Organon & Co. Q2 2025 Earnings Report

Organon & Co. EPS Results

• Actual EPS: $1.00
• Consensus EPS: $0.94
• Beat/Miss: Beat by +$0.06
• One Year Ago EPS: $1.12

Organon & Co. Revenue Results

• Actual Revenue: $1.59 billion
• Expected Revenue: $1.55 billion
• Beat/Miss: Beat by +$42.35 million
• YoY Revenue Growth: -0.80%

Organon & Co. Announcement Details

• Quarter: Q2 2025
• Date: 8/5/2025
• Time: Before Market Opens
• Conference Call Date: Tuesday, August 5, 2025
• Conference Call Time: 8:30AM ET

Organon & Co. (NYSE:OGN) is a science based global pharmaceutical company, which develops and delivers innovative health solutions through a portfolio of prescription therapies within women’s health, biosimilars and established brands. The company was founded on March 11, 2020, and is headquartered in Jersey City, NJ.

Organon & Co. Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Company raised full-year revenue guidance by $100 million at midpoint and affirmed its adjusted EBITDA margin guidance of 31–32% after delivering $1.6 billion in Q2 revenue.
• Positive Sentiment: Generated $522 million of adjusted EBITDA (32.7% margin) in the quarter and is on track to exceed $900 million of free cash flow before one-time costs in 2025.
• Positive Sentiment: Repaid approximately $350 million of long-term debt in Q2, targeting net leverage below 4× by year-end and 3.5× by 2026 to accelerate deleveraging.
• Positive Sentiment: Biosimilars outperformed expectations—HEDLEMA sales rose 68% YTD with interchangeability approval—and VITAMMA revenue jumped 70% with coverage expanding to 80% of lives by early 2026.
• Negative Sentiment: Loss of exclusivity for Adazet in the EU and ~2.5% pricing pressures weighed on revenue by about $60 million in Q2 despite 5.6% volume growth.

Presentation

[Operator]

Hello, and welcome to the Organon Second Quarter twenty twenty five Earnings Call and Webcast. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. I would now like to turn the conference over to Jennifer Halczak, Vice President, Investor Relations. You may begin.

[Jennifer Halchak, VP, IR at Organon]

Thank you, operator, and good morning, everyone. Thank you for joining Organon's second quarter earnings call. With me today are Kevin Ali, Organon's Chief Executive Officer and Matt Walsh, our Chief Financial Officer. Juan Camilo Arjona Ferreira, Organon's Head of R and D, will also be joining for the Q and A portion of this call. Today, we will be referencing a presentation that will be visible during this call for those of you on our webcast.

[Jennifer Halchak, VP, IR at Organon]

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 ks 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.

[Jennifer Halchak, VP, IR at Organon]

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

[Kevin Ali, CEO & Board Member at Organon]

Good morning, everyone, and thank you, Jen. Revenue for the second quarter was $1,600,000,000 down 1% at constant currency with our growth pillars and contributions from new assets mostly offsetting the loss of exclusivity of Adazet in the EU. Given year to date operational performance and our current view of movements in various foreign currencies, we are raising our revenue guidance range by $100,000,000 at the midpoint. Additionally, we generated strong adjusted EBITDA this quarter of $522,000,000 representing a 32.7% margin. Year to date, our adjusted EBITDA is $1,000,000,000 or 32.4% margin.

[Kevin Ali, CEO & Board Member at Organon]

Strength year to date was primarily due to favorability in adjusted gross margin, investment prioritization behind our growth pillars and the realization of savings from our restructuring programs to become a more fit for purpose organization. As a result, we are affirming our adjusted EBITDA margin guidance range of 31% to 32%. A strong focus on EBITDA generation underpins our objectives to deliver more than $900,000,000 of free cash flow before one time costs in 2025. Year to date, we're tracking well against that goal. As we signaled to you last quarter, we are committed to reducing our debt burden.

[Kevin Ali, CEO & Board Member at Organon]

To that end, in the second quarter, we repaid approximately $350,000,000 of principal on long term debt instruments, which sets us up on a path to achieving net leverage below four times by year end. Mid term, we'll aim to drive further improvements in net leverage with the goal of achieving net leverage of 3.5 times or below by the 2026. Let's now talk about franchise performance beginning with women's health. The women's health franchise grew 2% at constant currency in the 2025 compared with the 2024. The company's fertility business grew 15% at constant currency in the second quarter.

[Kevin Ali, CEO & Board Member at Organon]

This was driven by a favorable year over year comparison in Follastim related to the late twenty twenty three exit of a spin related interim operating model with Merck and increased demand. We expect continuous growth in The U. S. Along with geographical expansion to deliver high single digit growth in our global fertility business in 2025. Within women's health, Jada also grew double digit in the quarter and year to date.

