# Organon & Co.: Form 10-Q for the period ended Mar 31, 2026

- Company: [Organon & Co.](/companies/ogn.md) (CIK 1821825)
- Form: 10-Q
- Filed: 2026-05-04
- Accepted by EDGAR: May 4, 2026, 08:46 ET
- Period: 2026-03-31
- Accession: 0001628280-26-029532
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/1821825/000162828026029532/ogn-20260331.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1821825/000162828026029532/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2026-03-31.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Revenue | 3 months, 2026-01-01 to 2026-03-31 | $1.46bn | us-gaap:Revenues |
| Cost of revenue | 3 months, 2026-01-01 to 2026-03-31 | $677.0m | us-gaap:CostOfGoodsAndServicesSold |
| Gross profit | 3 months, 2026-01-01 to 2026-03-31 | $783.0m | us-gaap:GrossProfit |
| Selling, general and administrative | 3 months, 2026-01-01 to 2026-03-31 | $424.0m | us-gaap:SellingGeneralAndAdministrativeExpense |
| Interest expense | 3 months, 2026-01-01 to 2026-03-31 | $111.0m | us-gaap:InterestExpense |
| Income tax | 3 months, 2026-01-01 to 2026-03-31 | $67.0m | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months, 2026-01-01 to 2026-03-31 | $146.0m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2026-01-01 to 2026-03-31 | $0.55 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2026-01-01 to 2026-03-31 | $0.56 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2026-01-01 to 2026-03-31 | 262,896,000 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 3 months, 2026-01-01 to 2026-03-31 | $225.0m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 3 months, 2026-01-01 to 2026-03-31 | $37.0m | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Dividends paid | 3 months, 2026-01-01 to 2026-03-31 | $5.0m | us-gaap:PaymentsOfDividends |
| Cash and equivalents | at 2026-03-31 | $1.12bn | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2026-03-31 | $4.93bn | us-gaap:AssetsCurrent |
| Total assets | at 2026-03-31 | $13.00bn | us-gaap:Assets |
| Current liabilities | at 2026-03-31 | $2.50bn | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2026-03-31 | $12.09bn | us-gaap:Liabilities |
| Long-term debt | at 2026-03-31 | $8.55bn | us-gaap:LongTermDebtNoncurrent |
| Current portion of debt | at 2026-03-31 | $16.0m | us-gaap:DebtCurrent |
| Shareholders' equity | at 2026-03-31 | $903.0m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 36,371 characters.

### CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

Some statements and disclosures in this document are forward-looking statements. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “potential,” “possible,” “probable,” “outcome,” “likely,” “could,” “should,” “estimate,” “anticipate,” “plan,” “intend,” “would,” “future,” “target,” “seek,” “continue,” and other words of similar meaning, or negative variations of any of the foregoing. These forward-looking statements are based on our current plans and expectations and are subject to a number of risks and uncertainties that could cause our plans and expectations, including actual results, to differ materially from the forward-looking statements. Risks and uncertainties that may affect our future results include, but are not limited to, uncertainties as to the timing of the completion of the pending merger (the “merger”) with Sun Pharmaceutical Industries (together with its subsidiaries and/or associated companies, “Sun Pharma”); the risk that the merger may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the merger, including receiving, on a timely basis or otherwise, the minimum vote required by our stockholders to approve the merger; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the various conditions to the consummation of the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances which would require us to pay a termination fee; the effect of the announcement or pendency of the merger on our ability to retain and hire key personnel, our ability to maintain relationships with our customers, suppliers and others with whom we do business, or our operating results and business generally; risks related to diverting management’s attention from our ongoing business operations; the risk that stockholder litigation in connection with the merger may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the merger that may impact our ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the merger could have adverse effects on the market price of our common stock, including if the merger is not consummated; risks that the benefits of the merger are not realized when and as expected; expanded brand and class competition in the markets in which we operate; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to our customers and business partners; the impact of global business, political and macroeconomic conditions, including inflation, interest rate fluctuations, recessionary pressures, foreign currency exchange rates, volatile market conditions, and instability in the global banking system; global events, such as regional conflicts in the Middle East and elsewhere; our ability to remediate the material weaknesses in internal control over financial reporting and the related costs and management resources, as well as our ability to maintain effective internal control over financial reporting and disclosure controls and procedures in the future; our ability to access the public securities and other capital and credit markets in accordance with our financial plans, the cost of such capital, and overall condition of the capital and credit markets; actions that may be taken by credit rating agencies that could negatively affect either our access to or terms of financing or our financial condition and liquidity; our ability to meet our revenue and growth expectations and outlook; our ability to hire and/or retain members of our senior management (including a permanent CEO) and other key employees; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; any failure by us to retain market exclusivity for *Nexplanon* or to obtain an additional period of exclusivity in the United States for *Nexplanon* subsequent to the expiration of the rod patents in 2027; the success of our efforts to adapt our business and sales strategies to address the changing market and regulatory landscape in order to achieve our business objectives and remain competitive; restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the SEC and other U.S. and comparable foreign government agencies; difficulties in connection with future strategic transactions, including as a result of the impact of macroeconomic or geopolitical developments; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and healthcare reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting our business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; delays or failures to demonstrate adequate efficacy and safety of our product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of our product candidates; reduced research and development investment and increased reliance on fewer research and development programs for new products to generate future revenue and replace existing products that come to the end of their market life cycle; future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing healthcare insurance coverage; legal factors, such as product liability claims, stockholder litigation, governmental investigations, and patent disputes; lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the FDA and other regulatory authorities; the failure by us or our third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of our products; cyberattacks on, or other failures, accidents, or security breaches of, our or third-party providers’ information technology systems, which could disrupt our operations and those of third parties upon which we rely; increased focus on privacy issues in countries around the world, including the United States, the European Union, and China, and a more difficult legislative and regulatory landscape for privacy and data protection that continues to evolve with the potential to directly affect our business, including recently enacted laws in a majority of states in the United States requiring security breach notification; changes in tax laws including changes related to the taxation of foreign earnings; the impact of any future pandemic, epidemic, or similar public health threat on our business, operations and financial performance; changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to us; volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply our products; and other factors discussed in our most recently filed Annual Report on Form 10-K and subsequent filings, including those discussed in the “Business,” “Risk Factors,” “Cautionary Statement Regarding Forward-Looking Statements” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of those reports.

