Q3 2022 CorMedix Inc Earnings Call
Good morning, and welcome to <unk>, Inc. Third quarter 2022 earnings conference call.
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.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Danielle Saturday from lifestyle advisors. Thank.
Thank you and over to you.
Good morning, and welcome to the <unk> third quarter 2022 earnings Conference call.
Leading the call today is Joe <unk>, Chief Executive Officer of cosmetics and he is joined by Dr. Matt David Executive Vice President and CFO Dr.
Dr. Phoebe mounts EVP General counsel.
And head of technical operations Aaron Mystery.
SVP of commercial.
Before we begin I would like to remind everyone that during the call management may make what are known as forward looking statements within the meaning set forth in the private Securities Litigation Reform Act of 1095.
These statements are subject to certain risks and uncertainties and include but are not limited to any of the following.
Any statements other than statements of historical fact regarding management's expectations beliefs goals and plans about the company's prospects, including its clinical development program manufacturing activities and NDA approval for <unk> in the U S. Our other product candidates future financial position future revenues.
The projected costs and potential market acceptance of defend cath or other product candidates.
More specifically forward looking statements include any statements about our clinical development plans and the timing cost progress results estimates and interpretations thereof.
Projections as to the company's future capital, raising and spending and cash position.
Expectations as to the timing and nature of anticipated regulatory actions possible product licensing business development or other transactions.
Any commercial plans and expectations market projections for our current product candidates.
And expectations as to manufacturing and product component costs.
Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to <unk>.
Uncertainties related to clinical development regulatory approvals and commercialization.
These risks are described in greater detail in <unk> filings with the SEC, including our latest 10-Q filing.
Copies of which are available free of charge at the SEC's web site.
At Www Dot FCC dot gov or upon request from <unk>.
<unk> may not actually achieve the goals or plans described in these forward looking statements and investors should not place undue reliance on these statements.
Please note that <unk> does not intend to update these forward looking statements except as required by law.
At this time it is now my pleasure to turn the call over to Joe to Disco Chief Executive Officer of Carmax. Joe. Please go ahead.
Thank you Dan.
Good morning, everyone and thank you for joining us on this call.
Over the last three months. The company has continued to make excellent progress on all fronts working diligently in support of our CMO as they implement corrective action to the deficiencies received during the June FDA inspection as well as undertaking multiple steps to build out the team processes and systems to be ready for commercialization as quickly as possible.
Following a potential FDA approval.
While <unk> will provide a more detailed regulatory update and specifics around potential <unk> submission timing I am very pleased with the efforts undertaken by our CMO. These last three months to address the concerns cited by FDA during the site inspection.
Well with the work our team is doing to mitigate compliance risk by creating alternative supply chain option for Resubmission.
My goal is to cure secure final FDA approval of the deferred Caf NDA in 2023.
We are mobilizing all resources needed to increase our probability of success.
Oh.
From a commercial standpoint in addition to building out systems and processes for commercial operation. We are actively engaged in multiple prelaunch activities, such as disease state education and awareness.
The opinion leader engagement and early stage strategic discussions with key customers such as large health systems and IBM.
This past week the company exhibited and presented an abstract at the American Society of Nephrology meeting, which took place during kidney week, yes.
The abstract highlighted data generated by <unk> during a retrospective analysis of data from multiple clinical and claims database that track kidney failure patients.
Our analysis highlighted the significant intent and morbidity and mortality associated with catheter related bloodstream infection or <unk>.
Catheterize hemodialysis patients.
As the company broadens its presence at upcoming medical conferences and events, we intend to bring attention to the high incidence and severity of CRB ESI in the hemodialysis community.
Critical unmet medical need for which deferred caf can be a solution.
During our last earnings call, we were happy to announce that the center for Medicare and Medicaid services or CMS published in the Federal Register the conditional new technology add on payment or <unk> reimbursement for defend cap.
Last Monday, we were also happy to announce that CMS published in the Federal Register a revived then tap increasing the upper limit of reimbursement from $4387 50 per average hospital stay to $14259 38.
And cap calculation from CMS was based upon three vials of deferred cash utilized for catheter lock during <unk> III dialysis session.
The revised end cap is based upon a longer duration of hospital stay.
An average of nine seven vials will defend cap would be utilized.
And cap <unk> as calculated by CMS at 75% of the expected wholesale acquisition cost or WAC of the product and.
And is conditioned upon final FDA approval of the <unk> NDA prior to July one of 2023.
