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spk01: Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cirrus Corporation fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Jessica Hanover, Cirrus Vice President of Corporate Affairs. Dr. Hanover, you may begin.
spk12: Thank you and good afternoon. I'd like to thank everyone for joining us today. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at ir.cirrus.com. With me on the call are Obi Greenman, Cirrus' President and Chief Executive Officer, Vivek Jayaraman, Cirrus' Chief Operating Officer, Kevin Green, Cirrus' Chief Financial Officer, and Carol Moore, Cirrus' Senior Vice President of Regulatory Affairs and Quality. Cirrus issued a press release today announcing our financial results for the fourth quarter and year ended December 31, 2023, and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.siris.com. I'd like to remind you that some of the statements we will make on this call related to future events and performance rather than historical facts and our forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2024 product revenue guidance, our expectations for bottom line and non-gap adjusted EBITDA performance and our expected expense levels, expected future growth and our growth trajectory, the availability and related timing of data from clinical trials, and other statements that are not historical facts. These forward-looking statements involve risks and uncertainties that could cause actual events, performance, and results to differ materially. They are identified and described in today's press release, in our slide presentation and under risk factors in our Form 10-K for the year ended December 31, 2023, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, we will also be discussing non-GAAP financial measures, including non-GAAP adjusted EBITDA. These non-GAAP measures should be considered a supplement to and not a replacement for measures presented in accordance with GAAP For reconciliation of non-GAAP financial measures to the most comparable GAAP financial measures, please refer to today's press release and the slide presentation available on our website. We'll begin today with opening remarks from Obie, followed by Vivek to discuss recent business highlights, then Kevin to review our financial results and expectations for the rest of 2024, and lastly, closing remarks from Obie. And now, it's my pleasure to introduce Obi Greenman, Cirrus's President and Chief Executive Officer. Obi Greenman, Cirrus's President and Chief Executive Officer Thank you, Jessica, and good afternoon, everyone.
spk09: I'd like to open the call by spending a few minutes reflecting on 2023 as well as our expectations for 2024. During the fourth quarter of 2023, we surpassed the 16 million mark for cumulative kits sold for trans-usable intercept platelet and plasma doses. It's a significant figure, particularly with respect to the absolute number of patients who receive intercept-treated blood components on a daily basis across the globe. And it also represents the ever-growing and significant role played by our pathogen inactivation technology in the evolving healthcare landscape. The importance and relevance of pathogen inactivation were also visible during a special webinar in January of this year hosted by Yale University the American Red Cross, and the Association for the Advancement of Blood and Biotherapies, or AABB. The event was focused on addressing platelet insecurity with speakers from blood centers such as the American Red Cross and Canadian Blood Services, as well as from hospitals, the military, and government organizations. In addition to the recognition of the growing demand for platelets in the face of blood supply vulnerabilities, It is also clear that pathogen inactivation has become a foundational aspect of today's transfusion medicine landscape. It is this dynamic that drives our excitement about the continued potential for the intercept business, both in the U.S. and across the globe. We anticipate the near future to be driven by both international expansion of intercept platelets, as well as an increasing growth trajectory for intercept fibrinogen complex, or IFC, in the U.S. The VAPE will provide additional commentary on our commercial expectations following my introductory comments. We ended 2023 on several high notes, posting double-digit sequential growth for the fourth quarter, narrowing gap net loss attributable to Cirrus, and importantly, delivering positive non-gap adjusted EBITDA for the first time. Per our 2024 product revenue guidance announcement earlier this year, we expect to post year-over-year double-digit growth along with sustaining if not improving bottom line results. Kevin will provide more details in his comments following the vague. I would now like to turn the call over to the vague to discuss our commercial results and progress for the fourth quarter and full year 2023, along with color on the outlook for 2024.
spk02: Thank you, Obi, and good afternoon, everyone. As Obi indicated, we delivered strong sequential and year-over-year growth in the fourth quarter of 2023. This growth was driven by our Platelet franchise globally, as well as encouraging progress within our US IFC business. With inventory levels at most of our blood center partners stabilized, we witnessed a return to more typical ordering, manufacturing, and reordering patterns. Furthermore, we saw growth in both existing accounts, as well as a meaningful step up in new account activation, notably in our IFC business. Our Platelet franchise delivered strong growth across the globe. In the U.S., we believe that most of our customers have properly adjusted their intercept inventory in light of product dating issues and are now ordering at more consistent rates. As we make progress on our real-time aging studies, we remain confident in our ability to extend platelet kit shelf life. While we are not currently assuming material uplift in revenue associated with increased dating, we do believe this will likely lead to more comfort at the blood center to hold inventory. We continue to see positive traction at our blood center customers and believe Intercept remains the leading technology for platelet safety in the U.S. Our early experience in 2024 suggests that our U.S. platelet franchise is poised for solid growth this calendar year. Internationally, Canadian Blood Services, or CVS, is closing in on completing its rollout of Intercept platelets across its entire production operation. In the fourth quarter, CVS completed its implementation of Intercept for whole blood derived platelets which included its largest site in Brompton in the greater Toronto area. With this activity, now more than 85% of CVS platelet units issued to hospitals are intercept treated. In other words, the majority of platelet doses issued to hospitals in Canada are now intercept treated. CVS remains on track to complete the transition to 100% intercept platelets in the first half of this year. As it implements intercept for apheresis platelets at three sites, two of which are already producing whole blood intercept platelets. Meanwhile, Hema-Quebec, which produces approximately 25% of Canada's platelet supply, continues to advance its validation of intercept platelets. Q4 2023 was a strong quarter for our US IFC business. We gained commitment from blood centers to distribute IFC while starting commercial use at a number of influential hospitals. Our field sales organization meaningfully increased our in-hospital engagement, and we were able to host effective peer-to-peer educational forums at both key congresses and in one-off settings for hospitals. Real-world use of IFC continues to grow, and it has been encouraging to see the clinical enthusiasm for the offering. This momentum has continued through the first two months of 2024, and we feel confident in our ability to deliver compelling growth with our IFC business. On a going-forward basis, we will provide you with more detail on the progress we are making with IFC, and I am confident you will gain a greater appreciation for why we are excited about this business. I will now turn it over to Kevin to discuss our results and outlook in more detail.
