Cerus Corporation (CERS) Q4 2022 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cerus Corporation Fourth Quarter and Full Year 2022 Earnings Conference Call. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Joel Trujillo, Cerus' Senior Director of Investor Relations. Please go ahead.

Thank you, and 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 ir.cerus.com. With me on the call are Obi Greenman, Cerus' President and Chief Executive Officer; Kevin Green, Cerus' Chief Financial Officer; Dr. Laurence Corash, Cerus' Chief Scientific Officer; Vivek Jayaraman, Cerus' Chief Operating 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 fourth quarter and year ended December 31, 2022, 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'd 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 2023 product revenue guidance and goals, operating expenses, anticipated cash used from operations, gross profit 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 initiatives, including the timing of these events and activities. These forward-looking statements involve risks 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 December 31, 2022, which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, we will also be discussing non-GAAP financial measures, including non-GAAP adjusted EBITDA. These non-GAAP measures should be considered a supplement to, and not a replacement for, measures presented in accordance with GAAP. For a reconciliation of non-GAAP financial measures to comparable GAAP financial measures, please refer to today's press release. We'll begin today with some opening remarks from Obi, followed by Vivek to discuss some recent business highlights, and Kevin to review our financial results. We will conclude with commentary from Obi with closing remarks. And now it's my pleasure to introduce Obi Greenman, Cerus' President and Chief Executive Officer.

Thank you, Joel, and good afternoon, everyone. In 2022, Cerus kept assets momentum in progressing on our goal to safeguard the global blood supply, building upon efforts in establishing INTERCEPT as the standard of care in multiple geographies, most recently in the U.S. On our last several calls, we have spoken about the momentum the business has seen in the U.S., and we continue to see this trend play out in the fourth quarter with sustained growth of our INTERCEPT platelet business, driven by excellent commercial and operational execution as we manage the growth with an evolving manufacturing capacity expansion. Our success in deploying the INTERCEPT Blood System for platelets in the U.S. drove a record year for the company. The significant growth the company has realized over the past 5 years is enabling Cerus to lead a paradigm shift in transfusion medicine. Here is prerelease for our 2022 top line results in January. And I'm happy to report that in addition to a robust top line, the company has driven sustained margin expansion, run the business with low cash use from operations over the past several quarters, generated leverage from our SG&A investments and ended the year with a very strong balance sheet. We remain encouraged by the foundation for growth upon which our core business franchise is built, and expect a few near-term challenges that we referenced in our prerelease to moderate as we progress through the remainder of the year. Having established INTERCEPT as a standard of care in many national markets now, we have placed a substantial focus on being a trusted and reliable partner to our customers with over 13 million INTERCEPT platelet and plasma doses transfused to date. To realize our mission, Cerus continues to work with its partners to expand manufacturing capacity in multiple facilities to position itself to continue to grow INTERCEPT Blood System adoption in 2023 and beyond. We see significant opportunity to grow our top line over the next several years. And now in 2023 will have the necessary capacity to realize that growth. This growth is expected to be supported by the extension of our leadership in markets we currently serve and serving the new geographies such as Canada, China and Germany, and the commercial success of new products, including our INTERCEPT fibrinogen complex. The opportunities ahead for Cerus, particularly in the context of the organic growth of the company's total addressable market, or TAMs, are significant. We expect these TAMs to continue to grow, surpassing $1.5 billion and $200 million for the global and U.S. platelet opportunities, respectively, over the next 5 to 7 years, driven by mid-single-digit overall platelet demand growth. I would now like to turn the call over to Vivek to discuss the fourth quarter revenue highlights.

