7/30/2025

speaker
Conference Operator

Health First Quarter 2025 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. I will now turn the conference over to our host, Garen Serafian, Investor Relations at Bosch. You may begin.

speaker
Garen Serafian
Investor Relations

Good afternoon, and welcome to Bosch Health Second Quarter 2025 Earnings Conference Call. Participating in today's call are Thomas Appio, Chief Executive Officer of Bosch Health, and JJ Charon, Chief Financial Officer. Before we begin, I would like to remind you that our presentation today contains forward-looking information. We ask you to take a moment to read the forward-looking statements disclaimer at the beginning of the pages that accompany this presentation, as it contains important information. Our actual results may vary materially from those expressed or implied in our forward-looking statements, and you should not place undue reliance on any forward-looking statements. Please refer to our SEC filings and our filings with the Canadian Securities Administrators for a list of some of the risk factors that could cause our actual results to differ materially from our expectations. We use non-GAAP financial measures to help investors understand our operating performance. Non-GAAP financial measures may not be comparable to similarly titled measures used by other companies and should be considered along with, but not as an alternative to, measures calculated in accordance with GAAP. You will find reconciliations of our historic non-GAAP measures in the appendix of the pages that accompany this presentation, which are available on Bosch Health's investor relations website. Finally, the financial guidance in this presentation is effective as of today only. We do not undertake any obligation to update guidance. Our discussion today, Wednesday, July 30th, will focus on Bosch Health excluding Bosch and Loan. However, we will briefly comment on Bosch and Loan's results announced this morning. We will refer to -over-year comparisons with the same period last year, unless otherwise noted. With that, I would like to turn the call over to our CEO, Tom Appio. Tom?

speaker
Thomas Appio
Chief Executive Officer

Thank you, Garen, and welcome to everyone joining our earnings call today. In the second quarter, Bosch Health, excluding Bosch and Loan, continued to perform strongly, delivering our ninth consecutive quarter of revenue and adjusted EBITDA growth. I am proud of the great work by our team, especially as we navigate a more uncertain macro environment. Let me take a moment to share a few highlights from the quarter. We delivered -over-year revenue growth of 5% on both the reported and organic basis, leading to 10% adjusted EBITDA growth for Bosch Health, excluding Bosch and Loan, driven by double-digit revenue growth in Salix, Solta, EMA, and Canada. We continued to resolve legacy matters in the quarter. We announced after the quarter that we entered into an agreement to acquire direct corporation, which if all closing conditions are satisfied and the acquisition closes, will enable Bosch Health to use its hepatology expertise to develop direct main treatment for alcohol hepatitis. Therefore, we are reaffirming our full year 2025 guidance for revenue, adjusted EBITDA, and adjusted cashflow from operations. The second quarter was another strong quarter of performance where we made progress against our strategic priorities. First is unlocking value. As a reminder, we completed a $7.9 billion debt refinancing on April 8th, which extends our maturities with the options for additional proceeds in the future. We remain active in our efforts to improve our capital structure and are currently evaluating opportunities to take advantage of strong market conditions to address selected upcoming maturities. Just this past week, we announced actions to reduce debt maturing in 2026 and pay down our accounts receivable facility to reduce high interest debt and improve our capital structure. Unlocking value is a key focus and we are evaluating every option to maximize returns for our stakeholders. Next is growth. The second quarter was an excellent quarter of growth for Bosch Health. We achieved 5% top line revenue growth, then leveraged it to 10% bottom line adjusted EBITDA growth with nine consecutive quarters of year over year top line and adjusted EBITDA growth for Bosch Health, excluding Bosch and Long. The diversity of our core businesses across segments and geographies demonstrate both our resilience and momentum. Revenue for our Salix and Solta segments as well as EMEA and Canada regions within international grew double digit. Segment profit for Solta and Salix also grew double digits. The second quarter was our sixth consecutive quarter of top line organic growth in our Salix business where our segment profit increased 21%. Salix grew by 12% on both the reported and organic basis versus the prior year period, driven by Zifaxin's 10% growth in the quarter. Growth came across both indications, overt hepatic encephalopathy, OHE and IBSD, and multiple channel segments, retail and non-retail. 67,000 new patient starts were initiated in the second quarter, up 8% versus the prior year. Growth was driven by increased OHE media investment as well as Salesforce focusing on driving new patient starts as we continue to innovate using our customer insight engine. Given the incredibly high success rate and adherence that we have seen with this AI based platform, we are beginning to leverage these capabilities for Relistor to further support sales initiatives. Solta's strong double digit growth driven by South Korea repeated this quarter. And while growth in China temporarily soften due to tariff related headwinds in April and May, we remain confident in our ability to grow in these core markets. We also had another quarter of growth in Canada, the United States and EMEA. In June, 2025, we started shipments of our next generation Fraxel after US launched in this past April. These are positive indicators that point to Solta's growth opportunities beyond the Asia Pacific region and we continue to invest behind additional growth opportunities in this business. Within the international segment, our EMEA business sustained its ongoing trend of organic growth with 6% in the second quarter, marking the region's 10th consecutive quarter of organic growth. It is a broad footprint and diversified portfolio with no single drug accounting for double digit share of net revenue, minimizing the concentration risk and reinforcing the appeal of this business. In Canada, our team is executing against our plans for each promoted product offering alongside the many growth initiatives we have in place across the portfolio, yielding solid results. CabTrio's launch in Canada has been successful as we continue to broaden patient access with the goal to position CabTrio as a leading acne treatment in Canada. Realtris, another promoted product has gained steady traction since its 2023 launch in the Canadian market. Now turning to innovation. We continue to focus on advancing opportunities for pipeline expansion. We are making progress internally as we assess partnerships and licensing opportunities that can offer a reasonable probability of success on multiple fronts. In EMEA, we announced a strategic partnership this June with Yun Envi, a recognized leader in microbiome skincare solution. This collaboration has the potential to reshape the skincare landscape, starting with the expected launch of Yun's probiotic based products for acne prone skin to the Polish market later this year. Leveraging our broad footprint and seasoned salesforce, this partnership will focus on bringing new pro-biotherapy solutions, utilizing good bacteria for a variety of indications, including acne, fungus, atopic eczema, and baby skincare. These microbiome skincare solutions use live probiotics to help restore the skin's natural microbiome balance, offering a modern, science-driven approach to managing acne prone skin. As we shared last quarter, we launched our cardio metabolic brands in Latin America in June, which in addition to our current portfolio line, now includes two new brands. As a reminder, the cardio metabolic market is one of the fastest growing therapy areas in the Mexican pharmaceutical market, and we are excited to be able to participate in such a high growth area. Now turning to our internal product pipeline, we remain on track with our two global phase three studies for Red Sea, our amorphous solid soluble dispersion, SSD, refaximin complex, and we expect to see initial data readouts by early 2026. As a reminder, this program is centered on a solid soluble dispersion refaximin complex in unique, patented, non-crystalline, water soluble form that enables delivery throughout the entire gastrointestinal tract. Amorphous SSD refaximin is being studied in patients with cirrhosis prior to their first decompensation event from any form of liver disease. This product, if approved, has the potential to offer this patient population a therapy to slow disease progression and provide a meaningful clinical benefit. We look forward to sharing further updates in early 2026. A successful outcome may position us to address a significant unmet need in hepatology and to bring a novel therapy to cirrhotic patients on a global scale. I want to touch on our recently announced definitive agreement to acquire direct corporation. The agreement remains subject to the satisfaction of certain conditions, including a majority of the outstanding shares of direct being tendered in the tender offer that we intend to commence shortly. Through this proposed acquisition, we intend to advance the development and commercialization of direct lead pipeline candidate, Lorsuchostrol, an FDA breakthrough therapy designation asset targeting alcohol hepatitis, AH. There is currently no Food and Drug Administration or European Medicine Agency approval treatment for AH and novel therapeutic strategies are needed to improve patient survival. Assuming all conditions are met, including the successful completion of the tender offer, we anticipate closing the deal in the third quarter of 2025. As such, we are limited in what we can share at this time. I look forward to sharing more information regarding this transaction following the closing. I want to thank our business development team who has worked incredibly hard on this transaction. We are committed to intensifying our focus and rigor behind R&D and business development. This announcement demonstrates our commitment to hepatology and finding new ways to address unmet medical needs. Lastly, turning to legal matters. Year to date, we have settled nine more opt-out cases. Of the 37 cases, there are now 11 remaining. We continue to vigorously defend the remaining claims. Regarding the Granite Trust matter, I am very pleased to announce that near the end of the second quarter, we received communication from the Internal Revenue Service that the case has officially concluded. Consistent with the view we have communicated on prior calls, there will not be any negative cashflow as a result. In summary, it was another strong quarter. I remain confident in our ability to execute on our strategic priorities focused on delivering tangible results. We strive for operational excellence throughout our company, which will maximize long-term shareholder value. With that, I will pass it over to JJ to discuss the financial results in more detail. JJ.

speaker
JJ Charon
Chief Financial Officer

Thank you, Tom. Let's first review quickly our consolidated performance in more detail, starting with our non-GAAP financial results for the second quarter, which you will find starting on page 13. Revenue was ,000,000, up 5% on the reported basis and 4% on an organic basis compared to the same period a year ago. Adjusted gross margin was 70.6%, 30 basis points lower year over year. Adjusted operating expenses were ,000,000, an increase of ,000,000, compared to the same period last year. Adjusted EBITDA was ,000,000, an increase of ,000,000, or 5% year over year. Finally, adjusted operating cashflow was ,000,000. Moving now to the performance of Bausch Health, excluding Bausch and Lomb for the second quarter, starting on page 15. Q2 was undoubtedly another quarter of strong performance, nine quarters in a row of growth for revenue and adjusted EBITDA is outstanding, particularly when acknowledging that this was realized on an organic basis without any material business development or acquisition in the last three years. Revenue was ,000,000, up 5% when compared to the second quarter of 2024. Adjusted EBITDA was ,000,000, up 10%, demonstrating the continued commitment to driving operating leverage through positive segment mix and tight cost management. Adjusted operating cashflow of ,000,000, was up 34% versus the second quarter of 2024 due to our double digit adjusted EBITDA growth combined with the favorable timing of cash interest payments. On cash taxes, as we stated repeatedly during our prior quarter earnings calls, the conclusion of the Granae Trust Matter would not be associated with any negative outflow in the future. I am happy to confirm that there were none in the first half of 2025. Moving now to our second quarter performance by segment, starting with CLX on page 16. CLX revenues were ,000,000, an increase of ,000,000, or 12%, compared to the same period last year. Our strong performance was primarily due to favorable net pricing across our three major brands, namely Xyfaxon, RedStore, and Trulance. Separately, Xyfaxon had another strong volume performance with retail scripts up 6% and new scripts up 7%. Extended units also grew 7% and includes non-retail settings such as hospitals and outpatient clinics, which grew double digits. Revenues for the international segments were ,000,000, an increase of 1% compared to the second quarter of last year. The revenue in the second quarter was driven again

speaker
Xyfaxon

driven

speaker
JJ Charon
Chief Financial Officer

by our promoted products portfolio, which grew 12%. EMEA achieved an impressive milestone of 10 consecutive quarters of organic growth across the region, led by its top three markets, Poland, Serbia, and Russia. Finally, Latam's softer performance was a result of the ongoing macroeconomic challenges in the region, as well as some partial channeled stocking. Now moving to page 18 for a review of our Sultan Medical segments. Revenues were ,000,000, an increase of 25% on a reported basis and 26% on an organic basis compared to the same period last year. Sultan's performance continues to be fueled primarily by South Korea and to a lesser extent this quarter China. South Korea once again outperform expectations, resulting in 115% organic revenue growth year over year. China grew more monetary at 4% this quarter, mostly due to channel inventory reduction. The timing of our shipments from our plant in bottle Washington to China was managed to minimize the impact of tariffs on US imports in April and May. Finally, special mentions goes to our double digit growth of Sultan in the US and Canada, following our increased promotional efforts in these two regions. Third now, our focus to our diversified segment, which you will find on page 19. Revenues were ,000,000, a decrease of 13% compared to the same period a year ago. The decrease of our revenue was driven by both the neurology and dermatology businesses, which had benefit in 2024 from one-time pricing adjustments and unexpected demand for cardism from the Department of Defense due to generic supplier stock-outs. After adjusting for these non-recurring elements, our diversified segment was ahead of expectation, thanks to strong well-buttering performance and outstanding RX growth for CapTrio. Finally, Bakhshinlam's revenue were $1.3 billion, up 5% on reporting basis and 3% on organic basis compared to the same period last year. Now turning our focus to our balance sheet, starting on page 22. Our strong operational cash flow generation was largely upset by outflows associated with the $7.9 billion refinancing we closed on April 8. This resulted to our net debt remaining flat during the quarter. While growth debt stands approximately at $16.1 billion, our cash on hand at the NFQ-2 has now increased to almost $1.5 billion. This is allowing us to actively reduce the negative carry associated with our cash on hand without jeopardizing our financial flexibility for the future. As we announced earlier this week, about $900 million of available liquidities will be used in the coming weeks to repay some of our most expensive debts, namely our 9.25 2026 notes and our accounts receivables facility. This will still leave us with almost $600 million of cash on hand for general business purposes, including reinvestment in the business, business development related payments and working capital needs. Separately, given the current strength of the financial markets, we will be exploring options to push out some of our 2028 maturities either through our April 2025 financing agreements or other means. Let me now move to our full year guidance before wrapping up with our strategic priorities for the back half of the year, which you will find on page 24. We are reaffirming our full year 2025 guidance for Barsch Health excluding Barsch and Lomb, which remains as follows. Revenue is expected to be between ,000,000 and ,000,000. The midpoint of that range translates to a 4% increase year over year. Our adjusted EBITDA outlook is also unchanged and is still expected to be between ,000,000 and ,000,000. The midpoint of that range would represent a 5% increase versus 2024. Adjusted operating cash flow is still expected to be between ,000,000 and ,000,000. In summary, we had an outstanding first six months and remain on track for achieving our full year objectives. Our strategic priorities remain the same. First, increasing the value of Barsch Health operational assets through innovation, optimizing the growth of our portfolio brands across the globe, as well as pursuing opportunities to build further our portfolio of assets through business development. Second, evaluating all options for unlocking value for all stakeholders, including maximizing the value of our Barsch Health and Barsch and Lomb assets. And third, continuing to optimize our capital structure. As we indicated earlier, we have already identified specific opportunities to reduce the net cost of capital of our debt over the next couple of months. I will now hand the call back to Tom for the wrap up.

speaker
Thomas Appio
Chief Executive Officer

Thank you, JJ. Before we turn it over for questions, I want to thank the entire Barsch Health global team for their hard work and dedication, helping us to deliver another strong quarter, building our momentum through the first half of 2025 and positioning us well to continue executing against our strategic priorities for the remainder of the year. We remain confident in the growth opportunities ahead of us and our ability to deliver value for our stakeholders. With that, we will now turn to questions. Operator, please open the line for Q&A.

speaker
Conference Operator

Thank

speaker
Thomas Appio
Chief Executive Officer

you.

speaker
Conference Operator

And at this time, we will conduct a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. And our first question comes from Jason Garberry with Bank of America. Please state your question.

speaker
Jason Garberry
Analyst, Bank of America

Oh, thanks for taking my questions. Just wanted to follow up. So I think some of the commentary on capital deployment, I didn't hear buybacks. I think you guys did mention share buybacks as something of potential interest in one queue. So I'm just kind of curious. That's still something possibly being contemplated. And then on the DTC efforts with Sifaxon, can you just confirm, is this mainly on the IBS side? My recollection is the growth outlook was perhaps more robust on the IBS side, whereas HE market share had kind of hit a ceiling. So maybe if you just kind of confirm sort of the outlook there on the DTC side.

speaker
Thomas Appio
Chief Executive Officer

Sure. Okay. So I think we'll take the question on the share repurchase first. I'll hand that to JJ. Yeah.

speaker
JJ Charon
Chief Financial Officer

So our capitalization strategy remains the same. The first is to really deliver the business. Second is to reinvest in the business. And then if there's any surplus return capital to shareholders in different forms, and the share buyback could be one of those forms. We did mention that as a possibility last quarter, just because the stock price was so depressed. And so therefore, when there are exceptional circumstances, there's always, I think, the obligation to review the priority list and see if there's any opportunity to do a program limited in size. Since then, a number of things have changed. We've decided to reinvest in the business as evidenced by the direct deal that we've just announced. And so therefore, while we continue to evaluate the possibility, it has gone back to the back burner.

speaker
Thomas Appio
Chief Executive Officer

Yeah. Jason, I'll take the second part of your question regarding salix and Zifaxin. So the investment that we're making is in OHE DTC. In the past, we have had DTC campaigns for IVSD. But right now, our focus is growing OHE. And we have had broad growth on both indications, but we are focusing on our OHE indication and investing heavily behind it. I think when we look at the quarter and the 10% growth, we're getting a really nice growth in the volume side at 6% and a little bit on the price side at 3%. So again, driving volume, if you look at the TRX growth in the quarter is 6%. You look at the non-retail is 18, and total extended units is 7. With a total new to brand, as I said in my prepared remarks, 8% growth and 67,000 new patients starts. So our OHE business is growing very nicely. And clearly, as I've talked about in prior conference calls, our engine that we are using to drive our customers inside engine now is reaching heights of 90% adherence. So our focus continues to be investment in our field force, in the tools that they have, and of course, the DTC investments as well. Operator, next question.

speaker
Conference Operator

Thank you. And a reminder to the audience, to ask a question at this time, press star 1 on your telephone keypad. To remove yourself from the queue, press star 2. Once again, to ask a question, press star 1 on your telephone keypad. And your next question comes from Umair Rafat with Evercore ISI. Please state your question.

speaker
Umair Rafat
Analyst, Evercore ISI

Hi, guys. A couple of questions on the RefAximin franchise, if I may. First, the SSD trials, I wanted to confirm that lactulose background therapy is, in fact, allowed. And secondly, I also wanted to confirm the population you're using is, in fact, inadequate responders to lactulose in the primary prevention setting. And then finally, have you guys considered or debated internally the possibility of a Zifaxin OTC? Thank you.

speaker
Thomas Appio
Chief Executive Officer

Thanks, Duma, for the question regarding RefAximin. So I think that when we, again, when we look at what we're trying to achieve here, this is a prevention trial. And what I have to, when we look at it and the population that we can treat, just, I want to just level set the size of the opportunity, and then I can talk specifically about what your question was. 4.5 million patients in the US suffer from chronic liver disease and or cirrhosis. 2.5 million adults with cirrhosis. So if we take a look and then split it out, when we look at Zifaxin today, where we are, we're looking at a patient population of about 650,000 patients. On the SSD side, we're looking at 1.9 million patients. So we see this as a great opportunity to expand our franchise. I'll take the second part of your question. Have we considered the possibility of Zifaxin OTC? It's a good question. I have not really considered it at this time. When we look specifically to your question of wanting to know the combination of Laxulose, I'll have to get back to you on specifically how that was run in the trial with Laxulose, but that would be something the team can follow up with after this call. Operator, next question.

speaker
Conference Operator

Thank you. Just another reminder to ask a question, press star 1 on your telephone keypad. And your next question comes from Doug Meeham with RBC Capital Markets. Please state your question.

speaker
Doug Meeham
Analyst, RBC Capital Markets

Yeah, good afternoon. My question just first one just has to do with Zifaxin. Maybe you could provide any details as you think about them about potential IRA headwinds in 2027. And then the second one just has to do with, and maybe you touched on this a little bit, the discrepancy between revenue growth and prescription growth, both for Lister and TrueLens. Thanks very much.

speaker
Thomas Appio
Chief Executive Officer

Thanks, Doug, for the question. Yeah, we can touch upon the first one in terms of Zifaxin details in the IRA. As you know, Zifaxin was selected for the negotiation, and those negotiations are ongoing. Right now, it's scheduled to conclude in October of 2025, and CMS is expected to announce the final price by November of 2025. As we're going through the process, multiple meetings, we have a outstanding market access team monitoring the situation. Right now, we have the next meeting set for the coming month, and we'll see how the negotiation goes. But clearly, as we look at it, we're working hard on it and presenting our case. As we always said, Zifaxin today has a huge savings in the burden of the government payers, especially in the hospital setting. So we think that it continues to reduce hospitalization costs and creates a large savings to the health care system today. The discrepancies between revenue and the prescription growth for Relistor and TrueLens, on the Relistor side, we now have a new leader in place, and we're continuing to look for ways to grow that franchise. We have grown in the second quarter, and we're really seeing some really nice trends there. And then on the TrueLens side, the product continues to perform. As we look at it, the challenge on the TrueLens side is always from a -to-net standpoint. JJ, do you want to add anything to that?

speaker
JJ Charon
Chief Financial Officer

Hi, Doug. Yes. For the three brands, we got some variability on -to-net with some accruals that were released in the quarter. So that really explains the large discrepancy between the revenue performance of TrueLens and Relistor and the script or the volume behavior in the quarter. Perfect.

speaker
Thomas Appio
Chief Executive Officer

Operator, next question? Doug, you have another question?

speaker
Doug Meeham
Analyst, RBC Capital Markets

Well, yeah, I did want to just ask on direct. Is there any additional information you can provide on that? It looks like an interesting acquisition, given that you may be the only approved product if the results work out and you get approval, of course. Is there anything you want to add to the opportunity there?

speaker
Thomas Appio
Chief Executive Officer

Yeah. So, as you said, it's a very interesting opportunity. We're very pleased. As you know, with our announcement, we intend to commence a tender offer shortly. So I'm limited as what I can say. But assuming we successfully close the acquisition, I'm really looking forward to providing further detail on the thinking and the underlying science behind this acquisition. As we've talked about already on the call in terms of Zifaxin and hepatology and OHE and the opportunities to address this patient population, we are a hepatology company. We have really strong expertise in this area from the R&D side and also from the commercial side. So I'm really looking forward to providing more on the science after the deal closes. Sure. Thank you. Thank you. Next question?

speaker
Conference Operator

Arden, your next question comes from Mike Nadelkovich with TD Cowan. Please state your question.

speaker
Mike Nadelkovich
Analyst, TD Cowen

Hi. Thank you for the questions. I have two. My first is on the direct asset. It looks like -2-Coasterol missed its primary survival endpoint in phase 2B, though there was a positive trend. So what gives you the confidence that data will improve rather than worsen in a larger phase three trial? And on a related note, the press release suggests that only one phase three trial will be required. Am I understanding that correctly? And then my second question relates to rifaximin SSD. Although not approved for primary prevention, there are some studies that suggest Zifaxin could be effective in that setting. And so far, it's not totally clear that rifaximin SSD offers any differentiation. So it's in the risk of off-label generic rifaximin use for primary prevention. It might be relatively high. So my question, given this possibility, is whether you've considered running a -to-head trial between the two formulations. Thank

speaker
Thomas Appio
Chief Executive Officer

you. Yeah, Mike, thanks for the question. On the direct, there's, as I said on the previous question, I'm limited to what I can speak about at this time. Yes, you are correct in terms of the trial that they ran, but it was a very slight miss on the primary endpoint. As I said previously, our R&D team has, we are an expert in hepatology, and we believe that this is a very interesting asset for us. So I'm looking forward in the future to providing the science behind it. And yes, confidence in running one three-phase trial at the present time. On the second question, you know, we are, the SSD formula is quite different. The dosage is quite different, and the way it acts in the gut is quite different. So, you know, with this new formula, you know, we believe this is the product to use for prevention. And we are not at this time running, you know, plans to run any -to-head trials. Operator, next question.

speaker
Conference Operator

Thank you. And the last question will come from Umair Rafa with Evercore ISI. Please state your question.

speaker
Umair Rafat
Analyst, Evercore ISI

Hi, guys. Thanks for the follow-up. I just wanted to touch base again on some of the IRA points you made. I know your, the negotiations are ongoing, but just to level set and prepare the street, would you agree that some of the price points we saw for the 2026 drugs, which were anywhere between 40 and 80 percent and generally about a 60 percent cut median, is probably the zip code we're talking as the vaccine makes progress through this? Or would you rather point us to some of the emerging feedback that the ongoing negotiations are more, and HHS is being much more aggressive than previously? I just want to make sure we're all prepared for this.

speaker
Thomas Appio
Chief Executive Officer

Yes, Umair. Thanks for the follow-up question. I'll just touch on it briefly in terms of the negotiation, and then I'll hand it over to JJ. You know, as we look at this and in these negotiations, you know, we did not believe we should have been on the list to begin with. So, you know, if you look at some of the criteria, but we were, and so as we go through this negotiation and speaking to CMS, you know, and what our points would be and the savings already to the healthcare system, what I would say is, you know, we, our team is evaluating multiple levers here as we look to see what we can do as we get to the end and get to a price that, you know, would be the discount that we have to give. So, looking at our various options and many levers and turning over every stone to make sure that we try to minimize the impact. JJ?

speaker
JJ Charon
Chief Financial Officer

Umair, this is JJ. So, the way you're looking at it is accurate, but relies on a big assumption as to how the drug is classified, whether it's a long-term monopoly or a short-term monopoly. Then the regulations will drive a certain level of percentage, minimum and maximum that will be applied to really the gross revenue. So, you have to look at the size of the business that goes through basically Medicare Part D, how the drug is going to be classified. As we said repeatedly, those discussions are ongoing. And then as Tom alluded to, once you have an understanding of the baseline, then there are a number of strategies we can deploy to offset the potential impact associated with the increase in the rebate level. So, once all those variables settle, we'll be in a better position to really communicate to the market what's going to be the one-time impact in 2027.

speaker
Umair Rafat
Analyst, Evercore ISI

That's very helpful, JJ. Thank you.

speaker
Conference Operator

Thank you. And we have reached the end of the question and answer session. I will now turn the call over to Tom Happio for closing remarks.

speaker
Thomas Appio
Chief Executive Officer

Thank you for all joining the call today and for your continued interest and support of the company. We remain committed to executing against our strategic priorities and focus on unlocking value, driving sustainable growth and advancing innovation across our portfolio. We appreciate your ongoing engagement and look forward to sharing further updates on the progress in the quarters ahead. Thank you and have a good evening.

speaker
Conference Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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