Kevin Green
Analyst · Baird. You may begin
Thank you, Carol, and thanks to everyone on the call today for your time and interest in Cerus. Earlier this afternoon, we reported Q4 2017 product revenue of $16.2 million compared to $10.1 million for Q4 of 2016. For the full year 2017, product revenue was $43.6 million, up 17% from 2016. These results exceeded our expectations and were above the high end of our revenue guidance, previously set at $41 million to $43 million. Underlying the year-over-year Q4 revenue growth was an increase in demand for our kits, primarily platelet kits. Conversely, illuminator sales during fourth quarter of 2017 were down relative to the prior year as Q4 2016 was a record quarter for U.S. illuminator placement. For the full year, demand for INTERCEPT kits increased 21%. We are encouraged by the growth in demand for INTERCEPT kits, which we view as an important metric by which we measure our progress. During the fourth quarter, we received initial kit orders from our Q3 agreement with EFS and completed the initial placements throughout France. Initial kit orders from EFS were higher than our expectations. And while we are encouraged by these orders, we believe there was some level of inventory destocking. We continue to expect that EFS will be in routine use nationwide during the base contract period. Based on our current outlook for 2018, we are reaffirming our previously provided product revenue guidance of $51 million to $53 million, which represents 17% to 22% growth over 2017. Beyond product revenue guidance and not included in our guidance is, of course, the government contract revenue, we recognized from our BARDA agreement. That government contract revenue totaled $2.4 million for the fourth quarter and $7.8 million for the full year 2017. Now, I'd like to turn the discussion to gross margins. Gross margins on product sales for the fourth quarter were 44% compared to 45% in Q4 of the prior year. There were a number of factors that had offsetting effects and kept margins relatively consistent year-over-year, including a higher proportion of sales coming from our lower cost platelet kits relative to plasma kits, the benefit from the euro/U.S. dollar foreign exchange rates, which was offset by pricing incentives for high volume contracts. For the full year 2017, gross margins were 48% compared to 45% for the prior year. Throughout 2017, we were focused on and saw continued improvement in manufacturing and inventory management and our sales experienced a relative move in mix to platelet kits, which carry a higher margin over plasma kits. At the levels associated with our 2018 annual product revenue guidance and stable euro/U.S. dollar exchange rates, the anticipated gross margins will remain in the high 40s. And turning to operating expenses, total operating expenses for the fourth quarter of 2017 were $20.3 million compared to $21.5 million for the prior year period. Specifically, R&D expenses declined to $7.8 million in Q4 of 2017 from $8.8 million in the prior year. The decline in R&D expenses during this time primarily resulted from BARDA-related equipment purchase in Q4 of 2016 and the minimal expenses incurred in Q4 of 2017, given the recent closeout of the SPARC study, which was, of course, ongoing in Q4 2016. SG&A expenses during the quarter were relatively flat year-over-year as we continued to leverage our commercial and support investments in both Europe and the U.S. As you will recall, we began building out our U.S. commercial team in 2015 following our FDA approvals, which continued interest to 2016. We believe that we now have the structure and resources needed for commercial execution in the U.S. and EMEA and that we will continue to realize increased contributions from those levels of investment. The full year ended December 31st, 2017, operating expenses were $86 million compared to $80million for the prior year period. The increase was tied to the completion of the U.S. commercial team build out and expanded red cell clinical development activities, particularly associated with our BARDA efforts. On the bottom-line, net loss for the fourth quarter was $11.5 million or $0.10 per diluted share compared to a net loss of $13.5 million or $0.13 per diluted share in the prior year period. For the full year ending December 2017, net losses were $60.6 million or $0.56 per diluted share contrasted to a net loss of $62.9 million or $0.62 per diluted share. Looking at the balance sheet, we ended 2017 with cash and short-term investments of approximately $61 million compared to approximately $72 million at the end of 2016. Cash used in operating activities during the fourth quarter were $10 million and $52.2 million for the full year, in line with our estimates of $12.5 million to $15 million per quarterly average. Subsequent to year end, we raised approximately $57.5 million in the public offering of common stock. In addition, we expect that additional capital under our growth capital facility will become available to us should we choose to exercise our option under the agreement. The additional capital and access to flexibility on our growth capital facility provides us with the ability over the next few years to deliver on our commercial strategy and bring pipeline products to the market, including the continued rollout of INTERCEPT platelets and plasma in the U.S., INTERCEPT adoption throughout France and in Germany, the pursuit of CE Mark and planned commercial launch of INTERCEPT red cells in Europe, and development completion and planned commercial launch of extended storage pathogen-reduced cryoprecipitate in the U.S. And with that, I'll turn the call over to back over to Obi for closing remarks.