Q1 2021 Liquidia Technologies Inc Earnings Call
[music].
Good morning, and welcome everyone to the credit.
Corporation first quarter, 2021, and financial results and corporate update conference call. My name is Anthony and I'll be your conference. Operator today. Currently all participants are in a listen only mode. Following the presentation, we'll conduct a question and answer session and instructions will be provided and fast time for you to queue up for questions.
And if anyone has any difficulties hearing the conference. Please press star zero for operator assistance at any time on.
And like to remind everyone. This conference call is being recorded I'll now hand, the call over to Jason Adair, Vice President corporate development and strategy. Please go ahead.
Thank you Anthony.
My pleasure to welcome everyone for today's conference call to discuss our first quarter financial results for 2020, one and provide a business update before and again I'd like to remind everyone that today's call will contain forward looking statements based on current expectations.
Such statements may involve risks and uncertainties and may cause actual results to differ materially from these stated expectation for <unk>.
Further information on the company's risk factors, please see liquidity as filings with the SEC at Www, SEC Gov or on liquidity as web site <unk> Dot com.
I would now like to turn the call over to Chief Executive Officer, Damian to go up for our prepared remarks, after which he will open up the call for your questions.
Thank you, Jason and good morning, everyone.
I'm joined today by Mike <unk>, our Chief Financial Officer, and several other members of our management team and May be helpful and addressing your questions later on the call.
And the short time since I provided an update in March liquidity has continued to deliver on its plans and expectations at a rapid pace.
And April and May alone, we have delivered on multiple value, creating events, including the.
Expansion of the commercial opportunity for profitable injection.
And our generic formulation of our modular by.
By enabling subcutaneous route of administration.
The resubmission of the NDA for <unk>, six one putting us back on track for a potential FDA approval.
And strengthening our financial position through and active equity capital rates and refinance of our credit facility with Silicon Valley Bank.
These other results of the hard work from our committed dedicated team is helping to establish the reputation for delivering on results.
First the FDA clearance of the RG three ml medication cartridge has removed a major barrier to maximizing the utility and value of <unk> injection.
This achievement by our partner Chengdu Shifang medical technologies.
Demonstrates our commitment to providing valuable product to ph patients and community who support them now.
With both the IV and sub Q routes enabled we.
We expect that the market opportunity for our products will more than double.
Not only as a result of newly addressable sub Q remodel on patients, but also due to payers motivation to ensure the effective use of resources across this rare and expensive disease.
No longer will patients physicians and payers to be limited to a single brand of choice for the sub Q administration of <unk> Cross channel due to the restrictions imposed by other companies.
With this obstacle behind US we continue to believe that there are significant addressable market for contact.
Therapeutics reported that remodel and sales and U S.
Greater than $450 million and 2020.
We have been encouraged by the level of interest and look forward, providing more update and the future.
Our R&D and operations team have worked steadily towards resubmitting, the NDA for <unk>, one or <unk>.
Dry powder formulation of two cross channel.
Last Friday, we.
And we provided the FDA full response to the items mentioned and see our CRM issued last November.
We believe the data package submitted will speak directly to the items and questions raised by the FDA.
Related to CMC.
And Dubai Biocompatibility.
Given that no new data from the clinical trials or in vivo studies was required.
We anticipate that the FDA will classify the resubmitted NDA and the class two resubmission if accepted.
This would establish a six month review cycle from our submission date and potentially enable attended to approval and the fourth quarter. This year.
We look forward to working with the agency over the next few months and are prepared to host them for for.
And for our prior prior approval inspection.
<unk> one is in a good market position with the potential for growth and new indications.
861 was designed from the start to improve the therapeutic profile up to profitable by enhancing deep lung delivery and achieving higher dose level and current inhaled therapies.
And convenience alone of DPI for Nebulizer.
Should.
Displace a significant portion of the current nebulizer price the market and.
And 2020, United Therapeutics reported <unk> sales of more than $480 million with a single indication and who group one patients.
In addition, we believe the higher dosing of our DPI versus current nebulizer therapy.
As demonstrated on our and our clinical trials.
Prolonged duration of inhaled treatment for print before patients transition to more invasive parenteral administration.
As the market for inhaled profitable delivery expands and new indications, we believe that <unk> will be well positioned.
The recent approval of nebulizer based though to treat patients diagnosed with pulmonary.
Pulmonary hypertension.
