Vivek Jayaraman
Analyst · Josh Jennings from Cowen and Company. Your line is now open
Thank you, Obi. This is an exciting time for Cerus. The events of the past quarter and the compelling market opportunities in front of us give me great confidence that we can meaningfully expand patient access to safer blood. So today, Cerus is the pioneer and undisputed leader in providing pathogen reduced blood components. The market potential for our approved products is approximately $1 million. Furthermore, with line of sight for potential INTERCEPT Cryo and red cell approvals, we may soon have the opportunity to participate in segments of the transfusion medicines space with an aggregate market size north of $5 billion. Initial feedback from clinicians for pathogen reduced Cryo, which offers an extended post-thaw shelf life and immediate availability for transfusion, is very encouraging. Few companies have the potential to create and build opportunities at this magnitude. Cerus is well positioned to be first mover in many product categories, and also in many key geographies. Key to our success is pairing intelligent go-to-market strategies with disciplined commercial execution. Our results this past quarter give me confidence in our ability to deliver solid execution, going forward. Starting with the U.S., we have gained a great deal of valuable insight in the past year. This knowledge has come to a close partnership with blood centers, hospitals and clinicians. We are smarter today about the platelet production realities facing our blood center customers, and also better understand the efficiency gains required to make INTERCEPT a standard of care. Furthermore, we are more confident than ever in the clinical interest-in and demand-for pathogen reduction. Our cross-functional filed team, which includes sales, marketing, deployment and hospital affairs, are working hand-in-hand with blood banks to integrate INTERCEPT into their operations. They are also working closely with the hospitals to ensure that they are ready to receive product and with clinicians to drive education and raise awareness. During the last few months, our focus on optimizing the number of pathogen reduced units produced by our blood center customer has yielded significant results. As an example, during the recent AABB Meeting, a case study presented by the American Red Cross show that our collaborative efforts could increase the potential percentage of treatable platelets to over 70% by implementing modification for the collection and manufacturing process. Beyond the ARC, other blood centers presented similar findings when discussing their ability to optimize INTERCEPT production. Accordingly, we are confident that we have a clear path to addressing the early challenges that are unique to the U.S. market. Blood centers are no longer asking why they should adopt INTERCEPT. Instead, there is a clear focus on determining how to optimize production of INTERCEPT platelets. Another initiative for our field team is create awareness and to educate hospitals, administrators and transfusing clinicians. It is a balancing act to generate clinical demand, while making sure that blood banks are well positioned to supply INTERCEPT. Encouragingly, clinicians are stating a desire to move to an 100% adoption of INTERCEPT platelets. In response to this demand, many blood centers are diligently implementing production modifications to enable them to increase supply of INTERCEPT platelets. As hospital demand for pathogen reduced platelets continues to grow, blood centers are moving with increased urgencies to ramp up supply. Our activities at both the blood center and hospital level are generating results. U.S. sales were up both year-over-year and on a sequential basis. Q3 2017 U.S. platelet kit sales were up 90% when compared to Q3 2016. Through the first nine months of 2017, U.S. platelet kit sales were up nearly 140% when compared to the first nine months of 2016. It’s critical to increasing availability of supply as the BLA process for blood centers. BLAs allow for shipment of INTERCEPT components around the country from a centralized manufacturing location. As we announced last month, Rhode Island Blood Center was the first to receive their BLA approval. With the BLA in hand, Rhode Island is now shipping INTERCEPT platelets across state lines to places like Yale University. Seven other blood banks have submitted their BLAs, and we expected to see more approvals in the coming weeks and months. Driving a tighter connection between clinical demand at the hospital and available supply from the blood center continues to be our main focus. To that end, we made encouraging process in Q3. Now, turning to Europe. Obi mentioned our continued March forward in France, which is certainly exciting news. Also encouraging is the recent announcement by InEK, the German institute for hospital rumination to reimburse pathogen reduced platelets. This is a significant development and is a big step in opening up the largest platelet market in Europe. Based on the number of platelets produced, we believe that the German market opportunity is in excess of $30 million annually. As Obi mentioned, pathogen reduction allows German blood centers to store platelets for up to five-days versus four-day storage for conventional platelets. The ability to store pathogen reduced platelets for up to five days should decrease wastage rate, both at the blood centers and hospitals where platelet discards are currently as high as 20% of overall production. The combined potential improvement in platelets -- PLT logistics and favorable reimbursement makes us confident that the German market could be a significant growth driver for our European business in the years to come. In the immediate term, the usual budgeting process for German blood centers and the MAA process by the PI will take time. Right now, our goal is to facilitate the implementation and MAA submissions broadly in the German market. Once completed, we expect the German platelet market to be a key growth driver for our EMEA franchise. As we announced earlier this week, we secured a meaningful win in Spain. We were recently awarded a tender for the transfusion center of the community in Madrid, or CTCM. CTCM is one of the largest blood centers in Spain. We believe this contract award provides direct evidence of the value of our INTERCEPT products portfolio. It is encouraging to see this large and influential customer chose to follow up the standards been established in other European countries. We also announced our new Italian distribution agreement with Kedrion. Some of you may be familiar with Kedrion, a global manufacturer and distributor of blood products, with expertise in plasma collection and fractionation. With their global headquarters in Italy, they bring deep market knowledge and key customer relationships that we believe will be instrumental in defining new standards in Italian blood safety. This is also our first distribution agreement that encompasses all three blood components, platelets and plasma today and red cells, when they're launched in Europe upon receipts of the anticipated CE mark approval. Realizing importance of pathogen reduction and the manufacturer of plasma derivatives, Kedrion has fully engaged on this significant opportunity to establish INTERCEPT as a standard of care nationwide in Italy. As more countries across Europe adopt INTERCEPT as a standard of care, we are moving forward towards a tipping point across the continent. These are exciting times. In summary, I believe that we are on the cusp of significantly expanding patient access to safer blood. One of the things that most excites me about Cerus is the platform that our technology provides to positively impact healthcare on a major scale. We operate in $1 billion market today and expect to soon operate in markets that are in excess of $5 billion with inclusion of red cells and Cryo. From a commercial perspective, we made meaningful progress in this past quarter. I am excited to drive strong results in the years to come and feel confident that we have the right products, plans and people in place to deliver compelling sustainable top line growth. I'll look forward to continuing to update you on our commercial progress in the quarters to come. With that, let me turn it over to Kevin for a review of the financial results.