Ladies and gentlemen, thank you for standing by and welcome to the Cerus Corporation’s Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question and answer session. [Operator Instructions] It is now my pleasure to introduce Investor Relations Director, Tim Lee. Please go ahead.

Thank you, operator. 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 www.cerus.com/ir. 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; and Carol Moore, Cerus’ Senior Vice President of Regulatory Affairs and Quality. Cerus issued a press release today announcing our financial results for the third quarter ended September 30, 2020 and describing the Company's recent business highlights. You can access a copy of this announcement on the Company website at www.cerus.com. I’d like to remind you that some of the statements we will make on this call related to future event and performance, rather than historical facts and are forward-looking statements. Examples of forward-looking include those related to our future financial and operating results, including our 2020 financial guidance and goals, operating expenses, anticipated cash used 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 uncertainties 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 September 31, 2019, in our Form 10-Q for the quarter ended September 30, 2020 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 followed by Vivek, who will provide the commercial update, Kevin to review our financial results followed by Obi with a development pipeline update and closing remarks. And now, it's my pleasure to introduce Obi Greenman, Cerus' President and Chief Executive Officer.

Thank you, Tim, and good afternoon everyone. We are pleased to report another quarter of record product revenue, totaling $23.6 million, driven by strong commercial execution with gains in both North America and the EMEA markets. Robust top-line performance in the quarter was complemented by continued progress in our development programs on all fronts. In particular, we are eagerly awaiting the FDA anticipated approval decision on pathogen reduced cryoprecipitated fibrinogen complex or PR-Cryo which we think could happen next month. Later in the call, I’ll share with your our pre-launch activities in preparation for the anticipated approval for PR-Cryo. With the compliance period for the FDA guidance document on the bacterial safety of platelets coming to a close in five months, we are seeing an increasing adoption of our technology by both blood center and hospital customers in the U.S. As we have previously noted, we think most U.S. blood centers and hospitals will gravitate towards single-step methods, either pathogen inactivation or LVDS Large Volume Delayed Sampling to comply with the guidance. Our discussions with blood centers and hospitals indicate that rather than the two-step option, the single-step method provides the operational benefits and ease of availability. When comparing INTERCEPTs to LVDS, we think our technology offers several advantages such as replacement of GAMMA radiation, CMD serology, Babesia Testing and Zika Virus Testing, which gives us conviction in our belief that INTERCEPT will become the standard-of-care. Vivek will provide additional details on the U.S. platelet market during his prepared remarks. By now, hopefully you have had a chance to review our press release detailing our third quarter results. While the COVID-19 pandemic has had an impact on our business, I continue to be impressed with how the Cerus team is navigating these challenges in support of our customers and their increasing need to secure the safety of the blood supply. As we head into the winter months, we are seeing a substantial rise in the daily COVID-19 cases and hospitalizations both here in the U.S. and abroad. This surge could impact the availability of blood donors and staffing at donor centers. In light of the uncertainty as to where and when the COVID-19 surge will peak, we are narrowing our full year 2020 product revenue guidance range from $89 million to $93 million to $89 million to $91 million. Therefore, the implicit guidance range for Q4 product revenue will represent year-over-year fourth quarter growth between 21% and 30% and solid sales momentum heading into 2021. With that, let me turn the call over to Vivek for a more detailed review of our commercial operations.

