Q1 2020 Earnings Call
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Ladies and gentlemen, thank you for standing by today's conference is scheduled to begin momentarily until that time your lines will remain on music hold thank you for your patients.
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Ladies and gentlemen, thank you for standing by today's conference will begin momentarily until that time your lines will remain on music hold thank you for your patience.
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This time, all participants aren't I listen only mood. After the speakers presentation. There will be a question and answer session and you will need to press star one on your telephone keypad should ask a question. Please be advised that today's conference is being recorded.
It is now my pleasure to turn the color to your haste Mr. Tenley. Please go ahead.
Thank you operator in good afternoon.
I like to thank everyone for joining us today.
With me on the call our Ob Greenman, Sears is president Chief Executive Chief Executive Officer, Kevin Green, Sears is chief Financial Officer.
<unk>, our chief operating officer.
Dr launch crash, our Chief Scientific officer.
Carol more or senior Vice President of regulatory affairs from quality.
Serious issued a press release today announcing our financial results for the first quarter ended March 31st 2020, and also describing the company's recent business highlights you can access a copy of this announcement on the company website at Www dot serious dot com.
I like to remind you that some of the statements will make on this call relate to future events for much rather than historical facts you know we're looking statements.
Apples affording statements include those related to our future financial an operating results, including our 2020 financial guidance and goals.
Pretty expenses gross margins.
Commercial development efforts eat your growth growth strategy future product sales product launches the impact of current and future products Blood Center operations ongoing future clinical trials ongoing feature product development and the regulatory activities as well as a tiny that these events and activities.
We were lichtenstein involve risk and uncertainty that can cost actual events formants and results do differ materially.
Identified described in today's press release in under risk factors 110, K. for the year ended December 31st 2019, you know 110 Q. for the quarter ended March 31st 2020, which will fall surely we undertake no duty or obligation to a theater for looking statements.
On today's call will begin with opening remarks, Moby fall by the Big will provide an update on commercial operations in our supply chain.
Kevin would then read their financial results and finally, Oh, we will conclude with closing remarks.
Many of this year's employees hadn't sheltering employers and working remotely, including most of us on the call today.
We're done remotely to this costs of tease excuses for easy lags or delays that may occur.
And now it's my pleasure to induce will be greenman, Sears is president and Chief Executive Officer.
Thank you Tim and good afternoon, we appreciate your patients and dialing in today.
Months have probably been a challenging time for the world for businesses due to the impact of the curve in 19 endemic.
Since our fourth quarter conference call in mid February we implemented or crisis management plans to ensure the safety of serious employees.
Supplied to support our customers.
And the continuity of our operations.
And at the same time, you've taken decisive action to help blood centers and national transfusion services ramp up the implementation of covert Cobb wasn't plasma programs provide a bridging therapeutic option to acutely ill patients multiple countries.
Therapies and vaccines are available.
As of today I'm happy to report that are thought for planning and our experience team at Sears put us in a very strong position.
Not only do effectively navigate this pandemic crisis, but also to re frame the opportunity sat in front of us given the increased focus on supply chain security for blood safety and availability.
It's important to recall that the basic mechanism of action Repackage inactivation platform was designed to deal with the emerging pathogens with emerging pathogens such as the Sars could be two virus.
Working with our manufacturing partner for Sunniest Kabi with key sub suppliers, such as poor X. part of the filtration group, we have increased or safety stark product inventory since the beginning of the year in anticipation of potentially increased demand.
Resulted in first quarter product revenue of $18.6 million, which exceeded our internal expectations at the beginning of the year.
Well covert 19 is having a profound impact on our board Senator customers for both the supply and demand perspective.
We're still seen blood centers increase intercept orders in an effort to better safeguard their supply chains for blood component production.
Improving 19 epidemic has reinforced the importance of pandemic preparedness planning at both been centered in hospitals.
Especially in the context of the recent history of emerging infectious diseases.
Well first privy to as a respiratory virus and the data suggested is not considered a significant transfusion transmitted infectious disease risk.
In the blood supply chain is still profound.
In this context, the intercept blood system as well positioned to provide a solution for blood centers and hospitals in the post covert era that minimize the supply chain and logistics complexity.
And the search for a rapid therapeutic option to treat covert 19 patients one potential treatment involves collecting plasma from patients who have recovered from covert 19, making sure. It's free of front of virus and other infectious pathogens and transfer using the plasma to people who are sick.
A variant of this approaches to take the plasma concentrated in three hyperimmune intravenous immune globulin or <unk>.
