Cerus Corporation

Q1 2022 Earnings Conference Call

5/5/2022

spk01: Good day, ladies and gentlemen. Thank you for standing by and welcome to the Sears Corporation First Quarter 2022 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. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker host today, Mr. Matt Notaryani, Senior Director of Investor Relations. Mr. Notaryani, you may begin.
spk07: 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, Kevin Green, Cirrus' Chief Financial Officer, Vivek Jayaraman, Cirrus' Chief Operating Officer, Carol Moore, Cirrus' Senior Vice President of Regulatory Affairs and Quality, and Jessica Hanover, Cirrus' Vice President of Corporate Affairs. Cirrus issued a press release today announcing our financial results for the first quarter ended March 31, 2022, and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.cirrus.com. I'd like to remind you that some of the statements we will make on this call relate 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 2022 product revenue guidance and goals, operating expenses, anticipated cash use from operation, gross profits and gross margins, as well as commercial development efforts, future growth and growth strategy, future product sales, product launches, ongoing and future clinical trials, ongoing and future product development, and our regulatory initiatives, including the timing of these events and activities. These forward-looking statements involve risk and uncertainty that can cause actual events, performance, and results to differ materially. They are identified and described in today's press release and under risk factors in our Form 10-K for the year end of December 31st, 2021, and our Form 10-Q for the quarter ended March 31, 2022, which we will file shortly. We undertake no duty or obligation to update our forward-looking statement. On today's call, we'll begin with some opening remarks from Obie, followed by Vivek to discuss some recent business highlights, and Kevin to review our financial results. We will conclude with commentary from Obie with an update on our pipeline and closing remarks. 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 a reconciliation of non-GAAP financial measures to comparable GAAP financial measures, please refer to today's press release. And now, it's my pleasure to introduce Obi Greenman, CSRS President and Chief Executive Officer.
spk06: Thank you matt and good afternoon everyone our first quarter of 2020 to continue the momentum, we have seen over the past few years has intercepted option, particularly in the US is ramping. Our work is focused on establishing a new safety standard in transfusion medicine so blood centers and transfusion services can protect patients and ensure availability of blood components. In the context of the current pandemic and the prospect for future risk to the blood supply, the Cirrus mission is as relevant as it has ever been over the company's history. I am pleased that growing our top line means expanding access to intercept treated platelets and plasma for patients around the world. After I discuss our quarterly results, Vivek will spend some time today discussing recent significant announcements associated with long-term contract extensions with both the American Red Cross and Fresenius Cobby. But first, let's review the first quarter revenue highlights. Product revenues for the first quarter of 2022 are the highest for any first quarter in our history, as we report year-over-year growth in all major geographic regions to start 2022. With our 20th consecutive quarter of year-over-year revenue growth, we are demonstrating an enduring ability to expand access to intercept-treated blood components, even in the face of geopolitical and economic uncertainty. Our results were once again led by strong growth for platelets in the U.S., which was up over 130% on a year-over-year basis. Blood centers and hospitals are choosing the Intercept blood system for platelets as a means to comply with the FDA bacterial safety guidance because it provides proactive, broad-spectrum protection against pathogens beyond just bacteria, while also offsetting costs and generating operational benefits. As we look to diversify the ongoing growth of the Intercept platelet business in the U.S. and globally, We are making solid progress with our nationwide launch of intercept fibrinogen complex, or IFC, across the U.S. We have a robust funnel of accounts we look forward to bringing online through 2022 and into 2023. And we are just beginning to realize the leverage of our combined direct-to-hospital and blood center sales channels. As we know well from our prior product launches, bringing a new product into hospital transfusion services and changing clinical practice is a significant undertaking. But we are benefiting from the strong clinical interest around the opportunity to improve the patient treatment paradigm through the early administration of a fibrinogen-enriched product without delay, while also reducing frequent conventional blood product wastage. Hospitals that have adopted IFC are quickly seeing numerous benefits compared to conventional cryoprecipitate. Perhaps the most compelling example is at the University of Florida Shands Hospital, where IFC has now been included in the first round of the institution's massive transfusion protocol, and wastage rates have been reduced from over 20% to less than 0.5%. With an estimated demand for fibrinogen expected to grow in the mid-teens over the next five years, we are excited to be rolling out IFC across the country at a time when the awareness around early fibrinogen delivery is growing, both as a function of improved coagulation monitoring and lower transfusion thresholds. I would now like to hand the call over to Vivek to provide some updates about two of our partners, the American Red Cross and Fresenius Cabi.