spk11: Thank you, Vivek, and hello to everyone listening. On today's call, I will be discussing our financial results for the fourth quarter and full year of 2023, as well as our product revenue guidance for 2024. Beyond the line item components of our P&L, I'll be providing a breakdown on our important fourth quarter achievement of narrowed gap net loss attributable to CIRAS coupled with reaching our target of non-GAAP-adjusted EBITDA breakeven. This achievement marks the first time in the company's history of delivering positive adjusted EBITDA, and we are committed to sustaining, if not improving on this measure, for the full year 2024 as well. As preannounced in January, we posted product revenue of $46.8 million for the fourth quarter of 2023, representing year-over-year growth of 6%, and up 18% sequentially from Q3. Full year 2023 product revenues of $156.4 million were, as expected, down 4% year over year and in line with our guidance. In the U.S., fourth quarter 2023 product revenues exceeded prior year levels. Importantly, fourth quarter U.S. product revenues were up sequentially by 22% from Q3. In EMEA, fourth quarter product revenues were up 3% year over year, at around 2% compared to the third quarter of 2023. Year over year, FX rates provided a benefit for the EMEA business of around 430 basis points. On a consolidated basis, FX provided a benefit of around 1.3% when comparing Q4 2023 to that of the prior year period. and little to no impact on the full year comparative results. In addition to our product revenue and not included in our guidance, government contract revenue totaled $6.6 million in Q4 compared to $7.3 million for the prior year period. The conclusion of enrollment in our recipe study is the primary driver for the slight decline. Included in our government contract revenue are the revenues recognized as reimbursement under our contract with BARDA, our agreement with the FDA to further whole blood pathogen reduction, and our milestone-based agreement with the U.S. Department of Defense for lyophilized IFC. Let's turn now to our product gross profit and gross margins. Our fourth quarter product gross profit was $26 million, compared to $24.5 million during the prior year period. an increase of 6% year-over-year. Product growth margins for the quarter were 55.5%, relatively stable when compared to the prior year, and up slightly from Q3. These results are consistent with our expectations and our previous remarks during prior quarter calls. Q4 2023 margins improved over 2022 levels primarily due to increased volumes and lower inventory costs compared to the prior year, offset by net foreign exchange rate impact on our reported margins. Moving on, our fourth quarter operating expenses, which totaled $31.6 million, were over $10 million lower than the prior year period of $41.8 million, a 24% decline. Q4 2023 operating expenses included $4.9 million in non-cash stock-based compensation. By specific expense type, fourth quarter R&D expense totaled $14.3 million compared to $18.6 million during the prior year period. The impact of our June 2023 restructuring continued to result in lower ongoing costs, combined with lower costs associated with the recipe trial enrollment completion. ongoing R&D expenses included, but we're not limited to, work under our government contracts, CE-MARC pursuit for our red blood cell program, development work on our Next Generation Illuminator, ongoing change control work, and interactions with regulatory agencies. Beyond R&D, fourth quarter SG&A expenses were $17.3 million compared to $23.2 million during the prior year period. Similar to the R&D drivers, SG&A costs were lower year-over-year, in part due to the impact of our June 2023 restructuring, as well as lower non-restructuring-related compensation costs. We continue to expect that the financial benefit from our restructuring will provide at least $10 million in annual life savings relative to expense levels at the time of the restructuring. Let's focus on the bottom line and non-GAAP adjusted EBITDA results, which are perhaps the strongest financial results that we have to talk about on today's call. On the bottom line, reported net loss attributable to Cirrus for the three months ended December 31st, 2023 improved significantly when compared to the same period in the prior year. Net loss attributable to Cirrus for Q4 totaled $1.3 million, or a penny per diluted share, compared to $13.6 million, or $0.08 per diluted share for the prior year period. These results are also directly reflected in our non-GAAP adjusted EBITDA measure. As you can see from the results, and which I'm happy to announce, we surpassed our goal of breakeven and, in fact, generated almost $5 million of positive non-GAAP adjusted EBITDA. When compared to negative $3.7 million for the fourth quarter of 2022, and negative $1 million during the third quarter of 2023. This result is an improvement of over $8 million and $5 million respectively. This is a significant milestone in our history. And while we're clearly pleased with the results, we are committed to sustaining, if not improving upon it for 2024. As we had predicted, the combination of strong growth in our top line, coupled with stable margins and closely managed operating expenses allowed us to surpass non-GAAP-adjusted EBITDA breakeven in the fourth quarter. While we may have some fluctuations from quarter to quarter this year, we expect that with our product revenue guidance, coupled with stable and perhaps slightly improving gross margins, continued leverage from the business, and