### General

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to assist the reader in understanding our financial condition and results of operations. The following discussion and analysis should be read in conjunction with our Condensed Consolidated Financial Statements included in Part I, Item 1 of this report and with our audited financial statements, including the accompanying notes, and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2025. Operating results discussed herein are not necessarily indicative of the results of any future period.

We are a global healthcare company with a primary focus on improving the health of women throughout their lives. We develop and deliver innovative health solutions through a portfolio of prescription therapies within our women’s health and general medicines portfolios. We have a portfolio of more than 70 medicines and products across a range of therapeutic areas. We sell these products through various channels including drug wholesalers and retailers, hospitals, government agencies and managed healthcare providers such as health maintenance organizations, pharmacy benefit managers and other institutions. We own and operate six manufacturing facilities, which are located in Belgium, Brazil, Indonesia, Mexico, the Netherlands and the United Kingdom. Unless otherwise indicated, trademarks appearing in italics throughout this document are trademarks of, or are used under license by, our group of companies.

### Recent Developments

### Other Matters

On April 26, 2026, our Board of Directors appointed Joseph Morrissey our Interim CEO, to such role on a permanent basis.

### Business Development

### Sebela Pharmaceuticals (“Sebela”)

On February 19, 2026, we entered into an exclusive license agreement with Sebela for the global rights to *Miudella*, a hormone-free copper intrauterine device (“IUD”) that was approved by the FDA on February 24, 2025. Under the terms of the agreement, we will pay $27.5 million at closing, with potential sales-based milestone payments of up to $505 million, as well as tiered double-digit royalties based on net sales. The transaction closing is subject to regulatory approvals and FDA approval of alternate supply chain entities for *Miudella*, and other customary closing conditions. There can be no assurance that such regulatory approvals and other closing conditions will be received or satisfied.

### Laborie Medical Technologies Corporation (“Laborie”)

In January 2026, we divested the *Jada* System to Laborie for an aggregate payment of up to $465 million, comprised of consideration of $440 million, subject to certain closing adjustments, plus potential contingent consideration payments of up to $25 million based on the achievement of certain 2026 net sales targets. Approximately 100 employees transferred to Laborie as part of this transaction.

Upon the closing of the divestiture, we recognized a net gain on the sale of the *Jada* System of $81 million recognized in *Other (income) expense, net* in the Condensed Consolidated Statement of Income as of March 31, 2026.

### Operating Results

### Sales Overview

*($ in millions)*

|  | Three Months Ended March 31, 2026 | 2025 | % Change | % Change Excluding Foreign Exchange |
| --- | ---: | ---: | ---: | ---: |
| United States | $358 | $412 | (13)% | (13)% |
| International | 1,102 | 1,101 | — | (7) |
| Total | $1,460 | $1,513 | (4)% | (9)% |

Worldwide sales were $1.5 billion for the three months ended March 31, 2026, a decrease of 4%, compared to 2025. Worldwide sales during the three months ended March 31, 2026 were positively impacted by approximately $76 million, or approximately 5%, due to favorable foreign exchange rates.

Excluding the impact of foreign exchange rates, sales decreases for the three months ended March 31, 2026, primarily reflect lower sales of:

- *Nexplanon,* primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding. Outside of the U.S., sales declined due to the timing of shipments in selective emerging markets, partially offset by increased demand and access in Brazil;
- *Singulair®* (montelukast sodium), primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan;
- *Marvelon™*¹ (desogestrel and ethinyl estradiol pill) and *Mercilon™¹* (desogestrel and ethinyl estradiol pill), as a result of decreased demand and market contraction in China and the timing of shipments in Asia Pacific; and
- *Ontruzant,* due to increased competition in international markets and lower tendered volume from Brazil’s Ministry of Health when compared with the same period in 2025.

The foregoing decrease was partially offset by sales increases for the three months ended March 31, 2026 in:

- *Emgality,* as a result of continued uptake following the acquisition of the distribution and promotion rights from Lilly in January of 2024 in certain markets outside of the United States;
- *Hadlima,* due to stronger demand in the United States and increased demand in Puerto Rico;
- *Atozet™*¹ (ezetimibe and atorvastatin), primarily due to increased demand in China, due to the product launch in 2025, and in Asia Pacific as well as volume uptake in certain countries in Europe, partially offset by unfavorable pricing in Europe; and
- *Brenzys,* as a result of the timing of prior year tenders in Brazil.

Loss of exclusivity (“LOE”) negatively impacted sales of certain of our products by approximately $4 million during the three months ended March 31, 2026, based on the decrease in sales volume compared to 2025. Volume-based procurement (“VBP”) in China negatively impacted sales by approximately $2 million during the three months ended March 31, 2026. We expect VBP to continue to negatively impact our general medicines product portfolio for the next several quarters.

