Earnings Call Transcript - CATX Q3 2021

Operator, Operator

Greetings, welcome to the IsoRay Inc.'s Q3 Fiscal Year 2021 Call. 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. I'd now like to turn the conference over to Mark Levin of Investor Relations.

Mark Levin, Head of Investor Relations

Thank you, Operator. Good afternoon, and thank you for joining us today for IsoRay's fiscal third quarter 2021 earnings call for the quarter ended March 31, 2021. 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 other 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, May 13, 2021. As with any projection or forecast, they are inherently susceptible to uncertainty and changes in circumstance, 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 2021 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.

Lori Woods, Chief Executive Officer (CEO)

Thank you, Mark. Good afternoon, and thank you for joining us today for IsoRay's fiscal third quarter 2021 earnings conference call for the quarter ended March 31, 2021. Following my prepared remarks, our Chief Financial Officer, Jonathan Hunt, will provide a more detailed review of fiscal third quarter financial results. I am pleased to share with you the progress we've experienced in our fiscal third quarter as we look with increasing confidence to the future opportunities for growth at IsoRay. Fiscal third quarter revenue only decreased 10% from the record quarter a year ago, but increased 10% sequentially to $2.6 million. This was the best quarter revenue total since the onset of the pandemic. Although our prostate revenue declined from the record quarter a year ago, I have been encouraged by the 7% sequential growth we experienced in our core business, as well as our growing strength in adoption for the treatment of other hard-to-treat cancers. The sequential uptick in prostate brachytherapy revenue in our fiscal third quarter reinforces our belief that there is a significant backlog of patients who will be seeking treatment as a result of the many men who have delayed annual check-ups, screenings, and prostate cancer treatments during the pandemic. We expect continued gradual growth in our core prostate business as these patients come through the screening and treatment process at an increasing rate. We are also experiencing greater access to hospitals and physicians than we have had at any other time since COVID started last year. At the same time, we believe the mini strategic initiatives we have added over the past couple of years should drive continued share gains in prostate as the expected post-pandemic market rebounds. Initiatives, including product introductions such as BluBuild, our partnership with C4 Imaging, and our active support of physician training programs are expected to serve us well in that regard. Our non-prostate brachytherapy business, which encompasses surgical applications for other cancers like brain, head and neck, and lung, continued to grow and is increasingly a more meaningful part of our total revenue. Again in fiscal third quarter, non-prostate revenue increased 20% versus the prior year quarter and 22% sequentially to a record of $567,000. Once again, the majority of non-prostate revenue was from brain cancer treatments. Through the completed capital raise during the quarter and the subsequent strengthening of our balance sheet, we have greatly enhanced IsoRay's abilities to capitalize on significant growth opportunities. We believe that IsoRay's enhanced capital position will allow us to make important strategic moves over time. First, expect us to continue to focus on investing in our core prostate market with additional investment, particularly in sales and marketing. The goal here is to foster increasing brand awareness and product adoption. It will also allow us to capitalize on the steps we have taken to build IsoRay's leadership position over the past few years. Reflecting on this focus on our sales and marketing team, it's the recent addition of Donna Ford as Vice President of Sales and Marketing. We believe Donna's extensive background in establishing and leading successful sales organizations within our industry uniquely positions her to lead our sales and marketing efforts. You may remember in our recent announcement that