Iradimed Corp Q2 FY2020 Earnings Call

Welcome to IRadimed Corporation's Second Quarter 2020 Financial Results Conference Call. As a reminder, this call is being recorded today, July 30, 2020, and contains time-sensitive information that is accurate only as of today. Earlier, IRadimed released financial results for the Second Quarter 2020. A copy of this press release announcing the company's earnings is available under the heading News on their website at iradimed.com. A copy of the press release will also be furnished through the Securities and Exchange Commission on Form 8-K and can be found at sec.gov. This call is being broadcast live over the Internet on the company's website at iradimed.com, and a replay of the call will be available on the website for the next 90 days. The agenda for today's call will be as follows: Roger Susi, President and Chief Executive Officer of IRadimed, will present opening comments; then Chris Scott, IRadimed's Chief Financial Officer, will summarize the company's financial results before opening the call up to questions. Some of the information to be furnished in today's session will constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are those focused on the future performance or results, plans and events may include the company's expected results for 2020. IRadimed reminds you that future results may differ materially from these forward-looking statements due to a number of risk factors. For a description of the relevant risks and uncertainties that may affect the company's business, please see the Risk Factors section of the company's most recent reports filed with Securities and Exchange Commission, which again may be obtained for free from the SEC's website at sec.gov. I would now like to turn the call over to Roger Susi, President and Chief Executive Officer of IRadimed Corporation. Mr. Susi?

Thank you, and good morning. I am very pleased and energized to return to the role of Chief Executive. This is not a temporary arrangement, and I look forward to this position for an extended period. Taking a step back for nearly a year allowed me to focus on engineering developments and observe IRadimed's operations from a fresh perspective. I see a future filled with opportunities, and I am excited to help lead us forward. It feels great to be back. Now, let’s review our second quarter. Earlier today, we reported second quarter revenue of $6.8 million, which is a 26.3% decline compared to the same quarter last year. We also reported a loss of $0.17 per share on a GAAP basis, while our non-GAAP net income was $0.05 per diluted share. These results were significantly affected by the COVID-19 pandemic and a one-time charge of about $2.7 million related to the separation of our former CEO. The COVID-19 pandemic has disrupted the normal operations of governments, economies, and healthcare systems worldwide. It is no surprise that our customers are struggling with the various challenges created by COVID-19. We commend the frontline healthcare workers who confront uncertainty and danger every day. While some regions are more severely affected than others, most U.S. healthcare facilities have prepared for an anticipated surge of COVID-19 patients by reducing their normal services. Simultaneously, our customers have increased spending on personal protective equipment, medications, oxygen, and essential COVID-related equipment like ventilators. Access to their facilities has been significantly restricted for safety reasons, making face-to-face sales meetings exceptionally difficult. This combination of restricted access and increased COVID-related spending poses challenges for our sales team and, consequently, our ability to offer financial guidance. However, by sharing insights into our operations, we hope to provide some outlook for the future. As health experts indicate, the spread of the virus dictates the pace of operations, and IRadimed is not alone in feeling this pressure. Instead of offering financial guidance, I will review our business strategy moving forward. IRadimed operates in a specialized market for MRI-compatible medical devices with two main products. Our more established device is the only non-magnetic MRI IV pump system in the world. We have identified two types of customers for this device. The first group includes large potential customers who have yet to adopt our technology—such as patients needing IV therapy during MRI scans—who require extensive direct selling efforts that are challenging without direct hospital access for demonstrations and clinician engagement. Historically, these customers have represented about half of our IV pump sales. The other half comes from existing customers who are expanding their use of our products. Sales to new customers have been most affected by the pandemic, whereas orders from existing customers, while still difficult to secure, have seen less impact. Our second product, a newer MR patient vital signs monitor, similarly relies on repeat business from current pump customers and has a more stable replacement order process. We will discuss sales trends for these products in our Q2 financial results shortly. A positive sign is that our international business for both product lines has remained strong, and we anticipate this trend will continue as the global market opens up. What steps can we take? First, hospitals are not entirely closed to us. We have continued to provide product training, both on-site and virtually, and have been servicing our products. Our clinical application specialists are gaining admission to hospitals needing our support and training, which sometimes leads to increased needs from current customers. Additionally, we have managed a limited number of in-person demonstrations and have noticed a promising uptick in engaging hospital personnel through phone and video conferencing. We are actively adapting our strategies to attract business, frequently adjusting our plans. We are enhancing our abilities in virtual sales calls and demonstrations and developing tools to aid this initiative. While still in its early stages, we see encouraging signs that these new methods of engagement are effective and producing positive outcomes. We are also creating a sales strategy to leverage two recent developments: the FDA’s issuance of guidance related to infusion pump regulations allowing for remote monitoring, and the granting of a new patent for our system to enable remote communication with an infusion device. The FDA has recognized the potential hazards posed by IV pumps in crowded facilities and is encouraging the adoption of remote control solutions. Our IV pump, uniquely equipped with this capability and now under patent protection, offers an increase in safety for ICU beds with highly contagious patients, along with savings on PPE and medications. I expect to provide updates on this in future quarters. Our planning has adapted to the challenges posed by the pandemic, including exploring new sales methods and reviewing costs and value. We operated with reduced hours for several weeks, paused hiring, and lowered management's targets for bonuses and accruals. We also examined our sales territories and determined that several expansion areas would likely not develop quickly during the pandemic, leading us to consolidate seven territories into the more established 22. This strategy allows us to focus on proven sales plans while minimizing costs in areas where significant revenue might be delayed for several quarters. Regarding our product development, we have experienced only minor delays due to slowdowns with outside contractors, but we have made substantial progress on the next-generation MRI IV pump, with an FDA submission expected in the coming days. We are excited about the development of this device and the positive feedback from human factors studies. Additionally, we are making good progress with the FMD device and anticipate having at least a few operational units by year’s end. However, the launch of new devices may face significant delays if the pandemic continues to affect our customers. Now, I will hand the call over to Chris for a summary of our financial results.

