Cerus Corporation (CERS) Q3 2021 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, thank you for standing by. And welcome to the Cerus Corporation's Third Quarter 2021 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. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker of today Matt Notarianni, Senior Director of Investor Relations. Please go ahead.

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 Web site at ir.cerus.com. With me on the call are Obi Greenman, Cerus' President and Chief Executive Officer; Vivek Jayaraman, Cerus' Chief Operating Officer; Kevin Green, Cerus' Chief Financial Officer; Carol Moore, Cerus' Senior Vice President of Regulatory Affairs and Quality; and Jessica Hanover, Cerus' Vice President of Corporate Affairs. Cerus issued a press release today announcing our financial results for the third quarter ended September 30, 2021 and describing our company's recent business highlights. You can access a copy of this announcement on the company Web site at www.cerus.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 are forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2021 product revenue guidance and goals, operating expenses, anticipated cash use from operations, 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 activities, including the timing of these events and activities. These forward-looking statements involve risks and uncertainties that can cause actual events, performance, and results to differ materially. They are identified and described in today's press release and under the risk factors in our forms 10-K for the year ended December 31, 2020 and 10-Q for the quarter ended September 30, 2021, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, we'll begin with opening remarks from Obi, a commercial update from Vivek followed by Kevin to review our financial results. We will conclude with commentary from Obi with an update on our pipeline, recent announcements and closing remarks. And now it's my pleasure to introduce Obi Greenman, Cerus' President and Chief Executive Officer.

Thank you, Matt and good afternoon, everyone. Once again, we are excited to share our most recent quarterly results with you all. Before I turn the call over to the Vivek and Kevin to cover our third quarter results in more detail, I wanted to provide a few opening comments. 2021 is truly been a breakout year for Cerus as our annualized product revenue run rate continues to build the momentum we saw in the first half of the year. We continue to achieve major goals in 2021, both commercially and operationally. And I'm excited about the road ahead for the company going into 2022. Since 2014, when the FDA first issued the draft guidance to address bacterial contamination in platelets, we've been focused on making the case that our INTERCEPT blood system is a best in class offering to mitigate transfusion transmitted bacterial infection, while also providing a proactive solution to addressing blood safety and availability in general. We have built a unique and strong position in transfusion medicine, which is a medical field that takes a while to embrace innovation, but when it does, it establishes safety measures that endure. Our Q3 and year-to-date results were driven by US adoption of our INTERCEPT platelet platform, which enables strong blood thinner compliance with the FDA guidance that went into effect October 1. In parallel with the blood thinner benefits afforded by INTERCEPT, US hospital demand for pathogen these platelets continued to build given the logistical benefits of a single inventory of fresher platelets compared to managing inventories of platelets of various ages that are subjected to delayed release due to testing. As you can see from this quarter's results, our business in the US has grown rapidly. With all the work our team has done to get customers ready for the FDA compliance, we believe our current run rate is helping to establish pathogen reduction as a standard of care in the US platelet market with INTERCEPT treated platelets now representing the majority of platelets produced. Last month at the virtual ABB Annual Meeting, we were pleased to see our Phase IV PIPER study presented as a plenary lecture. PIPER represents the largest study of platelet transfusions ever conducted, and is the latest in a robust growing evidenced based body of real world data for our technology. With studies like this, combined with over a decade of routine use experience in Europe, we are solidifying the strong safety and efficacy profile for INTERCEPT. We believe such a strong body of evidence will allow us to realize continued growth on a global scale as we help deliver a new standard in transfusion medicine. To that end, cumulative kit sales for INTERCEPT platelets in plasma recently eclipsed 10 million doses globally, is a remarkable accomplishment in our company's history, and a reminder to all of us at Cerus, the 1000s of patients that receive INTERCEPT treated blood components every day. In summary, we are honored to support our blood center customers in their daily efforts to secure the blood supply. And we remain committed to our mission of making the INTERCEPT blood system, the global standard of care in transfusion medicine. Following Vivek and Kevin's remarks, I'll return to discuss our pipeline, which continues to make good progress and is positioning us for continued growth over the long-term. With that, I'll turn it over to Vivek.