her experience spans both biotechnology and medical device companies, all with an emphasis on radioactive isotopes and monoclonal antibody technologies. Donna has had a pivotal role in launching numerous complex, multi-disciplinary products, including three radioactive isotopes for cancer. Further, we feel confident that Donna's valuable experience in combination therapy with oncologic agents, including immunotherapy, will be particularly beneficial to IsoRay's strategic vision for growing new markets. Donna joins us at a pivotal time to take advantage of our expectations that projected prostate brachytherapy growth will be fueled by some key developments we have shared with you, including the implementation of the previously discussed future reimbursement changes, or RO-APM, along with the anticipated increased prostate cancer diagnosis as we emerge from the pandemic. As we look beyond our core prostate market, we see positives for IsoRay's market position. We are pleased to see a growing use of Cesium-131 for the treatment of brain cancers. As we continue to evaluate treatment of other cancers, we expect to increase investments in growing surgical applications where we believe there's similar promise. We are evaluating delivery technologies as well as further clinical studies to support the future growth of Cesium-131 treatments in these other cancers. As we have shared with you before, much like brain cancer patients and the doctors who treat them often run out of solutions to address aggressive cancers like lung and head and neck, we will also be increasing investments in research and development, particularly in the development of more clinical trials, which are essential given the weight of the data such trials yield. This is important not only for Cesium-131 as a standalone radiation therapy, but increasingly in combination with immuno-oncology and targeted therapies. As we have discussed, we have two immuno-oncology studies that are just getting underway. Those include the recurrent head and neck cancer trial with KEYTRUDA and the metastatic melanoma trial with Opdivo. Future investments in similar combination therapies for the treatment of other cancers will be critical to our position in the evolution of leading-edge cancer treatment options. The final area of investment focus we envision at this time will be for incremental opportunities to potentially broaden our portfolio of targeted radiation treatment therapies. This may come in the form of new delivery devices and technologies that could complement Cesium-131, or potentially by looking at other radioisotopes whose qualities may be valuable and best suited for treating various other cancers. We are evaluating such strategic products, which could come via acquisitions, partnerships, or internal development. It was with these growth opportunities and the execution of our strategic plans in mind that we hired Lisa Lauer, whom we recently announced as Vice President of Business Development. Lisa's accomplishments speak to her proven track record in commercial execution, market access, reimbursement, and strategic portfolio development and management. We also believe Lisa's direct responsibility over a broad endoscopic device portfolio that was focused on the diagnosis and treatment of malignant and benign lung disease lends itself well to a key area of focus in expanding market adoption for Cesium-131. In addition, her previous experience at IsoRay and the development and implementation of Cesium-131 seeds for prostate cancer is another value add. As we also remain focused on expanding our market share in our core prostate business, leveraging these strengths will be instrumental in the evaluation and development of go-to-market strategies to position IsoRay for the evolving cancer treatment marketplace. As you can see, these remain exciting times at IsoRay. Despite the pandemic, we are more optimistic than ever before about our future path and the success of our efforts. We remain focused on executing our strategic plans for continued growth. We believe our efforts will have long-lasting benefits to cancer patients and the doctors who treat them. Now I will turn the call over to Jonathan to review the results of our fiscal third quarter in more detail.