Due to changing market conditions, including ongoing conflicts, new and evolving U.S. and international tariffs, U.S. tax law changes and regulatory uncertainty that impact our business, as well as the pharmaceutical industry, we have been and will continue to adapt our business and sales strategies to address this changing landscape in order to achieve our business objectives and remain competitive. Such strategies may include implementing or continuing to assess product discount programs and wholesaler inventory levels under the relevant agreements or waivers of their terms for certain key products.

Highlights of the sales of our products for the three months ended March 31, 2026 and 2025 are provided below. See Note 5 “Product and Geographic Information” to the Condensed Consolidated Financial Statements for further details on sales of our products.

### Women’s Health

*($ in millions)*

|  | Three Months Ended March 31, 2026 | 2025 | % Change | % Change Excluding Foreign Exchange |
| --- | ---: | ---: | ---: | ---: |
| Nexplanon/Implanon NXT | $201 | $248 | (19)% | (21)% |
| NuvaRing | 24 | 22 | 10 | (1) |
| Marvelon/Mercilon | 26 | 39 | (34) | (36) |
| Follistim AQ | 61 | 69 | (12) | (15) |
| Jada | 5 | 15 | (66) | (66) |

### Contraception

Worldwide sales of *Nexplanon,* a single-rod subdermal contraceptive implant, declined 19% for the three months ended March 31, 2026, compared to 2025, primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding. In 2025, we submitted a similar application for a five-year duration period of use to the EU and UK Health Authorities. The application for five-year duration was approved for UK in April, 2026. The EU application is currently under review, with potential approval in 2027, subject to health authority review and approval. Outside of the U.S., sales declined due to the timing of shipments in selective emerging markets, partially offset by increased demand and access in Brazil.

Worldwide sales of *NuvaRing*, a vaginal contraceptive product, increased 10% for the three months ended March 31, 2026, compared to 2025, due to the favorable impact of foreign exchange and lower discount rates in the United States.

Worldwide sales of *Marvelon* and *Mercilon*, combined oral hormonal daily contraceptive pills not approved or marketed in the United States, but available in certain countries outside the United States, declined 34% for the three months ended March 31, 2026, compared to 2025, as a result of decreased demand and market contraction in China and the timing of shipments in Asia Pacific.

### Fertility

Worldwide sales of *Follistim AQ*, a fertility treatment, declined 12% for the three months ended March 31, 2026, compared to 2025, as a result of competitive driven price reduction in the United States partially offset by modest market growth in China. We anticipate a further decline due to the price reduction and increased competitive landscape in the U.S.

### Other Women’s Health

In January 2026, we completed the sale of the *Jada* System to Laborie. As a result, worldwide sales of *Jada,* a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, declined 66% for the three months ended March 31, 2026, compared to 2025.

### General Medicines

### Biosimilars

*($ in millions)*

|  | Three Months Ended March 31, 2026 | 2025 | % Change | % Change Excluding Foreign Exchange |
| --- | ---: | ---: | ---: | ---: |
| Renflexis | $57 | $57 | 1% | (1)% |
| Hadlima | 67 | 47 | 44 | 43 |
| Ontruzant | 5 | 18 | (71) | (72) |
| Brenzys | 20 | 14 | 39 | 32 |

*Renflexis* is a biosimilar to *Remicade2*(infliximab) for the treatment of certain autoimmune conditions. Sales increased 1% for the three months ended March 31, 2026, compared to 2025, primarily due to favorable foreign exchange and increased demand in Canada partially offset by the competitive pressure and unfavorable discount rates in the United States.

*Hadlima* is a biosimilar to *Humira2* (adalimumab) for the treatment of certain autoimmune and autoinflammatory conditions. Sales increased 44% for the three months ended March 31, 2026, compared to 2025, due to stronger demand in the United States and increased demand in Puerto Rico. We have commercialization rights to *Hadlima* in countries outside of the European Union, South Korea, China, Turkey, and Russia. *Hadlima* is currently approved in the United States, Australia, Canada and Israel.

*Ontruzant* is a biosimilar to *Herceptin2* (trastuzumab) for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Sales for the three months ended March 31, 2026, compared to 2025, declined 71%, due to increased competition in international markets and lower tendered volume from Brazil’s Ministry of Health when compared with the same period in 2025. We have commercialization rights to *Ontruzant* in all countries except in South Korea and China.

*Brenzys* is a biosimilar to *Enbrel2* (etanercept) for the treatment of certain inflammatory diseases. Sales for the three months ended March 31, 2026, compared to 2025, increased 39%, as a result of the timing of prior year tenders in Brazil. We have commercialization rights to *Brenzys* in countries outside of the United States, Europe, South Korea, China, and Japan.

### Established Brands

### Cardiovascular

*($ in millions)*

|  | Three Months Ended March 31, 2026 | 2025 | % Change | % Change Excluding Foreign Exchange |
| --- | ---: | ---: | ---: | ---: |
| Atozet | $85 | $77 | 11% | 5% |
| Zetia/Vytorin | 108 | 107 | 1 | (5) |
| Cozaar/Hyzaar | 57 | 55 | 4 | (1) |

Sales of *Atozet*, a medicine for lowering LDL cholesterol, increased 11% for the three months ended March 31, 2026, compared to 2025, primarily due to increased demand in China, due to the product launch in 2025, and in Asia Pacific as well as volume uptake in certain countries in Europe, partially offset by unfavorable pricing in Europe.