Thanks, Obi, and good afternoon. First, I echo Obi’s comments as the function of the teams’ resilience, it is my pleasure to report another record quarter led by strong commercial execution in both our North America and EMEA region. North American platelet kit demand increased almost 90% year-over-year and approximately 30% sequentially as adoption of INTERCEPT platelets continues to increase. We are happy to report meaningful year-over-year increases in our Q3 product sales to four out of the five largest blood center networks in the U.S. These gains were led by the American Red Cross, which continues to be a strong supporter of INTERCEPT and have stated their goal of getting to 100% INTERCEPT adoption by 2023. Earlier this month, the American Red Cross’ manufacturing facility in Tulsa, Oklahoma produced their first INTERCEPT treated platelets. With the Tulsa facility now online, 21 out of the 22 American Red Cross sites are making pathogen reduced platelets. As the FDA guidance compliance period nears its close at the end of March 2021, we believe that the overall economic and operational challenges of LVDS are increasingly being understood by U.S. blood centers and hospitals, when compared to the relative ease of use and added value conferred by pathogen reduced platelets. The recent virtual AABB Annual Meeting earlier this month highlighted the added relevance of action reduction for protecting the integrity of the blood supply as blood centers considered their COVID-19 experience and lessons learned toward future pandemics. We expect U.S. demand for INTERCEPT platelet kits to continue to increase even beyond the end of the FDA guidance compliance period eventually becoming the standard-of-care for platelet components over time. The seven day shelf life plan we are seeking for INTERCEPT platelets in the U.S. will likely be a critical determinant of the slope of…

Thank you, Vivek and good afternoon, everyone. Today, we reported third quarter 2020 product revenue of $23.6 million, which represents a 31% increase from the $18 million recorded during Q3 of last year. In the first nine months of 2020, product revenue totaled $63.7 million, up 19% compared to the $53.7 million reported during the prior year period. Global demand for INTERCEPT continued to increase during the third quarter. The calculated number of treatable platelet doses increased 23% year-over-year and looking at growth through the first three quarters, the worldwide calculated number of treatable platelet doses increased over 12%. In terms of product mix, platelet kits accounted for approximately 87% of total kit sales, while plasma sales accounted for the remaining 13%. This higher proportion of platelets compared to Q2 was anticipated as noted on the Q2 call when plasma kits accounted for approximately 18%, largely driven by the demand for pathogen inactivated CCP. In addition to our product revenue and not included in our guidance, government contract revenues totaled $5.6 million and $16.9 million for the three and nine month period ended September 30, 2020 respectively. Comparatively, government contract revenue totaled $4.8 million and $13.6 million for the corresponding prior year period. Going forward, we expect government contract revenue will continue to increase as BARDA reimbursed clinical trial activities have returned to enrolling patients and as we began working on our whole blood initiative funded by the FDA. Now, let’s move the discussion to our reported gross margins. Gross margins for the quarter were 54%, compared to 58% for the prior year period. Gross margins during the quarter were negatively impacted by a non-routine period charge of approximately $870,000 or 3.7 percentage points of revenue due to certain inventory components that failed to meet the company’s quality standards. And…

Thank you, Kevin. Before we open the call for questions, I would like to spend a few minutes providing a pipeline update. Based on our ongoing conversations with the FDA during their review of our PR- Cryo PMA supplement, we remain optimistic for an anticipated favorable FDA approval decision in late November. We are in the late stages of building out our therapeutic sales team and preparing them to target hospitals at level and level 2 trauma centers which regularly manage life threatening bleeding events. As a reminder, with an anticipated five day post thaw shelf life, PR-Cryo can be stocked in a ready to transfuse liquid form in hospital blood banks, operating rooms and emergency departments allowing for immediate administration to critically bleeding patients in need of fibrinogen and other coagulation factors. Following anticipated FDA approval our blood center manufacturing partners can began manufacturing PR-Cryo including performing the necessary validations and quality control analyses that must be completed prior to distributing the product to hospitals. Therefore, we expect PR-Cryo commercial sales could began in the first half of 2021. Regarding hospital reimbursement for PR-Cryo, earlier this month we submitted an application to the Center for Medicare and Medicaid Services for a New Technology Add-on Payment or MTAP. MTAPs are intended to provide additional reimbursement to help offset the incremental cost to hospitals. We expect the decision on our MTAP submission next year with an anticipated favorable decision allowing the additional reimbursement to begin in Q4 of 2021. Lastly, while the focus of our launch will be on PR-Cryo, it’s important to note that we also simultaneously filed a PMA supplement for a second blood component that is a byproduct of the PR-Cryo manufacturing process. This second component is called pathogen-reduced plasma cryoprecipitate reduced. Our proposed indication for use is…

[Operator Instructions] And our first question comes from the line of Matthew Blackman with Stifel.