Thank you, and good morning, everyone. As always, I'll be discussing our financial results on a GAAP basis as well as on a non-GAAP basis. Our non-GAAP operating results exclude stock-based compensation expense and other operating expenses that we believe are not indicative of our ongoing core performance. These items are not taken into account for our normal provision for income taxes. Free cash flow is cash flow from operations, less cash used for purchasing property and equipment. We believe the presentation of these non-GAAP measures, along with our GAAP financial statements, can be helpful in providing a more thorough analysis of our ongoing financial performance. You can find a reconciliation of these non-GAAP measures to the nearest GAAP measure on the last page of today's press release. As stated this morning, second quarter revenue decreased 26.3% compared to the second quarter last year. Revenue from domestic sales decreased 38.6% to $4.6 million during the current quarter. This decrease was primarily driven by lower device revenue, which we believe is tied directly to the COVID impact that Roger spoke about a moment ago. Revenue from international sales increased 29.3% to $2.2 million for the current quarter. The increase in international sales was driven by higher monitor revenue. Revenue from sales of our devices decreased 41% to $3.8 million for the second quarter of 2020. This decrease was driven by a 58.8% decline in IV pump revenue that was partially offset by a 1.9% increase in revenue from our monitoring systems. The average selling price of our MRI compatible IV infusion pump system during the 2020 quarter was approximately $30,200 compared to approximately $35,300 for the same period in 2019. This decrease in ASP relates to higher international sales of our infusion pumps recognized in revenue when compared to the second quarter last year. The average selling price of our MRI compatible patient vital signs monitoring system during the second quarter of 2020 was approximately $30,600 compared to approximately $32,200 for the same period in 2019. This decrease in ASP also relates to higher international sales of our monitoring system recognized in revenue when compared to the second quarter of last year. Revenue from sales of our disposables, services, and others increased 9.6% to $2.5 million for the current quarter from $2.3 million for the same quarter in 2019. Lastly, revenue from the amortization of extended maintenance contracts was consistent at $0.5 million for both periods. Gross margin was 72.6% for the 2020 quarter and 79.9% for the 2019 quarter. The decrease in gross margin percentage is a result of higher international sales as a percentage of total revenue and unfavorable overhead variances compared to the same quarter last year. Operating expenses were $7.6 million or 115.7% of revenue compared to $5 million or 54.1% of revenue for the second quarter last year. During the second quarter of 2020, we recognized G&A expense of $2.8 million related to our former CEO, of which $2.7 million relates to the separation. Additionally, we recognized higher salaries and benefits expenses due to higher headcount. These increases were partially offset by lower legal and professional fees and lower sales activity expenses. We recognized a tax benefit of $800,000 in the current quarter compared to a tax expense of about $400,000 in the 2019 quarter. Our effective tax rate for the 2020 quarter was 27.4% compared to 14.9% for the 2019 quarter. The higher effective tax rate is due to a limitation on the deductibility of certain executive compensation associated with the separation of our former CEO, partially offset by discrete items related to stock compensation and a U.S. state tax benefit. Additionally, we recognized the benefit resulting from the CARES Act that allowed us to carry back our net operating loss to years prior to the enactment of the Tax Cuts and Jobs Act, which increases the benefit to the previously enacted federal tax rate of 35% versus the current federal tax rate of 21%. On a GAAP basis, we recognized a net loss of $0.17 per share for the second quarter of 2020 compared to net income of $0.17 per share for the 2019 quarter. On a non-GAAP basis, net income was $0.05 per diluted share for the current quarter compared to $0.20 per share for the second quarter last year. From a cash flow perspective, we generated $2 million of cash from operations for the six months ended June 30, 2020, compared to $3.1 million for the same period in 2019. For the six months ended June 2020, cash provided by operations was positively impacted by cash inflows from accounts receivable and deferred revenue, and negatively impacted by inventory, prepaid income taxes, prepaid expenses, accrued payroll, benefits, and accounts payable. For the three months ended June 30, 2020, and 2019, our free cash flow, a non-GAAP measure, was approximately $700,000 and $2.4 million, respectively. Lastly, we exited the quarter with a combined cash and investments balance of $47.8 million and no third-party debt or other restrictive covenants. Before going into questions, I thought I would provide some financial context to Roger's comments on how COVID is impacting our business by reviewing recent trends in bookings. For the first six months of 2020, total bookings were down approximately 14% compared to the first six months last year. This decrease was led by a 44% decline in pump bookings, which shines a light on our past comments about roughly half of our pump business coming from the greenfield and Roger's commentary regarding the difficulty we are experiencing in accessing greenfield customers in the current COVID-induced environment. Despite this decline, we saw healthy growth in other areas of our business, led by a 28% increase in monitor bookings and an 18% increase in bookings for our disposable products during the year-to-date time frames. We view these as highly positive as the increase in monitor bookings is indicative of our ability to take market share in this competitive market and the higher disposable sales are an indication that our monitor and IV pump are being utilized more frequently. As of yesterday, these product booking trends appeared to be holding in the July over June sequential timeframe. And with that, I'll turn the call over for questions.