Thank you Obi and good afternoon, everyone. The third quarter was indeed a significant one for Cerus. We are now officially a month beyond the FDA guidance compliance deadline, and our results show that we have moved quickly to convert US blood centers across the country to the INTERCEPT blood system for platelets. Even with the commercial success we had last year and so far this year, we feel we can continue to increase our penetration in this key market has blood centers and their hospital customers realize the value of a single SKU patch and reduced platelet inventory. Blood centers across the country have helped champion INTERCEPT as the preferred method for safeguarding platelets. As these centers standardize on INTERCEPT, they do so recognizing that our product offers protection from bacterial contamination as well as other known and emerging pathogens. Our blood center customers can then offer these platelet units to hospitals with better pricing, value and ultimately safety for patients. As we continue to grow our presence we remain committed to continuing to be a valued partner and safeguarding the platelet supply for many years to come. Once again, we are pleased to report the largest product revenue quarter in the company's history. Third quarter 2021 product revenue grew 53% year-over-year to $36.1 million. On a sequential basis, product revenues grew 15% in the third quarter when compared to the 31.5 million product revenue reported in Q2 of this year. Drilling down to sales in our major geographies, product sales in North America grew 146% versus the prior year period. Product sales and EMEA grew 3% versus the prior year. On a year-to-date basis, our North American product revenues for the first three quarters of 2021 were slightly higher than our year-to-date product revenues in the EMEA region. Sales to the top five US blood centers, which provide roughly three quarters of the country's platelets supply increased over 170% versus the third quarter of 2020 and grew by nearly $5 million sequentially. Outside of the top five US blood centers product sales increased over 50% when compared to the prior year period. Turning to INTERCEPT Fibrinogen Complex or IFC, the third quarter marked the first commercial sales of this product to hospital account. You'll recall the launch of this product has been limited to five states in the US thus far, but I'm pleased to report that four of our blood center production partners submitted their BLAs during the quarter. As such, we look forward to rolling IFC out in a nationwide launch once these anticipated BLAs are in hand. We've recently had some of our initial customers speak publicly about their rationale for use of an early experiences with IFC. At the recent Society for the Advancement of Patient Blood Management annual meeting, two of our hospital customers, Texas Children's Hospital and Kaiser Permanente outlined the clinical need for ISC based on its pathogen reduced safety profile, its ability to be readily available to treat bleeding events earlier, and the lower risk of wastage compared to conventional cryoprecipitate. With both a nationally recognized Children's Hospital, and a major IDN leading the way, we continue to believe in the promise of this product to be a tremendous clinical utility, and to help support our continued revenue growth in the years to come. With that, let me turn the call over to Kevin for a more detailed review of our financial results.

