Cerus Corporation (CERS) Q4 2018 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen and welcome to the Cerus Corporation Fourth Quarter and Full Year 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, there will be a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to Tim Lee, Investor Relations Director. Sir, you may begin.

Thank you, operator and good afternoon. I would 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; Vivek Jayaraman, Cerus’ Chief Commercial Officer; Dr. Laurence Corash, our Chief Scientific 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 ending December 31, 2018 and also describing the company’s recent business highlights. You can access a copy of this announcement on the company’s website at www.cerus.com. I would 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 2018 financial guidance and goals, operating expenses, gross margins, 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 activity and activities of our regulatories as well as the timing thereof. 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 risk factors in our Form 10-K for the year ended December 31, 2018 which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. On today’s call, we will begin with opening remarks from Obi, followed by Vivek who will provide an update on our commercial operations, next, Kevin who will review our financial results with Obi providing closing remarks. And now, it’s my pleasure to introduce Obi Greenman, Cerus’ President and Chief Executive Officer.

Thanks, Tim. 2018 was a successful year for Cerus. Investors often ask what is different now in the context of Cerus’ long history and I would say there have been two key shifts in the U.S. market landscape that set the stage for pathogen reduction to become the standard of care. First, the FDA has maintained their strong advocacy for the role of pathogen reduction in safeguarding the U.S. blood supply. While each new draft is a point at bacterial safety guidance has featured at changing set of testing options, pathogen reduction consistently featured as an option that removes the need for any bacterial tests. Let me share FDA Commissioner Gottlieb’s language from the December press release, the company and the most recent draft guidance. I think while we have made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations in blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products. In addition to microbial testing of blood, the application of safe and effective pathogen reduction technologies is an important part of the agency’s blood safety efforts. And further, Gottlieb continued saying that the updated guidance further advances the potential for technology to be used to reduce the risk of contamination of the blood supply from known and emergent pathogens and to measurably increase the availability of safe blood products while ultimately reducing cost overall. Last week, approximately 2 months later, the FDA announced their planned 2019 publication list of blood related guidance documents, including the long anticipated guidance on bacterial safety. We also saw the recent consolidated appropriations legislation for the Department of Agriculture, which includes specific direction for the draft bacterial safety guidance to be finalized this year. With blood safety guidance that’s typically providing a 12-month compliance period issuing a final guidance this year would set a compliance deadline falling in 2020. We believe the clarity on this compliance deadline can accelerate the rate of adoption for pathogen reduction, but I am not yet assumed any effect of this acceleration in our 2019 product revenue guidance. The second important industry shift in 2018 is the growing confidence among U.S. blood centers that hospitals are willing to recognize the value of pathogen reduction. This new reality was perhaps most eloquently described in an open letter by the President of the American Red Cross Biomedical Services. Speaking at the U.S. healthcare community, the Red Cross argued for improved blood center cost recovery through renovation and adoption of value-based pricing for blood components. Improving blood center financial operations is critical for sustaining the U.S. blood supply as well as any future uptake of new technologies. Beyond these two critical changes in the U.S. market landscape, we made significant progress both commercially and on our development programs. 2018 was a standout year commercially with our team delivering results, which exceeded our internal expectations. We finished 2018 with highest quarterly and full year product revenue we have ever reported. France became the latest country to adopt INTERCEPT as the standard of care and now every patient who receives a platelet transfusion in France benefits from our pathogen reduction technology. This equates to approximately 1,000 patients a day receiving INTERCEPT treated platelet components in France alone, a significant increase of our global impact. We are approaching a critical inflection point with regard to the scale of our business. This year, we expect to ship INTERCEPT kits to treat more than 1 million transfusable components. 2018 was also a productive year for development of our product portfolio. We are particularly excited about our pathogen-reduced cryoprecipitate product, because of the clear impact it can have in providing clinically bleeding patients with more rapid access to a life-saving intervention. We believe the importance of this product was fully validated by its FDA breakthrough device designation, which we hope will accelerate the speed with which we are able to make the product available to hospitals and patients. In recognition of the important clinical and commercial opportunity that pathogen-reduced cryo represents for Cerus, we have formed a dedicated team within the company that will be solely focused on the operational and commercial execution for the product launch in 2020. Our December 2018 CE Mark submission for the INTERCEPT red cell program was also an important milestone. This regulatory application is supported by results from the Spark study, one of the largest transfusion studies ever conducted in the thalassemic population. In the U.S., we expanded our Phase 3 RedeS study into sites beyond Puerto Rico and also initiated enrollment in ReCePI, our Phase 3 study evaluating the safety and efficacy of INTERCEPT treated red blood cell transfusion in cardiovascular surgery patients. With that, let me turn it over to Vivek to provide additional color on our commercial operations.

Thank you, Obi. During the fourth quarter, we experienced strong year-over-year growth in our platelet kits driven by increasing awareness of the risks associated with transfusion transmitted infections. North America led the growth in platelet kit sales, but we experienced gains in all four product sales regions. In the U.S., demand for INTERCEPT platelets continues to strengthen as a result of our commercial team’s efforts as well as market awareness of the pending FDA guidance. The American Red Cross is an illustrious case study in the dynamics of the U.S. market. Since their presentation at our Investor Day last October, they have continued to expand the number of sites producing INTERCEPT and are now producing pathogen-reduced platelets at 15 of approximately 20 manufacturing sites nation-wide. Taking advantage of the December approval of their first BLA submission, they are using the CBE-30 pathway to extend rapid approval of approximately half of their Intercept sites by the end of Q1 with the reminder targeted for licensure in the first half of 2019. This progress allows the Red Cross to supply growing number of hospitals in the near-term as well as preparing the scale rapidly in the future in response to a final FDA guidance document. Our EMEA region delivered four quarters in 2018 with over 25% year-over-year growth primarily driven by nationwide France implementation of INTERCEPT platelets. Other contributors include the INTERCEPT conversions of major centers in Madrid and Warsaw resulting in double-digit growth from both Spain and Poland and starting the foundation for further market penetration in the years to come. In Italy, our distributor partner, Kedrion has already demonstrated strong performance and promising future prospects in a country starting to consolidate its blood banking industry. And last but not least, a number of manufacturing authorizations were submitted to the German national authorities, including applications from 3 out of the 4 German Red Crosses. We believe we are in the early phase of a multi-year growth trajectory. Last year’s product revenue growth was driven primarily by the 100% conversion of the French platelet market. This year, we expect much of the growth will be fueled by market uptake of INTERCEPT platelets in the U.S. Looking further ahead, we anticipate sustained growth from the U.S. market, incremental contributions from Germany and commercial revenue contribution from our pipeline opportunities following licensure. With that, let me turn it over to Kevin for a review of the fourth quarter and full year financials.

Thank you, Vivek and good afternoon everyone. Today, we reported fourth quarter product revenue of $16.5 million compared to $16.2 million recorded for Q4 of last year. Disposable kit sales were once again the driver of growth during the fourth quarter with a strong contribution from U.S. kit sales. For the full year, product revenue totaled $60.9 million, up 40% compared to the $43.6 million recorded for the full year of 2017. This translated into a full year increase into a full year increase in the global demand for our disposable kits of 54%. From a product mix perspective, platelet kits accounted for over 90% of the product revenue during the fourth quarter compared to approximately 75% in the prior year. As we have mentioned in the past, product mix has a significant impact on gross margins with platelet kits generally providing a higher gross margin than our other products. Switching gears, as most of you know, we also generate government contract revenue from our Barda agreement. Though that revenue is reported separately that is not contemplated in any of our guidance, Q4 government contract revenue totaled $3.7 million compared to $2.4 million during the prior year. For the full year, government contract revenue was $15.1 million compared to $7.8 million for the full year of 2017. Now, let’s turn from revenue to other fourth quarter results. Gross margins on product sales for the quarter were 49% compared to 44% for Q4 of 2017. Q4 gross margins benefited from the favorable product mix, including partial conversion to double-dose platelet kits from single dose platelet kits by the EFS in France. For the full year, gross margins totaled 48% in both 2018 and 2017. As we look ahead, we expect product margins to continue to benefit from economies of scale as our overall manufacturing volumes increase and as platelet kits continue to become a larger proportion of our overall product revenue results. Operating expenses during Q4 totaled $27.3 million compared to $20.3 million during the same period in the prior year. For the full year, operating expenses were $99.4 million compared to $86.3 million for the full year of 2017. Of the $27.3 million of operating expenses, SG&A expenses during the fourth quarter totaled $14.8 million compared to $12.6 million during the fourth quarter of 2017. The increase in year-over-year SG&A expenses was primarily due to higher U.S. commercial activity. For the full year, SG&A expenses totaled $56.8 million compared to $52.6 million during 2017 with the increase mainly due to higher head count costs. Despite the modest increase in the SG&A costs, we are continuing to see the leverage from the business and expect that to continue. To put this in quantitative context, SG&A was up 8% for the year, while product revenue was up 40%. Research and development expenses for the quarter were $12.4 million compared to $7.8 million during the prior year. The increase was primarily tied to the clinical development of INTERCEPT red blood cells, including preparation for the CE Mark submission, clinical activities for our Phase 3 studies in the U.S. as well as activities aimed at expanded label claims on the INTERCEPT platelets and plasma. For the full year, R&D expenses totaled $42.6 million compared to $33.7 million in 2017. As we contemplate 2019, we expect R&D expenses to increase largely due to elevated activity for our U.S. red blood cell program funded by Barda. We expect to have more sites and increased year-over-year enrollment numbers in both the RedeS and ReCePI trials and we will begin to incur other non-trial related costs associated with U.S. red blood cell program. Net loss for the fourth quarter totaled $16.2 million or $0.12 per diluted share compared to a net loss of $11.5 million or $0.10 per diluted share for Q4 of 2017. For the full year, net loss totaled $57.6 million or $0.44 per diluted share compared to a net loss of $60.6 million or $0.56 per diluted share in 2017. In terms of our balance sheet, we ended 2018 in a solid cash position with approximately $118 million on hand compared to approximately $61 million at the end of 2017. Throughout 2018, we were able to tightly manage our investments in working capital with lean inventory levels and historically low DSOs. With the anticipated growth in 2019 and beyond, we are anticipating higher investments in working capital as well as investments in quality, capacity and COGS reduction initiatives, which will likely result in an increased use of cash in 2019 relative to 2018. Before I turn the call back over to Obi, I want to reaffirm our 2019 product revenue guidance range of $70 million to $73 million representing a 15% to 20% year-over-year increase. As Vivek already highlighted, we expect 2019 revenue growth will be primarily driven by the continued market adoption of INTERCEPT in the U.S. in contrast to the EMEA driven growth we experienced in 2018. With that, let me turn it back over to Obi for some closing comments.