spk04: Thank you, Obi, and good afternoon. It is great to be able to share these results with you all today. In addition to the strong start to the year, I want to spend a few moments talking about a couple of recent developments that position us well for the long term, both commercially and operationally. First, last week we made an exciting announcement regarding our relationship with the American Red Cross. We are honored to have announced a five-year contract extension for intercept platelets with the American Red Cross. As you know, the Red Cross is responsible for supplying the U.S. with about 40% of its blood products. Their leadership in areas of transfusion medicine, like blood safety, serves as a model for other blood centers and national transfusion services globally. Because of Red Cross's focus on patient safety and timely compliance with the FDA guidance on platelet bacterial risk mitigation, Red Cross has become the largest producer of intercept components and is now our largest customer. The Intercept blood system for platelets is in routine use at each of the Red Cross's 22 platelet production sites across the U.S. This contract extension will help them realize their stated goal to transition toward a full patched and reduced platelet supply and represents yet another validation of the Intercept blood system and its ability to improve platelet availability while affording operational benefits when standardizing with an Intercept treated platelet inventory. Moving on to another recent announcement, we have also signed a 10-year contract extension with Fresenius-Cabe for the production of intercept kits. We are very excited about this agreement as well. The FENWAL team at Fresenius-Cabe has been a key partner to Cirrus for more than 20 years. And with this new agreement, we are able to ensure that additional capacity as well as redundancy in our manufacturing facilities are in place for the next decade. In anticipation of ever increasing production volume, this agreement will allow us to both reline additional economies of scale and also improve the cost profile for the intercept kit portfolio. On a related note, our manufacturing capacity efforts that we highlighted in our last quarterly call continue to track the plan. We look forward to completing the rest of this work, including obtaining the necessary regulatory approvals, which will help bring this capacity online. I will now turn it over to Kevin discuss our results in more detail.
spk08: Thanks, Vivek, and good afternoon, everyone. I'm pleased to provide the following update to you all today, recapping our first quarter and also spending some time discussing our non-GAAP-adjusted EBITDA measure, which we are reporting alongside our GAAP results today. Our first quarter 2022 product revenue of $37.4 million reflects year-over-year growth of 60%, and importantly, all of our major regions. North America, EMEA, and the rest of the world posted positive growth during the quarter. As anticipated, the growth in sales we saw in North America continues to lead the way, up 130% versus the prior year period. As a bit of context, our first quarter revenue in North America of $22.2 million is nearly as large as our total global product revenue was during the first quarter of 2021. Within North America, our sales to the top five US blood centers and the sales to the group of blood centers outside of the top five, both grew by more than 100% year over year. Turning to EMEA, the region returned to strong growth in the first quarter of 2022, up 11% year over year, and up 19% excluding the negative impact of foreign currency. Growth in the region was broad-based during the quarter, despite the turmoil that has been capturing headlines in Eastern Europe in particular. Moving on to our calculated platelet dose metrics, our first quarter growth in the calculated number of treatable platelet doses reflects a 141% year-over-year increase in the U.S. and a 28% increase internationally. In terms of product mix for the quarter, sales of Intercept disposable kits represented nearly 98% of our Q1 product revenue. In addition to our product revenue, and not included in our guidance, government contract revenue totaled $5.6 million in Q1 versus $6.2 million for the prior year period. Turning now to our gross profit and gross margins. Our first quarter gross profit was $19.4 million compared to $12.3 million during the prior year period, an increase of 58% year-over-year. The increase in gross profit was primarily driven by the higher product sales. Product gross margins for the quarter were 51.7%, which