Thank you, Vivek and good afternoon, everyone. I share my colleague's enthusiasm and pride in the progress we've made and look forward to the progress we expect in making INTERCEPT treated blood components available to even more patients globally. As Vivek mentioned in his remarks, we reported record product revenue during the third quarter, totaling $36.1 million, representing a 53% increase compared to the third quarter of 2020 and led by strong INTERCEPT platelet sales in the US. With year-to-date product revenues at the end of Q3, coming in only about a million dollars shy of our full year 2020 product revenues, this breakout year continues to demonstrate Cerus' strong position in transfusion medicine. Moving on to our calculated platelet dose growth globally, which as calculated depicts a 69% year-over-year increase and a 22% increase sequentially. In terms of product mix for the quarter, sales of INTERCEPT kits continue to represent more than 90% of our Q3 product revenue. Of that platelet kits represented over 80% of our total product sales underpinned by the steady EMEA market and growth in the US market. In addition to our product revenue, and not included in our guidance, government contract revenue totaled $6 million in Q3. Comparatively, government contract revenues totaled $5.6 million in the third quarter of 2020. As we have stated previously, government contract revenue is primarily comprised of BARDA reimbursement for red blood cell clinical trials, and, to a lesser extent our whole blood pathogen reduction contract funded by the FDA. As patient enrollment under the BARDA trials and activity on the whole blood effort rail, we expect government contract revenue to increase. Additionally, as we will discuss a little later, since this government contract revenue line is essentially an offset to a portion of our R&D spend. Beginning next year, we plan to strip out both the expense and offsetting revenues in an effort to highlight the core business adjusted EBITDA metric that we are using to measure progress of our core business activities. But that aside, for the time being, let's turn to product gross profit and gross margins. Third quarter gross profit was the highest in the company's history at $18.5 million, compared to $12.7 million during the prior year period. The increase in gross profit was primarily driven by higher product sales. Product gross margins for the quarter were 51.3% compared to 53.6% for the prior year period and were roughly flat when compared to our Q2 2021 product gross margins. As was the case during the first half of the year, and as we anticipated and forecast, the year-over-year decline in our product gross margin percentage was driven primarily by unfavorable product mix associated with selling a higher volume of single dose kids versus the prior year period. Today, our customers in the US market predominantly use single dose kits, which carry a lower margin contribution than our double dose platelet kits. Over time, we expect that the US market will use an increased number of double dose platelet kits. I now like to discuss operating expenses, which totaled $35.6 million during the third quarter and included $5.9 million in non-cash stock based compensation. During the third quarter we continued to demonstrate the operating leverage of our business with total operating expenses up only 11% versus the prior year on our strong product sales. Of the total Q3 operating expenses, SG&A expenses accounted for approximately $20.4 million, and were higher by about $4 million compared to the prior year period. The year-over-year increase in SG&A expenses was driven by costs associated with increased sales instead of compensation. Research and Development expenses for the quarter totaled $15.3 million compared to $15.9 million during the prior year. During the quarter, we continued to advance a variety of pipeline projects, including our US red blood cell efforts, and the LED illuminator along with increased stock based compensation costs. However, offsetting the investments in these programs, we realized lower R&D costs associated with certain mature projects rolling of such as our PIPER study and IFC, which has now passed development and being commercialized. On the bottom line, reported net loss attributable to Cerus for the three months ended September 30, 2021, improved when compared to the same period in 2020. Net loss attributable to Cerus for Q3 totaled $12.4 million, or $0.07 per diluted share, compared to $14.1 billion or $0.08 per diluted share for the prior year period. With respect to our path towards achieving cash flow breakeven, we've remained focused during this pivotal year on driving operating leverage in the business while continuing to invest in growth for both the short and long-term. As this remains a priority for us moving forward, we plan to provide more color on subsequent earnings calls, beginning in 2022. To help track our progress towards cash flow breakeven using a pro forma measure we are calling core business adjusted EBITDA. Essentially this metric will highlight our operating income or loss while adjusting our non-core business activities, such as our government contract revenue, and the corresponding costs as well as non-cash items such as stock based compensation, depreciation, amortization and the line items below in operating income, namely other income, expense and income taxes. In terms of our balance sheet, we ended the quarter in a strong position with approximately $120 million of cash, cash equivalents and short-term investments on hand. Cash used from operations for the third quarter was $6.6 million, which reflects a continued sequential improvement over the course of 2021. As we continue to see robust demand from our customers, we remain committed to continuing to ensure our ability to supply customers and to support their ability to deploy INTERCEPT platelets for the blood supply. To that end, expanding access to our revolving line of credit and debt facility will continue to play an important role and allow us to invest in the growth of the business without depleting our cash resources. Moving on to product revenue guidance to round out 2021. The strength of our business year-to-date, coupled with the visibility we have going into the balance of the year have resulted in us increasing and also narrowing our full year product revenue guidance range to 127 million to 129 million from the prior range of 118 million to 122 million. This new range reflects 38% to 40% growth when compared to 2020. With that, let me turn the call back over to Obi for some closing comments.