[Kevin Ali, CEO & Board Member at Organon]

Among hospitals that have the highest adoption rates, Jada is used in nearly half of all postpartum hemorrhage care situations. We're focused on driving similar usage rates across more hospitals and are driving to have Jada incorporated into the standard postpartum hemorrhage readiness and response protocols in US hospitals. Sales of Nexplanon declined 1% at constant currency in the second quarter. Revenue declined by 5% in The U. S.

[Kevin Ali, CEO & Board Member at Organon]

While outside The U. S, Nexplanon grew 10% at constant currency. For the first six months of the year, Nexplanon has grown 6% globally at constant currency. In The U. S, customers relying on federal and state subsidized programs are now facing potentially constrained funding.

[Kevin Ali, CEO & Board Member at Organon]

That is factoring into their purchasing decisions for contraceptive products. Despite these headwinds, we anticipate continued global growth for Nexplanon, building on its strong double digit expansion achieved in 2024. Current policy issues notwithstanding, we remain committed to building Nexplanon into a billion dollar franchise in the very near future, reflecting our confidence in its long term growth potential. For Nexplanon's five year duration indication, we have made our submission to the FDA, putting us in a position to be ready for launch later this year. As we have reiterated each quarter, we believe this indication is attractive to a much broader addressable market and we believe Nexplanon can continue to grow until the end of the decade.

[Kevin Ali, CEO & Board Member at Organon]

Turning the discussion to general medicines, which is our refresh term for our business outside of women's health. We believe it is a better characterization of the innovation we are introducing with products like Emgality and VITAMMA. We will continue to discuss our biosimilars products separately given their collective importance as a growth driver for the company. So then, let's start with biosimilars, which is performing better than our expectations. Year to date performance is largely driven by HEDLEMA, which has generated almost $100,000,000 as of June, up 68 compared with the prior year period.

[Kevin Ali, CEO & Board Member at Organon]

In The U. S, HEDLEMA continues to rank among the leading biosimilars in terms of total prescriptions. This performance reflects the strong clinical profile of HEDLEMA, which includes the recent interchangeability approval. HEDLEMA has also benefited from the effectiveness of our commercial strategy and our market access teams, which have expanded availability to a broader patient population. We've also added Topinence, the first biosimilar approved for Actemra to the portfolio in The US.

[Kevin Ali, CEO & Board Member at Organon]

Immunology is a market we know well in The US, notably the physician administered business, and as a result, we are uniquely positioned to drive Topitant sales. Finally, we will begin to launch a portfolio of HENLIUS products in late twenty twenty five with adanosumab biosimilar in The U. S. So it's better performance in the base business together with our outlook for new assets coming online that have improved our view of performance in the biosimilar business for the full year. Wrapping up the revenue discussion with established brands with a focus on DITAMA.

[Kevin Ali, CEO & Board Member at Organon]

DITAMA had strong performance in the second quarter with revenue of $31,000,000 up 35% sequentially and up 70% versus a year ago when it was still under Durmavant. In the second quarter, NRx and TRx each grew mid teens over Q1, representing the strongest quarterly performance among the peer set. Since launch, we have added over 20,000 new VITAMMA prescribers. When Organon acquired Dermavant, VITAMMA was accessible to about a third of the addressable population and broader access had significant barriers. We have achieved meaningful improvements in our access objectives to date and are on track to achieve 80% of the addressable population covered in both national and regional healthcare plans by early twenty twenty six.

[Kevin Ali, CEO & Board Member at Organon]

We've only just begun to unlock the potential of this asset. Butana is approved for patients as young as two years of age. This unlocks the pediatric segment where treatment options are limited and safety concerns with existing therapies are significant. Other competitors in this space have labels approved for six years of age and up. This is a subset of pediatrics where we have a significant advantage.

[Kevin Ali, CEO & Board Member at Organon]

As we reflect on the 2025, we're proud of several key accomplishments that have set a strong foundation for the remainder of the year. Our portfolio is performing well, overcoming and mitigating the negative effects of the LOE in The EU of our second largest product, Adazet. We have created efficiencies in our expense base, which are reflected in our year to date results and in our adjusted EBITDA margin guidance. We took action on our capital allocation priorities in order to accelerate the reduction of our net leverage paying down principal on long term debt and we have a clear pathway to achieving a net leverage ratio below four times by the end of this year. Finally, we acquired a new growth catalyst in VITAMA.

