OGN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-04

• Some statements and disclosures in this document are forward-looking statements. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “potential,” “p…

• On April 26, 2026, our Board of Directors appointed Joseph Morrissey our Interim CEO, to such role on a permanent basis.

• 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. Under the terms of the agreement, we will pay $27.5 million at closing, with potent…

• 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 (income) expense, net in the Condensed Consolidated Statement of Income as of March 31, 2026.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Some statements and disclosures in this document are forward-looking statements. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “potential,” “s…

• Internal Investigation Relating to Internal Control Over Financial Reporting

• On October 27, 2025, we announced an internal investigation conducted by the Audit Committee (the “Audit Committee”) of the Company’s Board of Directors (the “Board”) regarding our sales practices for wholesalers as described in the Form 8-K.

• As disclosed in the Form 8-K and Amendment No. 1 (the “10-K Amendment”), filed on November 10, 2025, to our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Original Form 10-K”) and amendments (the “10-Q Amendments” and, together with the 10-K Amendment, the “Amendments”)…

• revenue for the relevant quarterly periods), based on the results of the investigation, we have determined that without these sales practices, our consolidated revenue for the fiscal year ended December 31, 2024 reported in the Original Reports (and certain of the other Relevant Periods) would have …

Text added vs the prior filing · source: 10-Q · 2026-05-04

• As previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, we determined that certain material weaknesses in our internal control over financial reporting existed as of December 31, 2025. Those material weaknesses are described below and continued to ex…

• 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

• 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, which were not remediated as of March 31, 2026:

• These material weaknesses did not result in misstatements of our previously reported historical financial statements.

• We are committed to taking steps necessary to remediate the material weaknesses as described above. We are actively engaged and have devoted substantial resources towards the implementation of enhanced procedures and controls and the remediation of material weaknesses in our internal control over fi…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• As previously disclosed in the Form 8-K and in the Amendments, after concerns regarding the Company’s sales practices for wholesalers for Nexplanon were brought to the Board’s attention, the Audit Committee oversaw an independent, internal investigation into these sales practices. The Audit Committe…

• Based on the results of the Audit Committee’s investigation as further set forth in Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Recent Developments,” the Company determined that these sales practices for wholesalers involving Nexplanon in the Unit…

• Based on the evaluation described above, we identified the following material weaknesses in the Company’s internal control over financial reporting:

• For additional information, please see Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

• To address the material weaknesses in internal control over financial reporting, the Company, with the oversight of its Audit Committee, has developed a remediation plan, which is described below.

Text added vs the prior filing · source: 10-Q · 2026-05-04

• The closing of our proposed merger with and into Sun Pharma is subject to a number of conditions, many of which are largely outside of the parties’ control, and, if these conditions are not satisfied or waived on a timely basis, the merger agreement may be terminated and the transaction may not be c…

• On April 26, 2026, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Sun Pharma and the additional parties thereto, relating to the merger. The consummation of the merger is subject to various conditions, including, among others, customary conditions relating to: the adop…

• The governmental authorities from which authorizations under antitrust and foreign investment laws, including the HSR Act, are required have broad discretion in administering the governing laws and regulations. These governmental authorities may initiate proceedings seeking to prevent, or otherwise …

• The failure to satisfy all of the required conditions could delay the completion of the merger by a significant period of time or prevent it from occurring. Any delay in completing the merger could cause the parties to not realize some or all of the benefits that are expected to be achieved if the m…

• Failure to complete the merger could adversely affect our stock price and future business and financial results, and our ability to continue as a going concern may be adversely affected.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• The self-initiated Audit Committee internal investigation has been time-consuming and expensive and may result in additional expense and/or litigation.

• After concerns regarding the Company’s sales practices for wholesalers for Nexplanon were brought to the Board’s attention, the Audit Committee oversaw an independent, internal investigation into these sales practices.

• The Audit Committee’s investigation focused on the Company’s sales of Nexplanon to wholesalers. The investigation has found that the Company asked two wholesalers in the United States to purchase greater quantities of Nexplanon at the end of the Relevant Periods than they otherwise would have purcha…

• As a result of these purchases, the United States wholesalers significantly decreased or even halted their purchases of Nexplanon during the early weeks of the following quarters until their days of inventory on hand were reduced to levels within the contractual range. Although the incremental amoun…

• Additionally, while the Audit Committee’s investigation is complete, the Company has identified material weaknesses in its internal control over financial reporting as described in Part I, Item 4 of this report and, as a result, the Company’s management has determined that our disclosure controls an…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• In connection with the circumstances described in Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Recent Developments — Internal Investigation Relating to Internal Control Over Financial Reporting,” on October 26, 2025, Kevin Ali resigned as Chief Exe…