Q4 2021 Repro Med Systems Inc Earnings Call
Greetings and welcome to the medical Systems' fourth quarter 2021 earnings conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. Please.
Please note this conference is being recorded.
I'll now turn the conference over to Jos.
You may begin.
Thank you sure Molly and good afternoon, everyone earlier today Cobra Medical systems released financial results for the fourth quarter and full year ended.
December 31, 2021 copy of the press release is available on the company's website.
During this call, we'll make certain forward looking statements regarding our business plans and other matters. These.
These comments are based on our predictions and expectations as of today.
Actual events or results could differ materially due to many risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC.
We assume no obligation to update any forward looking statements.
Encourage listeners to have our press release in front of you, which includes our financial results as well as <unk>.
Terry on the quarter.
During the quarter management will just excuse me during the call management will discuss certain non-GAAP financial measures in our press release and accompanying investor presentation, and our filings with the SEC each of which are posted on our website.
You'll find additional disclosure regarding these non-GAAP measures, including reconciliations of these measures with comparable GAAP measures in our press release and accompanying investor presentation and those filings.
But the benefit of those listening to the replay. This call was held and recorded on Wednesday March 2nd 2022 at approximately 430 P M Eastern time.
Since then the company May have made additional comments related to the topics discussed.
And please reference the company's most recent press releases and filings with the SEC joining.
Joining us on the call today isn't Linda RB President and CEO of Cobra Medical Systems, Inc.
Aaron Fischer Cobra Medical's, Chief Financial Officer, Linda. Please go ahead.
Thank you Greg Good afternoon, everyone and welcome to Corium medical systems fourth quarter and full year 2021 earnings call.
Before reviewing our Q4 2021 highlights from the air I would like to start by thanking our incredible team.
Our company is supported by a talented and growing group of individuals who believe in our mission to improve patients' quality of life by developing and delivering high quality therapeutic drug delivery solutions for use in the home.
Each quarter, we continue to build upon our foundation and core medical today is a stronger organization due to each individuals continued dedication and hard work.
Today, we'll be using a slide deck to guide our comments.
I will begin with a brief overview of core medical systems, and our fourth quarter highlights.
Followed by an update on our strategic milestones delivered during the quarter.
I will then turn the call over to Karen to discuss the quarter and year end financials in more detail.
I will then review our 2022 guidance before ending with a few closing remarks.
After our prepared remarks, Karen and I will be happy to open the call up for Q&A.
Yeah.
Prior to jumping into Q4 highlights I wanted to begin with an overview of who we are today and how we are positioning ourselves to deliver continued value to our customers and shareholders.
We have enabled over 25000 patients to receive at home subcutaneous immunoglobulin treatments or SCID treatment via our market, leading corporate medical freedom infusion system.
We have a proven.
From a partnership model with over 11, commercialized drugs and indications on our freedom infusion system and registrations and over 26 countries.
As we continue to grow our business.
We have a scalable foundation from which we can build we have a recurring monthly consumables revenue stream.
<unk> led by our specialty pharmacy partners, who deliver to our patients in their home.
As we look to the future our goal is to expand our total addressable market from $300 million today to over $1 billion.
Through continued penetration of Sop cute there are P and to the broader market.
Further our intent is to add new drugs to our core of system.
The overall growth and drugs in our pipeline for Sop kids or delivery in the home continues to expand.
We will continue to solidify our position as a market leading SCID home infusion platform.
And further establish carbo medical as the Premier at home large volume drug delivery infusion company.
Turning to our results for the fourth quarter, we reported net revenues of $6 5 million an increase of 60%.
For 28% on an adjusted basis for 2020 stocking.
This represents a return to double digit growth.
And our fourth consecutive quarter of positive sequential growth.
On a year on year basis, we had strength across all three businesses domestic core international core and novel therapies.
For the fourth quarter year over year growth was driven by double digit pump growth in U U S domestic core market with our growth outpacing the overall market.
Higher consumer both due to new business wins and international car markets and through initial revenues recorded for new agreements and our growing novel therapies pipeline.
