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Cerus Corporation (NASDAQ:CERS)Q4 2019 Balance CallFeb 20, 2020, 4:30 p.m. ET

Operator



Ladies and gentlemen, acknowledge you for continuing by, and acceptable to the Cerus Corporation Fourth Division and Abounding Year 2019 Balance Appointment Call. [Operator Instructions] After the apostle presentation there will be a catechism and answers session. [Operator Instructions].

I will now about-face the appointment over to your host for today, Mr. Tim Lee. Sir, you may begin.

Timothy L. Moore — Broker Relations Director

Thank you, operator, and acceptable afternoon. I’d like to acknowledge anybody for abutting us today. With me on the alarm are Obi Greenman, Cerus’ President and Chief Executive Officer; Kevin Green, Cerus’ Chief Banking Officer; and Carol Moore, our Senior Vice President of Authoritative Diplomacy and Quality.

Cerus issued a columnist absolution today advertisement our banking after-effects for the fourth division and abounding year concluded December 31, 2019 and additionally anecdotic the company’s contempo business highlights. You can admission a archetype of this advertisement on the aggregation website at www.cerus.com.

I’d like to admonish you that some of the statements we will accomplish on this alarm chronicle to abutting accident and performance, rather than absolute facts and our advanced statements. Examples of advanced statements accommodate those accompanying to our abutting banking and operating after-effects and putting our 2020 banking advice and goals, operating costs and gross margins, bartering development efforts, abutting advance and advance strategy, abutting articles sales, artefact launches, the appulse or accepted and abutting articles on claret centermost operations, advancing and abutting analytic trials, advancing and abutting artefact development and our authoritative activities, as able-bodied as the timing of these contest and activities.

These advanced statements absorb accident and ambiguity that can account absolute events, achievement and after-effects to alter materially. They’re articular and declared in today’s columnist absolution and beneath accident factors in our Form 10-K for the year concluded December 31, 2019, which we will book shortly. We undertake no assignment or obligation to amend our advanced statements.

On today’s call, we’ll activate with aperture animadversion from Obi, followed by Kevin, who will accommodate a abundant banking analysis — a abundant analysis of our banking after-effects and with Obi accouterment closing remarks.

And now, it’s my amusement to introduce, Obi Greenman, Cerus’ President and Chief Executive Officer.

William M. Greenman — President and Chief Executive Officer

Thanks, Tim. Acceptable afternoon, everyone, and acknowledge you for abutting us on the call. As a aftereffect of the efforts of the absolute Cerus team, 2019 was accession standout year commercially. We accomplished 2019 with the accomplished annual artefact acquirement ever, appear at $20.9 million, up 27% compared to the fourth division of 2018. For the abounding year, artefact acquirement totaled $74.6 actor at the top end of our acquirement advice ambit of $72 actor to $75 million.

Over the accomplished three years, we accept angled our artefact revenue. But alike added importantly, there accept now been about 7 actor transfusable units of INTERCEPT platelets and claret alien worldwide, and we are still aboriginal in the all-around acceptance ramp. With the FDA’s arising of the final advice on the bacterial assurance of platelets in September of aftermost year, US claret centers and hospitals accept until the end of March 2021, to apparatus procedures to aegis their platelet supply.

We’re able-bodied positioned to advice our claret centermost barter in the US through the actual 13 months of the acquiescence aeon for the FDA advice documents. Above accouterment the proactive allowances conferred by a able-bodied antibody abridgement technology, INTERCEPT additionally allows claret centers through these platelet articles at atomic a day beforehand compared to the added options put alternating in the guidance.

By streamlining the logistic that’s carrying platelet articles to hospitals, we were able to authenticate amount accumulation by authoritative assertive claret centermost processes and assays, such as gamma irradiation, CMV serology testing and Zika virus testing redundant, thereby aspersing the cardinal of artefact codes and eliminating specific action costs. For the advancing FDA approvals for our connected day six characterization claims, and our amateur accumulator set for platelets, we accept that the INTERCEPT amount hypothesis for claret cleaners will be fabricated alike added compelling.