Thank you, Obi, and good afternoon to everyone joining today's call. Product revenues for the fourth quarter of 2022 grew 10% on a year-over-year basis and 11% on a sequential basis, once again driven by a strong contribution from our U.S. platelet franchise. In North America, we saw continued growth in platelet utilization across U.S. blood center customers with product revenues growing 27% year-over-year and 16% sequentially. In EMEA, ongoing currency headwinds adversely impacted year-over-year results. However, a 6% increase in volumes relative to the third quarter drove sequential product revenue growth of 3%. You will recall during the fourth quarter, we announced that Cerus secured Health Canada approval for a 7-day platelet shelf life claim. The company has been diligently working with Canadian Blood Services or CBS, to deploy the INTERCEPT Blood System in Ottawa. This approval allows CBS to begin rolling INTERCEPT out across their network of blood centers. This rollout is ongoing, and I look forward to providing more updates about our progress in Canada on a future quarterly earnings call. I will now turn it over to Kevin to discuss our results and outlook in more detail.

Thank you, Vivek, and good afternoon, everyone. With our substantial revenue growth in 2022 and our disciplined approach to operating expenses, we continue to move the business ever closer to our goal of cash flow breakeven. We expect this dynamic will continue during 2023. We posted fourth quarter 2022 product revenue of $44 million, representing year-over-year growth of 10%, led by sales in North America. Full year 2022 product revenues of $162 million were up 24% year-over-year, also driven by North American sales. FX headwinds continue to impact the top line, negatively impacting reported revenues by 4% for the fourth quarter and 5% for the full year. This headwind was offset by INTERCEPT platelet sales growth across our U.S. customer base, with sales to the largest blood center customers growing 18% year-over-year on a quarterly basis and 47% year-over-year on an annual basis. Meanwhile, sales to other blood centers grew 44% year-over-year on a quarterly basis and 59% year-over-year on an annual basis. In EMEA, as previously mentioned, the continued strength of the U.S. dollar negatively impacted the comparable growth year-over-year as reported in U.S. dollars. This FX headwind impacted shares throughout 2022, and we anticipate that it will continue at least partially through 2023. Accordingly, our annual revenue guidance is based on U.S. dollar to euro parity for the year. I'll discuss this further in a moment. Looking at pure growth of kits sold. Full year platelet kit growth in the U.S. was 49% on a year-over-year basis, while growth internationally was 9% on a year-over-year basis. Meanwhile, full year growth in the calculated number of treatable platelet doses reflects a 48% year-over-year increase in the U.S. and a 12% increase internationally. In terms of product mix for the quarter, sales of INTERCEPT disposable kits represented over 93% of our Q4 product revenue and approximately 95% of our full year 2022 product revenue. Government contract revenue, which is incremental to our product revenue and is not included in our annual revenue guidance, totaled $7.3 million in Q4, up from $6.8 million in the prior quarter. As a reminder, in addition to the work with U.S. BARDA on red blood cells and the whole blood initiatives supported by the FDA, our award from the Department of Defense for LyoCryo, a nonfrozen miopolized formulation of IFC will be recognized on this line over the next 2 years. The contract with the DoD is a milestone-based contract, which differs from the bill as incurred contracts that we have with BARDA and the FDA. Turning now to our product gross profit and gross margins. Our fourth quarter product gross profit was $24.5 million compared to $20.4 million during the prior year period, an increase of over 20% year-over-year. Product gross margin for the fourth quarter was 55.7%, up more than 450 basis points when compared to the prior year period and 35 basis points sequentially. As we've mentioned before, with the majority of our COGS denominated in euros, the strengthening U.S. dollar is supportive to our gross margins, particularly for sales of products that are U.S. dollar denominated. In addition, as our volumes have increased and the COGS reduction efforts that have been underway take effect, we expect to see modest but continued improvement to our gross margins. Moving on. Our fourth quarter operating expenses totaled $41.8 million, up from $37.6 million in the prior year period, driven primarily by investments in R&D. By expense type, fourth quarter R&D expense totaled $18.6 million compared to $15.6 million during the prior year. Fourth quarter SG&A expense was $23.2 million compared to $22 million in the prior year period. While we all have to contend with inflationary pressure, we are committed and remain focused on driving financial discipline in order to deliver operating leverage and improve bottom line results. On the bottom line, reported net loss attributable to Cerus for the 3 months ended December 31, 2022 was $13.6 million or $0.08 per share compared to a net loss attributable to Cerus for the year ago period, totaling $9.1 million or $0.05 per share. Our fourth quarter losses, as reported by our non-GAAP adjusted EBITDA narrowed by 14% and totaled to a negative $3.7 million compared to a negative $4.3 million during the fourth quarter of 2021. Full year 2022 losses, as reported by our non-GAAP adjusted EBITDA were 58% better than the prior year total with the full year 2022 figure totaling to a negative $12.4 million compared to a negative $29.5 million for the full year of 2021. We're very pleased with our progress on this front and remain steadfast in our efforts to reach our stated goal of reaching cash flow breakeven. Turning to the balance sheet and cash flows. We ended the fourth quarter with a robust cash balance of $102.2 million of cash and cash equivalents on the balance sheet. In terms of cash utilization, our cash used from operations for the year was $25.6 million compared to $33.9 million during the prior year period. To finish my update today, I'd like to wrap up with commentary around our full year product revenue guidance, our expectation of improvement across a few key areas and our confidence in achieving cash flow breakeven during the year. As we announced in January, the company expects full year 2023 product revenue to be in the range of $165 million to $170 million, reflecting a challenging macroeconomic environment as well as a few shorter-term factors that we expect to moderate as we move throughout the rest of the year. As I previously mentioned, we are assuming parity of the U.S. dollar to the euro in our guidance. This assumption creates a more difficult comparison when looking back at 2022, which had average rates of around 1.05, with the early part of 2022, seen rates as high as 1.15 and the back half of the year as low as 0.97. Today, spot rates are around 1.06. And while we can't predict where FX rates will go in the future, we will continue to provide you with updates on future calls. In sum, we remain confident in our ability to execute on our commercial plan, and we expect to see improvement across a few key areas during the year, including gross margin expansion, lower cash used from operations and increased operating expense leverage. As such, we anticipate realizing our goal of achieving cash flow breakeven as measured by our non-GAAP adjusted EBITDA metric in 2023. With that, let me turn the call back over to Obi.