[Kevin Ali, CEO & Board Member at Organon]

Year to date, we're right where we wanted to be with VITAMA, making significant progress on our access objectives, which gives us confidence in our ability to deliver on our 2025 VITAMA revenue objective.

[Kevin Ali, CEO & Board Member at Organon]

I'll now turn the call over to Matt, who will review the financials in more detail.

[Matthew Walsh, CFO at Organon]

Thank you, Kevin. Beginning on Slide eight, where we bridge our second quarter revenue of $1,594,000,000 year on year. Overall, revenue was down 1% both as reported and at constant currency, which aligns with our guidance expectations at the halfway point. Starting on the left, loss of exclusivity was about $60,000,000 for the quarter, which primarily reflects the impact of the LOE of AdaZed in Europe, which occurred in September 2024.

[Matthew Walsh, CFO at Organon]

Six months year to date, we are at $120,000,000 of impact from LOE, meaning we are about two thirds of the way through our full year estimate. We will see that Henwood mitigate in the fourth quarter when we start lapping the LOE of Adazet in the EU. VDP in China was de minimis in the second quarter and year to date, and we expect only a nominal impact on a full year basis for 2025. Our potential exposure this fiscal year will be more back half weighted as we expect Fosamax will be included in round 11. There was an approximate $40,000,000 impact from price for the second quarter or about 2.5%.

[Matthew Walsh, CFO at Organon]

Pricing pressure was primarily from the LOE of Adazet as well as from certain mature products in The U. S. Like NuvaRing, Dulera, Renflexis and Ontrazon. We also continue to face expected mandatory pricing revisions in certain regional markets, for example, Japan. Volume increased $90,000,000 in the quarter, representing growth of about 5.6%.

[Matthew Walsh, CFO at Organon]

Fertility, HEDLEMA, Emgality and VITAMA were the largest contributors to volume growth in the quarter. In supply other, here we capture the lower margin contract manufacturing arrangements that we have with Merck, which have been declining since the spin off as expected. And lastly, foreign exchange translation had an approximate $10,000,000 favorable impact in the quarter, which reflects the weaker U. S. Dollar versus the majority of foreign currencies in which we transact.

[Matthew Walsh, CFO at Organon]

Now let's turn to Slide nine, where we show key non GAAP P and L line items and metrics for the quarter. 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 purchase accounting amortization and one time items from cost of goods sold, which can be seen in our appendix slide. Adjusted gross margin was 61.7% for the second quarter compared with 62% in the 2024. The modest year over year decrease in adjusted gross margin primarily reflects the favorable impact of foreign exchange on our inventory turns in the period more than offset by price as I discussed.

[Matthew Walsh, CFO at Organon]

Year to date, our operating expenses are down 2%, which reflects operational discipline and an element of favorable timing of spend in both SG and A and R and D. Year to date adjusted EBITDA margin was 32.4%, which is running above the high end of our 31% to 32% guidance range for the full year. We expect second half adjusted EBITDA margins to moderate and expect the full year to land within our existing adjusted EBITDA margin guidance range as we continue to invest in the VITAMMA launch and the timing of clinical spending in R and D catches up with our full year expectation. On the full year, we expect total OpEx, which we define as the sum of SG and A and R and D expenses, to be generally flat with prior year based on our objective to achieve $200,000,000 of operational savings in 2025 that would help offset investment in our growth drivers, especially BTAMA. Turning to free cash flow now on Slide 10.

[Matthew Walsh, CFO at Organon]

We delivered $525,000,000 of free cash flow before onetime costs in the first half, ahead of where we were this time last year. This is a function of active cash cycle working capital management, lower interest expense on our debt, and favorable first half timing of cash tax payments. One time costs related to the spin off were completed in 2024 following the rollout of our global ERP system. And as a result, these costs are zero in the 2025 compared with 117,000,000 in the prior year period. Six months year to date, we recorded $175,000,000 in other one time costs broken out as follows.

[Matthew Walsh, CFO at Organon]

Approximately $75,000,000 relates to cash payments associated with the restructuring initiatives we are executing to deliver $200,000,000 of operating savings this year, as I mentioned earlier. Dollars 20,000,000 relates to the final payment on the microspherics legal settlement, and the remaining $80,000,000 relates to the planned exits from supply arrangements with Merck. We've discussed in past quarters these costs would be ramping up. These are activities that will enable Organon to redefine our appropriate sourcing strategy and move to fit for purpose supply chains while focusing on delivering efficiencies in terms of gross margin expansion, which we expect to begin realizing in 2027. Our original estimate for these restructuring and manufacturing separation activities was $325,000,000 to $375,000,000 in 2025.

