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spk05: Greetings, and welcome to ISRA Inc's Q3 Fiscal Year 2021 call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mark Levin of Investor Relations.
spk02: Thank you, operator. Good afternoon, and thank you for joining us today for the ISRA Fiscal Third Quarter 2021 Earnings Call for the quarter ended March 31st, 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 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 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, ISRA's Chief Executive Officer, and then Jonathan Hunt, ISRA'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.
spk01: Thank you, Mark. Good afternoon and thank you for joining us today for ISRA'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 the Fiscal Third Quarter financial results. I am pleased to share with you the progress we have experienced in our Fiscal Third Quarter As we look with increasing confidence to the future opportunities for growth at Issa Rae, 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 am encouraged by the 7% sequential growth we experienced in our core business, as well as our growing strength in adoptions 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 checkups, 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 many 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 Blue Build, 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 were 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 ISARAY's abilities to capitalize on significant growth opportunities. We believe that ISARAY'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 investments, particularly in sales and marketing. The goal here is to foster increasing brand awareness and product adoptions. It will also allow us to capitalize on the steps we have taken to build ISRA'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 Fort 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 this with an emphasis on radioactive isotopes and monoclonal antibody technologies. Donna has had a pivotal role in launching numerous, complex, multidisciplinary 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 ISARAY's strategic vision for growing new markets. Donna joins us at a pivotal time to take advantage of our expectation that projected prostate brachytherapy market growth will be fueled by some key developments we have shared with you. With the implementation of the previously discussed Future Reimbursement Changes, or ROAPM, along with the anticipated increased prostate cancer diagnosis as we emerge from the pandemic, we see positives for ISRA's market position. Beyond our core prostate market, we are pleased to see a growing use of cesium-131 for the treatment of brain cancers. As we continue to look at the treatment of other cancers, we expect to increase investments in growing surgical applications where we believe there is 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 targeted therapies. As we have discussed, we have two immuno-oncology studies which are just getting underway. Those include the recurrent head and neck cancer trial with Keytruda, The other is the metastatic melanoma trial with Optivo. 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 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 developments. 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 in the development and implementation of cesium-131 seeds for prostate cancer is yet 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 ISARAY for the evolving cancer treatment marketplace. As you can see, these remain exciting times for ISARAY. 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.
spk06: Thank you, Laurie. I'm going to discuss some of the financial information that was contained in our press release for the fiscal third quarter and in March 31st, 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 31st, 2021 decreased 10% to $2.6 million versus the record $2.88 million for the same period last year. As Laurie mentioned earlier, total revenue increased 10% sequentially. from the fiscal second quarter ended December 31st, 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% of revenue 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 cells to treat brain and lung cancers. Gross profit as a percentage of revenues for the third quarter ended March 31st, 2021 was 52.4% compared to 59.2% for the quarter ended March 31st, 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 Blue Build 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. ISRA'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 one cent versus the net loss of one cent for the quarter ended March 31, 2020. Basic and diluted share results are based on weighted average shares outstanding of approximately $122.6 million at 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 46 cents per share, compared to $2.39 million at the end of fiscal year 2020 and 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.
spk05: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate that your line is in the queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question is from Frank Takinen with Lake Street Capital Markets. Please proceed.
spk04: Hey, thanks for taking my questions. Congrats on the return to sequential growth in the quarter. Wanted to start with your primary prostate brachy 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.
spk01: So, we don't give guidance on specific numbers per se, but I would love Frank to address kind of what we're seeing in the marketplace and what's starting to happen and how excited we are about what we view is kind of 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. And 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 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. So we feel like that gives a lot of credibility to what we're seeing.
spk04: Got it. That's helpful. Wanted to move over to the 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 you feel that can trend over time.
spk01: Yeah, absolutely. So in brain brachytherapy, surprisingly, we've seen kind of the same kind of problem to some degree that we've seen with prostate. And that is, I think, 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 definitely as we report here today. And what we're expecting is to see that number continue to grow. There have been a lot of initiatives started with GT medical technologies that we've 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 they and us have been able to get back in front of neurosurgeons and radiation oncologists, again, where we haven't for the last few quarters had that same flexibility. And being able to talk to these physicians and help them understand the benefits of cesium-131 for brain and all of that is really coming back And you're seeing that in the numbers. And we expect that to grow and to continue because we have both, as we reported before, GT Medical Technologies has expanded their approval for treatment and now they can treat any metastatic cancer in the brain. And so that allows a broader group of patients to be selected for this particular procedure.
spk04: we see this this area continuing to grow and we expect to see some upticks in the upcoming quarters on this definitely 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 the head and neck area with keytruda as well as in the melanoma area with aptivo
spk01: Absolutely. So milestones would really be reflective of patients starting to accrue for the trials. And then you look at going out. And unlike our prostate data where we had to go at 10 years, we are expecting this to be a lot faster accrual. 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.
spk04: Perfect. Thanks for taking my questions.
spk07: Thanks, Frank.
spk05: Thank you. Our next question is from Mike Ott with Oppenheimer. Please proceed.
spk03: Good afternoon. Thanks for taking my questions and congrats on a nice quarter, Laurie and Jonathan. Thanks, Mike. On Blue Build, which is obviously unique to you guys, you mentioned that, you know, hospital access is improving. Have you seen any new customers, you know, evaluate or start using Blue Build, or are they all still fairly preoccupied with COVID?
spk01: 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. So, if you categorize them as in the evaluation process, we have several and an increasing number of people in that process. In terms of actually having them using the product, I think COVID has slowed us down, certainly in this area, and I think we'll start seeing as we come out of COVID and they start seeing more patients filling up. coming into their offices and getting scheduled brachytherapy, we'll start seeing them then move from that evaluation process into using the product.
spk03: That's great to hear. Okay. And then shifting gears on the C4 MRI marker that was cleared back in January, I wonder if you could just update us on, you know, any traction with KOLs and also your own internal validation work. Are you still targeting, I believe it's fiscal 22 for the full launch of that C4?
spk01: Yes, so we are definitely still targeting that timeline. We have been proceeding with our internal evaluations. 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, make sure that we're ready for our full market launch. So I would say that all the things that we had put in place that we needed to accomplish and the milestones for this are moving along just fine, and we're on our timeline on that to be able to release this product a little later this year.
spk03: Excellent. And finally, back in March, you signed a new purchasing agreement with JSC Isotope. Despite COVID tapering off in the U.S. anyway, we seem to be reading more about supply chain disruptions. Just curious how your supply chain is doing these days.
spk01: That's a great question. Our supply chain has been very solid for us throughout this entire epidemic and that really speaks to how well that the group over in Russia has managed what's happening in their particular facilities. We have not had any issues at all, any I think I've spoken to this before. Our biggest issue was with airlines, and that was easy to overcome by switching to different plans that we already had in place. So from an on-the-ground perspective in Russia and getting our isotope, we're not expecting any issues there, nor are we expecting any issues in getting the isotope here to us in the U.S., and that has been backed up by this last year of not having any issues at all.
spk03: Excellent. That's all for me. Thanks, Laurie.
spk07: Thanks so much, Mike.
spk08: Thank you. Are there any more questions?
spk05: Okay. If there are any more questions, then this will end the question and answer session, and I would like to turn the call back to Lori Woods for closing remarks.
spk01: Thank you, everyone, for joining us this afternoon. We appreciate your time and attention. Have a great afternoon. Bye-bye.
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