Thank you for standing by. And welcome to the Organon Q4 Full Year 2023 Earnings Call and Webcast. I would now like to welcome Jennifer Halchak, Vice President of Investor Relations to begin the call. Jennifer, over to you.

Thank you, operator, and good morning, everyone. Thank you for joining Organon's fourth quarter 2023 and full year 2023 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 new 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. The presentation will also be available following this call on the Events & 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.

Good morning, everyone, and thank you, Jen. Welcome to today's call where we'll talk about our 2023 results and provide financial guidance for the full year of 2024. We ended the year with a very strong fourth quarter. Revenue grew 8% both nominally and at constant currency with growth across all of our five geographies and all three franchises. For the full year of 2023, we came in above the high end of our revenue guidance range; revenue for the full year was $6.3 billion, resulting in 3% revenue growth at constant currency. Our women’s health franchise grew 3%, our biosimilars franchise grew 24%, and our established brands business grew 2% at constant currency. For the full year 2023 adjusted EBITDA was $1.9 billion, representing a 31% adjusted EBITDA margin and adjusted diluted EPS was $4.14. Importantly, free cash flow before one-time spin related items came in above the high end of our previous guidance range, finishing the year with $940 million. We continue to believe this business can generate $1 billion of free cash flow before those one-time charges, 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 leverage below four times by the end of 2024, and to continue doing business development in line with the types of transactions we have completed in the last couple of years. That includes licensing deals like our transaction with Eli Lilly to become the sole distributor and promoter for the migraine medicines, Emgality and RAYVOW, in Europe. We're very proud of the business development we've completed to date. These transactions share some important characteristics. First, our view that women's health goes beyond reproductive health; migraine medicines are a case in point as migraines are three times more common in women than in men. Second, these are transactions that leverage the size and scale of our international commercial infrastructure, enabling us to efficiently commercialize these products. And finally, the deal structures are skewed to success-based milestones, giving us the ability to complete multiple transactions while limiting upfront capital. The combined potential peak revenue of just the commercial stage deals we have completed to date represent almost three quarters of a billion dollars that we expect will be realized between now and the end of the decade. Collectively, these assets have already meaningfully enhanced our growth profile, and we continue to conduct due diligence and are focused on executing these types of opportunities in the future. As we think about what we can achieve as a company this year, we believe 2024 will be the third consecutive year in which we deliver low single-digit revenue growth on a constant currency basis. Our full year 2024 revenue range of $6.2 billion to $6.5 billion represents about 3% growth on a constant currency basis. On the profitability side, we've been at this a while now, and we know where the efficiencies are. Our adjusted EBITDA margin guide of 31% to 33% signals that we are committed to holding the line or better on adjusted EBITDA margins in 2024. Now let's review 2023 in more detail by franchise, starting with women's health. The women's health franchise grew 8% in the fourth quarter and 3% for the full year. Fertility, Jada, and Marvelon were the three strongest contributors to the growth of the women's health franchise in 2023, and together, they more than offset the expected LOE impact of NuvaRing and some one-time headwinds in Nexplanon. Globally, our fertility business grew 9% for the full year 2023. And as you may recall from our third-quarter earnings call, we guided to a very strong fourth quarter for our fertility business, based in part on a significant contract win with the largest PBM in the United States. Just like in other parts of our business, we've been proving that in our hands, and given proper focus, we can unlock additional value in our product portfolio. This particular win marked Organon’s return to U.S. market leadership in covered lives within the fertility space after almost two decades. China, which is also an important fertility market for us, performed strongly in 2023 as well. In the fourth quarter, we had some help by lapping a fourth quarter of last year that was significantly impacted by COVID, but fundamentally we're gaining share in China, primarily from domestic competitors, and we're seeing strong demand in the larger provinces. While the U.S. and China together represent about 60% of our fertility business, our Lamera region also had a very strong 2023, in part due to new launches in the back half of the year that will help drive the high single-digit growth we expect from the fertility business in 2024. Jada was also a key contributor to the women's health franchise last year, adding $43 million to our top line in 2023. Right now, most hospitals in the U.S. stock Jada. Over 45,000 women have been treated in the U.S. since launch. The second phase of growth for Jada involves driving depth of utilization in the U.S. as well as continued expansion outside the U.S. Jada is already available in nine markets outside the U.S., including Brazil, which was a new market for us late in 2023. In 2024, we anticipate further approvals throughout Asia, the Middle East, Latin America, and the EU, as well as Canada, bringing this needed device to many more women who can benefit. Marvelon and Mercilon together grew 24% in 2023, marking their second year of strong double-digit growth. The reacquisition of the rights to these products in selected territories in Asia, including China and Vietnam, is another example of the kind of transactions that are attractive to us, as they enable us to leverage our commercial network and maximize performance of these assets. Also late last year, we made our first U.S. shipment of Xaciato, an FDA-approved medication for the treatment of bacterial vaginosis developed by our collaborator, Daré Bioscience. We have now made Xaciato available nationwide. We continue to meet with healthcare professionals to review Xaciato and obtain