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Organon & Co.

OGNFDA catalysts, PDUFA dates & pipeline intelligence
$13.9
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Financials

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52W LOW $5.6952W HIGH $13.90
Volume
4.00 M
Value Traded
55.56 M
Short % Float
7.55%
Days to Cover
8.5
+0.36%Week
+1.02%1 Month
+1.46%3 Month
+3.58%6 Month
-65.12%5 Year
-56.68%All Time

Cash Data

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  • SEC Filing

Key Stats

Market Cap
3.65 B
EPS (TTM)
0.81
P/E Ratio
17.14
Ent. Value
10.75 B
Total Shares
262.52 M
Float Shares
260.94 M
Insiders
0.64%
Institutions
84.80%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 3 data presentation
VTAMA® (tapinarof) cream, 1%
moderate to severe atopic dermatitis
Phase 3Small MoleculesDermatologic System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

OGN Catalyst Timeline

Dated clinical, regulatory and corporate events for Organon & Co.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Organon & Co.

134Total events
5Upcoming
50Tier-1 (high impact)
2021 to 2027Coverage

Upcoming catalysts 2

T2Product Launch
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MiudellaApproved
T2Management Change
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Event history 50

▲Subgroup AnalysisVTAMAApprovedClinical Data
Consistent EASI75, vIGA-AD and PP-NRS responses across patient subgroups in pooled ADORING 1/2 data
atopic dermatitissource ↗
◆Poster PresentationHADLIMAApprovedPresentation
Poster presentation of real-world evidence on VA switch from HUMIRA to HADLIMA
rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitissource ↗
▲RWE DataHADLIMAApprovedClinical Data
Real-world evidence shows 1.3% switchback rate and $132M VA savings after switch to HADLIMA
rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitissource ↗
▲Interim Efficacy DataMiudellaApprovedClinical Data
Positive interim Phase 3 results for MIUDELLA through 6 years of use
◆Poster PresentationVTAMAApprovedPresentation
Real-world analysis of VTAMA cream in AD to be presented at 2026 Fall Clinical Dermatology Conference
atopic dermatitissource ↗
▲FDA Filing AcceptedMiudellaApprovedRegulatory Filing
FDA accepts for review Sebela's sNDA for MIUDELLA to extend duration of use to 6 years
prevention of pregnancysource ↗
▲REMS ModifiedMiudellaApprovedPost-Market
MIUDELLA REMS program opened for enrollment
prevention of pregnancysource ↗
▲Poster PresentationVTAMAApprovedPresentation
Poster of pooled ADORING 1/2 age-stratified data presented at 2026 SPD Annual Meeting
atopic dermatitissource ↗
▲Subgroup AnalysisVTAMAApprovedClinical Data
Pooled Phase 3 vIGA-AD and EASI75 results broken out by pediatric and adult age subsets
atopic dermatitissource ↗
●Quarterly UpdateCorporate
Second quarter 2026 financial results release via Form 10-Q
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How OGN actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-03-28VTAMA (tapinarof) cream, 1% Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