Combined global sales of *Zetia®* (ezetimibe), which is marketed as *Ezetrol™* in most countries outside the United States; and *Vytorin®* (ezetimibe / simvastatin), which is marketed as *Inegy™* outside the United States, medicines for lowering LDL cholesterol, increased 1% for the three months ended March 31, 2026, compared to 2025, primarily driven by favorable foreign exchange and increased demand in China, partially offset by less tender volume and the timing of shipments in the Middle East.

Combined global sales of *Cozaar®* (losartan) and *Hyzaar®* (losartan / hydrochlorothiazide), medicines for the treatment of hypertension, increased 4% for the three months ended March 31, 2026, compared to 2025, driven by favorable foreign exchange and increased demand in China, partially offset by decreased demand in various international markets.

### Respiratory

*($ in millions)*

|  | Three Months Ended March 31, 2026 | 2025 | % Change | % Change Excluding Foreign Exchange |
| --- | ---: | ---: | ---: | ---: |
| Singulair | $40 | $74 | (46)% | (49)% |
| Nasonex | 65 | 72 | (9) | (17) |
| Dulera | 35 | 43 | (20) | (21) |

Worldwide sales of *Singulair*, a once-a-day oral medicine for the chronic treatment of asthma and for the relief of symptoms of allergic rhinitis, declined 46% for the three months ended March 31, 2026, compared to 2025. This decline was primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan.

Global sales of *Nasonex*, an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, declined 9% for the three months ended March 31, 2026, compared to 2025, due to competitive pressure in various international markets.

Global sales of *Dulera®* (formoterol/fumarate dihydrate), which is also marketed as *Zenhale* in certain markets outside of the United States, a combination medicine for the treatment of asthma, declined 20% for the three months ended March 31, 2026, compared to 2025, primarily due to increased discount rate pressure and decreased demand in the United States.

### Non-Opioid Pain, Bone and Dermatology

*($ in millions)*

|  | Three Months Ended March 31, 2026 | 2025 | % Change | % Change Excluding Foreign Exchange |
| --- | ---: | ---: | ---: | ---: |
| Arcoxia | $59 | $62 | (5)% | (13)% |
| Vtama | 25 | 24 | 5% | 5% |

#### \* Calculation not meaningful.

Sales of *Arcoxia™* ¹ (etoricoxib), a medicine for the treatment of arthritis and pain, declined 5% for the three months ended March 31, 2026, compared to 2025, primarily due to the phasing of shipments in various international regions and decreased demand in China.

Sales of *Vtama,* a cream for the topical treatment of mild, moderate, and severe plaque psoriasis in adults and atopic dermatitis, also known as eczema, in adults and children two years of age and older, increased 5% for the three months ended March 31, 2026, compared to 2025, due to increased demand and favorable discount rates in the United States. We anticipate launching *Vtama* in certain international markets in 2026 and beyond, subject to health authority reviews and approvals.

### Other

*($ in millions)*

|  | Three Months Ended March 31, 2026 | 2025 | % Change | % Change Excluding Foreign Exchange |
| --- | ---: | ---: | ---: | ---: |
| Emgality | $54 | $32 | 69% | 50% |

#### \* Calculation not meaningful.

Sales of *Emgality,* a medicine for the preventive treatment of migraine, increased 69% for the three months ended March 31, 2026, compared to 2025, as a result of continued uptake following the acquisition of the distribution and promotion rights from Lilly in January of 2024 in certain markets outside of the United States.

### Gross Profit, Expenses and Other

*($ in millions)*

|  | Three Months Ended March 31, 2026 | 2025 | % Change |
| --- | ---: | ---: | ---: |
| Cost of sales | $677 | $672 | 1% |
| Gross profit | 783 | 841 | (7) |
| Selling, general and administrative | 424 | 420 | 1 |
| Research and development | 93 | 96 | (3) |
| Acquired in-process research and development and milestones | — | 6 | (100) |
| Restructuring costs | 31 | 86 | (64) |
| Interest expense | 111 | 124 | (10) |
| Exchange losses (gains) | 7 | (4) | \* |
| Other (income) expense, net | (96) | 12 | \* |

#### \* Calculation not meaningful.

### Cost of Sales

Cost of sales increased 1% for the three months ended March 31, 2026, compared to 2025, driven by our product mix. Cost of sales for the three months ended March 31, 2026 compared to 2025, includes amortization associated with the inventory fair value adjustment related to the Dermavant acquisition of $7 million and $9 million, respectively, and amortization of intangible assets of $47 million and $50 million, respectively.

### Gross Profit

Gross profit decreased 7% for the three months ended March 31, 2026, compared to 2025, due to the impact of unfavorable pricing and product mix and unfavorable foreign exchange.

### Selling, General and Administrative

Selling, general and administrative expenses increased 1% for the three months ended March 31, 2026, compared to 2025, due to increased costs associated with our *Jada* divestiture.

### Research and Development

Research and development expenses decreased 3% for the three months ended March 31, 2026, compared to 2025, primarily due to a decrease in clinical study activity. During 2025, we discontinued the clinical development programs for investigational candidates OG-6219 and OG-7191.

### Acquired In-Process Research and Development and Milestones

For the three months ended March 31, 2025, we recognized $6 million in acquired in-process research and development and milestones, related to the exit of our agreement with Centergene, due to the evolving fertility landscape in China.