Maybe to start with Kevin on guidance, if I just look at the third quarter geographic performance in particular the really steep U.S. growth inflection, it would seem that and you comment around here that the narrower range for the full year is coming more from Europe than the U.S. Is that fair? And sort of the follow-on to that is, I want to understand the potential COVID headwind that you called out, I sense you even see much of an impact in the first or second quarter. So, wondering what potentially maybe going on here in the latter part of the year that gives you a little bit of pause?

Yes. Thanks, Matt. I’ll start and then ask Vivek to chime in with the latter part of that question. I think you are right largely, we continue to see really strong growth in the U.S. and expect that that will continue for the fourth quarter and beyond. But we are hearing quite a bit of news and concern coming out of Europe with the spike in COVID cases and we want to be conservative here and we are not really sure where that’s going to hit or how long or at what magnitude. And so, we felt it’s prudent to narrow the range of guidance. And then, Vivek, if I can ask you to chime in on the last part of Matt’s question.

Yes. Sure. I’d be happy to. Hey Matt, thanks for the question and thanks for dialing in. I think Kevin expressed it well. In the U.S., as you accurately pointed out, we are experiencing strong growth and we continue to expect that strong growth will be an ongoing dynamic both in the fourth quarter and beyond. Part of that is a function of the sites – and I think the amount of head room still in the U.S. Right, so there is room to grow. We are a little bit more cautious in those end-markets where we have a 100% share in Western Europe where overall platelets utilization is coming down a bit of elective procedures are being either cancelled or postponed similar to what we saw earlier this year and our share there will change at all just the total number of procedures and platelet usage we anticipate will decline a little bit. And that’s a function of the hospitals pushing off these procedures. You heard this week that France is going back into a lockdown and then also note that need for blood centers to really focusing on donor recruitment, because there it seems some drop off there in terms of donors coming in. So, you are right to point it’s principally an international dynamic at play. But our U.S. growth will continue to be strong.

Okay. And I guess, - I heard you mentioned that – I think you said you saw growth in four of the five major U.S. blood banks. But I’ll maybe just get a little bit more color on the progress outside of the – in the big four outside of the Red Cross, how are those conversations going? What is the feedback? And do you feel increasingly more confident getting to similar utilization rates that that Red Cross has very publicly called out as they align mandates they’ve drawn. Just give us an update on how those conversations are going?

Yes. Sure. I’d be happy to. One of the things that we’ve talked about in the past is, we’ve made a concerted effort to focus on the big five blood center families which represent north of 70% of nationwide distribution of platelets and the feedback that we’ve been receiving is that their intention is to move towards PR as standard-of-care. And that’s been really consistent across all those blood center families. Now, the rate of growth and the timeline differs, I think part of that’s a function of where they are on the operational side of the house in terms of incorporating optimization measures for production and getting those things around. But what we’ve seen really across the board is, increasing age limit with hospitals moving towards getting PR platelets on to their hospital contracts and really understanding that there – those significant clinical value that they can offer with PR platelets and there is also an opportunity for them to improve their margin profiles on what’s historically been their highest margin product which is platelets. So, it is there, we think whether it’s - ARC is an explicit ability of their big five centers, our channel checks and feedback cycles from them and to make PR really there go to over time in terms of how they address platelet safety.

Okay. And then, one last quick one, I just want to confirm that the slight push out on the seven day label, that’s entirely enrollment base given that’s something that’s going on that we need to be concerned about?

Sorry, go ahead, Obi.

Yes, I think, we are targeting submission in Q1 and that’s largely a function of wrapping those final 12 subjects that’s well underway as we mentioned. So, I think we are optimistic that we’ll have a label claim assuming the FDA moves forward with that submission and through the 180 day review timeframe in the second half of next year. So, that will come into play at a very important time.

Alright. Thank you very much guys.

Thanks, Matt.

Thank you. And our next question comes from the line of Josh Jennings with Cowen.