close management of operating expenses will support potential improvement on this measure for 2024. On the balance sheet and associated cash flows, We ended the fourth quarter with a cash position of $65.9 million of cash, cash equivalents, and short-term investments on the balance sheet. In terms of cash utilization, our cash use from operations was $15.2 million for the fourth quarter, compared to $1.8 million during the prior year period. As we've spoken about in the past, we saw significant increases in working capital use, specifically with increased inventory levels. During Q4, we also made a conscious decision to pay down our payables due. As we now look to 2024, we expect that with the anticipated increase in revenues, we will work down our inventory balances, maintain payable levels near December 2023 levels, and manage other working capital line items. We expect that these initiatives and results will translate into improvements in operating cash flows for 2024, and could potentially result in positive operating cash flows for the year. Turning to our guidance, as we pre-announced in January, we expect full-year 2024 product revenue guidance to be in the range of $172 million to $175 million, reflecting double-digit growth from 2023. We anticipate this growth to be fueled by continued expansion of the Intercept Platelet business both in North America and Europe, as well as continued uptake of IFC in the U.S. As Vivek mentioned, we firmly believe in the prospects for IFC, evidenced by our commercial sales agreements with large national blood providers, as well as the growing utilization and recognition of the product's benefit at an increased number of U.S. hospitals. For the first time, we are now providing annual revenue guidance for IFC, which for 2024, we expect to be in the range of eight to $10 million. Going forward on a quarterly basis, we plan to break out IFC revenue on a comparative basis to provide visibility into our progress towards our guidance. I'd now like to turn the call back over to Obi for some closing remarks.
spk09: Thank you, Kevin. For the first two months of 2024 in the rear view mirror, we remain positive about the rest of the year ahead of us. With respect to the recipe trial, the first of two BARDA-funded U.S. Phase III trials for intercept red blood cells. We continue to anticipate providing the top-line readout after the data are unblinded in the near future. Between continued momentum in our commercial business and increased visibility into our pipeline, we look forward to providing you with updates throughout the year. Thank you for your continued interest in Cirrus. I will now turn the call over to the operator for questions.
spk01: As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster. Our first question will come from the line of Jacob Johnson with Stevens.
spk16: Hey, good afternoon, everybody. Congrats on the quarter. Maybe starting off on IFC, good to see the 8 to 10 million expectation in 2024. Maybe just for reference, could you kind of give us what that was in 2023? And then, you know, as this continues to hit its stride, can you just remind us the potential TAM for this offering and how we should think about the three to five year outlook for the IFC ramp?
spk07: Thanks, Jacob. I'll let him take this.
spk02: Thanks, Toby. Thanks, Jacob, for the question. You know, the guidance range for 2024 assumes about a 30% to 50% growth rate versus prior year. I think in the past we've talked about the TAM for the business being on the order of $200 million to $300 million. Part of it is going to be a function Obviously, as the blood center channel picks up the product and we sell through blood centers, it's going to be a combination of direct sales to hospitals and then also sales through blood center partners. But what I think is most encouraging for us is we announced the collaboration with large blood centers at the end of last year. We saw those first orders come through. And through the first few months of 2024, we're seeing continued pickup and new hospital activation. So I think we're all encouraged about the growth prospects for this franchise.
spk16: Got it. Thanks for that, Vivek. And then maybe, Kevin, for you, good to see the positive EBITDA in the quarter. You mentioned kind of sustaining, if not improving that, I guess, kind of as we're thinking about 2024, is a reasonable assumption positive EBITDA for the entire year, kind of like 4Q? Or could we see even kind of EBITDA be positive on a quarterly basis, if you could help us on that side of things?
spk11: Yeah, so our top-line guidance doesn't necessarily suggest linearity. So there is some chop to it. But for the balance of the year, we do expect in our targeting at least neutrality, if not improvement from the Q4 level. So I think we've got a lot of reasons to believe that that is very doable. And while we may see some chop quarter to quarter, I think for the balance of the year, we're moving in the right direction there.
spk15: Got it. Thanks, Kevin, and thanks for taking the questions. You bet. Thank you.
spk09: Thanks, Jane.
spk01: Our next question will come from the line of Emily Christie with Stiefel.
spk13: Good afternoon. Just a couple for me. I appreciate the transparency on the IFC business. That's great. Just on international issues, It sounds like Canada's on track with expectations. Can you talk to any other geographies that might be notable in 2024, like if we should expect meaningful contribution from Germany, and then maybe if there's an update from China from the regulatory situation there?
