Cerus Corporation

Ladies and gentlemen, thank you for standing by, and welcome to the SARIS Corporation's fourth quarter and full year 2020 financial results 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 then 1 on your telephone. It is now my pleasure to introduce the SARIS management team. Please go ahead.

Thank you, and good afternoon. I'd like to begin by introducing myself. My name is Matt Notoriani, and I am Cirrus' Senior Director of Investor Relations. 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 Jay Araman, 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 ended December 31, 2020, 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 2021 financial guidance and goals, operating expenses, anticipated cash use from operations, 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 activities, including the timing of these events and activities. These forward-looking statements involve risk and uncertainty that could 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 ended December 31, 2020. 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 opening remarks from Obie, followed by Vivek to provide the commercial update, Kevin to review our financial results, followed by Obie, who will comment on some recent announcements, provide a pipeline update, and make some closing remarks. And now, it's my pleasure to introduce Obie Greenman, Cirrus' President and Chief Executive Officer.

Thank you, Matt, and good afternoon, everyone. Right now, hopefully you've had a chance to review our press release detailing our fourth quarter and full year 2020 results. It goes without saying that the 2020 was a year filled with many challenges, but it turned out to be a significant year of progress for Cirrus. In the face of a global pandemic that stretched the capabilities of healthcare systems everywhere, our dedicated team rose to the challenge continued to make progress on multiple fronts. Our goal remains to establish Intercept as the standard of care in transfusion medicine for safeguarding the global blood supply against pandemic and other threats. As I think about the COVID-19 pandemic, I'm reminded that the company was founded largely as a result of another global health emergency in our history, HIV. In those early days, our founders recognized that threats could emerge and influence medicine in unexpected ways. Fast forward to today, we are seeing this play out in real time, and I'm proud that Cirrus is at the forefront of pandemic preparedness. As evidenced by our 2020 results, our team has been tirelessly working to commercialize the system with the goal of protecting the global blood supply from potential threats, including those that are not yet known. It was not always easy to accomplish so much of this work virtually, but I'm grateful to our employees for their dedication, our partners for their commitment to our shared goals, and our customers for their unending commitment to the safety of the blood supply for patients around the world. While the challenges we face did not end as we turned this calendar forward, there's much to look forward to as we head into 2021. As the experts anticipated, COVID-19 cases, hospitalizations, and deaths surge during the winter months and remain elevated. While we do not expect COVID-19 and its associated disruptions to abate anytime soon, we at Cirrus remain focused on continuing the momentum we generated on multiple fronts during 2020. Before we look ahead, I'm pleased to report our results for the fourth quarter and full year. As you saw in January, we announced record fourth quarter and full year 2020 product revenues with year over year growth of 35% and 23% respectively. Demand for Intercept continues to grow despite the COVID-19 crisis. Earlier this year, we provided a first look at our product revenue guidance for 2021, which at this time we continue to expect will be in the range of $106 to $110 million. This range reflects year over year growth of between 15 to 20% from our full year 2020 results. During the quarter and in response to the ongoing disruption blood centers have seen as a result of COVID-19, the FDA announced a delay in the compliance deadline for its platelet safety guidance. Previously, you will recall the deadline was set for April 1st, 2021. As a result of the change, the new compliance deadline is now October 1st, 2021. Both this change in deadline as well as the ongoing impact of COVID-19 were factors that we contemplated and included when we put together our 2021 plan. While we do not plan to provide quarterly guidance, what we will say about the new timeline for compliance is that we expect continual momentum throughout the year as our existing customers increase their overall production of intercept-treated platelets and as new blood centers come online in order to be compliant by the new deadline. Our discussions with blood centers and hospitals suggest that this new deadline provides additional time to increase production capacity of intercept platelets in order to meet strong hospital demand. We continue to hear that the preference of our U.S. blood center and hospital customers will be to implement single-step methods in order to comply with FDA guidance using intercept and or LVDS, large volume delayed sampling. The extension of the deadline does not change our expectation that Intercept will become the standard of care in the U.S., given the numerous advantages it has versus the other options for compliance with the FDA guidance. Vivek will provide additional details on the U.S. play that market during his remarks. During the fourth quarter, we announced FDA approval for our pathogen-reduced cryoprecipitated fibrinogen complex product, or PR-Cryo-FC for short. While it remains very early days for PR Cryo FC, we are excited to be bringing to market a product that addresses a currently unmet need and has the potential to help stabilize bleeding events for hundreds of thousands of patients. With the formation of the Cirrus Therapeutics business, this product puts us in front of a new set of customers, and our therapeutics team is focused on building out these relationships. To date, we are pleased to see that the value proposition for PR Cryo FC resonates well with hospital clinicians who value immediate access to a hemostatic therapeutic for controlling and treating hemorrhage in trauma and surgical patient populations. With the current shortage of conventional cryo across the U.S. and the production advantages conferred by our PR Cryo FC product label, we believe we have a unique opportunity to increase not only ease of access but also overall availability once we are able to realize nationwide distribution of the product post-BLA approvals. Our focus launch targeting level one and two trauma centers in four key states this year will cover about 25% of the U.S. volume of serious trauma cases. As the year progresses, we look forward to sharing insights on the commercial reception as well as expectations for the timing of a nationwide rollout in 2022. On the reimbursement front, our new technology add-on payment, or NTAP, application is currently under review by the Centers for Medicare and Medicaid Services, with a decision still expected later this year. With that, let me turn the call over to Vivek for a more detailed review of our commercial operations.