Hi guys. This is Eric on for Josh. I was just curious on the opportunity in Asia, you guys delivered the positive update on Hong Kong over the summer and we heard about the potential for a joint partner in China while Japan is still reviewing the technology. I was just wondering if there has been any further progress to note in those two markets. Thank you.

Vivek, do you want to cover just what’s happened in Hong Kong as far as getting off the Hong Kong Red Cross something going? And then I’ll be back and elaborate on what we are doing in APAC.

Sure, I’d be happy to. What was encouraging this past quarter in Hong Kong is we were able to get in with our technical services team; get those illuminators deployed and installed and they are now producing INTERCEPT platelets in Hong Kong. So, that’s an encouraging progress there and we really do view that as sort of a V check for us. And Asia Pacific region, that’s a very influential customer who has a, I think significant sway over the specific blood network. And then Obi, I’ll defer to you in terms of the China and Japan updates.

Okay. Yes, more broadly, I think across APAC, there is an awareness around the need for pandemic preparedness in securing both blood safety and availability. China over time will clearly be the largest market for transfuse supply components globally. We are continuing to see double-digit growth rates in overall platelet demand and availability in China. And there is a strong realization there that pathogen inactivation of platelets is for the ultimate transformational change to blood safety that’s required. And also theoretically we’ll increase availability. Most of the platelets in China today are derived from aphaeresis and they can’t really meet the current demand. And over time, the ability to do pooled whole blood derived platelets in China will increase overall availability. So that’s a strong selling point for us. We are in continued discussions with a joint venture partner there and hope – still hope to have something to announce before the end of this year. And then, in other markets, the China Red Cross is the other major market there. I think they really do look to what’s happening across the globe and specifically what happens with the American Red Cross. And so, I think over time what we should see increased awareness on there and as to how INTERCEPT has rolled out in the United States on the back of the FDA guidance for platelet safety in the United States.

Great. Thank you. And then, maybe just one more in the seven day label claim. So, in some of the countries that it’s being used currently, I think for instance with some of the news at the claim there. What has the experience in line so far? And then, is there anything to consider in the U.S. market that might cause this experience to differ?

Yes. Thanks, Eric. It’s a good question. We’ve had a great experience over the last, say, five years in Switzerland and France with the seven day label claim and that’s clearly something that reduces overall wastage and improves the logistics not only at the blood center but also at the hospitals. So if you have remote hospitals that have hard time managing their platelet inventories, this really gives them an increased flexibility. In the United States, with the two one-step option that we referred to in the prepared remarks, you’ve got INTERCEPT with currently a five day claim, but that can be released earlier and then the LVDS claim potentially going after seven days with blood centers, that still has a – the LVDS has a release at day three. So the effective shelf life isn’t as long as you’d expect. So, assuming that we get this seven day label claim in the U.S. it really has the longest effective shelf life and earlier release of the platelet component. So, we think the benefits that we’ve seen in Switzerland and France will also confer to U.S. customers and it will be a strong selling point for U.S. hospitals specifically.

Great. Thank you for taking the questions.

Thanks, Eric.

Thank you. And our next question comes from the line of Mark Massaro with BTIG.

Hey guys. Congratulations on the quarter and thanks for taking my questions. My first question is really around COVID-19. So, recognizing that obviously, we are still in the pandemic and we are seeing signs of – I guess, we are in a second wave. Can you just maybe clarify that the lowering at the top-end of the guidance is largely or completely related to COVID-19 in Europe? Or are you also taking some conservatism in the United States? And then, the second part of that question, recognizing that COVID-19 is certainly a headwind. I know that one of your studies at AABB demonstrated that that there was demonstrated inactivation of COVID-19 in human plasma with INTERCEPT. So I was curious if there is any potential opportunity to make COVID-19 actually a benefit to your business? And I am curious if you are exploring inactivation with INTERCEPT for platelets?

Well, Mark thanks very much for the questions. So, I’ll cover the first part. I am not sure I clearly understood your second question, but I’ll give a shot. And then, correct me if I’ve got it right or not. So, specifically, as it relates to the nearing of the guidance here in Q4, it really does relates specifically to sort of the resurgence of COVID in Europe. And as Vivek already mentioned, just with markets where we are a 100% penetrated to the extent that there is variability in platelet supply and demand either as a function of elective procedures getting pushed out or the availability of like compliance period, that’s what we just look at that and we thought it was prudent to know the range. It still represents is as we mentioned 21% to 30% growth year-over-year shows super strong growth. In the United States, we’ve seen strong growth throughout the COVID-19 pandemic. And that’s going to continue into Q4 and allow for strong momentum going into 2021. With regards to your last question, we clearly believe that INTERCEPT is very effective against – very effective in inactivating coronavirus families. So, we’ve done this historically with MERS in the Middle East respiratory virus and now with the COVID. But I guess, not really getting the part – the last part of your question as far as what you – we certainly see it as – it’s a benefit for future pandemic threats, because of the broad spectrum of inactivation that our technology affords.

Yes. No, that’s fair. I also want to ask about your expectations around the FDA approval. You are sort of in the late innings here and that comments are largely around labeling and without much heavy lifting in terms of the back and forth with the FDA?

We had a lot of back and forth and that’s been a very positive discussion today. So, yes, I guess, what we can say is that we don’t have the cost ups to-date. But maybe I can ask Carol to pine on sort of how she sees the next month playing out and sort of her overall optimism for where we are today.

Thank you, Obi and thanks for the question. Yes, I think we are very positive at this point about the progress we are making. FDA has told us in a number of correspondence that they are targeting to complete the review in a timely fashion. And we do when we get questions, we get them by email, which is a very good way to be have an effective question and answer opportunity, so that we can respond quickly and they can receive the information and process it quickly to move on to whatever else they’d like to have in the submission. So, we don’t have any indication of any concerns from FDA there. It’s a reasonable set of questions and answers and I think we remain optimistic that we’ll complete the process very shortly.

That’s great. And then, my final question, recognizing that the FDA deadline of March 2021 is rapidly approaching. And you’ve commented that you are seeing an increase from the other large blood centers, I mean, I’d say it’s at least four to five in total. Can you speak to maybe the rate of adoption that these other blood centers, I am trying to recognize if there is any penalty for not complying or just how do you think of – is this going to be other blood centers dipping their toe? Or do you see the potential for broader adoption after March?

We clearly see the March deadline as being sort of a point in time, but continued adoption in March towards standard-of-care beyond that. I think, Vivek already mentioned that the American Red Cross came out very clearly on sort of how they see the ramp looking through 2023 which they are targeting a 100%. I think they mentioned that they plan to be 40% penetrated by the end of February. So that’s in advance of the final guidance compliance date. Vivek, do you want to maybe add a few more comments just around sort of how you see the market evolving past the March timeframe?

Yes, I think the point you make about the Red Cross is fairly – and we know the – the other point that I would highlight is when we discussed the seven day label claim and the impact that will have I think in terms of further accelerating adoption, we certainly view and we are seeing steps that the blood centers are taking now around hospital contracting, things of that nature to ensure that they can continue to make that progress. So, while the guidance compliance deadline is March 31st, by no means to you that sort of the what the fixed adoption rate will be we in fact expect an accelerated adoption of PR beyond the guidance through the balance of the calendar year 2021 and really in 2022 and beyond. So, we are – and that’s frankly what we’ve been preparing for and the big reason why this seven day label claim will be a big push in terms of driving further adoptions.

Thanks very much.

Thanks a lot, Mark.

Thank you. And our next question comes from the line of Jacob Johnson with Stephens.

Hey. Thanks. Maybe just a quick follow-up on the last comment there. Just on the slight push out in the timeline for seven day platelet approval, I realize this doesn’t change the long-term outlook at all. But in the near-term could this slow the ramp of adoption for platelets, just given that I think that approval is key for some customers versus prior expectations?

Vivek, I’ll turn that if you, as well. I mean, Jacob, I think that this is we are talking about a month or two here. And so, I think overall, what we are hearing from customers is that they are looking forward to that claim in 2021 and that’s still very much in the timeframe that we talked about. Vivek, any other thoughts?