Thank you, Kevin. To wrap up today we have a few updates regarding several of our pipeline initiatives. First with respect to our seven day post collection storage claim for INTERCEPT platelets. We recently received questions from the agency regarding this submission, and have plans to meet with them in the near term to discuss their feedback. Given the fact that these questions have stopped the review clock the potential approval timing is no longer expected by December of this year. . With respect to our red blood cell program, I wanted to provide a quick update on our modular submission filing for CE Mark, which you will recall we completed with a TUV during the second quarter of 2021. While TUV continues its review, a portion of our submission is now also under review by the Dutch Competent Authority CBG rather than HPRA or the Irish Medicines Board, as we initially anticipated. This change is due to the MDR transition related resource constraints faced by all European regulatory bodies and could impact CE Mark timing. Finally, I wanted to wrap up with some great news regarding EFS, France's national transfusion Service. I'm pleased to announce that we have signed a multiyear contract extension with one of our most important customers, and one of the most highly regarded institutions in the field of transfusion medicine. The EFS has been a trusted partner to Cerus for more than a decade and began using INTERCEPT on 100% of its national platelet supply in 2017 in addition to treating a portion of its plasma production. With over a million platelet units transfused into arguably the world's most robust hemovigilance system the data supporting the strong safety profile of INTERCEPT platelets is significant. We see this contract extension as an important validation of our mission as a company to support our customers in their effort to safeguard the safety and availability of the blood supply. And it also validates the business model that we are building for the full INTERCEPT portfolio. In closing, our third quarter performance has established a clear path towards market leadership for INTERCEPT globally. Our commercial progress is reshaping our growth trajectory in 2021. As our top line continues to grow over the next several quarters, our team is focused on driving sustainable growth, while also demonstrating our ability to achieve cash flow breakeven. Our product pipeline continues to advance as well with a number of important product launches anticipated during the coming few years. With that, let me turn it back over to the operator for Q&A.

Thank you. [Operator Instructions] Now, first question coming from the line of Josh Jennings with Cowen. Your line is open.

Hi, good afternoon, thanks for taking the questions and it's great to see another record quarter printed. With the strength that the business - the momentum the business is seeing just wanted to touch base on the sustainable growth trajectory. And I think you guys have got to get close to 40% revenue growth and product revenue growth in 2021 presents a challenging comp. But seems there's a lot of layers to the growth story going forward as well. And just wanted to kind of touch base on your thoughts on a sustainable 20% plus revenue growth trajectory going into 2022 into 2023 and any of those layers that you call out as meaningful drivers as we head into 2022.

Well, thanks a lot, Josh. I think that's a really good question. And I'll start and probably turn it over to Vivek like halfway through. So we still remain very optimistic about sort of the continued growth of the business as we get through 2021 and move into 2022, just given the size of the market. I think the backdrop of the US platelet market is that typically is growing in sort of the mid-single digit range organically just given the demand for platelet components. And so that really puts a lot of pressure on both blood centers and hospitals to secure the supply. And so having a product that really allows for a single inventory - single SKU, it allows for greater supply chain efficiencies. But I think Vivek can really maybe elaborate more on sort of what's going on specifically in the US and with the American Red Cross.

Yeah, thanks Obi and thanks for the question, Josh. We feel very confident in our ability to sustain growth both domestically and internationally. As we indicated, in the prepared remarks, our progress with the big five blood center families in the US and again, they represent about three quarters of the market has been really strong, but there's still plenty of headroom within that segment of the market. And what we're seeing from hospital customers' independent and through their blood supplier is that they're expressing a clear preference for INTERCEPT treated platelets. And so those two factors really give us a lot of confidence. There's plenty of room to run domestically. In addition, we continue to make investments in key international growth markets, which over the course of the next few years should allow us to have ongoing waves of growth and product adoption. Fundamentally, what we're focused on is ensuring that as many patients who can have access to INTERCEPT in fact do.

