Organon & Co. Q1 2024 Earnings Call Transcript

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Provided by AlphaStreet
May 2, 2024
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Operator

Thank you for standing by. My name is Mandeep, and I'll be your operator today. At this time, I'd like to welcome everyone to the Organon & Co., First Quarter 2024 Earnings Call and Webcast. [Operator Instructions]

I would now like to turn the call over to Jennifer Halchak, Vice President of Investor Relations. You may begin.

Jennifer Halchak
Head of Investor Relations at Organon & Co.

Thank you, operator. Good morning, everyone. Thank you for joining Organon's First Quarter 2024 Earnings Call. With me today are Kevin Ali, Organon's Chief Executive Officer, who will cover strategy and operational highlights; and Matt Walsh, our Chief Financial Officer, who will review performance and guidance. Also joining us for the Q&A portion of this call is Organon's Head of R&D, Juan Camilo Arjona Ferreira.

Today, we will be referencing a presentation that will be visible during this call for those of you on our webcast. This presentation will also be available following this call on the Events and Presentations section of our Organon Investor Relations website at www.organon.com.

Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements. Actual results could differ materially from those stated or implied by forward-looking statements due to risks and uncertainties associated with the company's business, which are discussed in the company's filings with the Securities and Exchange Commission, including our 10-K and subsequent periodic filings. In addition, we will discuss certain non-GAAP financial measures on this call, which should be considered a supplement to and not a substitute for financial measures prepared in accordance with GAAP. A reconciliation of these non-GAAP measures to the comparable GAAP measures is included in the press release and conference call presentation.

I would now like to turn the call over to our CEO, Kevin Ali.

Kevin Ali
CEO & Director at Organon & Co.

Good morning, everyone, and thank you, Jen. Welcome to today's call, where we'll talk about our 2024 first quarter results. We entered this year with a clear focus to deliver our 2024 financial targets, improving our financial position and positioning ourselves for future growth. And to that end, the first quarter was a very solid start.

For the first quarter of 2024, revenue was $1.6 billion, with all 3 franchises contributing to a 7% growth rate at constant currency. I'm pleased to report that the Women's health franchise grew 12%. Our Biosimilars franchise grew 46%, and our established brands business continued its stable performance with growth of 2%. In the first quarter, adjusted EBITDA was $538 million, representing a 33.2% adjusted EBITDA margin and adjusted diluted EPS was $1.22. The strong performance in the first quarter strengthens our conviction in our financial guidance for the full year 2024, and we are affirming those ranges. We remain confident in our ability to deliver our third year of revenue growth on a constant currency basis, and we remain committed to delivering full year adjusted EBITDA margins that are in line with last year or better.

From a capital allocation standpoint, we continue to believe this business can generate $1 billion of free cash flow before onetime costs, and we will be driving towards that number in 2024. That strong cash flow will provide financial flexibility to comfortably service our dividend, make progress on achieving a leverage ratio below 4x by the end of 2024 and to continue to do business development in line with the types of transactions we have completed in the last couple of years. This includes transactions in biosimilars and the recent commercial agreement with Eli Lilly to license 2 migraine assets. These transactions have solid returns, but importantly, they're also aligned with our mission of offering solutions in women's health beyond the narrow definition of reproductive health.

Moving on to discuss our franchise performance. The first quarter growth in women's health franchise was led by NEXPLANON. The last year, we took the appropriate actions to position NEXPLANON for successful 2024 and the long-term growth opportunity we see for the product. We remain confident that the product can achieve robust revenue growth in 2024. NEXPLANON's first quarter, constant currency growth was 34%. The U.S. was up 35%, and the rest of the world was up 34%. Year-over-year growth in the U.S. reflected a shift in timing of our list price increase, which brought stability to distributor buying patterns.

As a result of this shift, going forward, we expect less volatility quarter-to-quarter in NEXPLANON results. For the full year, we expect growth to be driven by NEXPLANON's leadership in contraception, the benefits of our pricing strategy, including list price in the U.S. and management of the 340B channel as well as physician demand growth. Outside the U.S., NEXPLANON grew 34% ex-FX in the first quarter driven by the increased demand in the Lamera region and in the larger markets in the U.K. region like France, the U.K and Canada. Outside the U.S. for the full year of 2024 growth will be driven by continued strong performance in those markets as well as our ability to better meet increased demand in our access markets, which we cited as a priority for us in 2024.

As I mentioned nearly every quarter, we believe NEXPLANON will be on a $1 billion annual run rate in 2025. And beyond 2025, we believe there is still significant runway for growth up until the loss of exclusivity for NEXPLANON in the U.S., which, in our view, will not occur until 2030 for 3 specific reasons. First, our 5-year study is on track to close this year and pending FDA review and approval, our planning assumption is that we will be able to market it with a 5-year label in 2026. A differentiated label will give us 3 years of data exclusivity on that 5-year duration of use claim, which we know from our market research is preferred by women and providers. Second, we have IP protection on aspects of the applicator device 2030. We believe that any generic coming to market before then would have to develop their own device and training programs to go along with it.