The large consortium of most of the leading plasma fractionation companies is working to accelerate the evaluation of ideology and to scale up production.
Well remains to be determine what will be the most effective intervention of these two approaches.
There's a reason to believe that Cobb wasn't pleasant may have other potential benefits beyond just neutralize antibodies, including an impact on normalizing the patients correlation profile without blood clots.
Rolling maintaining the whole of the vascular endothelial.
Sears is playing a key role in supporting blood centers will hospitals with their corporate color wasn't plasma programs.
Have you been at the forefront of Cobb wasn't plasma historically as a result of our partnership with the Gates Foundation during the boy outbreak in West Africa in 2014 and 15.
Serious has again taken at leadership position.
We have been active in most of the countries in Europe, and particularly Italy with our partner cadre on to wrap intercept treated C.C.P. production during the myths of Italy's most critical period.
In France, the regulatory authority now requires intercept for C.C.P. production.
And the U.S., we have collaborated with the A.B.B. to help them establish a website MCC processing protocols that can be lovebirds across the national Blood Center infrastructure.
This effort overlaps with the significant focus and funds that the F.D.A. and American Red Cross and barter.
Have dedicated to standing up in nationwide C.C.P. program.
Based upon our previous experience with Cobb wasn't plasma and the issues of donor availability dos and product characterization.
We decided early on in this pandemic to former research consortium with the California Public Health Department Phytel Blood services academic laboratories at U.C., Davis, and U.C., Irvine and the San Francisco based biotech company called enable bio sciences.
You're collectively endeavor into better assess the key characteristics that influence the potential advocacy of C.C.P., including leveling profile of the source coby to antibodies optimal flux and timing dosing and how these factors influence responses to the therapy.
We believe intercept complain important role in C.C.P. production since it's offers the ability to reduce infectious risk in a therapy administer to patients with the damaged immune systems.
With all of our efforts around called wasn't plasma in the world wide focus on therapeutic options for critically ill a covert 19 patients were seen increasing interest by customers intercept plasma primarily in markets outside the U.S. During the time that we've been waiting for the F.D. approval for alternate plastic intercept plasma disposable kits.
But the F.B. approval now in hand, we will continue to wrap production of our plasma sets to be able to meet the demand in Europe and many other countries well bridging the current.
Ability shortfall in the U.S. within herself play that sets that are being used under emergency use protocols for treating convalescent plasma.
We have those four navigated the covert 19 pandemic challenges.
And it has provided new opportunities to reinforce the importance of our mission to ensure the safety and availability at the blood supply.
Let me know turn it over to the day to provide an update on the details of our commercial operations and our supply chain integrity.
Contradicts strong leadership, the commercial organizational little past three years.
I am grateful that he is accepted an expanded roll it serious to take on overall operations of the company related to our commercial products, including supply chain and manufacturing supply relationships.
And this role as our Chief operating officer, He's responsible for how we support all aspects of our customer engagement.
Maintaining their competence in serious given the critical role we play in the overall blood supply chain.
Thank you for the kind remarks, that'd be good afternoon at one.
First.
Right.
The kids.
Applied for their unwavering commitment to make sure blood centers.
Little and patients around the globe that that's good to intercept without their commitment during this time of crisis.
Particularly at some point to the disruption beginning as important first quarter was coming to close.
We would not have been able to deliver the top line results you're sharing with you today.
As a result, when it comes in 19 pandemic blood donation and blood products, either <unk> sharply starting in mid March and donor sheltered in place and as elected medical procedures were postponed.
In addition, we started to hear one button linked declined in platelet utilization, even though Clinton looked are primarily used in the central medical procedures.
Nevertheless, as showcase player strong keelan resolved global consumer demand and adoption intercept was robot.
First order like retinue of 18.6 million exceeded our pre pandemic internal plan and the up performance was broadbased encouraging results at Mount sales regions.
We continue to see strong demand for intercept pointing look the d.
He won 2020 product club in the in North America, almost 34% compared to keep 120 19.
We've mentioned previously the American Red Cross, leading that pledged to establish passage reduction as a standard of care with respect completely safety in the U.S.
Near deeply grateful to the air Steve for their strong partnership and their continued leadership.
Some keep 120 20 product sales to the air C. increase at any given faster rate than those recorded for overall North America.
The air he remained.
<unk> to make intercepted preferred method for complying with a dialog yeah guidance on bacterial safety.