While we don't expect this level of growth for each quarter in 2022. It is important to note that we are outperforming the underlying market for sub Q IGT therapy, and we look forward to continuing this momentum.
In December we held an investor day and rolled out our vision 2026 intended to drive the company to the next phase of value creation.
I want to reiterate the plants, we discussed and the key milestones related to our vision.
Our five year plan is designed to generate approximately $60 million of revenue by 2020 sex and importantly drive our addressable market from 300 million to over $1 billion as we move from being a leader in large volume home sub Q I G M fusion to being a leader in the much larger market of large volume sub Q drug delivery.
We know that to support our vision, we will need a strong foundation and we did great work. This year in building the foundation for an even better company.
We hired over 30, new employees this year, bringing our total head count to over 80.
With a specific focus on commercial excellence, particularly in U S sales and marketing and novel therapies.
Quality and regulatory to build to biopharmaceutical standards.
And then beginning to build out our innovation capabilities and research and development.
We also progressed, our outsource manufacturing agreement, enabling dual source of production and driving future gross margin improvement and.
And we ended the year, securing a new facility and a prime recruiting location in northern New Jersey that will become a center of excellence for our new products.
Our plan will be driven by two pillars of growth, including increasing <unk> penetration and extending that subcutaneous home infusion leadership position and to new novel therapies.
The first pillar is focused around accelerating our penetration in the market we participate in today.
This market is significantly underpenetrated with less than 15% of total IGT drugs administered today.
Levered sub Q.
The first area of focus in this area is on new patient starts we.
We are building our funnel, increasing our work with our pharma partners for the clinical development and regulatory approval process to gain on label indications.
Once the drug receives regulatory approval, our farmer partners began their physician detailing and we have recently increased our level of training and support to their efforts.
The second target area as SCID Prefills pre.
Pre sales have grown rapidly since their introduction about 18 months ago and now represent about three 5% of the total market, we see tremendous growth potential in pre sales because of their convenience for the patient.
As we have seen our ask you asked a lot you asked drug label expand you'll see further efforts in 2022 to define our international core sub Q strategy.
Turning to our second pillar of growth our goal is to extend our leadership position in <unk> drug delivery into novel therapies are not new sub two drugs in development.
Our team has identified a robust target list that spans all three clinical trial phases.
We have identified close to a thousand new drugs in development and are targeting roughly 100 of that was his volume has been established as over 10 a mouse.
We are projecting five new large volume drug candidates going through phase three trials with Claro medical by 2026, and we have assumed one additional new commercialized dropped by 2023.
To drive topline growth towards our pipe air cool.
We continue to build momentum as a broad drug delivery partner due to our patient satisfaction form factor with capability to handle drugs over 10 ml, our safety profile and track record of regulatory clearances.
We have the proven capability to ensure we can support the drive through approval and through the channel with our specialty pharmacy relationship.
Underlying our success in these areas is a renewed focus on innovation.
This is a major area of strategic investment for the company as we define opportunities to simplify and improve the infusion process for our patients.
Innovations include line extensions and product improvements all focused on improving comfort and convenience of the impeachment process for patients. Additionally, we are investing in a next generation system that will retain core freedom infusion system qualities and further improve convenience and add capabilities such as connectivity.
Yeah.
Now, let's transition to the progress we have made in Q4 and executing on our strategic initiatives regarding the first pillar increasing <unk> penetration a critical driver is additional FDA clearances for on label indications the company committed to having three new on label indications before the end of 2021 .
And I'm happy to report that we achieved that in the fourth quarter, making a considerable step forward.
In November we received five 10-K clearance for the use of our freedom edge infusion pump system to be used with high Sentra 20 ml Prefilled syringes.
<unk> is the most prescribed SCID product and the first to be available in a pre filled syringe format.
The pre filled syringe market has significant penetration potential due to its convenience and this FDA clearance, we will be in a central growth driver for us.
In late December we received FDA five 10-K clearance for on label use the freedom 60, infusions test system for two additional SCID drugs after pharmacy to quick and Brussels Zombify. This FDA clearance is a significant milestone as it allows us and our partners to market the freedom 60 as an odd.