Jonathan Hunt, Chief Financial Officer (CFO)

Thank you, Lori. I'm going to discuss some of the financial information that was contained in our press release for the fiscal third quarter ended March 31, 2021 that we released a short while ago. We anticipate that our Form 10-Q will be filed with the SEC on or around May 17th. Revenue for the third quarter ended March 31, 2021 decreased 10% to $2.6 million versus the record $2.88 million for the same period last year. As Lori mentioned earlier, total revenue increased 10% sequentially from the fiscal second quarter ended December 31, 2020. Prostate brachytherapy revenue declined 16% versus the third quarter of fiscal 2020 as procedure volumes continued to be impacted by COVID-19. Third quarter revenue was comprised of 78% for prostate brachytherapy with the balance, or 22%, attributed to other brachytherapy. Other brachytherapy revenue increased 20% versus the third quarter of fiscal 2020. The majority of other revenue in the quarter was comprised of Cesium-131 to treat brain and lung cancers. Gross profit as a percentage of revenues for the third quarter ended March 31, 2021 was 52.4% compared to 59.2% for the quarter ended March 31, 2020, driven by the year-over-year revenue decline. Third quarter gross profit dollars of $1.36 million decreased 20% when compared to the same period last year. Total operating expenses, consisting of research and development, sales and marketing, and general and administrative, totaled $2.13 million, representing a 6% decrease versus the third quarter of 2020. Total R&D expense increased 23% versus the comparable prior year quarter to $362,000. The increase in total research and development expenses was primarily the result of increased payroll, benefits, and share-based compensation from greater headcount and increased protocol expenses, which were partially offset by a reduction of development expenses for the BluBuild delivery system versus the comparable prior year period. Sales and marketing expenses decreased 28% versus the comparable prior year quarter to $581,000. The decrease in sales and marketing expenses was driven primarily by declines in travel and trade show costs due to COVID-19 limitations, as well as decreased incentive compensation resulting from lower revenue growth compared to the prior year comparable period. G&A expenses of $1.18 million represented an increase of 2% versus the fiscal third quarter 2020. The year-over-year increase was primarily the result of increased director and officer insurance expense, increased payroll due to merit increases, IT consulting expenses, and bad debt expense, but was partially offset by decreased travel costs due to COVID-19 restrictions as well as decreased employee hiring costs and legal fees. IsoRay's net loss for the third quarter ended March 31, 2021 was $745,000 compared to a net loss of $545,000 for the quarter ended March 31, 2020. The net loss per basic and diluted share was $0.01 versus a net loss of $0.01 for the quarter ended March 31, 2020. Basic and diluted share results are based on weighted average shares outstanding of approximately 122.6 million in the fiscal third quarter 2021 versus 67.6 million for the prior year period. As of March 31, 2021, the company had cash, cash equivalents, and certificates of deposit that totaled $64.8 million, or approximately $0.46 per share, compared to $2.39 million at the end of fiscal year 2020 as of June 30, 2020. The company has zero long-term debt. Shareholders' equity at the end of the fiscal third quarter 2021 totaled $68.1 million versus $5.7 million at the end of fiscal year 2020. I will now turn the call over to the operator to take questions from our analysts and institutional investors.

Operator, Operator

Thank you. We will now be conducting a question-and-answer session. Our first question is from Frank Takkinen with Lake Street Capital Markets. Please proceed.

Frank Takkinen, Analyst - Lake Street Capital Markets

Hey, thanks for taking my questions. Congrats on the return to sequential growth and growth in the quarter. I wanted to start with your primary prostate brachytherapy market. First, I was hoping that you could share some monthly procedural information with us as it trended over fiscal Q3. And if you could maybe give us an early taste into how those procedural volumes have been trending in the early part of fiscal Q4?

Lori Woods, Chief Executive Officer (CEO)

So we don't give guidance on specific numbers per se, but I would love, Frank, to address what we're seeing in the marketplace and what's starting to happen and how excited we are about what we view as coming out of the pandemic and starting to move forward. We've had a lot of access to hospitals and the physicians that we haven't had since the pandemic started. We hear from our physicians that they're seeing an increased number of patients coming through the system. It's not an immediate sort of thing that happens—the patient has to work through a couple of different physicians before they get to actually a brachytherapy procedure—but they're starting to see that those channels are filling up with patients who've gotten in, who've gotten diagnosed, and are moving through. So we're very excited to see that, and we are excited to see that our numbers are starting to reflect that as well. We feel like that gives a lot of credibility to what we're seeing.

Frank Takkinen, Analyst - Lake Street Capital Markets

Got it. That's helpful. Why don't I move over to the non-prostate or non-prostate brachytherapy revenues, particularly brain, as this continues to perform well. I was hoping you could just take a moment to kind of give us a broader overview of the brain cancer market specific to brachytherapy and how you feel you're positioned and how that can trend over time?

Lori Woods, Chief Executive Officer (CEO)

Yeah, absolutely. So in brain brachytherapy, surprisingly, we've seen in some degree the same kind of problem that we've seen with prostate, and that is most likely because patients haven't gotten diagnosed to begin with or aren't getting into the system. So surprisingly, we saw early on in the pandemic that those numbers were a little bit flat, but now we're seeing a return to growth in those numbers, which you're seeing in our report today. What we're expecting is to see that number continue to grow. There have been a lot of initiatives started with GT Medical that we reported previously about clinical trials and those kinds of things where they are going to be having centers that are enrolling patients. I think we're starting to see some of that. I think we're also starting to see that both GT Medical and us have been able to get back in front of neurosurgeons and radiation oncologists again, which we haven't for the last few quarters had that same flexibility to do. Being able to talk to these physicians and help them understand the benefits of Cesium-131 for brain treatment is really coming back, and you're seeing that in the numbers. We expect that to continue to grow because, as we reported before, GT Medical Technologies has expanded their approval for treatment, and now they can treat any metastatic cancer in the brain. That allows a broader group of patients to be selected for this particular procedure. So we see this area continuing to grow and we expect to see upticks in the upcoming quarters.