Do you expect this trend that the sales to be more heavily weighted towards international to hold for the second half of the year?

I think it's a reasonable expectation, just given the diversity of the rest of the world and how the pandemic is impacting different parts of the world at different points in time and how different governments are responding differently compared to just inside the United States. So I think it's a reasonable expectation that we will continue to see strength in the international channel.

Okay. During the second quarter, the device revenues were nearly a 50-50 split of pumps versus monitors. What are you seeing in the September quarter? Are you seeing a similar kind of split?

Yes. I think it goes to the comment I just made about recent bookings trends. And so far, as of yesterday, the booking trends that we're seeing in July are pretty consistent with the comments about the six-month periods.

Okay. And then one final question. You're very close to filing your 510(k) for the next-generation pump. Could you remind us what are the advantages of that pump versus the current model?

Yes, I would be happy to. So the 510(k), of course, is to seek clearance for our device. As we've said in the past, the one thing that we find, let's say, is a weakness is that our pumps are relatively few in number being only associated with MRI imaging within a given hospital versus the larger number of general-purpose pumps, which they often have—sometimes the ratio is skewed more than 10 to 1. So we find that people tend to—generally, as a whole in the hospital, some users shy away from using this more unfamiliar pump. To make that problem diminished, the primary design objective of the new pump was to make it easier to use, more attractive, and intuitive. This is the objective of this new pump. As I mentioned earlier, especially when we conduct human factors studies as part of turning in our submissions to the FDA, we gather a good number of clinicians together, and they use the product in a lab setting—not on patients, but in a controlled laboratory setting—where we scrutinize deeply how they engage with the device. That process has been exceedingly positive. I think we're all very excited to see that this aspect of why we set sail in making this new pump is indeed coming true.

We're very excited.

There are no questions at this time. Mr. Roger Susi, you may go ahead.

Thank you, and thanks, Chris, for the financial information. As we have seen, this pandemic exhibits wave-like cycles, which likely will continue. Providing guidance is not possible, unfortunately. Unexpected positive and negative twists and turns and their severity cannot be foretold. However, we are making and changing plans and methods to deal with the COVID-19 landscape and strive to show improving revenue and earnings in the upcoming quarters. We feel that since our products are not strongly tied to medical procedures, which can be postponed—such as elective procedures—with recent findings that some COVID patients experience neurological issues, the use of our devices in support of MRI imaging will remain a useful clinical tool. Plus, with the safety offered by our remote control capability, we expect to be able to maneuver through the COVID-induced crisis and see increasingly positive sales trends. Of course, we look forward to witnessing the positive effects of a successful vaccine and a return to normal life and business without the schedule of the pandemic. Thank you all for participating in the call today.

Thank you. This concludes the call. You may now disconnect.