In agreement of US bazaar share, based on our fourth division calm artefact revenue, we appraisal that we exited 2019 at about 16% bazaar penetration, compared to a 11% in fourth division of 2018. During 2019, the cardinal of US treatable platelet doses alien added about 80% compared to the above-mentioned year. This leads us with a abundant beginning US bazaar opportunity.

Through 2020, we apprehend our US bazaar assimilation to access advisedly and the access in acceptance to abide alike accomplished the acquiescence period. 2020 will additionally be authentic by the advancing barrage of our pathogen-reduced cryoprecipitate artefact in the US.

We are tracking on plan to abide our PMA supplement in the aboriginal bisected of this year, which translates into a abeyant approval by year-end. This fall, we plan to abide for a new technology add-on acquittal or NTAP for a antibody bargain cryo with the Centers for Medicaid and — Medicare and Medicaid Services or CMS.

Given the FDA advance accessory appellation awarded to pathogen-reduced cryo, we’re optimistic that we will accept an NTAP approval in 2021, which we accept will advisedly facilitate bazaar acceptance above the product’s advised appulse on analytic outcomes for trauma, cardiovascular surgery, and affectionate drain patients. The abeyant $300 added actor US bazaar for pathogen-reduced cryoprecipitate and its acceptable appulse on alarmingly bleeding accommodating adaptation outcomes has our accomplished aggregation at Cerus abundantly aflame about the advancing artefact launch.

Finally, we fabricated allusive strides aftermost year with attention to our INTERCEPT red corpuscle program, both in the ambience of the CE Mark analysis action and the Phase 3 analytic studies in the US. With the accomplishment studies on our GMP accumulation [Phonetic] labs from our account supplier is accepted to be completed in the added quarter, we plan to alteration our CE Mark submission, the new medical accessory adjustment or MDR alleyway in the added quarter.

At this juncture, we abide to accept the CE Mark approval from red claret beef is a 2022 accident until we accept added afterimage into the new MDR process. We’re alive agilely to abbreviate that timeframe and are optimistic.

With that, let me about-face it over to Kevin for a abundant analysis of our Q4 and abounding year financials.

Kevin D. Green — Chief Banking Officer

Thank you, Obi. And acceptable afternoon, everyone. Today, we recorded fourth division 2019 artefact acquirement of $20.9 million, up 27% from the $16.5 actor recorded during Q4 of 2018. For the abounding year, artefact acquirement totaled $74.6 million, an access of 23% compared to $60.9 actor appear for 2018. These after-effects are banausic from the basic abounding year after-effects we appear in aboriginal January.

In agreement of artefact mix awash during the quarter, platelet kit sales accounted for about 85% of appear artefact revenue. Attractive advanced to 2020, we apprehend able-bodied platelet kit growth, apprenticed abundantly from added appliance of INTERCEPT by US claret centers as they booty action to accede with the FDA advice document. Accordingly, we apprehend abounding year 2020 artefact acquirement will be in the ambit of $89 actor to $93 million, apery advance of about 20% to 25%.

Government arrangement acquirement totaled $5.6 actor and $19.1 actor during this three and 12 ages aeon concluded December 31, 2019, respectively, up from the $3.7 actor and $15.1 billion appear during the commensurable periods of 2018. Added acceptance in our RedeS and ReCePI studies, basic activities for added analytic activity, as able-bodied as CMC and in vitro development collection the access and are accepted to abide through 2020.

Now, let’s move the altercation to our appear gross margins. For the quarter, gross margins were 56%, compared to 49% for the above-mentioned year period. The cogent advance in gross allowance was attributable to economies of calibration and lower per kit COGS, consistent from the added aggregate of kits bogus to accommodated accepted and accepted advance and appeal for our products.

Additionally, gross allowance bigger as a aftereffect of the favorable artefact mix about-face to bifold those platelet kits in France. For the abounding year, gross margins were 55% compared to 48% during 2018. We apprehend gross margins will be almost abiding in the mid-50% range, as we attending advanced to 2020.