Frank Takkinen, Analyst - Lake Street Capital Markets

Perfect. And then just last one for me: I was hoping you could remind us of some timelines around potential milestones associated with your studies underway in that head and neck area with KEYTRUDA, as well as in the melanoma area with Opdivo.

Lori Woods, Chief Executive Officer (CEO)

Absolutely. Milestones would really be reflective of patients starting to accrue for the trials. Unlike our prostate data, where we had to go out 10 years, we are expecting these to be a lot faster. So getting out a year, 18 months, 24 months, we would expect that these centers would be wanting to talk about what's happening with the data sets and the patients involved in these clinical trials.

Frank Takkinen, Analyst - Lake Street Capital Markets

Perfect. Thanks for taking my questions.

Operator, Operator

Thank you. Our next question is from Mike Ott with Oppenheimer. Please proceed.

Mike Ott, Analyst - Oppenheimer

Good afternoon. Thanks for taking my questions and congrats on a nice quarter. Lori and Jonathan, I'm doing three questions which are obviously unique to you guys. You mentioned that hospital access is improving. Have you seen any new customers evaluate or start using BluBuild? Or are they all still fairly preoccupied with COVID? You mentioned that most physicians are staying with types of procedures they're familiar with. If you could expand on evaluation versus actual usage, that would be helpful. Second, shifting to the C4 MRI marker that was cleared back in January: I wonder if you could update us on any traction with KLS and also on your own internal validation work. Are you still targeting fiscal 2022 for the full launch? And finally, back in March you signed a new purchasing agreement with JFC Isotope. Despite COVID tapering off in the U.S., we seem to be reading more about supply chain disruptions. Just curious how your supply chain is doing these days?

Lori Woods, Chief Executive Officer (CEO)

You know, they tend to be fairly preoccupied with COVID, and what we've noticed during this period of time is that a lot of the physicians are staying with the types of procedures that they're familiar with. If you categorize them as in the evaluation process, we have several and an increasing number of people in that category, but in terms of actually having them using the product, COVID has certainly slowed us down in this area. I think we'll start seeing, as we come out of COVID and they start seeing more patients coming into their offices and getting scheduled for brachytherapy, that we'll start seeing them move from evaluation into actual use of the product. Regarding the C4 MRI marker, yes, we are still targeting that timeline for a full launch. We have been proceeding with our internal evaluations and I think we're very close to being finished. We have engaged with KOLs and MD Anderson in particular to do some evaluation for us to make sure that we're ready for our full market launch. All the things that we had put in place and the milestones for this are moving along just fine, and we're on our timeline to be able to release this product later this year. As for the supply chain, that's a great question. Our supply chain has been very solid for us throughout this entire period. That really speaks to how well the group over in Russia has managed what's happening in their particular facilities. We have not had any issues at all. I think the biggest issue early on was with airlines, and that was easy to overcome by switching to different plans that we already had in place. From an on-the-ground perspective in Russia and getting our isotope, we're not expecting any issues, nor are we expecting any issues transporting the isotope here to the U.S., and that has been backed up by this last year of not having any issues at all.

Mike Ott, Analyst - Oppenheimer

Excellent. That does it for me. Thanks. Sorry.

Operator, Operator

Thank you. Are there any more questions? If there are no more questions, this will end the question-and-answer session, and I would like to turn the call back to Lori Woods for closing remarks.

Lori Woods, Chief Executive Officer (CEO)

Thank you, everyone, for joining us this afternoon. We appreciate your time and attention. Have a great day.