Ethinyl Estradiol/Etonogestrel

Mithra reports full year 2023 financial results Revenues were EUR 40.2 million, down from the 2022 result of EUR 67.0 million which was positively impacted by exceptional upfront cash payments from partnerships.Product sales were EUR 18.7 million, up +19.3% vs EUR 15.7 million in 2022.ESTELLE® product sales reached EUR 10.4 million in 2023 beating the September 2023 guidance of EUR 8.5 million and up from EUR 9.2 million in 2022.Cash position, at EUR 9.0 million at end of 2023, is down compared to previous year (EUR 28.3 million end 2022).In an effort to maximize value for all of Mithra’s stakeholders, the Company has initiated a Monetization Process to realize value from its assets involving the sale of various selected assets, particularly Estetra SRL (which includes the US DONESTA® out-licensing process), and/or the business as a whole.The delay in the DONESTA® US NDA filing negatively impacted the process to consummate a US licensing agreement, also negatively impacting expected revenues.Triggered by the monetization process, management recognized an impairment loss of EUR 74.1 million on two of those assets (namely the Mithra CDMO and ZORELINE®). This accounting conclusion does not affect the management’s commitment to continue to find the best possible outcome for those assets. Due to these impairments (non-cash items), among other factors, the net loss for the period was EUR 173.5 million.Post-closing events include the 06 February 2024 announcement of Mithra’s cash position of EUR 6.5 million, the 15 February 2024 sale of balance of shares held in Mayne Pharma for approximately EUR 12.8 million, the 05 March 2024 announcement of up to EUR 18.5 million bridge facility to initiate a monetization process of key Mithra assets, and the 05 March 2024 change of management announcement. Liege, Belgium, 08 March 2024 – 7:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its financial results for the year which ended on 31 December 2023, prepared in accordance with IFRS. Financial Highlights See "Note regarding basis of preparation" on page 5 below. FY 2023 revenues were EUR 40.2 million compared to EUR 67.0 million in 2022.Out-licencing revenues at EUR 19.0 million were mostly driven by ESTELLE® in 2023. On top of EUR 3.75 million invoiced to our partner Fuji, another EUR 12.5 million has been recognized as revenue according to our IFRS 15 accounting policy (respectively EUR 2.5 million with Gedeon Richter for China and EUR 10.0 million with Fuji). Balance of out-licencing was primarily for DONESTA® with EUR 1.5 million invoiced to our partner Searchlight and EUR 1.13 million recognized under IFRS for China and Israel.ESTELLE® product sales, at EUR 10.4 million, were above 2022 level (EUR 9.2 million) and above our latest guidance (EUR 8.5 million) given in September. This is due to, amongst other items, our first deliveries to our Japan partner Fuji Pharma.Total number of cycles of ESTELLE® (NEXTSTELLIS®) sold by our partner in the US Mayne Pharma increased +136% to 385k cycles. The increase in sales is expected to continue in 2024.ESTELLE® cycle sales in Europe (DROVELIS® and LYDISILKA® brand names) increased by 103% to 3.2 million cycles in 2023.Novalon sales of generic products, including MYRING®, TIBELIA® and DAPHNE®, were EUR 8.1 million in 2023, up by +28% compared to the previous year while R&D contracting revenue from our CDMO remained steady at EUR 2.4 million.Cash collection from out-licensing milestones totalled EUR 56.4 million in 2023; EUR 51.5 million from DONESTA® (EUR 50.0 million from Gedeon Richter, out of which EUR 39.7 million was recognized in 2022 according to IFRS 15 and EUR 1.5 million from Searchlight); EUR 4.8 million from ESTELLE® (EUR 3.8 million from Fuji Pharma and EUR 1.0 million from Gedeon Richter for two LATAM territories previously recognised under IFRS).R&D expenses (excluding depreciation) decreased slightly (EUR 52.9 million in 2023 versus EUR 53.7 million in 2022) coming in below the guidance of EUR 60 million given in May 2023. The stable level of spend is a product of the continued strategy to focus on core R&D projects (DONESTA® and ESTELLE®) and discontinuing or pausing other research activities outside Mithra’s core scope.REBITDA was EUR -48.2 million in 2023 compared to EUR -12.3 million in 2022 year mostly due to lower out-licencing revenue and, to a lesser extent, an increase in G&A expenses and lower other operating income.Share-based payments expenses include the one-time (non-cash) expense of EUR 4.1 million relating to the 20 million warrants issued to Armistice Capital, LLC; the remaining being the balance of costs relating to previously awarded plans.Impairment on non-current assets: due to current cash runway situation, focus for non-core assets has now shifted to short-term sale or disposal. Accordingly, an impairment loss of EUR 74.1 million for two such assets has been recorded in FY 2023 financial statements: EUR 47.7 million for Mithra CDMO and EUR 26.4 million for ZORELINE®. This accounting conclusion does not affect the management’s commitment to continue to find the best possible outcome for those assets.Deferred tax assets: Balance of deferred tax assets previously recognized within Mithra CDMO and Novalon have been reversed as essentially relating to expected future taxable profit of ZORELINE®, now most likely to be sold in the short term.Cash position, at EUR 9.0 million at end 2023, is down compared to previous year (EUR 28.3 million end 2022) as revenue cash collection, capital increases and draw-down on existing financing lines did not compensate for expenses as well as reimbursement of several credit lines with some of our lenders.Equity was EUR -103.2 million at the end of 2023, down EUR 136.9 million compared to end 2022 (EUR 33.7 million). The total comprehensive loss for the period (EUR 167.1 million) was only partially compensated by a capital increase of EUR 2.5 million with Highbridge and Whitebox, a loan conversion by a lender under the convertible loan facility (EUR 1.2 million) and several contributions in kind against the issuance of new shares for interest to the lenders for a total of EUR 3.5 million (net of transaction costs) and by the private placement in equity with Armistice Capital LLC for EUR 18.4 million (net of transaction costs of EUR 1.6 million). Operational highlights Mithra announced