I’d now like to altercate operating expenses, which totaled $33.6 actor during the quarter, compared to $27.3 actor during Q4 of 2018. For the abounding year 2019, operating costs totaled $126.6 million, compared to $99.4 actor during 2018. The investments we’ve fabricated in SG&A and R&D during 2019 acquiesce us to aerate the advance befalling in 2020 and beyond.

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Of the absolute operating expenses, SG&A costs during the division accounted for $17.2 million, compared to $14.8 actor during Q4 of 2018. The access was apprenticed from investments we’ve fabricated in our accumulation alternation capabilities. The connected basic activities for advancing US pathogen-reduced cryoprecipitate launch, as able-bodied as college non-cash advantage costs.

For the abounding year, SG&A spending totaled $66.2 billion, compared to $56.8 actor during 2018. We’re committed to breeding advantage from our SG&A investments, acclimation conduct in SG&A absorb with advance in activities that advance to acquirement generation.

Turning now to R&D expenses. Analysis and development costs for the division totaled $16.4 million, compared to $12.4 actor during the above-mentioned year. The access in R&D costs was abundantly due to artefact accessory initiatives and activities angry to acknowledged claims expansion, including our amateur set for platelets, as able-bodied as our six, seven day characterization claim.

In addition, development activities to abutment our advancing PMA supplements for pathogen-reduced cryoprecipitate, as able-bodied as activities angry to the development of our red claret corpuscle diplomacy collection portions of the access in R&D. For the abounding year, R&D amount totaled $60.4 million, compared to $42.6 actor during the above-mentioned year period.

Looking ahead, we advanced college R&D spending in 2020 due to accepted increases in BARDA-related activities and the advancing development of our amateur set to the US market, six, seven day characterization affirmation and the MDD to MDR cutover for our products. As a reminder, BARDA-related R&D costs are reimbursed as government arrangement revenue.

Now, let’s attending at the basal line. Net accident for the division totaled $16.9 actor or $0.12 per adulterated share, compared to a net accident of $16.2 actor or additionally $0.12 per adulterated allotment for the above-mentioned year period. For the abounding year, net accident was $71.2 actor or $0.51 per share, compared to a net accident of $57.6 million, or $0.44 per allotment adulterated allotment for 2018.

As advanced mentioned, we’ve fabricated investments that will actualize a belvedere for us to accomplish INTERCEPT the accepted of affliction and which will calamus bottomward as we complete assertive R&D activities.

I’d like to accomplish a few comments about our antithesis sheet. We concluded 2019 with $85.7 actor of cash, banknote equivalents and concise investments on hand. To supplement that balance, beforehand this year we completed a accessible alms of accepted stock, adopting gross gain of $63.3 million.

With the FDA advice certificate accomplished and a antithesis area that allows us to accomplish INTERCEPT a adopted best for US claret centers and to barrage our cryoprecipitate product, Cerus is acutely focused on active to profitability. With the achievement of the contempo alms and accustomed the opportunities in advanced of us, we accept we can attain advantage during our cardinal planning period.

We are assured in our adeptness to abide growing, not alone the top line, but to ensure affection of accumulation and connected gross allowance improvement. At the aforementioned time, abounding of our accepted non-BARDA analysis and development programs are accepted to be complete in the near-term, blurred R&D costs, and of course, we accept a amazing befalling to access the advantage from our SG&A spend.

With that, let me about-face the alarm aback over to Obi for some closing comments.

William M. Greenman — President and Chief Executive Officer

Thanks, Kevin. Before I blanket up the call, I capital to briefly animadversion on the contempo beginning of the COVID-19 virus, which originated in Wuhan, China. Whether the coronavirus like SARS, MERS or COVID-19 are mosquito-borne virus like Zika, chikungunya and West Nile. The alone absolute abruptness would be to not accept accession one in the abreast future.

As we accept frequently witnessed, these bacilli accomplish their attendance accepted bound and with appulse via the animal assessment of anguish and bloodshed and the bang on civic infrastructure. The efforts adapted by healthcare providers beyond the apple as they abode an arising antibody are awe-inspiring in their scope.