spk09: Great. Thanks, Emily. I'll let Vivek take the first part of that question, and then I'll answer the China one.
spk02: Sure. Thanks for the questions, Emily. You know, a lot of the growth that we're expecting this year is a combination of continued depth with existing customers, their growth opportunities, and geographies where we've already started. So you referenced Canada. We certainly are anticipating continued progress in Germany. We also believe that the Middle East. I was recently at the Med Lab Congress in Dubai. There are great growth opportunities there, and they tend to draft off of what the US FDA does in terms of the blood banking community in that region. So we feel like there are meaningful pools of growth across the globe in terms of our platelet business and then it's referenced earlier in the call the US IFC business will start to be a meaningful growth driver as well so it's really a combination of factors but fundamentally what we're seeing is we're going deeper with customers and there's still significant headroom for growth I'll be I'll kick it back to you regarding China yeah thanks a lot Vivek yeah so regarding China we've submitted to the NMPA last year as you recall
spk09: and are in the process of receiving questions and feedback from the NMPA. It was a little delayed at the start of this year just because of the Lunar New Year, but it's underway. To date, we don't have any indication of a clinical trial being necessary, but we're not complete with the NMPA review yet.
spk13: Okay, great. And if I can just sneak one more in. We don't talk a lot about pricing. But I'm wondering how we should be thinking about pricing power in both new markets and in those where you have high penetration rates already.
spk07: Yeah, thanks, Emily. Again, I'll turn that back over to Vivek. Sure.
spk02: Yeah, we've been seen stable to slightly increasing pricing in light of inflation and other things. I feel really good about the pricing discipline that we've been able to execute on a global basis. I think Given the benefits of pathogen reduction and certainly the clinical benefits of IFC, we've been able to have more discussion around clinical utility and value than going in and competing against price. I mean, hospitals and blood banks certainly have budgetary constraints or are under pressures, but I think the global sales team has been disciplined in terms of ensuring that we're realizing value for the offering we're bringing.
spk01: Great. Thanks so much for the questions.
spk07: Yeah, thanks a lot, Emily.
spk01: Our next question will come from the line of Mark Massaro with BTIG.
spk14: Mark, your line is now open. Hey, guys. This is Vivian on for Mark. Thanks for taking the questions. So just on the 2024 guide, it looks like it calls for a bounce back in platelets in the U.S. business. So I just wanted to confirm what's excluded from the guide and where you're seeing sources of potential upside. And then maybe if you could also touch on any seasonality we should be modeling for in that. Thank you.
spk09: Yeah, thanks a lot, Vivian. Vivek, I'm sorry to turn it back over to you, but you're best placed to answer that question.
spk02: Yeah, no problem. I'm sorry. The first part of that question cut out on my end. Could you repeat that? Or maybe, Obi, if you could paraphrase that.
spk14: Just the puts and takes in the 24 guidance seasonality as well.
spk02: Okay, fair enough. You know, I think as we mentioned earlier, we're seeing sort of stabilization and strengthening across our business, but we have not modeled in in terms of embedded in our guidance as an example. a restocking of inventory levels at blood centers as we see improved shelf life in the U.S. Nor have we modeled in any accelerated assumptions around the recovery of platelet donors in Europe and the U.S., which leads to overall growth in the platelet market. So what we are really focused in on as we work kind of hand in glove with the blood center operations folks and our deployment teams, we're seeing continued ramp up in intercephalate production and then, you know, continued pass through the hospitals. And then on the ISC side, we're seeing a fairly methodical and strong ramp up in new hospitals. And when we get into hospitals in a particular clinical discipline, say, you know, high-risk OB as an example, once you get a couple of clinicians with experience with the product, we see that product being adopted in other hospitals. clinical centers in the hospital and see us gaining depth there. So those are the sort of some modeling assumptions that underpin our current growth assumptions and the guidance for the full year. But we've tried to really, I think, be sober to the challenges we've faced historically, but recognize we've got a few tailwinds right now at our back, which is a good place to be.
spk14: That's perfect. Thank you. And then just to follow up, as far as the recipe study, which I think should be reading out shortly here, could you just remind us what your expectations are there and just how that's tracking?
spk09: Yeah, thanks a lot, Vivian. So the database is locked for the recipe study, so we should be unblinding that data in the near term. As far as the study design, it's just to remind you all that it's a non-inferiority study design in cardiovascular surgery patients, many of whom are on bypass. with an acute kidney injury endpoint. And that was modeled after a bunch of publications in cardiovascular surgery recipients who had AKI rates typically, who were getting transfused, who typically had an AKI rate in the range of 28 to 30%. And the margin of non-inferiority for the study between test and control is 50%. Great.
spk14: Thanks so much for taking the questions.
spk07: Thanks very much, Vivian.
spk01: That concludes today's question and answer session. I'd like to turn the call back to Obi Greenman for closing remarks.
spk09: Well, thank you again for joining us today and for your interest in Cirrus. We will be presenting tomorrow at the T.D. Cowan's 44th Annual Healthcare Conference, and we look forward to sharing our progress with you throughout 2024.