Thank you, Kevin. Let me close today by outlining our major goals for 2019. First, we plan to build on our commercial success and to continue to deliver on our stated product revenue goals. Second, we expect important advances in our development programs. This includes expanding the number of U.S. blood center partnerships for pathogen-reduced cryoprecipitate beyond the 3 we currently have and also filing our planned PMA supplement in the second half of this year setting the stage for potential U.S. commercialization in 2020. For INTERCEPT red blood cells, our CE Mark filing is under review and in the U.S. we expect to finalize chronic transfusion data requirements for our FDA PMA pathway and to expand the number of participating hospitals in the ReCePI study. Third, we will take steps to expanding capacity of our kit manufacturing in support of our anticipated growing demand for 2020 and beyond. On this front, deployment of Bill Moore earlier this year as the Senior Vice President of Manufacturing, Operations and Supply Chain will provide additional manufacturing and operational expertise that will be critical in ensuring our supply chain integrity and our ability to improve our gross margin profile with the coming volume growth. Finally in closing, I would like to thank our dedicated employees who helped make 2018 a success. Without their tireless effort and dedication to the shared cause, we would not have achieved the important milestone this past year. I am looking forward to their continued contributions and another successful year in 2019. Operator, please open the call for questions.

Thank you. [Operator Instructions] Our first question comes from [indiscernible] with BTIG. Your line is open.

Hi thanks for taking the questions. Congrats on the quarter and also for fantastic year. I was wondering maybe starting out with the clarification your 2019 product revenue guidance does not contemplate the impact from the final FDA platelets guidance?

That’s correct.

That’s correct.

Okay. And then just out of curiosity, is the anticipation that the final guidance will be very similar to the draft guidance in terms of the different options that are available? And then to that effect, do you anticipate some of your customers to begin to adopt pathogen reduction or other types of options that might be available throughout 2019?

Yes. I think what we saw with regard to the guidance document, the revised draft that was issued in December was sort of an increase in the number of options available for blood centers. And I think the FDA was being responsive to some of the past comments. I think from our perspective, we have the preferred product offering to address bacterial safety in platelets and I think that’s been acknowledged by many of the top 5 blood centers in the United States, and specifically, the American Red Cross, which represents roughly 40%, 45% of the overall market. So, I think just from an overall ease of production and the ability to have a transfusion-ready platelet product at the hospital, we’re well positioned in the context of the current options outlined in the guidance. So, I don’t – to answer your question, I don’t really anticipate that the guidance document will change that much, because it really included a lot of the options that were suggested in the previous comment period. And then to your last part of your question, do we expect blood centers to comply with the guidance once it’s finalized, I think the – the answer there is clearly yes. They will have a number of options, but I think from an overall complexity standpoint, INTERCEPT is sort of the preferred option there. We obviously have established reimbursement in place for pathogen-reduced platelets, which I think is another attractive feature. As I alluded to in my prepared remarks, the fact that blood centers can actually do value-based pricing with INTERCEPT-treated platelet components, that’s an extra incentive for them to adopt INTERCEPT over the alternative approaches. And the final thing I would say is, there is ongoing concern about the overall sensitivity of the existing bacterial culture methodologies and INTERCEPT has a very strong track record in preventing septic transfusion reactions coming from platelets.

Yes, Larry, you might have one other comment.

Yes, just to amplify, I think it’s important to note that FDA has consistently held the position that the current bacterial detection methodology that people are overwhelmingly using will no longer be acceptable. So, changes coming no matter what option you may choose.

Okay, that makes sense. Thank you. And then just for the red cell CE Mark submission. Could you just remind us again what the timing is on that, when do you anticipate, how long would the review process take and when do you anticipate the approval?

Yes, we believe that this – when we submitted in December, we thought it would be roughly around a 15-month review time. And so as we get questions that, that will further inform us with regard to the timeline, but currently we anticipate that an approval could take place in 2020.

Great. And then just a last one for me, maybe for Kevin, just – I know you guys don’t provide guidance for your BARDA revenue, but was wondering, if you expect that to significantly increase in 2019 versus 2018? If you could just help us think about how to model that in the near-term that would be helpful? Thank you.

Sure, Sung Ji. So, as I mentioned in the prepared remarks, we do expect to enroll in both ReCePI and RedeS in more sites and within those sites with more patients. That’s going to be a direct contributor to increased cost and reported revenue from BARDA in 2019. I think if you look at the $3.7 million or so in Q4 that we recognized in model off of that assuming more sites enrolling and more patients at these sites, that’s what we would guide you to, although we’re not providing formal guidance on the BARDA number.

Okay, thank you.

Thanks, Sung Ji.

Thank you. Our next question comes from Catherine Schulte with Baird. Your line is open.

Hi, thanks for the questions. Obi, you mentioned forming a cryo dedicated team, how big is that team today and how much do you think you’ll grow that post launch?

Why don’t I have Vivek take that because he is the direct overseer of that team, so, I think why should you take that?

Direct overseer, good title. So, that team Catherine, thanks for the question, is relatively small at this point in time. We have four folks here in the U.S. that are dedicated to pull in the other the strategy and go-to-market planned for the cryo launch. I think as we’ve talked about in the past initially, before BLAs are filed and approved, we will be launching the product within states where we have a manufacturing partnership. So, that will allow us to get initial read on product adoption, and then as BLAs are filed, we’ll scale the team as appropriate. I think once we get a better sense for what adoption is we’ll be able to come back with you –come back to you, excuse me, with more specifics on scale. But we do believe that with the hospital customers we’ve identified with the market receptivity and excitement about the product that there’ll be a healthy amount of anticipation and ultimately demand for the product.

Okay, that’s helpful. And then how much is baked into guidance for contribution from Germany, you mentioned 3 of the 4 German Red Crosses has submitted their MAAs. When do you think we could see those approvals come through?

It’s always challenging to speculate as to when we’ll get approvals. We anticipate that the approval process will take the large part of 2019. So, in terms of the component of 2019 guidance that Germany comprises, it’s a relatively small amount. Having said that, these are pretty important foundational steps that we’re taking to ensure that we can get access to the large market over the course of the multi-year period, and we do see Germany as a contributor to growth in the forecast period and as we discussed back in October at our Analyst Day.

Okay. And then last one from me. Have you received any questions or comments on your red cell CE Mark submission, just curious, if you’ve gotten any early feedback there? Thanks.

Yes, I’ll let – thanks, Catherine for the question, I’ll let Carol answer that question.

Hi, thanks for that question. Yes, we have gotten some clarification request from that TUV, which is our notified body and the first regulatory body to start to review on the CE Mark. We’ve been asked for some documents and just some general clarifications at this point, but we are in a very interactive process with the TUV right now.

Great. Thank you.

Thank you.

Thank you. Our next question comes from Drew Jones with Stephens. Your line is open.

Hey guys, this is actually Mason on for Drew. Thanks for taking the questions.

Yes, no problem.

Hi, Mason.

So sorry if I missed this in prepared remarks, but looking at guidance, can you provide any color on 2019 growth coming from platelet kits versus how much is from potential illuminator sales, is the U.S. sufficiently covered?

Yes, Mason, thanks. The majority of our growth in 2019 is going to be from platelet sales predominantly from U.S. platelet sales, although, we’ll see growth in EMEA and many regions. The majority is a U.S. centric growth driver.

Okay, understood. And for the cryo opportunity, what are your expectations in terms of the manufacturing footprint needed to support that launch? How many manufacturing partners do you expect you will need?

No, our current target right now is somewhere between 5 and 8 at the time of launch and we think that will really give us the presence we need in key states where we’ll initially launch the product because of the BLA requirements to ship out of state. So, really through the 5 to 8 range at the time of launch is what we’re targeting.

Got it. Okay, thank you guys.

Yes, thank you.

Thank you. Our next question comes from Josh Jennings with Cowen. Your line is open.

Hi, good afternoon. Congrats again on the quarter and the year. I wanted to just start off on I think you said in your – in the press release as well as in your prepared remarks, the final pillar, back to [ph] your guidance document is anticipated by the end of this year. Is that coming from the FDA? Is that just kind of a general timeline post-draft guidance where you’re getting that from, just any other detail in terms of that statement and that timing would be helpful?

Yes. There was no timing that was specified in the FDA CBER guidance agenda was published last week, but in the appropriations legislation for the Department of Agriculture which funds the FDA. There were specific language in that document about having the guidance finalized by the end of September of this year.

So, end of September. Is that right?

Yes.

Okay. Is that a fiscal year?

Yes.

Okay, fantastic, Thank you. So, if – and then just – have there been any new sepsis cases from contaminated platelet unit transfusions I know that AABB in the fall that was kind of little bit of an uproar and that’s been impactful, but have you – have there been any anymore reported cases of sepsis in the U.S.?

Larry, do you want to handle that.

Yes, there have been some cases reported particularly for a bacteria called acinetobacter, which is an unusual contaminant, but there continued to be some cases reported. INTERCEPT inactivates that pathogen quite well.

Great. And then just thinking about France specifically in such a strong year in 2018, their conversion to doubles, should we be thinking about revenues coming from France growing in 2019 despite the comp in the conversion to doubles? Thanks for taking the questions.

Yes, thanks, Josh. I’ll let Vivek respond.

To add – so Josh as I think we indicated in the previous call, in the third quarter of last year, we started to see the conversion in France from 100% SV and LV kits to our double-storage kit. We – they have stated that they wanted to get to north of 50% DS kits exiting this calendar year. They are then that’s going to be a process really that plays out at each individual manufacturing center. At the time we indicated that there was probably about $3 million to $5 million headwind in terms of top-line revenue impact for 2019. And so we’re seeing the solid top-line growth in spite of that headwind from France. So, we with the U.S., with other geographies contributing, we believe that there are significant growth opportunities in our core business that will more than offset the decrease we’ll see in France as they convert to the DS kit.

Great, thanks again.

Thanks, Josh.

Thank you. Our next question comes from Craig Bijou with Cantor Fitzgerald. Your line is open.

This is Jordan Abrams on for Craig. You touched on it in the prepared remarks, but adding additional manufacturing capacity, can you maybe talk about where it is today and where it goes in a relative sense?

Yes, so obviously, as we scale our business and given our position in the market, supply, capacity and quality are the things that we spend a lot of time thinking about especially as we progress towards our mission of making the standard of care. So, over the last couple of years we’ve been doubling manufacturing capacity with our partner, Fresenius Kabi, and have in place now the plans for doing that again sort of throughout this year and end of 2020, such that we could respond to a final guidance in the timeframe that we mentioned previously. So, I think we’re in a good spot, but it’s – in a situation like this, you always want to be looking sort of 3 years to 4 years down the road. And I think that the team is clearly focused on the investments that we need to make to ensure the long-term quality and capacity that we need for this impending final guidance.

Great, thanks. And one more high-level, how should we think about revenue cadence throughout ‘19? Thanks for taking the questions.

Yes, Kevin, I’ll let you handle the last one.

Yes, so we throughout 2018 benefited really from some large customers converting namely the American Red Cross, as well as the EFS, who standardized on the platelet platform. And that really has smooth out the revenue ramp and decreased the quarter-over-quarter volatility. As we look to 2019, those order patterns continue and we expect that our guidance is predicated on those order patterns and overall growth trajectory. And so we should expect less quarter-over-quarter dynamic volatility that we saw maybe in 2017 and 2016.

Okay. Thanks.

Thanks, Jordan.

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

Yes, thank you all for joining us today and for your interest in Cerus. We will be participating in two upcoming investor conferences. First, we’ll be participating at the BTIG Healthcare Conference in Snowbird actually tomorrow, and the next month, we will be participating in the 39th Annual Cowen Healthcare Conference in Boston. We look forward to seeing many of you there in person. Thanks very much.

Ladies and gentlemen, this concludes today’s conference. Thanks for your participation. Have a wonderful day.