Q3 2025 CorMedix Inc Earnings Call
Good day and welcome to the CorMedix Inc. Q3 2025 Earnings Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
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please note this event is being recorded.
I would now like to turn the conference over to Daniel Ferry of Life side advisors. Please go ahead.
Thank you, operator. Good morning and welcome to the core Medics. Third quarter 2025 earnings and corporate update conference call.
Leading the call today is Joe to disco Chief Executive Officer of cormedix.
And he is joined by Liz Hurlburt EVP and Chief Operating Officer and Susan Blum EVP and Chief Financial Officer.
In addition, Beth zelnik, Kaufman EVP, and chief legal and compliance officer, and Dr. Matt David EVP and chief business officer are on the line and will be available during the Q&A session.
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 1995
These statements are statements other than statements of historical fact, regarding Management's, expectations beliefs, goals and plans about the company's prospects and future Financial positions.
Action results May differ materially.
From the estimates and projections on which these statements are based due to a variety of important factors.
Including the risks and uncertainties described in Greater detail in chromatics filings with the SEC, which are available free of charge at the scc's website, or upon request from cormedix.
Cormedix may not actually achieve the goals or plans described in these 4 looking statements and investors should not Place undue Reliance on these dates.
Chromatics does not intend to update these 4 looking statements, except this required by law.
During this call the company will discuss certain non-gaap measures of its performance. Gaap to non-gaap financial reconciliations and supplemental. Financial information are provided in core medic, earnings release and the current report on Form 8K filed with the SEC.
This information is available on the investor relations, section, coremedx website.
At this time, it's now my pleasure to turn the call over to Joe to disco Chief Executive Officer of core medics.
Joe, please go ahead.
Thank you, Dan.
Good morning everyone and thank you for joining us on this call. This has been an exciting quarter in the evolution of core Medics as we announced and closed the acquisition of more Therapeutics in a combination cache and stock transactions.
This deal is transformational for core, Medics creating a diversified specialty pharmaceutical company with a broad portfolio of commercial and late-stage pipeline products.
as we announced in October,
we expect to capture approximately 30 million of the projected, 35 to 45 million of total synergies on a run rate basis before the end of 2025.
I'm excited to announce today that, as part of our integration, CorMedix Inc. will be rebranding as Core Medic Therapeutics.
And all employees will unify under this company name.
We're also adopting a new logo to signify, the go forward organizational, commitment to develop and commercialize novel therapies for the prevention and treatment of life-threatening conditions.
This past quarter marks, the most successful quarter from a financial perspective. In company history, registering record levels for revenue of 104.3 million net, income of 108.6 million and adjusted ibida of 71.8 million.
Our Revenue performance was largely driven by faster than expected adoption by our defend cast, LDL customer.
Utilization growth from our existing customer base.
As well as the partial quarter contribution from the Momento portfolio assets.
Based on the recent momentum, today we are raising our pro forma combined full-year revenue guidance.
from a minimum of 375 million to a range of 390 to 410 million,
In addition, we are increasing our previous guidance for pro-forma. Fully synergized. Adjusted, ibaa for 2025, from a range of 165 to 185 million to new range of 220 to 249 dollars.
On the business development front, we also successfully closed our strategic minority investment in Tera Inc.
This small strategic investment gives us a foothold in a late-stage critical care product that is highly complementary to our core Medics acute care portfolio.
It's part of the transaction core medic is granted a right of first negotiation to acquire Tara following the announcement of phase 3 results which we anticipate to be available in the first half of 2026.
We will continue to evaluate Tara in the coming months, as their clinical trial progresses toward completion.
With respect to Defend CV, we are very pleased overall with the utilization of Defend Cast and the outpatient hemodialysis segment during our initial phase of TADAPA. We have now begun planning with customers for the post-ADAPA add-on periods, which we expect will begin in July of 2026.
In line with our strategy to increase patient utilization of Defense during our post adapa add-on periods. We'll be working over the coming months to finalize. The pride pricing with customers under existing contracts based upon the final post to dapa add on framework as well as engaging in conversations with Medicare Advantage, payers following the publication of our real world evidence data later this year.