spk01: This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you. Thank you. Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Sears Corporation fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Jessica Hanover, Cirrus Vice President of Corporate Affairs. Dr. Hanover, you may begin.
spk12: Thank you and good afternoon. I'd like to thank everyone for joining us today. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at ir.cirrus.com. With me on the call are Obi Greenman, Cirrus' President and Chief Executive Officer, Vivek Jayaraman, Cirrus' Chief Operating Officer, Kevin Green, Cirrus' Chief Financial Officer, and Carol Moore, Cirrus' Senior Vice President of Regulatory Affairs and Quality. Cirrus issued a press release today announcing our financial results for the fourth quarter and year ended December 31, 2023, and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.siris.com. I'd like to remind you that some of the statements we will make on this call related to future events and performance, rather than historical facts, and our forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2024 product revenue guidance, our expectations for bottom line and non-gap adjusted EBITDA performance and our expected expense levels, expected future growth and our growth trajectory, the availability and related timing of data from clinical trials, and other statements that are not historical fact. These forward-looking statements involve risks and uncertainties that could cause actual events, performance, and results to differ materially. They are identified and described in today's press release, in our slide presentation and under risk factors in our Form 10-K for the year ended December 31, 2023, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, we will also be discussing non-GAAP financial measures, including non-GAAP adjusted EBITDA. These non-GAAP measures should be considered a supplement to and not a replacement for measures presented in accordance with GAAP For reconciliation of non-GAAP financial measures to the most comparable GAAP financial measures, please refer to today's press release and the slide presentation available on our website. We'll begin today with opening remarks from Obie, followed by Vivek to discuss recent business highlights, then Kevin to review our financial results and expectations for the rest of 2024, and lastly, closing remarks from Obie. And now it's my pleasure to introduce Obi Greenman, Cirrus's President and Chief Executive Officer.
spk09: Obi Greenman Thank you, Jessica, and good afternoon, everyone. I'd like to open the call by spending a few minutes reflecting on 2023 as well as our expectations for 2024. During the fourth quarter of 2023, we surpassed the 16 million mark for cumulative kits sold for trans-usable intercept platelet and plasma doses. It's a significant figure, particularly with respect to the absolute number of patients who receive intercept-treated blood components on a daily basis across the globe. And it also represents the ever-growing and significant role played by our pathogen inactivation technology in the evolving healthcare landscape. The importance and relevance of pathogen inactivation were also visible during a special webinar in January of this year hosted by Yale University the American Red Cross, and the Association for the Advancement of Blood and Biotherapies, or AAVB. The event was focused on addressing platelet insecurity with speakers from blood centers such as the American Red Cross and Canadian Blood Services, as well as from hospitals, the military, and government organizations. In addition to the recognition of the growing demand for platelets in the face of blood supply vulnerabilities, It is also clear that pathogen inactivation has become a foundational aspect of today's transfusion medicine landscape. It is this dynamic that drives our excitement about the continued potential for the intercept business, both in the U.S. and across the globe. We anticipate the near future to be driven by both international expansion of intercept platelets, as well as an increasing growth trajectory for intercept fibrinogen complex, or IFC, in the U.S. The VAPE will provide additional commentary on our commercial expectations following my introductory comments. We ended 2023 on several high notes, posting double-digit sequential growth for the fourth quarter, narrowing gap net loss attributable to Cirrus, and importantly, delivering positive non-gap adjusted EBITDA for the first time. Per our 2024 product revenue guidance announcement earlier this year, we expect to post year-over-year double-digit growth along with sustaining if not improving, bottom line results. Kevin will provide more details in his comments following the vague. I would now like to turn the call over to the vague to discuss our commercial results and progress for the fourth quarter and full year 2023, along with color on the outlook for 2024.
spk02: Thank you, Obi, and good afternoon, everyone. As Obi indicated, we delivered strong sequential and year-over-year growth in the fourth quarter of 2023. This growth was driven by our Platelet franchise globally, as well as encouraging progress within our US IFC business. With inventory levels that most of our blood center partners stabilized, we witnessed a return to more typical ordering, manufacturing, and reordering patterns. Furthermore, we saw growth in both existing accounts, as well as a meaningful step up in new account activation, notably in our IFC business. Our Platelet franchise delivered strong growth across the globe. In the U.S., we believe that most of our customers have properly adjusted their intercept inventory in light of product dating issues and are now ordering at more consistent rates. As we make progress on our real-time aging studies, we remain confident in our ability to extend platelet kit shelf life. While we are not currently assuming material uplifts in revenue associated with increased dating, we do believe this will likely lead to more comfort at the blood center to hold inventories. We continue to see positive traction at our blood center customers and believe Intercept remains the leading technology for platelet safety in the U.S. Our early experience in 2024 suggests that our U.S. platelet franchise is poised for solid growth this calendar year. Internationally, Canadian Blood Services, or CBS, is closing in on completing its rollout of Intercept platelets across its entire production operation. In the fourth quarter, CBS completed its implementation of Intercept for whole blood-derived platelets which included its largest site in Brompton in the greater Toronto area. With this activity, now more than 85% of CVS platelet units issued to hospitals are intercept treated. In other words, the majority of platelet doses issued to hospitals in Canada are now intercept treated. CVS remains on track to complete the transition to 100% intercept platelets in the first half of this year. As it implements intercept for apheresis platelets at three sites, two of which are already producing whole blood intercept platelets. Meanwhile, Hemicobec, which produces approximately 25% of Canada's platelet supply, continues to advance its validation of intercept platelets. Q4 2023 was a strong quarter for our US IFC business. We gained commitment from blood centers to distribute IFC while starting commercial use at a number of influential hospitals. Our field sales organization meaningfully increased our in-hospital engagement, and we were able to host effective peer-to-peer educational forums at both key congresses and in one-off settings for hospitals. Real-world use of IFC continues to grow, and it has been encouraging to see the clinical enthusiasm for the offering. This momentum has continued through the first two months of 2024, and we feel confident in our ability to deliver compelling growth with our IFC business. On a going-forward basis, we will provide you with more detail on the progress we are making with IFC, and I am confident you will gain a greater appreciation for why we are excited about this business. I will now turn it over to Kevin to discuss our results and outlook in more detail.