While <unk> is working to obtain NDA approval as quickly as possible.
To mitigate the risk of approval delay beyond the July 1st Cutoff. The company also recently announced the submission of a duplicate and type application to CMS.
Which would be applicable should the company obtained NDA approval. After July one 2023.
As the criteria to obtain an end cap our objective in nature and the company successfully met the criteria during the last application.
And the criteria have not changed the company expect to remain eligible to receive and tap for defend cast should NDA approval occurred after July 1st of 2023.
The inpatient segment, though smaller than the outpatient segment in terms of Lehman lock volume has substantial potential dollar value due to higher price elasticity in comparison to the outpatient segment.
The inpatient segment is not only plagued by high incidence of <unk> in its catheter I chemo dialysis population.
But there is an extremely high readmission rate for recurring <unk> within 30 days.
The combination of high incidence in high readmission rates for recurring infections result, not only in adverse patient outcomes, but adverse financial outcomes for hospitals and health systems.
Fallout from the high incident, and readmission rates, coupled with the end cap reimbursement to the health care facilities provide a compelling justification for meaningful inpatient utilization and uptake.
As the initial phase of our launch will focus heavily on the inpatient market segment <unk>.
Securing and tap and CMS subsequent revision of the upper limit is a significant value driver for deferred caf and essential to driving market uptick.
While our end cap is specific to inpatient reimbursement, we continue to take a two pronged approach with respect to outpatient reimbursement.
First we remain committed to our efforts to secure transitional drug add on payment adjustment or to dapper as soon as practicable after securing our anticipated FDA approval.
<unk> is an incremental payment to the renal dialysis service bundle allocated by CMS to outpatient dialysis clinics.
While we do see to DAP as a viable reimbursement pathway to drive utilization of defend cap. We believe there are compelling argument that defend cap does not fall within the scope of products and services calculated as part of the dialysis bundle under the current statute and therefore, it should be reimbursed separately by CMS as an outpatient drug product with unique J code.
We believe the unique J code and separate reimbursement better incentivize dialysis operators to utilize the product for the betterment of patient outcome.
To be clear any decision to separately reimbursed defend cap or grant and kept the dapper is ultimately at the sole discretion of CMS, but we will be working diligently over these next few months along with other key stakeholders, such as Dallas, Operator health system and patient efficacy groups to make these arguments to CMS.
Final FDA approval of defend cap is required before we are able to submit a formal application towards the depth or unique J code and the estimated timing to a decision from CMS is approximately six months from submission of the application and bolt.
Yeah.
At this time I'd like to turn the call over to Phoebe who will provide an update on regulatory affairs and manufacturing maybe.
Thanks, Joe and good morning, everyone.
As we discussed on our last earnings call. The company received a complete response letter or <unk> in August , which noted no product related issues or deficiencies in the new drug application.
However, <unk> David that the NDA could not be approved in its present form until successful remediation of compliance deficiencies at both the CMO.
And the supplier heparin API DPI filed an anda.
To mitigate risk we are developing three alternative pathways for NDA resubmission.
The first pathway is based on resolution of compliance actions at both the CMO and the supplier heparin API filed an anda.
As we have previously discussed the FDA conducted a pre approval inspection of the CMO facility in June and subsequently issued a form FCA 43 with four observations.
The CMO developed a corrective and preventive action plan to address the four observations that included more than two dozen individual corrective actions on the part of the CMO.
As of the date of this call.
<unk> has informed <unk>.
That has it has implemented all but one of those corrective actions and is on track to close out the remaining item by the middle of December .
While FDA has not yet communicated the classification of before you can three as voluntary action indicated or be a high.
Or official action indicated or Oh AI.
It has engaged with the CMO in reviewing and verifying documentation on corrective actions completion.
We are encouraged by FDA active participation in the resolution process.
Also as discussed previously.
Pliers Heparin API filed an Anda received a warning letter in Q4 deficiencies associated with the operations buildings and equipment that are unrelated to their manufacturer of heparin.
The warning letter received by the API supplier.
Contains customary language that FDA may withhold final approval of new applications referencing to manufacture them.
Until the warning letter is resolved.
It is important to note that FDA has authority to exercise discretion on when to withhold new approvals based on risk assessment.
The API supplier has provided cosmetics with periodic update.
It has represented to the company that all corrective actions are on track for completion by the end of January 2023.
We remain hopeful for a timely resolution of compliance concerns at both the existing CMO and heparin API supplier as this remains our fastest pathway just securing FDA approval and commercialization.