Amongst abounding analytical parameters, assurance and availability of claret and its apparatus for admixture are axiological to our basic bloom arrangement and to ensuring absolute outcomes for actively ill and afflicted patients. Claret admixture has been acclaimed as one of the best accepted procedures administered in hospital — to and accessible inpatients and in abounding cases, is annihilation abbreviate of activity saving.

Cancer patients who accept the all-inclusive majority of all alloyed platelet articles are decidedly affected to communicable risks due to their basal ache and advancing analysis protocols. Arising bacilli affectation an advancing blackmail to the assurance and availability of the claret supply, while biking in alternation accept historically been the primary agency by which arising bacilli move dynamically beyond the world, accelerated urbanization over the aftermost aeon has additionally alien ample numbers of bodies to advanced abortive areas. All acquiesce diseases to move into beforehand burghal areas area citizenry anatomy has increased. Changes in rainfall, temperature and melancholia patterns accept been apparent to accord to broadcast agent populations and ranges, two factors that may acquiesce diseases to advance into areas area acclimate or acclivity may accept advanced served as a careful barrier.

The role of claret accumulation is allowance to assure society, yet accompanying defective aegis from communicable risks was accustomed by the admittance of claret centermost considerations in Communicable and All Hazards Accommodation and Advancing Innovation Act signing the law aftermost June in the United States.

Along these lines, the European Centermost for Ache Prevention and Control or ECDC convened a console of experts aftermost April to altercate arising communicable threats

And the role of antibody reductions to adequate claret supply. Several examples recited, in which antibody abridgement has been deployed to advance and assure the analytical accumulation of platelets.

To abode the appulse of an appearing antibody on the claret accumulation abundantly and rapidly, we charge arrange all accessible accoutrement at our disposal. Donor deferrals can advice awning out potentially adulterated donors. They can accept a abundant appulse on availability and bounded adeptness during the epidemics.

Testing can awning out adulterated products, but tests with adapted acuteness and specificity are not readily accessible in an emergency situation. Antibody abridgement can proactively abode a all-inclusive cardinal of pathogens.

Strategically deploying all three assurance measures allows for acclamation all the needs of the claret supply, befitting claret apparatus safe and readily available. This affectionate of a multipronged access for claret assurance availability is our best adventitious to amuse the charge for the abiding accommodation consort by the accessible bloom community.

In closing, I appetite to booty a moment to acknowledge all Cerus advisers who helped accomplish 2019 a success and for their connected affection for our mission to accomplish INTERCEPT the all-around accepted of care. Their adamantine assignment and assurance fabricated accessible accomplishing a abounding important milestones in 2019. I’m attractive advanced to all the abundant things that we will apprehend calm in 2020.

Operator, amuse accessible the alarm for questions.

Operator

Thank you. [Operator Instructions] Our aboriginal catechism comes from Mathew Blackman of Stifel. Your band is open.

Mathew Blackman — Stifel, Nicolaus and Aggregation — Analyst

Good afternoon, everyone. Acknowledgment for demography the questions. It didn’t complete like Vivek was there in the role alarm that Tim did. So maybe, Obi, if you could tackle, I’ve got a brace of questions with a follow-up. But could you aloof maybe allocution in added detail in accepted about the akin of claret centermost accommodation today versus, say, September 30th? And we all apperceive that Red Cross has been advanced of the curve, but I’m additionally analytical how the added big four are tracking? And afresh a brace of follow-ups on that?

William M. Greenman — President and Chief Executive Officer

Yeah. Thanks, Mathew. Yeah, the Red Cross continues to be at the beginning with commendations to their all-embracing action for actuality adjustable with the final FDA advice document. So, I anticipate that they will abide to be the advanced runner, aloof accustomed their history of alive with us. With attention to the actual four of the big bristles claret centers, there’s array of a spectrum of accommodation on their part.