spk11: Thank you, Vivek, and hello to everyone listening. On today's call, I will be discussing our financial results for the fourth quarter and full year of 2023, as well as our product revenue guidance for 2024. Beyond the line item components of our P&L, I'll be providing a breakdown on our important fourth quarter achievement of narrowed gap net loss attributable to CIRAS, coupled with reaching our target of non-GAAP adjusted EBITDA breakeven. This achievement marks the first time in the company's history of delivering positive adjusted EBITDA, and we are committed to sustaining, if not improving on this measure, for the full year 2024 as well. As preannounced in January, we posted product revenue of $46.8 million for the fourth quarter of 2023, representing year-over-year growth of 6%, and up 18% sequentially from Q3. Full year 2023 product revenues of $156.4 million were, as expected, down 4% year over year and in line with our guidance. In the U.S., fourth quarter 2023 product revenues exceeded prior year levels. Importantly, fourth quarter U.S. product revenues were up sequentially by 22% from Q3. In EMEA, fourth quarter product revenues were up 3% year over year, at around 2% compared to the third quarter of 2023. Year over year, FX rates provided a benefit for the EMEA business of around 430 basis points. On a consolidated basis, FX provided a benefit of around 1.3% when comparing Q4 2023 to that of the prior year period. and little to no impact on the full year comparative results. In addition to our product revenue and not included in our guidance, government contract revenue totaled $6.6 million in Q4 compared to $7.3 million for the prior year period. The conclusion of enrollment in our recipe study is the primary driver for the slight decline. Included in our government contract revenue are the revenues recognized as reimbursement under our contract with BARDA, our agreement with the FDA to further whole blood pathogen reduction, and our milestone-based agreement with the U.S. Department of Defense for lyophilized IFC. Let's turn now to our product gross profit and gross margins. Our fourth quarter product gross profit was $26 million, compared to $24.5 million during the prior year period. an increase of 6% year-over-year. Product growth margins for the quarter were 55.5%, relatively stable when compared to the prior year, and up slightly from Q3. These results are consistent with our expectations and our previous remarks during prior quarter calls. Q4 2023 margins improved over 2022 levels primarily due to increased volumes and lower inventory costs compared to the prior year, offset by net foreign exchange rate impact on our reported margins. Moving on, our fourth quarter operating expenses, which totaled $31.6 million, were over $10 million lower than the prior year period of $41.8 million, a 24% decline. Q4 2023 operating expenses included $4.9 million in non-cash stock-based compensation. By specific expense type, fourth quarter R&D expense totaled $14.3 million compared to $18.6 million during the prior year period. The impact of our June 2023 restructuring continued to result in lower ongoing costs, combined with lower costs associated with the recipe trial enrollment completion. Ongoing R&D expenses included, but were not limited to, work under our government contracts, CE-MARC pursuit for our red blood cell program, development work on our Next Generation Illuminator, ongoing change control work, and interactions with regulatory agencies. Beyond R&D, fourth quarter SG&A expenses were $17.3 million compared to $23.2 million during the prior year period. Similar to the R&D drivers, SG&A costs were lower year-over-year, in part due to the impact of our June 2023 restructuring, as well as lower non-restructuring-related compensation costs. We continue to expect that the financial benefit from our restructuring will provide at least $10 million in annual life savings relative to expense levels at the time of the restructuring. Let's focus on the bottom line and non-GAAP adjusted EBITDA results, which are perhaps the strongest financial results that we have to talk about on today's call. On the bottom line, reported net loss attributable to Cirrus for the three months ended December 31st, 2023 improved significantly when compared to the same period in the prior year. Net loss attributable to Cirrus for Q4 totaled $1.3 million, or a penny per diluted share, compared to $13.6 million, or $0.08 per diluted share for the prior year period. These results are also directly reflected in our non-GAAP adjusted EBITDA measure. As you can see from the results, and which I'm happy to announce, we surpassed our goal of breakeven and, in fact, generated almost $5 million of positive non-GAAP adjusted EBITDA. When compared to negative $3.7 million for the fourth quarter of 2022, and negative $1 million during the third quarter of 2023. This result is an improvement of over $8 million and $5 million respectively. This is a significant milestone in our history. And while we're clearly pleased with the results, we are committed to sustaining, if not improving upon it for 2024. As we had predicted, the combination of strong growth in our top line, coupled with stable margins and closely managed operating expenses allowed us to surpass non-GAAP-adjusted EBITDA breakeven in the fourth quarter. While we may have some fluctuations from quarter to quarter this year, we expect that with our product revenue guidance, coupled with stable and perhaps slightly improving gross margins, continued leverage from the