Associated with interstitial lung disease is meaningful and that it demonstrates and Hilton and Hilton <unk> ability to address another pulmonary hypertension patient population with an unmet need.
It would be our intent to volatile low end of that expanded indication and we.
Planned and discussed with the agency, whether and when we could include ph ILD and the 861 label.
As you know we are actively involved and hatch Waxman litigation brought by United Therapeutics as.
As well as pursuing enter par case reviews for IPR.
On a certain related patents at the U S patent trial and appeal Board.
We continue to maintain that for three patents asserted against us are not infringed and are invalid.
While we will not comment in detail about specific actions along the way, we remain confident and our position.
We have taken several actions and last for months to improve our balance sheet by reducing annual net spending increasing our cash position and.
And and the process, adding a new member to our board of directors.
As described and March management has already implemented measures to reduce net annual spending in 2021 by more than 40% compared to 2020.
The company refinanced its former credit facility, eliminating more than $10 million and required principal repayments over the next two years.
While providing access to an additional $10 million upon the achievement of certain regulatory milestones related to 861.
The refinanced debt complements our most recent financing.
Of $21 7 million from the sale of common stock to new and existing investors.
Not only do we benefit from the improved cash position.
But we are very excited to welcome David Johnson, a partner and co founder of Calgon partners to the liquidity of board of directors.
Calligan led the private placement of shares and Mr. Johnson has closely followed liquidity over the last year.
We look forward to a support and future discussions.
With this financial discipline and strategic focus in mind, we have recently decided to terminate the development of <unk> $8 five.
On a sustained release formulation of bupivacaine.
Targeting the treatment of local post operative pain.
We attempted department program, but we're unable.
I've chosen to focus internal resources on maximizing the value of our asset.
And to build a pipeline synergistic with our expertise and cardiopulmonary and rare diseases.
At this time I will turn the call over to Mike to review, our first quarter financial summary.
Yes.
Thank you Damian and good morning, everyone.
Our first quarter 2021 financial results can be found on the press release issued earlier today and our form 10-Q to be filed with the SEC later today, both of which will be available on our website.
To briefly summarize we recognized revenue of $3 1 million for the first quarter 2021, as compared to no revenue and the first quarter of last year.
The revenue recognized in 2021 relates to our promotion agreement with Sandoz and support of <unk> injection as a result of the acquisition on November 2020 erosion. Our wholly owned operating subsidiary now referred to as liquidity OTH.
Cost of revenue during the first quarter was <unk> 7 million.
Compared to no cost of revenue for the first quarter of last year prior cost of revenue recognized during 2021 related to the promotion agreement as previously noted.
Research and development expenses decreased to $6 1 million for the first quarter of 2021, compared with $10 8 million for the first quarter of 2020.
The decrease of $4 7 million or <unk> 44, 1% primarily related to lower expenses from our liquidity and it takes one clinical program, which was substantially completed prior to filing the NDA last year low expenses from our <unk> clinical program and lower expenses related to employees and consultants.
General and administrative expenses increased to $5 3 million compared to $3 8 million for the first quarter last year, the increase of $1 $5 million on 39, 6% was primarily due to $2 $1 million higher legal and professional fees associated with our corporate activities as well and our ongoing <unk> related litigation offset.
Lower consulting and personnel expenses as a result of lower head count year over year.
The net loss for the quarter ended March 31, 2021, with $9 2 million or 21 per basic and diluted shares.
Compared to a net loss of $14 8 million or <unk> 52.
Per basic and diluted share.
For the quarter ended March 31 2020.
Cash totaled $53 6 million and $65 3 million as of March 31, 2021, and December 32020, respectively. These cash figures do not reflect the $21 7 million and gross proceeds raised in April from the sale of common shares and a private placement.
As we look further into 2021, we expect net cash burn and future quarters to continue to degree decrease a reflection and a reduction in spending we believe that cash burn will will be further reduced by the anticipated positive contribution from the profit split arrangement with sandoz on the sale of property on injection, while we expect for possible injection and unit sales today.
Significantly and it's worth noting that our share of profit split with Sandoz has the potential to debt to decrease from 80% to 50% once we exceed our contractual cumulative revenue threshold, which we estimate maybe in the fourth quarter of this year, we will not be providing any specific revenue guidance. However, we are confident that the newly enabled subcutaneous administration.
On <unk> injection will help contribute more than our previous estimate of mid to high single digit millions.
We'll provide updates on future calls should this change in any material way.
