Organon & Co.
For the period ended Jun 30, 2025. Filed Aug 6, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 6, 2025
OGN$13.87+0.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-02.
0001821825-25-000023
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-06.
0001821825-25-000066
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 93 previous paragraphs and 105 current paragraphs.
38 unchanged; 46 reworded; 19 added; 8 removed; 1 previous and 2 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (19)
Current report
Worldwide sales were $1.6 billion for the three months ended June 30, 2025, a decrease of 1%, compared to 2024. Worldwide sales were positively impacted by approximately 1% or $9 million, due to favorable foreign exchange rates.
Current report
•Vtama, due to the acquisition of Dermavant in the fourth quarter of 2024 and launch of the atopic dermatitis indication in the United States.
Current report
•Hadlima® (adalimumab-bwwd), reflecting sales ramp up since its launch in July 2023 in the United States and a modest increase in international markets.
Current report
•Emgality® 2 (galcanezumab-gnlm), due to the acquisition of the distribution and promotion rights from Lilly in 2024 in certain markets outside of the United States.
Current report
•Atozet, primarily due to LOE in France, Spain and Japan partially offset by increased demand in Asia Pacific and Latin America.
Current report
•Ontruzant® (trastuzumab-dttb), due to unfavorable pricing in Brazil coupled with lower tendered volume from Brazil’s Ministry of Health when compared with 2024 and lower demand in the United States.
Current report
•Vtama, due to the acquisition of Dermavant in the fourth quarter of 2024 and launch of the Atopic Dermatitis indication in the United States.
Current report
•Hadlima, reflecting sales ramp up since its launch in July 2023 in the United States and a modest increase in international markets.
Current report
•Follistim AQ, due to a one-time buy-in as a result of our exit from our IOM agreement in the United States with Merck during the fourth quarter of 2023, which resulted in lower sales in the first half of 2024, demand increase and favorable discount rates in the United States as well as increased demand in select international markets.
Current report
•Atozet, primarily due to LOE in France, Spain and Japan partially offset by increased demand in Asia Pacific and Latin America.
Current report
•Singulair, due to the lower demand and negative impact from price reductions in Japan and China.
Current report
•Ontruzant, due to unfavorable pricing in Brazil coupled with lower tendered volume from Brazil’s Ministry of Health when compared with 2024 and lower demand in the United States.
Current report
Due to changing market conditions, 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 for certain key products.
Current report
General Medicines
Current report
Exchange (gains) losses were positively impacted for the six months ended June 30, 2025, compared to 2024, as a result of the strengthening of foreign currencies against the U.S. dollar in the first half of 2025.
Current report
Other (Income) Expense, net
Current report
On July 4, 2025, 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. We are evaluating the impacts of the OBBBA on our U.S. cash tax liability and income tax provision.
Current report
Net cash used in financing activities was $298 million for the six months ended June 30, 2025, compared with $208 million for the same period in the prior year primarily driven by the repurchase and cancellation of $242 million of the 2031 Notes and the payment and termination of the NovaQuest Funding Agreement partially offset by borrowings on our Revolving Credit Facility and decreased dividend payments in the current year.
Current report
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.
Removed paragraphs (8)
Previous report
•Vtama, reflecting the acquisition of Dermavant in the fourth quarter of 2024;
Previous report
•Atozet, primarily due to LOE in France and Spain partially offset by increased demand in South Korea and the Asia Pacific cluster;
Previous report
•Ontruzant, driven by the return to normalized levels of the contracted volume in Brazil and lower demand in the United States.
Previous report
Established Brands
Previous report
Established brands represents a broad portfolio of well-known brands, which generally are beyond market exclusivity, including leading brands in cardiovascular, respiratory, dermatology and non-opioid pain management, for which generic competition varies by market.
Previous report
Exchange (gains) losses increased for the three months ended March 31, 2025, compared to 2024, driven by gains in foreign currencies.
Previous report
Other Expense, net
Previous report
Net cash used in financing activities remained consistent for the three months ended March 31, 2025, compared with the same period in the prior year. The primary activities included routine debt repayments and the payment of dividends.