competitive managed care formulary status in the bacterial vaginosis marketplace. Rounding out women's health, as we spoke about last quarter in 2023, we made changes to the Nexplanon go-to-market model in the U.S. and we faced some headwinds outside the U.S. Still, in 2023, Nexplanon surpassed the best-selling IUD to achieve the number one market share in a long-acting reversible contraceptive market in the U.S. Moving to market leadership is a key milestone and speaks to how Nexplanon is driving the performance of the LARC category. The 1% FX growth we saw in Nexplanon for the full year 2023 included resetting the timing of our annual price increase and proactive management of discounts in the 340B channel in the U.S. Outside the U.S., growth in 2023 was impacted by lower volumes from a public tender in Mexico. However, we continue to see strong demand for Nexplanon in Mexico and globally, which we expect will drive strong growth opportunities in 2024, especially as we continue to expand production capacity to keep pace with this demand. These changes well-positioned Nexplanon for a strong 2024, and in the first quarter, we're already tracking with our expectations. We remain encouraged about the long-term prospects for Nexplanon. At the end of 2024, we anticipate having Phase III data from our five-year study. If approved, that will give Nexplanon three years of exclusivity on the five-year efficacy claim in the U.S. market. In our research, there's a clear patient preference for longer duration. We believe this will be a significant differentiator for our product and will extend the growth ramp well past the billion-dollar run rate we are aiming for in 2025. Let's move now to our biosimilars business, which grew 24% for the year. Biosimilars continue to be a key growth pillar for Organon, and we've especially been pleased with the continued growth of our immunology portfolio of products, including Renflexis, Brenzys, and Hadlima. Renflexis grew 24% for the full year 2023, delivering its sixth consecutive year of revenue growth, primarily driven by continued demand growth in the U.S. and Canada. We're retaining customers in a competitive market, and we've also been able to hold prices better than the competitive field, resulting in market share gains on a value basis. Hadlima, our biosimilar for Humira, had strong growth in 2023 with continued uptake in the U.S. following our July 1st, 2023 launch. With regard to Hadlima, we have focused our commercial efforts on payers who want to bring lower net costs to patients, and we've emphasized that's where we believe we can offer the highest value to patients. That strategy is paying off, and we're gaining good momentum. In fact, at the end of January, Hadlima continued to lead all biosimilars in total prescriptions, as it has for the last eight weeks. Our formulary access has also continued to improve, and we expect ongoing changes through 2024 and beyond as payers enable broader access to biosimilars. In the fourth quarter, we were added to several payers focused on low net cost customers, and we recently received notification that we exclusively won the national solicitation with the U.S. Department of Veterans Affairs. We are excited to see the VA supporting market formation of biosimilars to Humira, and we look forward to working with the VA to improve affordability of highly effective biologics. Rounding out the top line discussion, let's move to established brands. For the full year, established brands grew 2% ex-FX. This represents its second consecutive year of growth since our spin. We believe established brands continue to be the most underappreciated part of Organon's story. Over the past few quarters, we've talked about the drivers that have contributed to the stable performance of the franchise since our spin. You've heard us talk about optimizing manufacturing, especially for Nasonex and Atozet to meet the increasing demand. We've discussed our strategic approach around pricing and adapting our commercial model to compensate for payer pressure, as well as managing price declines in select markets through policy work. Last quarter, we talked about our broad product and geographic diversity contributing to stability. To round out the discussion we've been having over the last year, it's important to highlight our lifecycle management initiatives. Since our spin, we have actioned over 30 unique opportunities across 20 plus markets, representing all five of our geographic regions. These include the expansions of product indications, new market launches of existing products, new channels and go-to-market models, the launch of new pack sizes, the launch of clones, second brands and white box launches, and finally, incremental direct-to-consumer activities. We'll also continue to look at established brands for opportunities for business development, like the transaction with Lilly. These licensing transactions are attractive to us as they very efficiently leverage our commercial footprint and expertise. Moving now to slide eight, we take a look at revenue by geography. Our five geographies performed very well in the quarter and for the year. The full year performance in China was particularly impressive when you think about VBP and the general economic slowdown in the region and its impact on Chinese consumers. We have strong diversity in our business in China. No product represents more than 16% of revenue in China. Also, most of our established brands portfolio has already gone through VBP and has weathered those impacts. Since the beginning of the year, we have seen a recovery in China. Infertility as patients returned to the clinics with declining COVID, as well as in established brands in both the hospital and retail channels. Even with various healthcare initiatives in China, we expect that China will grow low single digit on an exchange basis for us in 2024, with more robust growth in 2025 and beyond. In the United States, we had a strong performance supported by fertility demand, Jada, biosimilars, and Dulera, which was partially muted by the LOE of NuvaRing. As we move into 2024, our priorities are to deliver our third year of constant currency revenue growth and to deliver stable to improving adjusted EBITDA margins. Delivering this financial profile is key for us to continue advancing on our mission of a healthier everyday for every woman. There's a tremendous opportunity in women's health to address significant unmet needs, and we're all well positioned at the forefront of that effort. Now let's turn the call over to Matt, who'll go into our financial results in more detail.