### Restructuring Costs

For the three months ended March 31, 2026, we incurred restructuring costs of $31 million related to our 2026 restructuring initiatives to streamline and optimize our research and development and manufacturing operations, focusing on enhancing efficiency and aligning resources with strategic priorities. For the three months ended March 31, 2025, we incurred restructuring costs of $86 million, comprised primarily of headcount-related restructuring expense associated with restructuring initiatives that were aimed at driving operational efficiencies in 2025.

### Interest Expense

Interest expense decreased 10% for the three months ended March 31, 2026, compared to 2025, due to the repurchase and cancellation of approximately $419 million of the Company’s 5.125% notes due in 2031 (“the 2031 Notes”) during the second and fourth quarters of 2025 combined with lower reference rates on our variable rate debt.

### Exchange Losses (Gains)

Exchange losses (gains) were unfavorable for the three months ended March 31, 2026, compared to 2025, primarily due to unfavorable movements in certain foreign currencies relative to the U.S. dollar.

### Other (Income) Expense, net

Other (income) expense, net was impacted for the year ended March 31, 2026, by an $81 million net gain related to the divestiture of the *Jada* System to Laborie in the first quarter of 2026 and $7 million related to the accretion of the Dermavant acquisition contingent consideration, related to changes in the timing of expected commercial milestones based on updated sales forecasts.

### Taxes on Income

The effective income tax rates were 31.4% and 13.4% for the three months ended March 31, 2026 and 2025, respectively. These effective income tax rates reflect the beneficial impact of foreign earnings, offset by the impact of U.S. inclusions under the Global Intangible Low-Taxed Income regime and a valuation allowance recorded against non-deductible U.S. interest expense. Also included in the first quarter tax rate, is the beneficial impact of the sale of the *Jada* System. There was a favorable impact to the 2025 year-to-date effective tax rate driven by a tax amortization benefit.

On July 4, 2025, U.S. House Resolution 1, referred to as the One Big Beautiful Bill Act (“OBBBA”), was signed into law. The OBBBA includes significant corporate tax provisions such as modifications to interest deductibility, the option to fully expense U.S.-based R&D costs, and changes to the taxation of foreign earnings. For 2026 and beyond, the impacts of the OBBBA are reflected in our U.S. cash tax liability and income tax provision primarily reflected as an increase in our interest expense limitation offset by a decrease in our foreign income inclusions.

### Liquidity and Capital Resources

As of March 31, 2026, we had cash and cash equivalents of $1.12 billion. We have historically generated and expect to continue to generate positive cash flow from operations. Our ability to fund our operations and anticipated capital needs is reliant upon the generation of cash from operations, supplemented as necessary by periodic utilization of our revolving credit facility. Our principal uses of cash in the future will be primarily to fund our operations, working capital needs, capital expenditures, repayment of borrowings, strategic business development transactions and the payment of dividends. We believe that our financing arrangements, future cash from operations, and access to capital markets will provide adequate resources to fund our future cash flow needs. Our ability to raise new capital or refinance our debt, will depend on the capital markets and our financial condition at such times.

Working capital is defined as current assets less current liabilities and was $2.43 billion and $1.96 billion as of March 31, 2026 and December 31, 2025, respectively. Working capital was positively impacted by our active cash cycle management, which includes the factoring of receivables and timing of vendor payments and the proceeds from the divestiture of the *Jada* System.

We have accounts receivable factoring agreements with financial institutions in certain countries. Under these agreements, we have factored $216 million and $217 million of our accounts receivable as of March 31, 2026 and December 31, 2025, respectively. See Note 11 “Financial Instruments” to the Condensed Consolidated Financial Statements for information on our accounts receivable factoring and related agreements.

Net cash provided by operating activities was $225 million for the three months ended March 31, 2026, compared to $75 million for the same period in the prior year due to our active cash cycle management.

Net cash provided by investing activities was $386 million for the three months ended March 31, 2026, compared to $172 million used in investing activities for the same period in the prior year, primarily due to proceeds from the divestiture of the *Jada* system and decreased milestone payments.

Net cash used in financing activities was $38 million for the three months ended March 31, 2026, compared with $75 million for the same period in the prior year, primarily driven by decreased dividend payments in the current year and increased repayments of debt in the current year.

As part of our post-spinoff plan to further optimize our manufacturing and supply network, we will continue to separate our supply chain through planned exits from supply agreements with Merck through 2031. This will enable us to redefine our appropriate sourcing strategy, and move to fit-for-purpose supply chains, while focusing on delivering efficiencies. We anticipate continuing to incur costs associated with this separation, including but not limited to accelerated depreciation, exit premiums and fees, technology transfer costs, stability and qualification batch costs, one-time resourcing costs, regulatory and filing costs, capital investment, and inventory stock bridges.

Our contractual obligations as of March 31, 2026, which require material cash requirements in the future, consist of contractual milestones, purchase obligations and lease obligations. Refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2025 for further details. As of March 31, 2026, there have been no material changes to our contractual obligations outside of the ordinary course of business.

During the first quarter of 2026, we paid cash dividends of $0.02 per share. On April 30, 2026, the Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of our common stock. The dividend is payable on June 11, 2026, to stockholders of record at the close of business on May 11, 2026.

We or our affiliates may, at any time and from time to time, seek to retire or purchase our outstanding debt through cash purchases and/or exchanges for equity or debt, in open-market purchases, privately negotiated transactions or otherwise. Such transactions, if any, may be material, and will depend upon such terms and at such prices as we may determine, and will depend on prevailing market conditions, our liquidity requirements, contractual restrictions and other factors.