Lastly as cormedix evolves I think it's important for investors to begin focusing on important near and medium-term catalysts and value drivers for the company beyond the hemodialysis sector.
First, and most importantly, the second quarter of 2026 is expected to bring Topline data for the use of Rosso as prophylaxis of invasive, fungal infections.
We believe the total addressable market for immune compromised patients that are currently undergoing. Antifungal prophylaxis is more than 2 billion dollars.
The Phase 3 RESPECT study is running head-to-head against the current standard of care, which is a combination of posaconazole and an antifungal, along with trimethoprim, an antibiotic that also has antifungal activity.
Demonstrates. Severe drug-to-drug interactions with many medications that Target patient. Population is currently taking including imunos drugs like tacrolimus and cyclosporine as well as numerous Therapeutics used in treating hematological, malignancies, such as leukemia multiple myeloma.
Or non Hopkins, lymphoma all patient populations. That may undergo bone and Marrow transplantation as part of their therapy.
For these patients, Rosso used as prophylaxis against these invasive. Fungal infections could represent a new standard of care. That may allow patients to experience less drug to drug, interactions, less frequent dosing, and more flexibility in their setting of care for treatment.
Our second year term catalyst outside of hemodialysis is the expected expansion of Defense into the prevention of claps for adult patients. Receiving total parental nutrition or TPM.
Our most recent market, research continues to highlight the critical unmet, medical need and pervasively. High bloodstream infection rates in this patient population.
Prophylactic intervention is urgently needed for these vulnerable patients.
50 million and anticipate Phase 3 completion as early as the end of 2026 or beginning of 2027.
I believe that cormedix has done. An exceptional job of maximizing, the value of the initial to dapa period afforded to defend cast.
Has a long-term strategy in hemodialysis for post adapa periods and as we deployed cash flow into a pipeline that can position the company for long-term sustainable growth.
I am excited about the future.
I would now like to turn the call over to our Chief Operating Officer, Liz Hurlburt, to provide an update on clinical activities, operations, and integration.
Liz, please go ahead.
Thank you, Joe and good morning. The combined clinical development and operation teams, along with field. Medical Affairs have been working diligently on numerous clinical activities as we shared in late. September enrollment for the global phase 3 respect study, evaluating Rosso for the prophylaxis of fungal infections. In allergenic bone marrow. Transplant patients has completed. This pivotal trial is being conducted by our Global partner, Mundy Pharma and the team has begun to progress the program in anticipation of study closeout. The team continues to work closely with investigators and clinical experts in the field to deepen, our understanding of the evolving clinical practices and needs of these patients, we expect to announce Topline results from the respect study in the second quarter of 2026.
Turning to defend cast, I'm pleased to share that the phase 3 Neutra guard clinical study, which evaluates the reduction, in central line Associated, bloodstream infections or clabsi for adult patients. Receiving total parental nutrition via a central venous catheter has garnered International interest. In the coming months, we will expand clinical study sites into turkey to broaden the diversity of patients and potentially expedite enrollment timelines. At this time, we are still anticipating study completion by the end of 2026 or early 2027
Lastly, our real world evidence study in collaboration with us, Renal Care has entered the second year of data collection. The team is currently conducting an analysis of the first year of data, and we anticipate sharing those interim results, by the end of this year.
This study is designed to demonstrate the real world effects of the broad. Use of defend cap in a real world setting and examines not only the reduction in catheter-related bloodstream, infections or crbsi but also reduction in costly infection related hospitalizations
Secondary data points, of mistreatment sessions antibiotic utilization and TPA utilization are also being reviewed.
Now turning to integration progress, I am heartened by the significant efforts of the teams to both integrate and optimize operations. As a unified organization, we have made meaningful strides emerging the teams. Identifying synergies and creatively, preserving key elements of both Legacy organizations, in addition to our new corporate branding, as core medic Therapeutics, we have refined our mission Mission Vision and values as a new organization and our excited to see our integrated teams work together to create a new culture and execute together on key objectives. Currently all functional areas have fully integrated from a Personnel standpoint which includes clinical medical Affairs, technical operations, supply chain, Finance, legal quality, human resources and Commercial.
Systems integration is still underway and is expected to complete in 2026, in line with our original estimates.
The Legacy contracted hospital sales team for DefendCAP will conclude its service by the end of this year, and DefendCAP promotion in the hospital setting will transition in January to the post-integration internal field organization.
Beginning in early Q1 2026, our unified sales organization, covering acute care clinics and hospitals, will seamlessly support all promoted portfolio products, including both DefendCast and Rosso, and will offer enhanced capabilities in customer support.
The collective expertise of our team positions us to deliver comprehensive solutions to many challenges in the acute care space and ultimately with a goal of driving better patient. Outcomes. We are incredibly proud of the team and their hard work in moving this integration forward while continuing to focus on sales and patient access.
Profitability.
Our results demonstrate solid growth across the business, including strong performance from Defend, Cast, and growth in the Legacy Melinda product portfolio.
We closed the Melinda acquisition on August 29th, 2025 and therefore 1 month of its operations are included in our Consolidated Financial results for the third quarter.
The company has filed its quarterly report on Form 10-Q for the quarter ended September 30, 2025. I encourage you to read the information contained in the report for a more complete discussion of our financial results.
As Joe mentioned for the third quarter, net revenue was 104.3 million, including defend, Cast Sales of 88.8 million, representing a total, net revenue, increase of 77.5 million year-over-year.
Revenue totaling approximately 15.5 million reflects the contribution from Melinda for the month of September 1288 million of which was driven by milenta portfolio sales.
Operating expenses for the third quarter, for 42.6 million compared to 14.1 million for cormedix on a standalone basis. In the same quarter of last year
The increase of 28.5 million over the prior period includes non-recurring costs of 12.7 million associated with the transaction and integration, as well as Severance costs associated with the Melinda acquisition.
Other increases in costs were driven by stock-based. Compensation Opex, contribution for mental business and increased investment in R&D associated with expanded indications, for defend cast, including the phase 3, clinical study for prevention of clabsi and tpn patients
While costs have increased in these areas this past quarter, they are aligned with our previously communicated expectations and support our strategic priority, which is to position the company for long-term sustainable growth. In addition, as Joe mentioned, we are working to quickly capture synergies associated with the Monta acquisition.
With approximately 30 million of synergies on a run rate. Basis expected to be captured from actions taken prior to the end of the year.
We expect to realize these synergies in the P&L, beginning in the fourth quarter of 2025.
Overall, for the third quarter of 2025, we achieved net income of $108.6 million, or $1.26 per diluted share, marking meaningful progress compared to the third quarter of 2024, during which period we recognized a loss of $2.8 million and a net loss per diluted share of $0.05.
A large driver of net income for the quarter. Was a substantial tax benefit of 59.7 million due. Primarily to the realization of deferred tax assets equating to 100% of the cormedix historical net, operating losses or nols,
the recognition of this sizable tax benefit, underscores, our confidence in sustained future profitability, which will drive the utilization of our nol carry forwards against taxable income.
Which equates to cash tax savings and tangible value for the company. And for shareholders
Returning to non-GAAP measures, adjusted EVAa for the third quarter of 2025 was $71.8 million, up from a loss of $2 million in the third quarter of 2024, reflecting the momentum of our operations over the past year. This non-GAAP measure provides additional insight into our core operating performance and profitability trends.
Highlights the underlying strengths of our operations and excludes one-time acquisition-related costs.
stock-based compensation and the tax benefit, we realized this quarter
Please refer to our press release that we issued this morning for a Reconciliation of this non-gaap measure to gaap net income.
on the cash front, we raised gross proceeds of 150 million in a convertible debt offering and those proceeds together, with cash on hand and 40 million in common, stock issued to the seller were used to fund the acquisition of milenta in August 2025,
This financing strategy supported the transaction while maintaining what we believe to be a healthy liquidity position and flexibility for future growth Investments.
As a result, our cash flow during the third quarter, reflects the timing of these financing and acquisition activities and we ended the quarter with cash cash equivalents and short-term Investments of 55.7 million.
We expect significant cash generation in the fourth quarter driven by strong operational performance.
We anticipate ending the year with approximately $100 million in cash and cash equivalents, supported by ongoing positive operating cash flow and working capital optimization to drive this balance. We are guiding to fourth quarter net revenue in the range of $115 million to $135 million, reflecting continued momentum from defense and a full quarter contribution from Melinda.
And now, I will turn the call back to Joe for closing remarks.
Joe, thank you, Susan.
The third quarter of 2025 marked, a period of meaningful, progress, and disciplined execution.
We advance our strategic objectives, strengthened our financial foundation, and delivered solid results. While completing a transformative acquisition.
We remain confident in the outlook for the remainder of this year and the path to sustained growth and profitability.
And now like the operator open up for questions.
We'll now begin the question and answer session to ask a question. You may press star then 1 on each touchtone phone,
If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then 2.
Our first question comes from Les suleski with truist. Please go ahead.
Good morning. Thank you for taking my questions and congrats on the progress. Um, first on the faf, do you have the sense of, uh, inventory stocking versus utilization in 3Q? And, you know, we understand, you're not providing guidance for next year at this time. But how should we think about potential seasonality throughout the year or, or how ordering rates could impact? Quarterly, Revenue, Cadence, and then outside of additional cohort, expansion? Um is 4 q, implied guidance, I guess, uh, a good representation of a normalized utilization patterns and I have a follow-up.
Thanks Les. I'm going to try and uh make sure I got all these uh right. So um, in terms of third quarter stocking, I think our smaller customers from what we've seen are holding on average about 2 to 3 weeks on hand. Uh, the ldo is somewhere between 3 to 4 weeks. And I, and I think that's what we saw normalized. I say there was probably a couple million dollars shipped at the cutover that, you know, uh, if if you're trying to kind of back into, um, third quarter verse fourth quarter, defend cast, uh, revenue and and kind of where we're, you know, where we're trending. Um, so there was a couple million dollars right on that, right? On that cut off that, that probably that ended up getting captured in in Q3 that, uh, you know, a day later is going to be in Q4. Um, but from the most part, I, I wouldn't say there's a, a significant amount of stocking in, in Q3 just normal, uh, normal stocking that they hold on hand
um,
The second question, I believe was about, was about, uh, quarter to quarter guidance in seasonality. Um, I the business certainly the deaf. Well, we'll separate the defend cast business from the moment to business. Um, doesn't have a historic seasonality in terms of times of year where, where patients, um, you know, receive you know, hemodialysis more than others, you know, as we've been progressing over the last few years and we've added new customers, we've added new cohorts, we've continued to see right, an increase in utilization, um, and growth in growth in overall Revenue. Obviously, I think there's a lot of eyes focused on next year. Um, I don't know, at what point, we're going to be ready to to provide
Uh, Financial guidance for 2026. I think, you know, everyone's aware just by the nature of to dapa and the change that comes in July, there should be, uh, a little bit of front-ended right to the overall Revenue, not necessarily utilization for the overall year and we're still trying to figure out what the, you know, what the full year uh, is going is going to look like. Now, in the meantime portfolio, uh,
Again, they're not though a large number of them are any infectives. Uh, they're not, you know, cough cold uh type products. So you wouldn't see that type of winter seasonality? I I think the you know, there is always a small amount of of December stocking in into January of all products. I don't know that it's going to be overly material to the to the business case. Um, but we we don't wouldn't expect to see significant seasonality uh there as well.
To grow with our existing customer base. Um, and that's something that we are continuing to focus on over the, the coming months. And even in the post adaptive periods, a big part of our post adaptive strategy, uh, is the engagement with Medicare Advantage. You know, we we we currently believe, uh, the overwhelming majority of the patients in which defend cath is being used in the outpatient setting, uh, our Medicare fee for service patients. Um, Medicare Advantage is is now the largest cohort of patients. Um, uh
and uh, a big part of the opportunity, for our for our future expansion, uh, post adapa
And you had a follow-up last.
I do. Thank you. Um, I I so it is on tap. I actually. So is the real world evidence that, uh, mutually inclusive with, with agreements on Final pricing around the post tapa period. Um, can you provide maybe some sort of a sense of of uh your your inklings into the price, negotiation period, and into the uh, heading into July on the tapa. Um, side. Thank you.
Well, look, and you have to separate the real world evidence. In our view is is going to be most applicable and useful with Medicare Advantage. Right Medicare Advantage is not bound by, uh, the post adapa add-on. They have the flexibility to contract separately, right? That's the strategy we want to employ. We have very little market share right now of Medicare Advantage patients and we think it's a it's a compelling value proposition for the ma plan. Ultimately, they are the payer of the
Those Downstream costs those hospitalizations um, that that drive so much cost in the Health Care system. So we want to, uh, obviously with data, make the argument that investing in prevention, right? Is is, um, is going to save them a significant amount of of value on the traditional Medicare side. It. There's, there's not much of an opportunity for negotiation less. It's really based on, uh, when the ESRD final rule publishes, you know what, they ultimately determine, uh, is going to be the, the, uh, fee for service adjustment, and we'll work around that once it's published
Very helpful. Thank you.
And the next question comes from. Jason Butler with citizens please go ahead.
Hi. Thanks for taking the questions and congrats on the quarter, um, 2 for me, Joe. Um, first 1, you mentioned that the ordering from the ldo has been faster than than you'd expected. How is the use been in terms of the number of patients and the type of patients that the ldo has been using the product in and then, secondly, when we think about the, the the real world data coming at the end of the year, can you just give us some color about what to expect in terms of? You know, the number of patients the end points and how we assess the, the benefit here relative, uh, for example, to the phase 3 results, if that's, if that is at all relevant. Thanks.
All right. Thanks Jason. So um,
Yes. So the, so, the ldo, it wasn't just a matter of ordering write faster, right? We we the data we're getting from inventory on hand demonstrates that the utilization is also faster than what we expected and the ramp. But I know that we had guided previously, uh, that the expectation was to Target initial rollout of of 6,000 patients. Um, we don't have today an exact number of where we are. We believe we are significantly higher than 6,000 patients. Um, and you know, we're we're so we're we're pleased with the with the roll out but we don't have the ability to give a a patient number at this time in terms of um kind of the the stratification. I don't know. If you were asking about high risk or type of insurance, you know, we don't have great visibility into that data. I think our expectation is that it's mostly fee for service patients. Um, at this time and that there's an opportunity with with uh, with Medicare Advantage
Uh, on the real world evidence. Uh, question I'm going to, uh, asked Liz to address. Sure. Hi Jason. So we are expecting the year 1 results to come out, uh, later this year, uh, it's approximately 2,000 patients. So we're we're double what we had in our faith 3, Lockett study. Um, and we expect that we're going to read out data on the reduction in in actual crbsi reduction, in hospitalizations due to crbsi. Um, there are some secondary end points, we're looking at as well, miss
Treatment sessions utilization of TPA and antibiotic utilization.
Um, and those are all being compared to the historic infection rates. So we should have that out. Uh, sometime in the next 6 to 7 weeks.
Right. Thank you for taking the questions.
Thanks sure.
And the next question comes from. Rowana Ruiz with lorinc Partners. Please go ahead.
So far, how should we think about the second half? 26 revenues and pricing Dynamics posted Dappa. And what are some of the pushes and pulls that could drive the St. Cath revenues either higher or lower after the cdap period.
Uh, thanks Rana. Um, you know, as I, I, I, I think I said, uh, you know, it's a less, you know, we're we're not in a position to give a lot of clarity right now. On on that back part of 26. Um, obviously we do know, there's there's going to be price compression, right? Because it's going to shift from the ASP method into the into the post, adapa add-on, um, absent the passing of of legislation that is, is current pending currently pending before the Senate, um, but the pushes and pulls would be, you know, related to how, uh, CMS does, uh, the calculation for utilization. Um, the, the method that they had proposed, uh, in the in the uh, in the proposed rule, uh, which we commented on would have created a or will create a, uh, a dynamic where the adjustment for the Q3 and 4 of 26 is is lower than the adjustment for 27. Um, and if that's the, the framework, I think we're prepared to to work around that. We're just waiting for, uh, a final, uh, determination in in the final rule. Uh,
Which was expected a couple weeks ago. I know the government shut down as delayed quite a few things. Uh we're expecting to come, you know, any day now. Um and you know once we have that we'll be able to finalize things with customers and and uh just continue moving forward.
Got it. That's helpful. And another quick follow-up for me, I was curious with your discussions with customers into the post tapa period. What are some of the goals of these discussions? And what data are you bringing forward right now to help those, uh, discussions as well?
Well, look, I think the real world evidence data is going to be critical, right? And and that should be, you know, even though its interim midpoint data, uh, available by the end of the year. And I think the ability to demonstrate the the impact on the Healthcare System. Uh, is is an important 1, you know, we've gotten anecdotal feedback, uh, from multiple customers that they've seen a noticeable difference, right, in in, in their infection rates, I know that's not data, right? But it's, if, if they are feeling it and Visually, you know, seeing it, uh, certainly that's a positive and something that we want to, we we want to build on
Got it, thanks.
And the next question comes from Brandon folks, with HC Wayne Wright. Please go ahead
Hi. Thanks for taking my questions and congrats on all the progress. Um, 2 From Me Maybe Just firstly any color on how you're viewing, the defend cast inpatient opportunity. Um, you know how's that progressing? And how do you expect that to progress in? 26, just given the scale and relationship.
trips that Melinda brings in that setting and then maybe secondly, um,
Just changing gears to niad.
You know, how are you thinking about that investment?
Uh, well, Intel Farah, but sort of niad as a product, you know, it seems like a product. You can sort of Simply drop into your commercial infrastructure and drive pretty strong ibido accretion on day 1.
Is that how you think about the product or do you think there's material investment required behind that opportunity? Should you execute on your options? Thank you.
Thank you Brandon. Thank you, Brandon. So, um, look on the inpatient side, I think we're continuing to, you know, over the course of this year. We've seen good progress. Um, you know, I I say it's it's a drop in the bucket. Compared to the the magnitude of the of what we've seen outpatient, but it has been, uh, good steady growth, um, over the over the course of the year, uh, as Liz mentioned in the script starting next year. Uh, with, you know, as we are migrating from the Legacy contracted field team that was inpatient for cormedix into the new combined. Uh, field team post Malone, integration will be training that team in December, uh, on defense Cath and in January, they'll begin, uh, promoting in the inpatient.
Segment. So I do expect to continue uh, to see lift their uh, as a as a good opportunity for growth and as we've talked a lot about uh, over the last 2, 2 years while the inpatient volume might be lower, right? The the pricing, there is a little bit better and the revenue per per patient higher, right? So it's so it's a good profit uh, opportunity right for defend cats in in the inpatient setting.
Farah. Um, I imagine there's some amount of of marketing expense related, uh, but I think from a sales deployment standpoint, you know, our current expectation as it fits very well with our existing call points.
Great, thank you very much.
And the next question comes from Sergey Benz with nidam and Company. Please go ahead.
Hi, good morning. Uh, couple for us Joe. Uh, the first 1. Can you just give us an update on the the pricing of death and cats over the um the the third quarter?
and then, uh, on to dapa, um,
Sounds like the es ESRD rule is going to determine uh, the calculation for post the post period starting in July. Um, are you going to be able to provide guidance once that the SRD rule is published? And then secondly, are you aware of any uh, legislation bills in Congress? Um,
That can modify uh, the tadapa reimbursement. Thanks.