Thank you, Kevin. While we continue to make progress, as Kevin just outlined, towards achieving cash flow breakeven, we are looking forward to a number of milestones related to the expansion of market opportunities and our development portfolio. First, one component of our global expansion strategy is our China JV. We are finalizing the preparation of the China dossier and will provide an update on the status during our next earnings call. Second, the company is working diligently on developing its LED-based next-generation illuminator. This project is advancing towards completion and we are performing the studies required for regulatory submissions globally. Next, with respect to the INTERCEPT red blood cell program in Europe, the company authority, CBG, reviewed our dossier that sets Cerus a list of questions, many of which related to chemistry, manufacturing and controls, or CMC. And Cerus is in the process of gathering information and collecting data to craft a comprehensive response. Finally, regarding BARDA-funded RBC Phase III clinical study progress on ReCePi and RedeS, we anticipate completion of enrollment in the second half of 2023 and in the end of 2024, respectively. As a reminder, ReCePi is a U.S. Phase III trial designed to evaluate the efficacy and safety of INTERCEPT red blood cells in patients requiring transfusion for acute blood loss during complex cardiac surgery. While RedeS is a Phase III study designed to evaluate the safety and efficacy of INTERCEPT-treated red blood cells compared to conventional red blood cells in regions impacted by the Zika virus. In summary, we expect to build upon our commercial momentum in 2022 and leverage the solid foundation we have built for future growth globally. We have multiple opportunities before us as we look out over the next few years. And our improving financial profile and focus on cash flow breakeven will allow us to self-fund these opportunities. Importantly, we look forward to further expanding access to INTERCEPT products for patients in the years ahead and provide a definitive safeguard for transfused blood components in the name of pandemic preparedness. With that, let me turn it back over to the operator for Q&A.

[Operator Instructions]. Our first question will come from the line of Mathew Blackman from Stifel.