Should those compliance concerns be resolved.
We believe it will be a class one resubmission of the NDA with the 60 day review clock because no new information would be submitted in the NDA.
As Joe mentioned earlier.
Company is working diligently on delinquency plans for our supply chain, India, then the compliance concerns linger at either the CMO or the API supply.
The second pathway provides an alternative.
Events at our CMO obtain compliance clearance, but the warning letter at the API supplier remains an obstacle.
We are in the process of validation of the manufacturing at our existing CMO with heparin from an alternative API supplier.
Should our CMO obtain compliance clearance before March <unk>.
Expect to be ready to resubmit the application from the current CLO with manufacturing data for a new API sourced by the beginning of March.
This filing incorporates new manufacturing data.
Would be a class two resubmission with a six month review cycle.
The third pathway to NDA resubmission.
Dresses the event, where neither our existing CMO or the current API supplier is able to obtain coupons clearance by March.
We have entered into a partnership with alchemy.
S ne aero manufacturer to qualify Anthony as an alternate manufacturing site for <unk>.
Data from mouth me, which would also utilize the new heparin API source.
It should be ready for submission by the end of March.
This submission also involves new manufacturing data it would be a class two submission of the NDA with a six month review clock.
While we remain hopeful of a timely resolution of complaints concerns at both our existing CMO and API supplier. These three work streams to provide the company with multiple alternatives to pursue a defend cap NDA approval in 2023.
I would now like to turn the call over to Matt who will provide a financial update for the quarter Matt.
Thanks, Neely I am pleased to be here today to provide an overview of our third quarter and year to date 2022 financial results as well as an update on our cash position.
The company has filed its report on Form 10-Q for the third quarter ended September 32022.
<unk> to read the information contained in the report for a more complete discussion of our financial results.
With respect to our third quarter of 2022 financial results.
Our net loss was approximately $6 9 million or <unk> 17 per share compared with a net loss.
$8 6 million or 22 per share in the third quarter of 2021.
The lower net loss recognized in 2022 compared with 2021 included a decrease in R&D expenses, partially offset by an increase in SG&A expenses versus the third quarter of 2021.
Operating expenses in the third quarter of 2022 decreased approximately 19% to $7 million compared with $8 6 million in the third quarter of 2021.
R&D expense decreased by approximately 51% to $2 3 million driven by a decrease in costs related to the manufacturing of defend count prior to its potential marketing approval and to a lesser extent by a decrease in consulting fees.
SG&A expense increased approximately 21% to $4 6 million compared with $3 8 million in the third quarter of 2021. This.
This increase was primarily attributable to an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of <unk>.
With respect to our year to date 2022 financial results.
Total operating expenses during the nine months year to date of 2022 amounted to $22 3 million compared with $21 7 million in the first nine months of 2021, an increase of 3%.
R&D expense declined 21% to $7 8 million driven by a net decrease in costs related to the manufacturing of defend cap prior to his potential marketing approval as well as net decreases in personnel expenses consulting expenses and clinical trial expenses.
SG&A expense increased approximately 22% compared with the first nine months of 2021, driven by increased costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of defend cap and increase in legal fees, mainly due to the securities litigation and higher.
Personnel expenses.
We recorded net cash used in operations during the first nine months of 2022 of $18 2 million compared with net cash used in operations of $15.
$3 million in the nine months of 2021 the.
The difference was primarily driven by an increase in net loss and a net decrease in accrued expenses and accounts payable for the period.
Okay.
[laughter].
<unk> remains in a good position from a balance sheet perspective, the company has cash and cash equivalents of $59 million as of September 32022. This includes approximately $11 7 million raised during the nine months year to date 2022.
Through our ATM program and approximately $6 million from the sale of unused New Jersey Nols.
We believe our cash and cash equivalent it gives the company flexibility to fund its operations at least through 2023 after taking into consideration costs related to manufacturing activities and costs related to the potential commercial launch of <unk>.
As Joe and Phoebe have discussed today, we remain optimistic about our progress toward an anticipated FDA approval for defend cap in 2023.
We believe that our current cash and equivalents as well as the various mechanisms available to us for future financing, allowing <unk> to be prepared to execute on its goals.
<unk>, bringing defend catheter patients following an FDA approval.
I will now turn the call back over to Joe for closing remarks, Joe.
Thanks, Matt.