So it's not until 2030 when IP protection on both implant and device would have expired that we might see the market start to alter with a similar 5-year product and applicator. And third, complex drug device combinations have demonstrated strong post-LOE performance, which could be due to the fact complex drug device development can pose significant challenges in terms of showing therapeutic equivalents. So overall, we're confident in the sales longevity of Nexplanon and further, when competition does come, we do not expect a traditional generics erosion curve.

Moving on to our fertility franchise. As expected, our global fertility business was essentially flat this quarter, down about $2 million or about 2% ex-FX. You'll recall that in the fourth quarter of 2023 in the U.S., we exited a spin-related commercial arrangement, and we onboarded a significant customer, resulting in a very strong buy in FOLLISTIM at the end of last year that we have largely worked through in the first quarter. Offsetting U.S. performance was strong growth in fertility in China, which grew double digits, benefiting from strong demand. We expect continued momentum in our fertility business in China in 2024, with growth supported by solid demand especially in key provinces like Beijing, where reimbursement for assisted reproductive technologies has been implemented.

Together, the U.S. and China make up north of 50% of our fertility business, strong demand in those markets, coupled with new launches and footprint expansion in other markets are supportive of the high single-digit revenue growth we expect to see in fertility on a global basis for the full year of 2024. Let's move now to our biosimilar business, which grew 46% in the first quarter and continues to be a solid growth pillar for Organon. We expect 2024 should be another year of double-digit growth on a global basis for our Biosimilars franchise.

In the U.S., the growth driver in 2024 for Biosimilars will primarily be the uptake of HADLIMA for getting very good traction with HADLIMA with Veterans Affairs, who within 60 days of exclusively carrying HADLIMA managed to convert more than 50% of the patients from HUMIRA to HADLIMA. This is a strong indicator of payers' ability to rapidly convert utilization which is a critical factor for accelerating conversion to Biosimilars in this market.

Behind the U.S., 2 other key markets in our Biosimilar business are Brazil and Canada. In Brazil, we are seeing strong performance from ONTRUZANT, in particular. The fourth quarter of 2023 was very strong for ONTRUZANT, driven by favorable timing of a tender in Brazil, but in Q1, we saw incremental volumes come through that we would characterize as opportunistic upside. In Canada, we continue to see strong performance, especially in HADLIMA and RENFLEXIS as the government mandated province by province transition to Biosimilar progresses.

As we have previously talked about, our aim in Biosimilars is to launch a new asset every couple of years. We are well positioned to execute on that beyond 2024. A great example of this is our collaboration with Shanghai Henlius Biotech, where we licensed commercialization rights for 2 investigational products, PERJETA or pertuzumab and Prolia and XGEVA or denosumab biosimilar candidates. Organon will have exclusive global commercialization rights to these assets outside of Mainland China, Hong Kong, Macau and Taiwan.

Clinical trials on both molecules have been progressing. In fact, we just recently announced that the Phase III comparative clinical trial for the denosumab biosimilar met primary endpoints. We expect regulatory filings for our 2 denosumab biosimilar candidates to occur during 2024 in certain markets, including the U.S. and EU followed by filings for the pertuzumab biosimilar candidate in the U.S. in late 2024 or early 2025.

And then rounding out the discussion with established brands, which grew 2% ex FX in the first quarter demonstrating the resilience of this business. Impact from VBP in China was more than offset by the initial contribution from the recent commercial agreement for the 2 migraine drugs Emgality and REYVOW. We also saw a recovery in our injectable steroid products following last year's market action. For full year 2024, we expect established brands to achieve flat performance on an ex-FX basis and Matt will go into more detail about the pushes and pulls on the established brands portfolio for 2024.

Moving now to Slide 6, where we take a look at revenue by geography. EUCAN grew 10% ex-FX in the quarter driven by the addition of the 2 migraine assets and the recovery of injectable steroids, both of which I just mentioned. We're still having solid growth in ATOZET in Europe which should be the trend for the 9 months of the year until it loses exclusivity in late third quarter of this year. U.S. was up 14% in the quarter, driven by performance in NEXPLANON as well as uptake of both HADLIMA and JADA post-launch. These factors offset rate pressure and the channel dynamics in fertility, which benefited the fourth quarter of last year as well as U.S. performance of ONTRUZANT.

The LAMERA region has been a significant contributor to Organon's growth since spin. The 36% ex-FX growth in the first quarter was primarily driven by opportunistic volume year associated with the ONTRUZANT tender in Brazil as well as strong growth in NEXPLANON across the access markets in Mexico. The APJ region was down 7% ex-FX this quarter. We expect it to be a challenging year in Japan as we face some national pricing revisions lack favorability from last year when some competitors were out of stock and work through the LOES of ATOZET and ROSUZET. China was down 5% ex-FX in the quarter. But for the full 2024, we expect China to grow particularly as we lap the economy-related challenges in China as we saw in the back half of last year. Overall, we are very pleased with the results through the first quarter of the year.