Label infusion device for two of the faster growing drugs in the market.
In addition, we are in the FDA recently review cycle and expect to have a palace happen for valley on label indication by end of Q2, 2022, and an EU label indication in Q1, propel us obese ASP of Alley.
Having these new clearances gives us and our drug partners. The greenlight to promote the freedom 60 for these drugs to our customers, which we believe to be a considerable advantage.
We are excited to hit three of the eight total 500 10-K commitments. We had made for the five year vision. They demonstrate the strong capabilities of our clinical research and development and regulatory leadership teams.
Regarding our second pillar of growth expanding novel therapies, we have made significant advancements to our pipeline.
During the fourth quarter of 2021, we closed four new novel therapies agreements.
We define a close to agreement as an agreement for current or future revenues based upon an exchange of products or services and.
In line with our strategy to other closed agreements are focused on increased sub Q penetration with phase III trials with IGT therapies and two are in earlier phase trials for non S. AIG therapies among.
Among the poor agreements, we are supporting trials for our current area of immunology, and we are expanding a new drug areas with new novel therapy agreements and respiratory and oncology drugs.
Three things of note for novel therapies first we're expanding beyond them in immunology and immuno globulin second is our pace improvement with four of the six agreements we have secured occurring in quarter four and finally, we have over 15, new opportunities that we're pursuing in our pipeline.
As reported on our pipeline progress is fairly new we will continue to mature and begin to expand both on total addressable market expansion as well as short term commercial opportunity for products and services.
With a strategy and a clear set of goals milestones and objectives. We look forward to and remain excited about the next phase of value creation at corporate medical.
Rooted in the strength of our foundation in existing business. We believe we have a pathway to execute on our innovation and strategic growth initiative areas.
We are excited to continue updating our milestone as we extend our leadership position in the home sub two drug delivery market.
I will now turn it over to Karen for a review of our financials.
Thank you Linda and good afternoon, everyone.
As a reminder, prior to discussion on Q4 financials I want to remind everyone of our three business areas.
Cobra medical defines revenues into three areas domestic core international core and novel therapies.
The core revenues consist of our product sales for specialty infusion therapies that are cleared for use with the Cobra medical infusion system now.
Novel therapies consists of product sales to support feasibility in clinical trials of biopharmaceutical companies and drug development process as well as nonrecurring engineering service revenues to ready or customize the freedom system for clinical and commercial use.
Each new signed agreement could represent potential revenues in subsequent quarters.
Once cleared for commercialization sales associated with these drugs will be reported as core revenue.
I am pleased to report net revenues for the fourth quarter of 2021 were six and a half million a 60% increase from the fourth quarter of 2020.
Adjusting for net inventory stocking of Vermilion last year net revenue grew 27, 6% with growth in all areas of our business domestic core driven by pumps and consumables international core driven by consumables at new key customers and increased novel therapies revenues as we expand our.
And execute on our strategy.
Sequential quarterly net revenue growth was 7% driven by international core.
Yeah.
Gross margin was 59% for the fourth quarter of 2021 an increase from prior year of 60, I'm, sorry, 56, 6% driven primarily by price increases.
Selling general and administrative expenses increased $1 9 million or <unk> 63, 4% in the fourth quarter of 2021 compared to the same period last year.
The increase was driven primarily by investments in commercialization regulatory and business development all in support of our strategic plan and to build our novel therapies pipeline.
Research and development expenses increased $1 million in the fourth quarter 2021 compared to the same period last year, driven primarily by increased headcount and consulting fees to support product development.
As previously reported we have engaged calero in order to expedite our development efforts, while we build our internal innovation capabilities.
Net loss for the fourth quarter of 2021 was $1 1 million or negative two cents per diluted share in line with <unk> <unk> per diluted share in the fourth quarter of 2020.
The loss was driven by our investments in building, our foundation and execution on our strategic initiatives.
Just described.
Yeah.
For the full year 2021, net revenues were $23 5, million% to 8% lower compared with $24 2 million in the prior year.