Pipeline Score
Pipeline Value
Commercial Value
Valuation Signal
1
Drugs Scored
rNPV / MCap
Top Drug
Top 47%
Small Cap
(rank 324 of 689)
Percentile Rank
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Sep 2026; product lines: last four quarters to Sep 2026 (10-K and 10-Q))
ProductRevenuePrior periodChange
Nexplanon/Implanon NXT
Zetia
Atozet
Hadlima
Other Non-Opiod Pain, Bone and Dermatology
Arcoxia
Nasonex
Renflexis
Follistim AQ
Emgality
Cozaar/Hyzaar
Singulair
Top 12 of 27 product lines shown.
Showing 70 of 141 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Tapinarof Small MoleculesMarketedNCT07265479Atopic DermatitisApproved ACTIVE NOT_RECRUITING 1,764Aug 1, 2027
OG-6219 Small MoleculesCompletedNCT05560646EndometriosisPhase 2 COMPLETED 354May 28, 2025
Mometasone furoate Small MoleculesMarketedNCT00635882AsthmaApproved COMPLETED 3,225Jun 1, 2009
MK0906, finasteride/ Duration of Treatment: 48 Weeks Small MoleculesMarketedNCT00396175Androgenetic AlopeciaApproved COMPLETED 355-
Desloratadine Small MoleculesMarketedNCT00757562Chronic Idiopathic UrticariaApproved COMPLETED 97Oct 1, 2003
Desloratadine Small MoleculesNot countedNCT01916980EczemaPhase 3 COMPLETED 94Mar 22, 2014
Desloratadine Small MoleculesNot countedNCT00817076Dermatitis, AtopicPhase 3 COMPLETED 40Jul 1, 2003
alendronate Small MoleculesMarketedNCT00480662Paget's Disease of BoneApproved COMPLETED 60Oct 1, 2002
etoricoxib Small MoleculesNot countedNCT01554163Osteoarthritis of the KneePhase 3 COMPLETED 239Mar 1, 2013
etoricoxib Small MoleculesNot countedNCT01208207Spondylitis, AnkylosingPhase 3 COMPLETED 1,015Nov 12, 2014
etoricoxib Small MoleculesNot countedNCT00264147Rheumatoid ArthritisPhase 3 COMPLETED 2,165Mar 1, 2008
Tapinarof Small MoleculesMarketedNCT04042103Plaque PsoriasisApproved COMPLETED 1,867Jan 9, 2020
Desloratadine Small MoleculesMarketedNCT01916967UrticariaApproved COMPLETED 521Mar 13, 2014
Mometasone furoate Small MoleculesNot countedNCT00599027Allergic RhinitisPhase 3 COMPLETED 1,763May 1, 2009
Mometasone furoate Small MoleculesNot countedNCT00383721Chronic Obstructive Pulmonary Disease (COPD)Phase 3 COMPLETED 2,251Jul 1, 2010
Mometasone Small MoleculesNot countedNCT00783224Perennial Allergic RhinitisPhase 3 COMPLETED 351Dec 1, 2005
Desloratadine Small MoleculesMarketedNCT01918033Perennial Allergic RhinitisApproved COMPLETED 608Jan 26, 2014
Desloratadine Small MoleculesMarketedNCT00794378Allergic RhinitisApproved COMPLETED 487Nov 1, 2004
Montelukast Granules Small MoleculesMarketedNCT01852812Perennial Allergic RhinitisApproved COMPLETED 87Dec 24, 2013
5-mg Desloratadine Small MoleculesMarketedNCT00405964Allergic RhinitisApproved COMPLETED 716Apr 1, 2008
5-mg Desloratadine Small MoleculesMarketedNCT00406783Rhinitis, Allergic, SeasonalApproved COMPLETED 547Nov 1, 2007
loratadine; montelukast Small MoleculesMarketedNCT00319995Rhinitis, Allergic, SeasonalApproved COMPLETED 1,095Jun 28, 2006
Desloratadine Small MoleculesMarketedNCT02320396Seasonal Allergic RhinitisApproved COMPLETED 503Apr 27, 2015
Mometasone furoate Small MoleculesNot countedNCT01386125Nasal PolypsPhase 3 COMPLETED 1,037Feb 1, 2013
Mometasone furoate Small MoleculesNot countedNCT03855189Seasonal Allergic RhinitisPhase 3 COMPLETED 2,393Oct 22, 1993
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PTRS, rNPV, enrollment velocity, trial design quality and ML risk signals for every asset above.
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Clinical Trial Results

Readouts, endpoints and source filings for every OGN program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
VTAMA atopic dermatitisPhase 32026-11-12EASI75: <10% BSA involvement 57.8% vs. 32.2%, ≥10% BSA involvement 64.4% vs. 23.2%, 0 · 5 years disease duration 70.0% vs. 31.8%, ≥6 years disease duration 58.8% vs. 21.7%, prior treatment 64.3% vs. 3.8%, no prior treatment 62.4% vs. 28.4%; v IGA AD: <10% BSA involvement 53.9% vs. 22.0%, ≥10% BSA involvement 46.0% vs. 15.2%, 0 · 5 years disease duration 53.2% vs. 17.6%, ≥6 years disease duration 45.3% vs. 16.7%, prior treatment 45.7% vs. 7.7%, no prior treatment 48.4% vs. 18.3%; PP NRS: <10% BSA involvement 61.3% vs. 26.1%, ≥10% BSA involvement 58.6% vs. 35.8%, 0 · 5 years disease duration 64.9% vs. 30.6%, ≥6 years disease duration 56.1% vs. 35.2%, prior treatment 55.0% vs. 20.8%, no prior treatment 60.0% vs. 35.3%Read MoreOrganon Presents New Analysis of Pooled Post-Hoc Phase 3 Data on VTAMA® (tapinarof) cream, 1%, Demonstrating Consistent Efficacy in Atopic Dermatitis Across Diverse Patient Subgroups at ACAAIRead More
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Inside Trades

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InsiderSideSharesPriceValueDate
Holzbaur LynetteOfficer (SVP and Corporate Controller)Option 2,418 4,590 held$0.00 11/07/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
Avidity Partners 1.2 % (-20 %) 6.20 M 640.00 K 19.63% ( 105.00 K)
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Shares held by hedge funds each quarter, and who bought or sold.

Ownership Trends

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Insider and institutional ownership, quarter by quarter.

OGN Short Interest

Shares sold short, counted twice a month.

7.55%
Short % of Float
of tradable shares sold short
19.7M
Shares Sold Short
+4.7% vs prior count
8.5 High
Days to Cover
trading days of normal volume to buy every short share back
2.3M
Avg Daily Volume
the average used for days to cover
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Two years of days to cover and shares sold short, with every count and its change.
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Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-11-20
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

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Competitive positioning

How OGN ranks across every disease it competes in

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See how OGN ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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OGN News

OGN
Nov 12, 2026
OGNPhases

Organon Presents New Analysis of Pooled Post-Hoc Phase 3 Data on VTAMA® (tapinarof) cream, 1%, Demonstrating Consistent Efficacy in Atopic Dermatitis Across Diverse Patient Subgroups at ACAAI

Organon presented new pooled data from Phase 3 trials of VTAMA cream at the ACAAI meeting. The analysis showed consistent efficacy in treating moderate to severe atopic dermatitis across various patient subgroups. Results indicated significant improvements in disease severity and itch from Week 1 through Week 8. VTAMA cream is well tolerated and offers a non-steroidal treatment option.

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OGN
Nov 7, 2026
OGNConferences/Events

New Real-World Evidence Presented by Organon at the American College of Rheumatology (ACR) Annual Meeting Evaluated a Large-Scale Switch to HADLIMA® (adalimumab-bwwd) Across United States Veterans Affairs Healthcare System

Organon presented new evidence at the ACR Annual Meeting showing a successful transition of over 16,000 veterans from HUMIRA to HADLIMA. The switch resulted in a low switchback rate of 1.3% and significant cost savings of $132 million for the Veterans Affairs Healthcare System. Average pharmacy costs decreased by $8,100 per patient in the first year.

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OGN
Nov 5, 2026
OGNConferences/Events

Organon to Present New Analysis on VTAMA® (tapinarof) cream, 1% at the 2026 American College of Allergy, Asthma & Immunology Annual Scientific Meeting

Organon announced a new analysis of VTAMA cream efficacy in atopic dermatitis, to be presented at the 2026 ACAAI Annual Scientific Meeting. The analysis evaluates data from Phase 3 trials, focusing on diverse patient subgroups. The presentation is scheduled for November 14, 2026, in Phoenix, Arizona.

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OGN
Oct 30, 2026
OGNGeneral

Organon Announces Quarterly Dividend

Organon announced a quarterly dividend of $0.02 per share, payable on December 10, 2026. Stockholders of record as of November 9, 2026, will receive this dividend. The company emphasizes its commitment to women's health and expanding access to essential treatments.

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OGN
Oct 27, 2026
OGNGeneral

Entera Appoints Global Research and Development Leader Dr. Juan Camilo Arjona Ferreira to Its Board of Directors

Entera Bio Ltd. appointed Dr. Juan Camilo Arjona Ferreira to its Board of Directors, effective December 1, 2026. Dr. Arjona Ferreira, currently at Organon, brings two decades of experience in clinical development and women's health. His expertise will support Entera's clinical strategy, particularly for its osteoporosis treatment, EB613.

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OGN
Oct 19, 2026
OGNGeneral

Organon to Report Third Quarter 2026 Results in Its Regularly Scheduled Form 10-Q Filing

Organon plans to release its third quarter 2026 financial results through a Form 10-Q filing with the SEC. The company will also provide non-GAAP financial measures in a Form 8-K filing on the same day. Currently, Organon does not expect to incur any milestone expenses for this quarter. The company has suspended its quarterly earnings calls due to a pending acquisition by Sun Pharmaceutical Industries.

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OGN
Oct 16, 2026
OGNPhases

Organon Announces Positive Interim Phase 3 Study Results for MIUDELLA®, a Hormone-Free, Intrauterine Device (IUD), Through 6 Years of Use to Be Presented at the 2026 Society of Family Planning Annual Meeting

Organon announced positive interim results from a Phase 3 study of MIUDELLA, a hormone-free IUD, showing efficacy and safety through 6 years of use. The study evaluated 465 participants, revealing a cumulative Pearl Index of 0.93. No new safety signals were reported, supporting the FDA's review for extended use. The findings will be presented at the 2026 Society of Family Planning Annual Meeting.

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OGN
Oct 1, 2026
OGNConferences/Events

Organon to Present New Real-World Analysis of VTAMA® (tapinarof) Cream, 1%, at the 2026 Fall Clinical Dermatology Conference

Organon is set to present its first large-scale real-world effectiveness analyses of VTAMA (tapinarof) cream, 1%, specifically targeting patients with eczema. This presentation will take place at the upcoming Fall Clinical Dermatology Conference, showcasing the company's commitment to advancing treatment options in dermatology.

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OGN
Sep 14, 2026
OGNFDA Updates

Organon Announces US FDA Has Accepted for Review a Supplemental New Drug Application for MIUDELLA®, a Hormone-Free Intrauterine Device

Organon has announced that the U.S. FDA has accepted for review its supplemental new drug application (sNDA) for MIUDELLA®, a hormone-free intrauterine device (IUD). The application seeks to extend the approved duration of use from 3 years to 6 years. This could provide patients with more options for long-term contraception.

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OGN
Aug 11, 2026
OGNGeneral

Organon Opens REMS Program for MIUDELLA® Ahead of Anticipated Commercial Availability

Organon has initiated the REMS certification process for its hormone-free copper IUD, MIUDELLA, in preparation for its upcoming commercial launch. Healthcare providers, settings, and pharmacies can now begin certification, indicating a proactive approach to ensure safe distribution. This move highlights Organon's commitment to expanding its product offerings in women's health.

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OGN
Jul 24, 2026
OGNPhases

New Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults1

Organon has presented new analysis from Phase 3 pooled data for its VTAMA (tapinarof) cream, 1%. The data indicates early and consistent improvements in patients with atopic dermatitis across various pediatric age groups and adults. This analysis highlights the potential effectiveness of VTAMA in treating eczema.

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OGN
Jul 16, 2026
OGNGeneral

Organon to Report Second Quarter 2026 Results in Its Regularly Scheduled Form 10-Q Filing

Organon plans to announce its second quarter 2026 financial results through a Form 10-Q filing with the SEC. The report will include certain non-GAAP financial measures along with their reconciliation to GAAP measures. This move reflects the company's commitment to transparency in its financial reporting.

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OGN
Jul 7, 2026
OGNConferences/Events

Organon to Present New Analysis on VTAMA® (tapinarof) cream, 1%, at the 2026 Society for Pediatric Dermatology Annual Meeting

Organon is set to present a new analysis of VTAMA® (tapinarof) cream, 1% at the upcoming 2026 Society for Pediatric Dermatology Annual Meeting. This presentation highlights the company's ongoing commitment to pediatric dermatology. Details regarding the analysis and its implications for treatment will be shared during the meeting.

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OGN
Jun 23, 2026
OGNGeneral

Organon Canada and Henlius Expand Access to Denosumab Treatments With Launch of BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection), Biosimilars to PROLIA and XGEVA

Organon Canada and Henlius have launched BILDYOS® and TUZEMTY®, biosimilars to PROLIA and XGEVA, aimed at expanding access to denosumab treatments. This initiative is expected to enhance treatment options for patients requiring denosumab therapy. The launch reflects a strategic move to provide more affordable alternatives in the market.

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OGN
Jun 22, 2026
OGNGeneral

Organon Completes Agreement to License MIUDELLA®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device

Organon has finalized an agreement to license MIUDELLA®, a hormone-free intrauterine device developed by Sebela Pharmaceuticals. This collaboration aims to enhance Organon's portfolio in women's health. The details regarding the financial terms of the agreement have not been disclosed.

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OGN
Jun 18, 2026
OGNGeneral

Organon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada

Organon and Samsung Bioepis have expanded their agreement to commercialize PYZCHIVA®, a biosimilar referencing STELARA® (ustekinumab), in Canada. This collaboration aims to enhance the availability of this treatment in the Canadian market. Further details regarding the terms of the agreement or expected timelines were not disclosed.

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OGN
Jun 10, 2026
OGNFDA Updates

Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19

Organon has secured FDA approval for TOFIDENCE® (tocilizumab-bavi), expanding its indications to include treatment for Cytokine Release Syndrome (CRS) and pediatric COVID-19. This approval enhances the therapeutic options available for these conditions, particularly benefiting younger patients. The decision reflects the ongoing need for effective treatments in critical health scenarios.

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OGN
May 15, 2026
OGNConferences/Events

Organon to Present New Research on Access and Value at ISPOR 2026

Organon will present new research at ISPOR 2026, focusing on women's health and biosimilars. The data, derived from eight accepted abstracts, emphasizes the importance of health economics in ensuring effective treatment access. Key topics include the budget impact of contraceptive methods and real-world healthcare utilization patterns. The conference will take place from May 17-20, 2026, in Philadelphia.

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OGN
Apr 30, 2026
OGNGeneral

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

Organon reported its Q1 2026 financial results, showing a total revenue of $1.460 billion, down 4% from the previous year. Women's Health revenue saw a significant decline, particularly in Nexplanon sales, which dropped 21% due to decreased physician demand and funding uncertainties. However, the company experienced growth in its biosimilars segment, with a 23% increase in revenue. Net income rose to $146 million, reflecting a 68% increase compared to Q1 2025.

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About Organon & Co.

Jersey City, NJ 10,000 employees organon.com
Headquarters30 HUDSON STREET, JERSEY CITY, NJ, 07302
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