positive preclinical data from its CSF-1R inhibitor program following the earlier announcement of its initial pre-clinical study successes. This was achieved in partnership with BCI Pharma and focused on tyrosine kinases inhibitors, a new development axis in the treatment of many pathologies including endometriosis, oncology and inflammatory disorders. Mithra announced promising topline safety results from DONESTA® Phase 3 Study in North America positive topline safety results for its E4 COMFORT clinical trial in the United States and Canada aiming at evaluating the efficacy and safety of DONESTA® for the treatment of Vasomotor Symptoms (VMS) in post-menopausal women.Mithra and the University of Liège secure proof-of-concept for novel manufacturing process of E4 delivering an improved manufacturing methodology to boost robustness and productivity while ensuring a limited environmental footprint. The new metal-free process is based on the thermolysis of a key sulfoxide derivative of estrone.Mithra granted an additional patent for NEXTSTELLIS® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) in the United States by the United States Patent and Trademark Office. The new patent will provide NEXTSTELLIS® contraceptive with oral-dosage-unit protection in the US market until 2036. The patent is a continuation of U.S. Patent No. 11,147,771 and was listed in the FDA’s Orange Book.Mithra received guidance from the FDA for the DONESTA® NDA marketing authorization filing in the US and received positive DSMB opinion on the DONESTA® European Phase 3 trial. Mithra received feedback regarding its new drug application (NDA) marketing authorization filing for DONESTA® in the United States. This follows an agreement in principle with the FDA for Mithra to conduct additional endometrial data analyses with a formal NDA submission now planned for Q4 2024 to allow for the time required to perform these additional analyses pursuant to FDA guidance. Pending regulatory approval, DONESTA® is expected to target a US market of nearly 63 million women between the ages of 45 and 65 years-old and experiencing vasomotor symptoms of menopause (VMS). Mithra also received a positive review from the independent Data and Safety Monitoring Board (DSMB) on its phase 3 program for DONESTA®.Mithra completed its pediatric study of ESTELLE® in adolescent patients, evaluating the safety, compliance, and pharmacokinetic profile of ESTELLE® in more than 100 participants aged 12 to 17 years old. The primary endpoint of the study, which was conducted in Estonia, Finland, Georgia, Latvia, Poland and Sweden, was to evaluate the safety of ESTELLE® in post-menarchal subjects.Mayne Pharma and Mithra announced the US launch of HALOETTE®, a vaginal hormonal contraceptive ring, resulting in a EUR 1.6 million milestone payment. HALOETTE® is a generic version of NUVARING®. According to IQVIA, NUVARING® US brand and generic sales were approximately USD 564 million for the 12 months ended November 2022.Mithra signs license agreement for the commercialization of DONESTA® with Gedeon Richter, Searchlight and Rafa Laboratories expanding its potential reach to Canada, Israel, Europe, the CIS countries, Latin America, Australia and New Zealand.Mithra received EUR 3.75 million milestone payments from Fuji Pharma under its ESTELLE® licensing agreement in Japan. A payment of EUR 1.25 million was triggered by completion of the interim clinical study reports of Phase 3 trials investigating ESTELLE® for the treatment of patients with dysmenorrhea or endometriosis. An additional EUR 2.5 million payment was made in October following the submission of an application for marketing approval in Japan in a drive to help combat dysmenorrhea.Mithra and Gedeon Richter signed a supply agreement for production of API for ESTELLE® and DONESTA® in August. The agreement specifies that Gedeon Richter will manufacture and supply the Estetrol (E4) native estrogen for Mithra’s leading products.Mithra and Gedeon Richter signed a binding Head of Terms to commercialize ESTELLE® and DONESTA® in China. Upon the finalization of the license agreements, Gedeon Richter will have the exclusive commercial rights for both products in China. Under the head of terms, Gedeon Richter to perform and fund the clinical studies required to obtain marketing approvals in China; upon the closing of the two licencing agreements, Mithra to receive a combined milestone payment of EUR 4.5 million. Events beyond the reporting period Mithra provided an update on its current cash position and its plans to address its runway and creating and optimizing value for all its stakeholders on 06 February, 2024. Announced the sale of all 4,221,815 shares it held in Mayne Pharma Group Limited on 15 February 2024. The shares were sold at a price of A$ 5.03 per share for aggregate net proceeds of A$ 21,129,551 (approx. EUR 12.8 million).Reported the last patient-out in the DONESTA® C301 Endometrial Safety Study. was reached on 8 February 2024. This marks the completion of patient treatments and the initiation of the data management/reporting phase.On 05 March 2024, Mithra announced the initiation of a monetization process and signing of a new secured bridge loan facility expected to fund that process through 30 April. The monetization process and Facility are further to Mithra’s 06 February 2024 announcement on its cash position. In an effort to maximize value for all of Mithra’s stakeholders, the Company has initiated a monetization process to realize value from its assets involving the sale of various selected assets, particularly Estetra SRL, and/or the business as a whole. The Company is finalizing negotiations with an internationally recognized investment bank to help conduct the Monetization Process in collaboration with DC Advisory and Alvarez & Marsal, who are advising on liquidity management and advising on monetization, among other things. Parties interested in participating in the Monetization Process should contact Ed Kulik of DC Advisory (Ed.Kulik@dcadvisory.com) and Thomas Dillenseger of Alvarez & Marsal (TDillenseger@alvarezandmarsal.com).Management Changes: Appointment of Christophe Maréchal1 and Xavier Paoli as co-CEOs following, 05 March 2024 termination of the management agreement of former CEO. Financial results Note regarding basis of preparation: The consolidated financial results of Mithra Pharmaceuticals SA and its