Q4 2022 Cryoport Inc Earnings Call
Good afternoon, and welcome to Cryo sports fourth quarter.
And full year 2022 earnings conference call.
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A brief question and answer session will follow the formal presentation.
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I will now turn the call over to your host.
Todd Fromer from Casey <unk> strategic Communications. Please go ahead.
Thank you operator before we begin today I would like to remind everyone that this conference call contains certain forward looking statements all statements that address our operating performance events or developments that we expect or anticipate occurring in the future are forward looking statements. These forward looking statements are based on management's beliefs and assumptions and not.
On information currently available to our management team our management team believes that these forward looking statements are reasonable as and when made however, you should not place undue reliance on any such forward looking statements because such statements speak only as of the date when made we do not undertake any obligation to publicly update or revise any forward looking statements whether as a result of new.
New information or future events or otherwise, except as required by law. In addition forward looking statements are subject to certain risks and uncertainties that could cause actual results events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include but are not limited to that.
As described in item <unk>.
Risk factors and elsewhere in our annual report on Form 10-K filed with the Securities and Exchange Commission and those described from time to time and the other reports we file with the Securities and Exchange Commission.
It is now my pleasure to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Bio Port Jerry the floor is yours.
Thank you Todd and good afternoon, ladies and gentlemen, we appreciate your joining our earnings call today.
Does this afternoon is our chief financial Officer, Robert Novakovich, Our Chief Scientific Officer, Dr. Mark Sawicki.
Vice President of corporate development and Investor Relations.
<unk>.
As a reminder, we have uploaded our fourth quarter and full year.
Fiscal year 2022 in review document to our website.
Can be found under Investor relations.
Vince and presentations section.
This document provides a review of our financial and operational performance and a general business outlook. If you have not had a chance to read it I would encourage you to go into our website and download it.
The Liza Destiny in terms of our development pathway and the initiatives, we are undertaking to assure our future.
Now I'd like to provide a brief update on our business and then we'll move on to entering your questions.
Okay.
Today, we reported a solid finish to 2022 with record total.
<unk> revenue of 237 million $237.300 million.
Led by <unk>.
24% increase in revenue from cloud Port systems.
Annual gross across Port systems was fueled by strong demand for our comprehensive suite of products and services and strong growth in the cell and gene therapy market.
At the end of the year, we supported a total of 654 clinical trials worldwide. A net gain of 52 clinical trials since year end 2021 seven.
<unk> 79.
On page three.
At the end of the year. We also supported 10 commercial therapies and increase from eight since year end 2021.
Further we anticipate.
Supporting up to 21 commercial therapies in 2023 as a result of our forecast of up to an additional 22.
Anticipated application filings 11, new therapy approvals and an additional 12 label or geographic expansion approvals for a combined total of 23 anticipated industry approvals in 2023.
The regenerative medicine market continued its development in 2022 is one of the fastest growing therapeutic segments.
Patient demand remain robust our commercial revenue ramp was partially impacted sequentially due to our clients call continued cell therapy manufacturing capacity constraints shortages of.
<unk> and.
And a pause in the shipment.
Auxiliary therapy dosage to bio storage for a specific client due to their supply chain issues.
Having said that the recent introduction of new cell and gene therapies into the market and set the stage for greater activity levels in 2023 over time, we expect the industry manufacturing capacity will increase in order to meet the pent up patient demand and as it does <unk>.
We'll continue to lead the way in the development of advanced their advanced temperature controlled supply chain solutions that will support the advancement of cell and gene therapies as well as our growth.
Notwithstanding.
Current manufacturing capacity constraints, many analysts to expect the regenerative medicine market to grow at a compounded annual growth rate of 25% to 30% over the foreseeable future.
Part of the reason for our confidence today is that 2022 marked a year of significant achievement for cloud fourth as reflected in our adjusted EBITDA, which was $13 $7 million for the year, we continued to make significant strategic investments to build out our informatics.
Competencies.
Global supply chain Center network manufacturing capacities.
Our service offerings and capabilities to support and accelerate our growth.
These actions are designed to further expand our end to end solution supporting the supply chain for the life Sciences market and specifically the cell and gene therapy market.
