CERS
NASDAQ · Healthcare · Medical - Devices · US
Next report
Analyst consensus
- Next report date
- Nov 5, 2026
- EPS estimate
- -$0.01
- Revenue estimate
- $63.3M
Latest reported
- Last report date
- Jul 30, 2026
- EPS actual
- -$0.01
- EPS estimate
- -$0.01
- Revenue actual
- $63.3M
- Revenue estimate
- $62.9M
Track record
Trailing twelve quarters
- EPS beats (12Q)
- 5
- EPS misses (12Q)
- 6
- EPS in line (12Q)
- 1
- Avg surprise (4Q)
- +52.8%
- Revenue beats (12Q)
- 1
Q1 FY2026 · Apr 30, 2026
AI summary of management’s prepared remarks and analyst Q&A · For informational purposes only, not investment advice
Management highlights
- Focus on three core priorities: driving sustainable double-digit growth, advancing innovation, and strengthening financial foundation. - Strong first quarter results with product revenue growth driven by global platelet franchise and accelerating U.S. IFC business. - Raised full-year 2026 product revenue guidance to $227 to $231 million and IFC revenue guidance to $22 to $24 million. - North America's platelet franchise growth with 6% increase in volumes and 9% in treatable doses compared to Q1 2025. - International RMA business strong, led by France and Belgium, with multi-year contract with French EFS. - Innovation includes rollout of next generation I&T 200 Illuminator, track to submit PMA for I&T 100 to U.S. FDA, and growth in U.S. ISD franchise. - Operating expenses declined 7% compared to Q1 2025, with SG&A largely consistent and R&D expenses down due to lower development costs of INT200. - Adjusted EBITDA for Q1 2026 totaled $4 million, marking eighth consecutive quarter of positive adjusted EBITDA.
Guidance
- Raised full-year 2026 product revenue guidance to $227 to $231 million, representing 10 to 12% year-over-year growth. - Raised full-year IFC revenue guidance to $22 to $24 million, approximately 30 to 40% year-over-year growth. - Expect to deliver third consecutive year of positive adjusted EBITDA results for the balance of 2026. - 2026 gross margin expected to be in the low 50s range, with potential relief if external factor assumptions prove conservative.
Segment performance
Product revenue in the first quarter was $53.7 million, up 24% compared to the first quarter of 2025. Total revenue, including government contract revenue, increased 23% year-over-year. North America accounted for nearly 70% of first quarter product revenue. EMEA revenues grew by 28%, with demand for platelet product being the primary contributor. First quarter IFC revenue was $5.7 million, up from $3 million in the first quarter of 2025, with demand increasing approximately 120% year-over-year by therapeutic dose equivalent and revenue growth approaching 90%.
Risks & headwinds
- Forward-looking statements involve risks and uncertainties that can cause actual events, performance, and results to differ materially, including risks related to future financial and operating results, clinical trial data availability, regulatory submissions, market opportunities, tariffs, inflationary pressures, etc. - Near-term challenges in certain regions like the Middle East with ongoing conflict creating logistical complexities that may impact shipment timing.
Analyst Q&A
Q: Good afternoon. Thanks for taking the questions and congratulations, Obi, on moving into your next chapter. It's been a long, resilient run by you and leaving the company in a position of strength here, looking at these one key results and being on the cusp of some RBC approvals globally. We'll miss you, but congratulations, Vivek, on your new CEO seat. I'd like to start just with... Just asking about guidance, it seems like the uptick is or looks like the uptick is being driven mostly by IFC strength, but also by intercept platelet strength. Maybe just talk about the outlook for the U.S. intercept platelet franchise versus the OUS intercept platelet franchise and where you're seeing more upside relative to the outlook at the beginning of the year.
A: Yeah, thanks a lot, Josh, and thanks for the kind comments to start. Vivek, do you want to handle that question? Yeah, I'd be happy to. Josh, echoing Obi's statement, thanks for the kind words. They're much appreciated, and certainly appreciate your continued interest in our story. You know, the thing that's most encouraging to me about Q1 results is that the strength of the performance is really broad-based, both globally and across product category. You're right to point out that ISD performed quite well and is a significant part of our revised upward guidance. But as you also correctly pointed out, platelets is a big component of that as well. If you recall late last year and earlier this calendar year, we pointed to the BCA agreement in the US and the opportunity to have effectively a hunting license in about half of the US market where relatively speaking, our platelets were under penetrated we saw good progress in the first quarter in that section of the market but we also saw strength with platelets internationally as evidenced by what kevin spoke to in terms of strengthen our emea organization and then we also highlighted the renewed contract with the ess so as we think about the outlook for the balance of the year We see continued solid platelet growth in both geographies, continued expansion in the U.S. under the umbrella of the BCA agreement, as well as continued adoption both in growth areas internationally, but then also in some of our core markets where we're seeing a recommitment for customers. So really there's a lot of enthusiasm coming out of first quarter results and the general qualification of demand in the marketplace.
Q: Thanks for taking the questions. Yeah, of course. Yeah, certainly happy to provide a bit more color there. There are multiple factors at play, Josh, that I'm sure you can appreciate. The first is we're actively in the process of moving our historical production partners under the BCA agreement. And as we do that, they're able to take advantage of the resource sharing model that BCA utilizes. So there are outlets in terms of potential both blood center customers, but ultimately hospital customers continue to grow. In addition to that, we've had BCA members who weren't previously IFC manufacturers reach out to us and initiate the process of beginning ISD manufacturing. And then fundamentally, as we've talked about previously, as we transition from selling the finished therapeutic to the kits to blood centers, that enables us to leverage and partner with the sales and marketing channels of the blood centers, thereby significantly expanding our reach and our ability to engage with more hospitals. So all of those factors come together and effectively create an environment where we're just reaching out to more hospitals, engaging a broader number of clinicians about IFC, and that's all occurring while the data we collect and the user experience on the product continues to grow. So it's been really encouraging, but still very much early days. We're proud of the Q1 results and the outlook that, you know, remind you that we're still a single-digit share in terms of market penetration. So there's a tremendous amount outside in this market.
