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Cerus (NASDAQ:CERS)

Q4 2012 Earnings Call

February 28, 2013 4:15 pm ET

Executives

Lainie Corten - Senior Director of Global Marketing & Investor Relations

William M. Greenman - Chief Executive Officer, President and Director

Laurence M. Corash - Co-Founder, Chief Medical Officer, Chief Scientific Officer, Senior Vice President and Director

Carol M. Moore - Vice President of Regulatory Affairs & Quality

Kevin D. Green - Principal Financial Officer, Chief Accounting Officer and Vice President of Finance

Analysts

Jeremy Feffer - Cantor Fitzgerald & Co., Research Division

Zarak Khurshid - Wedbush Securities Inc., Research Division

Joshua T. Jennings - Cowen and Company, LLC, Research Division

George B. Zavoico - MLV & Co LLC, Research Division

Blake C. Arnold - Robert W. Baird & Co. Incorporated, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the Cerus Corporation Fourth Quarter 2012 Results Conference Call. [Operator Instructions] As a reminder, today's conference call is being recorded. I'd now like to turn the conference over to your host, Ms. Lainie Corten, Investor Relations for Cerus. Please go ahead.

Lainie Corten

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, our Chief Financial Officer; Dr. Larry Corash, our Chief Medical Officer; and Carol Moore, our Senior Vice President of Regulatory Affairs, Quality and Clinical.

Cerus issued a press release today announcing our financial results for the fourth quarter and year ended December 31, 2012, and describing the company's recent business highlights. You can access a copy of this announcement on the company website at cerus.com.

I would like to remind you that during this call, we will be making forward-looking statements, including forecasts of revenue, annual growth rate and gross margin; and statements about operating expenses, product demand; commercialization progress; regulatory and governmental processes; the scope and timing of clinical trials and other research and development activities; and the reporting of results from such activities; the timing of U.S. regulatory submissions or approval; potential synergies between platelets and plasma regulatory submissions and launch planning activities; potential reactions to recent U.S. regulatory developments; sales; use of cash; finances; business prospects and the effects of currency fluctuation. The company's actual results may differ materially from those suggested by forward-looking statements the company will be making, and the company assumes no obligation to update guidance or other forward-looking statements.

I call your attention to the disclosure in the company's SEC filings, in particular Cerus' quarterly report for the fiscal period ended September 30, 2012, on Form 10-Q, including the sections entitled Risk Factors. This call will be archived temporarily on our website and will not be updated during that time.

And now it's my pleasure to introduce Obi Greenman, Cerus' Chief Executive Officer.

William M. Greenman

Thank you, Lainie. This week has been one of significant progress for Cerus. The culmination of 10 years of efforts to generate the safety and efficacy of clinical database towards the FDA agreement to proceed with a PMA filing for INTERCEPT platelets. In addition, we are proud to announce the first of 4 PMA modules for INTERCEPT plasma is being submitted today. Beyond these seminal FDA-related events, 2012 was a year of major achievements for Cerus as we continue to execute on sales growth while advancing our clinical development pipeline.

This afternoon, we reported 2012 annual product revenue of $36.7 million coming in above our guidance of $34 million to $36 million. This represents approximately 30% year-over-year growth in revenue on a constant-currency basis, exceeding our estimate of 20% to 25%. 2012 is our seventh consecutive year of revenue growth, and we have maintained a compound annual growth rate at over 50% since 2006. I believe it is significant that we are able to achieve this revenue target even with the continued economic distress in many European countries. It's also important to note that we achieved this without significant new conversion of major markets like France, Germany and U.K., which all remain as possible revenue inflection points in 2013 and beyond.

We believe that the recent progress with the FDA may further capitalize the possibility of these major markets converting to INTERCEPT in the 12 to 24-month time frame. In 2012, we improved our gross margins over margins reported in 2011 and with a disciplined approach to operating expenses and cash management, we ended 2012 with slightly more cash than we had at the end of 2011.

To provide some more color on our recent positive discussions with the FDA, I will now turn the call over to Dr. Larry Corash to explain the evolution of data that led to this important development for the company.

Laurence M. Corash

Thank you, Obi. Agreement to proceed forward with the PMA application is an important event in product development. Those who have followed the Cerus story for an extended time will appreciate just how pivotal an achievement this represents for the INTERCEPT platelet program.

In 2001, we completed the Phase III Sprint trial, which included 645 patients enrolled across 12 U.S. sites supported with 4,719 platelet transfusions. The trial's primary endpoint was designed to assess the hemostatic efficacy of INTERCEPT platelets compared to conventional platelets for prevention and control of bleeding due to low platelet counts. The protocol also included multiple secondary endpoints for additional measures of both efficacy and safety.

The Sprint trial met the primary efficacy endpoint. The INTERCEPT platelets were shown to be equivalent to conventional platelets according to a rigorous assessment of bleeding. However, upon submission of the clinical module to FDA in 2002, the FDA expressed concern regarding potential safety signals for several types of infrequent adverse events, including the important pulmonary event of acute lung injury.

Data from the Sprint trial were used to support EU regulatory registrations. However, prior to launching the INTERCEPT platelet system in Europe, and in response to FDA's concerns, Cerus sponsored an independent blinded review of pulmonary adverse events reported in the Sprint trial. A panel of external pulmonary experts reviewed the primary medical records of all Sprint patients with pulmonary adverse events and concluded that there was no difference in the frequency of acute lung injury events.

The review was submitted to FDA. However, it did not fully address FDA's concerns, and the agency requested that the frequency of pulmonary adverse events in patients supported with INTERCEPT platelets be confirmed in a second prospective clinical trial. Due to the low frequency of acute lung injury, the design of the study powered for these events proved to be extremely challenging. A statistically valid comparison for this safety endpoint requires a very large number of patients, beyond what Cerus believe logistically feasible.

Over a period of 6 years, Cerus presented a number of potential trial designs to FDA to address their concerns. But we were unable to reach a mutually acceptable design. In parallel with FDA discussions, following the launch of INTERCEPT platelets in Europe, we initiated a post-marketing haemovigilance program to obtain safety data in routine use. In addition, we carefully monitored the safety surveillance data collected by independent haemovigilance programs conducted by regulatory authorities in France and Switzerland.

During the years these data were being collected, Cerus continued to discuss with the FDA the possibility that European haemovigilance data could satisfy their concerns and enable us to move forward without conducting an additional safety study. This week, after 10 years of experience and more than 1 million INTERCEPT platelet transfusions in Europe, we reviewed with FDA the aggregate haemovigilance data obtained by EU regulatory authorities for over 130,000 INTERCEPT platelet transfusions in France and Switzerland.

This included a recent presentation by Swissmedic for 62,500 INTERCEPT platelet transfusions over 2 years in which they showed a reduction in severe adverse events, including respiratory events after national adoption of INTERCEPT platelets. In consideration of this body of haemovigilance data, in conjunction with the prior U.S. data and the EU randomized clinical trial data, FDA agreed that the combined data were sufficient to file a PMA for INTERCEPT platelets without conducting another prospective clinical trial.

Also we will be working with FDA to define a Phase IV postmarketing study plan, which will be included in our PMA submission.

Now I'd like to turn the call over to Carol Moore who will provide you with further comments about our FDA progress, as well as an update on our other development programs.

Carol M. Moore

Thank you, Larry. As Obi and Larry have already explained, we met with FDA on Tuesday. This meeting resulted in agreement on the steps required for a U.S. submission for INTERCEPT platelets. It's too soon to provide a timing estimate for the PMA filing or approval, but I can share with you what those steps will be.

Our next step with FDA will be to submit proposed PMA shell exactly as we did for the INTERCEPT plasma PMA last year. As with the plasma PMA, we will propose a sequence of modules that will allow us to begin with the data we already have on hand and conclude with the topics for which we may need additional time to assemble information. The FDA review of the shell proposal has a 30-day clock, and once we reach agreement we will have a defined series of modules and timing for the INTERCEPT platelet PMA process.