All right. Uh, thanks search. Um, in terms of you know uh specific pricing on defense, obviously we don't we don't give that, you know, we have we have guided historically that quarter over quarter slight erosion based on the structure of of the agreements. Um, we track, uh, you know, typically our our ASP is is um, you know, a discount off of
Our selling price is a discount off government ASP, which is kind of tracked down, you know, quarter over quarter. Um, but volume is as, uh, obviously grown significantly to more than offset. Um, you know, the, the changes in price. So, I I think that to Dapper Rule and the methodology will inform, you know. We, we, we set agreements in place with all of our customers, right? And there were there were formulas laid out for how pricing needs to be determined. I think 1 of the things we're waiting to see is, is that Dynamic whether or not, um, the, you know, CMS uses a methodology where, where the Q3 and 4 of 26 will be uh, lower than 27. And and if that's the case, we may try to uh, negotiate a blended price over a period of time. Um, but you know, that's really the only Nuance that that we're looking at. I I don't again don't know that I would want to give any customer specific pricing. Uh but we'll, we should be able to talk a little bit more directly uh in the early part of um, of next year about what we're going to see for the back part of the year.
Um, and then lastly, in, in terms of the legislation, um, there, there there is a bill that was proposed by, uh, Senator Booker Marshall Blackburn, bipartisan bill. Um, that would make significant changes, uh, uh, to to dapa in terms of incentivizing innovation. Um, I think, you know, most importantly it would expand the ASP based pricing period, from 2 years to 3 years. Um, it would make the post adapa add-on permanent but also have that add-on tract drug utilization.
Um, in terms of we follow drug utilization, you know, right now uh the methodology CMS uses. They bundle eyes based on market share of total dialysis. Um, irrespective of whether drug is dispensed, uh, the proposed methodology in in in the legislation, um, would would allocate that market share, based on uh, percentage of drug claims submitted over time. And I think that's a that's certainly a better measure and hopeful that that that legislation can make its way uh, into law in the early part of next year. I know the government shut down as has stalled quite a few things. Um, but hopefully the the new Congress in early, uh, 26. Um, you know, can can advance that forward
Thanks Joe.
I'll now pass it to Dan Ferry for roots and questions from the audience.
Thank you, operator. Uh, Joe, we had quite a few here, but it looks like a lot of them were covered during the live Q&A. I do have 1 additional 1 though.
Uh, that you might help us out with here. What do you think is misunderstood?
Regarding the Melinda transaction and why our investors are not crediting the value.
Of Melinda.
Quite a few questions around. What's going to happen in the back part of the year next year. Uh, with faf and you know, the momentum based business gives us, you know, a good stable base of revenue from which we were able to take operating synergies and and and you know really um you know entrench the business in a second. I think Rosso prophylaxis as a pipeline opportunity um is certainly not being valued appropriately. Um this has the potential to be a larger uh Peak sales product than than even defense. Um right you've got a total addressable Market over 2 billion dollars. You've got um, a market segment that is already getting uh, prophylactic Andy fungal, uh, therapy, right? Uh, these patients that are immune compromised. Um, so it's not as if we have to change patterns similar to the launch of Defense where nothing was being done prophylactically. We really had to change mindsets. This is a different situation. Where prophylactic action is already being taken and the standard of care.
Has some deficiencies with it, right? The severe drug drug interactions. I don't think should be discounted, um, the ability to, to shift to weekly dosing to to perhaps increase convenience for the patients. Um, as well as a large amount of the dosing, uh, or or Administration would be in an outpatient, you know, Hematology Oncology Clinic setting, uh, which is buying Bill reimbursement. Right. So, I think there's a lot of favorability, um, and opportunity around, uh, Rosso prophylaxis.
As a as a future growth driver, um, of the business as well as TPM, right? Um, I think we're excited about the opportunity for tpn, we've just done some updated, internal market research, right? That is has confirmed, you know, how high the infection rates, uh, are and that patient population, how much the doctors are looking for an intervention? Um, so I think you know, we're we're we're excited about the the, the future growth, uh, prospects for the business outside of hemodialysis. And I think that's that's an those are important catalysts that I think investors need to start focusing on.
Excellent. Okay, thank you. Joe
Operator, you may now close the call.
This concludes our question and answer session. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect