quarter. So regarding the revenues, I just wonder, you guys had a very strong first quarter growth year-over-year. Should we assuming that's the new run rate for the fiscal year 2020? And what would be the pull and the push for that revenue growth?

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Jonathan R. Hunt, IsoRay, Inc. - CFO & Co-Principal Financial Officer [12]

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Yes. Arthur, thanks for the compliment on the quarter, we appreciate that. Consistent with what we have been doing, we're not providing guidance at this point. There's just so many moving pieces that we're still working through, including with Blu Build and GammaTile that we're just not able to provide guidance on that.

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Yu He, H.C. Wainwright & Co, LLC, Research Division - Analyst [13]

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Understood. No problem. And I just want to -- regarding the Blu Build. So is that already being full launch mode? Or you guys still working on that to prepare the full launch later this year or early next year?

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Lori A. Holmes-Woods, IsoRay, Inc. - CEO & Director [14]

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We've publicly announced that Blu Build was being adopted by 2 facilities, Hollings Cancer Center and AnMed Health, both of who are in South Carolina. And as we get closer to a more commercial launch, we will be in communication with all of you.

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Operator [15]

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(Operator Instructions) And it appears there are no further questions at this time. I'll turn the call back over to Lori Woods for any closing remarks.

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

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Thank you, everyone, for joining us today. I really want to take just a moment to reach out and say, thank you to the entire team at IsoRay. They worked really hard, and I think this quarter really is a testament to the gains we've made, and I'm really excited about what the future looks like. Thanks, everybody, for joining us. Enjoy your afternoon or your evening.

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Operator [17]

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And that does conclude today's teleconference. We appreciate your participation. You may now disconnect your lines, and have a great day.