CareDx Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 10, 2023

Key Takeaways

  • CareDx delivered record patient testing volumes in Q1, outpacing market growth by 8 percentage points and achieving 17% year-over-year growth.
  • The company maintained strong cash collections at 110% of testing services revenues, ending the quarter with $286 million in cash and generating $0.7 million in net cash from operations.
  • Following two MolDX billing article revisions, CareDx paused submissions for ~3,200 AlloSure Kidney tests, deferring $8.9 million of Q1 revenue recognition to Q2.
  • CareDx withdrew its 2023 revenue guidance due to uncertainties over policy interpretation and timing of operational implementation.
  • Non-testing services, led by patient and digital solutions, achieved record Q1 revenues of $8.6 million, a 39% increase year-over-year.
AI Generated. May Contain Errors.
Earnings Conference Call
CareDx Q1 2023
00:00 / 00:00

There are 12 speakers on the call.

Operator

Greetings and welcome to the CareDx Incorporated First Quarter 2023 Earnings Conference Call. As a reminder, this conference is being recorded, Wednesday, May 10, It is now my pleasure to turn the conference over to Greg from the Gilmartin Group. Please go ahead.

Speaker 1

Thank you, Jennifer. Good afternoon and thank you for joining us today. Earlier today, CareDx released financial results for the quarter ending March 31, 2023. The release is currently available on the company's website at www.caredx.com. Reg Cito, Chief Executive Officer Abhishek Jain, Chief Financial Officer Alex Johnson, President of Patient Testing and Services and Robert Woodward, Senior Vice President of R and D will host this afternoon's call.

Speaker 1

Before we get started, I would like to remind everyone that management will be making statements during this call that include forward looking statements within the meaning of the federal securities laws, to any statements contained in this call that are not statements of historical facts should be deemed to be forward looking statements. All forward looking statements, listen, including without limitation, our examination of historical operating trends, expectations regarding coverage decisions, pricing enrollment matters and our financial expectations and results are based upon current estimates and various assumptions. These statements involve of material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, Please see our filings with the Securities and Exchange Commission.

Speaker 1

The information provided in this conference call speaks only to the live broadcast today, May 10, to the replay of 2020 3. CareDx disclaims any intention or obligation except as required by law to update or revise any information, of financial projections or forward looking statements, whether because of new information, future events or otherwise. This call will also include a discussion of certain financial measures that are not calculated in accordance with generally accepted accounting principles. Reconciliation to the most directly comparable GAAP financial measure may be found in today's earnings release filed with the SEC. I will now turn the call over to Reg.

Speaker 2

Thanks, Greg. Good afternoon, everyone, and thank you for joining us for CareDx's Q1 2023 earnings conference call. As you'll recall, we ended 2023 having been through a challenging environment in 2022. The 4 key challenges identified included listen. The growth of the transplant market, marking an idea of the low point in transplant since onset of COVID started 2022, changes in expectations in diagnostic sector, where we focus on achieving profitability and maintaining strong cash position 3, an increase in the commercial payer mix with the full impact of Medicare Advantage and the increase in our of testing services volumes with new launches and fall driving revenue growth also

Speaker 3

in our non testing service business lines.

Speaker 2

I will address the revised billing articles from Moldeck shortly. Before I do, I would like to highlight our strong operational performance that saw a successfully executed plan to address those 4 challenges. We continue that effort into Q1 2023, where the company: 1, delivered its highest ever patient testing services volume and grew faster than the market by 8 share points compared to the prior quarter. 2, we delivered cash collections at 110% of testing services revenues for a 2nd consecutive quarter, representing approximately 10% year over year increase. This maintained our strong cash position of $286,000,000 and helped generate $700,000 in net cash from operating activities.

Speaker 2

3, we delivered our highest non Medicare revenues through improved pay coverage and collections with a 19% increase in sequential revenues. 4, we delivered our highest ever Patient and Digital Solutions revenue quarter as we doubled our contribution from our non testing services business line. We're proud of these results and the strong operational performance and execution in Q1 2023. Now moving on to the billing article changes. We're now faced again with a new set of challenges with the introduction of 2 revisions to the billing article associated with Medicare coverage of allosur and elumab.

Speaker 2

The first revision was published on March 2nd and the second on May 4, 2023. Addressing these changes required significant management time and the reallocation of organizational resources. We've updated our 2023 plan, which is now largely focused on the operational implementation of the requirements of the billing articles. This will require significant ongoing effort throughout 2023. In parallel, we're aligning the company's cost structure to this new and evolving landscape.

Speaker 2

Notwithstanding our focus on implementation, the company believes the billing articles are inconsistent with the LCDs. Both Noridian and MolDX's response to public comments explain the intended scope listen of various LCDs and medical necessity. We believe the billing articles were changes to the LCD and not merely a clarification of existing coverage by MolDX to kidney services. For example, in Heart Care, MolDek's direction has changed and they acknowledge that the March billing article is a change as to its previous billing article, which provided coverage only when AlloSure Heart was using injunction with LmAb Heart. Adding to this complexity, There is uncertainty whether and when Noridian Medicare Administrative Contractor also known as a MAC will adopt and issue these new billing articles.

Speaker 2

To date, they have not adopted either billing article from MolDek. Given these factors and out of an abundance of caution, we adopted a conservative approach and paused Medicare reimbursement submissions, Falshore Kidney on March 7, 2023. The Board and management team made this decision in consultation with 3rd party advisors. The decision is designed to give the company further time to understand and evaluate the implications of the March filing article. As a result, we did not submit claims for approximately 3,200 list of our short kidney tests for Medicare reimbursement and did not recognize this revenue representing approximately $8,900,000 on these tests in the Q1 of 2023.

Speaker 2

We refer to these tests as impacted March tests. We will be submitting these tests plan to submit these tests during Q2. We've had numerous discussions with MolDX and plan to further discussions with them. We've also reached out to CMS on this matter and plan to reach out to Noridian. While the transplant centers in CareDx will adjust and evolve over time, what has been concerning is the impact to patient care during this time of evolution and uncertainty.

Speaker 2

It was unrealistic to have a 4 week implementation time line from when the March billing article revision was issued. Thousands of providers involved to the care of patients had to be educated on new forms and processes. Despite this being a near impossible feat, we're focused the organization on these hundreds of centers and solicitors who were not ready for this change nor had planned for this change, especially as soon as we're required to update their IT systems. The TransLink community listen have spoken out over the last few weeks on this unprecedented situation. The leading professional transplant associations ASTS, AST and ISATL T and the leading patient associations, EnCare from Treo have all reached out to MolDX directly in this matter.