I'll start with a multipart question and then one follow-up. I just wanted to circle back on Red Cross. And maybe just explain why we shouldn't view the inventory management going on there as a sign of, let's call it, perhaps softer demand. Is it simply that -- and these are just my words, you tell me that after sort of successfully scaling production over the last couple of years, the Red Cross doesn't need, let's call it something like safety stock. Just anything that helps us sort of understand what's going on there from an inventory demand side. And the follow-up is, is this a phenomenon we should be considering or concerned about for other customers in '23 and beyond? Just any sense of -- do you have contracts that are up in '23 that we should be thinking about? Really just how much visibility you have on the platelet demand excluding Red Cross as we think about '23. And then I'll have one follow-up.

Thanks, Mat. Vivek, would you mind tackling the 2-part question? And I think the second part of that question, it would be good to cover the organic sort of platelet growth that we typically see on an annual basis.

Yes, sure, I'd be happy to. Mat, thanks for the question. I don't think that you should interpret this as any sort of indication about impact on demand or anything along those lines. We are seeing there are broader macroeconomic factors that have influenced the need to better manage inventory and get to a more reasonable power levels. I think what we've been able to do, not only with Red Cross, but really with all of our key customers is to be more nimble and to ensure that we can provide the right amount of supply on an as-needed basis. And so the need to carry a lot of inventory, I think, has been largely mitigated. We don't anticipate this to be an ongoing issue through the balance of '23. I think we had indicated at the beginning of the year that this would acutely impact us in the first quarter and probably the first part of the first half of the year but then start to normalize and see growth again in the back half of the year. Underlying platelet demand and platelet shipment to hospitals continues to grow, and we continue to see share capture in terms of utilization of PR. And we, just based on our channel checks and continued demand level we anticipate that will continue, but it's really managing through this first quarter where we see the key issues.

Okay. I appreciate that. And then how should we be thinking about the business outside the U.S. platelet franchise? Can we just talk about some of the puts and the takes in international? Obviously, you've got Canada, Germany. I did notice in the fourth quarter that you obviously had some FX headwinds, but it did look like if I look at treatable doses, they were down internationally in the fourth quarter. And maybe that's more representative of underlying organic growth. Just help us understand about the international trajectory in '23? And I'm sure you're not going to give a specific IFC guidance range. But are there any sort of important milestones we should be thinking about, whether it's clinical data, peer-reviewed case studies, anything like that as we sort of check on the progress of the IFC rollout in '23?

Yes, no problem. Maybe I'll tackle IFC first and then talk a little bit about international platelet growth. From an IP perspective, you really addressed the issue. Continued account growth, getting new users on and we're getting a lot of good use cases now that are allowing us to really engage in peer-to-peer marketing, where you've got centers of influence take sample, for example, that are getting experience with the product you have . And they're starting to communicate that experience to their peers and other clinicians. And as you know, the peer-to-peer marketing aspect and experience sharing, that really goes a long way. So that use case and case studies experience is really starting to grow. And we anticipate that that's going to be a driver of ongoing adoption coupled with continued investment in hospital-facing sales personnel, who can develop clinical champions, generate demand and, ultimately, pair demand with supply. So we have a lot of reason for optimism in terms of being able to drive continued adoption of IFC. And the more folks we engage, the more validation we get for the clinical utility and need of that technology, which is certainly heartening. From an international platelet standpoint, you're correct to point to Canada and Germany as some near opportunities to drive growth. If you look at those, the one thing I would call your attention to is that not insignificant portion of our international sales are through distributors. And they tend to do bulk orders. And so the clarity into then dose utilization in the marketplace becomes a little bit more opaque. But having said that, there are -- there continue to be meaningful growth drivers not only in the near term internationally, but then as we projected a few years out, as Obi indicated in the prepared remarks, we continue to be excited about the opportunity in China with our joint venture partner. And there are significant markets internationally where there's been stated demand for PR. We need to work through the regulatory and clinical process. So still a lot of opportunity to drive penetration and faster adoption in international markets for platelets.