[Matthew Walsh, CFO at Organon]

While we are tracking to the midpoint of this range at the halfway point, our view into the second half is pointing to lower cash outlay. As a result, we are improving our estimate by $75,000,000 at the midpoint. Our updated estimate for restructuring and manufacturing separation activities for 2025 is now $250,000,000 to $300,000,000 with the improvement being realized in lower restructuring costs. We slightly increased our estimate of business development cash investments for 2025 from approximately $200,000,000 to approximately $230,000,000 with the increase being driven by the modest upfront payment to acquire commercial rights to Tofodin. On an absolute basis, the majority of the $230,000,000 pertains to commercial milestone payments tied to the sales of VITAMMA and GALITY and the biosimilar programs with Shanghai Hanlius.

[Matthew Walsh, CFO at Organon]

Through the first half of the year, we've paid about $150,000,000 towards that total. The achievement of these milestones means we are realizing value for business development deals already signed and validates the path to low to mid single digit revenue growth rate post 2025 that we've been saying Organon should be able to deliver. Turning now to leverage on Slide 11. In the first quarter, we revised our capital allocation priorities, increasing the retention ratio of our free cash flow with the stated goal of applying that cash to debt repayment. In the second quarter, we took immediate action and started to put that cash to work.

[Matthew Walsh, CFO at Organon]

During the quarter, we made principal payments on long term debt totaling three forty five million dollars We repurchased and canceled $242,000,000 of our five oneeight percent notes due in 2031 prior to maturity, which resulted in a pretax gain on extinguishment of debt of $42,000,000 at an average purchase price of 82.6 percent face value. We also paid off and terminated a legacy funding agreement in Dermavant valued at $103,000,000 which resulted in a pretax gain on extinguishment of $4,000,000 On an after tax basis, the $46,000,000 gain across both retirements added $0.14 per share to our GAAP earnings per share in the second quarter. The return on the debt repurchase was compelling, and we advanced our revolver to prudently maximize the trade. We intend to pay off the balance on the revolver by year end as discretionary cash builds in the second half of the year. As a result of these actions, we were able to maintain net leverage ratio flat to Q1 despite the impact of a weakening dollar, which increased by approximately $250,000,000 the translated U.

[Matthew Walsh, CFO at Organon]

S. Dollar value of our euro denominated debt. We continue to see a path to achieving net leverage below four times by year end. And over time, the capital preserved with a higher retention ratio creates a compounding improvement in financial flexibility, which offers us the opportunity to achieve faster and more meaningful deleveraging over the next few years. Now turning to 2025 full year revenue guidance on slide 12.

[Matthew Walsh, CFO at Organon]

We are raising our estimate for full year revenue based on year to date favorability in foreign exchange translation in our belief that this favorability will persist at or close to current spot rates for the remainder of 2025. In summary, we are raising our revenue guide by $100,000,000,000 at the midpoint of the range. The operational components of this revised revenue bridge look very similar to the one we provided in May following Q1 earnings. The only change of any significance is on FX. In May, we had said that currency could be as much as a $200,000,000 headwind in 2025, but should a weakening dollar persist, we would see upside, and that appears to be occurring.

[Matthew Walsh, CFO at Organon]

Given current rates, we are now estimating a $50,000,000 FX headwind year on year or approximately 75 basis points on our full year revenue growth driven by the euro, the Mexican peso, Canadian dollar, Chinese yuan and Korean yuan. Within the operational bars, we've modestly revised our ranges on LOE, VBP and volume. For volume, we narrowed the range and took down the midpoint a bit to reflect conservatism with regard to some risk in the general medicines based business, specifically as it relates to the respiratory portfolio. Those products have been under pressure in the first half of the year due to a mild respiratory season in certain markets. The 6% growth rate midpoint of the volume guide implies very strong volume growth in the second half of the year, which will mainly be driven by continued uptake of VITAMMA, but also Emgality, biosimilars and Nexplanon.

[Matthew Walsh, CFO at Organon]

Taken together, the midpoint of our constant currency revenue guide is still about flat versus prior year. We expect the uptake of VITAMMA, continued solid performance in Emgality, Nexplanon and HEDLEMA will help to offset the LOE of Adazet in Europe along with typical pricing headwinds in other parts of the portfolio. From a quarterly phasing perspective, we expect Q3 revenue should be flat with last year on a reported basis with some modest growth year over year coming in the fourth quarter. That will be driven by lapping the LOE of Adazet, which occurred in September 2024, as well as the continued uptake of BITAMA. Turning to Slide 13, where we show all components of our earnings guidance.

[Matthew Walsh, CFO at Organon]

We continue to expect adjusted gross margin to be in the range of 60% to 61%. Adjusted gross margin was strong year to date given favorable FX changes on our inventory turns. We expect adjusted gross margin will be lower in the second half, but we believe we will land the year closer to the high end of the range at 61%. With regard to tariffs, the industry does not yet have the clarity required to be able to talk about specific impacts. For Organon, we can say that our guidance incorporates documented tariffs related to Canada, Mexico, and China.

[Matthew Walsh, CFO at Organon]

As a hypothetical sensitivity, we can also say that the EU is our most significant exposure from an import standpoint to The US, and we're comfortable saying that an EU tariff on pharmaceuticals of up to 15% alone would not cause us to lower our range on adjusted gross margin for 2025. Moving on to OpEx. As I mentioned earlier, we still expect SG and A and R and D expense to land the year within the ranges we've been providing, with favorability in the first half attributable to timing. We continue to expect our adjusted EBITDA margin to be in the range of 31% to 32% for the full year. If you do a second half implied P and L calculation using the midpoint of our guide, you're probably modeling adjusted EBITDA margins in the neighborhood of 30.5% in the back half, which is a pretty good estimate for both the third and fourth quarters individually.

[Matthew Walsh, CFO at Organon]

For below the line items, our estimate for full year 2025 interest expense remains at $510,000,000 The lower interest expense from voluntarily retired debt is essentially fully offset by higher euro denominated interest expense due to FX translation and an acceleration of non cash amortization capitalized fees related to the debt retirement. As we think about next year, we would expect interest expense to be closer to $475,000,000 run rate as a result of the voluntary debt repayments completed this quarter, all else held equal. For 2025, we continue to estimate our non GAAP tax rate to be in the range of 22.5% to 24.5%. The uptick from 2024 is largely due to the impact of the 15% global minimum tax rate required under the OECD's pillar two. Depreciation of $135,000,000 remains our estimate for full year 2025.

[Matthew Walsh, CFO at Organon]

In summary, our year to date results were solidly aligned with our expectations at the start of the year. We see a very realistic path of maintaining total revenue about level with prior year, which is noteworthy given the LOE of Adazet, our second largest product that we're facing this year. VITAMMA will play an important role in achieving this result. From a profitability standpoint, we are tracking well to our cost reduction goals and we continue to improve our OpEx efficiency metric. 2025 is likely to be our strongest OpEx efficiency since the spin off.

[Matthew Walsh, CFO at Organon]

If we achieve the midpoint of our adjusted EBITDA margin guidance range, that would represent almost a full point of improvement over last year. And finally, we're on the right path with regard to deleveraging. Following our reprioritization of capital allocation, we were quick to act in the second quarter and were successful in repurchasing debt in the open market, yielding a very attractive return. Combined with free cash flow, which we expect will be in excess of $900,000,000 for 2025, we continue to see a path to sub-4x net leverage ratio by year end, which is an important mile marker on our way to even lower leverage in 2026. And with that, we'll now turn the call over to Q and A.

[Operator]

Thank you. You. Your first question comes from David Amsellem with Piper Sandler. Your line is open.

[Alex Riesemann, Equity Research Analyst at Piper Sandler Companies]

Hi, good morning. Thanks for taking our question. This is Alex on for David. Just one on the TAMA from us. Looking further ahead, can you talk to incremental sales and marketing investment whether it's DTC or sales force expansion or both?

[Alex Riesemann, Equity Research Analyst at Piper Sandler Companies]

And can you also remind us how many practitioners you are currently calling on and how many reps you currently have supporting the product? Thank you.

[Kevin Ali, CEO & Board Member at Organon]

So thanks for the question, Alex. So yes, as a matter of fact, in July, we started new telehealth and DTC campaigns coupled with pediatric initiatives or programs to penetrate into the pediatric segment. And so currently, we feel very comfortable with where we're going in terms of the investments for the second half of the year. They're more weighted or loaded towards the second half. And so things are moving along exactly where we thought they would be at this period of time.

[Kevin Ali, CEO & Board Member at Organon]

And we feel good in terms of overall positioning of where we are with VITAMMA right now, and we're expanding. And currently, in terms of your question around reps, so we did add more reps. And I talked about DTC, so we added more sales force and we've got now a total of more than 125 reps in the field.

[Jennifer Halchak, VP, IR at Organon]

Thank you. Maybe Thank next you.

[Operator]

The next question comes from Mike Niedzlkovich with TD Cowen. Your line is open.

[Michael Nedelcovych, Director - Equity Research at TD Cowen]

Hi. Thank you for the questions. I have two.

[Michael Nedelcovych, Director - Equity Research at TD Cowen]

The first is on Nexplanon. Can you elaborate on the federal funding headwinds you cited in The U. S? To what extent was the decline in U.

[Michael Nedelcovych, Director - Equity Research at TD Cowen]

S. Nexplanon sales this quarter related to purchase timing versus underlying pressures that might persist through the rest of the year and beyond? And then my second question is on capital allocation. As you approach and then exceed your leverage ratio targets, how do you expect your capital allocation priorities to change? What might become the top priority? Thank you.

[Kevin Ali, CEO & Board Member at Organon]

Yeah, Mike. I can get started with that. With Nexplan, it's a combination of both. Look, I mean, with the most recent big beautiful bill, there were some effects in terms of overall on Planned Parenthood and Medicaid related funding. And so there's a lot of kind of there's some nervousness in the market, especially when it comes to purchase of contraception as well.

[Kevin Ali, CEO & Board Member at Organon]

Remember that in the first quarter, we saw essentially the movement on USAID by the administration. But overall, we're seeing a lot of pickup ex U. S. In countries like Brazil, Egypt and many other countries that are starting to pick up the slack. And we have a lot of confidence that the USAID numbers will start to or investment will start to pay off with regards to other sponsors coming in picking up the tab on that.

[Kevin Ali, CEO & Board Member at Organon]

Now in regards to where we are with The U. S, still feel very confident that we'll grow this year with Nexplanon. But clearly, there's a lot of confusion in the market. We've got, I think, good news on Title X unfreezing in certain states that are key for us like California and Texas. But there is a little bit of hesitancy, especially around the Planned Parenthood issues that are there that needs to be dealt with.

[Kevin Ali, CEO & Board Member at Organon]

But we feel very confident that it's just a matter of in the near future, we'll reach that $1,000,000,000 threshold, and we'll see growth this year going forward. Whether it lasts for the long term, remember, the Planned Parenthood issues are really twenty twelve months in total. So once that's up and running, then ultimately, we'll be able to get back to it. But feel very good about Nexplanon being our key product. And remember that we're going to be launching the five year indication sometime at the end of this year, so we feel good about that.

[Kevin Ali, CEO & Board Member at Organon]

In regards to leverage, well, ask us when we get down below 3.5, and then we'll have a discussion on that. But right now, our focus is to delever. We did that with regards to the payment on principal debt in terms of the first quarter or what we just came right out with, and we'll continue to do that.

[Operator]

The next question comes from Terence Flynn with Morgan Stanley. Your line is open.

[Terence Flynn, Equity Research Analyst at Morgan Stanley]

Hi. Thanks for taking the question. Thanks for all the clarity on the call. You guys mentioned that 15% tariff out in the EU would not have an impact on 25 margins. Just wondering if you can look out to 26 and give us some idea what kind of impact it might have on 26?

[Terence Flynn, Equity Research Analyst at Morgan Stanley]

And then similar question as you look out to '26, how should we think about free cash flow conversion and some of the one time items? I know you've guided to those continuing to decline, but can you give us any sense of the magnitude there? Thank you.

[Matthew Walsh, CFO at Organon]

Yes. So I'll take that one. It's a little bit too soon to be talking about tariff impacts out in 2026. It's not the right time for that. Just investors should know that our largest import exposure into The United States comes from the EU.

[Matthew Walsh, CFO at Organon]

It's approximately two thirds of our imported value. So investors, knowing that, can make some of their own math, but it's just too soon for us to speculate about 2026, whether we're talking about tariffs or anything else.

[Kevin Ali, CEO & Board Member at Organon]

And free cash flow.

[Terence Flynn, Equity Research Analyst at Morgan Stanley]

Free cash flow, sorry, margin.

[Matthew Walsh, CFO at Organon]

Yes. Free cash flow should be growing in line with the business. We'll continue to see a reduction in onetime costs. So we have been we've needed to make a differentiation between gross free cash flow and free cash flow excluding onetime items. Those onetime items are declining.

[Matthew Walsh, CFO at Organon]

They've been declining this year. They will continue to decline into next year. So that would be a reason why you might see, in addition to normal growth of the business, discretionary cash flow increase pretty significantly next year.

[Operator]

The next question comes from Umer Raffat with Evercore. Your line is open.

[Umer Raffat, Senior Managing Director at Evercore ISI]

Good morning, guys. I was just looking at Batema volume data. I recall you guys obviously got the atopic derm approval in December. So a couple of months into the launch, I think around end of Feb, March timeframe, it was generally hovering around 6,000 TRx a week. And it's kind of in that same ballpark right now, few months later.

[Umer Raffat, Senior Managing Director at Evercore ISI]

And I'm just trying to think about how you're looking at the volume data because I feel like sometimes we do the year over year and it could mask what's happening more near term. And is there something you want to do differently to turn the trajectory around?

[Kevin Ali, CEO & Board Member at Organon]

Hey, Umer. Good to hear you. Listen, in regards to VITAMMA, I mean, there's a tug of war week by week. But overall, what I can tell you is the following, that we just started the investments right now. We need to settle down.

[Kevin Ali, CEO & Board Member at Organon]

Obviously, we just took over the product and get it launched and get it out there and do the right things in the initial stages. And now we have a very, I think, effective and full force behind our DTC campaign and our telehealth campaign and expanding in terms of sales force, in terms of what we're doing regarding penetrating into the pediatric segment as well as obviously continue to maintain our focus on the adult segment. But more importantly, the gross to net and lives covered continue to move in the right direction. Look, when you when access starts to open up, each individual physician's offices, whether it's a dermatology office or others, they know that when they start to hear that ultimately PBM start to accept it and for AD, you have less hesitancy about using, say, coupon cards. You have more fluency, more openness to be able to use the product on a more routine basis.

[Kevin Ali, CEO & Board Member at Organon]

And so now, as we predicted, our access teams are working incredibly hard. They've made huge strides, huge strides to get to 80% of the lives covered by Q1 We're making incredible movements in that space. As well, gross to net is precipitously dropping in the right direction real quick. So once those two things happen, it's funny how that affects volume.

[Kevin Ali, CEO & Board Member at Organon]

Volume starts to pick up because people understand it's being covered. In addition to that, you add our DTC and telehealth as well as our expansion in Salesforce, and I think you'll see good, solid volume getting picked up. But more importantly, that every script will mean more net revenue for us as we start to get the gross to net in the right place.

[Umer Raffat, Senior Managing Director at Evercore ISI]

But, Kevin, just to maybe expand on that, the new to brand is not so bad. It's kinda growing, which sounds to me like there's a duration issue more so than an access issue.

[Kevin Ali, CEO & Board Member at Organon]

Well, I think that right now, what you see is an uptick in TRx. So you've got some refills coming in as we speak. You know, you'll start to see more and more TRx uplift as the volume starts to move. But I I agree with you. Look, I mean, we've added a number of physicians right now who are new to brand, and we see these kind of seasonalities.

[Kevin Ali, CEO & Board Member at Organon]

But I feel really good about the second half of the year based on where we landed in terms of exiting q two. Q2, in terms of the last month, was a very strong exit. It gives me a lot of confidence in terms of where we're headed.

[Operator]

The next question comes from Chris with JPMorgan. Your line is open.

[Ethan Brown, Equity Research Analyst at JP Morgan]

Hi, this is Ethan on for Chris Schott. Thanks for taking our questions. Just starting off on VITAMMA, can you remind us what's driving the ramp in the second half of the year to get to the $150,000,000 in sales and how much of that is driven by volume versus price? And then on NEXLINON, as we think about the launch of the five year indication, can you remind us on how we should think about the impact to growth in 2026 and 2027? And specifically, what portion of current volumes are coming from implant replacements? Thank you.

[Kevin Ali, CEO & Board Member at Organon]

Okay. Let me try to address those Ethan one after the next. So second half uplift in terms of VITAMMA. We got this is global obviously the 150,000,000 We've got 56 in and another 90 something to go, 94 to go. And so I believe very strongly that where we are right now in implementing our new activities around DTC, around telehealth, around expansion of sales force, around some of the things that we're doing around volume is really a very important lever to believe in, at least for me, going forward.

[Kevin Ali, CEO & Board Member at Organon]

We're getting, obviously, a launch in Canada soon. We've got continuous implementation or rather contribution from Japan as well. But overall, in The U. S, that's the key market, and we feel really good about where we landed in terms of exiting Q2. And I think the ramp in terms of where we see it gets us to the 150,000,000 especially if you look at how we exited Q2 and especially you look at where gross to net is falling in the right direction.

[Kevin Ali, CEO & Board Member at Organon]

The gross to net issue was not great under the psoriasis indication, but the team has done a phenomenal job of both adding significant lives in terms of PBM additions as well as lowering our gross to net range because of less usage and reliance on the coupon card. So I think overall, get the volume where it needs to be, get a better gross to net picture, invest in expansion of the sales force as well as DTC, and I feel really good about the second half of the year, especially how we've exited Q2. Now in regards to Nexplanon, yes, I mean, that's still working its way out in terms of Planned Parenthood and Medicaid. But we've got opportunities in Title X on funding or rather being unfrozen in key states like Texas as well as California. And remember, we launched the five year duration indication by the end of this year.

[Kevin Ali, CEO & Board Member at Organon]

That will be a little bit of a small headwind in 2026, but then ultimately, it expands our ability for exclusivity through 2029 with the five year indication. And it's I don't want to get into I can give a soliloquy in terms of the issues on being able to try to continue to penetrate into this market. But what I can tell you is ex U. S. Is growing double digit robustly.

[Kevin Ali, CEO & Board Member at Organon]

U. S. Continues to be a growth driver for us, but we just got to get through this year. We got to launch the five year indication. And I think all signals point to the fact that, okay, a little disruption in terms of federal funding, but we feel good about where we are in terms of the patient cohort, in terms of expanding and where we are in terms of the performance year to date.

[Kevin Ali, CEO & Board Member at Organon]

We've got 6% growth year to date, which is very solid.

[Jennifer Halchak, VP, IR at Organon]

Thanks, Ethan.

[Operator]

Your last question comes from Jason Gerberry with Bank of America. Your line is open.

[Jason Gerberry, MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch]

Hey guys, thanks for squeezing me in. So maybe firstly on the 6219 endometriosis setback announced in July, do you still expect to invest in the space? I think there was some commentary in the lead up to that readout that there was a backup molecule. And if you saw at least the signal with 06/2019, you might pursue that. So I'm just kind of curious where things may stand on that front.

[Jason Gerberry, MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch]

And then secondly, I know there was some effort through Citizens Petition to modify the generic product specific guidance for developing a generic and next put on more around the applicator similarity. But I'm curious, when you get the five year, approval, do you expect the FDA, to have the real time release study, updated to mandatory five years? Or do you think there's still be an option to have a three year and a five year, release time or, I guess, time release study to be done by the generic supplier? Just curious your thoughts on that. Thanks.

[Kevin Ali, CEO & Board Member at Organon]

Juan Camilo, would you like to take that, those questions?

[Juan Camilo Ferreira, Head of Organon Research & Development - CMO at Organon]

Yes. I can handle both, Kevin. Yes. So first, regarding the six thousand two hundred nineteen, as we shared in our press release, we did not see a signal for efficacy for six two one nine, and, therefore, to your question on the on the back of molecule in the second asset, which was targeting the same the same, mechanism, we have decided to discontinue that program as well. And now second, with regard to the to the, citizen's petition and on the overall FDA guidance, we we don't comment on the decisions the FDA may make about the their guidance on how to develop a generic.

[Juan Camilo Ferreira, Head of Organon Research & Development - CMO at Organon]

We are working closely with the FDA to get the to get the right labeling for the for the five year indication in Nexplanon. And as you saw in the sixteenth petition, we provided our perspective of what is required and has been required for Nexplanon to be used with safely in in patients. So with that information, the FDA will make their own assessment and determine what is the right appropriate guidance they'll provide to generic manufacturers. But we are, as Kevin pointed out, we're really, excited and looking forward to bringing this new indication and the new labeling for Nexplanon through the finish line before the end of the year.

[Jason Gerberry, MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch]

Thank you, guys.

[Kevin Ali, CEO & Board Member at Organon]

What will say, though, is that patients and providers both clearly prefer, the longer duration of five years. It just gives them much more flexibility, especially for different segments, like, for example, the family complete segment, the older cohort in terms of because a lot of our business comes from the much younger cohort. And so this will open up a completely new segment for us. And so the question of can we see a three year and a five year coexisting in the market, very difficult. I think by the time that all plays out, I think the market will have moved securely into the five year segment.

[Kevin Ali, CEO & Board Member at Organon]

Just another hurdle to essentially for any potential generics to actually deal with in managing to get into this business.

[Operator]

This concludes the question and answer session and will conclude today's conference call and webcast. Thank you for joining. You may now disconnect.

Participants

Executives

• Kevin Ali, CEO & Board Member
• Matthew Walsh, CFO

Analysts

• Jennifer Halchak, VP, IR at Organon
• Alex Riesemann, Equity Research Analyst at Piper Sandler Companies
• Michael Nedelcovych, Director - Equity Research at TD Cowen
• Terence Flynn, Equity Research Analyst at Morgan Stanley
• Umer Raffat, Senior Managing Director at Evercore ISI
• Ethan Brown, Equity Research Analyst at JP Morgan
• Jason Gerberry, MD & Equity Research Analyst - Biotech & Pharma at Bank of America Merrill Lynch
• Juan Camilo Ferreira, Head of Organon Research & Development - CMO at Organon