Ladies and gentlemen, thank you for standing by and welcome to the Cerus Corporation Fourth Quarter and Full Year 2019 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker presentation, there'll be a question-and-answer session. [Operator Instruction] Please be advised that today's conference call is being recorded. [Operator Instruction] I will now turn the conference over to your host for today. Mr. Tim Lee. Sir, you may begin.

Thank you, operator, and good afternoon. I'd like to thank everyone for joining us today. With me on the call are Obi Greenman, Cerus' President and Chief Executive Officer; Kevin Green, Cerus' Chief Financial Officer; and Carol Moore, our Senior Vice President of Regulatory Affairs and Quality. Cerus issued a press release today announcing our financial results for the fourth quarter and full year ended December 31, 2019 and also describing the Company's recent business highlights. You can access a copy of this announcement on the Company website at www.cerus.com. I like to remind you that some of the statements we will make on this call will lead to future event and performance, rather than historical facts and our forward-looking statements. Examples of forward-looking include those related to our future financial and operating results and putting our 2020 financial guidance and goals, operating expenses and gross margins, commercial development efforts, future growth and growth strategy, future products sales, product launches is impacted current and future products on blood center operations, ongoing and future clinical trials, ongoing future product development and our regulatory activities, as well as 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're identified and described in today's press release and under risk factors in our Form 10-K for the year ended December 31, 2019, 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 Kevin, who will provide a detailed financial review of our financial resuls and with Obi providing the closing remarks. And now, it's my pleasure to introduce, Obi Greenman, Cerus' President and Chief Executive Officer.

Thanks, Tim. Good afternoon everyone and thank you for joining us on the call. As a result of the efforts of the entire Cerus team, 2019 was another standout year commercially. We finished 2019 with the highest quarterly product revenue ever, reported at $20.9 million, up 27% compared to the fourth quarter of 2018. For the full year, product revenue totaled $74.6 million at the top end of our revenue guidance range of $72 million to $75 million. Over the past three years, we have doubled our product revenue. But even more importantly they've now been approximately 7 million transfusable units of INTERCEPT platelets and plasma shipped worldwide, and we are still early in the global adoption ramp. With the updated issuance of the final guidance on the bacterial safety of platelets in September of last year, U.S. blood centers and hospitals have until the end of March 2021, to implement procedures to safeguard their platelet supply. We're well positioned to help our blood center customers in the U.S. through the remaining 13 months of the compliance period for the FDA guidance documents. Beyond providing the proactive benefits conferred by a robust pathogen reduction technology, INTERCEPT also allows blood centers through these platelet products at least a day earlier compared to the other options put forward in the guidance. By strong streamlining the logistic to delivering platelet products to hospitals, we were able to demonstrate cost savings by making certain blood center processes and assays such as gamma radiation, CMV serology testing and Zika virus testing, redundant thereby minimizing the number of product codes and eliminating specific procedure costs. For the anticipated FDA approvals for extended day 6 label claims and our triple storage set for platelets, we believe that the INTERCEPT value proposition for blood cleaners will be made…

Thank you, Obi, and good afternoon everyone. Today, we recorded fourth quarter 2019 product revenue of $20.9 million, up 27% from the $16.5 million recorded during Q4 2018. For the full year, product revenue totaled $74.6 million, an increase of 23% compared to $16.9 million reported for 2018. These results are unchanged from the preliminary full year results be announced in early January. In terms of product mix sold during the quarter, platelet kit sales accounted for approximately 85% of reported product revenue. Looking ahead to 2020, we expect robust platelet kit growth, driven largely from increased utilization of INTERCEPT our U.S. blood centers as they take action to comply with the FDA guidance document. Accordingly, we expect full year 2020 product revenue will be in the range of $80 million to $93 million, representing growth of approximately 20% to 25%. Government contract revenue totaled $5.6 million and $19.1 million during this 3-and 12-month period ended December 31, 2019, respectively, from the $3.7 million and $15.1 billion reported during the comparable periods of 2018. Increased enrollment in our RedeS and ReCePI studies, preparatory activities for additional clinical activity as well as CMC and in vitro development drove the increase and are expected to continue through 2020. Now, let's move the discussion to our reported gross margins. For the quarter, gross margins were 56%, compared to 49% for the prior year period. The significant improvement in gross margin was attributable to economies of scale and lower per kit COGS, resulting from the increased volume of kits manufactured to meet current and expected growth and demand for our products. Additionally, gross margin improved as a result of the favorable product mix shift to double those platelet kits in France. For the full year, gross margins were 55% compared to 40% during 2018.…