As I look toward our next few months I believe the company is in a strong position to execute on its key objectives, we are making great progress on our commercial strategy as well as shoring up our supply chain to hopefully secure final NDA approval during 2023.
Defend cap has the potential to address a critical unmet medical need and if approved by the FDA can significantly improve patient outcomes.
Also having an impact on the health equity disparity that is pervasive in our health care system.
Catheter related bloodstream infections, or CRB size places a heavy financial burden on the U S health care system estimated at roughly $2 $3 billion per year of incremental cost.
Dialysis patients with the <unk> side of double the rate of hospitalization non infected HD patients with an average duration of stay that it's four times longer and are three times higher fatality than in.
In addition African Americans represent under 14% of the U S population, but account for more than 35% of the patients undergoing hemodialysis.
To that extent African Americans are disproportionately at risk for a catheter related bloodstream infection compared to other demographic groups.
Venkat and clinical trials reduced <unk> by 71% and hemodialysis patients compared to the existing standard of care.
I remain confident in our ability to bring this product to market in order to address the significant unmet medical need.
And for your continued support of and interest in cosmetics.
Okay.
Yes.
Thank you.
Ladies and gentlemen, we will now be conducting a question and answer session.
If you'd like to ask a question. Please press star one on your telephone keypad.
Confirmation tone will indicate your line is in the question queue.
You May press Star two if you would like to remove yourself from the question queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please while report for questions.
We have a first question from the line of Joon Lee with tourists Securities. Please go ahead.
Good morning. This is awesome on for Joon, thanks for taking the questions.
I was wondering if you could just describe your commercialization strategy, specifically what type of settings, you'd think about targeting first given the variables <unk> across different health care systems. Thank you.
Thanks.
So as we as we kind of mentioned in the script.
The initial focus of our launch is going to be on the inpatient hospital segment, where.
We're going to be building a team that is focused on.
Getting the product on formulary of those hospitals and working through pvt committed getting it into the prescribing guidelines and then.
Pulling through for utilization at the individual hospitals.
The inpatient part of our focus is.
Due to the clarity that we have right now around reimbursement you got really strong reimbursement, we're very excited about CMS.
Tms upward revision.
The revision of the upper limit of N type reimbursement and we're going to focus heavily on the inpatient segment and the only part of our launch on the outpatient side thats going to come a little bit.
A little bit later, as we get more clarity around the outpatient reimbursement that will have an impact on how we price and how we build out our outpatient.
Outpatient team.
Yeah.
Thank you and then.
One must be find out the FDA classification of the European CMO with the var OE I. Thank you.
Okay.
I mean, I'll ask CBS television to comment on what she thinks of we would not be informed that the CMO would be the one that has informed directly but excuse me. Once you go ahead give any thoughts that you might have.
Yeah. It's a question everyone's asking and unfortunately, there is no statutory timeline by which FDA needs to communicate that.
So I am personally I'm the nine yeah.
Because the CMO has been very diligent.
In providing FDA with update on the implementation of its corrective action plans and the FDA anthem engage has been engaging in dialogue with them on execution of the corrective action plans.
Not having SBA throw any red flags coming up with or classification that is good news. So I think the important message is that the corrective actions around your way FDA is engaged in the process.
And hopefully it won't have a good outcome very quickly.
Thank you that's all for me.
Okay.
Thank you we have next question from the line of Jason Butler with JMP Securities. Please go ahead.
Hi, Thanks for taking the questions and appreciate all the color this morning.
The company has done a good amount of work building awareness of defend cath with the outpatient providers can you talk about what your perspective on the level of awareness and education and patient prescribers as of the <unk> data and can you talk about work that you are or can do to ensure that our minimum.
Is the risk that formulary approvals.
Get extended.
Thank you Jason.
We're engaging in a large amount of call prelaunch activities right now disease State education awareness.
I talked about our presence down at ASN.
What we are doing is engaging with key stakeholders to educate more on.
The unmet medical need that <unk> presents.
That opens the door for.
Discussions that can be had around defend catheter as a potential solution. So we're laying the groundwork now we're starting to have conversations at the IBM level at the hospital level and those are going to continue as we build up.
Toward launch.
What was the second part of the question, Jason I apologize just any work that you can do to given the.
We've heard through the pandemic, but formulary approval timelines have been extended as I work that you can do ahead of approval to I guess mitigate that.
Sure sure and I'm going to let Aaron comment momentarily as she is largely focused on on these initiatives, but the conversations that I've met I mentioned now the meetings with stakeholders, we are meeting with IBM engaging with payers.