Q: Thanks for the question, Bill. I presume you're talking about red cells and not the INT200, which we'll be filing for PMA imminently here in the United States. Talking about them both. Okay, great. Well, I'll start with red cells and I'll let Vivek cover INT200 because we're also really excited about that. For the near term, the milestones through the remainder of the year, we clearly are very focused on the ANSM review of the Red Salt Program, and we're happy to announce that this week we actually completed our recertification audit with TUV, so that's exciting. But we have two additional milestones for the CE mark. One is the ANSM review, and then ultimately an audit of the manufacturing facility. And then as far as a pathway to ultimate revenue there, we, you know, would, you know, once we have an anticipated approval of the Red Cell C mark, we'd move into sort of an early launch of that product with an iteration of the device, you know, to ultimately improve the overall scale-up and operational efficiency of processing Red Cells. So that's still, you know, a few years out, but, you know, the goal right now is to just focus on getting that CE mark so that we can launch the product. Malik, do you want to cover the INT200 in the U.S.? Sure, I'd be happy to. Thanks for the question, Bill. So as we indicated earlier, you know, we're moving towards a submission to the USDA, so CMA submission for the INT200 device this quarter, so in the second quarter of 2026. We would anticipate a launch in the first half of 27, and I anticipate, similar to what we're experiencing in international markets, that there'll be a lot of enthusiasm for that launch. It's clear evidence of our commitment to innovation in this space, which I think differentiates us from a lot of our peers, and it'll serve ultimately as the device foundation for the US market. You know, that is an upcoming catalyst and one that we're very excited about, given the positive receptivity to the Illuminator and international markets.
Q: Hey, guys. Thanks for taking the questions. Obi, it's been great working with you, and congrats as you transition into the chairman role, and Vivek, congrats on your well-deserved promotion to CEO. All right, so moving into the business, you know, I wanted to get a better sense on the guidance because, you know, when I look at the IFC business, you know, you grew 90% in Q1 here. The 2026 guidance for IFC has been raised to approximately 30% to 40%. So I'm just trying to get a sense. about the seasonality of this business. It looks like in Q3 last year, it was down sequentially. I recognize there's probably lumpiness as you roll this out, but can you just walk us through the assumptions as to, you know, just the delta between the really strong growth to start this year and, you know, your full year growth outlook for IFC?
A: Yeah, thanks for the question, Mark, and thanks for the comments to start as well. Vivek,你 want to cover that? Yeah, I'd be happy to. Mark, thank you for the kind words about the org transition. Much appreciated. You're right to point out that the business is a little bit lumpy as we're in this early growth stage. But I just want to emphasize that our conviction around continued growth and the fact that, you know, it's still we're a single digit市场 share. player and feel like there's a tremendous amount of headroom. I don't want any of that enthusiasm to be lost as we talk about some of the specifics about the current position itself. I'll remind你 that a year ago, there were some anomalies in terms of our posted results. If you recall, we deferred from an accounting standpoint, some revenue recognition to the second quarter as we were sort of starting the process of transitioning from a finished therapeutic sale to a kit sale. That transition continues and really we're driving towards being fully kit sales ideally by the end of this calendar year. That may bleed a little bit into 2027. So we've been talking about really unit volume from the standpoint of therapeutic dose equivalence as opposed to the revenue growth. And so you'll see that current transition, you'll see that transition accelerate through the balance of 2026. And that was part of what factored into the guidance for the full year. Obviously, we took it up pretty significantly from original guidance of 20 to 22 million for the full year now to 22 to 24. So underlying growth remains strong. There'll probably be some period to period idiosyncrasies just given that transition in the nature of our business model. But as we think about blood centers manufacturing IFC, hospital start, some of the things that now we're paying attention to, all of those trend lines are pretty strongly positive. So hopefully that could be a little bit more color, certainly halfway to answer any more questions about the IFC business as you have them.
Q: Yeah, thanks, Mark. So, I think right now it's probably safe to assume that it's being a first half 2027 approval timeline, just given that we don't know what questions ANSM will ask and, you know, the timeline for our responding to those questions. So, I think that's That's the time that you should be looking at. I think we'll have a lot more clarity through the year end, and I think specifically as we think about our Q3 earnings call, not only will there be the Phase 3 Reddit study readout in that time frame, but also some increased clarity around the ANSM timing. So that's the way我 think you should think about it.
Q: Yeah, thanks, Mark. Yeah, Blake, do you want to cover that? Yeah, I'd be happy to. So, Mark, it's a great question. We absolutely continue to be excited about the opportunity in the China market. We will be meeting with our joint venture partner, ZBK, at the upcoming ISBT meeting, which is scheduled to take place in Kuala Lumpur in mid-June. And so part of what we're continuing to refine is our strategy to collect in vitro data that's requested in the Chinese market for resubmission to the NMPA. But in parallel with our continued channel checks and clinical engagements, it sort of continues to validate the excitement for and the need for patent activation in that marketplace. So it's probably, you know, an opportunity that we'll realize in terms of revenue generation towards the latter part of this decade, but it's very much a market opportunity that we're working in partnership with BBK under our joint venture agreement to advance.
Reported results against consensus at the time of each report · Surprise is computed from the estimate on record · Data as of Nov 5, 2026