business, and close management of operating expenses will support potential improvement on this measure for 2024. On the balance sheet and associated cash flows, We ended the fourth quarter with a cash position of $65.9 million of cash, cash equivalents, and short-term investments on the balance sheet. In terms of cash utilization, our cash use from operations was $15.2 million for the fourth quarter, compared to $1.8 million during the prior year period. As we've spoken about in the past, we saw significant increases in working capital use, specifically with increased inventory levels. During Q4, we also made a conscious decision to pay down our payables due. As we now look to 2024, we expect that with the anticipated increase in revenues, we will work down our inventory balances, maintain payable levels near December 2023 levels, and manage other working capital line items. We expect that these initiatives and results will translate into improvements in operating cash flows for 2024, and could potentially result in positive operating cash flows for the year. Turning to our guidance, as we pre-announced in January, we expect full-year 2024 product revenue guidance to be in the range of $172 million to $175 million, reflecting double-digit growth from 2023. We anticipate this growth to be fueled by continued expansion of the Intercept Platelet business both in North America and Europe, as well as continued uptake of IFC in the U.S. As Vivek mentioned, we firmly believe in the prospects for IFC, evidenced by our commercial sales agreements with large national blood providers, as well as the growing utilization and recognition of the product's benefit at an increased number of U.S. hospitals. For the first time, we are now providing annual revenue guidance for IFC, which for 2024, we expect to be in the range of eight to $10 million. Going forward on a quarterly basis, we plan to break out IFC revenue on a comparative basis to provide visibility into our progress towards our guidance. I'd now like to turn the call back over to Obi for some closing remarks.
spk09: Thank you, Kevin. For the first two months of 2024 in the rear view mirror, we remain positive about the rest of the year ahead of us. With respect to the recipe trial, the first of two BARDA-funded U.S. Phase III trials for intercept red blood cells. We continue to anticipate providing the top-line readout after the data are unblinded in the near future. Between continued momentum in our commercial business and increased visibility into our pipeline, we look forward to providing you with updates throughout the year. Thank you for your continued interest in Cirrus. I will now turn the call over to the operator for questions.
spk01: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question will come from the line of Jacob Johnson with Stevens.
spk16: Hey, good afternoon, everybody. Congrats on the quarter. Maybe starting off on IFC, good to see the 8 to 10 million expectation in 2024. Maybe just for reference, could you kind of give us what that was in 2023? And then, you know, as this continues to hit its stride, can you just remind us the potential TAM for this offering and how we should think about the three to five year outlook for the IFC ramp?
spk07: Thanks, Jacob. I'll let him take this.
spk02: Thanks, Toby. Thanks, Jacob, for the question. You know, the guidance range for 2024 assumes about a 30% to 50% growth rate versus prior year. I think in the past we've talked about the TAM for the business being on the order of $200 million to $300 million. Part of it is going to be a function Obviously, as the blood center channel picks up the product and we sell through blood centers, it's going to be a combination of direct sales to hospitals and also sales through blood center partners. But what I think is most encouraging for us is we announced the collaboration with large blood centers at the end of last year. We saw those first orders come through. And through the first few months of 2024, we're seeing continued pickup and new hospital activation. So I think we're all encouraged about the growth prospects for this franchise.
spk16: Got it. Thanks for that, Vivek. And then maybe, Kevin, for you, good to see the positive EBITDA in the quarter. You mentioned kind of sustaining, if not improving that, I guess, kind of as we're thinking about 2024, is a reasonable assumption positive EBITDA for the entire year, kind of like 4Q? Or could we see even kind of EBITDA be positive on a quarterly basis, if you could help us on that side of things?
spk11: Yeah, so our top-line guidance doesn't necessarily suggest linearity, so there is some chop to it. But for the balance of the year, we do expect in our targeting at least neutrality, if not improvement from the Q4 level. So I think we've got a lot of reasons to believe that that is very doable. And while we may see some chop quarter to quarter, I think for the balance of the year, we're moving in the right direction there.
spk15: Got it. Thanks, Kevin, and thanks for taking the questions. You bet. Thank you.
spk09: Thanks, Jayden.
spk01: Our next question will come from the line of Emily Christie with Stiefel.
spk13: Good afternoon. Just a couple for me. I appreciate the transparency on the IFC business. That's great. Just on international It sounds like Canada's on track with expectations. Can you talk to any other geographies that might be notable in 2024, like if we should expect meaningful contribution from Germany, and then maybe if there's an update from China from the regulatory situation there?