Speaker 2

They also reiterated of non invasive molecular testing in transplant patient care and some went as far as to raise concerns about the implementation timeline and process and implications of patient care. In fact, on Monday, a press release was sent out highlighting the results of a new survey conducted by 4 leading patient groups: Transplant Families, Transplant Recipients International Organization and the Heart Brothers Foundation listen showing that 95% of patients surveyed are concerned that the new Medicare billing article limits coverage of non invasive pro transplant tests. Furthermore, the majority of patients surveyed believe that reduced coverage of non invasive blood tests would negatively impact their post transplant care and they should have been consulted as part of the process for Medicare policy changes. The survey included the views of over 1,000 patients as well as caregivers and families. Now on to Q1 results.

Speaker 2

Testing Services had a great Q1 with 17% year over year volume growth. We delivered almost 50,000 tests beating the year over year market growth of 10%. We also grew sequentially by 5% versus last quarter listen beating the minus 3 percent quarter over quarter market growth. In Q1, we recorded a total revenue of $77,300,000 If we had submitted the impacted March test to Medicare in the Q1, our total revenue would have been approximately $86,200,000 a year over year increase of 9%. In addition, our testing services revenue would have grown 6% to $70,700,000 Q1 would have been a record quarter for CareDx if we factor in the impacted test that we plan to submit to Medicare in Q2.

Speaker 2

Our non testing services business continues to deliver meaningful contributions to our overall revenues. Specifically, patient and digital solutions delivered the highest ever revenues of $8,600,000 representing a 39% year over year growth. For the Q1, we reported GAAP loss of 23,700,000 and a non GAAP loss of $5,800,000 and adjusted EBITDA loss of $6,400,000 If we'd included the revenue from the impacted March test, We would have recorded a positive adjusted EBITDA of $2,500,000 Notably, we would have achieved our key 2023 goal, which was to deliver a positive adjusted EBITDA in the first half of twenty twenty three. Abhishek will cover this in more detail in his section. Now I'll update you on our efforts to operationalize the changes by the March 31 effective date and the ongoing complexities.

Speaker 2

Firstly, it has taken a lot of effort and will require ongoing effort to support patient continued patient care. Since the March billing article was announced, we've been working nonstop to update our forms, our systems and processes to accommodate these changes. This has been a significant undertaking across our testing services business line. While the following is not an exhaustive list of what the company has been doing since March 2nd, It is truly amazing what has been accomplished over the past 9 weeks. Since the start of the billing article, we've reached out to 80% of our 550 plus transplant centers, community hospitals and practices.

Speaker 2

Each center, hospital and practice list has multiple providers and support staff that has to be educated requiring us to visit numerous times with some centers having more than 20 people that need to be educated. This has involved thousands of interactions. We've had to update our internal IT system processes and test requisition forms also called TRS and workflows. All centers using paper TRS have had to be updated with new requirements and centers using our portal are now being migrated over to our new customer care portal. All centers using electronic medical records are being worked listen as part of this process and we are dependent on the center adjusting its system workflows.

Speaker 2

Changes to IT systems need to be scheduled well in advance and working on this center by center. Secondly, the effective date for implementation was only 4 weeks after the billing article revision. It should be noted, we began our efforts to operationally implement the March billing article requirements during March to be ready by the effective date of March 31. While we've made excellent progress, it takes time for transplant centers and healthcare systems to make these operational changes and update their system workflows. We can report now as of the end of April, approximately 50% of the test orders received and now in the new forms and with the new required information.

Speaker 2

It has taken a Herculean effort to get to this stage. While we continue making strong progress on the operational implementation, we will not be completed by the end of the second quarter. As an indicator of this uptake in adoption, we've seen a progressive increase in percentage of completed submitted forms. We ended April, as as we mentioned 50% and we are trending in May at 60% and we expect to be at 80%, 85% of forms with requisite information by the start of the 4th quarter as more Transfence Systems are updated. Given the impact of the March billing article to our business model, we have taken steps to reshape the organization, which will deliver annualized cost savings of $40,000,000 to $50,000,000 Alba Shek will cover this in greater detail in his section.

Speaker 2

Moving on to guidance. Given the uncertainties between interpreting MolDX, MRIdian positions and our operational implementation taking time, we believe it is prudent to withdraw guidance. We will revisit this in our next quarterly earnings call once we've gained a better understanding of this evolving landscape. So what are the next steps for CareDx? Firstly, we will implement the updated 2023 plan in response to the revised billing articles by continuing the all hands on deck approach to operationalize the plan, list of physician centers and practices.

Speaker 2

Alex Johnson and his team have done a fantastic job working day and night to get this implemented. We're going to align the organizational structure and strategy as the landscape evolves. The management team has been working on this and that effort is also being led by Abhishek, our CFO. And we're going to be following up with MolDX, Neweridian and CMS about these changes. Secondly, we'll continue to deliver on the 2023 plan, especially the 3Cs.

Speaker 2

On collections, we have made significant progress over the last two quarters, while testing services collections are greater than testing services revenues. On coverage, We have captured wins from the recent ISHRT guidelines, especially with early reimbursement for AlloMap as early as 2 months and we're in multiple active discussions to increase commercial coverage. There has been significant work as part of our strategic plan. We now expect to see this to come together over the next few months. On Catalyst, We await decisions and have ongoing discussions in several pipeline catalysts.

Speaker 2

Given the recent VA changes, some of these dossiers have been updated. We'll continue to produce and submit clinical data demonstrating the clinical benefits of individual diagnostic tests and our multimodal offerings including heart care. Lastly, the company will be leaner, more efficient and aligned to the new and evolving landscape. We have enough cash in our balance sheet and we do to not anticipate needing to raise any cash in the near future. Before I hand the call over to Abhishek to go over the financials, I want to thank all the employees of CareDx who work listen closely to educate healthcare providers on the billing article changes and to help transplant centers become operation ready.

Speaker 2

The efforts were exemplary driven by their unwavering commitment to serving patients and the broader transplant ecosystem. Handing over to Abhishek.

Speaker 4

Thank you, Reg. We are pleased to share results from the Q1. The key takeaways are: number 1, we had a good quarter despite the operational challenges associated with the implementation of the billing article. Number 2, we have some early lead indicators to start assessing the financial impact of the billing article. Number 3, we now have plans underway to mitigate the financial impact number 4, we are withdrawing guidance due to the factors outside of our control.