Thank you, Wilby, and good afternoon, everyone. I'm pleased to discuss the results of another record quarter and full year for Cirrus. Our team has done tremendous work executing on our commercial goals, and I'd like to share some color on our efforts in the field that are positioning us for continued growth in the future. Quarterly demand for intercept platelet kits in North America increased almost 76% year over year and approximately 24% sequentially in the fourth quarter of 2020. Among the five largest blood center networks in the U.S., We saw an 80% year-over-year increase in product sales during the fourth quarter. As we have shared previously, the American Red Cross remains a leader in terms of intercept uptake, and they have publicly stated a goal of transitioning to a fully patch and reduce platelet supply by 2023. Earlier this month, the last ARC platelet production site went live. making for a total of all 22 American Red Cross platelet production sites producing pathogen-reduced platelets. Roughly 40% of the platelets now produced by the ARC are intercept treated. As Obi mentioned, the FDA recently extended the compliance deadline for its platelet safety guidance from the end of March to October 1st, 2021. With all the disruptions from COVID-19, This extension was disappointing, but not surprising. While COVID-19 has caused priorities and resources to shift at customer sites, the fact remains that bacterial contamination of platelets is a significant threat to patients and one that we are focused on globally with Intercept. In many ways, the global pandemic has also highlighted the need for blood safety and pandemic preparedness. We had previously anticipated and still do anticipate that the revenue ramp for intercept platelets will extend well beyond the compliance deadline. Our team is active in the field, bringing customers online and underscoring the benefits of action-reduced versus alternative options for compliance. We continue to expect that intercept platelets will become the standard of care in the U.S. One of the key drivers will be the FDA approval of the seven-day shelf life claim which we are targeting to have in hand as early as possible following the new compliance deadline. We believe extending the shelf life beyond the current five days can enable better inventory management and lower wastage rates and will position Intercept as a clearly superior solution compared to other options. In the EMEA region, fourth quarter reported product revenue increased 13% on a year-over-year basis, led by product sales across Western Europe. The calculated number of treatable platelet doses in our international region was up 17% year-over-year, contributing to the regional growth. Our Intercept Plasma business also positively contributed to product revenues during 2020. This was driven by the use of CCP among customers across the EMEA region. We are pleased to be able to partner with our blood center customers in all their efforts to address the pandemic. As Ovi mentioned, since our last call, we also received FDA approval for the PR Cryo FC product, which we are now launching in four states initially. I want to spend a moment to give an update on the commercial activities surrounding this launch. As we have previously mentioned, we have built a dedicated sales team and sales leadership group for this product. This team has already done much work to put us in the best position to succeed during this rollout. In each of the four states, the team has been calling on prospective hospital accounts to educate them on product and better understand who the early adopters are likely to be. From those conversations, it is clear that many healthcare providers already recognize the unmet need that PR CryoFC will address for critical patient populations. There is much work to do in order to turn these hospitals into customers. but the level of interest and engagement among large academic hospitals and level one and two trauma centers is very encouraging. I look forward to sharing more about the initial sales activities as the year progresses. With that, I will turn the call over to Kevin for a review of the fourth quarter and year-end financials.

Thank you, Vivek, and good afternoon, everyone. Consistent with our preannouncement last month, Today, we reported fourth quarter 2020 product revenue of $28.2 million, which represents a 35% increase from the $20.9 million recorded during Q4 of the prior year. For the full year, 2020 product revenue totaled $91.9 million, up 23% compared to the $74.6 million reported for 2019. Global demand for Intercept continued to increase during the fourth quarter and for the full year. For Q4, the calculated number of treatable platelet doses increased 34% year over year, and on a full year basis, the worldwide calculated number of treatable platelet doses increased 18%. In terms of fourth quarter product mix, platelet kits accounted for approximately 94% of total kit sales, while plasma sales accounted for the remaining 6%. For the full year, platelet kits accounted for 90% of total kit sales, and plasma sales represented the remaining 10%. As we've shared previously, demand for pathogen-inactivated CCP drove the share of plasma sales higher during 2020. As we think about the 2021 plan, we do not anticipate a significant contribution from CCP production, so it's likely that the Platelet kits, as a percentage of product sales, will continue to account for the majority of kit sales. In addition to our product revenue and not included in our guidance, government contract revenues total $5.4 million and $22.3 million for Q4 and full year 2020, respectively. Comparatively, government contract revenue totaled $5.6 million and $19.1 million for the corresponding prior year periods. For 2021, assuming enrolling sites are not significantly delayed due to COVID-19, we expect government contract revenue to increase with patient enrollment for BARDA-reimbursed clinical trials and as our work gets underway with the Whole Blood Pathogen Reduction Initiative funded by the FDA. Now, let's move the discussion to our reported gross margins. Gross margins for the quarter were 57 percent compared to 56 percent for the prior year period. Gross margins during the quarter benefited from increased production of Intercept disposable kits, driven by the growth we experienced in 2020, as well as the anticipated growth in demand for 2021. These higher production volumes drove economies of scale in manufacturing. Also contributing to the strong gross margins during the quarter was a benefit from a weakening US dollar relative to the Euro, particularly in the back half of 2020. On a full year basis, 2020 gross margins were flat compared to 2019 at 55%. For 2021, we expect gross margins will be fairly stable to slightly down. This is driven by the outpaced growth expected in the U.S. relative to our other commercial markets. As a general rule, U.S. customers predominantly use our single dose platelet kits compared to our EMEA customers. Our single dose platelet kits generally carry a lower gross margin contribution compared to our double dose platelet kits. I'd now like to discuss operating expenses, which totaled $35.8 million during the quarter and $131.4 million during the full year. Of the total Q4 operating expenses, SG&A expenses accounted for approximately $18.7 million and were higher by about $1.5 million compared to the prior year, driven by increased non-cash stock-based compensation and investments related to our PR Cryo FC launch. For the full year, 2020 SG&A spending totaled $67.0 million, compared to $66.2 million reported during 2019. On a quarterly and annual basis, SG&A expenses were slightly lower than they would have otherwise been, driven by lower travel and marketing related expenses as a result of the COVID-19 pandemic. Research and development expenses for the quarter totaled $17.1 million compared to $16.4 million during the prior year. On a full year basis, R&D expenses totaled $64.4 million compared to $60.4 million during the prior year period. The increase in R&D expenses was tied to product enhancement initiatives and programs intended to expand label claims for our U.S. platelet business. costs associated with our red blood cell program, as well as the ongoing development of a new illuminator. Reported net loss and per share losses for the three and 12 months ended December 31st, 2020 narrowed when compared to the same period in 2019. Reported net loss for Q4 totaled $14.4 million or nine cents per diluted share. compared to $16.9 million or 12 cents per diluted share for the prior year period. Similarly, on a full year basis, net loss was $59.9 million or 37 cents per diluted share compared to a net loss of $71.2 million or 51 cents per diluted share for 2019. In terms of our balance sheet, we ended the year in a strong position with approximately $133.6 million of cash, cash equivalents, and short-term investments on hand. In addition, in December, we expanded the availability of our revolving line of credit, which will allow us to continue to invest in the growth of our business, primarily in regards to working capital. We also extended the availability of the remaining $30 million of our debt facility to later in 2021. providing us with additional flexibility. Cash use from operations for the full year was $40.7 million compared to $65.8 million in 2019. The improvement was driven by increased revenues, steady gross margins, continued leverage in our SG&A spend, and improved working capital management. Moving on to guidance for 2021, As Obi mentioned earlier, and as you saw last month, we expect total product revenue for the year to be in the range of $106 to $110 million, reflecting 15 to 20% of year-over-year growth. As we look ahead, we continue to expect strong leverage from our SG&A investments and a transition to additional value-adding pipeline initiatives, as some of our more mature development programs conclude and transition to commercial enhancements. Cash management and a strong focus on achieving profitability over the course of our operating plan horizon are and will continue to be a focus of ours. With that, let me turn the call back over to Obi for some closing comments.