Thanks, Kevin. Before I wrap up the call, I wanted to briefly comment on the recent outbreak of the COVID-19 virus, which originated in Wuhan, China. Some more coronavirus like SARS, MERS or COVID-19 are mosquito-borne virus like Zika, chikungunya and West Nile. The only real surprise would be to not have another one in the near future. As we have frequently witnessed, these pathogens make their presence known quickly and would impact via the human toll of morbidity and mortality and the reverberation on societal infrastructure. The efforts required by healthcare providers across the globe as they address an emerging pathogen or monumental in their scope. Amongst many critical parameters, safety, availability of blood and its components for transfusion or fundamental to our vital health system and to ensuring positive outcomes for seriously ill and injured patients. Blood transfusion has been noted as one of the most common procedures administered in hospital -- to and possible inpatients and in many cases is nothing short of life saving. Cancer patients who received the vast majority of all transfused platelet products are particularly susceptible to infectious risks due to their underlying disease and aggressive treatment protocols. Emerging pathogens pose an ongoing threat to the safety and availability of the blood supply, while travel in train have historically been the primary means by which emerging pathogens move dynamically across the world. Rapid urbanization over the last century has also introduced large numbers of people to previously undeveloped areas. All allow disease to move into older urban areas where population density has increased. Changes in rainfall, temperature, and season patterns have been shown to contribute to expanded vector populations and ranges, two factors that may allow diseases to spread into areas where weather or elevation may have previously served as a protective barrier.…

Thank you. [Operator Instructions] Our first question comes from Mathew Blackman of Stifel. Your line is open.

It didn't sound like Vivek was there in the role call that Tim did. So maybe, Obi, if you could tackle I got a couple of questions with a follow-up. But could you just maybe talk in more detail general about the level of blood center preparedness today versus, say, September 30th? And we all know that Red Cross has been ahead of the curve, but I'm also curious how the other big four are checking and then a couple of follow-ups on that?

Yes, thanks Mathew. Yes, the Red Cross continues to be at the forefront with regards to their overall strategy for being compliant with the final FDA guidance document. So, I think that they will continue to be the front runner just given their history of working with us. With regard to the remaining four of the big five plus centers, there's sort of a spectrum of preparedness on their part. Certain blood centers are, I think, farther along than others and it really comes down to, are they sort of trying to determine what their blood centers will or their hospital customers will get, versus reacting to what's hospital demand is. And I think that really comes down to having a strategy by which you go to your hospital customers and say, we believe that pathogen reduction is our preferred option and here's the value proposition associated with the increased price relative to the other options that are put forth in the final guidance document.

Okay. That actually lends itself well to the follow-up, which was, a lot of time talking about blood bank preparedness. But how are you guys specifically also approaching and engaging the hospital end customers? How are those conversations going? And you mentioned it, but are you still seeing the ability for blood banks to drive premium pricing with the platelet product?

I think again, going to the Red Cross as an example just given how far along they are with regard to their overall plan strategy, it really is a partnered effort between Cerus and the American Red Cross. We have a dedicated team that works with the America Red Cross, but on the hospital affairs side as far as bringing on board INTERCEPT platelets and discussing the value proposition with those hospital customers and why we believe is an economic justification for increasing pricing, given the benefits conferred by pathogen reduction relative to the adoptions. One of those being increased platelet shelf life of earlier was the platelets. And the ability to standardize the platelets components that a hospital will receive via fewer codes, thereby making it easier for hospitals to have a transfusion ready product. I think the central theme there is having a treated product versus tested product. And then we also have a deployment team that works closely with the American Red Cross, not only on the production side as far as how quick they can ramp their INTERCEPT platelet production, but also the handoff to the hospital customers.