subsidiaries (“Mithra”) included in this release have been prepared in accordance with International Financial Reporting Standards as adopted by the European Union. These include International Financial Reporting Standards (IFRS) and the related interpretations issued by the International Accounting Standards Board (IASB), and the IFRS Interpretations Committee (IFRIC), effective at the reporting date and adopted by the European Union. These consolidated financial results have been prepared on the basis of a going concern. However, as announced on 06 February 2024 and 05 March 2024, there are material uncertainties about Mithra's ability to continue in operation beyond 30 April 2024. As of 07 March 2024, Mithra has approximately EUR 9.0 million in cash and cash equivalents including the first drawdown under the bridge facility. Its lenders have provided a committed bridge facility of up to EUR 13.5 million, plus an uncommitted "accordion" facility for a further EUR 5 million, in each case subject to milestones, as described in that 05 March 2024 press release, in order to fund a monetization process. However, as noted in that release there is a risk that Mithra will not be able to draw the full amount, for instance if it is not able to initiate a Monetization Process. Even if a Monetization Process is initiated, there is a material risk that that process will not be successful, in whole or in part, or may not significantly reduce Mithra's existing indebtedness. If Mithra is not able to draw funds under the new bridge facility or is otherwise not able to raise or generate sufficient cash, this will adversely affect Mithra's continued operations and ability to operate as a going concern. 1. Consolidated statement of profit or loss Thousands of euro (€)20232022 Revenue40,15566,997Cost of sales(21,950)(19,623)Gross profit18,20547,374Research and development expenses(63,170)(64,041)General and administrative expenses(22,085)(14,675)Selling expenses(2,271)(2,100)Impairment on non-current assets(74,147)-Other operating income4,3367,196Loss from operations(139,132)(26,245)Change in fair value of contingent consideration payable(1,510)28,335Net fair value gains/(losses) on financial assets at fair value through profit or loss--Financial income1,7459,852Financial expenses(22,899)(23,422)Loss before taxes(161,795)(11,480)Income taxes(11,707)(48,139)NET LOSS FOR THE PERIOD(173,502)(59,620) 2. Consolidated statement of financial position As at 31 DecemberThousands of euro (€)20232022ASSETS Property, plant and equipment13,40540,717Right-of-use assets38,08365,534Goodwill5,2335,233Other intangible assets108,713134,905Deferred income tax assets1,28916,354Contract assets1792.828Derivatives financial assets349-Investment in equity securities16,01521,437Other non-current assets9,8749,544Non-current assets193,139296,552 Inventories48,28950,312Contract assets19,53644,988Derivatives financial assets47-Trade and other receivables16,55622,277Other short-term deposits--Cash and cash equivalents8,98028,285Current assets93,408145,863 TOTAL ASSETS286,546442,414 As at 31 DecemberThousands of euro (€)20232022EQUITY AND LIABILITIES Share capital50,59441,228Additional paid-in-capital424,858408,647Other reserves10,586(19,934)Accumulated deficit(589,294)(396,254)Equity attributable to equity holders(103,255)33,687 Subordinated loans9,79110,710Other loans137,739127,052Lease liabilities31,63138,253Refundable government advances7,6478,127Other financial liabilities73,73174,210Derivatives financial liabilities13,63615,261Contract liabilities10,300-Provisions266266Deferred tax liabilities1,0814,420Non-current liabilities285,822278,298 Current portion of subordinated loans1,2521,252Current portion of other loans19,00145,980Current portion of lease liabilities6,4505,179Current portion of refundable government advances2,5071,417Current portion of other financial liabilities15,69815,959Derivatives financial liabilities-2,561Trade and other payables59,07258,082Current liabilities103,981130,431 TOTAL EQUITY AND LIABILITIES286,546442,414 3. Consolidated statement of cash flows As at 31 DecemberThousands of euro (€)20232022Cash and cash equivalents at beginning of year28,28532,872Net cash (used in)/ provided by operating activities(2,184)(56,819)Net cash (used in)/ provided by investing activities3,452(25,490)Net cash (used in)/provided by financing activities(20,538)77,869Net increase/(decrease) in cash and cash equivalents(19,270)(4,440)Effects of exchange rate changes on cash and cash equivalents(35)(147)Cash and cash equivalents at end of period8,98028,285 Statement of profit and loss The Group reported a net loss of EUR 173.5 million in 2023, compared to a net loss of EUR 59.6 million in 2022. The main contributor to this difference was an impairment loss of EUR 74.1 million registered on the value of Mithra CDMO and ZORELINE® assets. Revenues were EUR 40.2 million compared with EUR 67.0 million in 2022. The revenues breakdown as follows: Overall product sales of EUR 18.7 million were largely driven by ESTELLE® (EUR 10.4 million), which are higher than in 2022 (EUR 9.2 million) and MYRING® (EUR 6.0 million) that improves the revenue on our generic portfolio to EUR 8.3 million compared to EUR 6.5 million in 2022.Out-licensing revenue for the year was EUR 19 million from ESTELLE® and DONESTA® milestones (EUR 16.3 million and EUR 2.6 million, respectively). For ESTELLE®, on top of EUR 3.75 million invoiced to our Partner Fuji, another EUR 12.5 million has been recognized as revenue according to our IFRS 15 accounting policy (respectively EUR 2.5 million with Gedeon Richter for China and EUR 10.0 million with Fuji). Balance of out-licencing was primarily for DONESTA® with EUR 1.5 million invoiced to our partner Searchlight and EUR 1.13 million recognised under IFRS for China and Israel.Revenues from the R&D contracting activities of the CDMO were stable at EUR 2.4 million compared to EUR 2.3 million in 2022. R&D expenses (including depreciation) decreased slightly to EUR 63.2 million. The stable level of research expenses is due to the continued focus on our core R&D projects, namely the DONESTA® Phase II and III clinical studies and the ESTELLE® post-approval safety study (PASS). G&A and selling expenses increased +44% to EUR 24.4 million due to a higher impact of share-based payments accounting entries (charge of EUR 4.5 million compared to charge of EUR 2.0 million