spk09: Great. Thanks, Emily. I'll let Vivek take the first part of that question, and then I'll answer the China one.
spk02: Sure. Thanks for the questions, Emily. You know, a lot of the growth that we're expecting this year is a combination of continued depth with existing customers, their growth opportunities, and geographies where we've already started. So you referenced Canada. We certainly are anticipating continued progress in Germany. We also believe that the Middle East has recently had the MedLab Congress in Dubai. There are great growth opportunities there, and they tend to draft off of what the US FDA does in terms of the blood banking community in that region. So we feel like there are meaningful pools of growth across the globe in terms of our platelet business. And as referenced earlier in the call, the US IFC business will start to be a meaningful growth driver as well. So it's really a combination of factors. But fundamentally, what we're seeing is we're going deeper with customers and there's still significant headroom for growth. I'll kick it back to you regarding China.
spk07: Yeah, thanks a lot Vivek.
spk09: So regarding China, we've submitted to the NMPA last year, as you recall, and are in the process of receiving questions and feedback from the NMPA. I was a little delayed at the start of this year just because of the Lunar New Year, but it's underway. To date, we don't have any indication of a clinical trial being necessary, but we're not complete with the NMPA review yet.
spk13: Okay, great. And if I can just sneak one more in. We don't talk a lot about pricing. But I'm wondering how we should be thinking about pricing power in both new markets and in those where you have high penetration rates already.
spk07: Yeah, thanks, Emily. Again, I'll turn that back over to Vivek. Sure.
spk02: Yeah, we've been seen stable to slightly increasing pricing in light of inflation and other things. I feel really good about the pricing discipline that we've been able to execute on a global basis. I think Given the benefits of pathogen reduction and certainly the clinical benefits of IFC, we've been able to have more discussion around clinical utility and value than going in and competing against price. I mean, hospitals and public banks certainly have budgetary constraints or are under pressures, but I think the global sales team has been disciplined in terms of ensuring that we're realizing value for the offering we're bringing.
spk01: Great. Thanks so much for the questions.
spk07: Yeah, thanks a lot, Emily.
spk01: Our next question will come from the line of Mark Massaro with BTIG. Mark, your line is now open.
spk14: Hey, guys. This is Vivian on for Mark. Thanks for taking the questions. So just on the 2024 guide, it looks like it calls for a bounce back in platelets in the U.S. business. So I just wanted to confirm what's excluded from the guide and where you're seeing sources of potential upside. And then maybe if you could also touch on any seasonality we should be modeling for in that. Thank you.
spk09: Yeah, thanks a lot, Vivian. Vivek, I'm sorry to turn it back over to you, but you're best placed to answer that question.
spk02: Yeah, no problem. I'm sorry. The first part of that question cut out on my end. Could you repeat that? Or maybe, Obi, if you could paraphrase that.
spk14: Yeah, just to put some takes in the 24 guidance as well.
spk02: Okay, fair enough. You know, I think as we mentioned earlier, we're seeing sort of stabilization and strengthening across our business, but we have not modeled in in terms of embedded in our guidance as an example. a restocking of inventory levels at blood centers as we see improved shelf life in the U.S. Nor have we modeled in any accelerated assumptions around the recovery of platelet donors in Europe and the U.S., which leads to overall growth in the platelet market. So what we are really focused in on as we work kind of hand in glove with the blood center operations folks and our deployment teams, we're seeing continued ramp up in intersepolate production and then, you know, continued pass through the hospitals. And then on the ISC side, we're seeing a fairly methodical and strong ramp up in new hospitals. And when we get into hospitals in a particular clinical discipline, say, you know, high-risk OB as an example, once you get a couple of clinicians with experience with the product, we see that product being adopted in other hospitals. clinical centers in the hospital and see us gaining depth there. So those are the sort of some modeling assumptions that underpin our current growth assumptions and the guidance for the full year. But we've tried to really, I think, be sober to the challenges we face historically, but recognize we've got a few tailwinds right now at our back, which is a good place to be.
spk14: That's perfect. Thank you. And then just to follow up, as far as the recipe study, which I think should be reading out shortly here, could you just remind us what your expectations are there and just how that's tracking?
spk09: Yeah, thanks a lot, Vidyan. So the database is locked for the recipe study, so we should be unblinding that data in the near term. As far as the study design, it's just to remind you all that it's a non-inferiority study design in cardiovascular surgery patients, many of whom are on bypass. with an acute kidney injury endpoint. And that was modeled after a bunch of publications in cardiovascular surgery recipients who had AKI rates typically, who were getting transfused, who typically had an AKI rate in the range of 28 to 30%. And the margin of non-inferiority for the study between test and control is 50%. Great.
spk01: Thanks so much for taking the questions.
spk09: Thanks very much, Vivian.
spk01: That concludes today's question and answer session. I'd like to turn the call back to Obi Greenman for closing remarks.
spk09: Well, thank you again for joining us today and for your interest in Cirrus. We will be presenting tomorrow at the T.D. Cowan's 44th Annual Healthcare Conference, and we look forward to sharing our progress with you throughout 2024.
spk01: This concludes today's conference call. Thank you for participating. You may now disconnect.
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