### Critical Accounting Estimates

Our significant accounting policies, which include management’s best estimates and judgments, are included in Note 2 “Summary of Accounting Policies” to the Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2025. See Note 2 “Basis of Presentation” to the Condensed Consolidated Financial Statements for information on the adoption of new accounting standards during 2026. There have been no changes to our accounting policies as of March 31, 2026. A discussion of accounting estimates considered critical because of the potential for a significant impact on the Condensed Consolidated Financial Statements due to the inherent uncertainty in such estimates are disclosed in the Critical Accounting Estimates section of Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Organon’s Annual Report on Form 10-K for the year ended December 31, 2025.

### Recently Issued Accounting Standards

For a discussion of recently issued accounting standards, see Note 2 “Basis of Presentation” to the Condensed Consolidated Financial Statements included in this report.

## Market risk

As filed, 328 characters.

There have been no changes to our market risk during the quarter ended March 31, 2026. For a discussion of our exposure to market risk, refer to our market risk disclosures set forth under Item 7A.—Quantitative and Qualitative Disclosures About Market Risk in our Annual Report on Form 10-K for the year ended December 31, 2025.

## Controls and procedures

As filed, 10,815 characters.

### Quarterly Evaluation of Disclosure Controls and Procedures

As previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, we determined that certain material weaknesses in our internal control over financial reporting existed as of December 31, 2025. Those material weaknesses are described below and continued to exist as of March 31, 2026.

We have established disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer (“CEO”) (our principal executive officer) and Chief Financial Officer (“CFO”) (our principal financial officer), as appropriate to allow timely decisions regarding required disclosure, and ensure that information required to be disclosed in the reports we file or submit is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms.

Our management, with the participation of the CEO and the CFO, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026 in connection with the filing of this report. Based on this evaluation, the CEO and the CFO concluded that our disclosure controls and procedures were not effective as of March 31, 2026, due to the material weaknesses in internal control over financial reporting as described below.

Notwithstanding the material weaknesses, management has concluded that its condensed consolidated financial statements included in this report fairly present, in all material respects, our condensed consolidated financial position and results of operations as of March 31, 2026.

### Material Weaknesses in Internal Control Over Financial Reporting

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

As disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, we previously identified the following material weaknesses in our internal control over financial reporting, which were not remediated as of March 31, 2026:

- We failed to set an appropriate tone at the top. Specifically, our former CEO and leader of our U.S. commercial organization applied inappropriate pressure to achieve sales targets through sales of *Nexplanon* to two United States wholesalers above demand and engaged in inappropriate business conduct that violated our Code of Conduct.
- The material weakness with respect to our tone at the top contributed to an additional material weakness of not maintaining effective controls related to information and communication. We did not design and maintain effective controls related to the information and communication component of the framework in Internal Control — Integrated Framework issued in 2013 by the Committee of Sponsoring Organizations of the Treadway Commission. Specifically, our former CEO and certain senior members of our U.S. commercial organization did not ensure appropriate communication with, or provide complete information to, our Disclosure Committee and the financial reporting group to evaluate disclosures and financial reporting conclusions related to sales practices for wholesalers.

These material weaknesses did not result in misstatements of our previously reported historical financial statements.

Each of these material weaknesses could result in a misstatement of substantially all account balances or disclosures that would result in a material misstatement to our annual or interim consolidated financial statements that would not be prevented or detected.

### Remediation Plan and Activities

We are committed to taking steps necessary to remediate the material weaknesses as described above. We are actively engaged and have devoted substantial resources towards the implementation of enhanced procedures and controls and the remediation of material weaknesses in our internal control over financial reporting. We have established a Remediation Plan Task Force to serve as a Project Management Office to monitor our remediation efforts and have also engaged external legal, accounting, financial and other consulting and professional services firms to assist in the development and execution of our comprehensive remediation plan. We are in the process of implementing measures designed to improve our internal control over financial reporting and remediate the material weaknesses described above. Actions taken to date include:

- On October 27, 2025, our Board of Directors enacted Company leadership changes with the executive appointments of Joseph Morrissey as our Interim CEO and Carrie S. Cox as our Interim Executive Chair, with Mr. Morrissey and Ms. Cox being appointed to such roles on a permanent basis on April 26, 2026.
- Beginning in November 2025, we held multiple Founders meetings with employees, including Global Founders Forums and U.S. Commercial Town Hall. Senior leadership disseminated Company-wide and team-specific communications to emphasize our commitment to our core values, compliance, integrity and ethics.
- On December 2, 2025, our Board of Directors ratified our enhanced our Code of Conduct to clarify responsibilities related to our financial reporting and disclosures, including awareness of the options to raise concerns or questions to

our management, human resources, compliance, legal, the technical accounting department and/or through the SpeakUp Tool, which is available globally as an alternate, confidential channel for raising concerns.

- On January 30, 2026, we communicated and launched training on our Code of Conduct, as amended, regarding ethical tone, corporate culture and appropriate business practices;
- During the quarter ended December 31, 2025, we implemented revisions to our Quarterly Financial Certification Questionnaire to include targeted questions that are designed to (i) address areas tied to the material weaknesses we identified in our internal control over financial reporting, (ii) strengthen our disclosures and (iii) reduce the risk of misleading business practices.
- On February 2, 2026, our Audit Committee ratified an enhanced Disclosure Committee charter that was previously approved by our Interim CEO and CFO. These changes to the Disclosure Committee charter included, among other changes, (i) enumerating additional Disclosure Committee meeting requirements and guidelines for Disclosure Committee members and participants, (ii) providing for a Disclosure Committee Chair designated by the CEO and CFO, (iii) expanding the duties and responsibilities of the Disclosure Committee as to the type and scope of disclosure and risks for its review, (iv) requiring the Disclosure Committee to annually review its charter to identify any recommend changes and (v) mandating continuing education and training of the participants in our disclosure process. In addition, we strengthened our Disclosure Committee processes and procedures to facilitate active participation by Disclosure Committee members.
- During the quarter ended December 31, 2025, we implemented additional and enhanced Sarbanes-Oxley (“SOX”) sub-certifications and internal management representation letters to support our public reporting and disclosure. By January 15, 2026, we provided training to our Executive Leadership Team and to other Disclosure Committee members and participants on the purpose and importance of SOX, SOX sub-certifications and the process for evaluating the representations made that support the disclosure contained in our filings.
- On February 25, 2026, an enhancement to the Company’s Annual Ethics and Policy Certification was launched to all of our employees, requiring all founders to review and certify their understanding of ethical responsibilities and compliance with laws, regulations, and Organon policies, including the Code of Conduct.
- On March 31, 2026, we communicated and launched training to relevant commercial and finance employees on revenue-related business practices, emphasizing the importance of revenue recognition and related disclosures. This training reinforced our commitment to ethical conduct, transparency, accuracy and reliability and helped to strengthen credibility and trust in our financial reporting.
- We performed a comprehensive review of the quarterly Distribution Services Agreement payment process. Based on that review, we developed an internal policy to provide oversight and establish guidelines for management fee arrangements with wholesalers. This policy and related procedures were communicated to relevant U.S. Commercial employees on April 24, 2026.
- New internal controls were implemented effective Q1 2026 related to US sales monitoring, as well as enhanced reviews for inventory levels at the wholesaler and days on hand at the wholesaler.

We have completed the implementation of the remediation actions described above and have begun evaluating the operating effectiveness of the related actions and controls. However, because these controls have not been operating for a sufficient period of time to allow management to evaluate their effectiveness, management continues to conclude that the material weaknesses described above exist as of the reporting date of March 31, 2026. The process of designing and maintaining effective internal control over financial reporting is an ongoing process that requires management to anticipate and respond to changes in our business, economic, and regulatory environments and to expend significant resources. As we continue to evaluate our internal control over financial reporting, we may take additional actions to remediate existing material weaknesses or modify the remediation actions described above.

While we continue to devote significant time and attention to these remediation efforts, the material weaknesses will not be considered remediated until the related controls have operated for a sufficient period of time, and management has concluded, based on testing that the controls are effective.

### Quarterly Changes in Internal Control Over Financial Reporting

As described above under “Remediation Plan and Activities”, we implemented changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2026 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

## Risk factors

As filed, 11,523 characters.

Except as set forth below, there have been no material changes in our risk factors from those disclosed in Item 1A. Risk Factors, in our Annual Report on Form 10-K for the year ended December 31, 2025.

### Risks Related to the Merger with Sun Pharma

***The closing of our proposed merger with and into Sun Pharma is subject to a number of conditions, many of which are largely outside of the parties’ control, and, if these conditions are not satisfied or waived on a timely basis, the merger agreement may be terminated and the transaction may not be completed.***

On April 26, 2026, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Sun Pharma and the additional parties thereto, relating to the merger. The consummation of the merger is subject to various conditions, including, among others, customary conditions relating to: the adoption of the Merger Agreement by the holders of a majority of the outstanding shares entitled to vote on such matter at a stockholders’ meeting duly called and held for such purpose; the expiration or termination of any applicable waiting periods (and any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), and the receipt of certain non-U.S. antitrust and foreign direct investment approvals; the absence of any law or order making unlawful or restraining, enjoining or otherwise prohibiting consummation of the Merger; the absence of any “Company Material Adverse Effect” (as defined in the Merger Agreement) having occurred since the signing that is continuing as of the closing; the filing or receipt of required regulatory approvals without the imposition of any term, condition or consequence the acceptance of which would constitute a “Substantial Detriment” (as defined in the Merger Agreement) and other customary conditions relating to the accuracy of representations and warranties and performance of covenants.

The governmental authorities from which authorizations under antitrust and foreign investment laws, including the HSR Act, are required have broad discretion in administering the governing laws and regulations. These governmental authorities may initiate proceedings seeking to prevent, or otherwise seek to prevent, the merger.

The failure to satisfy all of the required conditions could delay the completion of the merger by a significant period of time or prevent it from occurring. Any delay in completing the merger could cause the parties to not realize some or all of the benefits that are expected to be achieved if the merger is successfully completed within the expected timeframe. There can be no assurance that the conditions to the closing of the merger will be satisfied or waived or that the merger will be completed within the expected timeframe or at all.

***Failure to complete the merger could adversely affect our stock price and future business and financial results, and our ability to continue as a going concern may be adversely affected.***

There can be no assurance that the conditions to the closing of the merger will be satisfied or waived or that the merger will be completed. If the Merger is not completed within the expected timeframe or at all, our ongoing business could be adversely affected and we will be subject to a variety of risks and possible consequences associated with the failure to complete the merger, including the following: following, or in connection with, the termination of the Merger Agreement, in certain circumstances, we will be required to pay Sun Pharma a termination fee of $120,000,000; we will incur certain transaction costs, including legal, accounting, financial advisor, filing, printing and mailing fees, and substantial acquisition-related costs, including employee retention expenses, regardless of whether the merger closes; under the Merger Agreement, we are subject to certain restrictions on the conduct of our business prior to the closing of the merger, which may adversely affect our ability to execute certain of our business strategies; and the proposed merger, whether or not it closes, will divert the attention of certain of our management and other key employees from ongoing business activities, including the pursuit of other opportunities that could be beneficial to us as an independent company.

In addition, the Merger Agreement restricts our ability to conduct certain significant financing transactions prior to the closing of the merger, and we may therefore be unable to raise the capital required to execute certain of our business strategies. Further, while we believe that our existing cash resources and cash generated by operations, supplemented as necessary by periodic utilization of our revolving credit facility, provide sufficient liquidity to support our near-term working and capital expenditure needs, service the ongoing principal and interest payments on our existing indebtedness, and satisfy our other funding and investment requirements for the next 24 months, we do not expect to generate sufficient cash from operations to repay at maturity the entirety of the then-outstanding balances of our term loan, 4.125% secured notes, and 2.875% euro-denominated secured notes, all of which mature in 2028 (collectively, our “2028 debt”). If the proposed merger does not close, we would be dependent upon our ability to access the credit markets or source additional equity investments to repay or refinance the outstanding balances of our 2028 debt. In addition, our ability to service our indebtedness and to fund our other liquidity requirements will depend on our ability to generate and access cash in the future, which is subject to general economic, financial, contractual, competitive, legislative, regulatory and other factors.

Failure to raise significant amounts of funding to repay our 2028 debt at maturity would adversely affect our financial condition and could result in a going concern qualification with respect to our annual audited financial statements. We could also be required to raise capital via equity transactions (which may be dilutive to existing investors or provide new investors with rights, preferences, or privileges senior to our common stock), sale of significant assets, and significant cost reduction measures. Even if we are able to reduce or refinance our existing debt, we expect that such actions would result in increased interest expenses, subject us to additional financial covenants and other lender protections, and require significant use of our other available liquidity and capital resources. Any of these measures may have an adverse impact on our ability to execute our business plan, take advantage of future opportunities, including our ability to raise capital, fund our business development initiatives, maintain relationships with third parties with whom we conduct business, including customers, vendors and lenders, or respond to competitive pressures or unanticipated financial requirements. The ultimate success of any such actions in sustaining our ability to continue as a going concern cannot be assured, and no assurance can be given that such financing or asset sales will be available or, if available, that they will be on commercially favorable terms.

If the merger is not completed, these risks could materially affect our business and financial results and our stock price, including to the extent that the current market price of our common stock is positively affected by a market assumption that the merger will be completed.

***The announcement and pendency of the merger could adversely affect our business, financial results and/or operations.***

Our efforts to complete the merger could cause substantial disruptions in, and create uncertainty surrounding, our business, which may materially adversely affect our results of operation and our business. For example, we may forego opportunities we may have otherwise pursued absent the proposed merger. Uncertainty as to whether the merger will be completed may also affect our ability to recruit prospective employees or to retain and motivate existing employees. Employee retention may be particularly challenging while the merger is pending because employees may experience uncertainty about their roles following the merger. A substantial amount of our management’s and employees’ attention is being directed toward the completion of the merger and therefore is being diverted from our day-to-day operations. Uncertainty as to our future could adversely affect our business and our relationship with vendors, suppliers, regulators and other business partners. For example, vendors, suppliers, and other counterparties may defer decisions concerning working with us, or seek to change existing business relationships with us. Changes to or termination of existing business relationships could adversely affect our results of operations and financial condition, as well as the market price of our common stock. The adverse effects of the pendency of the merger could be exacerbated by any delays in completion of the merger or termination of the Merger Agreement.

***The Merger Agreement limits our ability to pursue alternative transactions, which could deter, but does not prevent, a third party from proposing an alternative transaction that the Company could consider within the parameters set forth in the Merger Agreement.***

The Merger Agreement contains a customary “no-shop” provision which, subject to certain exceptions, restricts our ability to initiate, solicit or knowingly encourage or knowingly facilitate any inquiry or the making of any proposal or offer that constitutes, or would reasonably be expected to lead to, an Acquisition Proposal (as defined in the Merger Agreement) or to engage in discussions or negotiations relating to an Acquisition Proposal. It is possible that these or other provisions in the Merger Agreement might discourage a potential competing acquirer that might have an interest in acquiring all or a significant part of the outstanding shares of our common stock from considering or proposing an acquisition or might result in a potential competing acquirer proposing to pay a lower per share price to acquire our common stock than it might otherwise have proposed to pay.

***Litigation may arise in connection with the merger, which could be costly and divert management’s attention and otherwise materially harm our business.***

Lawsuits may be filed challenging the disclosures contained in the proxy statement and/or challenging other aspects of the merger. Regardless of the outcome of any future litigation related to the merger, such litigation may be time-consuming and expensive and may distract our management from running the day-to-day operations of our business. The litigation costs and diversion of management’s attention and resources to address the claims and counterclaims in any litigation related to the merger may materially adversely affect our business, financial condition and operating results. If the merger is not consummated for any reason, litigation could be filed in connection with the failure to consummate the merger. Any litigation related to the merger may result in negative publicity or an unfavorable impression of us, which could adversely affect the price of our common stock, impair our ability to recruit or retain employees, damage our relationships with our partners, or otherwise materially harm our operations and financial performance.

Filed May 4, 2026.
Source: SEC EDGAR, the filing index for accession 0001628280-26-029532. Last ingested by Listed: Oct 31, 2026, 03:06 ET. No prices; not investment advice.