Thanks for that. And just my follow up on IFC, the Cryo launch is in the early days, but just as you're seeing some of this early interest and demand creation can you talk about the historic TAM assumption of $300 million in the United States? And could that TAM calculation get higher? I think the Cryo market is growing close to 20%, at least last year and into this year. And then maybe how the business model could evolve from these initial five centers and potentially incorporate some of the bigger blood banks in the US. Thanks for taking the questions.

Yeah, thanks, Josh. And again, I'll start and turn it over to Vivek to provide some additional context. So as far as the TAM for our INTERCEPT Fibrinogen Complex product, it's really calculated on through the current use of crowd in the United States being roughly on the order of 750,000 800,000 grams equivalents of fibrinogen annually, and that is growing. It's hard to get great numbers on that, but it is from the last couple years growing, at least in the mid-single –mid-teens. And that's, I think, largely a function of the increased use of viscoelastic monitoring in surgical procedures, and then trauma cases. So we do see a growing demand for the early use of fibrinogen concentrates. Maybe just Vivek you could take the second half of Josh's question.

Sure, happy to. In terms of our launch, and how we see progress evolving, there are really kind of three key dimensions to focus on increasing production, with our production partners, making sure that their operations are appropriately organized, such that they can meet the demand that we start to generate, working with them on BLAs and other tools to ensure they can provide product across state lines, and then really going in and qualifying demand at the hospital level, educating them on the economics, the end tap, and we're making good progress across all of these fronts. What I would say is that COVID, in the context of hospital access does continue to be a bit of a headwind. This is different from our core business, and that we are responsible for the commercialization piece at the hospital. And as you probably know, from other companies you cover, hospital access is still limited when compared to pre-COVID days. But having said that, the underlying clinical interests, the feedback from initial users, and the understanding of the importance of the end tap in terms of taking any sort of economic or pricing concerns up the table really have proven out the initial hypotheses we laid out. And so we feel very good about the fact that this will be a growth driver for our organization. But I think most importantly, this will be a tool that clinicians can use at the end of the day, to help save patients by giving them earlier access to Cryo.

Great, thanks, again.

And our next question coming from the line of Brandon Folkes with Cantor Fitzgerald. Your line is open.

Hi, thanks for taking my questions and congratulations on a very good quarter. I think earlier this year, we've talked about the blood shortage in the US. So I guess just can you update there. And how do we think about that - the impact there on results with any catch up in the quarter or going forward how do we think about that potentially reversing? And then maybe secondly, how should we think about gross margins trending from here, just given the significant growth in the US and the French contract? Thank you very much.

Yeah. Thanks a lot, Brandon. Again, I'll take the first half of that question. And then Kevin, maybe you can take the gross margin question in the second half of our reply. So with regard to the overall shortage of blood components in the United States, that continues, for those of you who donate blood, it sort of get a daily reminder to go and donate, given the scarcity of blood components for red cells, platelets, and also plasma. So I encourage you all to go and donate it if you don't because it's very much needed. We really don't see it having a sort of a lot of - or creating a lot of variability within a quarter, just given sort of the growth trajectory we've seen through the first three quarters of this year and through the remainder of the year. I think the concern really is around can the overall platelets supply be sustained with the sort of mid-single digit growth and demand that we're seeing? That's a larger question, but I don't really think it has profound implications for Cerus in the at least immediate term. I think that's all I have for the first part of the question, Kevin, you want to handle the gross margin evolution?