Thank you, Kevin. Before opening up the call for questions, I would like to spend a few minutes discussing some additional news we have announced since our last quarterly call and also provide a pipeline update. First, our team has made some significant progress from a geographic expansion standpoint, and I'm excited about these opportunities longer term and just wanted to touch on them briefly. In December, we announced that our partner in Brazil, CEI, won a three-year tender with the Hemomenis Foundation for Intercept platelets. Intercept remains the only pathogen reduction system with local regulatory approval for platelets and plasma, And this represents a meaningful beachhead for us into the LATAM region. And we just announced our plans to create a joint venture with ZBK for the Chinese transfusion market. China represents one of the largest blood transfusion markets worldwide. And as a result, it has the potential to be a significant opportunity for Intercept. We expect it to be the largest market opportunity for our products over the coming decade, given the growth and demand for transfused blood components in China. In ZBK, we have identified a leader in the transfusion market, which we felt was critical and would position us for long-term success in the region. Alongside our new partner, we will work to develop and register and ultimately manufacture and fully commercialize the intercept blood system for platelets and red blood cells. This is a long-term partnership that will have many phases, but we are excited to get to work and we'll update you on our progress as we move forward together with ZBK. While the size of the Chinese transfusion market has eclipsed that of the U.S., the growth over the next 10 years is still unlikely to abate. Moving on to our red blood cell development program, Intercept for red cells remains an attractive market opportunity given the large number of red cells transfused globally and the benefits of potentially having a complete Intercept portfolio for all transfused blood components for our blood center customers. Our RBC program efforts are currently focused on two work streams, CE-MARC for European commercialization and progress toward a PMA submission with the FDA for future commercialization in the U.S. Beginning with Europe, you will recall we have already submitted the first two modules as part of the CE-MARC review process. We remain on track to submit the final two modules in the second quarter of 2021. Based upon the progress the team has made and our expectations around regulatory timelines, our launch of intercept for red blood cells in Europe could begin for specific patient populations in the second half of 2022. As we approach launch, we plan to focus on targeting segments of the market that involve some of the most critical patient populations, such as chronic anemia, where we have generated the most clinical data for intercept red cells. In the U.S., our team has made significant strides in preparing various elements of the PMA submission, leveraging the work being done for the CE-MARC dossier. The getting item to filing the PMA with the FDA remains the completion of our two ongoing Phase III studies, REDIS and RECIPE. We are still in a period of site expansion and patient enrollment for both studies, and COVID-19 has slowed our addition of new sites and patient enrollments. We continue to calibrate our estimates for study completion and ultimately regulatory submission. However, without a clear line of sight on a return to normal post-pandemic, it is premature for us to speculate on a precise timeline. It is likely that Intercept for red cells will be commercialized outside the U.S. for a few years before we are able to bring the system to the market in the U.S. During that period, in addition to executing on our U.S. Phase III trials, we will be working to build the clinical body of evidence and real-world experience for pathogen-reduced red blood cells with our early adopters in EMEA. In closing, we made considerable progress in 2020 on our mission to make Intercept a global standard of care, despite having to adapt to new ways of working and achieving our goals safely. I'm pleased to report that our momentum continues in 2021 on many fronts, We look forward to updating you on progress throughout the year and hopefully returning to normal at some point during 2021. With that, let me turn it back over to the operator for Q&A.

As a reminder, to ask a question, please press star then 1. If your question has been answered and you'd like to remove yourself from the queue, press the pound key. Our first question comes from Jacob Johnson with Stevens, Inc. Your line is open.

Hey guys, this is Mason on for Jacob. Just a few quick ones from me. With the Hong Kong announcement and then yesterday the JV announcement, could you give us some color on the regulatory pathway in China just from a high level and how should we just think about that looking forward?

Yeah, thanks Nathan. So we're working with ZBK now on putting together the dossier. Unfortunately, we've actually translated The full submission, we just have to work through, you know, what the clinical trial requirements will be. As you may recall, historically, we did a clinical study in Hong Kong, but, you know, that's not going to be completely sufficient for the submission, but just sort of working through, you know, what the requirements are going to be for a clinical trial, you know, relatively limited scope. And then, you know, once we have that clarity, we'll be able to give you more specificity about when we plan to get that submission in.

Got it. And then on the PR cryo launch this year, outside of manufacturing partners filing their BLAs and you hiring the sales force, which seems to be largely done, is there anything else you're focused on here? Do you plan on adding more manufacturers throughout the year?

Yeah, I mean, I think it would be nice to have a couple more states included in this sort of initial launch this year and into early next before we have the BLAs. That being said, as we sort of highlighted in the prepared remarks, the four states we're currently launching into represent roughly 25% of the trauma cases in the United States. And there's almost 100 level one, level two trauma hospitals in those four states. you know, I guess they probably can give you a little bit more color on sort of where we're at with regard to the launch and sort of the enthusiasm that we're hearing from the sales team.

Yeah, I think we captured the key themes of the, I mean, the other issue that we're working on right now is just ensuring we can get hospital access. That's a little bit restricted with everything that's going on with COVID, but we anticipate that those restrictions will lift as we get through, um, for the pandemic-related issues. And then the key thing will be contracting with hospitals. But as Ovi had mentioned, clinical feedback remains positive. There's a lot of enthusiasm out there. So I think the things that we went into the submission, believing would be true about the marketplace, still resonate. And we'll certainly be talking more about this as we move further along in terms of our commercialization.

Awesome. Thanks for taking the questions, guys. Thank you.

Our next question comes from Matthew Blackman with Stiefel. Your line is open.

Good afternoon, everyone, and thanks for taking my questions. To start, maybe for Kevin, I appreciate you're not giving explicit quarterly guidance, but just as we think about the shape of the year, would it be fair to sort of think about, and I don't know if it's just first quarter or maybe just first half of the year being sort of at the lower end of the 15% to 20% range and maybe the back half of the year at the upper end? Is that a fair way to think about the shape of the year? And then I've got a couple of follow-ups.

Yeah, Matt, thanks. You know, following our pre-release, I think, you know, how we would characterize this is that Q1, which is typically a slower quarter of the four, will likely be at the lower end of that guidance range. and that we'll see steady growth from here. Clearly, the acute COVID impact will occur, we hope, in the first half of the year before it resolves. And with that, I think you've characterized it right. In the back half of the year, we would expect it to be to the higher end of the range on a quarterly basis. So I think you're thinking about it correctly.

Okay, great. And then while I've got you – I had a couple of questions on the Illuminator side of the business. Can you provide what the Illuminator revenue generated in the quarter was? I know it's a little bit outsized, perhaps relative to historical trends. And then a couple of follow-ups there. If you've got that, I'll wait for that.

Yeah, I mean, for this particular quarter, as we pointed out, Earlier, we had a bolus of Illuminators that were placed. We think that bodes well for future kit demand. For the quarter, it was roughly a million and a half. So that's somewhat of an outsized quarter for us.

And to that point, Illuminators are a pretty good leading indicator for kit sales. Is there any rule of thumb on how quickly a new box is up and generating revenue from And then is there any way to sort of characterize where some of these illuminators went, whether they're existing customers that are expanding capacity or newer customers that are starting to adopt? Is it skewed any which way towards either of those types of accounts? Any color there would be great. Thanks.

Yeah, I mean, there's no real rule of thumb as far as the delay from when a device is placed until we see the kit throughput or, you know, a throughput per device. You know, some centers are higher capacity centers and they require one and in most cases have two devices. Other centers have much lower throughput and require the same number. So there's no real uh, you know, rule of thumb metric, uh, or algorithm that I can provide to you that'll allow you to model it. But, um, you know, as far as the mix of customers and characterizing those customers, it's really a mixed bag, um, a lot of new sites and a lot of existing sites that have placed illuminators, um, to increase their overall production and, and efficiency. So, you know, we, we remain, um, bullish and optimistic about, uh, what that foreshadows and expect that it will contribute to the growth in 2021.

I really appreciate it. Thanks so much.

Our next question comes from Josh Jennings with Cohen. Your line is open.

Hi, thank you. This is Eric on for Josh. Thanks for taking the question. And congrats on a strong end to the year here. Thinking about the US market for a second, we've seen some articles in recent months discussing blood centers. They're facing exceptionally low donation figures. So I'm just curious, now that we're starting to emerge from the harder hit winter months, what you guys are hearing from customers regarding donation levels and just how they're trending.

Vic, do you want to handle that just based upon some of the information we saw in the last couple of days?

Sure. You know, the sort of severe weather that we were experiencing could have an impact in terms of overall donors and donations. I think for the most part, the blood centers are capable of dealing with these acute issues and overcoming them. So I don't anticipate any longer-term impact. We have seen a recovery in donations as the pandemic kind of drags on. But the other thing to note, too, is in the course of all this, while total donations may drop a bit, the proportion of donations that ultimately become PR-treated has steadily grown. And so we think ultimately you'll see recovery on both ends, but you know, nothing that we believe we don't believe there'll be durable long-term impact in terms of donor colonies.

Understood. Thank you. And then in Asia pack, you've had some great progress there in the region. Um, what other countries do you think we could be hearing updates on in, in the near to medium term? Could Japan be something that we're, we're hearing in the coming quarters?

Yeah, Japan's a very large market opportunity. As I mentioned in the prepared remarks, the thing that's been fascinating is to see how quickly the, uh, the Chinese market grow over the last, I'd say, five years, I mean, double-digit growth, and there's still sort of not enough players to go around in China as their healthcare system evolves. Beyond Japan, I think Japan will continue to sort of take a little bit of a wait-and-see attitude with regard to what's happening in the United States. So I think the progress we're making in the U.S., and specifically with the American Red Cross, will really have a bearing on sort of how the Japan Red Cross looks at Intercept going forward. But there's other large market opportunities like in Taiwan and Korea and elsewhere where we have ongoing discussions. And I think that's sort of true actually globally where we've got a lot of large national transition services that are evaluating Intercept and our general approach to communicating. Progress on that front is that we don't really say anything until we're in routine use. But it's encouraging to see the broader community global realization of the utility that pathogen activation can play.

Excellent. Thank you for taking the question. Yeah, thanks, Eric.

Our next question comes from Brandon Fulks with Cantor Fitzgerald. Your line is open.

Hi, thanks for taking that question, and congratulations on another good quarter. Maybe just following on from that, as you look out sort of longer term, obviously I think we're all familiar with the growth that we expect in the U.S. near term, but how should we think about the size of the ex-U.S. opportunity and sort of growth on a longer-term basis versus what we have in the U.S.? And then maybe my second question, I'll just ask it up front if that's okay. You gave guidance about a month ago, so anything you're seeing in the environment that may have changed a little bit in terms of the assumptions you made at that stage, um, you know, it seems hopefully at least that we sort of moving in the right direction, but I guess I'd love to hear from your part, if there's anything, uh, that may have changed or anything you're watching, uh, from a month ago.