in 2022); increase in professional services to assist us in our attempt to strengthen our balance sheet and refocus on innovative R&D, but also relating to administration of our financial liabilities and uncomfortable cash position; and, to a lesser extent, an increase in insurance costs and salaries indexation. Impairment on non-current assets: as focus for non-core assets has now shifted to short-term sale or disposal of those assets, an impairment loss of EUR 74.1 million for two such assets has been recorded in FY 2023 financial statements: EUR 47.7 million for Mithra CDMO and EUR 26.4 million for ZORELINE®. Other operating income of EUR 4.3 million (compared to EUR 7.2 million in 2022) mostly consists of an R&D tax credit for EUR 1.3 million which is directly related to R&D expenses level and of EUR 1.4 million exemption from the withholding tax on professional income for R&D staff. Main reason for lower other operating income is that last year included a reinvoicing of costs of EUR 2.2 million that did not repeat in 2023. The negative impact of approximately EUR -1.5 million for change in fair value related to contingent consideration payable ESTELLE® is the consequence of the update of both the discount rate and the timing effect. The decrease in financial income to EUR 1.7 million from EUR 9.9 million in 2022 is explained by the lower impact of the remeasurement of refundable government advances measured at amortized cost following the update of forecasts (EUR 0.5 million in 2023 vs EUR 3.6 million last year). Last year also included EUR 3.0 million of dividend from Mayne Pharma as well as a realized gain of EUR 2.5 million following the early repurchase of EUR 34.1 million tranche of our convertible bonds due in 2025 at a discount to par, via the convertible loan signed with Highbridge Capital Management, LLC (“Highbridge“) and funds managed by Whitebox Advisors, LLC (“Whitebox”). Financial expenses remained stable compared to last year, albeit at a high level. The group recorded a tax loss of EUR -11.7 million for 2023 as the balance of deferred tax assets previously recognised within Mithra CDMO and Novalon have been reversed as essentially relating to expected future taxable profit of ZORELINE® now most likely to be sold in the short term. Statement of financial position Assets As of 31 December 2023, the statement of financial position shows a total of EUR 193.1 million in non-current assets-- the majority of which are other intangible assets (EUR 108.7 million); right-of-use assets (EUR 38.1 million); investments in equity securities (EUR 16.0 million); property, plant and equipment (EUR 13.4 million) and deferred tax assets (EUR 1.3 million). In 2023, new additions to the other intangible assets have been limited to a total of EUR 4.2 million (EUR 33.3 million in 2022) and almost offset by EUR 3.5 million of depreciation. Main change of 2023 was the result of the impairment testing of our CDMO and ZORELINE® that led to a one-time depreciation of EUR 27.0 million (EUR 0.6 million and EUR 26.4 million respectively for the CDMO and ZORELINE®). The same impairment testing also led to a one-time depreciation of EUR -47.2 million on our CDMO Tangible fixed assets (Property, plant and equipment and the right-of-use assets). Otherwise, limited additions during the year (EUR 1.2 million) were more than offset by depreciation of the period (EUR 8.2 million). Deferred tax assets decreased to EUR 1.3 million as balance of deferred tax assets previously recognised within Mithra CDMO and Novalon have been reversed as essentially relating to expected future taxable profit of our complex therapeutics products now most likely to be sold in the short term. Contract assets amount decreased to EUR 19.7 million (non-current and current) versus EUR 47.8 million in 2022. New contract assets recognized (essentially EUR 10 million for Fuji and EUR 3.5 million relating to ESTELLE® & DONESTA® in China) were more than offset by unbilled revenues recognised in prior year(s) and invoiced in 2023 (EUR 40.7 million for Gedeon Richter). Current assets at the end of 2023 are about EUR 93.4 million and include, besides contract assets explained here above, Cash and cash equivalents of EUR 9.0 million, Trade & other receivables of EUR 16.6 million, and Inventories of EUR 48.3 million. Equity and liabilities Total equity at year-end is negative at EUR -103.3 million as the total comprehensive loss for the period (EUR 167.1 million) was only partially compensated by several capital increases for a total amount of EUR 25.6 million (net of transaction costs). Non-current liabilities increased to EUR 285.8 million at the end of 2023, compared to EUR 278.3 million end of 2022. The main changes during the period relate to the access in June 2023 to a new tranche of the amended loan facility concluded with funds managed by Highbridge and Whitebox (“Convertible loans” in the above table) for an amount of EUR 12.5 million and the recognition of a contract liability of EUR 10.3 million with Gedeon Richter for DONESTA®. Current liabilities decreased to EUR 104.0 million at the end of 2023, compared to EUR 130.4 million in 2022. The decrease of the Current liabilities is mainly explained by the reimbursement of straight loans at maturity for an amount of EUR 26.8 million. Alternative performance measures Mithra uses some alternative performance measures (APMs) that are not defined in IFRS but that provide helpful additional information to better assess how the business has performed over the period. Mithra decided to use REBITDA and EBITDA in order to provide information on recurring items, but those measures should not be viewed in isolation or as an alternative to the measures presented in accordance with IFRS. REBITDA is an alternative performance measure calculated by excluding the non-recurring items and the depreciation & amortization from EBIT (loss from operations) from the consolidated statement of profit or loss prepared in accordance with IFRS. The Group considers share-based payments as non-recurring item above EBITDA. EBITDA is an alternative performance measure calculated by excluding the depreciation and amortization from EBIT (loss from operations) from the consolidated statement of profit or loss prepared in accordance with IFRS. Financial highlights are presented as follows in the first section of this press release (management