OGN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-10-30

• On September 11, 2026, the Samsung Agreement was amended to include additional dosage forms of Pyzchiva in Canada (“Amendment No. 11”).

• On February 19, 2026, we entered into an exclusive license agreement with Sebela for the global rights to Miudella, a hormone-free copper intrauterine device (“IUD”) that was approved by the FDA on February 24, 2025 and is estimated to launch commercial sales in the United States in late 2026. Under…

• In January 2026, we divested Jada to Laborie for an aggregate payment of up to $465 million, comprised of consideration of $440 million, subject to certain closing adjustments, plus potential contingent consideration payments of up to $25 million based on the achievement of certain 2026 net sales ta…

• Upon the closing of the divestiture, we recognized a net gain on the sale of Jada of $81 million recognized in Other income, net in the Condensed Consolidated Statement of Income for the nine months ended September 30, 2026.

• Three Months Ended September 30,% Change% Change Excluding Foreign ExchangeNine Months Ended September 30,% Change% Change Excluding Foreign Exchange

Text removed vs the prior filing · source: 10-Q · 2026-07-31

• On February 19, 2026, we entered into an exclusive license agreement with Sebela for the global rights to Miudella®, a hormone-free copper intrauterine device (“IUD”) that was approved by the FDA on February 24, 2025 and is estimated to launch commercials sales in the United States in late 2026. Und…

• In January 2026, we divested the Jada System to Laborie for an aggregate payment of up to $465 million, comprised of consideration of $440 million, subject to certain closing adjustments, plus potential contingent consideration payments of up to $25 million based on the achievement of certain 2026 n…

• Upon the closing of the divestiture, we recognized a net gain on the sale of the Jada System of $81 million recognized in Other expense (income), net in the Condensed Consolidated Statement of Income for the six months ended June 30, 2026.

• Three Months Ended June 30,% Change% Change Excluding Foreign ExchangeSix Months Ended June 30,% Change% Change Excluding Foreign Exchange

• Worldwide sales were $1.6 billion for the three months ended June 30, 2026, a decrease of 2%, compared to 2025. Worldwide sales were positively impacted by approximately $42 million or 3%, due to favorable foreign exchange rates.

Text added vs the prior filing · source: 10-Q · 2026-10-30

• Our management, with the participation of our Chief Executive Officer (“CEO”) (our principal executive officer) and Chief Financial Officer (“CFO”) (our principal financial officer), evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule…

• During the quarter ended September 30, 2026, there were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that materially affected, or are reasonably likely to materially affect, our internal control over financial report…

Text removed vs the prior filing · source: 10-Q · 2026-07-31

• We have established disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act is accumulated and communicated to…

• Our management, with the participation of the CEO and the CFO, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026 in connection with the filing of this report. Based on this evaluation, the CEO and the CFO concluded that our disclosure controls and procedures w…

• Remediation of Material Weaknesses in Internal Control Over Financial Reporting

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

• As disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, we previously identified the following material weaknesses in our internal control over financial reporting.