I really appreciate that. Can I sneak one quick one. Kevin, the cash flow breakeven at '23, is that a full year breakeven or you'll cross into breakeven territory at some point in the back half of the year?

Yes. The latter, we expect that we're going to continue to make steady progress. I think as we discussed in early January when we pre-released, clearly, the first half of the year on the top line, we'll see some headwinds due to the restocking FX, et cetera. But we expect that to moderate and rebound in the back half of the year. So our prediction on reaching that cash flow breakeven as defined by our adjusted EBITDA is meant to suggest that at a point in time in 2023.

Our next question will come from the line of Jacob Johnson from Stephens.

Maybe just for Kevin, just on kind of -- I appreciate the commentary around cash flow breakeven by the end of the year. As we think about gross margin and OpEx throughout the year, kind of any puts and takes on how those should trend throughout the year, especially maybe on the gross margin side as we think about the FX dynamics?

Yes. I think we're going to see some -- as we've mentioned in the prepared remarks, some modest but steady improvement to gross margins, really driven from economies of scale. As you know, we've been working on a number of cost reduction initiatives, which will continue to play out and contribute to that margin expansion. Offsetting that, of course, we're in an inflationary environment, and we're not immune to that. But we've also had several years where we have been pricing our products for the value that we believe they are delivering. And so all told, we expect that we'll see, like I said, modest but steady improvement, call it, 100 basis points or so of improvement and line of sight into continued improvement beyond that.

Okay. And then maybe going back to Vivek or for Obi. Just on the IFC side of things. I think Vivek, from some things you said, you're seeing some good use cases out there working to get kind of peer-to-peer communication. Can you just talk about any kind of key milestones for us, seeing kind of growth pickup in the IFC or become more -- that product to become more meaningful for you all? Is there any kind of additional data you need to publish? Do you need to hire more sales people? Just how should we think about the drivers of kind of IFC hitting at an inflection point?

Sure. Happy to address that. And Obi, certainly, weigh in, if I miss anything. You hit the right point there in terms of adding the feet on the street, continuing to get new accounts on contract and getting those initial uses, which will then lead to repeat utilization. So there isn't an environmental milestone in terms of publication of data or anything along those lines that we're waiting for. It's really about getting further at-bats with not all existing customers but getting kind of newer customers into the batter's box. And that happens by getting our reps out in the hospitals, calling on accounts. And so that -- the hiring process, we made great strides in terms of getting new folks on the team. I've personally been very encouraged by the quality of candidates that have been applying and our ability to bring solid new sales talent in the organization that's getting them training, getting them out in new accounts. And so we're seeing continued good progress there, and that's what will ultimately drive product adoption.

[Operator Instructions]. Our next question will come from the line of Brandon Folkes from Cantor Fitzgerald.

Maybe just coming back to the Red Cross. Any commentary in terms of what you've seen in January and February of this year just in terms of that inventory work down? Maybe since you gave guidance, has it been as expected? And then maybe just on the red cells in Europe. You talked about putting together a comprehensive response. Just any color in terms of timing when we may expect you to submit those responses.

Yes, Brandon, I'll take the first -- or last part of that question. And Vivek, maybe you can cover the Red Cross. So with regard to the red cell CE Mark process, the dialogue that we have with CBG is underway. And we're in the process of drafting responses to the questions they've raised. I think it's just too early right now to be prescriptive about timing. But we continue to be very optimistic about that program and our ability to answer the questions substantively. Vivek, do you want to Over the Red Cross?

Sure, I'd be happy to. What I would say is that it's early days, but year-to-date, things are rolling out as expected. And those -- that anticipation that led to the guidance we provided back around the time of the JPMorgan Healthcare Conference. We're really fortunate to have a strong partner in the ARC and they've really helped lead the way in terms of driving adoption of path-reduced platelets. So that partnership continues to be incredibly important to us. And I'd say, so far, we -- it's an area where we continue to feel really comforted by the progress that we've made.

And our next question will come from the line of Joshua Jennings from Cowen.

Maybe Obi, I wanted to just start off and ask about the other kind of 4 major blood centers and maybe some smaller ones in the United States. And has any other kind of stepped up and made a similar commitment as the American Red Cross to get to 100%, those platelet kind of manufacturing run rate? Or maybe just how would they progress? Maybe really focus on the other big 4 or the big 5.

Yes. Thanks, Josh. I'll start and then turn it over to Vivek maybe for some additional detail. So they're all at sort of various levels. And some of that's a function of sort of what they see the hospital demand is. Some of it is just sort of what they operationally believe they can deliver against at any given time. So I guess it's a mix of different approaches. I'd say one blood is probably closest to the American Red Cross with regard to their overall desire to offer a product that they believe is operationally easy to use as well as -- and probably most importantly, just the safest possible product for patients. And then the other, it's a spectrum. Vivek, would you have any additional context around that you'd like to provide?

Yes. No, I think you captured the key points. I mean from our perspective, Josh, what we want to continue to do is ensure that we provide the right technology to enable for the big 5 blood center families to optimize their PR production and distribution. Some of that's governed by what hospital demand that they're seeing organically. And some of that's driven by the demand that they themselves are generating at times of partnership with us at the hospital level. We've seen good progress there. The ARC came out and stated explicitly that they're going to lead the way in here. I certainly see that happening with others as well. But from our perspective, it's really about ensuring that we can provide the right supply at the right time. And we're seeing continued share capture, which is encouraging.

Excellent. I also wanted to just ask about manufacturing capacity buildout. I'm sorry, if I'm asking something already stated on the call, I'm catching up here a little bit. Can we speak about 2024 and where capacity will be in terms of what type of revenue run rate will capacity be able to support in '24 versus where you're at today in the beginning, early days of 2023?

Yes. Thanks for the question, Josh. So clearly, in 2022, we were sort of in an active inventory management mode, and we're still sort of expanding the manufacturing capacity at multiple sites. So by 2024, we really should be nonconstrained as it relates to potential sales opportunities. And that was the goal. I think really in this market, it's so critical that we are a reliable and dependable supplier to our blood center customers given the role -- an important role that they play. And so we really took that to heart and I think have done an exceptional job throughout 2022 and want to continue to deliver against that goal for our future. And so we really believe that throughout 2023, we'll have that capacity in place and it won't be a constraint on growth in 2024.

Excellent. And then maybe lastly, just to ask about the China submission. This may be old news now, if you did provide an update in your prepared remarks. But just wondering if there is an accelerated pathway that's open with your JV partner to submit without direct China data. And I'll leave it at that.

Thanks, Josh. So the prepared remarks, we mentioned that we are in the final process of putting together the submission. So that's well underway, and we'll plan to give an update on the Q1 call. As it relates to the need for clinical data, that's still TBD. We did -- we are planning to submit with data coming out of Hong Kong. We're just not -- we just don't know yet whether that will be sufficient or whether in-country data will be necessary for a final approval. And then Carol's with me here. Do you have any thoughts on -- around the expedited approval pathway or what our joint ventures approach is going to be there?

Well, we don't have clearly identified an expedited approach at this time. But once we get the dossier filed and we can get into a conversation with the NMPA, which is the FDA-like body there in China, once we can get into conversation with them, gauge the reaction, gauge the interest, then it's certainly my experience that they can do a lot to help us accelerate the review time line based on the content of the application and the interest in the product. So we're going to do all we can to leverage those considerations once we get it filed.

And I'm not showing any further questions in the queue. I'd like to turn the call back over to Obi for any closing remarks.

Well, thank you again for joining us today and for your interest in Cerus. We look forward to speaking with you at Cowen's 43rd Annual Healthcare Conference next week in March and sharing our progress throughout the remainder of the year. Thanks again.

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.