Speaker 4

We had a good first quarter where we delivered on our financial imperatives. Number 1, We maintained a solid cash position of $286,000,000 and generated positive cash from operations for a 2nd consecutive quarter. Number 2, our testing services volume growth beat market growth quarter over quarter and year over year. Number 3, We maintained our momentum in collections that increased 10% year over year and were at 110% of our reported testing services revenues. The impact of improved collections has started to show on ASP Dynamics.

Speaker 4

Number 4, we had our highest ever quarterly revenue listen for Patient and Digital Services Business and number 5, all three businesses improved gross margin year over year. And it would have been a record quarter if we were to consider revenue associated with the impacted March test of $8,900,000 as we would have listen to the next slide. Thank you, Dan. Thank you, Dan. Thank you, Dan.

Speaker 4

Thank you, Dan. Thank you, Dan. Thank you, Dan. Thank you, Dan. Thank you, Dan.

Speaker 4

Thank you, Dan. Thank you, Dan.

Speaker 5

Good morning, everyone.

Speaker 4

In Q1, we reported total revenues of $77,300,000 down 3% year over year. If we were to include the revenue to the impacted March test, we would have delivered revenues of $86,200,000 or adjusted revenue, Representing a 5% increase as compared to the last quarter and 9% year over year. This would have been our highest ever revenue in a quarter. Testing services revenue for the Q1 was $61,800,000 down 7% year over year. Testing services revenue, including the revenue associated with impacted March test, would have been 70,700,000 of highest ever testing services revenue in a quarter or adjusted testing services revenue, representing 8% growth as compared to last quarter and 6% year over year.

Speaker 4

Our testing services volumes grew by 5% quarter over quarter as compared to a negative 3% growth for the transplant volumes. Also, our testing volume growth of 17% Year over year beat the market growth of 10%. Despite tough market conditions, strong test volume growth to the value of our test with proven clinical utility. Turning to ASP. Adjusted testing services revenue growth of 8% outpaced volume growth of 5% or would have delivered a positive overall ASP change, an inflection point that we have been seeking with our focused strategic efforts.

Speaker 4

In Q1 2023, we would have improved the ASP despite the continued headwinds from volume mix shift, primarily driven by: number 1, getting paid for long outstanding Medicare Advantage claims and number 2, having an increased price per test as a result of improved collections in Q4 'twenty two. As a reminder, we use historical collections per test to recognize our revenues for non Medicare tests in a given quarter. Importantly, ASP on our pay test continues to be approximately $2,500 We track this measure to exclude the impact of mix shift as a result of our strategy and market dynamics as we had discussed in the past. This is a metric that we use to ensure that there is no price degradation for our test. Turning to testing services gross margin.

Speaker 4

Our GAAP testing services gross margin improved to 75% as compared to 73% in the same quarter last year. And non GAAP testing services gross margin improved to 77% as compared to 74% in the same quarter last year. Half of this improvement in gross margin was driven by volume growth and the impact of improved collections on revenues. The rest of the gross margin improvement was driven by 2 factors. Number 1, the positive impact of one time reversal of accrued amount Associated with royalty payment and it was partially offset by the impact on gross margin due to unrecognized revenues of 8,900,000 listen to the impact of mass test.

Speaker 4

The cost of running these tests has been part of cost of sales. Now turning to non testing services business. In Q1, our digital and patient solutions business revenue was at $8,600,000 a growth of 39% year over year and our highest ever for a given quarter for this business line. We are pleased to see our strategy of investing in our digital and patient solutions paying off and our acquisitions helping us both drive the business results GAAP and non GAAP gross margin for our Digital and Patient Solutions business were 23% 31% in the Q1 of 2023 as compared to 21% 28% in the same quarter last year. Though the non GAAP gross margin improved by 300 basis points year over year, the team is continuing to look for further opportunities to improve.

Speaker 4

Products business delivered $6,900,000 in revenue similar to same quarter a year ago. GAAP gross margin for our products business was 41% in Q1 of 23% as compared to 35% in the same quarter last year. Non GAAP product gross margin was 52% in the Q1 of 2023 as compared to 44% in same quarter last year, an improvement of 800 basis points. As discussed in our previous calls, improving gross margin for our products business of the core focus area for the company and we are making good progress at it. Turning to operating expenses and adjusted EBITDA.

Speaker 4

Non GAAP operating expenses for the Q1 was $61,700,000 up about $1,000,000 sequentially from Q4 'twenty two. The increase in our GAAP operating expenses was mostly driven by increased legal expenses. For the Q1 of 2023, we recorded negative adjusted EBITDA of $6,400,000 compared to negative adjusted EBITDA of 3.7 to the previous quarter. If we were to consider unrecognized revenues associated with March infected tests, We would have recorded a positive adjusted EBITDA of $2,500,000 Turning to cash. We continue to maintain a strong financial profile as emphasized by our robust balance sheet and cash balance of $286,000,000 and no debt.

Speaker 4

We generated positive cash from operating activities for the Q2 in a row. Importantly, the Q1 is usually a seasonally weak quarter for cash listen to usage as we pay annual bonus to our employees. Our focus on cash collections and working capital management to the Q1 of 2019. I would also like to note that we earned $2,700,000 of the interest income for the Q1 of 'twenty three. Now to the second takeaway, lead indicators to assess the financial impact of the billing listen.

Speaker 4

Reg has already provided color on how the billing article revisions have impacted our strategy and on the operational challenges to implement the changes required for hundreds of transplant centers and the ecosystem around to operationally implementing the changes required by the billing article. Though we are seeing adoption of revised processes, This is a Herculean effort that could not occur by the effective date of threethirty one, especially for our kidney services. Given the significant change, complexity and related uncertainty, it is difficult to assess the financial impact of the billing article yet. However, let me share with you lead indicators. Number 1, education.

Speaker 4

The first step in implementing the The education of the Transnalox Centers, Providers and Support Team. I'm pleased to inform that we have educated approximately 80% of all centers. It covers 90% plus of our volumes for kidney services and the education is ongoing. This sets the path for adoption of the new requirements. Also, it is important to note that after the 1st 4 weeks Post the effective date of billing articles, we are experiencing lower testing volumes as centers and clinicians are still learning, listen.

Speaker 4

Number 2, adoption. At the end of April, approximately 50% of our incoming test requisition were on newly implemented forms. That included required information to comply with the billing article. This is trending at approximately 60% in May so far. I think it speaks highly of our teams that have been working nonstop to implement new processes and system updates.

Speaker 4

We expect to continue to see an increase in the adoption to approximately 80% to 85% by the Q4 of 2023. Number 3, claim submission. For AlloSure Kidney test starting March 31, listen. 23, we have not been billing any test to Medicare unless they come with the requisite information on the new test acquisition forms. Otherwise, we are going back to the prescribing transplant centers to collect that information.