The shortfall was driven by lower year over year novel therapies as there was a large clinical trial order in 2020.
Domestic core net revenues for 2021 were 8% higher than last year, mostly driven by the price increase in the second half of the year.
International core net revenues were up 14, 5% compared to last year driven by growth in new customers.
For full year 2021, gross margin was 58, 6% compared to 61, 8% in 2022.
The decrease was primarily driven by delays in the transition to a secondary manufacturing source and product mix offset by price favorability in the second half of the year.
For the full year 2021, selling general and administrative expenses increased $5 8 million or 48, 5% compared to the same period last year.
This increase is due primarily to investments in our team to support commercialization and business development for novel therapies.
For full year, 2021 research and development expenses increased $1 2 million compared with the same period last year, reflecting innovation expenditures related to our prior communicated engagement with collateral in order to expedite our development efforts, while we build our internal innovation capabilities.
For full year 2021, net loss was $4 6 million or negative <unk> 10 per diluted share a decrease of 7% per diluted share from the same period in 2020.
Driven by our investments to expand our foundation innovation and product development and commercialization efforts.
I will now turn it back over to Linda for guidance and closing comments.
Thank you Karen.
Turning to expectations for fiscal 2022, our outlook reflects several key drivers underlying market growth, reflecting continued recovery from the COVID-19 pandemic related to new patient.
Patient starts plasma supply clinical trial activity and supply chain impact.
Currently we expect the F C J I G market to recover and grow in the high single digits.
Assuming this U S market growth, we believe that we will continue to outpace the market and grow our core business in the low to mid double digits, including a target of closing multiple new novel therapeutic agreements. We are guiding revenues for the full year in the range of $26 million to $27 million or to that 10 to 15 per.
<unk> growth in 2022.
We expect a slower start in Q1 in the U S market due to the late Q4 omnicom impact on new patient starts as from diagnosis to the start of coral freedom therapy could take between 30 and 90 days.
We are reiterating our gross margin guidance to begin in the first three quarters of 2022 roughly in line with 2021 and plan to exit the year at a 60% run rate as we expect the transition to our secondary source to be completed at that time.
In order to support our strategic initiatives and drive topline growth, we expect to increase operating expenses to roughly 27% to 28 million for the full year 2022.
Our operating expense includes continued investment in our strategic initiatives with near term goals of expanding our Tam through securing additional new non IGT novel therapy deals.
Building, our innovation pipeline, including advancements on our freedom system and development of our next generation product.
You can expect a 10% to 15% run rate off of where we finished Q4 2021 that will then hold fairly consistent quarter to quarter.
Looking at our balance sheet we.
We ended 2021 with $25 3 million in cash compared to $27 3 million at year end 2020.
And we continue to believe that we are well capitalized to drive value as we execute on our strategic plan.
We expect the majority of our investment to be in innovation with the remainder being split between efforts to drive growth through commercial efforts in selling and marketing and in strengthening our foundation, which includes investments in regulatory E. M D R and our new facility.
We will continue to be very disciplined in our approach and deployment of funds with monitored milestones and stop gates in place to drive the execution of the plan.
In closing as we look back on our fourth quarter and full year 2021, I'm incredibly proud of our progress at coral medical as reflected in our strong fourth quarter finish we.
We made several advancements in our strategic initiatives as we returned the company to double digit growth.
We added multiple new 500, 10-K clearances expanded our novel therapies pipeline and continue to build a strong team.
We remain confident that the objectives, we set going forward are achievable and we look forward to providing updates as we hit additional milestones.
Thank you and I'll now turn it back over to Somali the operator for Q&A.
Thank you and at this time, we will be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
The tone will indicate your line is in the question queue.
May press Star two if you will.
Question from the queue for participants using speaker equipment, it may be necessary to pick up your handset before Christmas turkeys.
Please while we poll for questions.
And our first question comes from the line of Matt O'brien with Piper Sandler. Please proceed with your question.
Hi, Good afternoon. This is drew on for Matt. Thanks for taking the questions and congrats on a solid into the end of the year here.
I do want to start off on the guidance I think you are.
