Iradimed Corp Q1 FY2026 Earnings Call

Welcome to IRadimed Corporation's First Quarter of 2026 Financial Results Conference Call. This call is being recorded today, May 1, 2026, and contains time-sensitive accurate information that is valid only for today. Earlier, IRadimed released its financial results for the first quarter of 2026. 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 was also furnished to the Securities and Exchange Commission on Form 8-K and can be found at sec.gov. This call is being broadcast live on the company's website at iradimed.com, and a replay will be available there for the next 90 days. Some of the information in today's session will constitute forward-looking statements with the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements focus on the future performance, results, plans, and events and may include the company's expected future results. IRadimed reminds you that future results may differ materially from these forward-looking statements due to several 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 the Securities and Exchange Commission, which may be obtained free from the SEC's website at sec.gov. I want to turn the call over to Roger Susi, President and Chief Executive Officer of IRadimed Corporation. Mr. Susi?

Thank you, operator, and good morning. Welcome to IRadimed's Q1 2026 earnings call. Sorry for the late start; we had a microphone problem. We once again have a very positive performance to announce with the first quarter 2026 revenue of $22 million, a 13% increase over the first quarter of 2025. These results reflect solid execution across our product lines with strong revenue contribution from our MRI-compatible IV infusion pump and our MRI patient monitoring, noting that revenue was substantially derived from the legacy 3860 pump system. There also continues to be growing revenue support for our Ferro-magnetic Detection System. Our continued revenue growth, combined with disciplined expense management, including a modified commission structure, drove operating income of $7.2 million, a 33% improvement over the first quarter of 2025, with net income of $5.8 million, or $0.45 per diluted share, a 22% increase over the prior year. Next, I'd like to provide a brief recap of our expectations for the new 3870 MRI IV pump. Recalling that in positioning this new product and its pricing, we had anticipated that the 3870 pump's ASP would increase by some 10% to 14% over the historical 3860 pump ASP. However, though just beginning, initial quoting and actual orders are showing a lift closer to 20% of 3870 ASP. Additionally, we are seeing that a majority of this new business is for quad, four-pump systems rather than simply replacing the older 3860 dual-channel system. Thus, we are seeing both a higher per-pump ASP and a larger group of customers purchasing twice as many pump channels, doubling the number of pump channels at a particular customer site. Though obviously our sales efforts are in the very early stages, these two factors present the most exciting prospect for bookings and revenue as the year progresses. Opportunities for the 3870 pump system, as previously described, are both increased penetration of greenfield, which are predominantly those facilities that continue to deal with IV fluid delivery in the MRI setting via various old-school workarounds, as well as the quite substantial replacement of IRadimed's aged installed base of 3860 pump systems, the most immediate and significant increase coming from the large replacement opportunity. This replacement opportunity will be our key growth driver for the next several years; as that growth, as mentioned, has now begun to be the driving factor in this second quarter. To provide some clarity to the revenue expectations in Q2 and beyond, it will not be a step-change, but rather a controlled ramp, which is initially composed of declining revenue derived from the older 3860 pump system domestic orders, which have trailed off as expected, offset positively by increasing revenue from the new 3870 system as we ramp up its production. John, our CFO, will provide our Q2 guidance for further quantifying how Q2 is expected to develop. To reiterate the source of the 3870 opportunity as given in our previous call, for the U.S. market, there are approximately 6,400 five-plus-year-old or older 3860, 3861 pump channels up for replacement. We have been selling approximately 1,100 such 3860 channels annually. With the new 3870, we are targeting adding another 1,000 channels per year to replacement sales from the existing 6,400 3860 units that are over five years old. As advertised, this starts in Q2 and continues through the rest of 2026 and beyond. It is also important to understand that replacing only 1,000 channels per year leaves many more to be replaced in the years to come. For our domestic business only, selling north of 2,000 3870 pump channels annually with the higher ASP currently being experienced, we expect to approach a $50 million annual revenue run rate for pumps. Adding disposables, maintenance, international sales, the MRI monitoring business, and the Ferro-magnetic Detection System, one can understand our confidence in achieving a $100 million-plus revenue run rate as 2026 progresses. Timing has been discussed previously as well, but to recap that, we did not launch our sales effort for 3870 until late January. As advised, we targeted shipping 130 to 135 3870s in Q2. Both the launch and the manufacture of those initial 130 to 135 3870s are progressing as planned. As we issued in this morning's press release, the interest in the new 3870 has been very gratifying. The number of orders and the dollar size are well ahead of our expectations this early in the product launch, giving us great encouragement. Still, however, Q2 revenue will not fully reflect this high level of exciting order activity, as shipping even 135 new 3870 systems, combined with the declining revenue of older 3860s, keeps Q2 revenue somewhat in check. Again, it will be the back half of 2026 that will shine as we continue to book more pumps at higher ASP and ramp production of this 3870 system. I'll turn the call over to John Glenn, our CFO, to review the quarter's financial results and provide deeper color on growth through the balance of the year. John?

Thank you, Roger, and good morning, everyone. As in the past, our results are reported on a GAAP basis and a non-GAAP basis. You can find a description of our non-GAAP measures in this morning's earnings release and a reconciliation to GAAP on the last page. For the three months ended March 31, 2026, revenue was $22 million, up 13% from $19.5 million in the first quarter of 2025. IV infusion pump systems contributed $7.7 million, up 28% year-over-year, reflecting the fulfillment of 3860 pump backlog from the beginning of the year. Patient vital signs monitoring systems contributed $7.1 million, up 9% year-over-year. Disposable revenue was $4.9 million, consistent with the prior-year period, while the Ferro-magnetic Detection System contributed $600,000. Domestic sales accounted for 82% of total revenue, consistent with the first quarter of 2025. Gross profit for the quarter was $16.8 million with a gross margin of 77%, up from 76% in the first quarter of 2025. Total operating expenses for the quarter were $9.6 million, roughly in line with the first quarter of 2025. General and administrative expenses were $4.6 million, sales and marketing were $4.1 million, and research and development were $1.1 million. The increase in R&D was largely due to the end of capitalized internally-developed software for the 3870 compared with Q1 of 2025, as well as new product development for the next-generation monitor. Income from operations for the quarter was $7.2 million. Net income was $5.8 million, or $0.45 per diluted share on a GAAP basis, a 22% increase over the prior year period. Non-GAAP net income was $6.4 million, or $0.49 per diluted share, up 17%. The effective tax rate for the quarter was approximately 25%. The increase in the effective tax rate for the quarter was largely due to the timing of deductions tied to the windfall deduction for equity grants, which is a discrete item taken at the time of vesting of the equity grant, most of which will occur in the fourth quarter of this year. Therefore, we anticipate that the rate will trend down and, by the end of the year, be more in line with previous years. We ended the quarter with cash and cash equivalents of $56.4 million. Cash flow from operations was $8.3 million for the quarter, compared to $4.3 million in the first quarter of 2025, an increase of 93%, reflecting higher net income and favorable working capital movements. Non-GAAP free cash flow was $7.8 million for the quarter after capital expenditures of approximately $500,000. Also today, the company's Board of Directors declared a regular quarterly cash dividend of $0.20 per share of outstanding common stock payable on May 29, 2026, to stockholders of record as of the close of business on May 15, 2026. And lastly, for our financial guidance, for the second quarter of 2026, we expect revenue of $20 million to $21 million, GAAP diluted earnings per share of $0.40 to $0.44, and non-GAAP diluted earnings per share of $0.44 to $0.48. For the full year 2026, we reaffirm our guidance with revenue of $91 million to $96 million, GAAP diluted earnings per share of $1.90 to $2.05, and non-GAAP diluted earnings per share of $2.06 to $2.21. The company expects stock-based compensation expense, net of tax, to be approximately $2.4 million for the full year and $600,000 for the second quarter of 2026. With that, I will turn the call over to questions. Operator?

Our first question comes from Frank Takkinen with Lake Street Capital Markets.

Congrats on all the solid progress. I was hoping to start with a follow-up on, Roger, your comments related to quad system ordering. How do you — maybe break that down a little bit why you think folks are going from a single dual-channel to ordering four individual channels? And then my assumption is you can't assume everybody goes to ordering four channels, but is there something specific to call out with some of these early customers that would make them more likely to order four systems at once? Or is it fair to assume that a lot of your customers reordering could fall into this camp of ordering four systems at once?

Yes, good question, Frank, and welcome. It's a bit of a surprise that more than half of these orders we've taken so far have been for quad systems. We were hoping for maybe 10% to 15% of customers to step up to doubling the number of channels, so this is a bit surprising. I have to give the sales force some credit. They are close to the customers and felt that with the new system, the way it presents to customers and the fact that it is smaller than the old pump, it changes the purchase consideration. The way they actually stack together on a pole, they work together as four very easily. When we show the quad stack to customers, many of them—though they had not been thinking in those terms before because they only had a two-channel version—fairly quickly see situations over the years where a third and fourth channel would be useful, which stimulates the budget conversation and leads them to order the additional channels. Another positive sign is that these orders have come in rather quickly; we only started selling the 3870 in late January, and the orders we've been getting have been quicker than the typical cycle time so far. So it's all very positive. In short, customers do have experience where extra channels were required in the past, and they're going ahead and taking advantage of buying a quad stack.

That's great. And then maybe just one follow-up on that. Is there a financial element to it as well? Are they getting a better per-pump deal if they're buying four at a time?

No, the pump ASP is, as I said, higher. The list price of the previous pump was $20,000. You could buy the second channel for about another $10,000. As we've said many times, our typical ASP pump deal was just under $40,000 by the time you get the pump and the sidecar, the pole, the remote, and all that. The quad systems we've been selling—the quad stack of the 3870s with the IV pole and the remote control—are each coming in at more than $100,000, so it's very exciting.

Wow, that's great. Maybe a bigger-picture question: the concept you laid out about going from around 1,100 pumps a year to adding another incremental 1,000 on top of that—what are the drivers of that? I assume the quad pump ordering is a significant driver, too, but is there an assumption of greenfield capture in that number as well? Or is it really just a replacement?

No. When I was speaking earlier in the call, I was referring specifically to taking 1,000 from the installed base where the old pumps are. Greenfield will be incremental to that. Frankly, the excitement level has been high and existing customers are calling us wanting to see the new pump; demand is strong right now. I don't see that we'll have time to start calling on greenfield customers for a while, so we have not factored any greenfield upside into that replacement number at this point.

And then just last one for me, and I appreciate all the time on manufacturing. How are you feeling from that standpoint? In our previous conversations, you felt really good about that. But as you're taking orders now and scaling, how is production and the supply chain holding up?

The sales team wants us to ramp up a lot faster, but we're taking a cautious approach to ensure quality and supply chain stability. For Q2 we're targeting shipping 130 to 135 pumps. The sales team would like us to ship over 200, but we are not going to push that now. We'll stay at the planned level, get them right, and then in Q3 plan to roughly double production, and ramp further in Q4 where we should be in a heavy stride on the number of new pumps we're shipping. We have a new facility with the space required; it's a matter of ramping up the know-how and stabilizing the supply chain. That's why we're being somewhat conservative on the ramp.

I'm showing no further questions at this time. I'd like to turn the call back over to Roger Susi for closing remarks.

Well, thank you all once again for joining us on today's call. I'd like to add as we close today that the market is very excited about the new 3870 pump system, and we are being invited into customer facilities to show the device at a very high rate; the sales team is rather inundated. Further, we have had bookings with greater-than-expected ASP, and the majority of those orders thus far are for double the number of pump channels. It's clear to us that the 3870 is gaining strong acceptance, generates great excitement, and motivates very positive and rather quick customer response. We're quite pleased. With that, we look forward to demonstrating IRadimed's success as we further execute the launch of this exciting 3870 MRI IV pump system and capitalize on the large replacement opportunity throughout 2026 and beyond. Thank you.

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