Speaker 4

I would like to note that this will add significant operational burden on CareDx. As shared earlier, there's still a large percent of incoming tests that are coming on old forms listen or are incomplete. Also, if a test is pending collection of requisite information, it will impact revenue recognition. For our elumab heart and elosure heart test, we are continuing to follow our Medicare reimbursement submission process. In addition, we plan to inform Noridian that until Noridian adopts the revised billing article, KDS will continue to submit AlloSure Heart test for reimbursement only when used in conjunction with AlloMap Heart, including the test where we have not obtained additional information as required by the billing article.

Speaker 4

However, post June 30, 23, we plan to submit to Medicare only those tests that meet the billing article requirements. Please refer to our 10 Q for further discussion on billing article and its impact and associated risks. Turning to our 3rd takeaway on our plans to mitigate the impact of the billing article. The billing article will impact testing services business Based on the early trends of lead indicators, therefore, we have started to align our cost structure. We expect these actions will help drive approximately $40,000,000 to $50,000,000 in annualized savings.

Speaker 4

As we increase our understanding of the financial impact, we will adjust our actions to minimize cash burn. It is important to note listen to the presentation period of operational implementation, we will require more resources to deal with significant additional to the administrative burden in certain areas. Here is a quick summary of various actions that we are taking. We are restructuring to our workforce and our goal is to reduce approximately 12% of our headcount as compared to what we had in the beginning of the year. Number 2, we are reviewing our test volumes specifically in areas where the tests are not covered and are not reimbursed even after a peak.

Speaker 4

Number 3, prioritization of clinical studies and R and D spend to stay focused on the most important areas that would help us improve coverage and drive revenues. Number 4, review of legal spend and reduction of discretionary spend to the extent possible. In addition to looking to reduce expenses, as Reg mentioned, we will continue to focus on our 3 Cs, of key strategic areas to drive upside. Turning to guidance. We are withdrawing our 23 revenue guidance at this time, given a multitude of unknown variables related to the billing article as we have discussed during this call, many of which are outside our control.

Speaker 4

Specifically, number 1, interpretation of moduleix policy in the context of 2 billing article revisions since March 2. Number 2, adoption of the billing article by Noridian and the updation of IT systems by centers to incorporate new test forms. Number 3, impact of transition on testing services volume during the period of education and implementation. Number 4, rate of adoption of new forms, percent completion of the requisite information and success in collecting missing information from the TRS. We will revisit this in our earnings call for Q2 of 2023 once we have gained a better understanding of the evolving landscape.

Speaker 4

In summary, we had a good Q1. It could have been even better had we not hit the challenges due to billing article revision. All efforts now are on operational implementation of the requirements of billing article division to increase the rate of adoption as much as possible. We are taking necessary actions towards just our cost structure and do not anticipate a need to raise cash in near future. We will continue to build on our key strategies by enhancing our efforts to improve coverage in collections areas that we can influence.

Speaker 4

With that, I'll hand over the call to Reg.

Speaker 2

Thanks, Abhishek. I think, let's have Greg if you can work with the operator to open line for

Speaker 3

Q and A. Thank you.

Operator

Certainly. And our first question is from the line of Matt Sykes from Goldman Sachs. Please proceed with your question.

Speaker 6

Hi, Hi, good afternoon. Thanks for taking my questions. Maybe the first one for you. I appreciate the color on the percentage of forms and Abhishek, I know you said list that volumes, testing volumes were lower as you've seen it recently. But maybe just help us frame the impact and listen.

Speaker 6

Maybe provide a little more granularity on sort of what testing volumes have trended to date and what it looked like in April and the 1st start of May, just so we can Kind of help frame sort of the revenue picture?

Speaker 2

Yes, Matt. Thanks for the question. I'll make some introductory remarks and I'll hand over to Talvish as part of that. And I think we have some early listen read on the market volume and clearly there's a bit of interim flux that we've gone through a few of the complexities listen as part of their process. For example, some of the centers with EMRs, we actually need to them to actually update the forms on their side, which has created a bit of an issue.

Speaker 2

So there is a bit of this transition dynamic. So I'll hand over to Abhishek on his specifics.

Speaker 4

No. Thanks, Edge. And as we were saying, Matt, this is a complex change and there are still a lot of education that the clinicians and the centers need to go through listen and transition their new processes. And of course, as we said that in the Q1, our testing services volume were pretty solid. But after we have implemented this new test requisition forms, it has started to basically due to the change management of this whole exercise, It's hard to kind of drop a little bit from that standpoint.

Speaker 4

It's in the range of high teens as of right now Based on the early indications like the 1st 3 or 4 weeks and we'll basically see as to how this shapes up in the next few weeks.

Speaker 6

Got it. Thanks for that color. And then maybe just in terms of like one of the debates post this has been sort of the frequency of tests. Listen and suppose you can change the forms and reeducate the centers. Do you foresee a drop in frequency for some of your tests in terms of that waterfall that you've traditionally had for your testing services?

Speaker 2

Yes. I'll add some of color and then I'll have Abhishek talk. So I mean, what we've found matching this process, the key is really getting operationally ready. I mean, I think centers We're focused less on is this trying to full course surveillance. The question is when will centers be ready and operation ready?

Speaker 2

That's the most important thing. And I think with 550 plus centers we've had to reach out and with many of these centers that weren't ready. That's the key bottleneck. It's this listen operational implementation. We've had thousands of interactions.

Speaker 2

If these aren't up, then that sort of discussion goes away. So I think what we've seen is This trend of how do we get the centers up and running and then how do we get these forms in the right format. So I think that's why the team under Alex We've made significant progress going from this 50% in at the end of April. And now in the start of May, we're starting seeing that 60% range, but I'll let Abhishek add some more color.

Speaker 4

Yes. I think you have covered it pretty well, Reg. We are still trying to assess and I don't know, Matt, if you know that There was another billing article that came late last week, and we're still trying to interpret everything that is out there, and we will basically make that assessment.

Speaker 2

Yes. There are some positives out there that new billing articles that have come through as well, Matt, which removes some of the earlier sort of issues that were listen to a phrase

Speaker 7

such as this what

Speaker 2

was known as the 7 day rule and also the requirement for a center to have the center protocol for example to shift in more of the physician side. Robert will cover that more in detail as questions come up, but there have been some changes that I think will address that as well.