Thank you, Kevin. Beginning on slide nine, you can clearly see in this year-over-year revenue bridge that the main driver of the 8% ex-FX revenue increase during the fourth quarter was solid volume growth. Fertility, biosimilars, and established brands all had very solid fourth quarters, which drove almost 9% volume growth during the period. Partially offsetting this solid volume growth was the impact from loss of exclusivity, which in the fourth quarter was about $10 million and was primarily related to ongoing generic competition for NuvaRing in the U.S., and to a lesser extent, the LOE of Atozet in Japan. Volume-based procurement or VBP in China was about $20 million in the quarter and reflects the implementation of round seven, which included Ezetrol, which prior to VBP was our largest product in China, as well as the July implementation of round eight that included Remeron and HYZAAR. We had a negligible impact from price in the fourth quarter, mainly due to actions we took in the Nexplanon 340B channel to peel back voluntary discounts, offsetting pricing pressure in established brands, where the portfolio is subject to mandatory price reductions in certain markets and in biosimilars, which inherently is subject to significant price competition. In Supply Other, we capture the lower margin contract manufacturing arrangements that we have with Merck and have been declining since the spin-off. Lastly, foreign exchange translation had a de minimis impact on revenue during the fourth quarter. Now turning to the full year on slide 10, revenue for fiscal year 2023 was approximately $6.3 billion, up 3% at constant currency. LOE impact for the full year was about $20 million, and just like the fourth quarter, was driven mainly by ongoing generic competition for NuvaRing in the U.S. and, to a lesser extent, the LOE of Atozet in Japan. Full year impact from VBP in China was approximately $95 million, related to the implementations of round seven and eight, impacting Ezetrol, Remeron, and HYZAAR as I just discussed. Moving on to price, we saw approximately $90 million of price erosion for the full year, equitably driven by familiar dynamics in established brands, the biosimilars portfolio, and fertility. Within fertility, globally and particularly in the U.S., health systems and commercial insurers are increasingly reimbursing fertility services. This is expanding the market and thus the volume opportunity for our fertility products and has also increased price competition. Volume growth for the year was approximately $420 million, or about 7% higher than last year, and we saw volume growth across multiple franchises. In women's health, we had strong volume growth from fertility as well as from Jada. Our biosimilar products also continued to see strong demand, and in established brands, volume growth outstripped pricing pressure during 2023. Finally, you can see the approximate 190 basis points of financial reporting headwind we had in foreign exchange translation, which is a function of more than 75% of our revenue being generated outside the U.S. Now let's turn to performance by franchise. As has been our convention, I'll target my comments over the next three slides to those areas most relevant to your modeling as we think about where we ended the year and what the near-term future may hold. So let's start with women's health on slide 11. The decision to forego our normal list price increase for Nexplanon in mid-2023 and opting instead to take price in early 2024 is reflected in Nexplanon’s performance in the fourth quarter. Specifically, during the fourth quarter of 2023, we didn't have demand pull forward or buy-in that we would normally see during a price protection period. In the full year Nexplanon results, you also see the impact of more limited participation in the tender in Mexico, as well as supply constraints in some fast-growing international markets like Asia and Africa that have since been resolved. The math on those collective headwinds would indicate that it's hard for us to envision a scenario that Nexplanon doesn't return to strong growth in the high single digits in 2024. As we think about phasing for next year, the first quarter of 2024 will be a relatively strong growth quarter, primarily because the first quarter of 2023 was light, following a strong Q4 of 2022 that was helped by that buy-in dynamic that I just discussed. By resetting the timing of list price increases for Nexplanon, we are better aligned commercially with our customers and healthcare peers in the U.S. And from a financial reporting perspective, in future periods, we expect to see less volatility in Nexplanon’s year-on-year revenue growth rates each quarter. Fertility had a strong fourth quarter as we expected, and there were two drivers. The first driver was increased demand in the U.S., primarily tied to onboarding a new and significant PBM customer. The second and actually larger driver was a one-time buy-in as a result of exiting a spin-off-related temporary commercial arrangement with Merck. Given that these volume drivers were one-time in nature, the first quarter of 2024 is likely to be the lightest of the year for fertility as inventory levels in the U.S. normalize. We will also benefit from expected continued recovery in China, as well as launches in select markets in the latter part of the year. Turning to biosimilars on slide 12, biosimilars had a very strong fourth quarter, helped by favorable timing of Ontruzant deliveries in Brazil to meet public sector demand. That timing represented about half of the biosimilars growth in the fourth quarter. If we back that out, biosimilars were up 24% in the fourth quarter and 17% for the year at constant currency. In 2024, the drivers in the biosimilars portfolio will continue to be supported by strong performance of Renflexis in the U.S., even after entering its seventh year on the market, robust growth in key markets such as Canada and Brazil, and continued uptake of Hadlima in the U.S. Turning to slide 13, as Kevin mentioned, established brands grew for the second year in a row, ex-FX. Performance was able to offset the impacts of VBP and the economic challenges in China, as well as for supply interruptions of several injectable steroid products stemming from the market action taken earlier this year. The roughly 2% constant currency growth for the full year was driven by a little over 2% growth in volume across the portfolio, partially offset by just under 1% price pressure. We expect approximately flat performance within the established brands franchise for the full year 2024 on an ex-exchange basis. Now let's turn to slide 14 where we show key non-GAAP P&L line items and metrics for the fourth quarter and full year performance. For your 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 one-time items related to the spin-off, which can be seen in our appendix slides. So let's talk about the fourth quarter first and then we'll move to the full year. Adjusted gross margin was 60.3% in the fourth quarter of 2023 compared with 63.1% in the fourth quarter of 2022. The unfavorable impact of foreign exchange translation within cost of goods sold and to a lesser extent product mix more than offset a favorable year-over-year comparison to the fourth quarter of 2022 when we took the market action on certain injectable steroid products. Non-GAAP operating expense was down in the quarter. SG&A expense was down 3%, and total R&D expense was down by 6%. Foreign exchange losses were also lower in the fourth quarter compared with the prior year period by about $15 million. One key driver of this improvement, in the fourth quarter of 2022 we increased the portion of our Euro-denominated debt that is designated as a net investment hedge from 85% to 100%. As a result, we are now able to fully report unrealized FX gains and losses on our Euro debt within other comprehensive income, which should dampen the volatility of gains and losses from foreign exchange, thus improving our overall quality of reported earnings, all else equal. These factors culminated in an adjusted EBITDA margin of 28.1% in the fourth quarter of 2023 compared with 25.6% in the fourth quarter of 2022. Non-GAAP adjusted net income was $226 million, or $0.88 per diluted share compared with $208 million, or $0.81 per diluted share in 2022. Higher EBITDA more than offset a higher non-GAAP tax rate in the fourth quarter of this year and a $10 million year-over-year increase in interest expense. While I'm speaking in non-GAAP terms here, there was a GAAP tax item in the fourth quarter that deserves mention. In December, a local tax holiday was terminated, giving rise to a deferred tax asset in the amount of $686 million. That was offset by a $210 million valuation allowance for a net benefit of $476 million to GAAP net income for the fourth quarter. For full year 2023, adjusted gross margin was 62.7% compared with 65.7% for full year 2022. The year-over-year decrease in adjusted gross margin reflects higher costs of sales due to foreign exchange translation and product mix and, to a lesser extent, higher post-COVID inflationary impacts on labor, materials, and distribution-related costs. Adjusted EBITDA margin was 31% for the full year 2023 compared with 33.8% for the full year 2022. The year-over-year decrease was a result of lower adjusted gross margin. Higher selling and promotional expenses were mostly offset by lower total R&D spend, and that lower R&D spend was driven by year-over-year comparability of IP R&D. There was $107 million of IP R&D in 2022 against only $8 million of IP R&D in 2023. Adjusted net income was $1.1 billion or $4.14 per diluted share for full year 2023 compared with $1.3 billion or $5.03 per diluted share in the prior year. The year-over-year decline in net income is primarily due to higher interest expense associated with increased interest rates and accelerated amortization of capitalized financing costs associated with voluntary debt prepayments on the company's U.S. dollar-denominated term loan. Turning to slide 15, let's take a look at free cash flow. We ended the year with $940 million of free cash flow before one-time costs, which is above the range that we had guided to in November. The upside was driven by the stabilization of our net working capital position as we continued to make progress towards the global implementation of our new ERP system. One-time spin-related charges totaled $344 million for the full year 2023, slightly favorable to the $350 million we had been guiding to. Free cash flow generation is obviously important to the investment thesis of Organon. So let's talk about what these line items could look like for 2024. Cash taxes will go up fairly substantially in 2024, largely due to the anticipated payment of certain non-U.S. taxes, as well as settlements in various jurisdictions that will trigger higher cash tax payments relative to 2023, which was an unusually low year for cash taxes. Interest expense is expected to be a bit lower than last year, and this guidance assumes no reduction in U.S. short-term interest rates during 2024. Working capital use will likely be about $100 million, which reflects typical working capital expansion as our business grows, partially offset by continued gradual work down of our working capital as the global ERP implementation progresses towards full completion in the second quarter of this year. Given our adjusted EBITDA guide for 2024, these components would put us in the range of $1 billion of net free cash flow before one-time spin-related costs for 2024. We expect to see a significant reduction in one-time spin-related costs in 2024, about 40% lower than 2023, and then again, an even larger reduction in 2025. Beyond 2025, we expect one-time spin-related costs to be de minimis. You can see on this slide an additional reporting line for other one-time costs, which is a catch-all line item for any one-time costs that are not spin-off related. For 2023, that $35 million represents the first of three annual installment payments in the $80 million settlement of the Microspherix litigation. Going forward, other items that may appear in this line item include costs related to restructuring, as well as costs related to optimizing our manufacturing and supply network as we continue to separate those activities from MERC. 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. By order of magnitude, we're talking about a total of a few hundred million dollars from now until the end of 2031, when our last MSA with MERC will terminate. These investments are not likely to be substantial in any given year, and because they're aimed at improving productivity, they will be gross margin accretive over time. Turning to our net leverage ratio on slide 16, we ended the year at 4.1 times net leverage, which is a significant improvement over third-quarter end. In addition to the strong Q4 cash flow, we dropped the low fourth-quarter EBITDA of last year. However, the strength in the euro at the end of the year increased the translated value of our euro-denominated debt by about $100 million. As we think about 2024, the anticipated EBITDA phase in quarter-by-quarter suggests that the net leverage ratio could tick higher in the first half of 2024 and come down in the back half, ending the year just under four times net leverage. Now turning to 2024 guidance on slide 17, where we highlight the items driving our 2024 revenue guidance range of $6.2 billion to $6.5 billion. Beginning with LOE, we expect an approximate $70 million to $90 million impact for the full year 2024. This is primarily from Atozet, which went LOE in Japan in 2023 and will lose exclusivity in the EU later this year, as well as a provision for Dulera in the U.S., where we have been expecting a generic since 2020. Turning to VBP, we expect the VBP impact to be in the range of $30 million to $50 million for the full year 2024, lower than what we saw in 2023 as we lapped the impact from Ezetrol, Remeron, and HYZAAR's inclusion. Our range also assumes that the implementation of round 10 could include Fosamax later in the year. By the end of 2024, we expect approximately 85% of the portfolio will have gone through VBP. We expect the impact from price to be in the $150 million to $200 million range, which is about 2.5 to 3 percentage points compared with the pretty low impact of 1.5 percentage points we saw in 2023. This is really more in the normal range of what we would expect for our business. And for volume, we expect growth of approximately $400 million to $550 million, with most of the volume coming from our growth pillars, Nexplanon, Fertility, Jada, Biosimilars, and China Retail, as well as now the latest addition of Lilly's Emgality and RAYVOW in Europe. Finally, based on current spot FX rates, FX could be a $50 million to $100 million headwind to revenue in 2024 or a range of 80 basis points to 160 basis points. Together, these factors result in full-year revenue guidance of $6.2 billion to $6.5 billion, which represents constant currency revenue growth a bit over 2.5 percentage points at the midpoint. That’s consistent with our guide of low single-digit growth that we provided at JPM back in January, and it would be our third consecutive year delivering constant currency revenue growth. Moving to other components of guidance on slide 18. Reiterating Kevin's comments around margin, our objective in 2024 is to deliver a P&L that combines constant currency revenue growth with potential operating leverage. We've incorporated this into our adjusted EBITDA margin range. So let's talk about the components of that adjusted EBITDA margin guide. From an adjusted gross margin perspective, we delivered a 62.7% adjusted gross margin in 2023, and we're guiding to a range of 61% to 63% for 2024. Over time, we aim to improve this metric in part through the network optimization efforts I discussed. To deliver adjusted EBITDA margin expansion, productivity pickup will need to come from operating expenses. In SG&A, we will have product launches like Xaciato, Hadlima, and international expansion for Jada, but these growth investments will be largely offset by cost management efforts achieved broadly across the company. As we think about phasing for the year, you can probably spread revenue. Margins will likely be better in the second half compared to the first half as we implement those company-wide cost savings. For R&D, the midpoint of that range would represent about a $50 million year-over-year improvement. Now, because IP R&D payments are hard to forecast, this number does not include any estimate of IP R&D in 2024. Potential milestone payments in 2024 would be primarily related to the two biosimilar assets in development with our partner Shanghai Henlius, Pertuzumab and Denosumab, none of which are individually material. On below-the-line items, interest expense should be a bit lower in 2024 based on current interest rates and lower debt balances year-on-year. Just a reminder that our interest expense guide assumes no movement in short-term rates. Any rate cuts by the Fed during 2024 would create upside to our interest expense guidance. Depreciation ticks up a bit this year and that's related to the implementation of our ERP system. Regarding tax, like most international companies, we are dealing with the implementation of Pillar 2. As a result of that and other impacts, we expect our effective tax rate to go up. In 2023 and 2022, our first two full years as a public company, our effective non-GAAP tax rate was low, about 18%, because we benefited from the termination of a tax holiday. Absent that benefit, our effective tax rate would have been several points higher. The impact of that termination, together with the implementation of Pillar 2, will increase our tax rate over the next few years, beginning with 2024, for which we are guiding to a range of 18.5% to 20.5%. Beyond 2024 is when we would start to see a more material increase in the rate, as these impacts and the increase in U.S. GILTI rates become fully realized. In closing, it was a strong end to 2023. We're optimistic that we can deliver on a third consecutive year of constant currency revenue growth that's also accompanied by some bottom line margin improvement and free cash flow of approximately $1 billion before one-time items. With that, now let's turn the call over to Q&A.

Our first question comes from Umer Raffat with Evercore ISI. Please go ahead.

Good morning, guys. Thanks for taking my question and follow-up. I know there's been a fair amount of investor confusion on what you guys are messaging exactly on dividend. Can you confirm you're fully committed to maintaining the current dividend regardless of any M&A intents? And also, could you just remind us the working capital unwind in Q4, what exactly drove that?

So let me take that, Umer. It's good to hear from you. Yes, you heard me at JPM be very declarative that we are very committed to being able to service our dividend. There was a question around free cash flow. With $940 million, it gives us quite a bit of space to comfortably not only pay our dividend but also engage in some tuck-ins like most recently with the Lilly deal. Absent any major M&A, which is not what we're looking at, we're focusing on tuck-ins because the size of these tuck-ins represents quite meaningful amounts. So the dividend continues and it's our focus. Regarding your last question around free cash flow, it is essentially networking capital; our increased focus on networking capital and more specifically around ERP costs started to come down a little less than we'd anticipated. Overall, we believe it's a very solid sign that we can continue to drive towards a billion dollars of free cash flow this year.

Thank you.

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

Hey, guys. Thanks for taking my question. My question, Kevin, is just regarding, I guess, this year, Teva disclosed the generic Nexplanon program and wondering how you're thinking about barriers to entry prior to 2027. I'm looking at the FDA kind of generic equivalence guidance for Nexplanon and it does mention there's a provision for like accelerated comparative in vitro release testing. If you get this five-year study for the intended period of use, just do you expect generics are going to need to do five-year comparative in vitro release testing? Or do you think that this provision for accelerated in vitro release testing is something that is surmountable? Just curious, sort of any perspective you can offer on that would be great. Thanks.

Oh, good. Jason. Yes. Can you hear me? Yes, you got cut off on Teva and FDA Nexplanon.

Yes. I can repeat it. So just curious, obviously the Teva generic program was announced this year. And so just wondering how you're thinking about barriers to a generic entry prior to 2027. I mean, the one thing when I look at the FDA is generic equivalence guidance for Nexplanon is whether or not one can do an accelerated comparative in vitro release test, especially if you get the five-year study that changes the intended period of use that I presume changes to five years. But wondering how you view the feasibility of doing accelerated in vitro release testing. It seems pretty critical to the assumption of whether there's any generic risk prior to 2027 if Teva were to file an IPR or something to try to expedite the path.

Yes, Jason, there's nothing that I see from the FDA in terms of guidance around kind of breaking the patent that we have. Clearly, through the end of 2027. The issue to keep in mind and more importantly, right, whoever announces what their intent is in terms of their focus on where they want to come in next. The FDA has never approved any complex generic drug during the first cycle review. Historically, it's been anywhere between 2.5 to 4-year approval timelines from the initial ANDA submission. For us, NuvaRing, which is by far much less complex than Nexplanon, received FDA approval after almost a 30-month delay and Teva's NuvaRing generic took 8 years to get to the market. Following that timeline, you're talking about a 2030 minimum introduction. And on top of that, you're going to have to have your proprietary device. Our device, our applicator device has patent protection through 2030. You will need your proprietary applicator device design and then launch it. You'll need to start investing in a sales force and medical affairs personnel to train physicians to insert and remove this product. Keep in mind, fundamentally, this is a buy-and-build product, which is much more complex. I do not expect any major issues with Nexplanon between now and the end of the decade. I expect that we're going to have the data at the end of this year for the 5-year indication, and we'll be able to launch that probably when we decide in the 2025, 2026 timeframe, which will take essentially exclusivity through the end of the decade.

Thank you.

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

Hi, good morning. Thanks for taking my question. Can you detail further your 2024 assumptions on operating expense management, where cost management will be focused on as well as your remaining tenders in Latin America that we should be aware of? And my second question is about the PBM's environment in 2024. Do you expect more PBMs to follow CVS Caremark, for instance? Thank you.

Yes. Let me start, Navann, with your last question. We're focused on the PBMs and payers and providers across the country who are focused on low net costs. Essentially, we're getting some of the uptake that we're having involves terms of the different PBMs that we've gotten to date, and we continue to add more PBMs. Our focus has been very successful. Recently, we were named the sole manufacturer for biosimilars for Humira for the VA. That's a very nice tuck-in, and it will have a halo effect in communities with significant VA participation. We continue to see market formation in 2024, as I've indicated. More market formation, although it will be a stronger year for Hadlima this year. You'll see much more breakthrough in 2025 and beyond. In terms of your first question around cost management, look, we know what we know now. When we spun out 2.5 years ago, there were inefficiencies around the company that we've been able to tailor down on. All discussions about OpEx savings in this year are not one-off in nature. They are efficiencies we can continue delivering going forward. There’s no bounce back of our OpEx next year, just a continuing focus on efficiencies. For Nexplanon, as to tenders in the U.S., we had news regarding a Mexico tender last year, but there are no further declines this year. We're starting to see significant growth in Mexico again, outside of the tender business. We don't see that as being a headwind. Rather, we expect a lot of tailwinds for Nexplanon in 2024, a solid year for it.

Thank you. If I can add just, the 4 times net leverage, below 4 times net leverage. Do you expect to do any voluntary debt prepayments in addition to EBITDA growth and close to the $1 billion annual free cash flow?

I can take that one. The guide on net leverage ratio would be independent, Navann, of any debt prepayments. However, we will be generating sufficient net cash flow during the year to have that decision with respect to investments in growth assets versus early prepayment of debt. But the net leverage ratio guide doesn't anticipate any debt repayments. The nature of that calculation is independent of it.

Thank you.

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

Hi, good morning and thanks for the questions. A couple of pretty helpful bridges in the deck, but I just want to push my luck there with the OpEx bridge. As I look at the operating margin guidance or EBITDA guidance for 2024, can you speak about the drivers for this improved outlook? I see that you're looking at around 200 basis points on the higher end of the range despite no material benefits coming in from gross margins or reduced SG&A? That's one. And secondly, on Hadlima, again, pretty impressive growth leading all biosimilars versions. Could you help us understand what you're factoring for 2024 in your guidance? How will the potential launch of an interchangeable high concentration version affect Hadlima specifically? Thank you.

I can take the first part of that question. So in terms of how we're going to deliver improved margins in 2024, it's really coming down to operating expense improvements as we've talked about in the prepared comments. Kevin just alluded to it. We've curtailed the number of pipeline projects that we have in the R&D space as we looked carefully at those projects in the context of new information; some of them just were not meeting our economic return requirements, which is driving the R&D number lower. We're broadly containing costs across the SG&A space while still providing for investments in product launches. In addition, we did have over $40 million of FX losses that we're not expecting to recur in 2024. While we don't forecast that kind of thing, it was embedded in the 2023 actuals, which drives the improvement year-on-year as well.

And Balaji, regarding your question about Hadlima and our expectations this year, we're not providing guidance by product. However, we are currently leading market shares for TRx and NRx among all the six or more that were launched last January. We actually surpassed Amgevita for TRx performance, which was launched six months before. We're very strong in our performance. In terms of interchangeability, they have basically completed the study and submitted. We expect to have interchangeability within the next few months. It is not going to be a major factor for us in terms of competition. We're in a very strong position. If the market moves from a $20 billion peak net revenue for Humira down to, worst-case scenario, $2 billion, a 90% discount to that original peak, as long as we stay in the top two or three, we'll deliver peak revenues as we planned, maybe just extend that timeline a bit.

Thank you.

Our next question comes from the line of Christopher Schott with JPMorgan. Please go ahead.

Great, thanks. Just two questions for me. Maybe the first one is, Matt, how should I think about EBITDA margins progressing beyond 2024? Just as a high level, is this 31% to 33% range a decent one to consider going forward, or can we see margin expansion? Is it fair to say that some of the cost opportunities you mentioned will be largely captured this year? Is more expansion possible? The second question is about business development. What does the funnel look like for more, I guess, Emgality-type transactions out there? Are there a wide range of these deals that you can look at or are these more kind of one-off opportunities for the company? Thanks very much.

So I'll take the first part of the question. On margin expansion beyond 2024, I think you'll see it come from potentially three places. We believe we can continue to grow revenues faster than our need to build the infrastructure around it, leading to leverage over our fixed costs, similar to what we're starting to realize this year. Over time, as I mentioned in the prepared comments, as we begin to peel away all of our manufacturing from Merck, these will be margin-up opportunities, though on a longer cycle. Additionally, as we roll out beyond 2024, we'll have higher contributions in our revenue mix from some of the newer products we're onboarding; these will have higher margins. That will depend, of course, on how swiftly other parts of our business grow, such as biosimilars, so that product mix remains a bit of a question mark.

And Christopher, great to hear your voice. In regards to our BD component, consider the Emgality product launch in the European Union; we see this as essentially a $170 million peak revenue business. In total from the BD efforts since spin, we’re discussing $750 million potential peak revenues in growth. We’re working on generic and regional business development deals. As I mentioned to you previously, we have some China-for-China deals lined up, along with European deals. So this is not a one-off; there’s plenty in the queue that we can pursue for ongoing revenue growth and EBITDA growth.

Thank you.

Our next question comes from the line of Karishma Raghuram with Goldman Sachs. Please go ahead.

Karishma on for Chris Shibutani. Thanks for taking the question. In regards to your women's health branch, what are kind of the key positive growth drivers and what dynamics are weighing on market growth? How is Organon's portfolio positioned to address these dynamics going forward?

Karishma, we're very confident about what we can achieve this year with our Women's Health franchise. Firstly, we decided to take a new go-to-market approach to pricing for Nexplanon. We will be taking full pricing this year. We've reduced our 340B voluntary discount; thereby, Nexplanon will continue to perform strongly globally as we no longer face some of the headwinds we did last year. Fundamentally, Nexplanon has become the number one product in the large segment in the United States, representing about 70% of our business globally. Fertility grew 9%, as I mentioned, with high single digits assumed this year driven mainly by China and the U.S. Together, the China and U.S. businesses represent about 60% of our overall business, alongside opportunities in regions like Lamera, which had recent launches and continue to drive high single-digit growth. Regarding Jada, we are early in the launch curve with over $40 million in sales in the U.S., aiming to enhance its peak global potential. We're launching in the EU and several emerging markets, including Brazil. Lastly, our oral contraceptives portfolio continues to thrive; we reintroduced Marvelon and Mercilon in Asia-Pacific, contributing to over 25% growth in 2023. Overall, our women's health business is diversifying and strengthening with ongoing launches such as Xaciato and a robust pipeline ahead, including 6219, which aims to treat endometriosis.

Thank you so much.

I would now like to turn the call over to Kevin Ali for closing remarks.

Thank you. We're entering 2024, and as you've heard from our discussion today, I'm feeling very good about delivering our third year of constant currency growth as a stand-alone company. Nexplanon and Fertility are positioned for strong performance in 2024. We expect another year of double-digit growth in our Biosimilars franchise, and we continue to demonstrate our ability to ensure continued performance of our established brands business. The combined businesses generate what we expect to be close to $1 billion of free cash flow before one-time charges in 2024. This gives us ample financial flexibility to continue servicing our dividend, executing on our business development agenda, and making progress towards achieving a net debt-to-EBITDA ratio of below four by the end of this year. I thank you very much, and we look forward to the next time we speak.

This concludes today's call. You may now disconnect.