Thank you. Yeah. Thanks, Brandon. I'll take the first part of that question and then the bank, I'll ask you to maybe to handle the second part. So, you know, I think that the nature of your question is, you know, where you see the growth opportunities in the medium to longterm and, and, uh, Obviously, for this year and going into 2022 and 2023, there's just a lot of growth coming out of the United States. We're very excited about the product launch for PR Cryo FC in the U.S. as well. But these are fairly large TAMs, but really small compared to the global opportunity for Intercept, for Playouts Plasma, Red Cells, and for Cryo. So then, you know, obviously we move into, you know, launching the RedSol system in 2022 and then, you know, trying to expand on that in EMEA initially and then ultimately more broadly. So I think it's just setting up very nicely for our longer-term growth prospects. And clearly this announcement we made yesterday about the China JV has been something that we've been working on for, I'd say, the last five years. really trying to identify the right partner. There was a lot of interest in Intercept from various Chinese companies, just given, you know, the opportunity to really transform blood safety and availability in China, you know, the likelihood that the Chinese government will play a role in how they think about blood safety and availability and really leapfrogging sort of conventional approaches. And so with ZVK, we found someone who, not only has a strong foothold with regard to their direct sales force and selling into the blood centers across China, but also a very modern manufacturing operation. So we're looking forward to initially focusing just on platelets, but also rolling out the red cell program there with the considerable size of that opportunity in China. Any other color, Vivek, you want? You want to add to that? And then I guess we'll handle the second part of your question around, you know, how our guidance thoughts have evolved over the last, you know, month.

Yeah, I think you captured most of the key points, though, being, you know, as we've talked about in the past, you know, our strategy has really been to line up opportunities and kind of continue to add arrows to the quiver such that we can maintain compelling growth through the near-term, mid-term, and long-term. And that's a combination of geographic expansion, expanding into new product lines, and then furthermore, you know, adding, augmenting what we have in terms of product line extensions and the rest. And so Asia Pacific and emerging markets will play a key role in terms of driving growth. But there are also some developed market opportunities that we're starting to realize and penetrate. So Germany would be an example of a, large market opportunity where we've made investments and we should start to see that pay off in the coming years. And so we continue to believe that as technology gains adoption in key markets, and this is a relatively small community that sort of engages quite a bit with one another, it'll create a positive flywheel that should allow us to continue to post compelling growth numbers and most importantly allow us to realize our mission which is to expand access to say, flood on a global basis. In terms of what we're seeing in the environment vis-a-vis any change point of view relative to when we first issued guidance, I'd say even though it's been about a month now, it's still a bit premature to conclude anything that would cause us to change guidance at this point. I certainly welcome Opie and Kevin to weigh in. You know, there have been some encouraging signs, certainly approval of new vaccines and associated rollout. is encouraging to the extent that it enables some travel restrictions and hospital access issues to be alleviated over time, but we're still very much early days. When it comes to that, we do continue to see strong demand for the product, and I think our team understands how to navigate the current pandemic-related issues to ensure that we can provide high levels of service and support to our customers and our supply chain and logistics teams continues to show a lot of resilience in the face of these ongoing challenges. We remain confident that we can deliver compelling growth numbers, but in terms of any material changes in the past month that lead us to believe that things could accelerate even further, it's probably still a bit premature to point to anything definitive. I don't know if you'd like to expand on that.

No, I think you've characterized it the way we've We're looking at guidance for 2021. Very excited about the opportunities, but until we sort of get better clarity around getting back to some kind of normalcy, then, yeah, I think it's premature to say anything.

Great. Thank you very much. I appreciate all the color. Thanks, Brent.

There are no further questions. I'd like to turn the call back over to Obie Greenman for any closing remarks.

Well, thanks, everyone, for joining the call today. We'll be presenting at the Cowan 41st Annual Healthcare Conference next week, and I imagine we'll be speaking with many of you on the phone today on Monday and Tuesday of next week. Thanks again for joining today, and I appreciate it.

Ladies and gentlemen, this does conclude the program, and you may now disconnect. Everyone, have a great day.