One last quick question. Any update on the number of approved BLAs in the U.S.?

Yes, thanks Mathew. I think we're still around 15. We've got 19 Red Cross blood centers that are using INTERCEPT out of their total 22. So, the BLA approval process is not rate-liming at this point with regards to most of our key customers and we don't expect it to be throughout 2020.

Our next question comes from Jacobs Johnson of Stephens. Your line is open.

Hey, thanks for taking the questions. Kevin, I think in the past you've given us some color and volume growth in the core, clearly pretty standout quarter for product revenue, but I'd be interested of you share any color about the volume trends you saw on the fourth quarter.

Yes. So for the quarter kit volume was quite robust, if you compare that to Q4, the prior year kit growth was up around 32%. For the full year, not too dissimilar but close to 25%

And then just Kevin, sticking with you. On the guidance for this year, can you just walk us maybe through the puts and takes of it, particularly, it sounds like this will probably be largely driven by U.S. platelet kits, but does assume any contribution from cryo maybe towards the back end of the year? And then any countries we should be aware of that are contributing to the guidance?

Yes, so most of the growth, the vast majority of the growth will be driven from U.S. platelets. So that's not to say that there won't be growth in other areas, but relative to the growth that we're expecting from the U.S. that will be modest. There is no cryo revenue modeled into our guidance. We do expect to submit in the first half of this year and assuming reasonable questions and response times could have approved by the end of the year. But we did not factor in any revenue into our guidance from cryoprecipitate.

Thank you. [Operator Instructions] Next question comes from Josh Jennings from Cowen. Your line is open.

Hi, this is Eric on for Josh. Can you hear me?

Yes, we can.

Just looking at your opportunity in Europe, what sort of contributions are you guys thinking could come out of Germany in 2020.

Yes. So, Germany continues to be somewhat of a slow ramp relative to what we said -- similar to what we saw in the U.S. There are a lot of what are called MAAs that are approved are in the process of being approved right now by the Paul-Ehrlich-Institute, which is the regulatory body that approves German blood centers to implement new manufacturing methods or I guess essentially it's the blood products in Germany are regulators biologics, [by the pie], and so those are all coming together. We do have hospitals -- sorry, blood center contracts there in place and they're in discussion. And then, the mechanics of how the existing reimbursement that's in place actually translate into hospital payments to blood centers for the products and something that we're working through today. So, there is dedicated Cerus team working on this. We are optimistic about the long-term opportunities that Germany represents, but in context of 2020 guidance, it's not something that we think is going to be delivering meaningfully, it's more of a 2021, a '22 event.

Great, thank you. That's very helpful. And then looking at the two Phase 3 studies you guys have ongoing for red blood cell. You previously mentioned a goal of having 10 sites up and running for ReCePI by year ends. I'm just wondering how progress on that goal has been? And then any comment on enrollment would also be helpful? Thanks for the questions.

Yes. So, as you mentioned, we have two Phase 3 studies that are enrolling in the United States. One is called RedeS and the other ReCePI. The RedeS study is enrolling really quickly and will continue throughout this year. So, we're optimistic about enrollment in that study. And ReCePI enrollment is starting to ramp as well. We have actually enrolled 10 plus sites in 2019 and are expanding number of sites over the next several quarters. So, with the additional sites that are coming on board, I think we're targeting more than 15 for this year. We should see an increased pace of the environment for the rest of the study in 2020.

Thank you. I'm showing no further questions at this time. I'd like to turn the conference back over to Obi Greenman for any closing remarks.

Thank you all for, again for joining us today and for your interest in Cerus. We will be participating in Q1 upcoming investor conferences in the next month. First, we'll be at the 40th Annual Cowen Healthcare Conference in Boston next month. We'll also be at the BTIG Snowbird, Utah Conference in March. We look forward to seeing many of you there in person. Thanks very much.

Ladies and gentlemen, this concludes today's conference. You may all disconnect. Have a great day.