Reworded paragraphs (46)
Previous wording
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,” “should,” “estimate,” “anticipate,” “plan,” “forecast,” “intend,” “would,” “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, expanded brand and class competition in the markets in which Organon & Co. (“Organon,” the “Company,” “we,” “our,” or “us”) operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential 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 Organon’s customers and business partners; economic factors over which we have no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; market volatility, downgrades to the U.S. government’s sovereign credit rating or its perceived creditworthiness, changing political or geopolitical conditions, market contraction, boycotts, and sanctions, as well as Organon’s ability to successfully manage uncertainties related to the foregoing; difficulties with performance of third parties we rely on for our business growth; the failure of any supplier to provide substances, materials, or services as agreed; 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 continued impact of the September 2024 loss of exclusivity (“LOE”) for Atozet™ (ezetimibe and atorvastatin); restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the U.S. Securities and Exchange Commission and other U.S. and comparable government agencies; difficulties and uncertainties inherent in the implementation of our acquisition strategy or failure to recognize the benefits of such acquisitions; pricing pressures globally, including rules and practices of managed care groups, judicial dec…
Excerpt shortened here; the source contains the full paragraph.
Current wording
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,” “should,” “estimate,” “anticipate,” “plan,” “intend,” “would,” “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, expanded brand and class competition in the markets in which Organon & Co. (“Organon,” the “Company,” “we,” “our,” or “us”) operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential 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 Organon’s customers and business partners; economic factors over which we have no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; market volatility, downgrades to the U.S. government’s sovereign credit rating or its perceived creditworthiness, changing political or geopolitical conditions, market contraction, boycotts, and sanctions, as well as Organon’s ability to successfully manage uncertainties related to the foregoing; difficulties with performance of third parties we rely on for our business growth; the failure of any supplier to provide substances, materials, or services as agreed; 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 continued impact of the September 2024 loss of exclusivity (“LOE”) for Atozet™1 (ezetimibe and atorvastatin); 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, which may include implementing or continuing to assess product discount programs and wholesaler inventory levels under the relevant agreements for certain key products such as Nexplanon; restructurings or other disruptions at the U.S. Food a…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
We are a global health care 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 and medical devices within women’s health, biosimilars and established brands. 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 health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. We 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.
Current wording
We are a global health care 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 and medical devices 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 health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. We 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.
Previous wording
In March 2025, we acquired from Biogen the regulatory and commercial rights in the United States for Tofidence® (tocilizumab-bavi), a biosimilar to Actemra 2 (tocilizumab), for intravenous infusion. Tofidence, launched in the U.S. market in May 2024, is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. Under the terms of the agreement, we will pay an upfront payment of $51 million in July 2025, as well as tiered royalty payments based on net sales and tiered annual net sales milestone payments of up to $45 million from a previous in-license arrangement with Bio-Thera Solutions Ltd., the product developer for Tofidence. In the first quarter of 2025, we recognized an intangible asset of $51 million, related to the upfront payment to Biogen, which will be amortized over 10 years.
Current wording
In March 2025, we acquired from Biogen the regulatory and commercial rights in the United States for Tofidence, a biosimilar to Actemra 2 (tocilizumab), for intravenous infusion. Tofidence, launched in the U.S. market in May 2024, is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. Under the terms of the agreement with Biogen, we paid an upfront payment of $51 million in July 2025, and will be obligated to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments of up to $45 million from a previous in-license arrangement with Bio-Thera Solutions Ltd., the product developer for Tofidence. In the first quarter of 2025, we recognized an intangible asset of $51 million, related to the upfront payment to Biogen, which will be amortized over 10 years.
