Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

开始日期2020-10-29

申办/合作机构

The Brigham & Women's Hospital, Inc.

100 项与富马酸福莫特罗/莫米松糠酸酯相关的临床结果

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100 项与富马酸福莫特罗/莫米松糠酸酯相关的转化医学

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100 项与富马酸福莫特罗/莫米松糠酸酯相关的专利（医药）

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项与富马酸福莫特罗/莫米松糠酸酯相关的文献（医药）

2022-02-01·Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

A real-world study of inhaled corticosteroid use in patients with severe eosinophilic asthma treated with mepolizumab

Article

作者: Bogart, Michael ; Molfino, Nestor A ; Packnett, Elizabeth ; Silver, Jared ; McMorrow, Donna ; Wu, Juan ; Corren, Jonathan ; Hahn, Beth

BACKGROUND:

Mepolizumab is a humanized anti-interleukin-5, monoclonal antibody approved for the treatment of patients with severe eosinophilic asthma (SEA). There is limited evidence that mepolizumab can reduce inhaled corticosteroid (ICS) use in these patients.

OBJECTIVE:

To investigate changes in ICS use and clinical outcomes in patients with SEA who initiated mepolizumab treatment.

METHODS:

This retrospective cohort study (GlaxoSmithKline identification: 212695/HO-20-19951) used administrative claims data from the IBM Watson Health MarketScan Database (identification period: November 2015 to March 2018). Eligible patients had SEA and were receiving high-dose ICS and mepolizumab. Use of ICS, oral corticosteroid (OCS), and short-acting β₂-agonist and exacerbation frequency were analyzed quarterly during the 12-month follow-up period after mepolizumab initiation.

RESULTS:

In total, 351 patients were included. The proportion of patients using high-dose ICS decreased in quarters 1 to 4 after mepolizumab initiation (79.8%, 74.6%, 68.9%, 65.5%, respectively); 49.0% of patients reduced or discontinued ICS for one or more quarter. Comparing patients who discontinued ICS vs those who remained on high-dose ICS, a lower proportion had chronic OCS use (3.4%-9.2% vs 13.9%-16.8%) and OCS burst use (15.4%-20.8% vs 19.7%-26.1%) in quarters 1 to 4; similarly in quarters 3 and 4, a lower proportion of patients had exacerbations (16.9% and 20.3% vs 27.2% and 27.7%) and short-acting β₂-agonist claims (35.4% and 39.2% vs 43.3% and 49.0%, respectively).

CONCLUSION:

In patients with SEA on high-dose ICS, a reduction in both ICS and OCS use was observed after initiating mepolizumab. These findings have important implications for clinical outcomes and follow-up care in this patient population.

2020-04-01·Pediatric pulmonology3区 · 医学

A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma

3区 · 医学

Article

作者: Amar, Niran J. ; Vermeulen, Jan H. ; Mok, Wilson ; Weinstein, Cindy L. J. ; Gates, Davis ; Jain, Neal ; Varnell, Tracey ; Zhang, Xiaoli

Abstract:

Objectives:

Asthma affects over 6 million children in the United States alone. This study investigated the efficacy and long‐term safety of mometasone furoate‐formoterol (MF/F) and MF monotherapy in children with asthma.

Materials and Methods:

This phase 3, multicenter, randomized controlled trial evaluated metered‐dose inhaler twice daily (BID) dosing with MF/F 100/10 µg or MF 100 µg in children, aged 5 to 11 years, with a history of asthma for greater than or equal to 6 months and confirmed bronchodilator reversibility, who were adequately controlled on inhaled corticosteroid/long‐acting beta‐agonist combination therapy for greater than or equal to 4 weeks. After a 2‐week run‐in on MF 100 µg BID, eligible patients received 24 weeks of double‐blind treatment and were followed for safety up to 26 weeks. The primary efficacy endpoint was the change from baseline in AM postdose 60‐minute AUC %predicted FEV1% across 12 weeks of treatment.

Results:

A total of 181 participants received at least one dose of MF/F (n = 91) or MF (n = 90). MF/F was superior to MF across the 12‐week evaluation period, with a treatment advantage of 5.21 percentage points (P < .001). Superior onset of action with MF/F over MF was achieved as early as 5 minutes postdose on day 1. Overall, approximately 50% of participants experienced one or more treatment‐emergent adverse events, with fewer occurring in the MF/F group.

Conclusions:

In children 5 to 11 years of age with persistent asthma, the addition of F to MF was well tolerated and provided significant, rapid, and sustained improvement in lung function compared with MF alone.

2019-04-01·The Journal of allergy and clinical immunology1区 · 医学

Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate

1区 · 医学

Article

作者: Tulin Shekar ; Robert A Nathan ; Ioana Agache ; Nicholas Ryan ; Cindy L J Weinstein ; Stephen J Lane ; Spiro Investigators ; Davis Gates

BACKGROUND:

The safety of long-acting β-agonists added to inhaled corticosteroids for the treatment of persistent asthma has been controversial.

OBJECTIVE:

We sought to determine whether administering formoterol in combination with mometasone furoate increases the risk of serious asthma outcomes (SAOs) compared with mometasone furoate alone. This clinical trial is registered as NCT01471340.

METHODS:

We conducted a 26-week, randomized, double-blind trial in adolescent and adult patients (≥12 years) with persistent asthma in 35 countries with the primary objective of evaluating whether mometasone furoate-formoterol increases the risk of SAOs (adjudicated hospitalization, intubation, or death) compared with mometasone furoate alone. The key efficacy end point was asthma exacerbation (composite of hospitalization of ≥24 hours, emergency department visits of <24 hours requiring systemic corticosteroids, or use of systemic corticosteroids for ≥3 consecutive days).

RESULTS:

Among 11,729 patients (mometasone furoate-formoterol, n = 5,868; mometasone furoate, n = 5,861), a total of 81 SAOs, all asthma-related hospitalizations, were observed in 71 patients: 45 events from 39 patients receiving mometasone furoate-formoterol and 36 events from 32 patients receiving mometasone furoate. The hazard ratio for the first SAO in the mometasone furoate-formoterol versus mometasone furoate group was 1.22 (95% CI, 0.76-1.94; P = .411). Asthma exacerbation occurred in 1,487 patients: 708 receiving mometasone furoate-formoterol and 779 receiving mometasone furoate. The hazard ratio for the first asthma exacerbation in the mometasone furoate-formoterol versus mometasone furoate group was 0.89 (95% CI, 0.80-0.98; P = .021).

CONCLUSIONS:

The addition of formoterol to mometasone furoate maintenance therapy did not increase the risk of serious asthma-related events and reduced the risk of asthma exacerbation.