figures): Year ended 31 DecemberThousands of euro (€)20232022 Revenue40,15566,997Cost of sales(21,189)(19,112)Gross profit18,96647,886Research and development expenses(52,869)(53,668)General and administrative expenses(16,450)(11,707)Selling expenses(2,213)(2,029)Other operating income4,3367,196REBITDA(48,231)(12,322)Share-based payments expenses(4,540)(1,983)EBITDA(52,771)(14,305)Depreciation(12,214)(11,940)Non-recurring items(74,147)-Loss from operations(139,132)(26,245)Change in fair value of contingent consideration payable(1,510)28,335Net fair value gains/(losses) on financial assets at fair value through profit or loss--Financial income1,7459,852Financial expenses(22,899)(23,422)Loss before taxes(161,795)(11,480)Income taxes(11,707)(48,139)NET LOSS FOR THE PERIOD(173,502)(59,620) Please refer to the table below for the reconciliation to loss from operations as presented within consolidated statement of profit or loss: Year ended 31 DecemberThousands of euro (€)20232022Loss from operations(139,132)(26,245)Depreciation12,21411,940Non-recurring items – impairment charges on non-current assets74,147-Share-based payments expenses4,5401,983REBITDA(48,231)(12,322)Share-based payments expenses(4,540)(1,983)EBITDA(52,771)(14,305) Annual report 2023The auditor, BDO Réviseurs d’Entreprises SRL, has stated that the statutory audit is still ongoing as of the date of this press release. Based on the unfinished status of the audit procedures and the uncertainty about the evolution of the group in the coming weeks, the auditor is not yet able to provide information on the audit opinion he intends to issue on the consolidated financial statements. Financial CalendarThe following are anticipated dates in the Company's 2024 financial calendar and subject to change: 16 April 2024: 2023 Annual Report16 May 2024: Annual General Shareholders’ Meeting26 September 2024: Half Year Report 2024 For more information, please contact: Mithra Pharmaceuticals SAAlex Sokolowski, PhDHead of IR & Communicationsinvestorrelations@mithra.com +32 (0)4 349 28 22Frédérique Depraetere Communications Directorinfo@mithra.com+32 (0)4 349 28 22 About Mithra Mithra Pharmaceuticals SA (Euronext: MITRA) is a Belgian biopharmaceutical company dedicated to transforming women’s health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill ESTELLE®, Mithra is now focusing on its second product DONESTA®, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, is headquartered in Liège, Belgium. www.mithra.com ESTELLE®, NEXTSTELLIS®, LYDISILKA®, MYRING®, HALOETTE®, ZORELINE®, TIBELIA® and DONESTA® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates. DROVELIS® is a registered trademark of Richter Gedeon Nyrt. DAPHNE® is a registered trademark of Ceres Pharma. NUVARING® is a registered trademark of Organon NV. Important informationThe contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. Subscribe to our mailing list on investors.mithra.com to receive press releases by email or follow us on social media:LinkedIn • X • Facebook 1 Acting through CMM&C SRL. Attachment 2024-03-08_Mithra_Press-release_FY2023-Results_FR

Full year 2023 revenue of $6.3 billion, up 1% as-reported and 3% at constant currency Full year 2023 diluted earnings per share of $3.99 and non-GAAP Adjusted diluted earnings per share of $4.14 Full year 2023 Adjusted EBITDA of $1.9 billion, representing a 31.0% Adjusted EBITDA margin Full year 2024 financial guidance ranges provided; full year revenue range of $6.2 billion to $6.5 billion and Adjusted EBITDA margin in the range of 31.0% to 33.0% JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN) today announced its results for the fourth quarter and full year ended December 31, 2023. "As we move into 2024, our priorities are to deliver our third year of constant currency revenue growth and to achieve a stable to improving Adjusted EBITDA margin. Delivering this financial pro key for us to be able to continue advancing on our mission of a healthier every day for every woman. There’s a tremendous opportunity in women’s health to address significant unmet needs and we are well positioned at the forefront of that effort." Fourth Quarter 2023 Revenue in $ millions Q4 2023 Q4 2022 VPY VPY ex-FX Women’s Health $ 465 $ 433 7 % 8 % Biosimilars 199 134 49 % 48 % Established Brands 915 888 3 % 3 % Other (1) 19 30 (37 )% (42 )% Revenues $ 1,598 $ 1,485 8 % 8 % (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties. For the fourth quarter of 2023, total revenue was $1,598 million, an increase of 8% on an as-reported basis as well as excluding impact of foreign currency (ex-FX), compared with the fourth quarter of 2022. Women’s Health revenue increased 7% on an as-reported basis, and increased 8% ex-FX in the fourth quarter of 2023 compared with the fourth quarter of 2022 driven primarily by strong growth in the company's fertility products, particularly Follistim AQ® (follitropin beta injection). Follistim grew 63% ex-FX in the fourth quarter due to a one-time buy-in as a result of the exit of the Interim Operating Model ("IOM") in the United States, increased demand in the U.S. that was largely tied to onboarding a new customer, as well as volume recovery in China tied to fertility patients returning to clinics following abating COVID-19 concerns. The Women's Health franchise also benefited from strong performance of oral contraceptives Marvelon™ (ethinylestradiol, desogestrel) and Mercilon™ (ethinylestradiol, desogestrel) which was driven in part by the reacquisition of rights in selected territories in Southeast Asia and China during 2022, as well as continued uptake of the Jada® system. Performance was partially offset by a 3% ex-FX decline in Nexplanon® (etonogestrel implant) primarily related to customer buying patterns associated with the company's decision to forgo its normal Nexplanon list-price increase in 2023, as well as a 12% ex-FX decrease in NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition. Biosimilars revenue increased 49% on an as-reported basis and increased 48% ex-FX in the fourth quarter of 2023, compared with the fourth quarter of 2022 primarily driven by Ontruzant® (trastuzumab-dttb), which grew 76% ex-FX and benefited from favorable timing of tender phasing in Brazil, and Renflexis® (infliximab-abda), which grew 28% ex-FX primarily due to U.S. strong volume growth. Revenue of Hadlima™ (adalimumab-bwwd) more than doubled