increased 60 basis points when compared to our Q4 2021 product gross margins. As we noted throughout 2021, our product gross margins were negatively impacted by higher sales volume of single-dose kits to U.S. customers, but had leveled out over the course of the year on a sequential basis. We expect a return to gross margin expansion on a full-year basis in 2022, as ongoing headwinds associated with elevated freight costs are expected to be offset by a more favorable product mix. as well as the beneficial COGS impact resulting from the recent decline in the Euro. Moving on, our first quarter operating expenses, which totaled $34.8 million, were fairly flat versus the prior year period and included $6.4 million in non-cash stock-based compensation. As you've heard me say over the years, we believe our business is structured to be able to generate significant operating leverage and I'm pleased that once again we are demonstrating our financial discipline in real time. By specific expense type, first quarter research and development expense totaled $14.1 million, compared to $15.7 million during the prior year. As we've seen projects reach completion and the associated spend roll off, we continue to invest in new R&D projects in support of our pipeline, including the new LED-based illuminators. First quarter SG&A expense was $20.7 million, up 8% versus the prior year period. With our existing commercial infrastructure, we have strong conviction that we will continue to see operating leverage as our product sales grow. On the bottom line, reported net loss attributable to CERES for the three months ended March 31st, 2022 decreased when compared to the same period in 2021. Net loss attributable to Cirrus for Q1 totaled $12.3 million, or $0.07 per diluted share, compared to $17.5 million, or $0.10 per diluted share for the prior year period. I would now like to take a few moments to discuss our non-GAAP adjusted EBITDA measure, which we have broken out for you for the first time this quarter. You'll recall this measure is intended to provide you with a view on how efficiently our commercial business is tracking to cash flow breakeven, which has been and continues to be a critical focus of the entire organization. As you can see on the current slide, we have prepared the calculation of this measure for the last five quarters. For the first quarter of 2022, our non-GAAP adjusted EBITDA was a negative $3.7 million. compared to a negative $11.5 million during the first quarter of 2021. To help everyone with historical modeling, we've provided the remaining quarterly reconciliations for 2021 and plan to continue to report this metric in future quarters as well. Over the last five quarters, we have seen a continued sequential improvement in our non-GAAP adjusted EBITDA. Turning to the balance sheet and cash flows, the first quarter of each year is typically our largest cash burn quarter due to a variety of seasonal items such as payment of certain accrued liabilities. With that said, we ended the first quarter in a strong cash position with $108.6 million of cash and cash equivalents on the balance sheet. In terms of cash flows, cash use from operations was $21.5 million for the first quarter compared to $17.5 million in the prior year period. Wrapping up my prepared remarks, with one full quarter behind us and the continued strong demand in the market, today we are raising our 2022 product revenue guidance range from $157 to $164 million to a new range of $160 to $165 million, which now reflects year-over-year growth in a range of 22% to 26%. As we indicated on our fourth quarter call a few months ago, we continue to closely manage the strong global customer demand we are seeing against our existing manufacturing capacity and inventory on hand. Additionally, the recent change in foreign currency rates, in particular the US dollar to Euro, results in a modest pressure to our top line versus our expectations earlier this year, but it's also offset further down the P&L, resulting in a neutral impact to the bottom line. Taken together, 2022 is shaping up to be another strong year of growth for Cirrus as we make solid progress on our key initiatives for the year, including facilitating further adoption of Intercept in Europe and the U.S., increasing our manufacturing capacity to meet the growing demand, launching our IFC product nationwide, executing on our targeted R&D portfolio, and moving towards our non-GAAP-adjusted EBITDA break-even goal. With that, let me turn the call back over to Obi to provide an update on our pipeline, as well as a few closing comments.