Yeah, sure, no problem. So we expected the US was the major contributor for growth in 2021, to see kind of the 100 to 200 basis point pullback that we are seeing from last year. With that said, I expect more of the same for the balance of the year. The EFS is an interesting question and how that will ultimately affect margins. I think you'll recall that the EFS has been a customer of ours for a number of years. And so we're extremely proud when such important and large customers and long standing customers sign up with us. Again, it's something that we pride ourselves in not only on the science and the technology, but our ability to be good partners with those customers and provide a world class level of customer service. So with that said, we are - as contracts come do seeing price increases. And so I think that will be somewhat of an offsetting effect to the predominant use of single dose kits in the US. So in summary, probably more of the same for the balance of the year. And then longer term we'll expect to get back to economies of scale and start to see some return to margin expansion.

Great, thank you very much. And congratulations again, on a very strong quarter.

Thank you.

Our next question coming from the line of Matthew Blackman with Stifel. Your line is open.

Good afternoon, everybody. Thanks for taking my questions. Maybe Obi, I wanted to start with you and ask about your comment about INTERCEPT platelets now being the majority, I think I heard you correctly the majority of platelets produced in the US. Anyway that you could at least maybe directionally break that penetration out by Red Cross versus the other big four versus sort of the other bucket. Clearly just trying to get at how much more runway there still is. And I guess the follow up to that is, in the past you've talked about standard of care being something north of 50%. It sounds like we're already there. Do you have any updated thoughts on where INTERCEPT penetration could go in the US? And then I do have one more follow up?

Yeah, thanks. I think those are good questions. And yeah, historically, we have at least internally at Cerus defined standard of care being at least 50%. I think that's an important terminology that we use sort of globally, just because of the impact of being standard of care on other markets. As you know, we're the standard of care in many European countries. And we do believe that that is highly influential for other markets as they look to safeguard their platelet supply and practice the standard of care, if you will. And then I think even in the United States, with the American Red Cross, moving towards their stated goal of getting to 100% pathogen reduction, because of the ability to safeguard the blood supply with our technology that also is a strong statement. As far as the breakdown within the US. I think there's clearly a lot of room for us to grow. The Red Cross has moved very quickly towards their stated objectives. So I would just say that they're well above 50% and moving directly towards their stated goal. I don't know when they'll actually achieve that in 2022 or maybe it's even 2023. But from all signs the demand coming from the hospitals is great. And they're trying to provide a single inventory to meet the hospital demand. Vivek, do you want to provide any more color about what's sort of going on at a macro level with the big five customers, maybe that provides a little bit more perspective for Matt.

Sure, I think you covered it well. First of all, Matt, thanks for the question. As indicated we really had focused on and very intentionally at big five strategy, trying to make sure that those larger customers had everything they needed from a deployment support standpoint, production support standpoint, to really drive adoption of INTERCEPT. And to date. I feel like we've had some good early success, but across all of those big five blood center families, including the Red Cross, there's still plenty of headroom. The Red Cross stated in their open letter that they intend to be at 100% ER by 2023. So there's still room to go there. And they're probably a little bit ahead of the others and so I think when you think about the US market you can sort of think about the big five leading the way and then the balance heading in that direction, but probably with more room to move to run, which gives us more upside, but probably we didn't hear in terms of specific breakdown by big five center, but suffice to say we believe there's still plenty of room for growth.

Alright, I appreciate that. And Vivek, while I have you, I wanted to ask about Cryo and is there any early reads and I'm focused mostly in sort of on the sales force, just the depth and breadth of the sales force. Yeah, how much you need to invest? Do you have the right people? Is it the right size, the sales force? Anything, frankly, you may have learned on the commercial front and the new business model over the last several months. Thanks. Appreciate it.