in the fourth quarter of 2023 compared with the fourth quarter of 2022 as a result of continued uptake since its July 2023 launch in the U.S. Established Brands revenue increased 3% as-reported and 3% ex-FX in the fourth quarter of 2023 despite the impacts of Volume Based Procurement (VBP) initiatives and a challenging operating environment in China. Growth in the quarter was driven by a 13% ex-FX increase in the respiratory portfolio. In the cardiovascular portfolio, continued growth in Atozet™ (ezetimibe and atorvastatin calcium) partially offset a decline in Cozaar®/Hyzaar® (losartan) products which are subject to ongoing generic competition. Fourth Quarter 2023 Profitability in $ millions, except per share amounts Q4 2023 Q4 2022 VPY Revenues $ 1,598 $ 1,485 8 % Cost of sales 683 594 15 % Gross profit 915 891 3 % Non-GAAP Adjusted gross profit (1) 964 937 3 % Adjusted EBITDA (1,2) 449 380 18 % Net income 546 108 406 % Non-GAAP Adjusted net income (1) 226 208 9 % Diluted Earnings per Share (EPS) 2.13 0.42 407 % Non-GAAP Adjusted diluted EPS (1) 0.88 0.81 9 % Acquired in-process research & development (IPR&D) and milestones — — — Per share impact to diluted EPS from acquired IPR&D and milestones — — — Q4 2023 Q4 2022 Gross margin 57.3 % 60.0 % Non-GAAP Adjusted gross margin (1) 60.3 % 63.1 % Adjusted EBITDA margin (1, 2) 28.1 % 25.6 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures (2) Adjusted EBITDA and Adjusted EBITDA margin include no acquired IPR&D in the fourth quarter 2022 nor the fourth quarter 2023 Gross margin was 57.3% as-reported and 60.3% on an adjusted basis in the fourth quarter of 2023 compared with 60.0% as-reported and 63.1% on an adjusted basis in the fourth quarter of 2022. Unfavorable foreign exchange translation and to a lesser extent, product mix more than offset a favorable year-over-year comparison to the fourth quarter 2022 when the company took a market action on certain injectable steroid products. Adjusted EBITDA margin was 28.1% in the fourth quarter of 2023 compared with 25.6% in the fourth quarter of 2022 primarily due to lower year-over-year operating expenses and lower loss on foreign exchange translation attributable to the year-over-year comparison of the amount of the company's Euro-denominated debt covered under a net investment hedge program. Net income for the fourth quarter of 2023 was $546 million, or $2.13 per diluted share, compared with $108 million, or $0.42 per diluted share, in the fourth quarter of 2022. Non-GAAP Adjusted net income was $226 million, or $0.88 per diluted share, compared with $208 million, or $0.81 per diluted share, in 2022. Reported GAAP net income for the fourth quarter includes a net $476 million tax benefit resulting from the termination of a Swiss tax arrangement. Revenues in $ millions FY 2023 FY 2022 VPY VPY ex-FX Women’s Health $ 1,702 $ 1,673 2 % 3 % Biosimilars 593 481 23 % 24 % Established Brands 3,847 3,874 (1 )% 2 % Other(1) 121 146 (17 )% (19 )% Revenue $ 6,263 $ 6,174 1 % 3 % (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA. Total revenue was $6.3 billion for full year 2023, an increase of 1% as-reported and an increase of 3% ex-FX, compared with the full year 2022. Women’s Health revenue increased 2% as-reported and 3% ex-FX for full year 2023 compared with 2022. Strong growth in the company's fertility portfolio, which was up 9% ex-FX for the full year, a 24% ex-FX increase in oral contraceptives Marvelon/Mercilon and continued uptake of the Jada System, were the strongest revenue contributors to the Women’s Health franchise in 2023. Together these factors more than offset an 11% ex-FX decline in NuvaRing, which continues to be impacted by generic competition. Modest growth of Nexplanon of 1% ex-FX for the full year reflects the impact of the limited participation of a tender in Mexico and customer buying patterns associated with the company's decision to forgo its normal list price increase for Nexplanon in 2023. Biosimilars revenue increased 23% as-reported and 24% ex-FX for full year 2023 compared with 2022, driven primarily by continued demand growth in the U.S. and Canada for Renflexis and favorable phasing of tenders in Brazil and increased demand for Ontruzant, partially offset by competitive pressures in Europe. Revenue for Established Brands declined 1% as-reported and increased 2% ex-FX for the full year 2023 despite VBP initiatives and a challenging operating environment in China as well as supply interruptions of certain of the company's injectable steroid products stemming from the market action taken earlier in the year. Performance was driven by 2% growth in volume across the portfolio, partially offset by 1% price pressure. The company expects flat performance in the Established Brands franchise for full year 2024 on an ex-FX basis. Full Year 2023 Profitability in $ millions, except per share amounts 2023 2022 VPY Revenues $ 6,263 $ 6,174 1 % Cost of sales 2,515 2,294 10 % Gross profit 3,748 3,880 (3 )% Non-GAAP Adjusted gross profit (1) 3,930 4,058 (3 )% Adjusted EBITDA (1,2) 1,944 2,085 (7 )% Net income 1,023 917 12 % Non-GAAP Adjusted net income (1) 1,061 1,284 (17 )% Diluted Earnings per Share (EPS) 3.99 3.59 11 % Non-GAAP Adjusted diluted EPS (1) 4.14 5.03 (18 )% Acquired in-process research & development (IPR&D) and milestones 8 107 (93 )% Per share impact to diluted EPS from acquired IPR&D and milestones (0.03 ) (0.33 ) (91 )% 2023 2022 Gross margin 59.8 % 62.8 % Non-GAAP Adjusted gross margin (1) 62.7 % 65.7 % Adjusted EBITDA margin (1, 2) 31.0 % 33.8 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures (2) Adjusted EBITDA and Adjusted EBITDA margin include $8 million in 2023 and $107 million in 2022 related to acquired IPR&D and milestones Gross margin was 59.8% as-reported and 62.7% on an adjusted basis for full year 2023 compared with 62.8% as-reported and 65.7% on an adjusted basis for full year 2022. The year-over-year decrease in Adjusted gross margin reflects higher cost of sales due to foreign exchange translation and product mix, and to a lesser extent, higher employee-related and distribution-related costs. Adjusted EBITDA margin was 31.0% for the full year 2023 compared with 33.8% for the full year 2022. The year-over-year decrease was primarily a result of a lower Adjusted gross margin. Higher selling and promotional costs were mostly offset by lower total research and