spk06: Thank you, Kevin. Before we open up to questions, I wanted to touch on a few quick updates about our R&D pipeline that continues to make good progress to start 2022. First, in China, we continue to work with our joint venture partner, ZBK, to bring intercept plates to this sizable market. While the recent COVID-imposed lockdowns have continued the challenges associated with regular meetings and other interactions in-country, our teams have been working together virtually on the plan to submit intercept playlists to the Chinese regulatory authorities with a goal of making this filing by the end of 2022. As a reminder, the need for an additional in-country clinical study beyond our previously completed Hong Kong study will be determined by the NMPA regulators after our filing. Finally, with regard to intercept red cells, our European submission continues through the CE-MARC progress as a Class III medical device, but the timeline has been impacted by bandwidth constraints by the competent authority CBG, who, like all others across Europe, have fallen behind schedule due to the MDD to MDR transition for medical devices. In the U.S., BARDA continues to fund and support our Phase III clinical studies. where we are seeing an uptick in enrollment as a function of the COVID impact waning a bit across the US sites. That said, we still see some regional differences in hospital engagement, and there remains an effort across the country to minimize blood component transfusions as a function of the national blood availability crisis during the pandemic. In summary, the entire Cirrus team continues to execute to make Intercept available to more patients across the globe each day. And we expect this to continue in the near term with our current portfolio of intercept playlets, plasma, and IFC, and over the long term with the addition of intercept for red cells and with continued geographic expansion to large markets like China. As we scale the business, I'm pleased with our progress to drive towards cash flow breakeven, which will provide us with the flexibility to self-fund our growth initiatives and our strong R&D pipeline. We believe our currently approved Intercept products, Intercept for red cells, and future product iterations position Cirrus as a leader in the field of transfusion medicine for many years to come. With that, let me turn it back over to the operator for Q&A.
spk01: Thank you, sir. Ladies and gentlemen, if you have a question at this time, please press star, then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Our first question comes from Brandon Folks. Sorry, our first question comes from Matthew Blackman from Stifel. Your line is open.
spk02: Buddy, thanks for taking my question. Just two for me to start. Maybe, Kevin, just a housekeeping one. I just want to see if I'm doing the math right. If I heard you correctly, the FX impact in the first quarter, was that roughly a million dollars? That's number one. And then you sort of touched on this. I was hoping to get a little bit more granularity. But in the new guidance, what's in there for FX versus maybe how we started the year? Clearly, you're absorbing it without performance. Just curious what the delta is in the new guidance versus where we started. And then just one follow-up after that. Yeah, you're right.
spk08: Matt, you're right. FX for the quarter was about $1 million, or roughly 4% year-over-year impact. On the bottom line, it's almost a wash, given that we source most of our product in Euro and are selling that to US customers. So as we begin to sell product that we procured at lower FX rates, we'll see some benefit from that as the US continues to grow. As far as what's in our guidance, I think, you know, we felt confident raising guidance, both lower end and top end. But with that said, do feel like there is some headwind potentially relative to Q1 and for sure where we started the year. So we had originally anticipated the year with roughly a 115 rate in mind, adjusted that down a bit. Who knows where it ends up, but we feel like we've factored that in to the new guides range.
spk02: Okay, appreciate it. And then the follow-up, maybe first for Vivek and maybe Kevin, too, to follow. But just a little bit more color on the Red Cross contract, Vivek. How does that improve your visibility, your ability to forecast, and I guess improve your ability – to serve the broader U.S. market? And then I'll just layer in the question for Kevin. How do we think about, if at all, the impact on the P&L from this? So I assume there are price volume tiers in there. I guess the question really asking is, should we be thinking about anything incremental that would somehow impact the top line or margins, just given the size of Red Cross as a customer? Thanks.
spk06: Yeah, Vic, I think you can handle both those questions for Matt. Why don't you go ahead?