Yeah, sure. No problem. Happy to. I mean as you know, we've talked about in different industries in the past, definitely tied to productivity, certain measures, thinking about how you want allocate the sales force across country, all of those things are considerations. The variable here that's probably the biggest wildcard has been trying to do all of this in the midst of COVID. And especially early on when hospital access was, for all intents and purposes shut down. And now even still, it's pretty restrictive, launching a de novo product in and of itself, is challenging. That just created a much higher level challenge, which is why I'm really excited about the receptivity that we have been seeing, nonetheless. I think are the salespeople that we've identified as a good ability to identify the key decision maker, as you can imagine, it's not uniform per site. And in many areas, there's a bit of a network of decision makers between clinical influencers and non-clinician administrators who ultimately be strength. And so I think we have an understanding now, whether it's at a single site or an integrated delivery network, who we need to influence to gain traction, and then who we need to partner with to sign contracts. A key piece is going to be production volumes with our partners, which is then dependent of the sales force, but obviously, we want to make sure that we're not generating demand too far ahead of being able to produce products. So there's always that delicate balance, we need to strike. I think we'll get a better understanding of outreach once we get more access to hospital customers that we can't necessarily access now because of some of the COVID restrictions. But I think there's leverage for us both in terms of the sales force we have, partnering with blood center production partners, and then potentially leveraging some of the folks we have on our platelets side as they're going out and connecting with hospitals who are adopting INTERCEPT platelets. So it's still early on and I apologize for the somewhat nebulous answer to the question, but the fact is, the hospital access piece that's been diminished during COVID really has created a situation where we need to get in a little bit more than we've been allowed to, and we're slowly starting to see that open up.

Alright, appreciate it. Thank you so much. And congratulations, guys.

Thanks a lot Matt.

Thank you.

Our next question coming from the line of Jacob Johnson with Stephens Inc. Your line is open.

Hey, thanks. Good afternoon, and congrats on a nice quarter. Obi, maybe for you, appreciate the update on seven day platelets. But I guess a bigger question around seven day platelet approval. I mean, how much more of the market will that open up for you? I think the results you're putting up this year, it seems like you're already able to capture a decent amount of the market without the seven day label just how incremental could that be from here?

Yeah, I mean it's obviously a difficult question to answer, given the demand that we are seeing and sort of the receptivity to the product offering given its earlier release compared to the alternatives, especially when you're in an environment where there's not enough platelets. So having that earlier, product release is important. In the same vein, though, if you had a seven day label claim, I think it does help hospitals manage their inventory more easily. And so that's ultimately the goal. So again I provide somewhat of a nebulous answers, I just - I'm not seeing it impact the demand for now and into the future. And that being said we obviously in other markets have seen the importance of a seven day claim for overall blood center operations and just sort of facilitates INTERCEPT becoming the standard of care much more quickly.

Got it. Super helpful Obi. And then maybe follow up for Kevin or maybe others want to chime in on this. Kevin, just on the gross margin outlook, I appreciate kind of expect the status quo as we had in the fourth quarter on gross margins. But as we think about the gross margin expansion, I think particularly from the US market, it'll be the shift to double those kits. It sounds like you're optimistic about that occurring in the future. But is there any kind of timeframe or way to think about when we could see that shift occur in the US.

I think it's happening, it's just happening a little bit slower. So as we see increased overall penetration in the US market and blood centers then start to look at ways to optimize their overall production, we'll start to see. And I don't know that we're going to see - well, we're not going to see it in the same depth as, say, EFS is, which is the majority of their overall production. But we will see some incremental progress as we move forward here, they'll just be less impactful than say the EFS was. And I think the other thing to keep our eye on for margin expansion is just some of the COGS reduction initiatives that we and our partners have been working on. And we didn't see a very significant price reduction due to economies of scale this year. We expect that we will, longer term and so that's something we're focused on. And we'll continue to work to drive our costs and make our manufacturing processes as efficient as possible, while at the same time ensuring our ability to meet global demand.

Got it. Thanks for taking the questions.

Thanks Jacob.

Our next question coming from the line of Mark Massaro with BTIG. Your line is open.

Hey, guys, this is Vivian on for Mark. Thanks for taking the questions. So any updates on when you might complete enrollment for your red blood cell studies? Could you also give us an update on the timing for the expected launch of INTERCEPT for red blood cells in Europe as well as the US? Thanks.