As we discussed previously, yes marketplaces fairly concentrated.
Five largest blood thinner families account for over 70% of nationwide platelet distribution.
February we convened an executive round table, let's senior leaders from the Big five blood centers in order to better understand their plans to comply with guidance and do offer our partnership and research support is needed.
Well the air Theater, clearly, leading the way it was encouraging be here. The other major players expressive similar beliefs that patch reduction would prove to me the first choice option for God's comply.
Well there.
Your turn on certain days about new hospitalization covered folks environment.
And used to be strong belief that that shouldn't reduction will become the standard of care and blacks.
In our current environment, we are developing strategies, an action plan to get hospitals engagement focused on complying with the guidance at a time when wanted their attention is consumed by that does this crisis.
Given the current pen that like it is unclear one we can start visiting hospitals and person too since the operational activities for their efforts to go lie with interest.
As a result visit celebrated online training and distance learning initiated which enables for about the hospital activation.
It also work aggressively with existing users to increase intercept penetration and help them more quickly to 100% error adoption.
Furthermore, we are piloting remote training and education toolbox for blood Center commercial teams and make sure they're up to date and best equipped as felons support P.R. operates in this current environment.
Well these disruption may slow the rate at new hospital implementation of dinner stopped his arm believed that this would be more than offset by increasing penetration with existing users across the globe.
Turning tear up we posted strong results and keep 120 20.
Towards the end of March we saw an increase in class market demand from early 'cause it 19.
Like Italy and Spain.
This increase in plasma demand contributed to our above fine performance and also provided support group for our core platelet franchise.
Italy or distributor partner Kendry on is playing a leadership wronged production and distribution of crime diverse kind of blood plasma to treat cause that 19 patients.
We are proud to be able to partner with in this effort.
Increased stale, Italy, Spain, or slightly offset by the ongoing French yes.
Into the D.F.K.
I didn't before product mix ships from the single into the double kit as long as negative impact the foreign currency translation right, we'll country because some your ear decline to report revenue in France and 2020.
Switching gears to Jeremy we are starting to see increasing interest in Paris, and activation technology, you in park interests and seats.
Recently, the Paul early against Dude endorsed the P.I.S. mechanism to mitigate central code. It 19 related downward her pearls.
Furthermore, we had a P.S. receipt customers.
Your P.I. efforts in order to be able to offered C.P.P. <unk>.
This is likely to have one.
Par Clinton franchise over time.
While we are encouraged to see enough to take in Germany.
Olympic premature to stay with 30 I'll be down to grapple involved.
Nevertheless, because when you look across our neighbor region, you're encouraged by the strength of our business.
[noise] give them the strong current in anticipated demand for your set the kids maintaining manufacturing security and supplying tint integrity continues to be a top priority to Dan and actually report that our global operations team proved up to the challenging Q1.
On an ongoing basis near dynamically affecting inventory levels.
Train at an increase the frequency of communication Keith suppliers apart.
Here that we can maintain service problems.
Manufacturing, our suppliers had implemented central distancing measures that their factories to comply with local safety regulation.
Assessing potential implications for production not putting an inventory volumes.
Given our strong growth excitation, we entered 2020 in the world Buck inventory position and that certainly quick need to get prudent inflation.
Well I got forecast exactly how the involving pandemic one I thought supply chain is aren't believed that we had position ourselves to successfully meet increasing constricting man and I sort of buttons.
I'm grateful to our supply chain operations on customer services teams for their commitment to ensuring patients gained access.
And tortilla third party suppliers for their communication partnership to me is unprecedented times.
In summary.
Oh, the pandemic is created disruption.
Also provide your hobby.
As a result of comes in 19, the concept of preparedness truly resonates and it's taken on greater significance.
Unfortunately, the rise an infectious disease threat is now a matter of it but rather bland, ensuring the global blood supply is it safe that can be it now more important than ever.
Clearly.
Plays at a major role and it's an enabling technology to optimize safety.
Serious bump position to be the partner choice pumping blood centers uncles maintain the safety and availability of blood components in the face.
Mmm today and in anticipation of feature disease outbreaks.
We feel honored could continue this important work and are grateful to our blood from hospital, one position partners across the world.
With that let me turn over the cabin for a detailed review the financials.
Thank you for the day and good afternoon, everyone.
Today, we recorded first quarter 2020 product revenue of $18.6 million.
Up 6% from the $17.5 million recorded during Q1 of 2019.
Foreign exchange rates negatively impacted the year over year comparable results by approximately two per se.