spk04: Sure, happy to. Thanks for the question, Matt. You know, I think starting off memorializing the contract extension with the American Red Cross is critically important in large part because, you know, they had stated explicitly that they want to get to 100% PR. This puts the contractual relationship in place. I think it enables us from a demand management forecasting operations planning standpoint to step into the next few years very confident that that demand will be there and we can sort of prompt the manufacturing machinery accordingly. So both the ARC and the FK agreements really kind of go hand in glove. In terms of progress, visibility, forecasting, all of those have materially improved in large part. as they brought all of their manufacturing centers online. Interesting thing to note, and I think that actually bodes well for us on a going forward basis, we are starting to see some underlying market growth in the marketplace and some increase in the ARC percentage of that market. And so obviously if that goes to PR, both of those factors accrue to our benefit. It's still early days to be very definitive about that, but certainly the initial trends are encouraging. You know, I'll defer to Kevin maybe a discussion around potential P&L impact and margins, but I have to say for us, just it increases our level of confidence and conviction as we step forward in terms of the ARC continuing to be a major growth driver for our overall business.
spk08: Yeah, I don't really have a whole lot to add there. I think You know, it certainly gives us confidence, coupled with the new manufacturing agreement with Fresenius Cavi, to expand geographically and return to economies of scale, which admittedly in 2021 we didn't benefit from. So I think those two combined are fairly seminal contracts for the company.
spk02: All right. Thanks again, everybody. Congrats. Thanks, Matt.
spk01: Our next question comes from Brandon Fowkes with Cantor Fitzgerald. Your line is open.
spk03: Hi, thanks for taking my questions and congratulations on the quarter. So maybe just following on the Red Cross contract, how should we think about that contract being memorialized and maybe driving others to follow the Red Cross's lead there towards higher PR levels? Is there any precedent in terms of how we should think about how long that could take or how impactful that may be towards others?
spk06: Yeah, thanks for the question, Brandon. I'll take a shot at that and maybe Vic can add some more perspective as well. But fundamentally, the American Red Cross is a leader in the field as it relates to blood safety policy and things that the Red Cross does either operationally or for blood safety reasons directly. Does carry over to other institutions, both in the US and globally. So I think what we've been able to accomplish with the Red Cross and thanks to their early advocacy for pathogen reduction is to really show the are demonstrate the operational benefits. And and sort of in an environment where there's increasing play that demand and and inadequate supplier, at least, you know, the pandemic effect on donor availability. you're actually able to see the benefits of earlier release of products and so better shelf life combined with the fact that intercept playlets have a single SKU, if you will, in the sense that it obviates the need to do CMV testing or gamma radiation. So you have a single product code that could be moved around hospitals and between hospitals more efficiently. Vic, do you have any other thoughts on that?
spk04: You know, what I would add is that the leadership that the American Red Cross has shown even prior to the contract extension with respect to the open letter they wrote to the industry and their move towards ensuring that blood products are distributed and recognized for the value they deliver as opposed to being viewed as commodities, all of those efforts are already impacting the market. And oftentimes hospital customers in the U.S. have multiple blood product suppliers, yet they want to standardize on a particular platform. So as their platelets from the Red Cross are pathogen-reduced, that's creating a push on their other suppliers to harmonize across the pathogen-reduced standard. And so we are seeing that start to take place, and as Obi indicated, and as you well know, you know, this is a multi-billion dollar industry, but it's really a cottage industry. There is a small number of customers. They interact with each other as congresses start to resume in-person activity. And even in a virtual setting, the American Red Cross story in terms of their adoption of fat stream reduction and the benefits it's provided, not only them internally, but also their hospital customers and their patients, that messaging is getting out there. So, Predicting the exact timing of how it influences uptakes from others is an inexact science, but we're certainly seeing the impact and the influence that they have across not only the U.S., but globally in terms of blood safety.
spk03: Great. Thank you. I appreciate all the color from both of you, and congratulations again.
spk06: Thanks a lot, Brandon. Appreciate it.
spk01: Again, if you would like to ask a question, please press star 1 on your touchtone telephone. Your next question is from Josh Jennings with Cowen. Your line is open.
spk05: Hi, this is Eric, all for Josh. Thanks for taking the question. Just thinking about the OUS intercept platelet business, are there any international adoption decisions that could go Sirius's way in the near to medium term? I appreciate the update on your China submission that's set for later this year, but can we get an update on any other potential international market opportunities that could materialize in the next 12 months or so?