Folks towards high single digit growth for the market.
The mid double digits for core rule.
Maybe we could just start off on the market a little bit here. What are you assuming from a COVID-19 perspective, maybe some color on Q1 would be nice and then just you know what's the number of factors that influenced the market over the last couple of years be it.
Ed.
The transition to sub Q, what data points are you using to triangulate on that high single digit market growth rate.
Sure.
So drew thanks for the question there was a lot in there. So let me try and let me try and unpack that so let's start with the market, which as you know we track the total.
Drug that has delivered sub Q into the marketplace and overall, we saw that market.
On a full year basis grow just over 1%, but are encouraged by what we saw in the fourth quarter, which fourth quarter grew about 7% versus quarter three.
So that is encouraging.
<unk> said that.
As we look at early indications in January in the market, we think theres going to be a slight hangover from army Kron that we all experienced in the latter months of quarter four and generally what are what happens is our patients from time of diagnosis to time, a start is about 30%.
90 days. So we project, we're gonna start out of the gates are still at double digits versus.
Versus 2021 for our business, but a little bit of a slower start in the U S market in particular, so where we ended up.
And it does.
And I would project quarter, one being a double digit growth.
I think I got everything carrying did I Miss I think southern did I Miss anything.
No that was perfect. Thank you. So maybe maybe there is one thing you asked sorry, there is what went into their obviously market growth. We look at sub Q conversions, we look at the palace commercialization, we look at pre filled syringe, we got a lot of assumptions that go on in there, but they get you to that number that I talked about.
Perfect very helpful.
And then just on the spend side you know it looks like you're guiding to a little bit of a larger step up in opex here in 2022.
Maybe you could just help US understand you know how those dollars are being allocated is it feed on the street, where theyre going to drive sales this year or next or is the focus more going to be on.
You know building out the novel therapies pipeline, where we should really start to think about those probably paying dividends and in a couple of years down the road.
Yeah. So so first I would I would say some of it is short term and you've already started to see the improvement. So are we made.
Some significant investments first in our commercial capabilities, so when our U S sales and marketing teams we added.
Some new people in and turned over that team and you're already starting to see the impact.
Of our growth that we recorded in Q4 in the U S market second area for commercialization as we added a couple of new people to our novel therapies team to really drive even again you saw four agreements being secured in quarter. Four so some of it is short term and you'll start to see see that the other area that we added.
Significant.
Experience and and.
Expertise and is in our quality and regulatory function and again you saw three new law on label indications occur.
Company the firsthand in several years, so you're starting to see some short term impact there.
And then I'll get into you know the other spans which are going to be a little bit longer term, which are our R&D investments. So our R&D investments you can see the company really had not invested a lot of money in this area are when I say not a lot under a million dollars.
The run rate that the company was looking at so we're really starting from a low basis here and for us to really capture that billion dollar plus novel therapies pipeline, we're going to need to innovate on the product that we have today, a great product high patient satisfaction, we need to make it more convenient and we need to make it connected.
That's going to open up that billion dollar plus addressable pipeline. So some of those R&D investments are going to take a little bit longer for us to pay off and then we've got some investments in things like E. U M D R.
And we've got some investment some some minor investment in the building move or just stop.
Breaking out of the themes here at the company since its founding over 20 years ago. It's been based on the site and we need to be in a new location to attract some some new talent. So we're moving to a to a great area for that so in summary short term its commercialized nation efforts, which youre seeing the benefit up almost.
Mediately, along with quality and regulatory what you are seeing the benefit of the mid to longer term, you'll see some product innovation introductions and then our next generation system over the next two to two to five years, you'll see that.
Yeah.
Okay, perfect that's very helpful as well.
And just quick last question for me here one of the big topics of conversation has been the pre filled syringe side. It sounds like you're very excited about that can you just give us an update on where that stands commercially just any feedback even if it's anecdotal.
We're seeing so far in and then just can you remind us if any of your competitors have greenfield products out there.
Okay. So maybe I'll just start with where the market is that and then I'll and then I'll bring it down right to our customer base and our competition. So currently the market is about three 5% penetration just over a year of Prefills being launched so we think that's fantastic.