Speaker 6

Got it. If I could squeeze one more in, just Abhishek, just on the $40,000,000 to $50,000,000 annualized of savings. In terms of how we should think about that phasing in over the course of this year, could you maybe help with a little additional color on that?

Speaker 4

Yes, sure. Absolutely. So we have already started to take the actions and then my sense is that you will start to see In Q3, a proportionate impact will start to happen, right? Not necessarily the full one of that $40,000,000 to $50,000,000 but I would say still a significant portion of that you will start to see in Q3 and then you'll start to build from listen there and then Q4 and Q1, we'll probably start to see one fourth of that impact and the benefits start to show up.

Speaker 6

Great. Thank you very much.

Operator

And our next question comes from the line of Andrew Cooper with Raymond James. Please go

Speaker 5

ahead. Hey, everybody. Thanks for the question. Maybe first, listen. You gave a lot of those comments on kind of the rate of completed forms.

Speaker 5

But I just want to understand, when you say completed forms, are those completed in a way that, to your knowledge, Does meet the requirements for reimbursement or just completing the information that then CMS or MolDX or Noridian would need to contemplate To decide whether or not to actually reimburse for that test, meaning in the indication where you need to be replacing a biopsy, Is it just that there's commentary to support or is it you think this is enough to actually justify the payment?

Speaker 4

Yes, Andrew. So I'll make a few comments and then I'll let Robert make additional comments there. The way we have rolled out the new test requisition forms, we basically specifically ask the information that ensures that So, yes, if they are complete, that would mean that they are billable. And what the numbers that we have been sharing in our call, I would say the 90% plus of those forms, they are basically billable to Medicare. Okay.

Speaker 2

That's helpful.

Speaker 5

And then, I think when we initially spoke kind of after The first of the billing articles came out. There was some conversation around some incremental data, some things you could do on multi modality Sooner versus later, I think potentially the comment was within sort of a month of that early March start. Can you give us an update for where you are in terms of Driving more confidence in multimodality as opposed to single modality as a path forward?

Speaker 2

Yes. Andrew, I mean, I think Molson and Adaldi, I'll make some comments and hand it over to Robert. But this is an area where we've obviously Seeing a lot of cleaning utility and demand from the marketplace given to the complementary technologies that will come. And I think we've had very good active dialogue with Molinix as part of that. So, Robert?

Speaker 8

Yes. We certainly think there's sufficient evidence to demonstrate listen. The validity and the utility of heart care are primary multimodality that we'd be discussing. There's even several independent publications So we discussed our approach with MolDX, and they requested we submit some data. So we're preparing a detailed analysis that we will

Speaker 5

Great. That's good to know. And Lastly, I know you made sure to point out no not anticipating a need for cash. We did see during the call a shelf get filed. So just A little bit of thought, is that just corporate housekeeping?

Speaker 5

Anything we should be thinking about, kind of any comments in regards to those two things as they fit together?

Speaker 4

Sure. I'll take this one, Andrew. And then I just want to highlight that we as a company have been extremely prudent and you would be able to see this from our performance in the last few quarters that we have been very focused on managing our cash. We ended the quarter at 2 of $6,000,000 in Q1, Ben. Last year, we used almost like $20,000,000 This year, we were positive on the operating cash flow generation.

Speaker 4

So that basically shows the importance of cash for us as a management team. And this is going to stay the focus that As we assess and as we basically build a better understanding of the financial impact here, we've attempted to make sure that we are doing the right things so that we don't have to raise cash.

Speaker 2

Yes. It's just part of standard housekeeping. And as we mentioned in prepared remarks, there's no plan to do any raising. Thank you.

Speaker 5

Great. I'll stop there. Thanks guys.

Operator

And our next question is from the line of Brandon Couillard from Jefferies. Please proceed with your question.

Speaker 2

Hey, thanks. Good afternoon. I have a check on the $8,000,000 to

Speaker 9

$9,000,000 listen to the late March orders that you expect to submit in 2Q. Isn't there a chunk of additional orders in April May? Listen. Also getting deferred, so I don't think about recouping that, but also a portion of

Speaker 4

It was very difficult to hear you, Brandon. I'm sorry. If I were to You're talking about the $8,900,000 of tests that we did not submit in Q1 that we plan to submit in Q2. So it's a question around the revenue recognition for those tests.

Speaker 9

Yes, that's right. I'm talking about the $8,000,000 to $9,000,000 that you didn't submit in March, but you expect to recognize in 2Q. Isn't there another chunk listen in 2Q that would also get pushed out. So how do you think about the magnitude, I guess, of those two numbers?

Speaker 4

No, I think that's the part of the complexity, right, Brandon, that we are trying to get better handle on. So For example, the adoption of the new or the new test acquisitions that we are seeing where the adoption has been about 50% and it has improved to 60%. There will still be remaining 30% to 40% that will come in Q2, where we will have to go back and supplement the information listen so that that meets the requirement of the new billing article. And then to your point, till the time we have been able to collect that information On those set of forms, we will not be able to recognize the revenue. So you are right that there will be more like a listen.

Speaker 4

Lag now on some of those tests that we were able to recognize revenue very easily in the past.

Speaker 2

Yes. And Brandon, part of that is why also Abhishek factored that into the consumer guidance. I would break this into the time point of March 31, the effective date. And I think listen the test from that pre effective date was submitted. I think what you're hearing from us is that given the changes in the billing out of requirement in different forms that If we have them complete on new forms and in the right format, then those will be submitted.

Speaker 2

And I think we've communicated Yes. They're trending at the 50% mark in May, now trending at 6% mark. We continue that to increase. For those other tests, we will go back to the centers and request that information. So that's of the lag curve that you're talking about.

Speaker 2

But we'll have a better feel on that adoption rate, which is why that's so critical.

Speaker 9

Okay. That's helpful. And then the $40,000,000 to $50,000,000 of targeted cost savings, can you bucket that for us between of the 3 OpEx lines, R

Speaker 7

and D, SG and A and sales

Speaker 9

and marketing. And is that net of additional remediation costs that you're having to spend all the list

Speaker 5

of questions. So I

Speaker 4

would say that, yes, listen. Instead of providing you the color, breakdown the COGS and the OpEx, I think this is kind of so recent That we are still I'd probably just tell you that it's primarily related to the headcount, a lot of actions that we have already taken. And then those headcounts are basically cutting across, I would say, different P and L lines on the R and D on S and M and the G and A. On the COGS side, you will not see a lot of headcount reduction as of right now because we are still processing of the tests that we are receiving. And as we basically build more understanding of the volumes and everything, we'll probably see.

Speaker 4

But at the same time, Any actions that we were supposed to be taking on the headcount, we've already taken those actions. And then, of course, some of the other pieces that I highlighted list that we're looking into the discretion spend, the legal spend and focusing on the rightful studies on the clinical trials and everything. So there are a lot of pieces there. And I would say that we are looking across all functions. It's fairly sizable from the magnitude standpoint.

Speaker 9

Okay. Last one. You do have a buyback authorization out there. Is that currently being listen contemplated given the sell off in the stock? And number 2, what are the prerequisites exactly to feeling comfortable enough to list.

Speaker 9

Reestablish guidance to help us understand what you need to see and get clarity on before feeling comfortable putting that back out there. Thanks.

Speaker 4

Sure. So on the share buyback, we put a pause on the buyback after the billing article came. So that's the first answer, Brendan. And once we get more understanding, then we will make a decision on that one.

Speaker 2

Yes. I think also on the guidance, I'll I'll make some comments. I'll also let Abhishek talk more about it. I think we've talked about we're 4 weeks in, so we have some lead indicators now. And I think the other things that listen.

Speaker 2

Abhishek was going through, I think the key ones is understanding that adoption, for example, and that uptake, which we're trending at the moment. I think the other thing is understanding when, for example, Meridian adopts the first or the second of the billing articles they have in this time point. I think also discussion with MolDX. They've done 2 revisions within 8 weeks as well during this time. I think one of the other key variables is that of our control centers.

Speaker 2

And so I think, for example, we've gone back to some of the centers and these large institutions and They're fully supportive of what we do as a company and have gone back to the IT systems

Speaker 7

that

Speaker 2

takes a couple of weeks. And then we have the meeting with IT systems that takes a couple of weeks. So In other words, with best practice, you have centers wanting to work with us. And as you're aware, to schedule these IT listen to the meeting sometimes in a normal scheme of things takes up to a year. So I do think there are these variables, which I think we'll have more insight into and I think we communicated in prepared remarks, we'll look at that, at the next quarter.

Speaker 2

But I do think we'll have certainly more of these lead indicators and Sort of more understanding of some of these uncertain variables. Abhishek, anything else to add?

Speaker 4

You guys are saying that.

Operator

And our next question is from the line of Mark Massaro with BTIG.

Speaker 10

Hey guys, thanks for taking the questions and sorry to hear the headaches from this new policy. My first question, I understand of course that you suspended the 2023 revenue guidance. I just wanted to make sure that it would be logical that you're also suspending your adjusted EBITDA positivity goal in the first half of twenty twenty three.

Speaker 4

And that's true, Mark. We never guided the adjusted EBITDA. That was basically our goal. Listen. The guidance was around the revenues and that's the reason we were more explicit in calling that one out.

Speaker 4

But of course, given all the impacts and everything, listen The adjusted EBITDA goal for the Q2 is not there anymore.

Speaker 2

Yes. One thing, Mark, I think it's an excellent question because I think in our prepared remarks, we really wanted to focus on the listen. Elyse mentioned the operational execution and the plan that we had in 2022 and how we continue that into 2021. I mean, I think what we once included the impact of March test, we had the adjusted EBITDA of $2,500,000 which happened during what we had sort of projected and why we had this operational focus. And We thought part of that commentary might have been lost if we didn't mention it upfront.

Speaker 2

So I think it's a good reminder of what we've executed as an organization, particularly over the last 6 to 9 months to get there and listen focusing on those 3 Cs, which remain unabated and a core focus for us. But yes, I think Abhishek has answered where we are with that position in the course of the billing

Speaker 10

Okay, great. And Medicare is not your only payer. So I'm curious if you've had conversations listen with any commercial health plans, whether or not they have any intent of following the new Medicare policy.

Speaker 2

Yes, Mark. That's excellent. We talked about the 3 Cs. And I think what we've demonstrated with, firstly, the first C with collections is that we can build an excellent plan and execute on it. And I think that's where you're seeing these collections exceeding the revenues and adding to the cash each quarter.

Speaker 2

So we're really excited by what we've been able to do there. On the prepared remarks, you probably heard about coverage. And I think this is an area where we you're right. There's significant opportunity in other areas including listen where we've covered ICHLT guidelines getting all the coverage for on the AlloMap. And I think also as we look at some of the areas both We have active areas of both on the kidney and the heart side that we're working on to share some news with in the next few months, which I think will be positive for the organization.

Speaker 2

So I do think this is the next stage of an area of significant opportunity for us. I do think there are multiple areas working with payers where We can talk about all the great work that we've developed the science supporting our products And I think this is well underway. So we feel good about what we'll be able to share in the next few months on the commercial side of things. Again, listen. It all starts with the plan, Mark.

Speaker 2

And I think we did this deliberately last year with the 3 Cs. We're really executing the collection side. You're seeing that flow through. And I think now As we work with our commercial coverage team, we're starting to see some really exciting good discussions, which we'll share more in the next few months.

Speaker 10

Okay. You guys have been committed to data development and one of the large studies you're working on is the SHORE study. Listen. It would seem that if you could publish perhaps an interim readout of that, I think the goal is to enroll I think 3,000 patients. But I think if you were to put out an interim readout that might help satisfy perhaps CMS.

Speaker 10

Can you give us a sense for 1, whether or not you think that's true? And 2, what are your plans to Potentially show interim data like when do you think we might be able to see that?

Speaker 8

Hi, this is Robert. So We're actively working on that. As you know, when you start one of these clinical trials, you start enrollment, but it takes time to get the full enrollment started and then you have to follow each of those patients for the assigned number and amount of time. And in the middle of SHORE, COVID happened. And so enrollment took longer than we expected.

Speaker 8

That kind of explains where we are today. However, we do have the same goal that you've mentioned of listen and read out as soon as we can put one together. So we're actively in analysis of the data we have and working with our clinical operations group to to ensure we've got quality data that we're working with to produce a publication.

Speaker 10

Okay. Thanks. Maybe last one for me. I think this has been asked, but maybe I'll try again. So you guys talked about the 50% in April, now 60% on the forms.

Speaker 10

I think what we're trying to extrapolate is, does that suggest the sort of an impact of up to 40% of volumes going forward. And I think related to that, I think another transplant player in the space Talked about, I think headwinds of somewhere around 10% to 15%. So I guess I'm trying to marry the 10% to 15% I heard yesterday to trying to interpret the 60% metric that you gave tonight.

Speaker 4

Yes. Let me take a shot at it, Mark. So the adoption rate that we are providing of the new of TRF that 50% and it has gone up to 60% in May. So for the remaining 30% to 40%, we will still go back to those of transplant centers and we will require or request for that information. So there's an additional administrative burden there, But that doesn't mean that you cannot recognize the revenue.

Speaker 4

So it's not lost. So I think I just want to make sure that that's pretty clear. The other piece that you're probably looking for, I don't know what is that 10% to 15%, but maybe the other piece that we discussed in the call was around this listen to the initial impact on the volumes, the early indicators that we have seen that I basically discussed earlier. So that's the only other piece that On the volumes, the early indicators, some of the headwinds that we are seeing.

Speaker 2

Yes, Mark, I think just to be consistent, I think the Initial disruption volume trends, I think, were fairly consistent with what others have said actually. If I looked at the range, I think Abhishek had shared, it was the listen. Teams, right? And I think that's consistent with what we've heard from others. I think what you're sharing what we're sharing here is that we as a company, listen we take what we do seriously.

Speaker 2

And I think at the same time what we're doing is the forms have to be updated and we know that of systems have to be updated and we have responsibly to that, which is what we're doing. I think if certain centers who are on EMRs and we're dependent on them, we can't say let's list submit all forms just because they've been sent over because they need to be we need to go back and say, can you please clarify? I just want to make that important distinction, Mark, As a company, that's important for us to follow that process and that's what has been requested. So that the good thing about that is it's time to go back to those centers as part of what's allowed in this process. But we just want to make clear that it doesn't mean it's lost volume.

Speaker 2

It means that What you do is you want to make sure what you submit is what's being required. And I don't know if others certainly have a list of emails where they can certainly if they haven't changed them, then they need to be updated at those centers.

Speaker 10

Okay. Yes, that makes sense. Thank you for the clarification.

Speaker 2

Absolutely. Thank you.

Operator

And our next question is from the line of Alex Nowak with Craig Hallum Capital.

Speaker 7

Okay, great. Good afternoon, everyone. Maybe a similar question along the same vein. The $8,900,000 of revenue that was withheld to the reimbursement here in Q1. Is that basically an absolute worst case scenario of what the impact to revenue and volume Could be from March 7 to the end of Q1.

Speaker 4

So basically, these are the tests for our AlloSure Kidney Medicare and these are the all the tests, Every single test because we did not bill anything during that period. So yes, you are right.

Speaker 7

But it includes for cause and for surveillance. I guess I'm trying to understand it or is it only surveillance?

Speaker 4

No, it includes every single Medicare test.

Speaker 7

Okay, understood. And then I just want to be clear. So on one hand, you're making these big cost cuts, you're laying off 12% of the workforce a list At CareDx. But on the other hand, you're also saying you're going to challenge Neuridian directly. You're saying that the billing articles aren't consistent with the LCDs you opened up with that, That Neridian still needs to pay for these tests.

Speaker 7

So is that challenge to Neridian a bit of a Hail Mary out there And potentially pushing them to maybe not implement the MobyX policy.

Speaker 8

This is Robert. I think what we said was that we believe these are changes. I don't know that list. There's a specific challenge to Neridian there. We will, of course, follow them as the we've worked with Molbex to make sure that we understand and what we need to follow-up.

Speaker 8

We do believe that these are changes and we'll work to address that as you've seen

Speaker 7

listen.

Speaker 2

Yes, Alex. I think in our prepared remarks, we had numerous discussions with MolDX and planned our full discussions with them. We also reached out to CMS for the matter and plans

Speaker 3

to reach out to Meridian. So I think this is dialogue.

Speaker 7

Okay. And from the CAC meetings that were in November and also from the coverage policies that came out, It looked like it was pretty clear that Medicare wanted more utility data on the surveillance population. I think they even said that and one of the KOLs said that during the CAC meetings. So beyond new forms, You had the K OAR study, which did have a big surveillance aspect. When should we expect to see more data from K OAR get published in a peer reviewed journal?

Speaker 7

And then other than forms, what other data could you show to generate why using cell free DNA, why using gene expressions in one of these patients It's ultimately better for patient care in both the for cause and the surveillance setting.

Speaker 2

Yes, Alex. I'll let Robert, add some more commentary. But I just want to go back to what we shared before. I think if ourselves and others have seen this team's sort of impact, what we're sharing is that with the remaining, those percentages is what we're working with is getting that updated. And I think that's the key.

Speaker 2

And I think listen what we've seen is the getting the right forms is the focus and the faster we do that the better. So I do think That has been the focus of how do we ensure that as we've as with others have had this teen impact, then what do we do with all the forms that are coming out? It's making sure they're compliant and what we see per the billing article request. So Robert, I don't know if you want to add more in terms of list of payroll data plus also some of the areas that Alex asked about.

Speaker 8

Sure. We've got multiple approaches to this aspect of of evidence generation in surveillance. And one of those of course is K OAR as you mentioned. It is a more mature study. It's been around longer than SHORE and of the same requirements that I mentioned for sure, but the additional requirement that as if you're looking for listen to have a measure of surveillance, you need to have the full time course for all of the patients.

Speaker 8

And so as that nears completion this year, Then we'll start working on those and analysis and publications. We don't have a timeline yet.

Speaker 7

Okay. Understood. And then just a last question. Just any status update of of the DOJ investigation, the state inquiries. And were any of these inquiries related to the reimbursement that MolDX ultimately changed?

Speaker 7

And then I saw there's a lawsuit you filed against your liability insurance provider. Just what was that for?

Speaker 4

Yes, there isn't any material update on the DOJ and the SEC side of the side. And I didn't catch the second part of your question if there was any.

Speaker 7

Yes. I mentioned it was in the 10 Q. It mentioned CureDx filed a lawsuit against Your liability insurance provider?

Speaker 4

Yes. So maybe that is basically that we might have initiated something with our insurance provider to recover some of the expenses that we have incurred on some of these legal cases.

Speaker 7

Got it. Okay. All right. Thanks for the update.

Operator

And our next

Speaker 11

Maybe one just on how you're thinking about the market overall sizing it up at this point, assuming This policy plays out as it's written, I guess. So how do you think about of the overall testing opportunity for AlloSure kidney. Thinking about the number of new kidney transplants each year as well as the number of patients living with a kidney who would be more likely surveilled. I guess just how do you how are you thinking about the testing opportunity now?

Speaker 2

It's a really good question about the market dynamics. I think one thing that hasn't been covered as much, I think we've talked about the impact on of the market and we obviously continue to beat the market growth as a company. But as particularly at ICHC, of for example and in other meetings that there's a real excitement about what some of these organ transfer, organ perfusion companies can do plus also with some of the other list of the latest approaches to expand the organ base such as using NRP. And so as we look at this and we've always had this as part of our listen. Longer term look at the transplant market is that it has potential to double number of transplants in space.