spk06: Yeah, thanks a lot, Eric. I'll start, and again, I'll turn it over to Vivek for additional perspective. We just have completed the submission for seven days in Canada and are happy to see that deployment sort of evolve quickly, and so we're hoping to see some real progress later this year and into 2023. I think it's always difficult to speculate on when some of these key markets, given that there's oftentimes just a single transfusion service that's running the transfusion medicine business in these countries. But there are always a number that are sort of in play. And, you know, obviously one of the key questions always is around Germany, given the size of that market. And so I'll maybe turn over to Vivek to add a little bit more context there.
spk04: I think you said it well, Obi. I mean, if you look at Canada and the progress we've made there, we anticipate impact really just start to show up later this year and into 2023. Similarly, we've talked in the past about Germany. That's the single largest market in Western Europe, and we're seeing good customer interest there, which we believe should start to materialize here over the course of the next couple of years also. The one watch out is just where we are with the pandemic and avoidance of any major ways going forward, but a lot of the initial spade work in some of these key geographies has been done, so it's a matter of continuing to push forward. There are some other markets where we have tender activity ongoing, but speculating on when a tender may come to fruition is always a bit risky, so we haven't necessarily banked on those in terms of our underlying forecast, but our goal is just to have sufficient arrows in our quiver such that when things materialize, we can continue to layer on meaningful growth over the course of the past three years, what's been pretty compelling top-line progress. So the international geographies will continue to be critically important for us on a going-forward basis, and those will be complemented by continuing strength in our U.S. franchises.
spk05: Okay, understood. And on the IFC launch, it's great to see you making progress, picking up BLAs with your partners across the country. When should we be thinking about a potential inflection point for IFC in our models here? Is early 2023 kind of the right way to be thinking about that?
spk06: Yeah, thanks, Eric. It's been great to see the progress we've made on the BLAs and that really opening up a nationwide launch here in Q1. And I think certainly with some of the headwinds that have been presented by uh, COVID, uh, and just sort of access to hospitals, you know, it's, it's, um, it's hard to, to make the progress, um, that, you know, you'd like to make, but at the same time, we're really excited about the clinician interest and, and the, and the contracting that's underway. Uh, but I think just to, to maybe give additional perspective, again, you know, the vex, you know, closest to this, do you have any additional thoughts?
spk04: Sure. You know, I'd say that, uh, the progress with our production partners and their ability to ramp supply coupled with what I think is a validation of the clinical end that need and the unique utility that IFC brings to clinicians. We've made meaningful progress on all of those fronts. Uh, it's a de novo product. So as you're probably aware, we ended up having to go to new product committees that either hospitals or, um, group purchasing networks. And those new product committee meetings have been held less frequently in COVID than previously. You know, if you think about all the work we did on the platelet side, a lot of the foundational work in terms of getting on contract, getting incorporated into hospital IT systems, things of that nature, that occurred before the COVID crisis hit. So when COVID hit, we were really driving same-store sales and going deep. Here, we're trying to do a lot of that initial preparatory work in the midst of COVID. Now, access is starting to open up a little bit more. Our reps have been able to get into hospitals, get in front of C-suite executives at key hospital networks, and we're starting to generate those initial influencers and key customers as evidenced by what we've seen in parts of the U.S., and so Things are opening up, and I think we're pretty optimistic, and that should lead to, over the course of the next few years, you know, 23 and beyond, really the IFC business being, you know, a strong driver in addition to our overall top-line progress.
spk05: That's great. Thank you for the questions. Thanks a lot, Eric.
spk01: Once again, if anyone would like to ask a question, please press star then the number one on your touchtone telephone. I am showing no further questions at this time. I would now like to turn the conference back to our President and CEO, Obi Greenman.
spk06: Well, thanks very much for joining us today and for your continued interest in Cirrus. We're looking forward to updating you on our progress throughout the remainder of the year and later this summer on our Q2 results. Thanks very much.
spk01: Thank you so much, presenters. Ladies and gentlemen, this concludes today's conference. Thank you again for your participation, and have a wonderful day. You may all disconnect.
Disclaimer

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