Certain claret centers are, I think, added alternating than others and it absolutely comes bottomward to, are they array of aggravating to actuate what their claret centers will or their hospital barter will get, against reacting to what the hospital appeal is. And I anticipate that absolutely comes bottomward to accepting a action by which you go to your hospital barter and say, we accept that antibody abridgement is our adopted advantage and here’s the amount hypothesis associated with the added amount about to the added options that are put alternating in the final advice document.

Mathew Blackman — Stifel, Nicolaus and Aggregation — Analyst

Okay. That absolutely lends itself able-bodied to the follow-up, which was, we do absorb a lot of time talking about claret coffer preparedness. But how are you guys accurately additionally abutting and agreeable the hospital and customers? How are those conversations going? And you mentioned it, but are you still seeing the adeptness for claret banks to drive exceptional appraisement with the platelet product?

William M. Greenman — President and Chief Executive Officer

Yeah. I anticipate again, activity to the Red Cross as an example, aloof accustomed how far alternating they are with attention to their all-embracing platelet strategy. It absolutely is a partnered accomplishment amid Cerus and the American Red Cross. We accept a committed aggregation that works with the America Red Cross, but on the hospital diplomacy ancillary as far as bringing on lath INTERCEPT platelets, discussing the amount hypothesis with those hospital barter and why we accept there’s an bread-and-butter absolution for accretion pricing, accustomed the allowances conferred by antibody abridgement about to the adoptions.

One of those being, added platelet shelf activity or beforehand absolution of platelets and the adeptness to assimilate the platelets apparatus that a hospital will accept via beneath codes, thereby authoritative it easier for hospitals to accept a admixture accessible product. I anticipate the axial affair there is accepting a advised artefact against activated product. And afresh we additionally accept a deployment aggregation that works carefully with the America Red Cross, not alone on the assembly side, as far as how quick they can access their INTERCEPT platelet production, but additionally the hand-off to the hospital customers.

Mathew Blackman — Stifel, Nicolaus and Aggregation — Analyst

All right. And one aftermost quick question. Any amend on the cardinal of accustomed BLAs in the US? And that’s all I have. Acknowledgment so much, guys.

William M. Greenman — President and Chief Executive Officer

Yeah. Thanks, Mathew. I anticipate we’re still about 15, we’ve got 19 Red Cross claret centers that are application INTERCEPT out of their absolute 22. So absolutely the all-embracing BLA approval action is not rate-limiting at this point with commendations to best of our key customers. And we don’t apprehend it to be throughout 2020.

Mathew Blackman — Stifel, Nicolaus and Aggregation — Analyst

Thanks again, guys.

William M. Greenman — President and Chief Executive Officer

Thank you.

Operator

Our abutting catechism comes from Jacobs Johnson of Stephens. Your band is open.

Jacobs Johnson — Stephens Inc — Analyst

Hey, acknowledgment for demography the questions. Kevin, I anticipate in the accomplished you’ve accustomed us some blush about aggregate advance in the quarter. Clearly, a appealing standout division for artefact revenue, but I’d be absorbed if you’d allotment any array of blush about the aggregate trends you saw on the fourth quarter?

Kevin D. Green — Chief Banking Officer

Yeah. So for the division kit aggregate was absolutely robust, if you analyze that to Q4 of the above-mentioned year. Kit advance was up about 32%. For the abounding year, not too dissimilar, but abutting to 25%

Jacobs Johnson — Stephens Inc — Analyst

Got it. That’s helpful. And afresh aloof Kevin, afraid with you. On the advice for this year, can you aloof airing us maybe through the puts and takes of it. Particularly, it sounds like this will apparently abundantly apprenticed by US platelet kits, but does it accept any addition from cryo, maybe against the aback end of the year? And then, any countries we should be acquainted of that are accidental to the guidance?

Kevin D. Green — Chief Banking Officer

Yeah. So best of the advance — the all-inclusive majority of the advance will be apprenticed from US platelets. So that’s not to say that there won’t be advance in added areas, but about to the advance that we’re assured from the US that will be modest. There is no cryo acquirement modeled into our guidance. We do apprehend to abide in the aboriginal bisected of this year and bold reasonable questions and acknowledgment times could accept approval by the end of the year. But we did not agency in any acquirement into our advice from cryoprecipitate.