Great. Thanks Vivian. So maybe I'll take the last part your question first. So right now, as we mentioned in the call, and we are working through the CE Mark approval process in Europe, and that has transitioned to our competent authority, which is now the Dutch Competent Authority. So just given some of the uncertainties around the MDR timing that that could drift beyond the second half of next year, but we're still anticipating a product launch in 2023. And so everyone's very excited about the opportunity there just because of our ability to offer the full portfolio of INTERCEPT products to treat all transfuse blood components and the reception that we believe we'll get from our existing customers of INTERCEPT platelets in plasma. Now, with regard to the Phase III study in the United States, they do continue to enroll both ReCePI and RedeS. It has been impacted a little bit by COVID. It's almost regional, just where there's been high impacts of COVID on hospitals. We've seen lower enrollment than we anticipated. And we've seen other sites sort of coming out of COVID. So with that overall mix, we hope to see improvement as we move into 2022 and be able to provide an update sometime in the first half of next year on where we think we are with regard to overall enrollment, timing and completion of the studies.

Okay, awesome. And just a quick follow up. How should we think about modelling international growth moving forward just given that EFS renewal? Are there any additional geographies to maybe enter that could enable that same pace of growth internationally? And if you could touch on some of the key drivers there? Thanks.

Thanks Vivian. Vivek, would you mind handling that question?

Sure, I'm happy to. In terms of international growth kind of over a multiyear horizon, earlier this year, we announced our joint venture with China and while that won't manifest in terms of revenue goes probably towards the outer end of this strategic planning period. That's certainly a significant opportunity for us in terms of accelerating patient access to INTERCEPT. Similarly, to continue to make investments in the single largest opportunity in Europe, which is Germany, and we're seeing good progress there. And we're going to be seeing our initial revenue in Canada next calendar year as well, which is a great thing. That's good markets. So ultimately, if you think about near term growth, it's going to continue to be driven by US platelets, but we believe that we're planting seeds that should really flower and provide pretty meaningful growth opportunities for our entire global franchise over the course of the strategic planning period.

Awesome, thanks for taking the questions.

Thank you.

Our next question coming from the line of Ram Selvaraju with H.C. Wainwright. Your line is open.

Hi, this is Boobalan dialing in for Ram Selvaraju. Thanks for taking my question. Just a quick one from our end. Can you comment on the whole blood market opportunity sort of various factors at play and the competitive dynamics in the space? Thanks.

I'm not sure I quite understood your question just because there was a break up in the line. Would you mind repeating it?

Sure. So in your pipeline, you mentioned the whole blood. So we just wanted to know, can you comment on the whole blood market opportunity and competitive dynamics in this space?

Okay, thanks so much for repeating that. Yeah. So we have a whole blood program that's been underway for some time with the Swiss Red Cross through their philanthropic humanitarian fund. And that's really directed at blood transfusion in Sub Saharan Africa and trying to create a solution that addresses the need for whole blood and maternal hemorrhage and traumatic injury. We also have a partnership with the US FDA that secured funding to look at next generation approaches to our INTERCEPT technology to treat whole blood and then ultimately separate that into individual components. And so that is underway as well. As far as sort of the overall competitive landscape, we really don't see a lot of competition in that space. But it is also sort of an outlier of - that's not the right word. It's a secondary priority for us, relative to our existing product portfolio for platelets, plasma, INTERCEPT Fibrinogen Complex and red cells. So it's I guess it's further down the line, but we are making progress in that area.

All right, thank you.

Yeah, thank you.

I'm showing no further questions at this time. I would now like to turn the call back over to Mr. Obi Greenman for any closing remarks.

Thank you. Well, thank you again for joining us today and for your interest in Cerus. We look forward to speaking with you at the Stifel 2021 Virtual Healthcare Conference later this month, as well as the Stephens Annual Investment Conference next month. Thanks for joining us on the call today.

Ladies and gentlemen that does conclude our conference for today. Thank you for your participation. You may now disconnect.