Operational execution is progressing very nicely. We also have our eye on smart deals that fit within our desired financial profile while moving us forward as a company. And finally, there is potential value yet to be unlocked in our clinical portfolio. In life cycle management, in addition to the NEXPLANON 5-year study and the 2 biosimilar assets with Shanghai Henlius that I spoke about earlier, we're making progress in the development of Mercilon for Primary Dysmenorrhea in Japan. On the innovative side, both assets we acquired through Forendo are progressing well, and our OG-6219 study investigating a novel approach for treating endometriosis is progressing towards a Phase II readout next year.

We're also awaiting first in human dosing for our OG 719 program targeting the symptoms related to PCOS later this year, for which there is no current treatment. Additionally, we are anticipating preclinical data related to our collaboration with Cirqle, which is a novel method for nonhormonal contraception. It's great to see progress not only happening on the commercial execution side of things, but also in positioning Organon for future growth through our innovative therapies.

Now let's turn the call over to Matt, who will go into our financial results in more detail.

Matthew M. Walsh
Executive VP & CFO at Organon & Co.

Thank you, Kevin. Beginning on Slide 7.

Here, we bridge revenue for the first quarter year-over-year, In February for modeling purposes, we suggested that you could consider evenly spreading revenue over the year, which would mean every quarter would be slightly under $1.6 billion in revenue, if you're working from the midpoint of our guidance range. We did a little better than that in the first quarter of 2024 driven by stronger volume especially from NEXPLANON and biosimilars, followed by recovery in injectable steroids namely DIPROSPAN, as well as continued growth from JADA. Outside of FX, the other revenue drivers were fairly neutral in the quarter.

Taken in totality, these other drivers finished Q1 ahead of our expectations, which drove the margin favorability we saw in the quarter. We'll discuss margins in more detail shortly. LOE was about $5 million of impact in the first quarter, which reflects the LOE of ATOZET in Japan. The impact of VBP in China was also about $5 million in the first quarter and reflects lingering effects of the July 2023 implementation of round Round 8 that included REMERON and HYZAAR. There was negligible impact from price in the first quarter.

The benefits of our NEXPLANON pricing strategy in the U.S. muted expected pricing pressure in other parts of our business, particularly in biosimilars and to a lesser degree, fertility. In Supply Other, we captured the lower-margin contract manufacturing arrangements that we had with Merck and have been declining since the spin-off as expected. And lastly, Foreign exchange translation had an approximate $30 million impact or 2 percentage point headwind to revenue, and that's a function of more than 75% of our business being generated outside the U.S. Now let's turn to performance by franchise. As has been our convention, I will target my comments over the next 3 slides to those areas most relevant to your modeling as we think about where we ended the quarter and what the near-term future may hold.

Let's start with women's health on Slide 8. As Kevin mentioned, we expect robust growth for NEXPLANON in the full year. With such strong growth in the first quarter and the benefit of our annual price increase in the U.S., which we took in January. NEXPLANON could achieve double-digit growth this year on a constant currency basis. For fertility, growth will be skewed towards the second half of the year.

In the first half, we'll be absorbing the two Q4 2023 issues that Kevin referenced. First, the buy-in that resulted from exiting a temporary spinoff-related commercial arrangement in the U.S. and second, initial supply chain stocking related to the large contract initiation, which is also in the U.S. In the second half of the year, we will have the benefit of lapping what was a difficult fertility environment in China last year plus, we expect volume growth from the provincial expansion of reimbursement and new launches in other markets, as Kevin referenced.

Turning to biosimilars on Slide 9. With ONTRUZANT, we have had competitive success as a key supplier of a biosimilar of HERCEPTIN in Brazil. And in the quarter, we had the benefit of incremental upside coming from additional volume through that tender. I would note that ONTRUZANT growth would have been down this quarter, if not for the incremental upside we had from these additional volumes in Brazil. In fact, on a global basis, we expect ONTRUZANT will be declining this year due to competition in other markets. And on U.S. HADLIMA, we had a strong first quarter, but given that this market has been difficult to predict and continues to evolve, we'll only say that it is our objective to grow that product sequentially each quarter this year.

Turning to Slide 10. Let's talk about pushes and pulls on established brands for the full year 2024. We'll see VBP impacts pick up later in the year, driven by FOSAMAX's inclusion in round 10 expected late in the third quarter. ATOZET will go through LOE in the EU in September of this year, and that product has been doing very well for us in that market. We expect those headwinds to be offset by continued volume growth. For example, contribution from the new migraine assets in Emgality and REYVOW. We expect injectable steroids to continue to recover and you already see that here with 19% ex-FX growth in the Non-opioid Pain and Bone & Derm portfolio.

These factors should result in about level performance for the established brands portfolio in 2024 FX change. Now let's turn to Slide 11, where we show key non-GAAP P&L line items and metrics for first quarter performance. For reference, GAAP financials and reconciliations to the non-GAAP financial measures are included in our press release and the slides in the appendix of this presentation. For gross profit, we are excluding from cost of goods sold, purchase accounting amortization and onetime items related to the spin-off, which can be seen in our appendix slides.