Our investments are designed to strengthen our market position and to create new and diverse revenue streams.
To provide you with some examples of our investment and our investments in June of 2022, we opened our first two new global supply chain centers located in Houston, Texas, and Morris Plains, New Jersey.
Our state of the art facilities that employee cutting edge technologies, providing advanced logistics combined with GMP bio services operations designed to support cell and gene therapy with storage secondary labeling kitting and fulfillment.
Clients have already begun to acknowledged the value of these novel services and others are in the process of qualifying our facilities to join those who are already enjoying its benefits.
We also continue the development of Skytrax, a revolutionary condition monitoring system and the next generation of the crowd port to leap one of shippers.
Which includes elite ultra coal and the elite cryo sphere.
Which will officially launch during the second quarter of 2023.
At MGE biological solutions, we have strengthen the innovation pipeline and have a number of new initiatives that we will announce as they mature.
Guarding cryo PDP, we continue.
<unk> built out.
The most advanced global Biopharma logistics network in the World, which in 2022 was expanded in India and into Japan, Ireland, Poland and Spain.
And we have not forgotten the growth opportunities for our bio storage operations as crowd gene will be expanding into San Antonio and Philadelphia markets during 2023.
Our strategic initiatives. During 2022 included targeted acquisitions, such as selling co <unk> services in France, and sell matters and Belgium, selling co. The first plant bio repository.
Wired to provide a foothold for our global supply chain Center network in EMEA.
And we will soon expand that operation into our Paris.
The acquisition of cell matters provided us cryopreservation expertise for launching our integra sale platform and Tegra sale will offer the cell and gene therapy, a standardized <unk> collection and in the end Cryopreservation service for Leukapheresis derived.
<unk> and allogeneic cell therapies. This is important to the cell and gene therapy industry as it will be the first time biopharma manufacturers will be able to source consistent higher quality, starting materials from which to manufacture their therapies.
Our actions in 2022 were a step in the development of initiatives that are designed to lay a very strong foundation to help drive our long term growth.
The development of our continually advancing technologies to meet industry needs and support requirements globally gives us an unmatched capability.
To support the rapid advancement of clinical and commercial cell and gene therapies.
Considering these actions and the impacts of our planned initiatives in 2023, we're providing a full year 2023 revenue guidance in the range of 270 million to $291 million.
This represents top topline growth of 18% at the midpoint.
Over the over 2022 revenue.
Our 2023 outlook reflects our expectations of a continued solid demand environment with micro conditions, improving and the continued development of our exciting array of initiatives.
As we closed a successful 2022 and headed into this new year. We are excited and confident about 2023, and our long term growth prospects. We believe crowd, Florida has never been in a stronger industry leadership position than it is today as we enter 2023 with a strong balance sheet.
Cash position and a fantastic team of highly motivated people.
Our continually advancing technology and global footprint gives us the critical infrastructure and unmatched stability to support the script growth of cell and gene therapies from research to commercialization we.
We do not think that there is any other company that offers such a wide range of comprehensive end to end solutions to support these life saving therapies.
Now, we'll be happy to take your questions.
Operator.
Thank you we will now be conducting a question and answer session.
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One moment, please while we poll for questions.
Our first question is from the line of with.
SBB Securities. Please go ahead.
Uh huh.
Hi, you have Michael on for Puneet, Congrats on a strong finish to 2022.
I was hoping to start with getting a bit more clarity on the guide I was wondering how much of this is reflecting a recovery in MBE. Prior PDP. After some hiccups in 2022 and how much is strength in clinical trials or some of these new commercial therapies coming online.
I'll, let <unk>.
Robert answer that question.
Yes, maybe maybe just a couple of things on the guidance. One we do have strong conviction on the revenue guidance.
On the 18% growth over 2002 at the midpoint and 22% growth at the high end of the range.
Based out in mind wandering if you look at <unk> and <unk>, we do expect them to go back to double digit growth.
But a few things that we did have some unanticipated headwinds in 2022 and if you just look at Q1 of last year, where we had the fire damage at our MBE <unk> facility, where we had about a $9 4 million revenue loss. If you were to add that back to the 'twenty two number and look at it at constant currency.
