Ethinyl Estradiol/Etonogestrel

First quarter 2024 revenue of $1,622 million, up 5% on an as-reported basis and 7% at constant currency First quarter 2024 diluted earnings per share of $0.78 and non-GAAP Adjusted diluted earnings per share of $1.22; both reported and non-GAAP Adjusted diluted earnings per share include $15 million expense, or $(0.05) per share, for acquired in-process research and development (IPR&D) and milestones First quarter 2024 net income of $201 million and Adjusted EBITDA (non-GAAP) of $538 million Full year 2024 financial guidance ranges affirmed JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2024. "We entered this year with a clear focus: to deliver our 2024 financial targets while staying true to our mission of improving the health of women, and the first quarter was a very solid start," said Kevin Ali, Organon's Chief Executive Officer. "We remain confident in our ability to deliver our third year of revenue growth on a constant currency basis and we remain committed to delivering full-year non-GAAP Adjusted EBITDA margins that are in line with last year, or better." First Quarter 2024 Revenue in $ millions Q1 2024 Q1 2023 VPY VPY ex-FX Women’s Health $ 422 $ 381 11% 12% Biosimilars 170 116 46% 46% Established Brands 1,001 1,002 —% 2% Other (1) 29 39 (27)% (29)% Revenues $ 1,622 $ 1,538 5% 7% (1) Other includes manufacturing sales to third parties. For the first quarter of 2024, total revenue was $1,622 million, an increase of 5% on an as-reported basis and an increase of 7% excluding the impact of foreign currency (ex-FX), compared with the first quarter of 2023. Women’s Health revenue increased 11% on an as-reported basis, and increased 12% ex-FX in the first quarter of 2024 compared with the first quarter of 2023 primarily driven by 34% ex-FX growth in Nexplanon® (etonogestrel implant). Nexplanon's strong performance was primarily due to the favorable year-over-year comparison of customer purchasing patterns associated with the timing of U.S. list-price adjustments, coupled with favorable price and discount rates in the U.S. and the favorable timing of tenders to markets outside of the U.S. Worldwide sales of the Jada® system, a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, nearly doubled compared with the prior year period, benefiting from continued uptake in the United States following the product's launch in early 2022. Performance in the Women's Health franchise was partially offset by sales of NuvaRing® (estonogestrel / ethinyl estradiol vaginal ring), a vaginal contraceptive product, which declined 19% ex-FX during the period due to ongoing generic competition. The fertility portfolio was down 2% ex-FX in the first quarter, following a very strong fourth quarter of 2023 for Follistim AQ® (follitropin beta injection) which benefited from a one-time buy-in associated with the planned exit of a temporary spin-off related commercial arrangement in the U.S. and increased demand that was largely tied to onboarding a new customer. Biosimilars revenue grew 46% on an as-reported basis and 46% ex-FX in the first quarter of 2024, compared with the first quarter of 2023. This revenue growth was primarily driven by Ontruzant® (trastuzumab-dttb), which benefited from incremental demand from a tender in Brazil. Renflexis® (infliximab-abda) grew 12% ex-FX primarily due to continued demand growth in the U.S and Canada partially offset by unfavorable rates in the U.S. Worldwide revenue of Hadlima® (adalimumab-bwwd) was $30 million during the three months ended March 31, 2024, compared with $5 million in the prior year period, primarily related to continued uptake following the product's July 2023 launch in the U.S. Established Brands revenue was flat on an as-reported basis and grew 2% ex-FX in the first quarter of 2024. Contribution from the recent licensing of Emgality® (galcanezumab) and RayvowTM (lasmiditan)(1, 2), together with a recovery in certain injectable steroid products following last year's market action offset the impacts of Volume Based Procurement initiatives in China. Performance was equally driven by growth in volume and price. The company expects revenue growth in the Established Brands franchise to be about flat for full year 2024 on an ex-FX basis. (1) Emgality is a trademark registered in the United States in the name of Eli Lilly and Company (used under license). (2) Rayvow is a registered trademark of Eli Lilly in the European Union and other countries (used under license). First Quarter 2024 Profitability in $ millions, except per share amounts Q1 2024 Q1 2023 VPY