To evaluate our results without being talked to foreign currency exchange rates War product mix, yes.
We track the calculated number of treatable quite but don't suit.
Which increase near be 14 per se you're over here.
But the kids sales accounted for approximately 90% of recorded product revenue.
Similar to the prior your period.
Making the treatable doses comparison true barometer for the top line.
We believe this metric is reflected of the underlying strength of our business.
So we have not currently experience the disruption to our commercial business.
The covert 19 pandemic has clearly created uncertainty for all businesses.
Polluting serious in our suppliers.
Well the crisis persist.
We have less visibility in to work full your outlook, but.
But.
Based on the current trends and the medical you essential nature of Transfuse blood components, we are cautiously optimistic.
Clearly, while there will be puts and takes.
We expect are recorded product rubbing to grow to accelerate.
Driven by boat increased demand for platelet kids.
And a renewed interest in our plasma products in part driven by convalescent possible.
Accordingly.
Today, we are reaffirming our full year 2020 product revenue guidance range of $89 million to $93 million.
Representing growth of approximately 20% to 25%.
Separately and not included in our gardens.
Government contract revenue recognized under our barter.
$6 million during the first quarter of 2020 <unk>.
Compared to $4.5 million during Q1 of 2000 in 19.
In the short term as a result of the current covert 19 outbreak.
Right S.N. recipe sites are temporarily suspended enrollment.
Accordingly, we anticipate that we could see a decrease embargo reported revenue while this persist.
As the issues related to the pandemic subside.
We do expect studying enrollment and the corresponding bartered related revenue to increase meaning.
Now what's move the discussion from revenue.
You are reported gross margins.
For the fourth quarter gross margins were 55% compared to 52% to the per year period.
The improvement in gross margin was attributable to economies of scale and lower per unit cost of goods sold.
The lower per unit costs resulted from increase manufacturing levels over the past year.
Implemented to me current and expected grow up in demand for our products.
Additionally, gross marching improve your over here as a result of the shift to the double dose platelet kids in France.
Based on a reaffirmed guidance and assuming steady for court foreign currency exchange rates.
We expect gross margins will be relatively stable in the mid 50 per cent range for the balance of 2020.
I'd like to discuss operating expenses, which totaled $31.7 billion during the quarter.
Paired to $29.6 million during Q1 or 2019.
Noncash stock based compensation costs comprised $3.8 million or almost 12 per se total operating expenses during the quarter.
Of the total operating expenses.
Many expenses during the quarter accounted for $15.9 million.
Compared to $16.2 million during Q., what a 2019.
Noncash stock based compensation for S.G.N.A. was close to $3 million during the quarter.
Appeared to $2.4 million per year.
The overall decrease in R.S.D.N.A. expenses was driven by lower marketing and travel related expenses as many industry trade shows where either cancel or postponed due to the coping 19 pandemic.
Turning out to research and development expenses.
R. and D. expenses for the quarter totaled $15.8 million compared to $13.4 million during the prayer year.
The increase in our in D. expenses was largely due to product enhancement initiatives and activities tied to label claim expansion.
Namely are triple platelet sat and extended storage platelets at both for the U.S. market.
In addition activities related to the Red blood cell program in the U.S.
<unk>, we're up year over year.
Interest expenses decreased $2 million during the first quarter of 2020 compared to the same period in the prior year.
In conjunction with our March 2000 in 19 debt refinancing.
And moved to our current grow capital facility and revolving credit we incurred one time expenses tied to the pre payment of a previous mode agreement Q1 of 2000 in 19.
No, but look at the bottom line.
Net loss for the first quarter total $16.5 million or 10 cents per diluted share.
Compared to a net loss of $18.8 million for 14 cents per w. to chair for the prior year period.
I'd like to make a few comments about our balance sheet now.
We ended the quarter with cash cash equivalent in short term investments on had totally $133 million.
The capital we have on hand will allow us to execute against our strategy to make intercept the preferred choice of blood centers in hospitals in the U.S. as they prepare to comply with the F.D.A. guides by March 2021.
In addition, we are well Capitalised to fund our commercial launch a passage and reduce crime, which we expect in early 2021.
I'd like to close with a statement about our financial focus and plan.
We are confident in our ability to continue growing not only the top line, but bomb term gross margin expansion, while delivering leverage from R.S. Genie investments.
In addition, many of our current <unk> research and development programs are expected to be near completion and are barred related research and development costs are reimbursed and recorded as an offsetting government contract rubber anyone R.P. you know.
In short.
We're focused on advancing not only platelets in plasma globally.
Bringing passage and reduce crowded market.
Launching red blood cells in Europe, and ultimately the U.S.
Oh by moving the company toward operating income.
What's that let me turn it back over to obey for a few closing comments.
Thanks, Kevin the covered pandemic and they increased emphasis on supply chain security for blood centers.
Evidence of our full intercept prod portfolios never been more important.
I would like to provide an update on our two key development projects pathogen reduce crab precipitant intercept red blood cells.
As we announced on April 20th we amended our contracts with barter for the intercept or B.C. program to include another $14 million in funding to support our ongoing clinical trials. The further evaluate the efficacy of intercept to an activate Sars koby too.
Well the additional funding the potential value of the contract now totals $214 million Nondilutive capital.
Part has been a fantastic partner in or clinical development and manufacturing scale up activities.
Enrollment in our phase three U.S. studies has been impacted by the coded 19 pandemic due to kiosk decide suspended research activities.
We are planning to re initiate site enrollments as quickly as possible.
That said some sites continued to enroll in both the redness and recipe studies and we've been notified by some additional sites that they're ready to initiate now.
Europe as a result of the covert 19 pandemic.
Imitation of the M.D.R. regulatory pathway has been postponed to may of 2021.
<unk> discussions with our regulatory body T.U.V., we're moving forward with the transition to the MDR submission pathway for intercept or B.C.'s now.
So as to not delay further.
Well, we are still projecting it possible 2022 timeline for approval of the C.D. Mark the overall timing will be better define once we have clarity on the modular submission schedule under the M.D.R.
We should have more visibility on our ability to compress the review timeline by our next quarterly call.
To date or submission dossier continues to dance and we were making solid progress on R.C.M.C. activities, including the inclusion of data from our new good are found supplier.
Finally, with regard to our pathogen reduce crime program, we continue to be excited about the opportunity and the overall impact on our product portfolio.
Or pathogen reduce crap, except it is designed to be a source if I bring engine another calculation factors.
It's all been continues to track on plan and we expect to follow the P.M.A. supplement this quarter, which could set the stage for F.D. approval later this year.
And the commercial launch in early 2021.
The reason up your approval for alternate plastics intercept plasma kit was a prerequisite for this submission.
In conclusion in spite of the global club in 19 challenges the company isn't a good place with a number of commercial and regulatory milestones to be realized through the end of this year.
Well, we still have some risk around the monthly production output from our manufacturing operations, we are an assault position and stand to benefit from the increase awareness about the importance of preparedness planning for the next wave of this pandemic and for future pandemic threats.
I would like to conclude with an expression of gratitude for the resilience of the serious team at this time.
We also have a profound appreciation for all the heroic work or blood center and National Transfusion service customers are doing to stand up cobin convalescent plasma production around the globe.
There are focus on responding to the urgent requests from families need not helping these acutely ill covered patients is remarkable.
Opera, please up in the cold for questions.
Please.
Okay question. Please press start then the number one on your telephone keypad.
And to ask a question. Please press start one on your telephone key pads.
Your first question comes from the line of Matthew Blackman, Some stiefel.
Oh good afternoon, everyone. Thanks for taking my question I could start me a a big picture question for O.B. and.
Do you want to champion you alluded to rate in both of your prepared comments, but perhaps just to be more direct.
That would keep growth drivers over the next several years, so U.S. appointment adoption pipeline.
Covitz slow you down at all as you actually <unk> execute against those drivers or let me in fact could potentially accelerate adoption that the portfolio like the value proposition becomes increasingly more compelling an obvious and I've got a couple of follow.
Thanks, Matthew and I'll I'll start and then probably <unk>, maybe some more specifics on on a country by country basis. So.
On the whole clearly, yes intercept was developed back in the early nineties to deal with the pandemic threats at that time with H.I.V. and hepatitis C. the blood supply.
There's been a number of that Democrats over the last 25 years, and obviously there'll be additional ones in the future. So I think what this you know highlights for serious is sort of.
I guess affirmation of the company's mission and and what we're trying to do to safeguard but saved in availability globally. So I think it really does create an an awareness opportunity for us to to work with our butts in our customers and those that we're not going to customers to understand sort of you know why this.
Safeguards overall blood supply chain.
You know clearly I think there's some issues that we discussed in are prepared remarks around sort of how quickly hospitals come back on line and started doing elective procedures in our ability to go out and and talk to those hospitals as far as onboard in.
But on the on the margin I'd say you know this you know really sort of is an opportunity for serious to re frame. It's it's a it's opportunities that maybe they can give you some more specifics around the U.S. marketing and markets in Europe.
Thank Kirby and that's the question that I think that Oh beat summarizing well you know if I took a step back and take the long meal I think that.
Situation with because at 19.
Does help further clarify the importance on the need for.
Optimized blood safety, and so I think it'll serve <unk> tail and right.
<unk> he really deals.
<unk>.
Wanting to append, making it so think about the importance of been proactively implementing.
Public health and safety measures. So I think you'll see an increased interest him about things.
Allergies acutely, though I think visibility into the puts it takes or a little more difficult yeah, we talked a bit about.
Commercially in the us in terms of being able to engage hospitals and visit them in person the dots Elizabeth Bobby now at hospitals, and then no grass they restricting visitors to focus on the code response. We're also actively managed saying the operations and supply chain <unk> you know I think we feel like weren't pretty good position.
Now but.
Sensing measures and things of that nature are implemented in areas, where we manufacture and all that they have implications for our product.
And ultimately our ability to provide product I think in both cases, where it pretty solid shape and so that's reflected in our keep on results and you know in our decision to maintain our for your guidance on but I think in you know <unk> no p. as a renewed interest in class nine we're saying that.
Key geography is in Europe in the U. out so bad.
Indeed push forward your standard apparently you us in terms of our claim the franchise.
Hi, guys that consent that that response sponsors maybe just put to death, telling that that <unk> demanding than in the U.S.. It's that sounds like Red Cross is is that made the driving force you talked a little bit about some of your copy written conversations with the other four but <unk> <unk>.
Call. It the other for just a matter of pine, whereas there's something specific that when you speak to the <unk> they call out as a a barrier secure adoption of course I'm talking beyond Covantas for anything.
Conversations I confess my comes up as a reason.
Why packs are not moving as fast as the Red Cross and I'm one follow up after that.
So that they cover the specifics of the Big <unk>, One thing I wanted to point out pretty your previous question as well matched is that.
Yeah, the guidance document the F.D. a finalize run pleaded safety in September of last year, you know really speaks to bacterial contamination risk alone and so of all the options that were presented for blood centers to be compliant.
Without guidance document.
The intercept technology is the only one that deals with future pandemic French so I think that's a really important thing just a recognized in the context of the F.D.A. <unk> compliance period.
Thank you can add some more color you know how to big five or thinking about pathogen activation.
Sure I do I think there you know the.
To your question about you know for the other there for the think five are there any particular sticking items or or or close their adoption matter perhaps fun.
In a bit more slowly than <unk> I think for.
Thread crackpot leave with the first the sort of.
Clearly and make a decision on what they wanted me what happens reduction independence or the guy in the and then another guidance document so they communicated prior to finalization of the buttons document that they intended to move aggressively and make the our strategic priorities are they had a bit of that I had start and as we talked on the path.
There are no regulatory items like scaring B.L.A. things of that nature that on some level I have a certain amount of lead time between submitting and then securing those clearances and the other blood centers are working through those are working through the operational activities and there are partnering with their hospital customers to get them on board.
<unk>.
Alpert to know how hospital customers.
With respect to intercept they're dealing with the adults challenging trying to get attention and then gain access to these sites and Miss totally.
Firemen, whereas the red cloth that I could imagine a number of hospitals prior to depend on that can for an hour moving toward dry.
Port standard of care. So those are probably I wouldn't sit there and neat unique barriers necessarily it's it's really matter just when they started and arnold's relative to when the air seat started myrtles, but that's encouraging to me is now the destination problem is is quite the same place, which ultimately will be to say for blood supply.
Alright, that's very helpful. As L.A.'s and then the last one here on on the pipeline.
We read the additional funding from from Florida for the Red cell programs that simply think of it it sort of an offset from you know what you need to expand or or it could that income application of cash somehow accelerate your ability wants to trials are back up and running.
Alright, your your timeline can offer to one with a complete that trial now that you've got more additional funds. That's all I have thanks, so much.
Yeah, Thanks Bad Yeah.
Editors part is very supportive of what we're trying to do with regard to get into red. So programmed to appear may approval and have it available to safeguard the Red Sox supplying the United States that that was the overall mission from the construction of the the the collaboration.
And they just saw the this was an opportunity to to fund not only clinical trial activities, but also the Sars coby to an activation work across the for for intercept portfolio.
I think it's just reaffirmation of of well their support for our endeavors and certainly the context of this this Cobra 19 pandemic you know.
The the rationale for for their support from the previous pandemic around or epidemic. If you will for around Zeke. It's it's been sport in that regard.
So.
Yeah, I don't think it'll it'll fundamental accelerate things are just allows us to open sites and and maintain the schedule.
Data appreciate it thank you.
Your next question comes from the line of Josh Jennings from Kelly.
[noise] Hi, good afternoon, Thank you and graduations on the progress and thanks for the work your team's doing on that.
<unk>.
Convalescent plasma just wanted to start.
Some of our check suggested that in the United States per team selection procedures declining.
That hospital pilot demand.
From hostile customers to blood centers has has declined you guys are clearly on a different tracks on the overall platelet market.
In the United States is senator still adopt again since you're not linked to those Christmas you help us understand.
The market is seeing just overall in the United States from a platelets maybe also in Europe.
<unk>.
Hi, Josh yet why don't you handle that Vic.
Yeah.
Josh Thanks to the question Yeah, you know they indicated to my comments earlier, you know really at the start kind of that early mid March time frame.
We're hearing yeah from our customers that a lot of concerns about probably significant drop off in London is coming in and then similarly as they were trying to understand other partners than a riyadh some concerns about the plus.
Procedures, having impact on the utilization of blood components and.
There wasn't they can't drop and the number of down or is something which was fairly quickly followed by is.
Pretty meaningful surge going and then wanting to do their civic duty and and donate blood and while there while we have seen.
We have seen a reduction and blood products the utilization.
Your point earlier, because I didn't even for platelets as well, but yeah do you.
Partly from my eyes are there.
The amount of hadn't been <unk>, we add in terms of increasing the percentage.
Overall platelet center P.R. treated provide sufficient upper under which to grow so we're able to do that but you know I think there won't be frankly until we start to see the light the speakers come back that patient sorry for that back in.
Fish and sending some weibo better sense, and how platelet volume for their conventional or are treated local out, but we certainly didn't see and then complain that can find a bit of a drop in terms of utilization you to be because it 19 issue.
Thanks for that and just to follow up on the Red blood, so they're separate but equal opportunity. We had thanks for consult suggested this pandemic could kind of light a fire on the F.T.A. and potentially.
Spark no accelerated with you pathway or.
Breakthrough designation or something along those lines.
Money is that.
No tar to call, but is that there been any bugs around that and then secondarily just on the the C.E. Mark path can we just want make shrum clear on.
Description here you guys are going to use the M.D.R.
Pathway, but could we potentially see an approval timeline that's in front of that 2022.
Here, that's that's been put on the tape historically.
Yeah. Thanks, <unk> take a shot that maybe then turned over to Carol for some comments around through how the F.D. It might look at US. We obviously have ongoing discussions with the F.D. about what the clinical requirements are for an approval appear may approval of the United States and so.
Oh, that's a a dialogue that's that's underway you know I think right now the the general disposition to the F.D.A. historically spend that they wanted to approve the product for all indications and so you know that required a a fairly robust data set to be able to do that.
And so on before I turn over to Carol to answer sort of the specifics around you know what might be possible.
I just won't cover the M.D.R. question you had so.
Discuss <unk> you know, we'll we'll have more clarity around what the actual counter it looks like as far as a module or submission schedule for that M.D.R. pathway by the next quarterly calls so I think it's probably safer to say Hey, we'll give you an update in in end of July early August on that but yeah.
That we have had good discussions with T.V., so far and and and we'll just have to see sort of what what their thoughts are on on the timeline for that modular submission schedule, what they can handle them and ultimately what H.P.R.A. can't handle which is our our notified body.
I'm, sorry competent authority for the the submission.
You want to comment anything on on the F.D.A. thinking in the context of covert 19.
Well I think I'll be you've summed it up just just right I think that just the point that I would emphasize is that we are in constant discussion with the F.T.A. about all of our products and opportunities that might exist. We we are.
Not shy about asking for out of the box considerations in terms of moving our products forward in obtaining the licenses as quickly as we can or moving trying to do part of our study pretty license and and consider collecting the rest of that.
Ready data post license. So we don't have any of those patterns.
Solidified at this point, but but it is an important effort that we maintain that continue to look at so.
Environment, especially at that impacts the U.S. patients and.
Discuss those opportunities with F.D.A. and have them give us some feedback on on their their point of view, but I think hobbies.
Point about seeking obeisance that covers all indications for red cells, it's important because.
That that alone will save this time, rather than doing individual studies and so we are trying to keep that in balance with our requests for discussion and evaluation with F.T.A.
Oh, that's just tanks in the last question just fun.
Similar type of questions with could could could cope with 19 Pandemics spark.
Regulatory decisions and other countries, but particularly one of the focus on a an ancient China, China, and Japan, specifically, it's or in any movement. There in terms of from service or from regulatory bodies were you opinion leaders to those two countries too bored with pathogen reduction adoption. Thanks a lot.
Yeah. Thanks, Josh So you know obviously, they're big markets in Asia.
That they've been hit part, but the <unk> 19 pandemic.
We are an ongoing discussions with potential a joint venture partners in China, and hope to be able to update you on the next couple of quarterly calls as relates to that effort clearly that blood supply in China also has to be safeguarded and there's a realization by many large companies in China about the need to do.
So I'm optimistic but prefer it to differ any additional comments into the future quarterly calls and then there's a number of other countries throughout Asia Pacific region that or in contact with us about convalescent plasma.
But I think the majority of our focus right now I was still on the U.S. <unk>, just given you know our supply chain or ability to support those customers as as the business gross.
Thanks. Thanks.
Thanks, Thanks, a lot.
Your next question comes from the line of Jacob Johnson from Stevens.
<unk>, maybe while we're on the regulatory practiced just harder quick one.
With many hospitals.
Pandemic and focus on yup saving People's lives in a number of other things right now.
Any chance that he <unk> platelet safety cricket course back from the Mark deadline next Gardner Yep.
If the industry another three months versus what they mostly prepared.
But that could get pushed back just as a confession to to the hospital industry.
Yeah, I'd Jake apparently question. So it's clearly a consideration we have yeah I think what makes for a touched on this before he was talking about the Red Cross is that it really doesn't drive sort of the Red cross decision making per se.
You know made a commitment to make intercept the standard of care to improve pointing to safety and then yeah. I think the F.D. has given blood centers initial six months on top of the the 12 typical <unk> 12 month compliance period. So that you extended from September of of this year to March of 2021.
I think it's yeah, it's possible that they'd say that they need additional time I'm sure that some of the blood centers were saying I'd given the impact of this crisis in the same time from an F.D.A. perspective, yeah. The the reason why the guidance document is in place is that patients are dying from transfusion related <unk> for for play a transfusion and so.
There's sort of an issue there if you're trying to improve point patient safety.
You you, obviously, a wannabe addressing the requirements in the guidance document and then and as I initially commented <unk>.
The one thing that we should highlight is that.
Then of all the options and the guidance document.
The only one that addresses Sars coby to wear a future pandemic threats is in or something and so I think on the whole even if the the guns were to be delayed it puts us Navy even stronger position. This pandemic does.
Got it. Thanks, Thanks that every maybe their question for cat that that's where we could get by with everyone expected it sounds like Mad.
Things her lack of credit says et cetera.
Should we expect a to kind of.
Similar levels, maybe next next quarter, you know given that doesn't seem like life is coming back to normal are quite yet and then similar and the art dealer and just give them the.
Enrollment or clinical study.
Maybe that try to quite a bit lower as well.
Yeah, I think you're right in both account certainly in Q. to.
Stay at home order is we're doing less traveling there's not as many conferences and I think we could expect to see that clearly through may and maybe even be on June but after that it really just depends on.
Where everyone is and what the winters are in in that depend gimmick upstate to what we do expect will ultimately to get back to business on the R. and D. fronts.
You know there will be pause right now in enrollment but into.
The same time over our teams are really focused on his utilizing their their skills and in other areas covered by BARDA.
Making sure that wants to sites, helping back up wearing a great spot Jim really accelerate continue enrollment so that'd be a little bit at the debt for a period of time, but we don't we don't expect a significant dead or.
A a longstanding issue with the with the overall program.
Great. Thanks for taking the question.
He's Jacob.
No further questions at this time I won't have time to call back to Mr. Tim leaf or any closing remarks.
Great. Thanks, everyone for joining guess sneak think again for drawings on the call today and your interest in serious we are planning to hold her a second quarter conference gone that late July early August timeframe in the interim you know please don't hesitate to contact Investor Relations Chip should you have any questions. So thanks again I like.
Ladies and gentleman. This sounds conclude today's conference. Thank you for your participation you may now disconnect.
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