Adjusted gross margin was 62.1% in the first quarter of 2024 compared with 65.2% in the first quarter of 2023. In the first quarter of 2024, the lower adjusted gross margin was primarily related to unfavorable product mix, foreign exchange translation and higher inflation impacts to material and distribution costs. Despite being below last year, gross margin actually came in stronger than we expected in the first quarter, mostly driven by better performance in price across the aggregated portfolio.

Total non-GAAP operating expense was down 3% in the quarter, excluding IP R&D, reflective of our cost containment efforts. That is especially the case in R&D, where we have reprioritized clinical spending and rationalized headcount to better align with the types of business development programs we've recently completed and plan to pursue in the near term.

IP R&D expense was $15 million in the first quarter compared with $8 million in the prior year period. The $15 million of milestone expense in the first quarter was related to development progression of a denosumab biosimilar. Milestone payments are inherently difficult to forecast, so we will continue to utilize the same convention that we employed this quarter, and that is to include an estimate of IP R&D and milestones to be recorded in the quarter in our earnings date press release, which will be posted as soon as practical after the close of each quarter.

Foreign exchange losses were modestly lower $6 million in the first quarter of 2024 compared with $9 million in the prior year period. In both periods, these are foreign exchange losses primarily driven by normal course business activities in countries where it's not feasible to hedge movements in the local currency. These factors culminated in an adjusted EBITDA margin of 33.2% in the first quarter of 2024 compared with 33.7% in the first quarter of 2023. Non-GAAP adjusted net income was $315 million or $1.22 per diluted share compared with $276 million or $1.08 per diluted share in 2023.

Turning to Slide 12. We provide a closer look at our cash flow for the quarter. For the last 2 years, our free cash flow generation has followed the approximate pattern of 30-70. 30% of our free cash flow was generated in the first half of the year and 70% is generated in the back half. In 2022, we generated $875 million of free cash flow before onetime charges. In 2023, that figure rose to $940 million. And in 2024, we expect to reach approximately $1 billion of free cash flow before onetime items underpinned by our financial guidance. Like many companies with December fiscal year-end, Q1 free cash flow was impacted by accrual runoff, largely related to the timing of annual incentive payments, and that represented about 1/3 of that working capital consumption number.

Typical to the first quarter, we also see seasonal fluctuations in working capital, which drove the remainder of the change. For onetime cash costs related to the spin-off, in February, when we gave full year 2024 guidance, we said to expect about a 40% reduction from 2023, which would put us in the $200 million ballpark. The $68 million you see here is consistent with that expectation. Of note, we have completed the implementation of our global ERP system as of April, which was the main driver of onetime costs up until this point. Next year, we would expect even lower onetime spin-related costs and beyond 2025 and we expect onetime spin-related costs to be de minimis.

In the $36 million of other onetime costs, here, we capture headcount restructuring initiatives and the transition of our manufacturing network related to the spin-off. These costs are distinct from the spin-related standup costs and that they're associated with actions, which will ultimately drive cost efficiencies. Some of which we realized in Q1 and which are already incorporated into our earnings guidance for 2024.

Moving to slide 13 now on debt and leverage. When we provided guidance in February, we were bracing ourselves for leverage to tick higher in the first half of the year before coming down in the second half, ending the year better than 2023 with a view to ending the year below 4x. With stronger-than-expected EBITDA performance in Q1, our net leverage ratio has remained level with 2023 year-end and is holding at 4.1x. This solid result gives us greater confidence in our February commentary around lowering our net leverage ratio during the year.

Now turning to 2024 guidance on Slide 14, where we highlight the items driving our 2024 revenue guidance range of $6.2 billion to $6.5 billion. Some of the individual drivers have changed, but our top line revenue guidance is remaining unchanged. For LOE, that approximate $70 million to $90 million impact for the full year 2024 incorporates ATOZET, both Japan and in the EU later this year.

We also have a provision for DULERA, where we have been expecting a generic since its LOE in 2020. VBP impact is still expected to be in the range of $30 million to $50 million for 2024. By the end of the year, we expect approximately 85% of the portfolio to have gone through VBP. Though minimal in Q1, we expect the impact from price to be in the $180 million to $220 million range, which is up $25 million at the midpoint from the $150 million to $200 million range we talked about in February.

Overall, this represents a bit over a 3 percentage point headwind versus prior year and is more in line with our longer-term expectations of price impact across our entire business, given pricing pressure in Biosimilars and U.S. fertility and the mandatory pricing revisions we expect to see in certain international markets. And for volume, we are raising our estimate by $75 million at the midpoint to $450 million to $650 million to primarily reflect the upside we saw in Biosimilars in the first quarter. Overall, that almost 9% volume growth we expect over last year will be coming from our growth pillars.

NEXPLANON, Fertility and JADA within women's health, Biosimilars and China retail as well as the latest addition of Lilly's Emgality and REYVOW in Europe. And finally, based on current spot rates, we think we could see an increasing headwind from FX, now at 160 to 200 basis points, paired with 80 to 160 basis points that we were forecasting back in February. We've absorbed that impact with an improved view of volume growth. So our constant currency revenue guide effectively went up a bit.

Moving to the other components of guidance on Slide 15. For adjusted gross margin, we are continuing to guide to a range of 61% to 63% for 2024. On opex expense, even though we are tracking to the lower end of the ranges for SG&A and R&D expense, if you simply annualize Q1, it's a little too early in the year to be calling those ranges down. For SG&A, we have some expense in the second half related to product launches. The migraine products, HADLIMA, XACIATO and JADA internationally to cite a few examples.

And that will be partially offsetting the favorable impact of our restructuring cost containment efforts. For R&D, the $400 million to $500 million range still feels good, even inclusive of IP R&D to date, but we'll continue to evaluate this as the year progresses and milestone achievement becomes more clear. Interest, tax and depreciation expense ranges are all unchanged.

All things considered Q1 was a solid start to the year. We're heading in the right direction on volume growth, margins and operating expense discipline, and we're tracking to another year of constant currency revenue growth.

With that, now let's turn the call over to questions and answers.

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Operator

[Operator Instructions] Our first question comes from the line of Umer Raffat with Evercore ISI. Please go ahead.

Umer Raffat
Analyst at Evercore ISI

Hi, guys. Thanks for taking my question. I just wanted to focus on free cash flow for a quick second. it's about $109 million before onetime costs. And I guess the true free cash flow is $6 million for this quarter. So it's roughly flat, roughly neutral. And my question is, I knew the working capital was the biggest drag of about $300 million.

But 1Q last year wasn't exactly similar. Wasn't it half that at $160 million? So how do we square those knowing that the ERP costs had actually come down, but also knowing that maybe heading into 2025, 2026, you could potentially have NEXPLANON headwinds from a free cash flow perspective as patients switch to a 5-year regimen instead of 3-year regimen.

Matthew M. Walsh
Executive VP & CFO at Organon & Co.

So we'll take the 2024 free cash flow part of your question first, Umer. And in our forecasting, it's the seasonality of working capital that will start to reverse in the latter quarters of the year. And so that really enables us to recover to the $1 billion before onetime items that we are forecasting.

Overall, onetime costs related to the spin-off, which were about $344 million last year. We do see that number coming down about 40%, and that will really all be real. You'll see that really in the back quarters of the year. So, just returning to the seasonality of that cash flow being more 70% driven in the back half really, the first quarter performance, Umer, just gives us confidence that we'll be able to hit the full year number.

Kevin Ali
CEO & Director at Organon & Co.

And Umer, on your second question in regards to Nexplanon being a headwind in the 25%, 26% range. We don't expect the 5-year indication likely be instituted until 2026, first of all. And second of all, we see 2 reasons to believe that, that will not be a headwind. First, there's always a possibility of taking price, but we haven't -- in terms of additional price in the 5-year indication, we haven't decided on that yet. There's a lot of research required, but that's definitely there on the table.

And second, and probably more importantly, there's a large chunk of health care providers and patients who would prefer to actually have the 5-year indication who potentially right now are using other forms of contraception. So it is potentially a net gain for us as opposed to a significant headwind.

Umer Raffat
Analyst at Evercore ISI

Thank you very much.

Kevin Ali
CEO & Director at Organon & Co.

Fair enough.

Operator

Our next question comes from the line of Balaji Prasad with Barclays. Please go ahead.

Your line is open, please go ahead.

Jennifer Halchak
Head of Investor Relations at Organon & Co.

Maybe we come back to Balaji.

Kevin Ali
CEO & Director at Organon & Co.

Next operator. Let's go to next.

Operator

Our next question comes from the line of Terence Flynn with Morgan Stanley. Please go ahead.

Dan
Analyst at Morgan Stanley

Hi, this is Dan on for Terence. Thanks for taking our questions. Just two from us. I guess, first, just on U.S. NEXPLANON to get a little more color just on the underlying volume trends that you saw in the quarter and how you're thinking about the rest of the year?

And then on HADLIMA, how you're thinking about maybe initially the opportunity in '25 at this point? And any color on some of your initial PBM contracting conversations? Thank you.

Kevin Ali
CEO & Director at Organon & Co.

Yeah. Thanks for the question, Dan. It's Kevin. So I would tell you that the components of NEXPLANON growth this year in the U.S. are strong. We believe that we made the right decision in terms of moving price to Q1 within the Q, within the quarter, so ultimately, any kind of any type of buy-in and buyout scenario will happen in that given quarter. Also, demand is starting to really move nicely, both in the 340B channel as well as the commercial side of the things. So we feel really good and that solid. There's going to be a very solid year.

Overall, I do believe it will be a double-digit growth year for NEXPLANON globally and driven by the U.S. performance. And there's just good signals coming out of a number of things that we've done on the ground in order to drive demand in NEXPLANON in the U.S.

And secondly, in regards to HADLIMA, I would tell you that HADLIMA is also progressing very well. It's I keep -- I've said for it feels like forever now, but for the last few years that it's going to be a slow moving market formation period of time. Right now, you see, for example, more and more PBMs starting to move over to essentially prefer Biosimilars to HADLIMA. We want, of course, exclusive contract with the VA. And so there's going to be more of the market formation as you start to look at 2024 and 2025. And I think as you go through 2025 to 2026, you'll start to see much more erosion of HUMIRA.

And as I've always said, as long as you're in the top 2 or 3, you will benefit from that opening of the market. And I continue to say that our peak revenues that we've signaled a couple of hundred million in the U.S. is definitely achievable -- definitely achievable. Hopefully, we'll do more than that as time progresses. But we feel very good. It's just the time continuum of being able to kind of push forward and do what we want to do on our strategy for HADLIMA, and I feel very confident about the product for the coming years.

Operator

Our next question comes from the line of Chris Shibutani with Goldman Sachs. Please go ahead.

Chris Shibutani
Analyst at The Goldman Sachs Group

Thank you very much. Good morning. Two questions. Perhaps, if we think about the operating margin progression beyond 2024 based upon the progress that you're making so far? Can you give us a sense for your confidence of potential sources for where and the scope of how that could improve?

Secondly, on business development, maybe update us on where you are in terms of seeing opportunities in particular, the opportunity that you had with Emgality was quite attractive. Are there more such opportunities do you favor certain segments of the business or geographies?

Matthew M. Walsh
Executive VP & CFO at Organon & Co.

So I'll start, Chris, on the operating margin part of this. So as we look out into the future, we see margin accretion coming in a few areas. And that will be offsetting, we believe, sort of the constant issues that we face with price in our markets, which are highly competitive, as you know. On the upside, we will -- we believe that our product mix over time will be mixing towards higher-margin products as things come out of the pipeline and then become commercial. We see productivity efforts and overall cost of goods sold improvement efforts coming from the network rationalization work that we'll be doing as we transition away from Merck services.

And finally, we believe that we'll be able to generate operating leverage off of our fixed costs which, as you know, we're in the process of realigning this year, and you saw some of the benefits of that in the first quarter itself. So those are the margin up areas that we're really working hard to pursue. And you know, once again, as we referenced in some of the prepared comments that we believe will help us more than offset sort of that constant drumbeat of price that we see around our aggregated network.

Kevin Ali
CEO & Director at Organon & Co.

Chris, in regards to your question around business development. Yeah, I mean there's going to be more and more of those type of deals that you saw with Lilly deal with REYVOW and Emgality. Our deals that we do is essentially focused on opening the aperture, as I've mentioned before, of women's health. In that case, it was migrane, which essentially 2/3 of patients who suffer from migraine are --- happen to be women. So there are opportunities. They're coming fast and furious over our desk in terms of regional specific, country specific, like, for example, China -- for China, we have opportunities.

We do see China as being a growth country for us in the future in a number of different areas, including women's health, of course. So we'll continue to do that. We'll be very disciplined in the sense that we'll be picking out on those opportunities that clearly fit into our capacity and so that we don't really have to dedicate much operating expense to expanding that portfolio that we bring in. And essentially, it's just accretive pretty soon. And so we'll be doing more of those, and we'll always have our eye towards more of the larger deals as well that move the needle.

And they are more infrequent as you would expect, but we're definitely looking there. And -- but this year, it's really all about focusing on our financial execution, on making sure that we deliver the numbers and even better, hopefully in the future in this year and working on our leverage and all those nice things that we need to do in order to be able to have more flexibility in the future to do more transformative things, and I think just stay tuned.

Chris Shibutani
Analyst at The Goldman Sachs Group

Thank you. Helps a lot in getting your perspective. Thanks.

Operator

Our next question comes from the line of Navann Ty with BNP Paribas. Please go ahead.

Jane-Marie Lai
Analyst at BNP Paribas

Hi, it's Jane-Marie for Navann. Thanks for taking our question. Can you comment more on what your expectations are for the HUMIRA biosimilar market for this year and the next considering the rise in HUMIRA assets and Rx after CVS Caremark effectively remove HUMIRA from its major formulary.

Matthew M. Walsh
Executive VP & CFO at Organon & Co.

Yeah, Jane. Sure, I can address that. So I do think it's what I've been essentially predicting for the last couple of years that it's going to be a slow, steady beat -- drumbeat of wins that you see across the channels, whether it's in the PBM world, and you've just mentioned one large PBM in CVS deciding to go with a different product and obviously, the HUMIRA in terms of exclusivity, which is one of the large PBMs. And then you talk about our strategy, which is really on the low net cost providers like the VA and Blue Cross Blue Shield, Medicare and Medicaid, which is about 40% -- 45% of the lives covered in the U.S. today.

They're looking more to try to save money quicker. And look, at the end of the day, more like -- something like about 25% to 30% of patients in the commercial plans today are still paying $1,000 or more per month out of pocket for the use of something like HUMIRA. And I think that is something that we're working to try to bring more savings to not only patients but the system so that there's more headroom for best than other innovative things that need to be done.

So I do think that the market will open up slowly. It was very slow in '24, I think it will be more in '25 than I think it really will open up in '26 and beyond.

Jane-Marie Lai
Analyst at BNP Paribas

Thank you so much.

Operator

Our next question comes from the line of Jason Gerberry with the Bank of America. Please go ahead.

Jason Gerberry
Analyst at Bank of America

Hey, guys, for taking my questions. Just a follow-up on some of HUMIRA. So it looks like Sandoz and Teva have had some success of these private label type deals with large insurer groups. I think Optum is still up for grabs. Is there -- do you see that as a strategy of interest to you? Because I know that at least with the exclusive to Cigna.

And then another question just on next on NEXPLANON OUS, your 10-K, you talked about next year majority of countries where NEXPLANON is commercialized out by ex U.S., is this going to expire. So how do you think about that erosion profile with the loss of exclusivity in bulk of your OUS geography? Is that sort of typical OUS kind of down 30% or not a typical U.S. cliff type dynamic? Or is it better than that? Just curious how you think about the NEXPLANON OUS in '25?

Matthew M. Walsh
Executive VP & CFO at Organon & Co.

Thanks, Jason. Let me take the first question, which is really around what's happening with the HUMIRA biosimilar kind of event or HUMIRA LOE event. Yes, I mean you said it right in the sense that Sandoz was able to acquire the CVS business and then Teva has announced something recently. And of course, Optum, we've got more than 50% access already in the Optum business as we speak today. And I do think that our strategy is resonating with our providers, which is, again, I'll reinforce. We do have, obviously, penetration into the Optum world in regards to a large PBM, but we also have really good pickup state-by-state level, whether you're talking about the VAs at various levels or whether we're talking about Blue Cross, Blue Shield in various states, certain systems.

And I think those are probably more resilient, more sticky business over the long term. Is that -- if you look at it as more kind of diversified. The more diversified you are in the biosimilar business, the more you can retain share as it gets more competitive over time. And I still do hold the fact that I think in '25 -- '24 as the year progresses, you'll see better overall penetration into that world. But '25 will definitely open up for us in terms of what we expect to do with HADLIMA.

Turning to your question about NEXPLANON. I don't foresee any market erosion for the ex-U.S. business. Look, 70% of our business is in the U.S. That's where everybody is going to be looking forward to try to penetrate first. And I think after that, you would get into the much, let's just say, less attractive pricing environment in ex-U.S., whether it's the access markets in the emerging markets or whether it's in Europe. I think that it's just too fragmented and too difficult to penetrate, unless you've got essentially the breadth of being able to get into the U.S.

And I don't think -- as I've mentioned earlier in my prepared remarks, I clearly think there's a lot of fat out there. This is not just suppositions, a lot of fat that would lead one to believe that this is a 2030 event. Our applicator alone globally has a patent protection until 2030, and somebody would have to develop their own applicator, which in itself is not as easy as you may think because you've got to do studies around safety, around efficacy of the applicator device alone before you can actually show anything else in regards to the rod itself. So I think this is a 2030 event globally and beyond.

Jason Gerberry
Analyst at Bank of America

Thanks.

Operator

Our next question comes from the line of David Amsellem with Piper Sandler. Please go ahead.

David Amsellem
Analyst at Piper Sandler Companies

Hey, thanks. So 2 questions. One is longer term on EBITDA margins beyond control in spend, do you think there's room for margin expansion based on the top line? Anything in the established brands business that can drive margin expansion over time, anything in terms of the women's health business or just its overall footprint that can drive margin expansion over time? This is more of a beyond '24 question, that's number one.

And then number 2 is, help us better understand long-term leverage targets, particularly with the 2028 maturities. How are you thinking about that? Looking at say Teva, they have a leverage target in '27 at 2x. I'm not trying to pin you down on the target necessarily, but some of your peers do talk about that. So where do you get comfortable in terms of a steady-state net debt to EBITDA?

Matthew M. Walsh
Executive VP & CFO at Organon & Co.

Yes. Okay, David. So we'll start with your comment on longer-term margin accretion, basically through revenue mix, I think, is your question. And really where we'll be able to achieve that is in what we have coming out of the pipeline towards the latter part of the decade and what we can acquire in during that time frame. So we -- I think we will continue to see stability amongst the portfolio of products that we have now. So I think really, the improvement in revenue mix comes from the relative mix of the things that are growing faster that are in the portfolio right now, and I'm mainly thinking about NEXPLANON, JADA and then what we bring into business development.

In terms of leverage, really, since the spin, we've had the same commentary, the same view that this business can run very effectively at leverage levels underneath 3.5x. And how far underneath would be dependent on business conditions at the time or just the overall marketability of the stock in terms of investor comfort with leverage ratio on this business. So we see ourselves getting to underneath 4x by the end of this year and then by 2025, getting to that 3.5x target that we've been referring to.