Currently the Prefills are in of 510, and 20 ml format and Ah Hi, Ventura is the only company with with pre felt on the marketplace. So we are we are working today on training, we're trying to get a white paper together to talk about the patient convenience factor. So we should have that out.
There we hope in the next quarter. So that we can really begin to push into our specialty pharmacy customers.
Clinical evidence that shows the advantage that the patients have seen both and reduce time to use the product and overall increased preference because of pre felt.
We believe that the market will continue to move it if you look at any market outside of I G. Prefills are.
Think about the Covid.
Covid vaccination that you received that was in a pre cell format right you didn't see anybody drawing up out of a vial. So the broader market is in a prefill format, and we think <unk> will get there over time.
And to date, we are the only pump that is approved for use with that CSL pre filled syringe.
So we've.
We've got numbers in here for female Prefills, they start off pretty small given its three 5% of the market, but it's really a three to five year strategy that we think we have the early ly again and and we're working very closely with all our pharmaceutical partners on their developments in this area.
Great. Thank you.
And our next question comes from the line of Alex Nowak with Craig Hallum Capital. Please proceed with your question.
Great. Good afternoon, everyone, hoping to stay on the AG market here for a couple of questions. Maybe just expand on how things are going with regards to sub Q conversion out there in the market. The increased new patient starts is that starting to accelerate and then where supply kind of for plasma today and the.
Uptake of these not identical so cute drugs.
Yeah.
Okay. So maybe I'll start with with new patient starts overall and.
An early indication for us is our pump sales, which that's why we were so encouraged by the double digit growth that we saw in the U S marketplace.
For pump so that to us is a great indication.
If I look at and we think most of that is likely being driven by our activities in the market and our increased share that we're driving in the marketplace on.
Regarding sub Q conversion, we've done a lot of work on this one Alex.
And we're really beginning to unpack, both the economic and clinical evidence that is already existing out there, but putting it together for our customers in a way that makes it easy to convert because what we're finding is once a patient starts on therapy converting a patient base.
It's difficult for us to do I want to remind everyone, though it doesn't take a lot right Theres 300000 patients on IV therapy. There is currently a shortage as everyone knows on IV sets for IV infusion, we're hoping that that shortage takes a little longer than we might get some natural conversion over from that but just converting 10 person.
Some of that base is doubling our market. So it just takes a little bit to really grow that marketplace and we are specifically focused on the new patient start and ensuring that that new patient start and end via the growth in our pumps. We think we're beginning to make headway there.
Supply with plasma we do.
I do not see any concerns at this point C. S. L reported some ex U S concerns.
But we don't and conversations with our drug partners are adding new capability in this area. So we don't see any any major or long term impact of plasma supply.
Regarding non I G. Obviously, we spoke about Asps Asps valley will be on our EU label indication in Q1, and we are chomping at the bet with our partners at a palace for <unk> to be added to our label and we're quite confident that we'll get that in Q2, we filed in December .
So we're right on track with our filing and we're hopeful that we have it by the end of Q2.
No that's great. That's very helpful and I understand the guidance range that you said kind of the puts and takes that you have there is you got to obviously include the kind of the other card impact in Q1, but also to the point here for Q4, you did have 20 over 20% growth in Q4, when you back out some of the channel issues from 2020.
Just curious if we have COVID-19 clear here throughout the rest of the year you combine that with pre filled syringe is new <unk> drugs coming online hopefully some more so cute conversion for my G. Could this business returned to a 20% growth sort of number here in 2022, and just kind of one of the levers to get you there.
Yeah. So great question and I think there are two levers that get us to two that 20% growth area.
The first one as you noted is the IGT market right. If the IGT market growth right now we have it kind of high single digits. If it gets back to double digits. That's the biggest thing that's going to drive us there.
Again encouraged by Q4 versus Q3, but one quarter does not a market, making and so we're thinking about the army chrome impact, but that number one is the <unk> market grows double digits, that's going to help us. The second thing is more success in our novel therapies pipeline.
Of all of you know all of the progress we make in the organization. We're excited about that's probably the one that we're most excited about the revenues that you see in quarter four are not reflective of the total value of the agreements that we signed a number of those will come into effect through 2022, as we deliver on our commitments and with more deals.
And that's what could push us over over the numbers that we're communicating to you.
Okay, no that makes total sense.
Europe is a third I mean, we haven't invested a lot of energy in Europe at this point relative to strategic and in and looking at that area I think Europe with more on label indications coming in 2022 could also could also pushes there.
Okay. It makes total sense and then two housekeeping items here just the new office in New Jersey is that going to become the main headquarters or will you be running two facilities here.
In the future and then the three of you you mentioned hitting three of the 8-K that you're expecting I know one of the 510 cases evolving what are the other indications or other type of case, we should be watching for.
Okay.
So first first question is yes, it will become our headquarters.
The facility located in Mahwah, New Jersey.
And we have exciting and extension just from a risk mitigation perspective that we will maintain the core room facility in Chester New York until the end.
Of 2022, so we expect to move to the new facility in June .
Production startup between Q3.
And then.
Close the close to the existing facility in Q4.
Regarding the three five 10-K's of course they were the.
And the first one was the Prefill for CSL and the other two were cute equations amplify and then what you see coming on the horizon.
I can't talk about all of them because some of them are confidential, but the one I can talk about is the ASP of alley and empathy early indications that I spoke about that we'll see in Q1 and Q2 of 2022.
Then you can expect to see more of what we've talked about already right, there's probably going to be expanded prefill indications, you'll see some new product introductions from us.
We hope to file by the end of 2022.
So and.
Obviously other things beyond that as soon as we know that that we filed something.
Alex you and are you and team will be amongst the first to know.
That sounds good I appreciate the update thanks. Thank you.
Yeah.
And our next question comes from the line of pilot rules with Canaccord. Please proceed with your question.
Good evening. This is Brian on for Kyle Congrats on the strong quarter and thanks for taking the questions to start within novel therapies, maybe how did the Q4 shake out in terms of U S versus O U S contribution.
Linda maybe following up on one of the points you just made as the novel therapies pipeline begins to commercializing come online you to maybe how should we begin to think about longer term or U S contribution.
Okay. So I think two questions. One is specific to novel therapies and I want to make sure I have this right djabran. It. It's how many of the novel therapies deals where U S versus ex U S.
Correct, yes.
Okay. So one was ex U S. Four registration and an ex U S market for our current on market drug and three were.
Three are.
Essentially what could be global I mean.
One is a product development initiative and two are for drugs that are likely will have global launches, but they're earlier in their faces.
And then the second question was how do we see our revenues breaking out over time.
I think it was what's the question that today the domestic core is about 80% of our business International core is about 20% of our business I think over time you can project that are that overall split between those two we don't see changing dramatically with both mark.
It's growing double digits.
The big change, you'll see is our novel therapies growth continue to expand and represent.
About 20% of our business overall over the next five years, where today it represents.
Less than three or 4% of our business. So that's going to be the biggest area, we see expanding our business.
Great. That's helpful. Appreciate the color there Linda and then maybe just one more from our end what did year end patient numbers look like between PID D and C. I D. P and I know you had alluded to some of the dynamics in the Q1, but maybe anything specific to call out there thus.
Thus far this quarter.
Yeah, I wish I had those numbers.
This is a we do not have numbers for patient starts per PID D and C. I D. P. I can tell you our overall that the overall growth in the market was about 7%.
And in terms of overall drug drug that went into the market, but I don't know the difference at this point between PIV D&C IDP.
Fair enough had to ask appreciate you taking the question great. Thanks.
And we have reached the end of the question and answer session I will now turn the call back over to Linda for closing remarks.
Great. So I just wanted to end by saying Thank you for the to the team for a fantastic effort in 2021 in particular and a very strong close to the year and I want to thank all of our investors for your participation today. Thank you and have a great day stay safe and stay healthy.
And this concludes today's conference you may disconnect. Your line at this time.
Thank you for your participation.
[music].