Previous wording
Geopolitical developments, global trade issues such as tariffs imposed by or on the United States, shifting U.S. federal government policies, policies hindering market access, and worsening macroeconomic conditions could impact our business and results of operations and may stress our working capital resources. While tariffs have not, to date, had a material impact on our business, future tariff actions could potentially have a significant effect on our supply chain and operating costs. Regulatory agency developments, including disruptions at the FDA and other agencies, could increase the time needed for review and approval of new drugs and medical devices, potentially delaying our product launches and impacting our business operations. Additionally, proposed cuts to Medicaid and changes in federal funding policies could reduce access to healthcare services for low-income individuals and impact our ability to develop new drugs. Management will continue to evaluate the potential impacts of the shifting geopolitical and macroeconomic landscape on our business, results of operations, liquidity, and capital resources. For additional information, please refer to Item 1A — Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024.
Current wording
Geopolitical developments, global trade issues such as tariffs imposed by or on the United States, shifting U.S. federal and state government policies, policies hindering market access, and worsening macroeconomic conditions could impact our business and results of operations and may stress our working capital resources. While tariffs have not, to date, had a material impact on our business, future tariff actions could potentially have a significant effect on our supply chain and operating costs. Regulatory agency developments, including disruptions at the FDA and other agencies, could increase the time needed for review and approval of new drugs and medical devices, potentially delaying our product launches and impacting our business operations. Additionally, proposed cuts to Medicaid and changes in federal funding policies could reduce access to healthcare services for low-income individuals and impact our ability to develop new drugs. Management will continue to evaluate the potential impacts of the shifting geopolitical and macroeconomic landscape on our business, results of operations, liquidity, and capital resources. For additional information, please refer to Item 1A — Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024.
Previous wording
•Follistim AQ, due to a one-time buy-in as a result of our exit from our interim operating model agreement in the United States with Merck during the fourth quarter of 2023, which resulted in lower sales in the first quarter of 2024, demand increase and favorable discount rates in the United States; and
Current wording
•Follistim AQ® (follitropin beta injection), due to a one-time buy-in as a result of our exit from our interim operating model (“IOM”) agreement in the United States with Merck during the fourth quarter of 2023, which resulted in lower sales in the first half of 2024, demand increase and favorable discount rates in the United States as well as increased demand in select international markets.
Previous wording
This performance was more than offset by decreases for the three months ended March 31, 2025 in:
Current wording
This performance was offset by decreases for the three months ended June 30, 2025 in:
Previous wording
•Singulair® (montelukast sodium), due to the lower rate of respiratory infections in China when compared to 2024, lower demand in Japan and the impact of the mandatory annual price reductions in Japan; and
Current wording
•Singulair® (montelukast sodium), due to the lower demand and negative impact from price reductions in Japan and China.
Previous wording
Worldwide sales were $1.5 billion for the three months ended March 31, 2025, a decrease of 7%, compared to 2024. Worldwide sales during the three months ended March 31, 2025 were negatively impacted by approximately 3%, or $44 million, due to unfavorable foreign exchange rates.
Current wording
Worldwide sales were $3.1 billion for the six months ended June 30, 2025, a decrease of 4%, compared to 2024. Worldwide sales during the six months ended June 30, 2025 were negatively impacted by approximately 1%, or $34 million, due to unfavorable foreign exchange rates.
Previous wording
•Nexplanon, due to increased demand and favorable pricing in the United States and the acceleration of our institutional business in Africa in order to meet demand;
Current wording
•Nexplanon, primarily due to favorable pricing in the United States and increased demand in Brazil and our institutional business in Africa.
Previous wording
LOE negatively impacted sales of certain of our products by approximately $63 million during the three months ended March 31, 2025, based on the decrease in volume period over period. This was primarily driven by the LOE of Atozet in France and Rosuzet™ (ezetimibe and rosuvastatin) in Japan. Volume-based procurement (“VBP”) in China had an immaterial impact on our sales during the three months ended March 31, 2025. We expect VBP to continue to impact our established brands product portfolio for the next several quarters.
Current wording
LOE negatively impacted sales of certain of our products by approximately $60 million and $123 million during the three and six months ended June 30, 2025, respectively, based on the decrease in volume period over period. This was primarily driven by the LOE of Atozet in France, Spain and Japan and Rosuzet™ (ezetimibe and rosuvastatin) in Japan. Volume-based procurement (“VBP”) in China had an immaterial impact on our sales during the six months ended June 30, 2025. We expect VBP to continue to impact our general medicines product portfolio for the next several quarters.
Previous wording
Our operations include a portfolio of products. Highlights of the sales of our products for the three months ended March 31, 2025 and 2024 are provided below. See Note 5 “Product and Geographic Information” to the Condensed Consolidated Financial Statements for further details on sales of our products.
Current wording
Our operations include a portfolio of products. Highlights of the sales of our products for the three and six months ended June 30, 2025 and 2024 are provided below. See Note 5 “Product and Geographic Information” to the Condensed Consolidated Financial Statements for further details on sales of our products.
Previous wording
Worldwide sales of Nexplanon, a single-rod subdermal contraceptive implant, increased 13% for the three months ended March 31, 2025, compared to 2024, primarily due to increased demand and favorable pricing in the United States and the acceleration of our institutional business in Africa in order to meet demand.
Current wording
Worldwide sales of Nexplanon, a single-rod subdermal contraceptive implant, decreased 1% for the three months ended June 30, 2025, compared to 2024, primarily due to softer demand in the United States partially offset by favorable pricing in the United States, increased demand in various international markets, including Brazil and our institutional business in Africa. Sales increased 6% for the six months ended June 30, 2025, compared to 2024, primarily due to favorable pricing in the United States and increased demand in Brazil and our institutional business in Africa.
Previous wording
Worldwide sales of NuvaRing, a vaginal contraceptive product, declined 43% for the three months ended March 31, 2025, compared to 2024, due to ongoing generic competition and the negative impact of increased government discount rates in the United States. We expect a continued decline in NuvaRing sales as a result of generic competition.
Current wording
Worldwide sales of NuvaRing, a vaginal contraceptive product, declined 4% and 26% for the three and six months ended June 30, 2025, compared to 2024, respectively, due to ongoing generic competition. We expect a continued decline in NuvaRing sales as a result of generic competition.
Previous wording
Worldwide sales of Marvelon™(desogestrel and ethinyl estradiol pill) and Mercilon™(desogestrel and ethinyl estradiol pill), combined oral hormonal daily contraceptive pills not approved or marketed in the United States, but available in certain countries outside the United States, increased 19% for the three months ended March 31, 2025, compared to 2024, as a result of increased demand and the phasing of shipments in China.
Current wording
Worldwide sales of Marvelon™1 (desogestrel and ethinyl estradiol pill) and Mercilon™1 (desogestrel and ethinyl estradiol pill), combined oral hormonal daily contraceptive pills not approved or marketed in the United States, but available in certain countries outside the United States, declined 18% and 2% for the three and six months ended June 30, 2025, compared to 2024, respectively, as a result of the phasing of shipments in Asia Pacific and China.
Previous wording
Worldwide sales of Follistim AQ, a fertility treatment, increased 49% for the three months ended March 31, 2025, compared to 2024, due to a one-time buy-in as a result of our exit from our interim operating model agreement in the United States with Merck during the fourth quarter of 2023, which resulted in lower sales in the first quarter of 2024, demand increase and favorable discount rates in the United States.
Current wording
Worldwide sales of Follistim AQ, a fertility treatment, increased 18% and 31% for the three and six months ended June 30, 2025, compared to 2024, respectively, due to a one-time buy-in as a result of our exit from our IOM agreement in the United States with Merck during the fourth quarter of 2023, which resulted in lower sales in the first half of 2024, an increase in demand and favorable discount rates in the United States, as well as increased demand in select international markets.
Previous wording
Worldwide sales of Jada, a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, increased 20% for the three months ended March 31, 2025, compared to 2024. The sales increase is due to continued uptake in the United States following the Jada launch in early 2022 and favorable price and discount rates in the United States.
Current wording
Worldwide sales of Jada, a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, increased 24% and 22% for the three and six months ended June 30, 2025, compared to 2024, respectively. The sales increase is due to continued uptake in the United States following the Jada launch in early 2022 and favorable pricing in the United States.
Previous wording
Renflexisis a biosimilar to Remicade 2 (infliximab) for the treatment of certain autoimmune conditions. Sales declined 18% for the three months ended March 31, 2025, compared to 2024, primarily due to unfavorable discount rates in the United States.
Current wording
Renflexis® (infliximab-abda) is a biosimilar to Remicade 2 (infliximab) for the treatment of certain autoimmune conditions. Sales declined 9% and 13% for the three and six months ended June 30, 2025, compared to 2024, respectively, primarily due to unfavorable discount rates in the United States partially offset by increased demand in Canada and Australia.
Previous wording
Hadlima is a biosimilar to Humira 2 (adalimumab) for the treatment of certain autoimmune and autoinflammatory conditions. We have commercialization rights to Hadlima in countries outside of the European Union, South Korea, China, Turkey, and Russia. We recorded sales of $47 million during the three months ended March 31, 2025, reflecting sales that have continued to
Current wording
Hadlima is a biosimilar to Humira 2 (adalimumab) for the treatment of certain autoimmune and autoinflammatory conditions. We have commercialization rights to Hadlima in countries outside of the European Union, South Korea, China, Turkey, and Russia. We recorded sales of $50 million and $96 million during the three and six months ended June 30, 2025, respectively, reflecting sales ramp up since its launch in July 2023 in the United States and a modest increase in international markets. Hadlima is currently approved in the United States, Australia, Canada, and Israel.
Previous wording
Ontruzant is a biosimilar to Herceptin 2 (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, 2025, compared to 2024, declined 54%, following the return to normalized levels of the contracted volume in Brazil and lower demand in the United States. We have commercialization rights to Ontruzant in all countries except in South Korea and China.
Current wording
Ontruzant is a biosimilar to Herceptin 2 (trastuzumab) for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Sales for the three and six months ended June 30, 2025, compared to 2024, declined 35% and 43%, respectively, due to unfavorable pricing in Brazil coupled with lower tendered volume from Brazil’s Ministry of Health when compared with 2024 and lower demand in the United States. We have commercialization rights to Ontruzant in all countries except in South Korea and China.
Previous wording
Brenzys is a biosimilar to Enbrel 2 (etanercept) for the treatment of certain inflammatory diseases. Sales for the three months ended March 31, 2025, compared to 2024, declined 39%, as a result of the timing of international tenders in Brazil. We have commercialization rights to Brenzys in countries outside of the United States, Europe, South Korea, China, and Japan.
Current wording
Brenzys™1 (etanercept) is a biosimilar to Enbrel 2 (etanercept) for the treatment of certain inflammatory diseases. Sales for the three and six months ended June 30, 2025, compared to 2024, increased 76% and 1%, respectively, as a result of the timing of international tenders in Brazil. We have commercialization rights to Brenzys in countries outside of the United States, Europe, South Korea, China, and Japan.
Previous wording
Sales of Atozet, a medicine for lowering LDL cholesterol, declined 42% for the three months ended March 31, 2025, compared to 2024, primarily due to LOE in France and Spain, partially offset by increased demand in South Korea and the Asia Pacific cluster. We anticipate a continued significant decline in sales of Atozet in 2025 due to LOE, which occurred late in the third quarter of 2024, in certain markets in Europe.
Current wording
Sales of Atozet, a medicine for lowering LDL cholesterol, declined 38% and 40% for the three and six months ended June 30, 2025, compared to 2024, respectively, primarily due to LOE in France, Spain and Japan, partially offset by increased demand in Asia Pacific and Latin America. We anticipate a continued significant decline in sales of Atozet in 2025 due to LOE, which occurred late in the third quarter of 2024, in certain markets in Europe.
Previous wording
Combined global sales of Zetia® (ezetimibe) and Vytorin® (ezetimibe / simvastatin), medicines for lowering LDL cholesterol, declined 4% for the three months ended March 31, 2025, compared to 2024, primarily driven by the decrease in demand and pricing pressure in various international markets, partially offset by increased demand in China.
Current wording
Combined global sales of Zetia® (ezetimibe) and Vytorin® (ezetimibe / simvastatin), medicines for lowering LDL cholesterol, declined 1% and 3% for the three and six months ended June 30, 2025, compared to 2024, respectively, primarily driven by the decrease in demand and pricing pressure in various international markets.
Previous wording
Combined global sales of Cozaar®(losartan potassium) and Hyzaar® (losartan potassium and hydrochlorothiazide), medicines for the treatment of hypertension, declined 18% for the three months ended March 31, 2025, compared to 2024, driven by decreased demand in China and Japan and mandatory annual price reductions in Japan.
Current wording
Combined global sales of Cozaar®(losartan potassium) and Hyzaar® (losartan potassium and hydrochlorothiazide), medicines for the treatment of hypertension, declined 6% and 13% for the three and six months ended June 30, 2025, compared to 2024, respectively, driven by decreased hospital demand in China and decreased demand in Japan.
Previous wording
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, decreased 24% for the three months ended March 31, 2025, compared to 2024, due to the lower rate of respiratory infections in China when compared to 2024, lower demand in Japan and the impact of the mandatory annual price reductions in Japan.
Current wording
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, decreased 29% and 27% for the three and six months ended June 30, 2025, compared to 2024, respectively, due to lower demand and the negative impact from price reductions in Japan and China.
Previous wording
Global sales of Nasonex® (mometasone), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, declined 7% for the three months ended March 31, 2025, compared to 2024, due to the prior year phasing of shipments related to the implementation of our enterprise resource planning (“ERP”) system in various international markets.
Current wording
Global sales of Nasonex® (mometasone), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, increased 9% and remained consistent for the three and six months ended June 30, 2025, compared to 2024, respectively, due to increased demand in China, Japan and the Middle East.
Previous wording
Global sales of Dulera® (formoterol/fumarate dihydrate), which is also marketed as Zenhale TM in certain markets outside of the United States, a combination medicine for the treatment of asthma, declined 22% for the three months ended March 31, 2025, compared to 2024, primarily due to the loss of a customer contract, discount rate pressure in the United States and decreased demand in Canada.
Current wording
Global sales of Dulera® (formoterol/fumarate dihydrate), which is also marketed as Zenhale TM in certain markets outside of the United States, a combination medicine for the treatment of asthma, declined 13% and 18% for the three and six months ended June 30, 2025, compared to 2024, respectively, primarily due to the loss of a customer contract in the first part of the year combined with increased discount rate pressure in the United States.
Previous wording
Sales of Arcoxia™ 1(etoricoxib), a medicine for the treatment of arthritis and pain, declined 18% for the three months ended March 31, 2025, compared to 2024, primarily due to the phasing of shipments in various international regions.
Current wording
Sales of Arcoxia™ 1(etoricoxib), a medicine for the treatment of arthritis and pain, declined 7% and 13% for the three and six months ended June 30, 2025, compared to 2024, respectively, primarily due to decreased demand in Asia Pacific and China and the phasing of shipments in various international regions.
Previous wording
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, were $24 million for the three months ended March 31, 2025. Vtama is a product that we acquired as part of our acquisition of Dermavant in the fourth quarter of 2024.
Current wording
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, were $31 million and $54 million for the three and six months ended June 30, 2025, respectively as a result of our acquisition of Dermavant in the fourth quarter of 2024 and launch of the atopic dermatitis indication in the United States.
Previous wording
Sales of Emgalitya medicine for the preventive treatment of migraine and Rayvow, a medicine for acute treatment of the headache phase of migraine attacks, increased for the three months ended March 31, 2025, compared to 2024, primarily due to a full quarter of sales in 2025 as compared to a partial quarter of sales in 2024 as a result of our the acquisition of the distribution and promotion rights from Lilly in January of 2024 in certain markets outside of the United States.
Current wording
Sales of Emgality, a medicine for the preventive treatment of migraine and Rayvow™2 (lasmiditan), a medicine for acute treatment of the headache phase of migraine attacks, increased for the three and six months ended June 30, 2025, compared to 2024, as a result of our acquisition of the distribution and promotion rights from Lilly in 2024 in certain markets outside of the United States.
Previous wording
Cost of sales increased 1% for the three months ended March 31, 2025, compared to 2024, primarily due to increased amortization expense due to the acquisition of intangibles in the prior year, amortization of $9 million associated with the inventory fair value adjustment related to the Dermavant acquisition, partially offset by foreign exchange translation. Cost of sales includes amortization of intangible assets of $50 million and $33 million for the three months ended March 31, 2025 and 2024, respectively. Separation costs associated with manufacturing-related headcount reductions have been incurred and are reflected in Restructuring costs.
Current wording
Cost of sales increased 8% and 4% for the three and six months ended June 30, 2025, compared to 2024. Cost of sales for the three and six months ended June 30, 2025, includes amortization associated with the inventory fair value adjustment related to the Dermavant acquisition of $10 million and $19 million, respectively, an impairment charge related to a currently marketed women’s health product of $9 million and amortization of intangible assets of $53 million and $103 million, respectively. Cost of sales for the three and six months ended June 30, 2024 includes amortization of intangible assets of $34 million and $67 million, respectively. In addition, the three and six months ended June 30, 2025 benefited from the impacts of favorable foreign exchange rates. Separation costs associated with manufacturing-related headcount reductions have been incurred and are reflected in Restructuring costs.
Previous wording
Gross profit decreased 12% for the year ended March 31, 2025, compared to 2024, due to the impact of unfavorable price and decreased sales due to volume and foreign exchange translation.
Current wording
Gross profit decreased 7% and 10% for the three and six months ended June 30, 2025, compared to 2024, respectively, due to the impact of unfavorable price, decreased sales, unfavorable product mix and foreign exchange translation.
Previous wording
Selling, general and administrative expenses decreased 3% for the three months ended March 31, 2025, compared to 2024, due to lower costs related to the prior year implementation of our ERP system offset by increased costs associated with the promotion of our recently acquired products.
Current wording
Selling, general and administrative expenses increased 4% and 1% for the three and six months ended June 30, 2025, compared to 2024, respectively, due to increased costs associated with the promotion of our recently acquired products and Nexplanonand reserves for legal settlements offset by lower costs related to the prior year implementation of our ERP system.
Previous wording
Research and development expenses decreased 14% for the three months ended March 31, 2025, compared to 2024, primarily due to a decrease in clinical study activity.
Current wording
Research and development expenses decreased 18% and 16% for the three and six months ended June 30, 2025, compared to 2024, respectively, primarily due to a decrease in headcount related expenses and clinical study activity. In July 2025, we announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. Based on these results, we will discontinue the OG-6219 clinical development program.
Previous wording
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 current agreement with Centergene, due to the evolving fertility landscape in China. We will continue to assess and evaluate future commercial opportunities with Centergene. For the three months ended March 31, 2024 acquired in-process research and development and milestones of $15 million represents the research and development milestones related to Henlius that were determined to be probable of being achieved.
Current wording
For the six months ended June 30, 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. For the three months ended June 30, 2024, acquired in-process research and development and milestones of $15 million represented the research and development milestones of $5 million for Henlius and $10 million for Cirqle Biomedical (“Cirqle”), which were determined to be probable of being achieved. For the six months ended June 30, 2024, acquired in-process research and development and milestones of $30 million represent the research and development milestones of $20 million for Henlius and $10 million for Cirqle, which were determined to be probable of being achieved.
Previous wording
For the three months ended March 31, 2025, we incurred $86 million of headcount-related restructuring expense associated with restructuring initiatives that were aimed at driving operational efficiencies in 2025. The restructuring activities combined with other Company cost savings initiatives are expected to result in approximately $200 million of annual savings. For the three months ended March 31, 2024 we incurred $23 million of headcount-related restructuring expense related to the optimization of our internal operations, primarily the research and development function.
Current wording
For the three and six months ended June 30, 2025, we incurred restructuring costs of $2 million and $88 million, respectively, comprised primarily of headcount-related restructuring expense associated with restructuring initiatives that were aimed at driving operational efficiencies in 2025. The restructuring activities combined with our other cost savings initiatives are expected to result in approximately $200 million of annual savings. For the six months ended June 30, 2024 we incurred restructuring costs of $23 million, comprised of headcount-related restructuring expense related to the optimization of our internal operations, primarily within the research and development function.
Previous wording
Interest expense decreased 5% for the three months ended March 31, 2025, compared to 2024, reflecting lower interest rates as a result of refinancing a portion of our long-term debt in the prior year and lower reference rates on our variable rate debt, partially offset by interest related to the debt acquired as part of the Dermavant acquisition.
Current wording
Interest expense remained consistent and decreased 3% for the three and six months ended June 30, 2025, compared to 2024, respectively, and reflects lower interest rates as a result of refinancing a portion of our long-term debt in the prior year and lower reference rates on our variable rate debt, offset by interest related to the debt acquired as part of the Dermavant acquisition and previously unamortized debt issuance fees of approximately $2 million associated with the repurchase and cancellation of $242 million of the 2031 Notes.
Previous wording
Other expense increased for the three months ended March 31, 2025, compared to 2024, due to the accretion of the contingent consideration related to the Dermavant acquisition.
Current wording
Other (income) expense increased for the three and six months ended June 30, 2025, compared to 2024, due to a $46 million pre-tax gain related to the repurchase and cancellation of approximately $242 million of the 2031 Notes and the repayment and termination of the NovaQuest Funding Agreement offset by the accretion of the contingent consideration related to the Dermavant acquisition.
Previous wording
The effective income tax rate was 13.4% and 14.7% for the three months ended March 31, 2025 and 2024, 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 partial valuation allowance recorded against non-deductible U.S. interest expense. There was a favorable impact to the 2025 year-to-date effective tax rate driven by a tax amortization benefit. The favorable impact to the 2024 year-to-date effective tax rate was driven by the favorable closure of the two non-U.S. tax audits and a return to provision adjustment for an entity in Switzerland.
Current wording
The effective income tax rates were 37.0% and 17.3% for the three months ended June 30, 2025 and 2024, respectively, and 29.8% and 16.0% for the six months ended June 30, 2025 and 2024, 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 partial valuation allowance recorded against non-deductible U.S. interest expense. There was a favorable impact to the 2025 year-to-date effective tax rate driven by a tax amortization benefit. The favorable impact to the 2024 year-to-date effective tax rate was driven by the favorable closure of the two non-U.S. tax audits and a return to provision adjustment for an entity in Switzerland.
Previous wording
As of March 31, 2025, we had cash and cash equivalents of $547 million. 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.
Current wording
As of June 30, 2025, we had cash and cash equivalents of $599 million. 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.
Previous wording
Working capital is defined as current assets less current liabilities and was $1.76 billion and $1.63 billion as of March 31, 2025 and December 31, 2024, respectively. Working capital was impacted by our active cash cycle management, which includes the factoring of receivables and timing of vendor payments, as well as an increase in receivables due to the timing of shipments, a lower cash balance due to milestone payments and the timing of annual incentive compensation payments in the first quarter of 2025.
Current wording
Working capital is defined as current assets less current liabilities and was $1.82 billion and $1.63 billion as of June 30, 2025 and December 31, 2024, respectively. Working capital was impacted by our active cash cycle management, which includes the factoring of receivables and timing of vendor payments; milestone payments; and net repayments of debt.
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Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Excluding the impact of foreign exchange rates, sales increases for the six months ended June 30, 2025, primarily reflect the performance of:
Current report — wording carried from elsewhere
This performance was offset by decreases for the six months ended June 30, 2025 in:
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
-27- ramp up since its July 2023 launch in the United States and a modest increase in international markets, partially offset by unfavorable discount rates in the United States. Hadlima is currently approved in the United States, Australia, Canada, and Israel.