development spend, which includes in-process research and development (IPR&D). Net income for 2023 was $1.0 billion, or $3.99 per diluted share, compared with $917 million, or $3.59 per diluted share in 2022. Non-GAAP Adjusted net income was $1.1 billion or $4.14 per diluted share, compared with $1.3 billion, or $5.03 per diluted share in 2022. The year-over-year decline in net income was primarily due to higher interest expense due to increased interest rates, and accelerated amortization of capitalized financing costs associated with voluntary prepayments on the company’s U.S. dollar-denominated term loan. Capital Allocation Today, Organon’s Board of Directors declared a quarterly dividend of $0.28 for each issued and outstanding share of the company's common stock. The dividend is payable on March 14, 2024, to stockholders of record at the close of business on February 26, 2024. As of December 31, 2023, cash and cash equivalents were $693 million, and debt was $8.8 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 2024 financial guidance is presented below on a non-GAAP basis. For full year 2024, Organon expects constant currency revenue growth in the low-single-digit range and expects stable to improving Adjusted EBITDA margin, which Organon expects to achieve, in part, through operating expense management. 2024 Full Year Guidance Revenues $6.2B-$6.5B Adjusted gross margin 61.0% - 63.0% SG&A $1.5B - $1.7B R&D (excluding IPR&D) $400M - $500M Adjusted EBITDA margin 31.0% - 33.0% Interest ~$520M Depreciation ~$130M Effective non-GAAP tax rate 18.5% - 20.5% Fully diluted weighted average shares outstanding ~259M Webcast Information Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its fourth quarter and full year 2023 financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at . 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 must register in advance by clicking on this link: Following registration, participants will receive a confirmation email containing details on how to join the conference call, including dial-in information and a unique passcode and registrant ID. Pre-registration will allow participants to bypass an operator and be placed directly into the call. About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) 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 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. You should refer to Table 4 and Table 5 of this press release for 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 2024 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 uses non-GAAP financial measures in its operational and financial decision making and believes that it is useful to exclude certain items in order to focus on what it regards to be a more meaningful representation of the underlying operating performance of the business. 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 future financial performance and prospects, including full-year 2024 guidance estimates and predictions regarding other financial information and metrics, and franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as "foresees" “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” 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, an inability to fully execute on our product development and commercialization plans within the United States or internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; changes in tax laws or other tax guidance that could adversely affect our cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception or fertility products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; the impact of higher selling and promotional costs; any failure by Organon to obtain an additional period of market exclusivity in the United States for Nexplanon subsequent to the expiration of certain key patents in 2027; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. 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 Securities and Exchange Commission ("SEC"), including the company’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site ( ). TABLE 1 Organon & Co. Condensed Consolidated Statement of Income (Unaudited, $ in millions except shares in thousands and per share amounts) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Revenues $ 1,598 $ 1,485 $ 6,263 $ 6,174 Costs, Expenses and Other Cost of sales 683 594 2,515 2,294 Selling, general and administrative 469 470 1,893 1,704 Research and development 134 142 528 471 Acquired in-process research and development and milestones — — 8 107 Restructuring costs 58 17 62 28 Interest expense 129 119 527 422 Exchange losses 17 32 42 11 Other expense, net 4 — 15 15 1,494 1,374 5,590 5,052 Income Before Income Taxes 104 111 673 1,122 Taxes on income (442 ) 3 (350 ) 205 Net Income 546 108 1,023 917 Earnings per Share: Basic $ 2.14 $ 0.42 $ 4.01 $ 3.61 Diluted $ 2.13 $ 0.42 $ 3.99 $ 3.59 Weighted Average Shares Outstanding: Basic 255,617 254,367 255,239 254,082 Diluted 256,590 255,390 256,270 255,169 TABLE 2 Organon & Co. Sales by top products (Unaudited, $ in millions) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 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 $ 154 $ 76 $ 231 $ 172 $ 67 $ 239 $ 572 $ 257 $ 830 $ 573 $ 261 $ 834 Follistim AQ 51 31 83 26 25 50 125 136 262 105 124 229 NuvaRing 16 19 35 21 20 40 66 86 152 85 88 173 Ganirelix Acetate Injection 4 18 22 6 20 25 19 91 110 26 97 123 Marvelon/Mercilon — 37 37 — 24 24 — 134 134 — 110 110 Jada 13 — 13 8 — 8 43 — 43 20 — 20 Other Women's Health (1) 20 26 44 22 24 46 72 101 171 90 94 184 Biosimilars Renflexis 63 14 77 51 9 60 234 43 278 196 30 226 Ontruzant 10 52 62 13 22 35 46 109 155 48 74 122 Brenzys — 28 28 — 23 23 — 73 73 — 75 75 Aybintio — 9 9 — 10 10 — 43 43 — 39 39 Hadlima 15 8 23 — 6 6 17 26 44 — 19 19 Established Brands Cardiovascular Zetia 3 65 67 1 70 71 8 299 306 8 350 357 Vytorin 1 28 29 1 25 26 6 124 129 8 123 130 Atozet — 122 122 — 107 107 — 519 519 — 457 457 Rosuzet — 18 18 — 16 16 — 70 70 — 71 71 Cozaar/Hyzaar 2 55 57 2 66 68 10 272 281 13 310 323 Other Cardiovascular (1) — 28 29 1 39 40 2 151 155 3 156 159 Respiratory Singulair 2 111 114 3 92 95 11 393 404 11 400 411 Nasonex — 65 65 — 56 56 — 252 253 10 229 238 Dulera 40 10 50 42 10 52 156 38 194 140 40 180 Clarinex 1 29 30 2 25 27 5 132 136 4 121 125 Other Respiratory (1) 8 8 15 12 5 17 49 28 77 46 36 83 Non-Opioid Pain, Bone and Arcoxia — 51 51 — 56 56 — 257 257 — 241 241 Fosamax — 35 36 2 34 36 3 156 159 4 148 152 Diprospan — 33 33 — 31 31 — 91 91 — 122 122 Other Non-Opioid Pain, Bone and Dermatology (1) 4 64 67 5 56 62 14 261 275 15 257 273 Other Proscar — 20 20 — 23 24 1 96 97 1 99 101 Propecia 2 31 33 2 28 30 7 118 125 7 118 125 Other (1) 1 78 79 3 72 75 13 308 319 24 302 326 Other (2) 1 18 19 (1 ) 30 30 (1 ) 121 121 — 146 146 Revenues $ 411 $ 1,187 $ 1,598 $ 394 $ 1,091 $ 1,485 $ 1,478 $ 4,785 $ 6,263 $ 1,437 $ 4,737 $ 6,174 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. Revenues from Jada were previously reported as part of Other Women's Health. Revenue from an arrangement for the sale of generic etonogestrel/ethinyl estradiol vaginal ring is included in Other Women's Health. (2) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties. TABLE 3 Organon & Co. Sales by geographic area (Unaudited, $ in millions) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Europe and Canada $ 414 $ 389 $ 1,673 $ 1,631 United States 411 394 1,478 1,437 Asia Pacific and Japan 261 256 1,129 1,143 China 203 196 864 917 Latin America, Middle East, Russia, and Africa 279 230 965 895 Other (1) 30 20 154 151 Revenues $ 1,598 $ 1,485 $ 6,263 $ 6,174 (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties. TABLE 4 Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited, $ in millions except per share amounts) Three Months Ended December 31, 2023 GAAP Spin related Costs(1) Restructuring Stock-based Compensation Amortization Other(2) Non-GAAP Adjusted Revenues $ 1,598 $ 1,598 Cost of sales 683 (17 ) — (4 ) (28 ) — 634 Gross profit 915 964 Gross margin 57.3 % 60.3 % Selling, general and administrative 469 (47 ) — (18 ) — (3 ) 401 Research and development 134 (2 ) — (5 ) — — 127 Acquired in-process research and development and milestones — — — — — — — Restructuring costs 58 — (58 ) — — — — Interest expense 129 — — — — — 129 Exchange losses 17 — — — — — 17 Other expense (income), net 4 (4 ) — — — — — 1,494 1,308 Income before income taxes 104 290 Taxes on income (442 ) 7 12 5 5 477 64 Net income $ 546 $ 226 Earnings per share - Diluted $ 2.13 $ 0.88 (1) One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US. (2) Other costs primarily includes a tax benefit resulting from the termination of a Swiss tax arrangement and one-time costs related to inventory step-up adjustments and legal reserves. Three Months Ended December 31, 2022 GAAP Spin related Costs(1) Restructuring Stock-based Compensation Amortization Other(2) Non-GAAP Adjusted Revenues $ 1,485 $ 1,485 Cost of sales 594 (7 ) — (4 ) (28 ) (7 ) 548 Gross profit 891 937 Gross margin 60.0 % 63.1 % Selling, general and administrative 470 (36 ) — (16 ) — (4 ) 414 Research and development 142 (3 ) — (3 ) — (1 ) 135 Acquired in-process research and development and milestones — — — — — — — Restructuring costs 17 — (17 ) — — — — Interest expense 119 — — — — — 119 Exchange losses 32 — — — — — 32 Other expense (income), net — (3 ) — — — 3 — 1,374 1,248 Income before income taxes 111 237 Taxes on income 3 12 4 6 4 — 29 Net income $ 108 $ 208 Earnings per share - Diluted $ 0.42 $ 0.81 (1) One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US. (2) Other costs primarily includes one-time costs related to inventory step-up adjustments and legal reserves. TABLE 4 (continued) Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited, $ in millions except per share amounts) Year Ended December 31, 2023 GAAP Spin related Costs(1) Restructuring Stock-based Compensation Amortization Other(2) Non-GAAP Adjusted Revenues $ 6,263 $ 6,263 Cost of sales 2,515 (47 ) — (17 ) (116 ) (2 ) 2,333 Gross profit 3,748 3,930 Gross margin 59.8 % 62.7 % Selling, general and administrative 1,893 (178 ) — (68 ) — (91 ) 1,556 Research and development 528 (12 ) — (16 ) — — 500 Acquired in-process research and development and milestones 8 — — — — — 8 Restructuring costs 62 — (62 ) — — — — Interest expense 527 — — — — — 527 Exchange losses 42 — — — — — 42 Other expense (income), net 15 (17 ) — — — — (2 ) 5,590 4,964 Income before income taxes 673 1,299 Taxes on income (350 ) 49 13 17 21 488 238 Net income $ 1,023 $ 1,061 Earnings per share - Diluted $ 3.99 $ 4.14 (1) One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US. (2) Other costs primarily includes a tax benefit resulting from the termination of a Swiss tax arrangement and one-time costs related to inventory step-up adjustments and legal reserves. Year Ended December 31, 2022 GAAP Spin related Costs(1) Restructuring Stock-based Compensation Amortization Other(2) Non-GAAP Adjusted Revenues $ 6,174 $ 6,174 Cost of sales 2,294 (25 ) — (13 ) (116 ) (24 ) 2,116 Gross profit 3,880 4,058 Gross margin 62.8 % 65.7 % Selling, general and administrative 1,704 (122 ) — (51 ) — (21 ) 1,510 Research and development 471 (11 ) — (11 ) — (3 ) 446 Acquired in-process research and development and milestones 107 — — — — — 107 Restructuring costs 28 — (28 ) — — — — Interest expense 422 — — — — — 422 Exchange losses 11 — — — — — 11 Other expense (income), net 15 (23 ) — — — 3 (5 ) 5,052 4,607 Income before income taxes 1,122 1,567 Taxes on income 205 36 6 13 19 4 283 Net income $ 917 $ 1,284 Earnings per share - Diluted $ 3.59 $ 5.03 (1) One-time spin-related costs includes costs from the separation of Merck & Co., Inc., Rahway, NJ, US. (2) Other costs primarily includes one-time costs related to inventory step-up adjustments, impairment charges and legal reserves. TABLE 5 Organon & Co. Reconciliation of GAAP Income Before Income Taxes to Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Income before income taxes $ 104 $ 111 $ 673 $ 1,122 Depreciation (1) 30 24 118 96 Amortization 28 28 116 116 Interest expense 129 119 527 422 EBITDA $ 291 $ 282 $ 1,434 $ 1,756 Restructuring costs 58 17 62 28 One-time costs (2) 73 58 347 226 Stock-based compensation 27 23 101 75 Adjusted EBITDA $ 449 $ 380 $ 1,944 $ 2,085 Adjusted EBITDA margin 28.1 % 25.6 % 31.0 % 33.8 % (1) Excludes accelerated depreciation included in one-time costs. (2) One-time costs primarily include costs incurred in connection with the spin-off of Organon, inventory step-up adjustments, impairment charges and legal reserves. View source version on businesswire.com: Contacts Media Contacts: Karissa Peer (614) 314-8094 Kate Vossen (732) 675-8448 Investor Contacts: Jennifer Halchak (201) 275-2711 Alex Arzeno (203) 550-3972 Source: Organon & Co. View this news release online at: