Organon & Co.
For the period ended Sep 30, 2025. Filed Nov 10, 2025.
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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.
Sep 30, 2025 · Filed Nov 10, 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 2025-06-30; filed 2025-08-06.
0001821825-25-000066
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001628280-25-050795
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 105 previous paragraphs and 120 current paragraphs.
43 unchanged; 51 reworded; 24 added; 9 removed; 2 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 (24)
Current report
Internal Investigation Relating to Internal Control Over Financial Reporting
Current report
On October 27, 2025, we announced an internal investigation conducted by the Audit Committee (the “Audit Committee”) of the Company’s Board of Directors (the “Board”) regarding our sales practices for wholesalers as described in the Form 8-K.
Current report
Overview of Audit Committee Investigation and Findings
Current report
As disclosed in the Form 8-K and Amendment No. 1 (the “10-K Amendment”), filed on November 10, 2025, to our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Original Form 10-K”) and amendments (the “10-Q Amendments” and, together with the 10-K Amendment, the “Amendments”) to our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2025 and June 30, 2025 (such original filings, the “Original Form 10-Qs” and, together with the Original Form 10-K, the “Original Reports”), after concerns regarding our sales practices for wholesalers for Nexplanon were brought to the Board’s attention, the Audit Committee oversaw an independent, internal investigation into these sales practices. The Audit Committee’s investigation focused on our sales of Nexplanon to wholesalers. The investigation found that we asked two wholesalers in the United States to purchase greater quantities of Nexplanon at the end of the fourth quarter of 2022, the third and fourth quarters of 2024 and the first, second and third quarters of 2025 (collectively, the “Relevant Periods”) than they otherwise would have purchased based on wholesaler demand. In certain instances, we waived inventory management fee performance metrics associated with caps on days of inventory to allow wholesalers to be paid the inventory management fees they would have earned but for the Company’s ask to purchase additional inventory. As a result of these purchases, the United States wholesalers significantly decreased or even halted their purchases of Nexplanon during the early weeks of the following quarters until their days of inventory on hand were reduced to levels within the contractual range. Although the incremental amount of Nexplanon sales that occurred during the Relevant Periods represented less than 1% of our consolidated revenue for the year ended December 31, 2022 or December 31, 2024, as applicable (and less than 2% of the Company’s consolidated
Current report
-27- revenue for the relevant quarterly periods), based on the results of the investigation, we have determined that without these sales practices, our consolidated revenue for the fiscal year ended December 31, 2024 reported in the Original Reports (and certain of the other Relevant Periods) would have fallen short of our guidance range and/or certain external expectations. The Audit Committee investigation did not find that the use of these sales practices for wholesalers extended to sales other than sales of Nexplanonin the United States during the Relevant Periods, or that these sales practices for wholesalers were otherwise used for any other Company products.
Current report
In connection with the investigation, the Audit Committee found that (i) our former Chief Executive Officer and leader of our U.S. commercial organization applied inappropriate pressure to achieve sales targets, which resulted in two United States wholesalers being asked to purchase inventory in excess of current customer demand for Nexplanon, (ii) our processes with respect to reporting and documenting the sales practices for wholesalers during the Relevant Periods, including with respect to inventory management fee performance metric waivers, were not followed, (iii) the former Chief Executive Officer did not reasonably ensure that relevant information was appropriately communicated; rather, relevant information was withheld from our independent directors, the Audit Committee, and the independent registered public accounting firm, and (iv) our former Chief Executive Officer and leader of our U.S. commercial organization engaged in inappropriate business conduct that violated our Code of Conduct. There were no investigative findings that other members of our executive leadership team, including the Company’s Chief Financial Officer, or any member of our accounting and financial reporting group involved in the preparation of our financial statements, were aware that these sales practices resulted in the United States wholesalers being asked to purchase inventory that exceeded their demand or contractual limits, or that waivers were given so that the United States wholesalers would continue to receive inventory management fees. The Audit Committee’s investigation is complete.
Current report
Based on the results of the Audit Committee’s investigation, we determined that these sales practices for wholesalers involving Nexplanon in the United States during the Relevant Periods were improper, and that certain of our prior disclosures relating to these sales practices for wholesalers and their effect upon revenues and product demand in our periodic filings were inaccurate or incomplete. As a result, we filed the Amendments.
Current report
Company Determinations Following the Audit Committee Findings
Current report
As disclosed in the Amendments, as a result of the investigation and the Audit Committee findings, our management, in consultation with the Audit Committee, has re-assessed the effectiveness of our disclosure controls and procedures and its internal control over financial reporting as of December 31, 2024.
Current report
As a result as reported in the Amendments, we concluded that there were material weaknesses in our internal control over financial reporting as of December 31, 2024 and that management’s assessment of our disclosure controls and procedures and our internal control over financial reporting as of December 31, 2024 that were included in Item 9A of the Original Form 10-K should no longer be relied upon, as a result of the material weaknesses disclosed in the 10-K Amendment.
Current report
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 the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. For additional information, see Part I, Item 4 of this report.
Current report
We have determined that there will be no restatement or revision to our previously issued financial statements, including those filed with the Original Reports.
Current report
Change in Management
Current report
In connection with the Audit Committee investigation, on October 26, 2025, (i) Kevin Ali resigned as Chief Executive Officer of the Company and as a member of the Board, (ii) Joseph Morrissey, the then-current Executive Vice President and Head of Manufacturing & Supply of the Company, was appointed Interim Chief Executive Officer (and principal executive officer) of the Company, (iii) Carrie S. Cox, Chair of the Board, was appointed Executive Chair for an interim period, and (iv) Robert Essner, a member of the Board, was appointed to the position of Lead Independent Director. Additionally and in connection with the Audit Committee investigation, on October 26, 2025, the Company terminated the employment of its Head of U.S. Commercial & Government Affairs.
Current report
International reference pricing frameworks, including Most-Favored-Nation (“MFN”) mandates, may further constrain our pricing flexibility and commercial strategy. Voluntary price concessions in certain European markets and increased rebate negotiations across the European Union have introduced additional pressure on net pricing and margins. These developments may influence our commercial strategy, constrain pricing flexibility and delay product launches. 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 and Part II. Item 1A below.
Current report
•Nexplanon, primarily due to lower demand and decreased funding of government programs in the United States, partially offset by increased demand in Brazil and the timing of tenders, primarily in Mexico. Nexplanon sales for the nine months ended September 30, 2025 included an estimated $17 million of sales resulting from the identified sales practices for wholesalers described in the “Recent Developments” section above, which was offset by an estimated $15 million of sales from such sales practices for wholesalers that were pulled forward into the year ended December 31, 2024, resulting in a net impact of $2 million for the nine months ended September 30, 2025. The impact was estimated using average daily sales, inventory levels at the wholesaler and days on hand at the wholesaler; and
Current report
•Dulera® (formoterol/fumarate dihydrate), 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. In the third quarter, demand was further impacted by supply constraints.
Current report
•Vtama, due to the acquisition of Dermavant in the fourth quarter of 2024, launch of the atopic dermatitis indication in adults and children two years of age and older in the United States and launch of the topical treatment of plaque psoriasis in adults in Canada in the third quarter of 2025;
Current report
•Atozet, primarily due to LOE in France, Spain and Japan, partially offset by increased demand in Asia Pacific, Latin America and China;
Current report
•Singulair, due to lower demand outside of the United States and the negative impact from price reductions in Japan and China; and
Current report
•Dulera, 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. In the third quarter, demand was further impacted by supply constraints.
Current report
Worldwide sales of Nexplanon, a single-rod subdermal contraceptive implant, decreased 8% for the three months ended September 30, 2025, compared to 2024, primarily due to lower demand and decreased funding of government programs in the United States, partially offset by increased demand in Brazil and the timing of tenders, primarily in Mexico. Sales increased 1% for the nine months ended September 30, 2025, compared to 2024, primarily due to increased demand in Brazil and the timing of tenders in various international markets offset by lower demand and decreased funding of government programs in the United States. Nexplanon sales for the nine months ended September 30, 2025 included an estimated $17 million of sales resulting from the identified sales practices for wholesalers described in the “Recent Developments” section above, offset by an estimated $15 million of sales from such identified sales practices for wholesalers that were pulled forward into the year ended December 31, 2024, which resulted in a net impact of $2 million for the nine months ended September 30, 2025. For the three and nine months ended September 30, 2024 there was an estimated $5 million of Nexplanon sales resulting from the identified sales practices for wholesalers described in the “Recent Developments” section above. The impact was estimated using average daily sales, inventory levels at the wholesaler and days on hand at the wholesaler. The Company ceased the identified sales practices for wholesalers described in the “Recent Developments” section above, which will adversely impact the fourth quarter 2025 sales. With regard to Nexplanon’sfive-year duration indication, we continue to have collaborative discussions with the FDA. Though we were recently notified that the agency needs more time to complete the review of our submission, the PDUFA three-month extension is not material to our original timeline, which was to launch in late 2025 or early 2026.
Current report
Exchange Losses
Current report
Exchange losses increased for the three and nine months ended September 30, 2025, compared to 2024, primarily due to unfavorable movements in certain foreign currencies relative to the U.S. dollar. While the U.S. dollar weakened overall during 2025, several currencies in which we have exposure experienced adverse shifts, resulting in increased losses.
Removed paragraphs (9)
Previous report
•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 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.
Previous 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.
Previous report
•Nexplanon, primarily due to favorable pricing in the United States and increased demand in Brazil and our institutional business in Africa.
Previous report
•Singulair, due to the lower demand and negative impact from price reductions in Japan and China.
Previous 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.
Previous report
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 report
Exchange (Gains) Losses
Previous 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.
Reworded paragraphs (51)
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,” “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.
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 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; uncertainties surrounding the Audit Committee investigation described in our Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 27, 2025 (the “Form 8-K”); the impact of litigation, regulatory investigations and inquiries, and other legal matters, including risks to our reputation and relationships with customers, wholesalers, suppliers, and other business partners; risks related to potential disruptions to our business as a result of the leadership changes announced in the Form 8-K, including the risk that appointing a new Chief Executive Officer may take longer than anticipated; our ability to remediate the material weaknesses in internal control over financial reporting and the related costs and management resources in connection therewith, as well as our ability to maintain effective controls 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; unfavorable publicity and media reports; the potential impact that actions by activ…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
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, 2024. Operating results discussed herein are not necessarily indicative of the results of any future period.
Current wording
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, 2024, as amended. Operating results discussed herein are not necessarily indicative of the results of any future period.
Previous 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.
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 impacting our ability to develop new drugs, 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.
Previous wording
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 wording
Worldwide sales were $1.6 billion for the three months ended September 30, 2025, an increase of 1%, compared to 2024. Worldwide sales were positively impacted by approximately 2% or $36 million, due to favorable foreign exchange rates.
Previous wording
•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 wording
•Vtama, due to the acquisition of Dermavant in the fourth quarter of 2024, launch of the atopic dermatitis indication in adults and children two years of age and older in the United States and launch of the topical treatment of plaque psoriasis in adults in Canada in the third quarter of 2025;
Previous wording
•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 wording
•Hadlima® (adalimumab-bwwd), reflecting sales ramp up since its launch in July 2023 in the United States and a modest increase in international markets; and
Previous wording
•Singulair® (montelukast sodium), due to the lower demand and negative impact from price reductions in Japan and China.
Current wording
•Singulair® (montelukast sodium), due to lower demand outside of the United States and the negative impact from price reductions in Japan and China;
Previous wording
•Atozet, primarily due to LOE in France, Spain and Japan partially offset by increased demand in Asia Pacific and Latin America.
Current wording
•Atozet, primarily due to LOE in France, Spain and Japan, partially offset by increased demand in Asia Pacific, Latin America and China;
Previous 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.
Current wording
Worldwide sales were $4.7 billion for the nine months ended September 30, 2025, a decrease of 2%, compared to 2024. Worldwide sales during the nine months ended September 30, 2025 were positively impacted by approximately $2 million, due to favorable foreign exchange rates.
Previous wording
Excluding the impact of foreign exchange rates, sales increases for the six months ended June 30, 2025, primarily reflect the performance of:
Current wording
Excluding the impact of foreign exchange rates, sales increases for the nine months ended September 30, 2025, primarily reflect the performance of:
Previous wording
•Hadlima, reflecting sales ramp up since its launch in July 2023 in the United States and a modest increase in international markets.
Current wording
•Hadlima, reflecting sales ramp up since its launch in July 2023 in the United States and a modest increase in international markets; and
Previous wording
This performance was offset by decreases for the six months ended June 30, 2025 in:
Current wording
This performance was more than offset by decreases for the nine months ended September 30, 2025 in:
Previous 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.
Current wording
LOE negatively impacted sales of certain of our products by approximately $47 million and $170 million during the three and nine months ended September 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 nine months ended September 30, 2025. We expect VBP to continue to impact our general medicines product portfolio for the next several quarters.
Previous wording
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 wording
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 or waivers of their terms for certain key products.
Previous 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.
Current wording
Our operations include a portfolio of products. Highlights of the sales of our products for the three and nine months ended September 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 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.
Current wording
Worldwide sales of NuvaRing, a vaginal contraceptive product, increased 9% for the three months ended September 30, 2025, compared to 2024, due to increased demand in the United States, partially offset by ongoing generic competition. Sales declined 17% for the nine months ended September 30, 2025, compared to 2024, due to the loss of a customer contract in 2024 and ongoing generic competition, partially offset by favorable discount rates in the United States associated with a new agreement. We expect a continued decline in NuvaRing sales as a result of generic competition.
Previous 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.
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, remained consistent for the three and nine months ended September 30, 2025, compared to 2024, respectively, as a result of favorable pricing in Asia Pacific offset by the phasing of shipments in various international markets. The nine months ended September 30, 2025 was impacted by increased demand in China.
Previous 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.
Current wording
Worldwide sales of Follistim AQ, a fertility treatment, increased 1% and 20% for the three and nine months ended September 30, 2025, compared to 2024, respectively, due to increased demand in select international markets. The nine months ended September 30, 2025 was impacted by a one-time buy-in as a result of our exit from our interim operating model agreement in the United States with Merck related to this product during the fourth quarter of 2023, which resulted in lower sales in the first half of 2024.
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 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.
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 30% and 25% for the three and nine months ended September 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. Subsequent to September 30, 2025, we entered into a definitive agreement to divest the Jada System to Laborie Medical Technologies Corporation. The transaction is expected to close in early 2026, subject to regulatory approvals and other customary closing conditions.
Previous 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.
Current wording
Renflexis® (infliximab-abda) is a biosimilar to Remicade 2 (infliximab) for the treatment of certain autoimmune conditions. Sales declined 2% and 9% for the three and nine months ended September 30, 2025, compared to 2024, respectively, primarily due to competitive pressure and unfavorable discount rates in the United States, partially offset by increased demand in Canada.
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 $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.
Current wording
Hadlima is a biosimilar to Humira 2 (adalimumab) for the treatment of certain autoimmune and autoinflammatory conditions. Sales increased 57% and 62% for the three and nine months ended September 30, 2025, compared to 2024, respectively, due to sales ramp up since its launch in July 2023 in the United States and a modest increase in international markets. 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.
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 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.
Current wording
Ontruzant® (trastuzumab-dttb) 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 September 30, 2025, compared to 2024, increased 54% due to increased demand and timing of tenders in Brazil partially offset by unfavorable pricing in Brazil. Sales for the nine months ended September 30, 2025, compared to 2024, declined 25%, due to competitive pressure in the United States, unfavorable pricing and lower tendered volume from Brazil’s Ministry of Health when compared with 2024. We have commercialization rights to Ontruzant in all countries except in South Korea and China.
Previous 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.
Current wording
Brenzys™1 (etanercept) is a biosimilar to Enbrel 2 (etanercept) for the treatment of certain inflammatory diseases. Sales for the three and nine months ended September 30, 2025, compared to 2024, declined 13% and 5%, respectively, as a result of the
Previous 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.
Current wording
Sales of Atozet, a medicine for lowering LDL cholesterol, declined 24% and 35% for the three and nine months ended September 30, 2025, compared to 2024, respectively, primarily due to LOE in France, Spain and Japan, partially offset by increased demand in Asia Pacific, Latin America and China. We anticipate a continued significant decline in sales of Atozet in 2025 due to LOE, which occurred late in the third quarter of 2024.
Previous 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.
Current wording
Combined global sales of Zetia® (ezetimibe) and Vytorin® (ezetimibe / simvastatin), medicines for lowering LDL cholesterol, increased 10% and 1% for the three and nine months ended September 30, 2025, compared to 2024, respectively, primarily driven by increased demand in China, partially offset 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 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.
Current wording
Combined global sales of Cozaar®(losartan potassium) and Hyzaar® (losartan potassium and hydrochlorothiazide), medicines for the treatment of hypertension, declined 7% and 11% for the three and nine months ended September 30, 2025, compared to 2024, respectively, driven by decreased demand in Japan and Latin America. Additionally, the nine months ended September 30, 2025 was impacted by decreased hospital demand in China.
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 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.
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 37% and 30% for the three and nine months ended September 30, 2025, compared to 2024, respectively, due to lower demand outside of the United States 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, 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.
Current wording
Global sales of Nasonex, an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, declined 5% and 1% for the three and nine months ended September 30, 2025, compared to 2024, respectively, due to decreased demand and an increase in competitive pressure in various international markets.
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 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.
Current wording
Global sales of Dulera, which is also marketed as Zenhale TM in certain markets outside of the United States, a combination medicine for the treatment of asthma, declined 31% and 22% for the three and nine months ended September 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. In the third quarter, demand was further impacted by supply constraints, which are expected to continue into the fourth quarter.
Previous 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.
Current wording
Sales of Arcoxia™ 1(etoricoxib), a medicine for the treatment of arthritis and pain, increased 4% for the three months ended September 30, 2025, compared to 2024, due to the impact of foreign exchange offset by decreased demand in Latin America and the phasing of shipments in various international regions. Sales declined 8% for the nine months ended September 30, 2025, compared to 2024, primarily due to decreased demand in Latin America and Asia Pacific 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 $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.
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 $34 million and $89 million for the three and nine months ended September 30, 2025, respectively as a result of our acquisition of Dermavant in the fourth quarter of 2024, launch of the atopic dermatitis indication in the United States and launch of the topical treatment of plaque psoriasis in adults in Canada in the third quarter of 2025.
Previous 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.
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 nine months ended September 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 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.
Current wording
Cost of sales increased 13% and 7% for the three and nine months ended September 30, 2025, compared to 2024. Cost of sales for the three and nine months ended September 30, 2025, includes amortization associated with the inventory fair value adjustment related to the Dermavant acquisition of $12 million and $31 million, respectively, an impairment charge in the nine months ended September 30, 2025 related to a currently marketed women’s health product of $9 million and amortization of intangible assets of $52 million and $155 million, respectively. Cost of sales for the three and nine months ended September 30, 2024 includes amortization of intangible assets of $35 million and $102 million, respectively. In addition, the three and nine months ended September 30, 2025 were impacted by increased costs to optimize our manufacturing and supply network and unfavorable 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 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.
Current wording
Gross profit decreased 7% and 9% for the three and nine months ended September 30, 2025, compared to 2024, respectively, due to increased costs to optimize our manufacturing and supply network, the impact of unfavorable price, unfavorable product mix and foreign exchange translation offset by an increase in volume.
Previous 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.
Current wording
Selling, general and administrative expenses decreased 2% and remained consistent for the three and nine months ended September 30, 2025, compared to 2024, respectively, 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 and Nexplanonand reserves for legal settlements.
Previous 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.
Current wording
Research and development expenses decreased 24% and 19% for the three and nine months ended September 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 made the decision to discontinue the OG-6219 clinical development program.
Previous 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.
Current wording
For the nine months ended September 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 September 30, 2024, acquired in-process research and development and milestones of $51 million primarily represents the research and development milestones related to our agreement with Henlius, which were determined to be probable of being achieved. For the nine months ended September 30, 2024, acquired in-process research and development and milestones of $81 million primarily represents the research and development milestones of $70 million for our agreement with Henlius and $10 million for our agreement with Cirqle, which were determined to be probable of being achieved.
Previous 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.
Current wording
For the nine months ended September 30, 2025, we incurred restructuring costs of $88 million 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 nine months ended September 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 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.
Current wording
Interest expense increased 2% for the three months ended September 30, 2025, compared to 2024, and reflects interest related to the debt acquired as part of the Dermavant acquisition, partially offset by lower interest rates as a result of refinancing a portion of our long-term debt in the prior year and the repurchase and cancellation of the 2031 Notes. Interest expense decreased 1% for the nine months ended September 30, 2025, compared to 2024, and reflects lower interest rates as a result of refinancing a portion of our long-term debt in the prior year and the repurchase and cancellation of the 2031 Notes combined with 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 (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.
Current wording
Other (income) expense, net was impacted for the three months ended September 30, 2025, by the fair value adjustments and accretion of the Dermavant acquisition contingent consideration, related to changes in the timing of expected commercial milestones based on updated sales forecasts. Other (income) expense, net was impacted for the nine months ended September 30, 2025, by 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 and the fair value adjustments and accretion of the Dermavant acquisition contingent consideration, related to changes in the timing of expected commercial milestones based on updated sales forecasts.
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Current report — wording carried from elsewhere
-26- 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; loss of key employees or inability to identify and recruit new employees; 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, 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 (as amended), Quarterly Reports on Form 10-Q (as amended) and Current Reports on Form 8-K, 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.
Current report — wording carried from elsewhere
-32- timing of international tenders in Brazil, partially offset by increased demand in Asia Pacific. We have commercialization rights to Brenzys in countries outside of the United States, Europe, South Korea, China, and Japan.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
•Vtama, due to the acquisition of Dermavant in the fourth quarter of 2024 and launch of the Atopic Dermatitis indication in the United States.
Previous report — wording carried elsewhere
•Atozet, primarily due to LOE in France, Spain and Japan partially offset by increased demand in Asia Pacific and Latin America.