Putting ourselves in a position where the process through the PMT Committee can hopefully the timing can be minimized to the extent possible, we're going to have to go.
IBM by IGN and helpful from a health system and work through.
Each process is different at each health system. So.
Eric do you want to provide a little bit more color on some of the activity that your team is going on.
Sure. Thanks, Joe.
Yeah, I mean, I think it's very similar to what Joe said, there isn't it a layer of segmentation work that has been down and we will continue to be refined over the next couple of months.
The key hospitals that have.
Our highest ever BSI rate that have high readmissions that have a lot of initiatives around these types of patients those are the key focus areas right and to get into those systems.
Really need to understand.
The inner workings of that specifics and just as Joe mentioned, each one is a little bit different and nuanced and so we have we have the ability to to really start to talk with these folks we've talked to several of them already and will continue to do so heavily over the next couple of months.
In combination with the.
The disease awareness campaign, which we started that digital campaign in Q4 and will continue to.
Identify more data.
We have a lot of inpatient data that we've come out with recently and as as we continue to get more and more data. There is a lot of wind at our back.
For the initiatives that we're trying to push through.
And then the other piece of this is the economic component right. So we will continue to drive that economic discussion with P&G members with value Committee members and keep physician champions within the hospital system.
Great.
Thanks for taking the questions.
Thank you.
Next question from the line of search Phalanger with Needham <unk> co. Please go ahead.
Yeah.
Hey, good morning, Thanks for taking my question.
First one for phebe on the regulatory issues.
Just curious what your expectations for the <unk>.
For FDA reinspection.
Across the three different pathways that you outlined.
And then secondly, I guess for Joe.
News this week that CMS was.
Revising the impact reimbursement significantly higher.
Just curious what that means to the opportunity in the hospital in patient segment.
And then I guess it would be good.
What what do you think the average stay of.
The patients are in the hospitals and how this change in reimbursement would affect.
The usage of the product.
Thanks, So much alright, CVD want to go first on the re.
And the inspection question Yep. Thanks, <unk>. Thanks, Joe.
Obviously SBA has discretion.
On whether or not it will require an onsite inspection to assess the effectiveness of it.
Corrective action.
As always our focus in developing corrective actions and submitting progress reports to the agency. It's imperative that you convince the agency that not only have you developed.
Good appropriate corrective actions, but that you're executing on the plan and that those corrective actions are being effective to resolve any deficiency the agency identified.
So that has been part of the strategy all along is to provide documentation to the agency to make it very clear is that there is progress being made that's what deficiencies are being remedied. So we are very hopeful that FDA can evaluate implementation of the corrective actions without meetings.
Onsite inspection, but again.
In these days of no big concerns the agency continues to remind folks that.
On site doesn't necessarily mean, a physical visit they have the option to do remote interactions as well so.
Another important part of that dialogue is whats the timing of the FDA does need to do an inspection and that's obviously something that.
The CMO and.
Sure.
<unk> heparin API supplier engaging in dialogue with FDA on.
Thanks, David.
So I mean, just to answer to get them to address the question on the CMS revision of untapped.
We do actually think is incredibly important part of our.
The value proposition for defend Kathryn the inpatient market the original and tap while we were happy with.
With the end up being granted.
The CMS had made a determination based on what we saw as the minimum usage.
For defense in a chronic setting as are their label is expected to be for chronic hemodialysis the.
The minimum for chronic is seven days or more so our minimum utilization of hospital theoretically would be three vials over the course of one week.
On dialysis that said, we believe the average stay is likely closer to 13 days.
Where patients are dialyzed.
Some are Dialyzed daily some every other day some every three days.
And we took a weighted average based on the data that we've seen and we came with the calculation.
$9 75, vials. So what that means is as hospitals utilizing defend cat in the treatment of a patient in an in patient setting.
Had the original end cap.
Or and have kept the calculation has been in place.
If a patient was in the hospital for three weeks the maximum reimbursement to the facility would have been 4400.
Approximately $4400.
Now if they are therefore for three weeks, we have the opportunity to be reimbursed for $2000. So it is a meaningful incentives to the institutions into the health care facility to utilize the product. So we do think it's very important.
Thank you search do you have any further questions.
Oh.
Okay. Thank you.
Thank you.
Gentlemen, we have reached the end of the live question and answer session and I'd like to turn the call back to Daniel Farrell for written questions.
Then over to you.
Thank you operator.