Speaker 2

It's a really good point because I do think transplant is a fairly unique space and I think it's one which still has that ability to grow. I think we talked a bit about the kidney side with living donors being of the most impacted during that COVID period and haven't reached its sort of previous peak point post COVID. But I do think it's as you look at the space overall, there are multiple players entering to say how can we sort of increase the number of organs or increase the viability organs Or how do we expand alternative types of organs for this space. So it remains to be active because at the end of the day, Mason, what you have is basically a lot of patients who don't have enough organs available and so that unmet need remains and you have Essentially, a large number of patients who get an organ, but this organ doesn't last a lifetime. And so I think you see the importance, for example, those New Times New York Times article by one of the unfortunately one of the patients who shared her experience with this where listen.

Speaker 2

She did pristine management of her organ, but where ultimately she was dealt with some of the secondary issues of long time immunosuppression with malignancy. So I do think it's a really good point of transplants can double, but also at the same time that we continue to play a role in this space because I think This space still has a lot of areas to grow, particularly if you think of the impact of immunosuppression in other areas that we can address. So really, really nice points, Mason.

Speaker 11

Yes. Thanks for that. And maybe to expand there a little bit, in terms of listen to the change in testing frequency. If surveillance patients, if you can only use these non invasive tests, listen when a surveillance biopsy would use be used, or for a for cause biopsy, That's the only time these tests could potentially be reimbursed. I know we're still figuring that out.

Speaker 11

But do you feel like AlloSure's listen to the question. Tam has shrunk. Do you still feel confident that it's a large opportunity based on this new billing policy? I guess just any additional color there?

Speaker 2

Yes. I think what we've seen along with others is this teen sort of impact in the first 4 weeks that's the lead indicator that we both have. And I think the goal now is of those, of the tests we received is how do you make sure that they can be filled in the right forms. But I think us and others have seen sort of a similar impact, which is around the teens, right? The high teens is what yes, is what was described.

Speaker 2

So I think for us transplant at the end of the day is a set of patients who we think should be treated listen in a way that gives them every opportunity to have that organ for life. And I think in many ways, They're a very unique group who actually have to face with lifelong an expression. They're a group who know that the organs, hysterically have failed. So For us, it's important to support that patient group. At the end of the day, that's our mission as an organization to do that.

Speaker 2

And I think that's really important. So I think it's still early. It's a really good question. But I think one of the things is we've highlighted it's early. We have for the full week of data and now we have a week of May to talk about.

Speaker 2

And I think the good thing is more and more information will come through during this time listen as part of that process. But the goal is to operationally focus. We've demonstrated during the course of 2022 that we were able to operationally focus, which is why We sort of wanted to get out front the Q1 results and also how we were able to deliver on that. And now we have a new plan, which is Alex and his team, how do they listen to the centers are operationally updated, the key gating step obviously being systems. So We can't force centers to update their EMRs, but there will be a subset of centers which will not have those EMRs up to date, right, and will take time.

Speaker 2

So I think that's really important for us to focus tone as well.

Speaker 11

Got it. Thanks for that, Reg. And last one for me here. And I apologize if you guys have answered this, but In terms of the centers that have integrated their systems and are up and running, so to speak, have you seen A difference or a decrease in orders from those centers in general, are they still using Alloster kidney at the same frequency as they previously were or has that changed at all? Are there any early indicators about how that's

Speaker 2

listen. Yes. I think everything's center by center. I think what we've seen is similar to others about this No, Teams impact. So I think at a macro level that's probably the what we've observed, what others observed as well.

Speaker 2

I don't know if there's any additional commentary the team has to that, but I think that covers what we've seen and others have seen at the moment across the business.

Operator

And our next question is from the line of Yi Chen with H. C. Wainwright. Please go ahead.

Speaker 3

Hey, this is Chetan on behalf of Yi Chen. I'm sorry if I missed this during your prepared remarks, but Could you provide color on the total number of centers you anticipate to indicate every quarter and subsequently hope to see Implementation of these new processes.

Speaker 2

Yes. What we shared is that the complete universe of heart, kidney and looking at not just centers, but also in a practice or community practice as well. I think we shared there were more than 550 in that total universe and the team has listen focus on where 90% of the volume is and that they've had 80% of those centers now currently educated as part of that process.

Speaker 3

Okay, great. Thank you. And the last one on of future catalysts. I know you made a brief remark about it, but and also you addressed a few in your question and answer session. But are there any other

Speaker 2

Yes. A lot of I think a lot of and I'll let Robert add as well. I think a lot of the good questions came out in terms of When do we have some additional updates on areas which heart care is being prepared based on MolDX feedback for resubmission. I think also Yes, some of the other analysts talked about on the kidney side and on the heart side some of the studies we're doing, so they're going prepared. I think when we talk about Catalyst flow.

Speaker 2

We were specifically talking about some of the new introductions. And so there would be things such as when active discussions still in allostor lung for example. I think another area was UroMet, which I think is a new modality, which provides a really interesting approach to the portfolio just given there are list commercially available urine tests out there and this comes from Cornell by the world leading expert there and also multiple New England Journal publications. So listen. I do think this space is welcome to additional types of what we call catalyst offerings, which I think the day is bringing new innovation to the space.

Speaker 2

And so, yes, there are other areas that we would look at particularly for UroMab for this year. Robert, anything else you want to add?

Speaker 8

I think on specifically about publications and I think, I've mentioned that those are of things that we work on as soon as we can from the output from the K OAR study and an interim readout on the SHORE study. Listen. Others are always in the works, but it's difficult to predict timing of publications that involve peer review, etcetera. So Hard to comment on timing of those. As Reg mentioned, we still are pursuing all of our catalysts.

Speaker 8

They're all of things that are of high impact to patient care and we want to make sure that we make those available for patient care as soon as we can.

Operator

And there are no further questions in the queue at this time. I will now turn the call back over for closing remarks.

Speaker 2

Thanks very much. I want to thank the analysts and the investors listening to this call and if there are any different folks or patients for example as well. And I think we listen. Know that it's been a tough time. We also know that what we do is a very unique space and one where I think there's obviously been some changes.

Speaker 2

And I think for us We had a specific plan in 2022, which I think we've continued to deliver on Q1. I think moving forward, we have an updated plan, which The team is committed to executing on now as well and addressing some of the newer challenges that come through. And again, we thank you for your

Powered by Quartr