Revenues $ 1,622 $ 1,538 5% Cost of sales 665 580 15% Gross profit 957 958 —% Non-GAAP Adjusted gross profit (1) 1,007 1,003 —% Net income 201 177 14% Non-GAAP Adjusted net income (1) 315 276 14% Diluted Earnings per Share (EPS) 0.78 0.69 13% Non-GAAP Adjusted diluted EPS (1) 1.22 1.08 13% Acquired in-process research & development (IPR&D) and milestones 15 8 — Per share impact to diluted EPS from acquired IPR&D and milestones (0.05 ) (0.03 ) — Adjusted EBITDA (Non-GAAP) (1,2) 538 518 4% Q1 2024 Q1 2023 Gross margin 59.0 % 62.3 % Non-GAAP Adjusted gross margin (1) 62.1 % 65.2 % Adjusted EBITDA margin (Non-GAAP) (1, 2) 33.2 % 33.7 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. (2) Adjusted EBITDA and Adjusted EBITDA margin included $15 million in the first quarter of 2024 and $8 million in the first quarter of 2023 related to Acquired IPR&D and milestones. Gross margin was 59.0% as-reported and 62.1% on a non-GAAP adjusted basis in the first quarter of 2024 compared with 62.3% as-reported and 65.2% on a non-GAAP adjusted basis in the first quarter of 2023. The lower non-GAAP Adjusted gross margin was primarily related to unfavorable product mix, foreign exchange translation and higher inflation impacts to material and distribution costs. Net income for the first quarter of 2024 was $201 million, or $0.78 per diluted share, compared with $177 million, or $0.69 per diluted share, in the first quarter of 2023. Non-GAAP Adjusted net income was $315 million, or $1.22 per diluted share, compared with $276 million, or $1.08 per diluted share, in 2023. Non-GAAP Adjusted EBITDA margin was 33.2% in the first quarter of 2024 compared with 33.7% in the first quarter of 2023 primarily due to cost containment initiatives targeting operating expenses, particularly in research and development, that were offset by higher cost of goods sold. 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 June 13, 2024, to stockholders of record at the close of business on May 13, 2024. As of March 31, 2024, cash and cash equivalents were $575 million, and debt was $8.7 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, except for revenue. Previous guidance as of February 15, 2024 Current guidance Revenues $6.2B - $6.5B Unchanged Adjusted gross margin 61.0% - 63.0% Unchanged SG&A $1.5B - $1.7B Unchanged R&D* $400M - $500M Unchanged Adjusted EBITDA margin (Non-GAAP) 31.0% - 33.0% Unchanged Interest ~$520M Unchanged Depreciation ~$130M Unchanged Effective non-GAAP tax rate 18.5% - 20.5% Unchanged Fully diluted weighted average shares outstanding ~259M Unchanged *R&D expense includes $15 million of IPR&D and milestone expense year-to-date March 31, 2024. R&D guidance does not take into consideration a forward looking view of IPR&D and milestone expense. Webcast Information Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its first quarter 2024 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 EBITDA margin, Adjusted gross margin, Adjusted gross profit, Adjusted net income, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company’s financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. Please refer to Table 4 and Table 5 of this press release for additional information, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. In addition, the company’s full-year 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’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about Organon’s 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 March 31, 2024 2023 Revenues $ 1,622 $ 1,538 Costs, Expenses and Other Cost of sales 665 580 Selling, general and administrative 431 435 Research and development 112 129 Acquired in-process research and development and milestones 15 8 Restructuring costs 23 4 Interest expense 131 132 Exchange losses 6 9 Other expense, net 3 6 1,386 1,303 Income Before Income Taxes 236 235 Taxes on income 35 58 Net Income $ 201 $ 177 Earnings per Share: Basic $ 0.78 $ 0.70 Diluted $ 0.78 $ 0.69 Weighted Average Shares Outstanding: Basic 255,695 254,392 Diluted 258,362 256,170 TABLE 2 Organon & Co. Sales by top products (Unaudited, $ in millions) Three Months Ended March 31, 2024 2023 U.S. Int’l Total U.S. Int’l Total Women’s Health Nexplanon/Implanon NXT $ 153 $ 67 $ 220 $ 114 $ 52 $ 165 Follistim AQ 11 35 46 26 29 55 NuvaRing (1) 16 22 38 25 24 49 Ganirelix Acetate Injection 6 23 29 6 23 30 Marvelon/Mercilon — 33 33 — 37 37 Jada 13 — 13 7 — 7 Other Women’s Health (1) (2) 15 28 43 9 28 38 Biosimilars Renflexis 55 14 69 55 7 62 Ontruzant 8 31 39 13 8 21 Brenzys — 24 24 — 19 19 Aybintio — 8 8 — 10 10 Hadlima 22 8 30 — 5 5 Established Brands Cardiovascular Zetia (1) 2 82 84 2 87 89 Vytorin 1 27 28 2 28 29 Atozet — 132 132 — 128 128 Rosuzet — 16 16 — 18 18 Cozaar/Hyzaar 3 65 67 2 83 85 Other Cardiovascular (1) (2) — 37 38 1 34 35 Respiratory Singulair 2 95 98 3 117 120 Nasonex (1) — 77 77 — 71 71 Dulera 43 13 56 38 8 46 Clarinex 1 36 37 1 39 39 Other Respiratory (1) (2) 7 3 9 12 3 15 Non-Opioid Pain, Bone and Dermatology Arcoxia — 75 75 — 71 71 Fosamax 1 38 40 — 37 38 Diprospan — 29 29 — 14 14 Other Non-Opioid Pain, Bone and Dermatology (1) 5 68 72 4 59 63 Other Proscar — 26 26 — 27 27 Propecia 2 21 23 2 31 33 Other (1) (4) 5 89 94 4 76 80 Other (3) — 29 29 — 39 39 Revenues $ 371 $ 1,251 $ 1,622 $ 326 $ 1,212 $ 1,538 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) Sales of the authorized generic versions of NuvaRing, Zetia and Nasonex were previously included in other and have been reclassified to their respective brand name product. (2) 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. (3) Includes manufacturing sales to third parties for current and prior periods. (4) Includes revenues from the migraine medicines Emgality and Rayvow. TABLE 3 Organon & Co. Sales by geographic area (Unaudited, $ in millions) Three Months Ended March 31, 2024 2023 Europe and Canada $ 450 $ 400 United States 371 326 Asia Pacific and Japan 287 324 China 206 225 Latin America, Middle East, Russia, and Africa 274 214 Other (1) 34 49 Revenues $ 1,622 $ 1,538 (1) Other includes manufacturing sales to third parties. TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited, $ in millions except per share amounts) Three Months Ended March 31, 2024 GAAP Spin related Costs(1) Manufacturing Network Related Costs(2) Restructuring Stock-based Compensation Amortization Other Non-GAAP Adjusted Cost of sales $ 665 (3 ) (10 ) — (4 ) (33 ) — $ 615 Gross profit 957 3 10 — 4 33 — 1,007 Gross margin 59.0 % 62.1 % Selling, general and administrative 431 (40 ) — — (18 ) — — 373 Research and development 112 (2 ) — — (4 ) — — 106 Restructuring costs 23 — — (23 ) — — — — Other expense (income), net 3 (4 ) — — — — — (1 ) Taxes on income(3) 35 9 2 6 4 6 — 62 Net income 201 40 8 17 22 27 — 315 Earnings per share - Diluted $ 0.78 $ 1.22 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. (3) Represents the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments. Three Months Ended March 31, 2023 GAAP Spin related Costs(1) Restructuring Stock-based Compensation Amortization Other(2) Non-GAAP Adjusted Cost of sales $ 580 (10 ) — (4 ) (29 ) (2 ) $ 535 Gross profit 958 10 — 4 29 2 1,003 Gross margin 62.3 % 65.2 % Selling, general and administrative 435 (46 ) — (15 ) — (1 ) 373 Research and development 129 (3 ) — (3 ) — — 123 Restructuring costs 4 — (4 ) — — — — Other expense (income), net 6 (6 ) — — — — — Taxes on income(3) 58 13 1 4 6 — 82 Net income 177 52 3 18 23 3 276 Earnings per share - Diluted $ 0.69 $ 1.08 (1) 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. (3) Represents the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments. TABLE 5 Organon & Co. Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended March 31, 2024 2023 Net Income $ 201 $ 177 Depreciation (1) 30 28 Amortization 33 29 Interest expense 131 132 Taxes on income 35 58 EBITDA $ 430 $ 424 Restructuring costs 23 4 One-time costs (2) 59 68 Stock-based compensation 26 22 Adjusted EBITDA (Non-GAAP) $ 538 $ 518 Adjusted EBITDA margin (Non-GAAP) 33.2 % 33.7 % (1) Excludes accelerated depreciation included in one-time costs. (2) Represents spin-related, manufacturing network, and other one-time costs. Spin-related costs reflect certain costs incurred in connection with activities taken to separate Organon from Merck & Co., Inc., Rahway, NJ, US. These costs include, but are not limited to, $21 million and $37 million for the three months ended March 31, 2024 and 2023, respectively, for information technology infrastructure, primarily related to the implementation of a stand-alone enterprise resource planning system and redundant software licensing costs, as well as $14 million and $6 million for the three months ended March 31, 2024 and 2023, respectively, associated with temporary transition service agreements with Merck & Co., Rahway, NJ, US. Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs, and totaled $10 million for the three months ended March 31, 2024. As these costs are directly related to the separation of Organon and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provide meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance.

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