So our view on that really hasn't changed. I think investor sentiment around leverage has changed but really, our view in terms of where this business runs most effectively has not. So we still feel the same, and that's sort of what we're targeting as we think about the capital structure going forward.

David Amsellem
Analyst at Piper Sandler Companies

That's helpful. Thank you.

Operator

Our final question comes from the line of Balaji Prasad with Barclays. Please go ahead.

Balaji Prasad
Analyst at Barclays

Hi. Good morning and thank you for taking me back on again. Apologies for missing the earlier call. And again, apologies if this has already been covered, please feel free to refer to the transcripts, if so. Refer me to the transcript.

A couple of things. Firstly, on the biosimilar market, clearly, the private label moves with Cardiva, Zymos and what we saw with ALVO and Teva recently with SIMLANDI seems to be the one which is shaping the market and getting greater market share dynamics. So can you comment on your thoughts or expectations around that?

On a related note, can you also remind us of HADLIMA path to interchangeability? Or is it still on track for June approval? When would you have to wait till Alvotec's exclusivity ends next year for you to claim interchangeability? One. Secondly, on the established brands side, now that we see Emgality and REYVOW in contributing. Can you help me understand a bit more on the dynamics here and the expectations for these brands going forward? Thanks.

Matthew M. Walsh
Executive VP & CFO at Organon & Co.

Balaji, its good to talk to you. So I would say the first question in regards to biosimilars and HADLIMA, I do think that it's a good signal, by the way, that, for example, the first signal being CVS, essentially going strictly with the Sandoz product. It really is a good signal for the market formation that we keep talking about itself. But remember, the market has split into 2 pieces. It's the PBMs that are about 55-or-so percent of the overall lives covered, and it's all the other low net cost providers, as I've mentioned many times, that represent about 45% of the business.

And they're really more focused -- lives, rather, covered. They're more focused on low net cost products, they're not laying the rebate game as well. They're just focusing on lower net costs. So I think it is going to be very dynamic as we think about what's going to happen over this year and next year. And we're continuing to be very competitive, and our strategy is pulling through. We're among the top 1 or 2 Biosimilars currently in TRX and NRX in the U.S. And we feel very strongly that we'll be in a very solid position as time progresses to continually grab share from the originator and to drive for our peak revenues where we've always signaled that we feel very strong about in terms of the couple of hundred millions in the U.S.

In regards to established brands and where we're going with REYVOW and Emgality. Look, we've just started right now in terms of promotion in the EU. Some countries still have yet to come in in terms of that. I think that will happen in the coming months. It's a fast-growing segment actually in Europe in terms of the migraine segment. And we are really well positioned because these are 2 products that are well known. Recently launched, have a good reputation, and we've got a great team that are really, really excited and very energized about being able to take over and showing what we can do with these 2 products.

And look for more of these type of deals to happen that are accretive, that make use of our scale and our global infrastructure, and that really makes sense in terms of fitting into what we're trying to do and generating more cash for us to be able to do more business development on a larger scale over time.

Balaji Prasad
Analyst at Barclays

Thank you. If I could just have a follow-up to it. I appreciate the detailed explanation. In light of this performance, the outlook, I thought guidance could have raised possibly? How conservative are you with the guidance retaining or reaffirming what you had said earlier? Thanks.

Matthew M. Walsh
Executive VP & CFO at Organon & Co.

Yes. So while we were certainly encouraged by the first quarter performance really across all of our franchises, Balaji, but the thing that we were considering most when thinking about what to do with guidance was really what's going on with foreign exchange. The dollar is persistently strong. When we created our initial guidance in 2024, the euro was somewhere between $1.08 and $1.09. It's since come back.

And so like we said in the prepared comments, when we look at the nuts and bolts aspects of our top line revenue, we're actually up on constant currency basis. And it's really just the FX dynamic that is causing us to be a little bit reticent about raising guidance this early in the year. We'll revisit this when we issue Q2 results. But once again, the performance in first quarter gives us a lot of confidence in the initial guidance that we gave, and we're just optimistic as we leg into the second quarter here.

Balaji Prasad
Analyst at Barclays

Thank you.

Operator

Thank you. That concludes our question-and-answer session. I would now like to turn the call back over to Kevin Ali for closing remarks.

Kevin Ali
CEO & Director at Organon & Co.

I want to thank you. I want to close today's call by essentially repeating what I began today's call with, namely that we came into 2024 looking at it as a year to focus on execution, delivering on our projections, improving our financial positioning and of course, building for our future pipeline. And through Q1, we can definitely say that we're progressing well towards those goals.

And I want to thank all of you for a great discussion today, and we look forward to continuing engagement.

Operator

[Operator Closing Remarks]

Corporate Executives
  • Jennifer Halchak
    Head of Investor Relations
  • Kevin Ali
    CEO & Director
  • Matthew M. Walsh
    Executive VP & CFO
Analysts

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