项与富马酸福莫特罗/莫米松糠酸酯相关的新闻（医药）

2026-04-30

·BioSpace

Organon Reports Results for the First Quarter Ended March 31, 2026

First quarter 2026 revenue of $1.460 billion, down 4% as-reported and down 9% excluding the impact of foreign currency. First quarter 2026 diluted earnings per share of $0.55 and non-GAAP Adjusted diluted earnings per share of $0.71. First quarter 2026 net income of $146 million and Adjusted EBITDA (non-GAAP) of $415 million, representing an Adjusted EBITDA margin of 28.4%. On April 26, 2026, the company announced its pending merger into Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, “Sun Pharma”) in an all-cash transaction (the “merger”). The merger is expected to close in early 2027, subject to customary closing conditions, including receipt of required regulatory approvals and approval by Organon stockholders. In light of the pending merger, Organon will not be providing financial guidance or hosting quarterly earnings calls. JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2026. First Quarter 2026 Revenue in $ millions Q1 2026 Q1 2025 VPY VPY ex-FX Women’s Health $ 389 $ 463 (16)% (19)% General Medicines Biosimilars 173 141 23% 21% Established Brands 880 887 (1)% (7)% Other (1) 18 22 (15)% (21)% Revenue $ 1,460 $ 1,513 (4)% (9)% Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to third parties. For the first quarter of 2026, total revenue was $1.460 billion, down 4% on an as-reported basis and down 9% excluding the impact of foreign currency (ex-FX), compared with the first quarter of 2025. Women’s Health revenue declined 16% as-reported and declined 19% ex-FX in the first quarter of 2026, compared with the first quarter of 2025. Sales of Nexplanon® (etonogestrel implant) decreased 21% ex-FX in the first quarter compared with the first quarter of 2025. In the U.S., sales of Nexplanon declined 28% primarily due to both decreased physician demand following the five-year label approval which as expected, has delayed reinsertions; and continued uncertainty around federal funding. Outside of the U.S., Nexplanon sales declined 4% ex-FX, due to the timing of shipments in selective emerging markets, partially offset by increased demand and access in Brazil. Sales of oral contraceptives Marvelon TM (desogestrel and ethinyl estradiol pill) and Mercilon TM (desogestrel and ethinyl estradiol pill) declined 36% ex-FX in the first quarter of 2026 primarily due to decreased demand and market contraction in China and the timing of shipments in Asia Pacific. Global Fertility revenue was down 9% ex-FX as a result of competition-driven price reductions in the U.S. partially offset by modest market growth in China. In January of 2026 the company completed the sale of the Jada® system to Laborie. Biosimilars revenue increased 23% as-reported and 21% ex-FX in the first quarter of 2026, compared with the first quarter of 2025, primarily due to the strong performance of Hadlima® (adalimumab-bwwd) associated with stronger demand in the U.S., and increased demand in Puerto Rico. Biosimilars also benefitted from contribution from new assets, Bildyos® (denosumab-nxxp) and Bilprevda® (denosumab-nxxp) which were approved by the U.S. Food and Drug Administration (“FDA”) in the third quarter of 2025, and Tofidence® (tocilizumab-bavi), which the company acquired in the second quarter of 2025. Established Brands revenue declined 1% as-reported and declined 7% ex-FX in the first quarter of 2026. Revenue contribution from Emgality® (1) (galcanezumab-gnlm) partially offset a decline in the respiratory portfolio, which was driven by pricing pressure, as well as volume declines related to the adoption of revised medical guidelines that deprioritize the use of montelukast, including Singulair® (montelukast sodium) , in various international markets, most recently, in China. Global sales of Dulera® (mometasone furoate and formoterol fumarate dihydrate) also declined in the first quarter of 2026 primarily due to pricing pressure and decreased demand in the U.S. VTAMA ® (tapinarof) grew modestly in the first quarter of 2026 compared with the first quarter of 2025. (1) Organon acquired certain European licensing and distribution rights to Emgality from Eli Lilly and Company (“Eli Lilly”) beginning in early 2024. Emgality is a registered trademark of Eli Lilly in the European Union and other countries (used under license). First Quarter 2026 Profitability in $ millions, except per share amounts Q1 2026 Q1 2025 VPY Revenues $ 1,460 $ 1,513 (4)% Cost of sales 677 672 1% Gross profit 783 841 (7)% Non-GAAP Adjusted gross profit (1) 861 934 (8)% Net income 146 87 68% Non-GAAP Adjusted net income (1) 188 265 (29)% Diluted Earnings per Share (EPS) 0.55 0.33 67% Non-GAAP Adjusted diluted EPS (1) 0.71 1.02 (30)% Acquired in-process research & development (IPR&D) and milestones — 6 NM Adjusted EBITDA (Non-GAAP) (1) 415 484 (14)% Q1 2026 Q1 2025 Gross margin 53.6 % 55.6 % Non-GAAP Adjusted gross margin (1) 59.0 % 61.7 % Adjusted EBITDA margin (Non-GAAP) (1, 2) 28.4 % 32.0 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. Reported gross margin in the first quarter of 2026 was 53.6% compared with 55.6% in the prior year period. Non-GAAP Adjusted gross margin was 59.0% in the first quarter of 2026, compared to 61.7% in the first quarter of 2025. Unfavorable pricing and product mix as well as foreign exchange rates were notable drivers in the decline of both reported gross margin and non-GAAP Adjusted gross margin. Net income for the first quarter of 2026 was $146 million, or $0.55 per diluted share, compared with net income of $87 million, or $0.33 per diluted share, in the first quarter of 2025. For the first quarter of 2026, non-GAAP Adjusted net income was $188 million, or $0.71 per diluted share, compared with $265 million, or $1.02 per diluted share, for the first quarter of 2025. Non-GAAP Adjusted EBITDA margin was 28.4% in the first quarter of 2026 compared with 32.0% in the first quarter of 2025. The year-over-year decline was primarily driven by a decrease in Adjusted Gross Margin. Capital Allocation Today, Organon’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. The dividend is payable on June 11, 2026, to stockholders of record at the close of business on May 11, 2026. As of March 31, 2026, cash and cash equivalents were $1.12 billion, and debt was $8.57 billion. Webcast Information As is customary during the pendency of an acquisition, Organon has suspended its quarterly earnings calls and will not host a conference call in conjunction with today’s first quarter earnings release. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at and follow us on LinkedIn , Instagram , X , YouTube , TikTok and Facebook . Cautionary Note Regarding Non-GAAP Financial Measures This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are correspondingly not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles (“GAAP”). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted gross margin, Adjusted gross profit, Adjusted net income, Adjusted EPS, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company’s financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. Please refer to Table 4 and Table 5 of this press release for additional information, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. The company’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the merger, including the anticipated timing of completion thereof. Forward-looking statements may be identified by words such as “proposed,” “will,” “continue,” “expects,” “believes,” “estimates,” “opportunity,” “pursue,” “anticipate,” “be able to,” “intend,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to uncertainties as to the timing of the merger; the risk that the merger may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the merger, including receiving, on a timely basis or otherwise, the minimum vote required by Organon’s stockholders to approve the merger; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the various conditions to the consummation of the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances which would require Organon to pay a termination fee; the effect of the announcement or pendency of the merger on Organon’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generally; risks related to diverting management’s attention from Organon’s ongoing business operations; the risk that stockholder litigation in connection with the merger may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the merger that may impact Organon’s ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the merger could have adverse effects on the market price of Organon’s common stock, including if the merger is not consummated; risks that the benefits of the merger are not realized when and as expected; and legislative, regulatory and economic developments. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K, Current Report on Form 8-K, filed by the company on April 27, 2026, and other SEC filings, available at the SEC’s Internet site ( ). Additional Information and Where to Find It This press release may be deemed to be solicitation material in respect of the proposed merger. In connection with the merger, Organon intends to materials with the SEC, including Organon’s proxy statement in preliminary and definitive form on Schedule 14A (the “Merger Proxy Statement”). Organon will mail the Merger Proxy Statement and a proxy card to its stockholders in connection with the merger. INVESTORS AND STOCKHOLDERS OF ORGANON ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE MERGER PROXY STATEMENT (WHEN THEY ARE AVAILABLE), BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ORGANON, SUN PHARMA AND THE MERGER AND RELATED MATTERS. Investors and stockholders of Organon are or will be able to obtain these documents (when they are available) free of charge from the SEC’s website at , or through the investor relations section of Organon’s website, . Participants in the Solicitation Organon and its directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be “participants” in the solicitation of proxies from stockholders of Organon in favor of the proposed acquisition. Information about Organon’s directors and executive officers is set forth in the 2026 Annual Meeting Proxy Statement, filed with the SEC on April 24, 2026, and which is available at . To the extent holdings of Organon’s securities by its directors or executive officers have changed since the amounts set forth in the 2026 Annual Meeting Proxy Statement, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC, which are available at . Additional information concerning the interests of Organon’s participants in the solicitation, which may, in some cases, be different than those of Organon’s stockholders generally, will be set forth in the Merger Proxy Statement when it becomes available. TABLE 1 Organon & Co. Condensed Consolidated Statement of Income (Unaudited, $ in millions except shares in thousands and per share amounts) Three Months Ended March 31, 2026 2025 Revenues $ 1,460 $ 1,513 Cost of sales 677 672 Gross Profit 783 841 Selling, general and administrative 424 420 Research and development 93 96 Acquired in-process research and development and milestones — 6 Restructuring costs 31 86 Interest expense 111 124 Exchange losses (gains) 7 (4 ) Other (income) expense, net (96 ) 12 Income before income taxes 213 101 Income tax expense 67 14 Net income $ 146 $ 87 Earnings per share: Basic $ 0.56 $ 0.34 Diluted $ 0.55 $ 0.33 Weighted average shares outstanding: Basic 260,370 257,862 Diluted 262,896 261,001 TABLE 2 Organon & Co. Sales by top products (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 ($ in millions) U.S. Int’l Total U.S. Int’l Total Women’s Health Nexplanon/Implanon NXT $ 127 $ 74 $ 201 $ 176 $ 72 $ 248 Follistim AQ 21 39 61 35 34 69 NuvaRing 6 18 24 6 16 22 Ganirelix Acetate Injection 2 24 26 5 23 27 Marvelon/Mercilon — 26 26 — 39 39 Jada 5 — 5 15 — 15 Other Women’s Health ( 1) 17 30 46 15 27 43 General Medicines Biosimilars Renflexis 42 15 57 44 12 57 Hadlima 51 16 67 33 14 47 Ontruzant 4 1 5 4 14 18 Brenzys — 20 20 — 14 14 Other Biosimilars (1) 11 13 24 — 5 5 Established Brands Cardiovascular Atozet — 85 85 — 77 77 Zetia 1 86 87 1 84 85 Cozaar/Hyzaar 2 55 57 2 53 55 Vytorin 1 20 21 1 22 23 Rosuzet — 6 6 — 4 4 Other Cardiovascular (1) 1 27 28 — 30 30 Respiratory Singulair 2 38 40 2 72 74 Nasonex — 65 65 — 71 72 Dulera 23 12 35 34 10 43 Clarinex 1 30 31 — 34 34 Other Respiratory (1) 11 1 12 10 3 13 Non-Opioid Pain, Bone and Dermatology Arcoxia — 59 59 — 62 62 Fosamax — 29 29 1 32 33 Diprospan — 35 35 — 30 30 Vtama 23 2 25 20 4 24 Other Non-Opioid Pain, Bone and Dermatology (1) 3 65 68 4 65 68 Other Propecia 1 28 30 1 24 26 Emgality — 54 54 — 32 32 Proscar — 26 26 — 24 24 Other (1) 3 85 87 3 76 78 Other (2) — 18 18 — 22 22 Revenues $ 358 $ 1,102 $ 1,460 $ 412 $ 1,101 $ 1,513 Totals may not foot due to rounding. Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies. (1) Includes sales of products not listed separately. (2) Other includes manufacturing sales to third parties. TABLE 3 Organon & Co. Sales by geographic area (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 Europe and Canada $ 412 $ 376 United States 358 412 Asia Pacific and Japan 226 251 China 194 204 Latin America, Middle East, Russia, and Africa 247 240 Other (1) 23 30 Revenues $ 1,460 $ 1,513 (1) Other includes manufacturing sales to third parties. TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 GAAP Gross Profit $ 783 $ 841 Adjusted for: Manufacturing network costs (1) 21 29 Stock-based compensation 3 4 Amortization 47 50 Acquisition-related costs (2) 7 9 Other — 1 Adjusted Non-GAAP Gross Profit $ 861 $ 934 (1) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. (2) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5. Three Months Ended March 31, 2026 2025 GAAP Gross Margin 53.6 % 55.6 % Total impact of Non-GAAP adjustments 5.4 % 6.1 % Adjusted Non-GAAP Gross Margin 59.0 % 61.7 % Three Months Ended March 31, 2026 2025 GAAP Selling, general and administrative expenses $ 424 $ 420 Adjusted for: Stock-based compensation (13 ) (16 ) Restructuring related charges — (6 ) Other (13 ) (3 ) Adjusted Non-GAAP Selling, general and administrative expenses $ 398 $ 395 TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) (Unaudited, $ in millions except per share amounts) Three Months Ended March 31, 2026 2025 GAAP Research and development expenses $ 93 $ 96 Adjusted for: Manufacturing network costs (1) (3 ) (3 ) Stock-based compensation (3 ) (4 ) Other (1 ) (1 ) Adjusted Non-GAAP Research and development expenses $ 86 $ 88 (1) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. Three Months Ended March 31, 2026 2025 GAAP Reported Net Income $ 146 $ 87 Adjusted for: Cost of sales adjustments 78 93 Selling, general and administrative adjustments 26 25 Research and development adjustments 7 8 Jada divestiture (81 ) — Restructuring 31 86 Change in fair value of contingent consideration (5 ) 11 Other (gain) expense, net (3 ) 4 Tax impact on adjustments above (1) (11 ) (49 ) Non-GAAP Adjusted Net Income $ 188 $ 265 (1) For the three months ended March 31, 2026 and 2025, the GAAP income tax rates were 31.4% and 13.4%, respectively, and the non-GAAP income tax rates were 29.3% and 19.2%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments. Three Months Ended March 31, 2026 2025 GAAP Diluted Earnings per Share $ 0.55 $ 0.33 Total impact of Non-GAAP adjustments 0.16 0.69 Non-GAAP Adjusted Diluted Earnings per Share $ 0.71 $ 1.02 TABLE 5 Organon & Co. Reconciliation of GAAP Net (Loss) Income to Non-GAAP Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 GAAP Reported Net Income $ 146 $ 87 Depreciation (1) 38 32 Amortization 47 50 Interest expense 111 124 Income tax expense (benefit) 67 14 EBITDA (Non-GAAP) $ 409 $ 307 Restructuring and related charges 31 92 Manufacturing network related (2) 27 36 Acquisition-related costs (3) 7 9 Change in contingent consideration (5 ) 11 Jada divestiture (81 ) — Other costs 8 5 Stock-based compensation 19 24 Adjusted EBITDA (Non-GAAP) $ 415 $ 484 Adjusted EBITDA margin (Non-GAAP) 28.4 % 32.0 % (1) Excludes accelerated depreciation included in one-time costs. (2) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs. (3) Acquisition related costs for the three months ended March 31, 2026 and 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. As the costs described in (1) through (3) above are directly related to the separation of Organon and acquisition related activities and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provides meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance. Contacts Media Contacts: Felicia Bisaro (646) 703-1807 Kate Vossen (732) 675-8448 Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129

2026-03-23

·乙酰水杨酸投研

默沙东主要药品全球销售收入分析（2003年至2025年）

默沙东（MSD）介绍及公司主要历史变迁默沙东（Merck Sharp & Dohme，MSD）是全球著名的医药公司，总部位于美国新泽西州肯尼沃斯市，在美国和加拿大称为默克（Merck & Co），在其他地区称为默沙东（MSD）。默沙东由德国默克集团建立于1891年，现已成为全球制药领域的巨头。默沙东凭借处方药、疫苗、生物制品和动物保健品，为140多个国家提供创新的医疗解决方案。 1668年，弗雷德里奇·杰考伯·默克收购了位于德国达姆施塔特的天使药房。 1816年，海因里希·伊曼纽尔·默克接管了天使药房，开始着手将天使药房发展成一个全球化的公司。1891年，默克在美国纽约成立了分公司Merck& Co.。美国的默克就是默沙东的前身。 1917年，默克位于美国的子公司Merck& Co.因为第一次世界大战被没收，从此默克与Merck& Co.被迫分家。美国默克（Merck& Co.）被美国接管成为独立的公司，自此与德国默克切断了关系。 1936年， Merck& Co.首次成功合成维生素；1940年，发现并推广抗生素链霉素；1948年，凭借磺胺喹噁啉打入动物保健市场；1950年，合成首个商品化皮质醇。 1953年， Merck& Co.与沙东公司（Sharp & Dohme）合并为默沙东（总部位于美国新泽西州罗威市，公司在美国与加拿大称为默克，在其他地区称为默沙东）。默克拥有广泛的化学研究和生产设施，沙东拥有制药研发、营销能力和国际市场，沙东位于宾夕法尼亚威斯特波因特（West Point）的设施也在此合并范围内，二者强强联合。 1958年，公司的氯噻嗪上市（DIURIL），公司成为领先的心血管药物公司。19世纪70年代，旋毛虫病（由食用生肉或未煮熟的肉引起）可引起高烧、肌肉疼痛和肿胀以及其他严重症状。1961年，威廉·坎贝尔（William Campbell）博士领导的一个研究小组发现了噻苯达唑（thiabendazole），这是第一种能杀死羊、山羊、牛和猪体内旋毛虫寄生虫的药物。当北极圈的驯鹿群受到寄生虫感染的严重影响时，默沙东的科学家们前往北方，用噻苯达唑为它们治疗。 1971年，默沙东开始分发麻疹-腮腺炎-风疹（M-M-R）联合疫苗，由Maurice Hilleman和Eugene B. Buynak开发。M-M-R由三种疫苗组成：ATTENUVAX，默沙东麻疹疫苗的更新版本；风疹疫苗MERUVAX；以及腮腺炎疫苗MUMPSVAX。 1977年，默沙东的肺炎疫苗PNEUMOVAX（肺炎球菌疫苗多价）获批。1978年，美国FDA批准了MEFOXIN（头孢西丁），适用于治疗由某些细菌引起的许多感染，包括革兰氏阳性和革兰氏阴性病原体。1985年，血管紧张素转换酶（ACE）抑制剂VASOTEC（依那普利）被FDA批准用于治疗高血压和充血性心力衰竭。VASOTEC在1988年成为默沙东第一个十亿美元的产品。1986年，默沙东的重组乙肝疫苗RECOMBIVAX HB（重组乙肝疫苗）已获得FDA批准，是首个用于人类的重组乙肝疫苗。1989年，默沙东将RECOMBIVAX HB疫苗技术转移到中国。1987年，默沙东推出了第一个商业化的他汀类药物洛伐他汀，这是FDA批准的首个他汀类药物。 1982年，默沙东与Astra AB签署协议，开发和商业化Astra的产品。1994年11月，默沙东与Astra共同成立联营企业Astra Merck Inc.(AMI)，各自持股50%股份，继续进行合作。1998年，默沙东收购了Astra在AMI的股份，将AMI更名为KBI Inc.，以KBI的资产有限合伙企业Astra Pharmaceuticals L.P.出资，换取1%的有限合伙权益。Astra以其在美国子公司的资产换取Astra Pharmaceuticals L.P.的99%的普通合伙权益。此有限合伙企业在1999年Astra与Zeneca Group Plc.合并后，更名为AstraZeneca LP（AZLP）。2014年6月30日，阿斯利康收购默沙东在其联营企业里的权益。 1993年，默沙东收购了Medco Containment Services, Inc.（收购后被称为Medco Health）。主要从事药品流通领域，处方药销售。2003年8月19日，默沙东完成了Medco Health的分立。分立后，默沙东恢复为专注于药品研发、生产、销售的公司。 1996年，CRIXIVAN （INDINAVIR SULFATE）获FDA批准用于治疗HIV。1998年，孟鲁司特钠（SINGULAIR）已被FDA批准用于预防和治疗哮喘。2006年，FDA批准了西格列汀（JANUVIA），一种用于治疗2型糖尿病的DPP-4抑制剂。同年，美国FDA批准了GARDASIL[人乳头瘤病毒四价（6、11、16、18型）重组疫苗]，用于预防某些HPV类型引起的宫颈癌。 2003年，默沙东将其在Banyu的股权从51%增至99.4%。 2006年5月，默沙东收购了Abmaxis，专注于单克隆抗体产品的开发。6月，默沙东收购了GlycoFi，专注于糖蛋白工程。12月，默沙东收购了Sirna，专注于RNAi技术。 2007年9月11日，默沙东收购了NovaCardia，专注于心血管代谢类疾病药物开发的公司。 2009年11月3日，默沙东公司与先灵葆雅公司（Schering-Plough）合并。 2009年由于合并带来了15%的收入增长，并入了先灵葆雅的Remicade (infliximab)用于感染类疾病，Temodor (temozolomide)用于脑肿瘤，Nasonex (mometasone furoate monohydrate)系列鼻喷雾剂用于过敏症状，PegIntron (peginteferon alpha-2b)用于慢性丙肝，Clarinex (desloratadine)抗组胺药，Zetia (ezetimibe)和Vytorin (ezetimibe/simvastatin)用于高胆固醇血症，同时也并入了先灵葆雅的动物健康以及消费健康产品。2010年由于合并，使得默沙东的销售收入较2008年收入几乎翻倍。 2014年8月，默沙东完成收购Idenix，专注于人类病毒疾病药物的开发和商业化。12月，默沙东收购了OncoEthix，专注于肿瘤药物的开发。 2014年10月1日，默沙东完成将其消费健康业务出售给拜耳公司，出售价格142亿美元，拜耳收购的业务主要包括OTC业务，包括国际品牌Claritin和Afrin，默沙东实现税前收益112亿美元。2014年5月，默沙东将眼科产品出售给 Santen Pharmaceutical Co., Ltd。2015年12月，默沙东将剩余的眼科业务出售给Mundipharma Ophthalmology Products Limited。 2015年1月，默沙东收购了Cubist，其主要专注于广谱抗生素业务，总收购价值83亿美元。 2016年1月，默沙东收购了Iomet Pharma Ltd，主要专注于癌症治疗创新药物开发。7月，收购了Afferent Pharmaceuticals，专注于靶向P2X3受体类的药物开发。2016年，与Moderna Therapeutics签署协议共同开发和商业化新型信使RNA癌症疫苗药物。 2021年6月2日，默沙东完成了其妇女健康、生物仿制药以及一些成熟品牌业务的剥离，这些业务作为Organon & Co.公司自默沙东分立出来，独立上市。分立出来的成熟品牌包括皮肤科、非阿片类疼痛管理、呼吸以及心血管代谢类品种等。 2021年11月，默沙东收购了Acceleron Pharma Inc.，收购价格115亿美元，包括sotatercept，一种基于新机制的肺动脉高压3期管线，以及Reblozyl（luspatercept），红细胞成熟剂，用于β地中海贫血，为与BMS的合作产品，有权获得20%~24%的销售分成。 2023年6月，默沙东收购了Prometheus，专注于免疫调节疾病疗法开发以及诊断产品开发。2023年2月，默沙东和科伦药业签署合作协议，获得科伦药业7个ADC产品的权利，科伦药业保留其7个ADC临床前产品在中国及港澳地区的权利。2023年10月，默沙东终止了其中2个产品的权利。2023年1月，默沙东收购了Imago，主要专注于骨髓增生肿瘤等疾病的疗法开发。 2024年3月，默沙东收购了Harpoon，专注于开发临床阶段免疫肿瘤学T细胞接合剂疗法；7月，收购了EyeBio，专注于眼科的公司；9月，自Curon Biopharmaceutical处收购了MK-1045，在研临床阶段用于治疗B细胞相关疾病的双抗；12月，自Hansoh（豪森药业）获得MK-4082，临床前口服小分子GLP-1受体激动剂的权利；12月，与LaNova签署合作授权协议，获得MK-2010，PD-1/VEGF双抗的权利。默沙东总体营业收入情况默沙东2003年至2025年期间的主要业务包括创新药业务、动物健康、消费健康等。但除了创新药以外的业务规模较小，创新药业务的销售收入占据了全部销售收入的85%以上。2010年及以前未对动物健康、消费健康等业务进行单独披露。2014年10月1日，消费健康业务出售给拜耳公司。其他业务包括AZLP的合作收入以及其他收入等。自2003年至2025年，默沙东的营业收入情况如下图所示。由于在2009年底与先灵葆雅公司（Schering-Plough）实现合并，2010年销售收入相比2008年未并入时几近翻倍。2022年由于新冠的爆发以及新冠药物的推出总营业收入增长了22%。2025年总营业收入达650.11亿美元。默沙东创新药部门分类销售收入情况根据默沙东每年披露制药部门各药品营业收入情况，按照药品性质分类的销售收入数据如下图，默沙东年报上没有披露的品种的销售收入统一归入其他类。根据2003年至2025年的数据，默沙东有披露数据的品种的销售收入之和占制药部门总销售收入的80%~96%。 2021年起披露销售收入的品种占部门销售收入保持在95%以上。从图中可见，2003年起，心血管代谢类药物占所有产品的主导，随后逐年下降。疫苗类销售收入自2005年开始逐年增长。肿瘤类产品销售收入自2016年起逐年显著增长。至2025年，肿瘤和疫苗类产品仍然占据默沙东销售收入的主导地位，占全部制药销售收入的77.41%。糖尿病品种自2007年开始销售收入逐年增长至2017年之后又逐年下降。抗病毒类品种2022年由于新冠药物的推出销售收入有激增。呼吸系统药物自2003年开始逐年增长，至2012年起又逐年下降。默沙东披露的各制药品种销售收入情况根据每年默沙东年报披露的主要药品销售收入情况整理的各年单品种销售收入变迁情况见下图。可见，默沙东在2010年前，Singular（顺尔宁，孟鲁司特）、Cozaar（科素亚，氯沙坦/氢氯噻嗪）、Fosamax（福善美，阿仑膦酸钠）以及Zocor（舒降之，辛伐他汀）占主导地位，2010年后，Januvia（捷诺维，西格列汀）、Janumet（捷诺达，西格列汀/二甲双胍）、Remicade（类克，英夫利昔单抗）以及Zetia（益适纯，依折麦布）占比增加，Gardasil（人乳头瘤病毒疫苗）和ProQuad（麻疹腮腺炎风疹水痘疫苗）销售收入平稳增长。在近十年，Keytruda（可瑞达，帕博利珠单抗）， Gardasil（人乳头瘤病毒疫苗）增长显著。Keytruda的销售收入在2025年达316.41亿美元，占制药收入的54.42%。2025年又推出了Keytruda的皮下制剂（Keytruda Qlex），未来仍有一定的增长空间。默沙东2025年主要动态及产品专利情况财务业绩方面：2025年默沙东实现总营业收入650.11亿美元，相比去年增长1.31%。总营业收入主要包括制药部门（包括疫苗）、动物健康部门及其他业务收入，具体组成如下图。制药部门实现营业收入581.42亿美元，占全部营业收入的89.43%。动物健康部门实现营业收入63.54亿美元，占全部营业收入的9.77%。默沙东2025年主要动态及产品专利情况默沙东2025年合作授权及收并购情况如下表，合作授权交易包括：与恒瑞医药关于HRS-5346用于降低动脉粥样硬化风险、Blackstone资助默沙东开发Sacituzumab tirumotecan用于非小细胞肺癌、以及自Dr. Falk Pharma GmbH处获得MK-8690用于炎症性肠病的相关交易。收并购交易包括：对Verona Pharma plc的收购，获得Ohtuvayre用于阻塞性肺病、收购Cidara Therapeutics, Inc.，获得预防甲流和乙流候选药物。默沙东2025年制药部门药品销售收入情况根据2025年披露的各药品销售收入数据，将各药品分类，未披露销售收入数据的药品全部归入其他类。各分类的销售收入如下图所示。默沙东制药部门2025年实现销售收入581.42亿美元，包括肿瘤、疫苗、糖尿病、心血管代谢、抗病毒、神经、抗菌药、血液、呼吸系统以及其他品类。肿瘤类为第一大品类，占制药部门总销售收入的60%。疫苗为第二大品类，占部门总销售收入的17%. 默沙东2025年各品种销售收入如下表，Keytruda为第一大品种，销售收入316.41亿美元，占部门总销售收入的54.42%。Gardasil为第二大品种，占部门总销售收入的9%。披露的肿瘤/疫苗/糖尿病药品销售收入情况根据每年默沙东披露的各品种销售收入情况整理的肿瘤/疫苗/糖尿病药物各单品销售收入变迁情况见下图。根据每年默沙东披露的各品种销售收入情况整理，默沙东2003年至2025年的财报上披露有销售数据的肿瘤药物有7个品种，2025年销售收入为349亿美元，疫苗有10个品种，2025年销售收入为101.07亿美元，糖尿病类药物有2个品种，2025年销售收入为25.44亿美元。肿瘤品种包括：Keytruda（可瑞达，帕博利珠单抗）、Keytruda Qlex（帕博利珠单抗皮下制剂）、Lynparza（利普卓，奥拉帕利）、Lenvima（乐卫玛，仑伐替尼）、Welireg（维利瑞，贝组替凡）、Temodar（替莫唑胺）以及Caelyx（楷莱，盐酸多柔比星脂质体注射剂）。可瑞达2014年获批，为PD-1抗体，上市后销售收入迅速增长，2025年全球销售收入增至316.41亿美元，超过了2025年默沙东制药部门销售收入的一半。利普卓和乐卫玛均为对外合作授权药物，报表上披露的销售数据为默沙东分得的净收益分成。利普卓为人多聚ADP核糖聚合酶抑制剂，2025年分成收益为14.50亿美元，乐卫玛为多种酪氨酸激酶抑制剂，2025年分成收益约10.53亿美元。维利瑞是2021年刚刚获批的缺氧诱导因子-2α抑制剂，还有很大增长空间。替莫唑胺是1999年获批的老药，为烷基化剂，为和先灵葆雅公司合并时并入的品种。楷莱为1996年获批的老药，多柔比星脂质体注射剂为细胞毒性药物，属于蒽环类抗癌药物，用于多种癌。综上，默沙东的肿瘤品种以可瑞达一枝独秀，销售收入超过300亿美元，且仍有增长的趋势。利普卓和乐卫玛为合作授权品种，但销售收入也超过了10亿美元，且合作销售收入也还在增长之中。疫苗品种包括：Gardasil（佳修达，人乳头瘤病毒疫苗）、ProQuad（麻疹腮腺炎风疹水痘疫苗）、 Vaxneuvance（肺炎链球菌疫苗） Capvaxive（21价肺炎链球菌疫苗）、RotaTeq（乐儿德，轮状病毒疫苗）、Pneumovax 23（肺炎链球菌疫苗）、Vaqta（甲肝疫苗）、Zostavax（带状疱疹疫苗）以及未进行详细披露的肝炎疫苗和其他类疫苗。佳修达2006年获批，上市后销售收入稳步增长，2023年峰值销售收入达89亿美元，2024年销售收入有所下降，2025年有明显下降。ProQuad于2005年获批，上市后销售收入较稳定，2015年后销售收入略有缓慢增长，2024年销售收入达24.85亿美元，2025年销售收入略有下滑。Vaxneuvance为较新研发的肺炎链球菌疫苗品种，为结合疫苗，抗原是将细菌荚膜多糖与蛋白载体结合，免疫时间长，2021年获批，2025年实现销售收入8.25亿美元。Capvaxive为21价肺炎链球菌疫苗，2025年获批，2025年实现销售收入7.59亿美元。乐儿德于2006年获批，销售收入稳定在6~8亿美元。Vaxneuvance，Capvaxive和Pneumovax23均为肺炎链球菌疫苗，Pneumovax23为多糖疫苗，免疫时间短，早在1977年就在美国获批，2020年峰值销售额约10.87亿美元。Vaqta为甲肝疫苗，1996年获批，近年来销售额为1~2亿美元。Zostavax为带状疱疹疫苗，2006年获批，2014年销售额达峰，约7.65亿美元。综上，默沙东的疫苗品种中，佳达修为主要的品种，但佳达修2025年的销售收入出现了大幅下降。ProQuad，Vaxneuvance及Capvaxive虽然销售收入仍处于上升区间，但增加的销售收入可能难以抵挡佳达修的销售收入下降。整体疫苗品类的销售收入处于下降趋势。糖尿病品种包括：Januvia（捷诺维，西格列汀）以及Janumet（捷诺达，西格列汀/二甲双胍），捷诺维2006年获批，为DDP-4抑制剂，2012年达峰值销售额约40.86亿美元。捷诺达为西格列汀和二甲双胍的复合制剂，2007年获批，2018年达峰值销售额22.28亿美元。捷诺达于2025年的销售收入均较上一年下降，但捷诺维2025年的销售收入较上一年有较大增长，糖尿病类品种整体销售收入在2025年销售收入有所增长。默沙东的糖尿病品类虽然2010年至2020年期间销售收入很多，但目前已处于销售收入的下降趋势，虽然2025年销售收入略有增长。肿瘤和疫苗品类的销售收入占制药部门的销售收入比重比较大，肿瘤品类销售收入近年来仍然保持增长，但疫苗品类销售收入已出于下降趋势。披露的抗病毒/神经/免疫药品销售收入情况根据每年默沙东披露的各品种销售收入情况整理的抗病毒/神经/免疫药物各单品销售收入变迁情况见下图。根据每年默沙东披露的各品种销售收入情况整理，默沙东抗病毒/神经及免疫药物有销售收入数据的品种有21个。其中，抗病毒品种有11个，2025年实现销售收入21.60亿美元。神经类药物有5个品种，2025年实现销售收入20.27亿美元。免疫类药物有5个品种。抗病毒品种包括Prevymis（普瑞明，来特莫韦）、 Lagevrio（利卓瑞，莫诺拉韦）、Isentress（艾生特，拉替拉韦）、Delstrigo（多拉米替，多拉韦林/拉米夫定/替诺福韦）、Pifeltro（沛卓，多拉韦林）、Zepatier（择必达，艾尔巴韦/格拉瑞韦）、PegIntron（佩乐能，聚乙二醇干扰素α-2b）、Victrelis（博赛泼维）、IntronA（甘乐能，重组人干扰素α-2b）、Crixivan（佳息患/施多宁，茚地那韦/依非韦伦）以及Rebetol（利巴韦林）。普瑞明为抗巨细胞病毒感染药物，2017年获批，2025年销售收入增至9.78亿美元。利卓瑞为2021年新获批的新冠药物，2022年达峰值销售额56.84亿美元。艾生特、多拉米替、沛卓、佳息患/施多宁为抗HIV-1病毒感染药物，最老的佳息患/施多宁1996年获批，较老的艾生特，为2007年获批，多拉米替和沛卓为2018年获批品种，2025年多拉米替销售收入为3.06亿美元，沛卓销售收入为1.71亿美元。佳息患/施多宁在研究期间披露的销售收入逐年下降，2005年销售收入近3.5亿美元。艾生特自上市后销售收入缓慢增长，2014年达峰值销售额约16.73亿美元。抗丙肝小分子药物包括择必达、博赛泼维、利巴韦林，干扰素药物包括佩乐能和甘乐能。利巴韦林是1998年获批的老药。博赛泼维2011年获批，2012年达最高销售额5.02亿美元。择必达2016年获批，2017年达最高销售额约16.60亿美元。干扰素类药物甘乐能为先上市的重组干扰素产品，最早1986年获批，佩乐能为聚乙二醇干扰素，延长了干扰素作用时间，2000年获批，佩乐能为合并先灵葆雅带来的品种，合并后首年2010年实现销售收入7.37亿美元。综上可见，抗病毒类品种中，新冠药物利卓瑞只是在新冠期间2022年销售收入大涨，之后迅速退潮。新品种普瑞明销售收入处于上涨阶段，多拉米替和沛卓销售收入尚未成气候，因此，整体来看，抗病毒类品种由于新冠药物利卓瑞的销售收入退坡，使得整个品类的销售收入2025年有所降低。神经类品种包括Bridion（布瑞亭，舒更葡糖）、Belsomra（suvorexant）、Remeron（瑞美隆，米氮平）、Maxalt（苯甲酸利扎曲普坦）以及Subutex（赛宝松，丁丙诺啡/纳洛酮）。布瑞亭为肌松逆转药，2008年获批，上市后销售收入逐年增加，2023年销售收入达峰为18.42亿美元，2024年销售收入有所下降，为17.64亿美元，2025年销售收入增至18.41亿美元。Belsomra为2014年获批的食欲素受体拮抗剂，用于失眠症，2020年达峰值销售额约3.27亿美元。瑞美隆为1996年获批的抗抑郁老药。苯甲酸利扎曲普坦为偏头痛老药，1998年获批，2011年销售收入最高，约6.39亿美元。赛宝松为2002年获批老药，用于阿片类成瘾。综上，神经类品种新药布瑞亭暂时较为稳定略有增长，贡献了神经品类的主要销售收入。因此，总体来看，默沙东神经品类2025年销售收入相比2024年略有增长。免疫类品种包括Simponi（欣普尼，戈利木单抗）、Remicade（类克，英夫利西单抗）、Clarinex（恩理思，地氯雷他定）、Claritin（氯雷他定）以及Asmanex（糠酸莫米松）。欣普尼和类克分别为2009年和1998年获批的肿瘤坏死因子α单抗，用于II类免疫疾病，2018年欣普尼峰值销售额约8.93亿美元。欣普尼为和强生合作的品种，默沙东获得北美以外的分销权。类克来自于合并先灵葆雅的品种，先灵葆雅拥有类克美国之外市场的收入，合并后2010年销售收入为27.14亿美元，之后逐年下降。氯雷他定和地氯雷他定均为组胺受体拮抗剂老药，地氯雷他定2001年获批，氯雷他定1993年获批。糠酸莫米松为糖皮质激素抗炎老药。总体来看，默沙东免疫品种处于收入下行阶段。披露的心血管代谢/抗菌/血液类药品销售收入情况根据每年默沙东披露的各品种销售收入情况整理的心血管代谢/抗菌/血液类药物各单品销售收入变迁情况见下图。根据每年默沙东披露的各品种销售收入情况整理，心血管代谢/抗菌/血液类药物有销售收入数据的品种有19个。包括心血管代谢类药物9个品种，2025年实现销售收入约22.25亿美元。抗菌类8个品种，2025年实现销售收入约5.59亿美元。血液类2个品种，2025年实现销售收入约5.25亿美元。心血管代谢类品种包括： Winrevair（sotatercept）、合作项目Adempas/Verquvo（安吉奥/维可同，利奥西呱/维立西呱）、Adempas（安吉奥，利奥西呱）、Zetia（益适纯，依折麦布）、Atozet（阿托伐他汀/依折麦布）、Cozaar（科素亚，氯沙坦/氢氯噻嗪）、Vytorin（葆至能，依折麦布/辛伐他汀）、Zocor（舒降之，辛伐他汀）以及Vasotec（悦宁定、依那普利）。其中Sotatercept为2024年新获批的阻断激活素品种，为自Acceleron Pharma Inc.收购的品种，用于肺动脉高压，2024年上市首年销售收入约4.19亿美元，2025年实现销售收入14.43亿美元。Adempas/Verquvo合作项目收入为与拜耳合作的，在拜耳地域内的销售分成，2025年销售收入约4.70亿美元。安吉奥为次级可溶性鸟苷酸环化酶，用于肺动脉高压，2013年获批，2025年销售收入约3.12亿美元。益适纯为2002年获批的老药依折麦布，2013年达峰值销售额，约26.58亿美元。Atozet为阿托伐他汀和依折麦布的复方制剂，用于高胆固醇血症，2014年获批。科素亚为氯沙坦类制剂，1995年获批，2009年达峰值销售额35.61亿美元。葆至能为依折麦布和辛伐他汀复方制剂，用于高胆固醇血症，2010年达峰值销售额20.14亿美元。舒降之为1991年获批老药，辛伐他汀，用于高胆固醇血症，在研究期间数据有限，2004年销售额最高，约51.97亿美元，随后销售收入逐年下降。悦宁定为1985年获批老药，依那普利，用于高血压，研究期间内销售收入已逐年下降，2003年销售收入约7.64亿美元。总体来看，心血管代谢类品种其实是默沙东的传统品种，很多经典老药均出自默沙东，包括辛伐他汀等。21世纪初心血管代谢类是默沙东的主要品类。但随着市场竞争的加剧，销售收入逐渐下滑。2024年新推出的Sotatercept销售收入在2025年有了大幅增长，安吉奥的销售收入也处于稳步增长阶段。但整体来看，心血管代谢品类的销售收入难以重复21世纪初的辉煌。抗菌药类品种包括：Zerbaxa（ceftolozane/他唑巴坦）、Dificid（非达霉素）、Noxafil（诺科飞，泊沙康唑）、Primaxin（泰能，西司他丁/亚胺培南）、Invanz（怡万之，厄他培南）、Cancidas（科赛斯，卡泊芬净）、Cubicin（克必信，达托霉素）以及Avelox（拜复乐，莫西沙星）。Zerbaxa为2014年获批的较新的品种，属于头孢类药物和他唑巴坦的复方制剂，2025年实现销售收入3.12亿美元。非达霉素2011年获批，为大环内酯抗生素，2025年销售收入为2.47亿美元。诺科飞为三唑类抗真菌药，2006年获批，2018年达峰值销售额约7.42亿美元。泰能为西司他丁和亚胺培南复方制剂，1985年获批，2007年峰值销售额约7.64亿美元。怡万之为厄他培南单药，2001年获批，2017年达峰值销售额6.02亿美元。科赛斯为老药卡泊芬净，2001年获批，2014年达峰值销售额约6.81亿美元。克必信为老药达托霉素，环脂肽类抗生素，2003年获批，2015年达峰值销售额11.27亿美元。拜复乐为老药莫西沙星，1999年获批。默沙东的抗菌药物也是传统品类，也有很多耳熟能详的老药。整体来看抗菌药物品类也处于下行阶段。血液类品种包括：合作品种Reblozyl（利布洛泽，罗特西普）以及Integrilin（依替巴肽）。利布洛泽为2019年获批新药，为红细胞成熟剂，用于β地中海贫血，默沙东记录的收入为销售分成收入，2025年实现收入5.25亿美元。依替巴肽为血小板抑制剂，防止凝血，为1998年获批的老药。血液类品种销售收入主要看利布洛泽的销售收入，近年来其销售分成收入处于上升趋势。但血液品类整体销售收入规模很小，在默沙东制药部门的占比较低，难以带动默沙东制药部门的销售收入增长。披露的其他类药品销售收入情况根据每年默沙东披露的各品种销售收入情况整理的其他类药物各单品销售收入变迁情况见下图。根据每年默沙东披露的各品种销售收入情况整理，其他类药物有销售收入数据的品种有16个。包括激素调节类药物6个品种，呼吸系统类药物5个品种，解热镇痛药2个品种，消化系统、骨科和眼科各1个品种。这些品种的药物自2021年的销售数据默沙东年报里均未予以披露，可能归入了其他药品收入里。2021年，默沙东完成了其妇女健康、生物仿制药以及一些成熟品牌业务的剥离，这些业务作为Organon & Co.公司自默沙东分立出来，独立上市。分立出来的成熟品牌包括皮肤科、非阿片类疼痛管理、呼吸以及心血管代谢类品种等。因此，这些其他类的品种很多都随着Organon & Co.分立出去。但Ohtuvayre为2025年新收购的品种。激素调节类品种包括：Implanon/Nexplanon（依伴侬，依托孕烯）、NuvaRing（依托孕烯/炔雌醇）、Follistim AQ/Puregon（普丽康，重组促卵泡素β）、Propecia（保法止，非那雄胺）、Cerazetta（去氧孕烯）以及Proscar（保列治，非那雄胺）。其中，用于避孕药的有依伴侬、NuvaRing和Cerazetta，NuvaRing为2001年获批的避孕药，包括依托孕烯和炔雌醇两种激素，2018年峰值销售额9.02亿美元。依伴侬2006年获批，为仅包含孕激素的避孕药，安全性更好，Cerazetta也为仅含孕激素的避孕药。普丽康为促进排卵的药物，用于取卵，2004年获批。保法止和保列治为用于不同用途的非那雄胺。保法止用于男性秃发，保列治用于前列腺增生。保列治于1992年获批，2005年达峰值销售额约7.41亿美元，保法止于1997年获批，2010年达峰值销售额约4.47亿美元。呼吸系统药物包括：Ohtuvayre（恩塞芬汀）、Singulair（顺尔宁，孟鲁司特）、Nasonex（内舒拿，糠酸莫米松喷鼻剂）、Dulera（糠酸莫米松/富马酸福莫特罗）以及Proventil（沙丁胺醇）。恩塞芬汀于2024年获批，为默沙东2025年自Verona Pharma plc收购的品种，2025年实现销售收入1.78亿美元。顺尔宁为1998年获批老药，抑制LTC4，LTD4，LTE4于CysLT1受体结合，用于哮喘过敏性鼻炎，2011年达峰值销售额54.79亿美元。内舒拿为1997年获批老药，糠酸莫米松，糖皮质激素，用于鼻炎，2013年达峰值销售额13.35亿美元。糠酸莫米松和富马酸福莫特罗的复方制剂2010年获批，2015年达最高销售额5.36亿美元。沙丁胺醇为1981年获批的老药。解热镇痛药包括：Arcoxia（安康信，依托考昔）以及Vioxx（万络，罗非昔布）。两者均为COX-2抑制剂，万络1999年获批，安康信2002年最早获批，2014年达峰值销售额5.19亿美元。万络在研究期间内只披露了2003年和2004年的销售收入，2003年销售收入约为25.49亿美元。消化系统药包括：Emend（意美，阿瑞匹坦），为人P物质神经肽1受体拮抗剂，止吐药，2003年获批老药，2017年峰值销售额约5.56亿美元。骨科药物包括：Fosamax（福善美，阿仑膦酸钠），为骨代谢调节剂，用于绝经后妇女骨质疏松症，1995年获批，在研究期间内，2005年达峰值销售额31.91亿美元。眼科药物包括：Cosopt/Trusopt（盐酸多佐胺/噻吗洛尔），为碳酸酐酶抑制剂/β受体阻滞剂，用于降低开角型青光眼的眼压，1994年获批，研究期间2007年达峰值销售额约7.87亿美元。以上这些品类大部分归入Organon & Co.于2021年自默沙东分立出去。默沙东2025年制药部门各单品销售收入增长情况默沙东2025年制药部门销售收入总体相比2024年增长了7.42亿美元。增长主要来自于Keytruda、Winrevair、Capvaxive等品种销售收入的增长。Winrevair及Capvaxive均为近年新获批品种。2025年，Winrevair实现销售收入增长10.24亿美元，Capvaxive实现销售收入增长6.62亿美元。2025年Keytruda单品销售收入超过300亿美元，贡献了默沙东制药部门超过了一半的销售收入。Keytruda2025年贡献了21.59亿美元的销售收入增长。Keytruda的专利也起到了很好的保护作用，预计销售收入还有一定的增长空间，但是2028年专利就要到期，近年来也会面临仿制药的威胁。 Gardasil/Gardasil 9的销售收入在2025年有大幅下降（33.50亿美元）。由于新冠的退潮，Lagevrio的销售收入也有大幅下降。总体来看，Keytruda和Winrevair及Capvaxive的收入增长对冲了Gardasil的收入下降冲击，使得2025年默沙东制药部门整体销售收入略有上涨，但Keytruda很快也要面临专利悬崖的威胁。总结根据每年默沙东制药部门披露的各品种销售情况整理，默沙东有披露销售收入数据的药品品种有75个。在2003年时，默沙东心血管代谢类药、呼吸系统药及骨科（妇女骨质增生）药为其重要的部分。包括当时的明星品种顺尔宁（Singulair）、科素亚（Cozaar/Hyzaar）、福善美（Fosamax）、舒降之（Zocor）等，都是目前看来的经典老药（孟鲁司特、氯沙坦/氢氯噻嗪、阿仑膦酸钠、辛伐他汀）。随着时间的推移，默沙东肿瘤、疫苗以及糖尿病品种不断研发，销售收入逐步增长，西格列汀（捷诺达Janumet，捷诺维Januvia）的上市销售为默沙东的销售收入带来了很长时间的增长，捷诺维峰值销售额超过40亿美元。同时，默沙东开拓了疫苗领域，Gardasil（人乳头瘤病毒疫苗）4价和9价疫苗在近年来增长较快，近年来成为默沙东除了可瑞达（Keytruda）以外的最重要的品种，近年来专利即将到期，竞争压力使其销售收入迅速下行。2009年与先灵葆雅公司合并使得默沙东的销售收入加倍，同时带来了类克（Remicade）等肿瘤大品种。2014年可瑞达（Keytruda）诞生，为默沙东的销售收入带来了近十年的迅速增长，2017年，可瑞达销售收入超过了捷诺维，成为默沙东的最大品种，2025年销售收入超过300亿美元，已超过默沙东制药部门总销售收入的一半。从历史情况来看，默沙东有持续的新品推出能力。但近年来大品种可瑞达占据其销售收入的较大。疫苗类产品也处于垄断地位，受政策影响很大。近年来，可瑞达和Gardasil疫苗专利即将到期，短期内可瑞达可能还可以继续增长，但Gardasil的销售收入已经进入迅速下滑阶段。Gardasil销售收入迅速下滑对于默沙东2025年的收入有很大的冲击。但2025年默沙东推出了Winrevair及Capvaxive等新品种，起到了一定的抵御作用。同时Keytruda还可以支持一段时间。目前看来，默沙东对于可瑞达依赖很重，未来如何应对可瑞达专利悬崖，是否能推出继承此单品的重磅产品，还需要继续关注。默沙东主要药品全球销售收入数据整理（2003年至2025年）可在B站（阿司匹林投研）及T宝（阿司匹林投研）店获得，加入知识星球（阿司匹林）还可获得本文可编辑图表excel文件

2025-11-10

·Business Wire

Organon Reports Results for the Third Quarter Ended September 30, 2025

Third quarter 2025 revenue of $1.602 billion, up 1% as-reported and down 1% excluding the impact of foreign currency Third quarter 2025 diluted earnings per share of $0.61 and non-GAAP Adjusted diluted earnings per share of $1.01 Third quarter 2025 net income of $160 million and Adjusted EBITDA (non-GAAP) of $518 million, representing an Adjusted EBITDA margin of 32.3% Revenue guidance range for full year 2025 lowered to $6.200 billion to $6.250 billion; Adjusted EBITDA margin guidance lowered to ~31.0% JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the third quarter ended September 30, 2025. “I am humbled to be working alongside our talented team during this pivotal time for Organon,” said Joe Morrissey, Organon’s Interim Chief Executive Officer. “We are harnessing the company's many strengths, including a diverse portfolio that we expect will generate more than $900 million in free cash flow before one-time costs this year. We also remain committed to exercising cost discipline and reducing our debt burden proactively, where possible. These actions will create additional balance sheet capacity, positioning us to pursue future growth opportunities in women’s health and further our mission to deliver impactful medicines and solutions for a healthier every day.” Third Quarter 2025 Revenue in $ millions Q3 2025 Q3 2024 VPY VPY ex-FX Women’s Health $ 429 $ 440 (3)% (4)% General Medicines Biosimilars 196 165 19% 19% Established Brands 956 951 1% (3)% Other (1) 21 26 (15)% (18)% Revenue $ 1,602 $ 1,582 1% (1)% Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to third parties. For the third quarter of 2025, total revenue was $1.602 billion, up 1% on an as-reported basis and down 1% excluding the impact of foreign currency (ex-FX), compared with the third quarter of 2024. Women’s Health revenue declined 3% as-reported and declined 4% ex-FX in the third quarter of 2025, compared with the third quarter of 2024. Sales of Nexplanon® (etonogestrel implant) decreased 9% ex-FX in the quarter compared with the prior year period primarily due to lower demand in the United States primarily driven by decreased funding of government programs, partially offset by increased demand in Brazil and the timing of tenders, primarily in Mexico. Third quarter Nexplanon performance was partially offset with 5% ex-FX growth in NuvaRing® (etonogestrel / ethinyl estradiol vaginal ring), 4% ex-FX growth in MarvelonTM (desogestrel and ethinyl estradiol pill) and MercilonTM (desogestrel and ethinyl estradiol pill), as well as a 29% ex-FX increase in Jada® system. *Estimated net impact from pull-forward Nexplanon revenue associated with the company's sales practices for wholesalers in the U.S. as referenced in the company’s Current Report on Form 8-K, filed with the SEC on October 27, 2025, was approximately $2 million during the third quarter ended September 30, 2025. The company has ceased these sales practices for wholesalers. Biosimilars revenue increased 19% on both an as-reported basis and ex-FX in the third quarter of 2025, compared with the third quarter of 2024, primarily due to strong performance of Hadlima® (adalimumab-bwwd) and the favorable timing of an international tender for Ontruzant® (trastuzumab-dttb). To a lesser extent, during the third quarter the Biosimilars portfolio also benefitted from contribution from new assets; Bildyos® (denosumab-nxxp) and Bilprevda® (denosumab-nxxp), which was approved by the FDA in September 2025, and Tofidence® (tocilizumab-bavi), which the company acquired in the second quarter of 2025. Established Brands revenue increased 1% as-reported and declined 3% ex-FX in the third quarter of 2025. Revenue contribution of Emgality®(1) (galcanezumab-gnlm) and Vtama®(2) (tapinarof) partially offset the impact of the loss of exclusivity (“LOE”) of Atozet™ (ezetimibe and atorvastatin) in key markets in Europe as well as declines in the respiratory portfolio. Performance in the respiratory portfolio was primarily driven by an approximate 40% ex-FX decline in Singulair® (montelukast sodium), due to lower demand outside of the United States and the negative impact from price reductions in Japan and China as well as performance of Dulera® (formoterol and fumarate dihydrate), which declined 30% ex-FX 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, as well as supply constraints. (1) Organon acquired certain European licensing and distribution rights to Emgality and Rayvow from Eli Lilly and Company (“Eli Lilly”) beginning in early 2024. Emgality and Rayvow are registered trademarks of Eli Lilly in the European Union and other countries (used under license). (2) Vtama was acquired as part of Organon's acquisition of Dermavant Sciences Ltd. (“Dermavant”), which closed on October 28, 2024. Third Quarter 2025 Profitability in $ millions, except per share amounts Q3 2025 Q3 2024 VPY Revenues $ 1,602 $ 1,582 1% Cost of sales 745 659 13% Gross profit 857 923 (7)% Non-GAAP Adjusted gross profit (1) 966 976 (1)% Net income 160 359 (55)% Non-GAAP Adjusted net income (1) 263 226 16% Diluted Earnings per Share (EPS) 0.61 1.38 (56)% Non-GAAP Adjusted diluted EPS (1) 1.01 0.87 16% Acquired in-process research & development (IPR&D) and milestones — 51 —% Adjusted EBITDA (Non-GAAP) (1, 2) 518 459 13% Q3 2025 Q3 2024 Gross margin 53.5 % 58.3 % Non-GAAP Adjusted gross margin (1) 60.3 % 61.7 % Adjusted EBITDA margin (Non-GAAP) (1, 2) 32.3 % 29.0 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. (2) Adjusted EBITDA and Adjusted EBITDA margin for Q3 2024 includes $51 million, related to acquired IPR&D and milestones. Reported gross margin in the third quarter of 2025 was 53.5% compared with 58.3% in the prior year period. One-time costs associated with optimizing the company’s manufacturing and supply network was the most significant driver in the year-over-year decline in reported gross margin. Non-GAAP Adjusted gross margin was 60.3% in the third quarter of 2025, compared to 61.7% in the third quarter of 2024. Unfavorable foreign exchange in inventory turns, pricing pressure and product mix were drivers in the decline of both reported gross margin and non-GAAP Adjusted gross margin. Net income for the third quarter of 2025 was $160 million, or $0.61 per diluted share, compared with $359 million, or $1.38 per diluted share, in the third quarter of 2024. For the third quarter of 2025, non-GAAP Adjusted net income was $263 million, or $1.01 per diluted share, compared with $226 million, or $0.87 per diluted share, in 2024. Non-GAAP Adjusted EBITDA margin was 32.3% in the third quarter of 2025 compared with 29.0% in the third quarter of 2024. The year-over-year improvement in Adjusted EBITDA margin was primarily driven by a 14% reduction in non-GAAP operating expenses. Capital Allocation Today, Organon’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. The dividend is payable on December 11, 2025, to stockholders of record at the close of business on November 20, 2025. As of September 30, 2025, cash and cash equivalents were $672 million, and debt was $8.83 billion. Full Year Guidance Organon does not provide GAAP financial measures on a forward-looking basis because the company cannot predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts, and acquisition-related expenses. These items are uncertain, depend on various factors, and could be material to Organon’s results computed in accordance with GAAP. Full year 2025 financial guidance is presented below on a non-GAAP basis, except revenue. Previous Guidance as of August 5, 2025 Current Guidance Revenue $6.275B - $6.375B $6.200B - $6.250B Nominal revenue growth (2.0%) - (0.4%) (3.2%) - (2.4%) FX translation impact ~$50M headwind ~ $35M - $45M tailwind Ex-FX revenue growth (1.2%) - 0.3% (3.7%) - (3.1%) Adjusted gross margin 60.0%-61.0% Unchanged SG&A Mid 20% range Unchanged R&D Upper single-digit Unchanged IPR&D* $6 million Unchanged Adjusted EBITDA margin (Non-GAAP) 31.0%-32.0% ~31.0% Interest ~$510M Unchanged Depreciation ~$135M Unchanged Effective non-GAAP tax rate 22.5%-24.5% Unchanged Fully diluted weighted average shares outstanding ~263M Unchanged *The company does not provide guidance for forward-looking IPR&D and milestone expense. The $6 million of forecasted IPR&D expense reflects IPR&D expense recorded through September 30, 2025. Webcast Information Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its third quarter financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at https://www.organon.com/investor-relations/events-and-presentations/. A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website. Institutional investors and analysts interested in participating in the call may join by dialing (888) 596-4144 (U.S. and Canada Toll-Free) or (646) 968-2525 and using the access code Conference ID: 1036555#. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at http://www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Non-GAAP Financial Measures This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are correspondingly not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles (“GAAP”). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted gross margin, Adjusted gross profit, Adjusted net income, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company’s financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. Please refer to Table 4 and Table 5 of this press release for additional information, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. In addition, the company’s full-year 2025 guidance measures (other than revenue) are provided on a non-GAAP basis because the company is unable to reasonably predict certain items contained in the GAAP measures. Such items include, but are not limited to, acquisition-related expenses, restructuring and related expenses, stock-based compensation, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts and other items not reflective of the company's ongoing operations. The company’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about Organon’s full-year 2025 guidance estimates and predictions regarding other financial information and metrics, as well as expectations regarding Organon’s franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as “guidance,” “potential,” “should,” “will,” “continue,” “expects,” “believes,” “future,” “estimates,” “opportunity,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, expanded brand and class competition in the markets in which Organon 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 Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; uncertainties surrounding the Audit Committee investigation described in Organon’s 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 Organon’s reputation and relationships with customers, wholesalers, suppliers, and other business partners; risks related to potential disruptions to Organon’s 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; Organon’s 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 its ability to maintain effective controls over financial reporting and disclosure controls and procedures in the future; Organon’s ability to access the public securities and other capital and credit markets in accordance with its 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 Organon’s access to or terms of financing or its financial condition and liquidity; Organon’s ability to meet its revenue and growth expectations and outlook; unfavorable publicity and media reports; the potential impact that actions by activist stockholders could have on the pursuit of our business strategies; the loss of key personnel or highly skilled employees; 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 Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as Organon’s products lose patent protection; any failure by Organon to retain market exclusivity for Nexplanon® (etonogestrel implant) 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 LOE for Atozet™ (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;” restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the SEC and other U.S. and comparable government agencies; difficulties and uncertainties inherent in the implementation of Organon’s acquisition strategy or failure to recognize the benefits of such acquisitions; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and health care reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon’s business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; delays or failures to demonstrate adequate efficacy and safety of Organon’s product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of Organon’s product candidates; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care insurance coverage; legal factors, including product liability claims, antitrust litigation and governmental investigations, including tax disputes, environmental claims and patent disputes with branded and generic competitors, any of which could preclude commercialization of products or negatively affect the profitability of existing products; lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the FDA and other regulatory authorities; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of Organon’s products; cyberattacks on, or other failures, accidents, or security breaches of, Organon’s or third-party providers’ information technology systems, which could disrupt Organon’s operations and those of third parties upon which it relies; 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 Organon’s 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 Organon’s 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 Organon; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon’s products. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov). TABLE 1 Organon & Co. Condensed Consolidated Statement of Income (Unaudited, $ in millions except shares in thousands and per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Revenues $ 1,602 $ 1,582 $ 4,709 $ 4,811 Cost of sales 745 659 2,137 1,992 Gross Profit 857 923 2,572 2,819 Selling, general and administrative 415 422 1,288 1,290 Research and development 84 111 275 339 Acquired in-process research and development and milestones — 51 6 81 Restructuring costs — — 88 23 Interest expense 128 126 383 388 Exchange losses 17 6 12 11 Other (income) expense, net (30 ) — (53 ) 9 Income before income taxes 243 207 573 678 Income tax expense (benefit) 83 (152 ) 181 (77 ) Net income $ 160 $ 359 $ 392 $ 755 Earnings per share: Basic $ 0.61 $ 1.39 $ 1.51 $ 2.94 Diluted $ 0.61 $ 1.38 $ 1.50 $ 2.92 Weighted average shares outstanding: Basic 259,975 257,498 259,266 256,830 Diluted 260,653 259,757 260,611 258,908 TABLE 2 Organon & Co. Sales by top products (Unaudited, $ in millions) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 ($ in millions) U.S. Int’l Total U.S. Int’l Total U.S. Int’l Total U.S. Int’l Total Women’s Health Nexplanon/Implanon NXT $ 146 $ 77 $ 223 $ 172 $ 70 $ 243 $ 486 $ 225 $ 711 $ 497 $ 207 $ 704 Follistim AQ 24 40 64 26 37 63 89 117 206 59 113 171 NuvaRing 9 17 26 7 17 23 21 54 75 33 57 90 Ganirelix Acetate Injection 3 19 22 5 20 26 10 67 77 16 65 82 Marvelon/Mercilon — 31 31 — 29 29 — 103 103 — 103 103 Jada 20 — 20 15 — 16 53 1 54 42 1 43 Other Women’s Health (1) 17 26 43 14 28 40 47 80 128 41 78 119 General Medicines Biosimilars Renflexis 51 19 70 56 16 72 141 49 190 167 43 210 Hadlima 47 16 63 29 11 40 116 44 159 71 27 98 Ontruzant 4 28 31 5 15 20 12 68 80 23 84 107 Brenzys — 23 23 — 27 27 — 59 59 — 63 63 Other Biosimilars (1) 6 3 9 — 7 7 9 13 22 — 22 22 Cardiovascular Atozet — 95 95 — 125 125 — 257 257 — 396 396 Zetia 1 91 93 2 80 81 4 248 252 5 235 240 Cozaar/Hyzaar 2 53 55 2 57 59 6 160 166 7 179 186 Vytorin 1 25 25 1 25 26 3 72 75 4 78 82 Rosuzet — 6 6 — 11 11 — 16 16 — 36 36 Other Cardiovascular (1) 1 33 33 — 27 29 1 97 98 2 97 99 Respiratory Singulair 2 51 53 2 83 85 6 187 193 7 268 275 Nasonex — 60 60 — 63 63 — 197 197 — 200 200 Dulera 24 10 34 38 10 48 89 28 118 120 31 151 Clarinex 1 25 25 1 26 27 1 92 93 2 97 100 Other Respiratory (1) 9 2 12 11 3 14 32 9 40 26 10 35 Non-Opioid Pain, Bone and Dermatology Arcoxia — 71 71 — 69 69 — 195 195 — 211 211 Fosamax — 40 40 1 37 38 2 106 107 3 109 112 Diprospan — 41 41 — 37 37 — 112 112 — 102 102 Vtama 31 3 34 — — — 80 9 89 — — — Other Non-Opioid Pain, Bone and Dermatology (1) 4 75 80 5 69 74 11 217 229 15 212 227 Other Propecia 2 31 33 2 27 28 4 86 90 5 74 79 Emgality/Rayvow — 51 51 — 29 29 — 125 125 — 69 69 Proscar — 27 27 — 23 23 1 73 73 1 72 73 Other (1) — 86 88 3 80 84 6 245 253 12 229 241 Other (2) 1 21 21 1 26 26 2 66 67 (2 ) 87 85 Revenues $ 406 $ 1,196 $ 1,602 $ 398 $ 1,184 $ 1,582 $ 1,232 $ 3,477 $ 4,709 $ 1,156 $ 3,655 $ 4,811 Totals may not foot due to rounding. Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies. (1) Includes sales of products not listed separately. (2) Other includes manufacturing sales to third parties. TABLE 3 Organon & Co. Sales by geographic area (Unaudited, $ in millions) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Europe and Canada $ 417 $ 436 $ 1,212 $ 1,343 United States 406 398 1,232 1,156 Asia Pacific and Japan 251 260 752 806 China 219 212 627 634 Latin America, Middle East, Russia, and Africa 286 243 810 768 Other (1) 23 33 76 104 Revenues $ 1,602 $ 1,582 $ 4,709 $ 4,811 (1) Other includes manufacturing sales to third parties. TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Unaudited, $ in millions) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Gross Profit $ 857 $ 923 $ 2,572 $ 2,819 Adjusted for: Spin-related costs (1) — — — 6 Manufacturing network costs (2) 39 14 101 39 Stock-based compensation 4 4 12 13 Amortization 52 35 155 102 Acquisition-related costs (3) 12 — 31 — Other 2 — 12 — Adjusted Non-GAAP Gross Profit $ 966 $ 976 $ 2,883 $ 2,979 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. (3) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5. Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Gross Margin 53.5 % 58.3 % 54.6 % 58.6 % Total impact of Non-GAAP adjustments 6.8 % 3.4 % 6.6 % 3.3 % Adjusted Non-GAAP Gross Margin 60.3 % 61.7 % 61.2 % 61.9 % Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Selling, general and administrative expenses $ 415 $ 422 $ 1,288 $ 1,290 Adjusted for: Spin-related costs (1) — (10 ) — (79 ) Stock-based compensation (16 ) (17 ) (46 ) (53 ) Restructuring related charges — — (10 ) — Other (5 ) (4 ) (34 ) (4 ) Adjusted Non-GAAP Selling, general and administrative expenses $ 394 $ 391 $ 1,198 $ 1,154 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) (Unaudited, $ in millions except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Research and development expenses $ 84 $ 111 $ 275 $ 339 Adjusted for: Spin-related costs (1) — (2 ) — (5 ) Manufacturing network costs (2) (2 ) — (8 ) — Stock-based compensation (4 ) (4 ) (12 ) (13 ) Other (2 ) — (3 ) — Adjusted Non-GAAP Research and development expenses $ 76 $ 105 $ 252 $ 321 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Reported Net Income $ 160 $ 359 $ 392 $ 755 Adjusted for: Cost of sales adjustments 109 53 311 160 Selling, general and administrative adjustments 21 31 90 136 Research and development adjustments 8 6 23 18 Restructuring — — 88 23 Change in fair value of contingent consideration (32 ) — (9 ) — Other expense (gain), net 4 4 (37 ) 14 Tax impact on adjustments above(1) (7 ) (227 ) (69 ) (276 ) Non-GAAP Adjusted Net Income $ 263 $ 226 $ 789 $ 830 (1) For the three months ended September 30, 2025 and 2024, the GAAP income tax rates were 34.0% and (73.7)%, respectively, and the non-GAAP income tax rates were 25.3% and 24.7%, respectively. For the nine months ended September 30, 2025 and 2024, the GAAP income tax rates were 31.6% and (11.3)%, respectively, and the non-GAAP income tax rates were 24.0% and 19.3%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments. Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Diluted Earnings per Share $ 0.61 $ 1.38 $ 1.50 $ 2.92 Total impact of Non-GAAP adjustments 0.40 (0.51 ) 1.53 0.29 Non-GAAP Adjusted Diluted Earnings per Share $ 1.01 $ 0.87 $ 3.03 $ 3.21 TABLE 5 Organon & Co. Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Reported Net Income $ 160 $ 359 $ 392 $ 755 Depreciation (1) 37 32 102 93 Amortization 52 35 155 102 Interest expense 128 126 383 388 Income tax expense (benefit) 83 (152 ) 181 (77 ) EBITDA (Non-GAAP) $ 460 $ 400 $ 1,213 $ 1,261 Restructuring and related charges — — 98 23 Spin-related costs (2) — 16 — 104 Manufacturing network related (3) 46 14 118 39 Acquisition-related costs (4) 12 — 31 — Change in contingent consideration (32 ) — (9 ) — Other costs (5) 8 4 3 4 Stock-based compensation 24 25 70 79 Adjusted EBITDA (Non-GAAP) $ 518 $ 459 $ 1,524 $ 1,510 Adjusted EBITDA margin (Non-GAAP) 32.3 % 29.0 % 32.4 % 31.4 % (1) Excludes accelerated depreciation included in one-time costs. (2) Spin-related costs reflect certain costs incurred in connection with activities taken to separate Organon from Merck & Co., Inc., Rahway, NJ, US. These costs include, but are not limited to, $7 million and $47 million for the three and nine months ended September 30, 2024, respectively, for information technology infrastructure, primarily related to the implementation of a stand-alone enterprise resource planning system and redundant software licensing costs, as well as $20 million for the nine months ended September 30, 2024, associated with temporary transition service agreements with Merck & Co., Inc., Rahway, NJ, US. (3) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs. (4) Acquisition related costs for the three and nine months ended September 30, 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. (5) Other costs for the nine months ended September 30, 2025 include $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 funding agreement with NovaQuest Co-Investment Fund VIII, L.P. and legal settlement reserves. As the costs described in (1) through (5) above are directly related to the separation of Organon and acquisition related activities and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provides meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance.

并购上市批准财报生物类似药引进/卖出

100 项与富马酸福莫特罗/莫米松糠酸酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10295	-	R03AK09	-

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
哮喘	美国	Organon & Co.	2010-06-22

未上市

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适应症	最高研发状态	国家/地区	公司	日期
慢性阻塞性肺疾病	临床3期	-	Organon & Co.	2006-09-01
慢性阻塞性肺疾病	临床3期	-	Novartis AG	2006-09-01
持续性哮喘	临床3期	-	Organon & Co.	2006-07-01
气道病变	临床2期	-	Organon & Co.	2008-02-01

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02741271 (MK-0887A-087 \| 0887A-087, CTgov)	临床3期	持续性哮喘	181	Prednisone/Prednisolone+Albuterol/Salbutamol PRN+MF MDI 100 mcg BID (Open Label)+MF/F MDI 100/10 mcg BID (MF/F MDI 100/10 mcg BID)	繭膚願膚襯選齋獵艱願(膚鏇築網觸齋選淵壓鏇) = 築遞衊鹽構積廠製鏇壓築鹽選顧襯製襯繭簾艱 (鬱廠憲衊遞齋築窪壓襯, 11.44) 更多	-	2019-05-22
				Prednisone/Prednisolone+Albuterol/Salbutamol PRN+MF MDI 100 mcg BID (MF MDI 100 mcg BID)	繭膚願膚襯選齋獵艱願(膚鏇築網觸齋選淵壓鏇) = 範築鏇膚廠顧積襯鹹蓋築鹽選顧襯製襯繭簾艱 (鬱廠憲衊遞齋築窪壓襯, 12.79) 更多
NCT01471340 (P06241, Pubmed \| J Allergy Clin Immunol)	临床4期	哮喘	11,744	Mometasone furoate-formoterol	積廠製廠選餘鹽築觸窪(製獵膚願遞鹽鏇觸憲製): hazard ratio = 1.22 (95% CI, 0.76 ~ 1.94) 更多	-	2019-04-01
				Mometasone furoate
NCT02045875 (CTgov)	临床4期	哮喘 \| 间歇性哮喘	50	Dulera (Dulera Adherence Monitoring)	鏇蓋繭獵齋網獵繭鹽襯(壓簾製網淵蓋衊衊餘網) = 齋鏇醖築願積範艱鹽製觸簾繭窪蓋網壓蓋襯醖 (鹹簾製獵蓋蓋餘壓簾選, 0.924) 更多	-	2018-06-20
				Dulera (Dulera Standard of Asthma Care)	鏇蓋繭獵齋網獵繭鹽襯(壓簾製網淵蓋衊衊餘網) = 願獵遞遞膚製淵餘鏇獵觸簾繭窪蓋網壓蓋襯醖 (鹹簾製獵蓋蓋餘壓簾選, 0.839) 更多
NCT01471340 (P06241 \| SPIRO, CTgov)	临床4期	持续性哮喘	11,744	MF/F (MF/F MDI BID)	獵襯憲襯窪選鏇築顧網 = 構觸鏇鬱糧壓餘構選夢鬱蓋範廠繭襯壓鹽廠廠 (壓憲遞襯襯齋淵壓顧醖, 簾憲遞憲觸觸壓網糧憲 ~ 醖襯選膚顧膚夢鹽鹹觸) 更多	-	2018-01-05
				MF (MF MDI BID)	獵襯憲襯窪選鏇築顧網 = 蓋鏇餘築餘繭遞範積繭鬱蓋範廠繭襯壓鹽廠廠 (壓憲遞襯襯齋淵壓顧醖, 夢顧構壓願齋鏇鹹構齋 ~ 憲築膚廠鏇壓選窪衊鏇) 更多
NCT01258803 (Pubmed \| Pediatr Pulmonol)	临床2期	持续性哮喘	87	MF/F MDI with spacer	獵淵鏇憲獵鬱襯繭築衊(廠積遞廠築壓膚選獵憲) = 醖鏇構範獵鑰願醖鬱膚顧遞觸簾齋窪觸夢衊鬱 (築築壓繭鏇選鬱壓鏇襯 )	-	2014-05-01
				MF/F MDI without spacer	醖餘顧鏇鹹窪窪醖齋繭(膚網獵窪獵壓選觸憲願) = 獵顧餘顧簾淵網積繭憲觸鏇憲淵襯範遞衊艱願 (鏇艱製願繭憲簾鹽鹽衊 )
NCT01566149 (P08212, CTgov)	临床3期	持续性哮喘	49	Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI (MF/F 200/10 mcg MDI BID)	網簾選築鹽獵鹽顧築憲 = 遞廠蓋顧願製遞衊構網鬱獵廠窪鬱積鏇餘觸醖 (廠築淵選壓壓積選網膚, 齋鑰壓遞窪淵醖觸鑰醖 ~ 構壓淵餘醖積醖糧鏇鹽) 更多	-	2013-07-29
				Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI (MF/F 400/10 mcg MDI BID)	網簾選築鹽獵鹽顧築憲 = 蓋鬱蓋憲鏇簾鏇夢齋觸鬱獵廠窪鬱積鏇餘觸醖 (廠築淵選壓壓積選網膚, 廠壓獵夢齋糧鏇顧鬱鏇 ~ 膚鬱鑰構獵醖襯淵齋窪) 更多
NCT01258803 (P06476, CTgov)	临床2期	持续性哮喘	92	MF/F (MF/F MDI With Spacer)	遞衊餘壓簾糧襯積鹹選(選鏇築夢蓋齋鹽顧範夢) = 選膚鑰憲膚醖醖廠膚鏇鬱壓繭餘鏇夢觸範製膚 (膚願遞餘簾糧鏇蓋夢夢, 0.016) 更多	-	2013-07-18
				Placebo (Placebo MDI With or Without Spacer)	遞衊餘壓簾糧襯積鹹選(選鏇築夢蓋齋鹽顧範夢) = 獵窪選夢範餘蓋積積憲鬱壓繭餘鏇夢觸範製膚 (膚願遞餘簾糧鏇蓋夢夢, 0.016) 更多
NCT00635882 (Pubmed \| Respir Med)	临床2期	哮喘	93	Mometasone furoate/formoterol 100/10 μg	顧窪觸鬱鹹餘繭獵獵網(鑰鏇簾網餘選糧夢蓋願) = 範餘廠獵簾醖遞蓋壓壓襯簾鹹顧衊鑰築夢積獵 (膚獵艱醖獵構膚製餘壓 )	-	2013-05-01
				Mometasone furoate/formoterol 200/10 μg	顧窪觸鬱鹹餘繭獵獵網(鑰鏇簾網餘選糧夢蓋願) = 網衊壓鑰鏇鹹鹽願範願襯簾鹹顧衊鑰築夢積獵 (膚獵艱醖獵構膚製餘壓 )
NCT00424008 (Pubmed \| Allergy Asthma Clin Immunol)	临床3期	持续性哮喘	722	Mometasone furoate/formoterol (MF/F)	壓構淵製鑰廠壓齋鹹糧(艱選鏇餘簾憲醖艱構網) = 繭鹹夢夢鑰築淵鹹膚衊窪鑰繭簾蓋窪範鏇壓齋 (遞壓鏇鹽築窪鹽網蓋網, -0.40 ~ 0.76) 更多	-	2011-12-07
				Fluticasone propionate/salmeterol (FP/S)	壓構淵製鑰廠壓齋鹹糧(艱選鏇餘簾憲醖艱構網) = 襯繭築壓獵餘鬱簾鏇範窪鑰繭簾蓋窪範鏇壓齋 (遞壓鏇鹽築窪鹽網蓋網 ) 更多
NCT00383721 (P04230, CTgov)	临床3期	慢性阻塞性肺疾病	1,196	Mometasone furoate/formoterol (MF/F) combination (MF/F MDI 400/10 mcg BID)	製繭餘襯艱遞蓋顧餘願(艱鹹選繭鏇壓淵鑰襯積) = 願餘顧簾襯繭憲鹽積觸鑰網膚膚艱獵範糧餘鏇 (範構顧範憲簾餘範蓋蓋, 0.408) 更多	-	2011-10-26
				Mometasone furoate/formoterol (MF/F) combination (MF/F MDI 200/10 mcg BID)	製繭餘襯艱遞蓋顧餘願(艱鹹選繭鏇壓淵鑰襯積) = 夢範繭積選鏇鏇廠簾顧鑰網膚膚艱獵範糧餘鏇 (範構顧範憲簾餘範蓋蓋, 0.408) 更多