Jacobs Johnson — Stephens Inc — Analyst

Got it. I leave it there. Acknowledgment for demography the questions.

Kevin D. Green — Chief Banking Officer

You’re welcome. Acknowledge you.

Operator

Thank you. [Operator Instructions] Our abutting catechism comes from Josh Jennings from Cowen. Your band is open.

Eric Assaraf — Cowen and Aggregation — Analyst

Hi. This is Eric [Phonetic] on for Josh. Can you guys apprehend me?

William M. Greenman — President and Chief Executive Officer

Yeah. We can.

Eric Assaraf — Cowen and Aggregation — Analyst

Great. Aloof attractive at your befalling in Europe, what array of contributions are you guys cerebration could appear out of Germany in 2020?

William M. Greenman — President and Chief Executive Officer

Yeah. So, I anticipate Germany continues to be somewhat of a apathetic access about to what we — agnate to what we saw in the US. There are a lot of, what are alleged MAAs that are accustomed or in the action of actuality accustomed appropriate now by the Paul-Ehrlich-Institute, which is the authoritative anatomy that approves German claret centers to apparatus new accomplishment methods or I guess, about it’s the — claret articles in Germany are regulators biologics by the pie[Phonetic], and so those are all advancing together.

We do accept hospitals — sorry, claret centermost affairs that are in abode and they’re in discussion. And then, the mechanics of how the absolute agreement that’s in abode absolutely construe into hospital payments to to claret centers for the artefact is article that we’re alive through today. So there is a committed Cerus aggregation alive on this. We are optimistic about the abiding opportunities that Germany represents, but in the ambience of 2020 guidance, it’s not article that we anticipate is activity to be carrying meaningfully, it’s added of a 2021, ’22 event.

Eric Assaraf — Cowen and Aggregation — Analyst

Great, acknowledge you. That’s actual helpful. And afresh attractive at the two Phase 3 studies you guys accept advancing for red claret cell. I anticipate you advanced mentioned a ambition of accepting 10 sites up and active for ReCePI by year ends. I’m aloof apprehensive how advance on that ambition has been? And afresh any animadversion on acceptance would additionally be helpful? Acknowledgment for the questions.

William M. Greenman — President and Chief Executive Officer

Yeah. So, as you mentioned, we accept two Phase 3 studies that are enrolled in the United States. One is alleged RedeS and the added one is ReCePI. The RedeS abstraction is enrolling absolutely bound and will abide throughout this year. So we’re optimistic about acceptance in that study. And ReCePI acceptance is starting to access as well.

We accept absolutely enrolled 10 added sites in 2019 and are accretion the cardinal of sites over the abutting several quarters. So with the added sites that are advancing on board, I anticipate we’re targeting added arctic of 15 for this year, we should see an added clip of the ambiance for the ReCePI abstraction in 2020.

Eric Assaraf — Cowen and Aggregation — Analyst

Thank you.

Operator

Thank you. I’m assuming no added questions at this time. I’d like to about-face the appointment aback over to Obi Greenman for any closing remarks.

William M. Greenman — President and Chief Executive Officer

Thank you all for, afresh for abutting us today and for your absorption in Cerus. We will be accommodating in two accessible broker conferences abutting month. First, we’ll be at the 40th Annual Cowen Healthcare Appointment in Boston abutting month. And we’ll additionally be at the BTIG Snowbird, Utah Appointment in March. We attending advanced to seeing abounding of you there in person. Acknowledgment actual much.

Operator

[Operator Closing Remarks]

Duration: 28 minutes

Timothy L. Moore — Broker Relations Director

William M. Greenman — President and Chief Executive Officer

Kevin D. Green — Chief Banking Officer

Mathew Blackman — Stifel, Nicolaus and Aggregation — Analyst

Jacobs Johnson — Stephens Inc — Analyst

Eric Assaraf — Cowen and Aggregation — Analyst

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