Yes. No, it’s a fair question. I don’t anticipate it slowing any near-term adoption, simply because our number of activities prior to transacting kits that needs to occur for the blood centers and hospitals to be in a position to adopt the technology. So, the production optimization measures which we talked about in the past need to be adopted at the blood center operations level. That – with Red Cross has been ahead of the curve on this, but other blood center families are making the resource investments required to do that. There is also the contracting fees at the hospital that needs to occur and so those activities are ongoing and they are not seeing delays or slow at all due to the timing of our date and the submission. So I think what you’ll see is continued strong progress and then it will simply serve as a further accelerant because by the time that arrives, you’ll have a lot of the other operational issues either completely or primarily addressed at that point.

Got it. That makes sense. And then, maybe a question for Kevin. I think you already say, gross margins for the balance of the year should be in the mid-50s. I think if you look ex the inventory charge, they would have been towards 50% this quarter. Is that a fair proxy for how we should be thinking about fourth quarter gross margins? Are there some other puts and takes we need to be aware of?

Yes. There was about a 3.5% impact to our overall gross margins. So, you are right. We would have expected the abnormal trading and product mix that would have been on par with where they were last year and we do think that that’s good proxy. We expect platelets to continue to be strong. In Q2, as we discussed we had a fairly high concentration historically speaking of plasma kits which carry the lower margin, that’s reversed and I think as we move forward with the platelet demand that we are seeing in the U.S., we’d expect that the numbers would be fairly consistent. Of course, we can’t predict what’s going to happen with our tax rates. So that’s a wildcard, but assuming normalcy, I think your comments are accurate.

That makes sense. Thanks, Kevin and thanks for taking the questions.

Yes. Thanks, Jacob.

Thanks, Jacob.

Thank you. [Operator Instructions] Our next question comes from the line of Brandon Folkes with Cantor Fitzgerald.

Hi. Thanks for taking my question. Maybe just following on from an earlier question regarding the FDA deadline, could we be in a situation where Sentiss maybe or in a position where they comply with the deadline, but they don’t adopt INTERCEPT just because some maybe reluctance to change the standard operating procedures, just given everything else they are dealing with in COVID. And then, once we get past COVID, we actually see Sentiss moving towards INTERCEPT given its advantages. And then, my second question is, can you just elaborate in terms of what you are seeing in terms of volume at blood donation centers post the quarter end? Thank you.

Thanks a lot, Brandon for the question. I will start and then maybe, Vivek can add some comments. I think, what we are seeing is that, most partners have already adopted INTERCEPT in some shape or form. They continue to optimize it. So they can maximize the production of INTERCEPT treated platelets to meet the demand that they are seeing from hospitals. At the same time, even the Red Cross has communicated to all their hospital customers that they will be providing INTERCEPT as well as LVDS platelets for a period of time and so that the hospitals have to have that in their systems to be able to accept both products just to be able to fulfill their supply requirements. So, I think, to your question about sort of is this something that transitions over time as hopefully the COVID pandemic subsides, I think that’s true to some extent. I think, by and large it really comes down just sort of optimization of their ability to increase overall INTERCEPT platelet production. Vivek, would you have anything else you want to add to that?

I think you captured alone I think, I just will keep coming back to it, but I think the ample of that is just what the Red Cross has stated explicitly to the external market that they intend to be at the 100% in 2023 timeframe, which I’d say implies that you’ll see continued progression for them beyond the March 2021 deadline. I think the key thing is, for them is messaging that to the hospitals certainly contracts in place and preparing to manage inventory, things of that nature and I think you’ll see other blood center families following a similar path.

Thank you. And I am showing no further questions at this time. So with that, I’ll turn the call back to President and CEO, Obi Greenman for any further remarks.

Well, thank you again for joining us today and for your interest in Cerus. Next month, we will be participating in the Stephens Virtual Investment Conference and the Stifel Virtual Healthcare Conference. We hope to connect with many of you there. Thanks again.

Ladies and gentlemen, this concludes today's conference. Thank you for participating, and you may now disconnect.