With a strong balance sheet.
And access to the credit facility that Phoebe, we feel well positioned to deliver on potential value, creating events related to regulatory approval and litigation activity in 2021, and 2022 I would now like to turn the call back over to Damien.
Thank you Mike.
Before ending our prepared remarks, I thought it would be helpful to reinforce our corporate priorities that we see very clearly in 2021.
They are.
Maximize the revenue from <unk> injection with the launch of the subcutaneous route of administration.
Advance our IQ Asics, one successfully through the FDA and the ongoing litigation.
We reinforced the financial discipline and established by the management team and.
And remain opportunistic and our pipeline to drive near term and long term value for shareholders.
Thank you for listening and I would be pleased to take any of your questions now.
And in order to ask a question and I wanted depressed for one and there's on the phone and can withdraw your question press the pound key.
Please standby and while we compile the Q&A queue.
And your first question comes from the line of can be scanty from Jefferies. Your line is now open.
Morning, Damian this is <unk> on for Chris.
I guess three questions for me and could.
And you tell us a little bit more about your expectations for the <unk> opportunity and.
And how they impact your revenues.
And then.
And.
And the third question is would you develop.
Or would you potentially develop ph ILD.
Label expansion on a parallel timeline with the litigation and our pursuit of that opportunity. After some sort of litigation resolution. Thank you so much.
Thanks, Tom and let me try to address those one by one if I can.
First of all in terms of the sub Q opportunity I think as Mike said, we are confident we do think it's going to expand obviously the universe of the addressable market is at least double if not more.
I think that and the path, we haven't been able to get as much payer support as you would expect for a very high price rare orphan disease drug where theres a generic option that's available at a significant discount and I think now that we've been able to address both routes of administration.
I think that that's going to provide some additional payer support but as Mike also noted we do have a little bit of a headwind and the context of.
On.
Our profit split will decrease theoretically depending on when we reached the threshold from 80% to 50%, which is which is significant so even though we're going to increase volume and do all of that from a P&L perspective revenue will obviously have the adjustment from the from the profit split that we'll have to we'll.
We'll be overcoming.
In terms of the claims construction and I don't think that we have anything in particular to comment on at this point I think it's.
We believe that we're prepared for it and.
Expect a good resolution there I would just note that.
It has been delayed due to due to court scheduling I think it's now June for so.
You mentioned this month and it was originally scheduled for this month, but is now postponed till next month.
And then in terms of ph ILD, we're already we've already reached out to the FDA reviewer to ask and start having discussions with them about what does it mean now that <unk> had.
Additional expanded label.
And we've heard at least from the United Therapeutics.
Releases.
They're time based on DPI that's gone in.
Was for both indications and so I think they have every intention of trying to get at.
Approved at this first path for.
And for both indications and so I guess I would say that we are.
We're focused on whatever the FDA recommends, but we've already initiated that dialogue.
Alright, Thank you so much David.
Thanks.
And your next question comes from the lineup for <unk>.
The current from Wedbush. Your line is now open.
Hi, the pushback on on plenty on on <unk>.
Thank you for taking my question for you.
I'm just curious on.
And that was submitted for the deal for this mine.
Brian on your Resubmission.
Yes. So this was related in relation and CRM as you've kind of commented and the path majority of that was and the CMC area and the device biocompatibility.
Sections and.
So in terms of the device biocompatibility I mean this is the.
Typical device.
Information on studies that you would need to do we've chosen to redo all of those and we did that and provided a complete and robust package related to that and then relation and CMC. As you do know this is a new technology from a manufacturing perspective, and so there's certainly some questions around that that we were addressing and I think.
As you know we didn't have the benefit of a PKI during the original submission review.
And which maybe would've.
Offered an opportunity for us to address some of those during a kind of and interactive discussion, but nonetheless, it was centered around CMC and device biocompatibility.
Got it thank you.
And again, if you would like to ask a question just press for one on your telephone keypad.
And there are no further questions at this time please continue.
Okay, well I would like to thank everyone for joining and.
Stay tuned and the future as we continue to provide hopefully positive updates of our execution and delivering 861 and for cross sell injection and the market and then looking for other opportunities that will leverage our print technology and <unk>.
And opportunities or assets into the pulmonary hypertension area.
Thanks for joining.
Yeah.
And this concludes today's conference call and you May now disconnect presenters. Please stay on the line for the post conference.
[music].
Sure.