Right that will be about 14% constant currency with that add back so as you compare that with the 18% midpoint.
Certainly achievable, but more importantly, Gerry talks about some of the initiatives that we've put in place during 2022, and expanding our <unk> and Houston and New Jersey, the acquisition of <unk>, which adds biosciences capabilities in Europe , and then a number of key new product introductions in Q2 of this year.
All of these will contribute to the revenue growth in 2023. So I think that's important to realize the other part is as we've seen in the growth of clinical trials, we're seeing not only growth in clinical trial basis, but also maturation of the clinical trials and advancements into the filing.
<unk> as well as into expected approvals that will be supported so there is a significant.
Kind of dynamics within our market with our customer base that allows us really to drive the revenue growth for 2023.
Alright, great. Thanks that clarifies a little bit and then I also had a question about the global balance for service network, you're building out I was just curious what sort of incremental Opex, you expect that to drive and if there's any.
Gross margin contribution we can expect as new capacity comes online.
Well in general in terms of the margin contribution from <unk>, a couple of things, where we're still expecting overall targeted gross margin of 55% that is our target clearly we're not quite there yet.
43, 8% of gross margin when you look at the <unk>, It's a significant revenue capture opportunity and all of our initiatives are really.
Designed to capture revenue along the temperature controlled supply chain supporting cell and gene therapy space Bio services, one of those components and we expect certainly the margin contribution to be accretive to our overall margin based on that service in terms of the operating expenses. If you look at Houston and new.
Jersey, Yes, those are in already baked in because as we've talked about in Q3, while we set up these <unk> capabilities that we have to have a fully staffed before clients can come in and do their audits at this point that corporate systems I think we have an audit every week.
That really further demonstrates the interest and the movement on Biosciences.
Okay, great if I could just squeezing one more I'm just curious if you have any color on China I know last quarter, you mentioned, some headwinds and <unk> from the closure of Chengdu and we've heard some other tour players having a headwind with the Covid narrow unwinding I'm just curious if you have any.
Thoughts there.
We monitor China on a regular basis.
China is an important country to us we manufacture in China, we export from China, we manufacture domestic products and we import in China and in.
And so far everything is working well.
<unk>.
<unk> is the immunity builds up in the Society then of Coke for Covance.
That becomes less of a threat and we haven't had any rolling shutdowns lately, so and we don't expect any so China, China. We think is in is in good shape no. One knows what president she is going to do in the future and what is 2025 initiatives are going to entail, but we're prepared to work with those because we do have a strong internal base than we have.
A fantastic team in China.
Great. Thank you very much.
Thank you our.
The next question is from the line of.
Brandon Calia with Jefferies. Please go ahead.
Hey, Thanks. This is Matt on for Brandon, maybe sticking with that theme I think on the third quarter call that was kind of three items you guys discussed for the guidance reset.
Cesar pricing, China, and then some headwinds at PDP. So you just touched on China, but be curious Jerry to get your thoughts on kind of the updated status of the.
The freezer pricing and trade down dynamics as well as some of the headwinds you saw in PDP, how those fared in four Q and kind of how youre thinking about them heading into 'twenty three.
Okay.
Okay. So yes.
Yes. Thanks for the thanks for that question I mean, it's a good thing to be following up with the mix of the mix of the business.
We are still challenged in the fourth quarter due to the macro environment and some of the pushback that we were getting but but then stabilizing and it's beginning to turn back as I explained to you about those uncertainties that we just.
Capital allocation reservations because of that macro the macro conditions.
Those things.
Attended normalize right now and we don't that's disappearing.
And I think we discussed that a little bit earlier, but the.
In terms of Cryo PDP.
It's moving along well we have expanded our operations in crowd PDP some of your initiatives did impact our.
Our income statement as I alluded to in my earlier comments and Robert alluded to because.
They are investments. So we did we did move into five different countries last year for core countries expansion wise and then.
Massive development in India, where we lead the market with cryo PD <unk>.
Services.
Thanks, that's helpful and then.
Guys have discussed a lot the slew of new products and services coming online 23 from the crowds sphere to the crowd for elite elite as well as some of the newer global supply chain centers ramping up.
And the Takeda service as well and just to name a few is there any way you can kind of talk about or quantify how those are expected to contribute revenue in 2023, and maybe if you don't have dollars for each one maybe stack rank, which could be potentially the biggest new product catalysts as we think about 'twenty three here. Thanks.
Yes, let's let's start with the Integra cell platform, because I think that's the one that ties back into the Takeda and <unk> announcements.
From our perspective is one of the most exciting concepts to hit the cell and gene therapy industry and.
In quite a while it's really the first opportunity for the space to be able to provide accessibility to fully standardized high qualify high.
High quality Luca packs and it addresses.
Also a significant patient accessibility issue.
And obviously, it's going to take some time to build this infrastructure out and it has to also go through obviously regulatory and audit.
Activity with our with our clients.
So we're not going to obviously disclose anything financially on that at this point, but we do believe that we'll start to see revenue, although modest late and late in 'twenty, three and it will start to ramp and become more material in 'twenty four.
The other two platforms, the <unk> and the elite platforms. So cryo sphere is as Jerry mentioned will launch in early Q2. It is ready to go our clients are now initiating validation related activity around it as well as the elite line, which is early focused around gene therapy distribution.
Those processes take a little bit of time, because they have to go through a full validation process, which can take upwards of a year. So we don't know.
Some of these have already been started with like for example for ALLETE. We do have folks that have been actively working in conjunction with us for that validation and we will see contribution on the negative 80 elite line this year Chris.
<unk>, we won't see a material impact until next year.
Great. Thanks, I'll leave it there.
Yeah.
Thank you.
Our next question is from the line of Jon <unk> with UBS. Please go ahead.
Hi, Thanks for taking the question if.
If you look at clinical trials year to date, I think up around 9% and I think also in your prepared remarks, maybe mentioning I think you are taking some market share could you just talk about some of the competitive wins at credit Port system in any just thoughts on what your market share is looking like across.
<unk> III trials.
Yes, as we had mentioned were at 79 programs in phase III, we continue to add programs.
And increase our overall portfolio within the space itself.
Theres not a direct head to head compare our competitor in the market and we have some folks that are complementary to certain aspects, but it's not a completely.
Direct correlation from that perspective, so we don't have a concern from that regard.
We are the clear market share leader in the supply chain support.
And.
As you guys are aware of cell and gene therapy is a very very fast growing market within life Sciences and.
We're continuing to grow that base.
Related revenue. So we are anticipating upwards of 11, new commercial approvals cryo port portfolio companies. This year as well as another potential 12 lines and geographic expansions of existing portfolio. So that's going to really start to to drive.
Obviously revenue on the commercial side.
I appreciate that maybe just adding on to that so if you think long term here and I think you also mentioned regenerative medicine growing 25%, 30% youre at around 18% here for the midpoint in the 'twenty Three guide do you think theres an opportunity to add.
As these trials mature to commercialize to accelerate your growth to maybe closer to where some of the industry analysts are pointing for the range.
Yes, so all of these therapies, they kind of move up in a stepwise manner.
There's been headwinds as it relates to ramp associated with a couple of factors one is manufacturing capacity and a lot of our commercial portfolio entities have really been working hard to increase overall capacity. The second issue that these guys are seeing right now is and you can see this in a lot of our commercial clients. The recent earnings.
Commentary that they are only they are only supporting about 30% of patient demand today, and that's really down to a patient accessibility issue.
So one of the reasons, we launched the Integra cell platform was to drive accessibility.
And to provide accessibility to facilitate ramp for them. So as these things come online we absolutely believe they will they will contribute to acceleration in that number.
Maybe just to add to it if you look at <unk> systems will be the revenue growth there.
It was 24% and actually commercial revenue grew 27%. So it is continuing to increase.
And then as Mark alluded to any other significant dynamics in 2003 that will further.
Health revenue increase.
And remember that.
Our net number and sell they don't they also account for programs that have dropped out and others.
We have seen in the second half year, a little bit more volatility on the number of drops in ads.
So it is a net number.
I guess, maybe last one here just on that last point so.
Is that on the drops in ads and some of that.
Macro funding related are you seeing or any slowdown.
Projects, there I guess any additional color.
Yeah.
Slowdown not no slowdown at all in fact, we see accelerating activity with a lot of our clients.
There are still over $12 $5 billion put into the market and a bad and a bad fiscal year, which is which is a significant investment in our space.
Great I appreciate all the color thanks for the question.
Yes.
Thank you.
Next question is from the line of David Larsen with BTG. Please go ahead.
Hey, congratulations on a good quarter can you talk a little bit more about <unk>.
He like roughly what percentage of total revenue was coming from MGE and we're now almost through February or two out of three months in the first quarter have you seen an uptick in the large freezer shipments and.
With a warmer summer have energy costs improve over in Europe is that having a favorable impact just any more color there what youre seeing through February would be really helpful. Thanks.
Yes.
As I mentioned earlier <unk> to the returning to normalcy.
So.
<unk>.
Sure.
It will grow this year in this next year.
And.
The impact and there is nothing to talk about about the impact of energy prices in Europe at this particular time.
Look we had a nothing goes in a straight line and we had a little bit of a blip, while nothing has happened while the market is buoyant for.
<unk> systems.
There was a pause therefore for MBE Richard straightened out.
Progress is being made there so.
The product orders are back into the normal mix.
Okay, Great and then for cryo poor systems, 24% year over year revenue growth that sounds fair.
High to me just can you provide any color around what the mix is between like incremental clinical trials that you've picked up versus pricing versus additional products that you're selling into those customers, what's driving that 24% growth.
So as you guys can recall I mean, a lot of these initiatives that we've been really focused on building our starting to pay dividends.
Really focused around revenue diversification of our portfolio of clinical and commercial entities and I think what youre seeing is that this disconnect between number of trials added versus revenue is a manifestation of that strategy a successful manifestation of that strategy related to revenue diversification.
Okay, and then just one last one any thoughts on your clients investments into manufacturing capacity. I mean are you generally seeing that across the board with like.
Bristol Novartis Gilead just.
Any like are you seeing that happen now and I guess that should be a tailwind in 'twenty three.
Yes, there has been a substantial investment in manufacturing capacity and it continues on kite launch their significant facility in Frederick Maryland, The middle of last year BMS is very very active in building out additional two additional facilities, one in Massachusetts, and one in the Netherlands, So we elapsed.
Let me see.
Accelerating activity associated with that <unk>. We're also building out Dave. So it's it's the outsource manufacturing is growing in addition to the customer direct on manufacturing.
Okay. Okay. Okay, great. Thanks, Thanks, very much congrats on a good quarter I'll hop back in the queue.
Thank you.
Thank you.
The next question is from the line of David Saxon with.
And the <unk> company. Please go ahead.
Yeah.
Hey, guys. Thanks for taking my questions and congrats on the quarter, maybe just to follow up on that last question about <unk>.
Yeah.
Customer capacity.
You guys have in the past talked about.
Revenue per therapy being in the $2 million to $28 million range. So.
And as far as I can tell.
One of your therapy are tracking to that I guess on average.
Do you have a path to reaching that.
Your visibility into customer manufacturing capacity expansion and how we how should we think about one said therapy gets approved how long that is.
It could take to kind of reach the steady state run.
Run rate yes.
Can't remember these are still these programs are still early in the evolutionary cycle from a pharmaceutical maturation standpoint.
One of the one of the keys here around achieving that at $28 million.
The threshold is is is broadening out the accessibility of that product line with moving from third line or fourth line to third line and now third line second line as well as those geographic expansions.
Those are going to really facilitate.
Acceleration of that revenue associated with these these therapies I mean, if you take a look at some of these alone.
If you look at.
The BMS products.
Their patient population went from 8000 to 14000, I mean, that's almost a two X increase in potential patients that can be treated by that therapy. So so you can you can kind of do the math in your head and what they thought.
<unk>.
What we could attribute as an upside opportunity for that just as one example.
Okay. Thanks, and then on the P&L.
I mean, it was nice to see gross margin expanded modestly, but SG&A came in quite a bit above what I was modeling it base I guess, what's driving that and how should we think about opex.
For 'twenty three and then if I could just sneak a third one in quickly.
But last quarter. You were you mentioned you might give kind of updated thoughts on an MRP.
The $6 50 to 750, so I guess any update there and thanks, so much for taking the questions.
Yes, no problem at all just real quick on the gross margin I mean youre right. If you look at the full year gross margin was 43, 8% slight increase over last year in Q4, we had about 43, 5%.
Which is up about 250 basis points over the prior year fourth quarter and you see that for services as well as for product we've seen an increase in gross margin.
And having said that obviously, we have a number of initiatives in 'twenty two as well as in 'twenty three that have some impact on the margin overall margin contribution in terms of the operating expense one thing I would do on a direct you look at the.
Quarter end review document.
We put there what we call appeal back in terms of what we've been doing in 'twenty two what initiatives, we've put in place and how that has impacted our EBITDA. When you look at that that Peel back analysis, you can see that there's been significant investments that we made not only on the capex side Capex was about $22 1 million or 22. This.
Slightly down from 2021.
But in geographic expansion that.
That have probably an impact on opex and without an EBITDA about 7 million new service offerings that we've talked about that relates to integra cell as well as to the biosciences.
Then other parts of our <unk> technology and the software we've talked about so that's the total impact of about $23 million and 22 related to initiatives that are all geared towards revenue capture to further establish ourselves as the really the essential player in supply chain for the cell and gene therapy space.
In terms of looking at the 2025 guidance.
Look we understand that.
People like to have long term guidance.
But given the macroeconomic condition with volatile markets that are still present today in the level of uncertainty we felt that it was not the right time to give long term guidance. The overall economic environment related to inflation and supply chain issues COVID-19, the situation in Ukraine. There are still a lot of factors.
That we're all aware of but given that we felt it is best not to provide that guidance at this point in time, where we're at.
Constantly obviously evaluating the stop topic and will provide long term outlook when we believe it's appropriate.
Okay, great. Thanks, so much for the color.
Thank you our next.
Next question is from the line of Jacob Johnson with Stephens. Please go ahead.
Hey, Thanks, Good afternoon, everybody maybe following up a couple of follow up on those last questions Robert.
Robert just first on kind of the path to mid 50% gross margin can you just talk about the product line to the areas, where the greatest opportunity for margin expansion as I think about that path to the mid <unk> from where we are today on the gross margin side.
Yes, absolutely I think Chris.
A critical area of core margin improvement is clearly on the services side and on the services side really within both the corporate systems offering and the broadening of the offering as well as quite a PDP as well as quite a few moves more and more into cell and gene, especially Korea logistics, but if you look at the <unk> system.
And we said that early on we are still at the early stage with cell and gene with only.
A couple of meaningful therapies in the market that are.
<unk> been launched globally.
Operating revenue.
If you fast forward in the next two years, you'll see really a significant number of new.
Approvals of cell therapies coming into the market, both autologous as well as those who make and as we are expanding our solutions and expanding beyond the timber logistics into bio services into the integrity offering you'll see significant operating leverage and improving the margins.
So it's really based on the maturity of these clinical trials.
Commercial launch and then the maturation in the industry.
On a commercial basis.
Okay got it and then.
Robert just another long term question and then one other quick follow up on guidance, but the other long term question here, you guys talked about 25% to 30% growth.
From the end market and certainly I think much less degree this.
Bright days ahead for the industry, but as we think about the <unk> business.
Probably one that moves around a little bit lower than the services side of things.
Flattish last year, I guess double digit growth expected in 2023 is there any way to think about the long term kind of growth outlook for Andy.
Yes, I mean, I think one thing to have mind looking at last year is the fact that there was a one time event in the new credit facility that had an impact on the revenue of about $9 4 million and because of the significant order backlog that we have for that part of the business, we werent really able to make up that revenue during 2022.
You do have to look at that when you look at kind of an apples to apples putting to over 21.
Having said that.
<unk>, obviously has a very strong reputation in the market for quality.
And we see demand we have a very very strong distributor network on a global basis.
So I think we have line of sight acknowledging certainly that theres still lot of uncertainty in the marketplace in general.
We do and do the right kind of bottoms up view for the next year and upwards to see what we can expect.
One part I do want to mention on.
And b they have a good gross margin I think there's still some upward mobility on the gross margin.
But more importantly out there they are there.
A solid profitable company. So they have good EBITDA contribution.
And we expect that to continue.
Okay, Great and then just last one for me.
Can you quantify the headwind to the commercial.
Revenue in the quarter and then the other question on commercial revenue you talked about 11 potential approvals. This year is that something that included in guidance or is that something that perhaps could be upside as the year plays out.
Yeah. So.
Yes, the headwind to approximate the approximation of about $1 million in the quarter for Q4 was the headwind on the commercial number.
And so if you account for that in our growth rate on commercial is really closer to 35% for the year.
Obviously, the very strong number.
We have modeled.
So conservatively, obviously, the commercial launch activity because.
As everybody is aware.
Theres a lot of volatility associated with timing, even though there is expectation for the potential of 11, new therapies coming to market in 12 line expansions.
We don't know the exact timing of that so if they all come to fruition on schedule. There, obviously, it's lepton upside opportunity.
Associated with that but when you do account more conservatively for those launches from a N a.
Our guidance standpoint.
Got it that's helpful. Thanks for that Dr. <unk> and thanks for taking the questions.
Sure.
Thank you.
Next question is from the line of Angie.
<unk> Securities. Please go ahead.
Good afternoon, and thank you for taking our questions.
Zone so.
If you allow the new approvals you guys anticipate him with.
Without disclosing who they are can you comment on how many autozone anticipated.
Anticipated to.
Got FDA approval in the U S.
Yes, all of us.
Okay.
That'd be nine.
Yeah.
Got it.
And.
There are a few of the commercial lives or near commercial near commercialization of cell and gene therapies due to not use logistics services provided by <unk> systems as we see more manufacturing sites coming online is there a plan plan to take market.
Shares from those territories.
Could you restate it.
Are you talking about therapies.
That are on the market that are not using cryo poor currently or are you referring to potential new approvals that wont be using cryo port.
I guess, both if there are any.
Although there is some gene therapies that are approved.
That are not cryogenic shipments that were not supporting today.
They are primarily at minus 80 or the dry ice temperature range.
Now that we have our cryo port elite minus 80, Ultrashape, which is being released in conjunction with one of our new.
Gene therapy.
Customers I think youll see us wait into those other gene.
Gene therapy that Havent had a cryo port solution before so we're going to target that I don't know if mark you want to comment more.
Yes.
I'll point out.
The credit part of lead Ultra Cold Sherpa was actually designed in conjunction with one of our key gene therapy partners, who has a.
Significant.
Amount of filing activity coming.
Around around their portfolio. So it's been custom built specifically for cell and gene and we do believe strongly that.
And the feedback from the industry has been extremely positive that we'll be able to pull share from other existing offer.
Offerings on the market today that are supporting gene therapies in Q.
Got it.
Sure.
Thank you for the California inside of there and one last question from Us So for Cryo PTP can you remind us Lazar it provides services to those therapies beyond the cell and gene therapies could add provide logistics for radio pharma, Australia of pharmaceuticals, as well for <unk>.
I see a lot of similarities between the cell and gene therapy and Radiopharmaceuticals.
Yes. There is there is there are some similarities with cloud PDP is focused on biopharma and and and.
We can focus on moving to cell and gene therapy, and that's that's the direction Biopharma and cell and gene therapy PDP.
Got it thanks for taking our questions.
Yes.
Thank you.
There are no further questions at this time I would like to turn the floor back over to Jerry Shelton CEO for closing comments.
Okay.
Thank you operator, and thank you for your questions on our discussion.
And today in closing during 2022, we took a number of strategic actions to drive <unk> long term growth. They are outlined in our quarter and year end review.
Now as we entered 2023, we're excited about our prospects as we are prepared to launch several new products and services with more to come.
We continue to be driven by the rapid growth of cell and gene therapy, and we will benefit from the expansion of industry manufacturing capacity.
Our team is committed to our vision mission and we look forward to demonstrating.
This to you in the coming months, we want to thank you for joining US today. We appreciate your continuing support and interest in our company.
We look forward to updating you on our progress again next quarter.
Nashville, Tennessee, we bid you a good evening.
Thank you.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Yeah.
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Yeah.
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