We have a few written questions here for you.
The first one and I know <unk> touched on this briefly.
But if you could please.
Please walk us through the various scenarios for resubmitting the NDA.
Gives me.
And the follow up question there would be what gives you confidence that <unk> may see approval.
2023.
Okay. Thanks.
Thanks, Dan and I actually think I want to address the second question first in terms of our confidence for getting approval in 2023 as Phebe mentioned in her script. The CRM that we received had no product specific observations or deficiency, so where the understanding that the only.
Great. Let me step here is the compliance data set the CMO and API facility right to that extent, we've created three pathways. We believe we are on target to resubmit by the by the end of March and that certainly there can always be minor delays.
Chuck could generate stability data, but we believe we're on track and.
If it's a type one submission right it could be a 60 day review of the type two submission should be a six months or so.
So that's kind of a guiding our thoughts around timing and why we're hopeful.
To get an approval in 2023.
I think I also feel we did a really good job of clearly walking through the three pathways.
That we are pursuing to get.
Yeah.
For Resubmission in the first quarter and the fastest path to market as we said remained a compliance clearance by FDA of both the CMO and the API facility.
And if both of those are events.
Those compliance equate acquaintances do come in the first quarter of next year.
Could be in a position to resubmit with a type one submission at a 60 day review clock Thats why that remains.
Fastest pathway to market.
Now the other two pathways as phebe laid out.
One would be the existing CMO with a new API source and that would be for an instance, where the CMO gains clearance, but our API site.
It remains under warning letter this gives us the ability to.
To resubmit from the existing CMO would still be a type two resubmission. However.
Its new manufacturing data, but it would only be new API data as opposed to a new site and API data. So we wanted to create that flexibility and give us that option for Resubmission and then the third pathway as we've talked about to our agreement with alchemy.
We've.
Given ourselves the ability if neither of the CMO, nor the API supplier are able to gain compliance clearance in the first quarter. We believe we have the ability to resubmit.
Some alchemy type two submission.
Okay.
Excellent Thanks, Joe.
The next question would.
It would be along the lines of alchemy and kind of how are you thinking about alchemy.
As well as the alternate supplier of heparin is playing a role going forward and the regulatory process.
Okay.
Yes, I do want to actually make sure that we're clear that alchemy is going to be a part of our ongoing supply chain, regardless of whether or not we utilize them as the primary.
Filings in terms of getting gaining or hopefully gaining FDA approval as we talked about in our third scenario or if we ultimately utilize them as a as an alternate.
Manufacturer to mitigate supply chain risks from having our our product come only from one site.
We're really looking at them as well as a <unk>.
Long term partner as we would with our alternate supplier of heparin API, we want to make sure that we always for key components and materials maintain two sources of supply.
Okay.
Okay excellent.
Yeah.
More along the lines of.
The balance sheet, given the anticipated approval in 2023.
Is the company thinking about financing.
Okay I'm going to.
Let Matt jump in and comment on cash.
Sure.
Thanks, Joe Thanks, Dan as you can see from our latest filings <unk> been judicious regarding the use of our ATM program. So we believe we're in a good position with cash and equivalents.
And this can take us through the initial stages of the commercial launch that said, we're always keeping an eye on alternative sources of capital is to make sure that the company has sufficient funds to execute on our plans forward.
Yeah.
Okay, Great and then the last question.
For Joe and we get this question a lot from investors Joe.
What do you think investors are missing.
About the <unk> story.
That is a good question I do get that a lot as well.
Obviously over the last 30 45 days, we've had a lot of conversations with investors.
And I think what is most underappreciated and not fully understood is the value proposition around our inpatient launch strategy I realize that this is something we started talking about only probably a quarter or two ago and really started to shine a spotlight on it with data.
But there is a it's a compelling value proposition I think.
The reimbursement through the <unk> tap is significantly higher than what anyone had anticipated even though the volume of that market is lower than the outpatient side.
The value of that reimbursement creates a multibillion dollar market opportunity so our ability.
To gain market share and drive value right I think it's a significant value driver for the company and I think that that's something that's not fully appreciated or understood I think even.
Some of our coverage has yet to included in their updated models and hopefully that will be forthcoming.
But this is this is the core focus of the initial phase of our launch and I think it's a real value driver for the company that needs to be better appreciated by investors.
Thank you Joe.
Operator. This concludes the written question portion of this call you may now close the call.
Okay.
Thank you ladies and gentlemen. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.
Yeah.
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