[music].
And.
And then.
[music].
[music].
[music].
[music].
Good morning, and welcome everyone to the credit.
Corporation first quarter 2021, and actual results and corporate update conference call. My name is Anthony and I'll be your conference. Operator today. Currently all participants are in a listen only mode. Following the presentation well conduct a question and answer session and instructions will be provided at the start time for you to queue up for questions.
If anyone has any difficulties hearing the conference. Please press star zero for operator assistance at any time on.
I'd like to remind everyone. This conference call is being recorded on.
And I'll hand, the call over to Jason Adair, Vice President corporate development and strategy. Please go ahead.
Thank you Anthony it's my pleasure to welcome everyone for today's conference call to discuss our first quarter financial results for 2020, one and provide a business update before and again I'd like to remind everyone. On today's call will contain forward looking statements based on current expectations such statements may involve risks and uncertainties that may cause actual.
Actual results may differ materially for me stated expectations.
Further information on the company's risk factors, please see liquidity as filings with the SEC at Www, SEC Gov or on liquidity as website credit Dot com.
I would now like to turn the call over to Chief Executive Officer, Damian to go up for our prepared remarks, after which he will open up the call for your questions.
Thank you, Jason and good morning, everyone.
I'm joined today by Mike just said on our Chief Financial Officer, and several other members of our management team and May be helpful and addressing your questions later on the call.
And the short time since I provided an update in March and liquidity has continued to deliver on its plans and expectations at a rapid pace.
And April and May alone, we have delivered on multiple value creating events, including.
The expansion of the commercial opportunity for profitable injection.
Our generic formulation of our modular.
Enabling subcutaneous route of administration.
The resubmission.
And of the NDA for <unk> 861.
Putting us back on track for a potential FDA approval.
And strengthening our financial position through and active equity capital raised and refinance of our credit.
Facility with Silicon Valley Bank.
These are the results of the hard work from our committed dedicated team is helping to establish the reputation for delivering on results.
First you have to get clearance of the RG three ml medication cartridge has removed a major barrier to maximizing the utility and value of Coprostanol injection.
This achievement by our partner Chengdu, She thing medical technologies.
Demonstrates our commitment to providing valuable product for ph patients and community who support them now.
With both the IV and sub Q naval.
We expect that the market opportunity for our product will more than double.
The other way as a result of newly addressable sub Q or module on patients, but also due to payers motivation to ensure the effective use of resources across this rare and expensive disease.
No longer will patients physicians and payers to be limited to a single brand of choice for.
On the sub Q administration, which cross channel due to the restrictions imposed by other companies.
With this obstacle behind US we continue to believe that there are significant addressable market for contact United Therapeutics reported that remodel and sales and the use of greater than $450 million and 2020.
We have been encouraged by the level of interest and look forward, providing more update on the future.
Our R&D and operations team have worked steadily towards resubmitting, the NDA for <unk> one on.
Dry powder formulation of profitable.
Last Friday.
We provided the FDA full response to the items mentioned and see our CRM issued last November.
We believe the data package submitted will speak directly to the items and questions raised by the FDA relate.
Related to CMC.
And Dubai Biocompatibility.
Given that no new data from the clinical trials or in vivo studies was required.
We anticipate that the FDA will classify the resubmitted NDA and the class two resubmission if accepted.
This would establish a six month review cycle from our submission date and potentially enable attended up approval and the fourth quarter. This year.
We look forward to working with the agency over the next few months and are prepared to host them for.
For our prior prior approval inspection.
Apex, one and then a good market position with the potential for growth and new indications.
<unk> one was designed from the start to improve the therapeutic profile up to profitable by enhancing deep lung delivery and achieving higher dose level and current inhaled therapies.
And convenience alone of DPI versus a nebulizer.
Should.
Despite the significant portion of the current nebulizer price the market and.
And 2020, United Therapeutics reported high based on sales for more than $480 million with a single indication and who group one patients.
In addition, we believe the higher dosing of our DPI versus current nebulizer therapy and.
As demonstrated on our and our clinical trials could prolong the duration of inhaled treatment for print before patients transition to more invasive parenteral administration.
As the market for inhaled and profitable delivery expands and new indications, we believe that <unk>, one will be well positioned.
The recent approval of a nebulizer based though to treat patients diagnosed with pulmonary.
Pulmonary hypertension.
Those stated with interstitial lung disease and <unk>.
And that demonstrates and health and healthy profitable and ability to drive another pulmonary hypertension patient population with an unmet need.
It would be our incentive volatile low and of that expanded indication and we.
Planned and discussed with the agency, whether and when we could include ph ILD and the 861 label.
As you know we are actively involved and hatch Waxman litigation brought by United Therapeutics as well as pursuing enter partakes reviews for IPR.
On a certain related patents that the us patent trial and appeal board.
We continue to maintain that for three patents asserted against us are not infringed and are invalid.
While we will not comment in detail about specific actions along the way, we remain confident and our position.
We have taken several actions and the last for months to improve our balance sheet by reducing annual net spending.
Increasing our cash position and.
And and the profit, adding a new member to our board of directors.
As described and March management has already implemented measures to reduce net annual spending in 2021 and more than 40% compared to 2020.
The company refinanced its former credit facility, eliminating more than $10 million and required principal repayments over the next two years.
While providing access to an additional $10 million upon the achievement of certain regulatory milestones related to <unk> one.
The refinance debt complements our most recent financing.
Of $21 7 million from the sale of common stock and.
New and existing investors.
Not only do we benefit from the improved cash position.
But we are very excited to welcome David Johnson, and a partner and co founder of Calgon partners.
Liquidity at board of directors.
Kal Calligan led the private placement of share and Mr. Johnson has closely followed liquidity over the last year.
We look forward to support and future discussions.
With this financial discipline and strategic focus in mind, we have recently decided to terminate the development of <unk> $8 five.
Our sustained release formulation of bupivacaine.
Targeting the treatment of local post operative pain.
We attempted department program, but we're unable.
Chosen to focus internal resources on maximizing the value of our assets.
And to build a pipeline and characteristic with our expertise and cardiopulmonary and rare diseases.
At this time I will turn the call over to Mike to review, our first quarter financial summary.
Yes.
Thank you Damian and good morning, everyone.
Our first quarter 2021 financial results can be found on the press release issued earlier today and our form 10-Q.
Q to be filed with the SEC later today, both of which will be available on our website.
To briefly summarize we recognized revenue of $3 1 million for the first quarter 2021, as compared to no revenue and the first quarter last year.
The revenue recognized in 2021 relates to our promotion agreement with Sandoz and support of <unk> injection as a result of the acquisition on November 2020 erosion. Our wholly owned operating subsidiary now referred to as liquidity and th.
Cost of revenue during the first quarter was <unk> 7 million.
Compared to no cost of revenue for the first quarter of last year prior cost of revenue recognized during 2021 related to the promotion agreement as previously noted.
Research and development expenses decreased to $6 1 million for the first quarter 2021, compared with $10 8 million for the first quarter of 2020.
Decrease of $4 7 million or 44, 1% primarily related to lower expenses from our liquidity and it takes one clinical program, which was substantially completed acquired for filing the NDA last year lower expenses from our <unk> clinical program and lower expenses related to employees and consultants.
General and administrative expenses increased to $5 $3 million compared to $3 8 million for the first quarter last year.
Increase of $1 5 million or 39, 6% was primarily due to $2 $1 million higher legal and professional fees associated with our corporate activities as well as our ongoing 861 related and litigation offset by lower consulting and personnel expenses as a result of lower head count year over year and.
Net loss for the quarter ended March 31, 2021 was $9 2 million or 21 cents per basic and diluted shares.
<unk>, two and net loss of $14 8 million or <unk> 52.
Per basic and diluted share for the quarter ended March 31 2020.
Cash totaled $53 6 million and $65 $3 million as of March 31, 2021, and December 32020, respectively. These cash figures do not reflect the $21 7 million and gross proceeds raised in April from the sale of common shares and the private placement.
As we look further into 2021, we expect net cash burn and future quarters to continue to degree decrease on a reflection and a reduction in spending we believe that cash burn will will be further reduced by the anticipated positive contribution from the profit split arrangement with standard on the sale of property on injection, while we expect your possible injection and unit sales.
Very significantly and it's worth noting that our share of profit split with Sandoz has the potential to decrease from 80% to 50% once we exceed our contractual cumulative revenue threshold, which we estimate maybe in the fourth quarter of this year will not be providing any specific revenue guidance. However, we are confident that the newly enabled subcutaneous administration.
And <unk> injection will help contribute more than our previous estimate of mid to high single digit millions and we will provide updates on future calls should this change and any material way.
With a strong balance sheet.
And access to the credit facility that Phoebe, we feel well positioned to deliver on our potential value, creating events related to regulatory approval and litigation activity in 2021, and 2022 I would now like to turn the call back over to Damien.
Thank you Mike.
For ending our prepared remarks, I thought it would be helpful to reinforce our corporate priorities that we see very clearly in 2021.
They are.
Maximize the revenue from <unk> injection with the launch of the subcutaneous route of administration.
Advance our IQ 861 successfully through the FDA and the ongoing litigation.
Reinforced the financial discipline and established by the management team Andrew.
And remain opportunistic and our pipeline to drive near term and long term value for shareholders.
Thank you for listening and I would be pleased to take any of your questions now.
And in order to ask a question and I only need to press star one and Theres all the phone and can withdraw your question first apparently and.
Please standby holds compile the Q&A queue.
And your first question comes from the line of can be scanty from Jefferies. Your line is now open.
Morning, Damian this is a combi for on for Chris.
I guess, the three questions for me and could.
And you tell us a little bit more about your expectations for <unk> and <unk>.
And.
<unk> revenues.
If you have any expectation that second question and if you have any expectations out of the claims construction.
Based on.
And then.
And the third question is would you develop.
Or would you potentially develop ph ILD.
Label expansion on a parallel timeline with the litigation and our pursuit of that opportunity out there.
Litigation resolution, thank you very much.
Thanks, Tom and let me try to address those one by one and by Ken.
First of all in terms of the sub Q opportunity I think as Mike said, we are confident we do think it's going to expand and obviously the universe of the addressable market.
<unk> is at least double if not more.
I think debt in the past, we haven't been able to get as much payer support as you would expect for a very high price rare orphan disease drug where theres a generic option that's available at a significant discount and I think now that we've been able to address both routes of administration I think that that's going to.
Provide some additional payer support but as Mike also noted we do have a little bit of a headwind and the context of.
Our profit split will decrease theoretically depending on when we reached the threshold from 80% to 50%, which is which is significant so even though we're going to increase volume and do all of that from a P&L perspective revenue will obviously have the adjustment from the from the profit split that will have to.
And we'll be overcoming.
In terms of the claims construction and I don't think that we have anything in particular to comment on at this point I think it's.
We believe that we're prepared for it and.
I expect a good resolution there I would just note that.
It has been delayed due to due to court scheduling I think it's now June for so I think you mentioned this month and it was originally scheduled for this month, but is now postponed till next month.
And then in terms of the ph ILD, we're already we've already reached out to the FDA reviewer to ask and start having discussions with them about what does it mean now that <unk> had.
Additional expanded label.
As we've heard at least from the United Therapeutics.
Releases there.
<unk> ACO DPI, that's gone and.
And what's for both indications and so I think they have every intention of trying to get at.
Approved at this first half.
For both indications and so I guess I would say that we are.
We're focused on whatever the FDA recommends, but we've already initiated that dialogue.
Alright, thank you so much Jamie.
Thanks.
And your next question comes from the lineup for <unk>.
Good current from Wedbush. Your line is now open.
Hi, the pushback on linear and on Mcarthur.
Thank you for taking my question.
Goldberg and additional information that was submitted.
For fiscal <unk>.
On the Resubmission.
Yes. So this was related in relation to the CRM as you kind of comment and the path majority of that was and the CMC area and the device biocompatibility.
On.
Sections and.
So in terms of the device biocompatibility.
The typical device.
Information on studies that you would need to do we've chosen to redo all of those and we did that and provided a complete and robust package related to that and then relation and CMC. As you do know this is a new technology from a manufacturing perspective, and so there's certainly some questions around that that we were addressing and I think.
As you know we didn't have the benefit of a PKI during the original submission review and which maybe would have.
Operating and opportunity for us to address some of those during a kind of and interactive discussion, but nonetheless, it was centered around CMC and device biocompatibility.
Got it thank you.
And again, if you would like to ask a question just press star one on your telephone keypad.
And there are no further questions at this time please continue.
Okay, well I would like to thank everyone for joining and please stay tuned and the future as we continue to provide.
Positive updates of our execution, and delivering 861, and and cross channel injection and the market and then looking for other opportunities that will leverage our print technology <unk>.
And opportunities or assets into the pulmonary hypertension area.
And for joining.
Yes.
And this concludes for this conference call and you May now disconnect presenters. Please stay on the line for the post conference.