There are elements within the PMA filing where considerable overlap exists between data we're submitting for the INTERCEPT plasma and the data required for the platelet submission. For example, both products use the same active compound, so the toxicology information submitted regarding amotosalen will be substantially the same across both applications. Likewise, the treatments used very similar disposable kits manufactured by the same supplier, and the same elimination device is used for both processes.

As we move forward, we will be thinking of ways to leverage the synergy between INTERCEPT platelets and plasma and streamline the assembly and review of the PMA submissions where possible.

Speaking of our U.S. plasma application, module one has been fully assembled and is packed and now on our loading dock waiting for pickup for shipment to the FDA. As a reminder, there is a 90-day interval between each module submission and the final 180-day review following the submission of the final module. We continue to expect a review decision or completion of the review as early as the second half of 2014.

I'd like to conclude my comments with an update on our INTERCEPT red cell development program. Our U.S. Phase II red cell trial, a recovery and survival study in healthy volunteers using the final commercial processing set, is fully enrolled. We expect the last patient will complete the second period of the crossover study over this summer, putting us in a position to report data in Q4.

In Europe, we are continuing to work through the steps necessary to secure final regulatory and site approvals in both the Phase III acute and chronic anemia studies. The acute anemia trial initiation is pending upon final authorization from German authorities expected later this quarter. The chronic anemia study has received approval from the Italian Ministry of Health, but still requires completion of final ethical committee requirements.

And now I'd like to turn the call over to Kevin.

Kevin D. Green

Thank you, Carol. As we reported earlier today, revenue for Q4 was $10.5 million culminating in full year product revenue of $36.7 million. Year-over-year, 2012 product revenue represents an increase of approximately 20% as reported in U.S. dollars or almost 30% when compared in euros. Driving this growth was increased demand for INTERCEPT disposable kits, up 28% year-over-year. Relatively consistent with prior periods, disposable kits represented more than 90% of product revenue. For 2013, we are projecting full year product revenue in the range of $41 million to $43 million, representing approximately 16% to 21% growth on a constant-currency basis.

Consistent with our approach to 2012 revenue guidance, we are basing this estimate on continued progress from a mix of new customers and incremental adoption from existing customers, such as a platelet customer beginning to use the plasma system. Given the concentration in decision-making in many of the largest European markets and the difficulty in predicting when those markets may adopt INTERCEPT, we have excluded potential revenue in those major markets from our guidance. This leaves substantial upside if and when those markets convert.

Another area where we have seen progress is around our gross margins. Our gross margins during the fourth quarter were 51%, up sequentially from 47% in Q3. We anticipate some continued quarterly volatility with our gross margins, but expect that margins will trend in the mid-40s at planned annual production levels, improving with increased levels of kit production to meet the anticipated growing demand.

Turning now to operating expenses. Total operating expenses for Q4 2012 were $9 million compared to $7.6 million during the same period in 2011 and $8.2 million sequentially from Q3. For the full year 2012, operating expenses were $33.5 million compared to $30.4 million incurred in 2011. We expect operating expenses to increase in 2013, driven primarily by increased research and development activities.

When looking at our bottom line. Net loss for Q4 was $1.7 million compared to $7.7 million during Q4 2011. For the full year 2012 net losses narrowed to $15.9 million from $17 million in 2011. The majority of this change was due to the assumed difference in the valuation of our outstanding warrants for each respective period.

Operationally, higher revenues, improved gross margins on product revenue and relatively close management of operating expenses all led to the improvement in our bottom line. We ended the year strong with cash of $26.7 million and access to the remainder of our $7 million revolving line of credit. Tight management of working capital was instrumental to ending the year with relatively little cash used for operations.

And now I'd like to turn the call over to Obi for some concluding remarks.

William M. Greenman

Thank you, Kevin. The great news this week about a pathway for INTERCEPT platelets in the U.S. comes at a very opportune time, given the inherent synergies with the INTERCEPT plasma launch. We are now revising our INTERCEPT plasma launch plans to incorporate the future launch of INTERCEPT platelets, which we expect can largely be supported with same sales, marketing and commercial support team that we will build out to support the plasma launch. The U.S. market is very concentrated with approximately 15 customers representing almost 80% of the annual blood component production. This market dynamic may have profound implications on our future operating margins.

Looking ahead to 2013, we will continue to provide updates on our U.S. regulatory progress as we complete the plasma PMA, prepare to initiate our first platelet PMA module and refine our plans for the U.S. launches. We also expect another active year in our growing EMEA markets including updates on key markets like Germany, Russia and CIS, South Africa and Latin America, all of which may benefit from today's announcement.

Finally, initiation of both Phase III red cell trials for European approval is expected to take place in the near term, and we plan to report data from the U.S. Phase II trial in Q4. We believe 2013 will be a pivotal year for Cerus with continued revenue growth and major advances in our development programs.

Operator, please open the call for questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from Jeremy Feffer of Cantor Fitzgerald.

Jeremy Feffer - Cantor Fitzgerald & Co., Research Division

So yes, indeed it has been a good week for you. I recognize that you're not giving specific timelines right now because a lot is still up in the air, but is it reasonable to at least think this is probably a 2015 approval?

William M. Greenman

Jeremy, I think it really is going to be dependent about our receiving sort of the final agreed-upon schedule with the FDA, and so I really think it's premature to even estimate when the timing might be. But I think that the best thing we can say is that no, it is really to look at what happened with regard to the PMA shell for plasma and try and sort of make your estimates from there.

Jeremy Feffer - Cantor Fitzgerald & Co., Research Division

Okay. That's fair. And I just want to make sure I understood your last comments, Obi. Are you saying that you would, depending on the platelet timeline, you would hold back the plasma launch to try and have it coincide with platelets?

William M. Greenman

No, I'm not saying that. Understand that it's really -- you're launching a product with the same customers. There's a lot of interest about INTERCEPT platelets in the United States just as a function of the ongoing concerns about bacterial contamination risk for platelets. And I think the ideal scenario is to have the launch in close proximity -- the launches in close proximity to one another.

Jeremy Feffer - Cantor Fitzgerald & Co., Research Division

Okay, okay, that makes sense. And then just one other, Kevin, just as we think about 2013 on the cost side, gross margin obviously had a nice steady quarter-to-quarter improvement throughout 2012. What's a gross margin -- logical or reasonable gross margin run rate that we should think about in '13?

Kevin D. Green

Sure, Jeremy. So mid-40s is an annualized margin number that we think is attainable. We do expect quarterly lumpiness.

Operator

Our next question comes from Zarak Khurshid of Wedbush Securities.

Zarak Khurshid - Wedbush Securities Inc., Research Division

So just curious, is there any reason why the platelet timing of submission, et cetera, would not play out in a similar case as the FDA process around plasma?

William M. Greenman

I'll defer to Carol on this. I mean, I think that we tried to allude to this in the script where there's a lot of similarities. But just absent having through that agreement on the shell, we're reluctant to give specific timing, but Carol, do you have any additional comments on that?

Carol M. Moore

Well, only to add that it is a modular submission. Modules are submitted about 90 days apart. So what we need to decide is how many modules to support this application with and then we'll be in a better position to determine then the sequence. And then as we said earlier, it's 180 days after the last module is submitted for them to provide you a complete review letter. So those are just the parameters that the PMA schedule incorporates. And I think it's really dependent on us now to figure out what the modules are composed of and how many modules there will be.

Zarak Khurshid - Wedbush Securities Inc., Research Division

Understood. And then, if you could, can you maybe talk about costs around this new path forward on platelets? Does this increase the spend at all for 2013?

William M. Greenman

Again it's sort of very new news. So -- and I think that we have increased the burn a little bit this year as it relates to the PMA submission for plasma, and then what we really need to look at is what the incremental burn might be for doing that for platelets as well. We don't think that's going to be that substantial, but then also as we sort of look at our launch planning activities, we need to factor that in. So I think right now, we're just comfortable with the comments that Kevin made on the call, in that there's going to be some modest increase of cash burn going forward in 2013 relative to 2012. Kevin, do you have any additional?

Kevin D. Green

Well, I think it's tempered also by top line revenue growth. We're not sure what impact, if any, this news will have on our current markets, but we'll expect to monitor that and see how it plays out.

William M. Greenman

Further to Kevin's comments, this is a very meaningful event globally for the National Blood Services because a PMA submission pathway is something that means -- is meaningful to them. And as I mentioned in prior calls, an FDA approval of any product is a strong validation around the globe, both with customers and with regulators.

Zarak Khurshid - Wedbush Securities Inc., Research Division

So reading between the lines, it sounds like this may have some positive implications for France and their adoption of platelets?

William M. Greenman

We definitely think that they'll be taking this into consideration. I mean, I think really what this is, is a testimony around sort of the FDA's belief that we are able to now start the PMA submission pathway. And Larry, I don't know if you want to comment on -- so, your perspective on this.

Laurence M. Corash

No, but I think that it -- certainly the FDA's conclusion that further clinical trials are not required, I think will send a signal to people that the data package is at least sufficient for the submission.

Zarak Khurshid - Wedbush Securities Inc., Research Division

Okay, and then a couple of other questions just on the Phase IV study. I guess, how involved would that be, and would that be kind of limiting the sort of addressable market assuming everything goes according to plan?

William M. Greenman

Well, I think that Phase IV commitments can go on as the product is being rolled out and implemented. It has 2 benefits. Number one, of course, it responds to FDA's concerns to gather additional data. But in addition, it will provide valuable information based on our experience in Europe for publications that we think will further support and potentially there are opportunities to even extend label claims if one does certain types of Phase IV studies. So I think that these are things that we'll look at and negotiate with FDA in terms of duration and scope of study, and we'll have a better assessment of that in the coming months.

Zarak Khurshid - Wedbush Securities Inc., Research Division

Got it. Should we expect any panel meetings around platelets?

William M. Greenman

Carol, do you want to answer that?

Carol M. Moore

I think it's too soon to say. As you know, there's all the -- each of the FDA divisions like to use their advisory panels when they feel they have a question that helps them think about issues. But we certainly don't know what CEBR is thinking at this point about that -- about using a BPAC.

Operator

Our next question comes from Josh Jennings of Cowen and Company.

Joshua T. Jennings - Cowen and Company, LLC, Research Division

Just first on the PMA submission for platelets, can you just talk about exactly what you are submitting? And just to review, I know Dr. Corash went over this one on the call, but is the Sprint trial data going to be included as long as the -- the long-term vigilance data that you presented at the FDA this week or last week?

William M. Greenman

Larry do you want to handle that one?

Laurence M. Corash

Yes, the Sprint data is our pivotal phase III on the U.S. clinical file will also include and FDA as already seen clinical trial reports for our Phase III on euro spread trial that was conducted in Europe and also a trial that we did in Europe looking at transfusion of platelet components to work for 6 and 7 days. So those are all part of the package. As our both the Cerus haemovigilance studies, the haemovigilance studies that have been conducted by the French medicinal authority, ANSM and also Swissmedic and then a number of independent observational trials conducted in Switzerland by the Swiss Red Cross in Germany by various blood centers and in Sweden by other blood centers and also 9 years of experience in Belgium with the Mont-Godinne Blood Center. So all of this will become part of the package?

William M. Greenman

Carol, you want to amplify?

Carol M. Moore

I think that's what we should -- like the clinical model.

Laurence M. Corash

That's what we model [ph] with FDA and that's what they would like to see.

Joshua T. Jennings - Cowen and Company, LLC, Research Division

Great and then just -- I mean, can you give us any color on what got us over the hump or got you over the hump with the FDA, and just in terms of looking at the Sprint trial and the historic concerns about acute respiratory distress syndrome? I know with such a low number historically in that data set. Was it just the overwhelming body of evidence that is coming out of Europe or was there something else? Was it...

Laurence M. Corash

I think it's the data from Europe and particularly the data coming from regulatory authority haemovigilance programs. In France, haemovigilance is mandatory. All transfusions are reported, and they look at all adverse events in the first 24 hours after each transfusion. The same is true in Switzerland and this is a very large body of data that we would never be able to achieve in a clinical trial setting. We're looking at more than 130,000 monitored transfusions.

Joshua T. Jennings - Cowen and Company, LLC, Research Division

Great. And did you have any recent discussions with the U.S. blood centers just about this PMA channel opening up or about -- there was some positive sentiment that had -- the sentiment had shifted to positive in terms of a channel potentially opening up and have any of these U.S. blood centers communicated their enthusiasm or optimism for INTERCEPT in the U.S. for the platelet indication?

William M. Greenman

Larry, just quickly we've been actually talking to a number of blood centers about plasma in trying to get an understanding of how that product might be received and the operational considerations and always in the context of those discussions. And I think we've probably talked to 70% of the U.S. blood supply in the last some couple of months. There's been a lot of enthusiasm about the possibility of platelet packaging and activation. That being said, this is the first we discussed with anyone about the outcome of the meeting with the FDA on Tuesday. So we have yet to have a discussion about the PMA pathway for platelets with anyone prior to this call.

Laurence M. Corash

I would add that starting in July, there were a series of meetings around how to deal with bacterial contamination of platelet components, and the observations that the current interventions have not resolved that problem. And a number of key opinion leaders from the transfusion medicine community have spoken out saying that pathogen inactivation would appear to be a reasonable step to take. And they have been watching the European data. So I think that there is an appreciation and the AABB standards now include the statement that pathogen inactivation or pathogen reduction can serve as a modality to meet their requirements for measures to limit the risk of bacterial contamination.

Joshua T. Jennings - Cowen and Company, LLC, Research Division

Excellent. And, Kevin, quickly just in Q4, were there any revenue recognition issues that push any revenues out in the Q1? My understanding, you did receive that $700,000 benefit from Q3 getting pushed out into Q4, but was there anything in Q4?

Kevin D. Green

There was not. So the Q4 benefit is in that $700,000.

Joshua T. Jennings - Cowen and Company, LLC, Research Division

Okay. And then just on guidance for 2013, I mean, if you look at the sort of onetime contribution from the benefit you received in France, what plant shutdowns, I mean, is there any way to give us kind of an apples-to-apples impact there in 2012 and then what -- if you normalize that where does the 16% to 21% growth guidance for 2013 fall?

Kevin D. Green

I can't really speak to sort normalizing per the bump that we received in early 2012 from the EFS plasma adoption. But I think that what we're looking at as Kevin alluded to is just sort of steady growth both -- from existing customers and from new customers roughly split 50-50. And I think that the guidance that we provided today 16% to 21% in constant currency reflects that. So we're comfortable. I think we now have a history of giving guidance and meeting it and so we feel comfortable in these numbers -- with these numbers.

Operator

Our next question comes from Klaus von Stutterheim [ph] private investor.

Unknown Attendee

It's for Kevin. I think you've sort of answered the question already. I was going to ask about expected cash burn for 2013.

Kevin D. Green

Yes, Klaus, we're not giving formal guidance on cash burn. I think it's a function of top line revenue growth and then getting the red cell programs, as well as the U.S. plasma PMA process completed and then now there will be some incremental spend for U.S. platelets, but we'll continue to titrate our operating expenses.

Operator

[Operator Instructions] Our next question comes from George Zavoico of MLV and Company.

George B. Zavoico - MLV & Co LLC, Research Division

A couple of questions. With the U.S. market now possibly opening up in 2015, what are you thinking in terms of manufacturing capacity for all the disposable kits? U.S. is a huge market. It could open up fairly rapidly considering the new AABB guidelines and the BPAC concerns.

William M. Greenman

Well, as you know, George, we currently manufacture out of a facility in France that's now owned by Fresenius formerly Fenwal. That plant has a lot of extra capacity right now and should be able to manage through increased demand over the next several years. We are also actively looking at other manufacturing opportunities throughout the globe. It's evident that we need to have some kind of manufacturing capacity in Asia ultimately to manufacture a product for the Japanese Red Cross when and if that product is ever approved or deployed there. And so I think what we really need to do is look at all the different alternatives before us and factor in the demand growth over the next several years. So I think it's just a function of making sure that we have the right strategy and then making sure that we can manufacture to the specifications of the various blood services that might choose to deploy this technology.

George B. Zavoico - MLV & Co LLC, Research Division

The sizes of the Japanese disposable kits are a little smaller. Is that correct?

William M. Greenman

Yes. They have a smaller platelet dose. So there's going to be -- have to be some modification to the existing INTERCEPT set.

George B. Zavoico - MLV & Co LLC, Research Division

It seems to me relying -- well, apart from having different specifications, it seems to me that having redundancy in manufacturing would be a good thing anyway.

William M. Greenman

Indeed, that's part of our strategy for this year.

George B. Zavoico - MLV & Co LLC, Research Division

Okay. And a question I guess for Larry and Carol in terms of -- you're talking about the Phase IV, how different is that than what you might put in place and call haemovigilance anyway? What's the difference between the 2?

Laurence M. Corash

Well, I think that it will be more structured in that we are going to be monitoring for specific safety events that we know FDA has concern around, which will be focused on the pulmonary system. And it will be certainly highly structured, and we will use a control group because we believe that, that's important. So it will be more than one might do for passive types of haemovigilance, but more in line with the type of active haemovigilance data that we have been able to collect in some of the European countries.

George B. Zavoico - MLV & Co LLC, Research Division

I see, okay. And would this be on the scale do you think of what the FDA might have been asking you to do a few years ago in terms of number of patients?

Laurence M. Corash

I think that one could certainly start from that point and consider that a reasonable approach.

George B. Zavoico - MLV & Co LLC, Research Division

Okay. So this is just going to be confirmation of what you've already provided just from haemovigilance studies conducted or haemovigilance -- not studies, but just haemovigilance from Europe then in a way.

Laurence M. Corash

Indeed, but the data should be consistent. We think that the data coming out of Switzerland and France in particular for the endpoints of acute lung injury, which requires mechanical ventilation and assistance, so it's something that clinicians do not miss in the first 24 hours of -- after a transfusion. So we think that we will see similar types of data, but we have to do the study.

Operator

Our next question comes from Chris Raymond of Robert W. Baird.

Blake C. Arnold - Robert W. Baird & Co. Incorporated, Research Division

This is Blake in for Chris. Could you just quickly remind us how big the U.S. market is for platelets relative to Europe?

William M. Greenman

It's roughly about the same. We don't have the latest data because there's an annual survey that comes out every couple of years, and I think it was supposed to be published at the end of 2012. And so we're sort of waiting for it right now. We'll provide that to you as soon as we have it. The most recent numbers were from 2009, is that right, Lainie? And I think the numbers were around 2.4 million platelet doses a year from that. And of that, about 90% are [indiscernible].

Blake C. Arnold - Robert W. Baird & Co. Incorporated, Research Division

Okay, great. And then shifting gears here for a moment. I'm sorry if I may have missed this, but could you remind us or tell us the breakdown between kit sales and Illuminators in Q4?

Kevin D. Green

Sure, Blake. Disposable kits were more than 90% -- just over 90%.

Blake C. Arnold - Robert W. Baird & Co. Incorporated, Research Division

Okay. And then so with your 2013 guidance, I mean, are we to assume that there's any assumption embedded in there for additional Illuminator sales in some of these newer geographies or is this all [indiscernible]?

Kevin D. Green

Well, we expect that as new customers come online, of course, they'll illumination devices and that the product mix will be roughly the same as what we experienced in the current quarter and in fact, in prior quarters.

Operator

We have a follow-up from Zarak Khurshid of Wedbush Securities.

Zarak Khurshid - Wedbush Securities Inc., Research Division

Just curious for 2012, what was the split between platelets and plasma?

William M. Greenman

Roughly 2/3 platelets, 1/3 plasma.

Operator

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

William M. Greenman

Well, thank you, all, for joining us today. We look forward to updating you again on our next call in late April. Thanks.

Operator

Ladies and gentlemen, this does conclude today's conference. You may all disconnect, and have a wonderful day.

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