Etonogestrel

Guidance ranges for full year 2025 revenue and Adjusted EBITDA margin are affirmed; company expects to generate over $900 million of free cash flow before one-time costs in 2025 Vtama on track to achieve $150 million revenue target for full year 2025; double-digit growth in Nexplanon in the first quarter Company resets capital allocation priorities to accelerate progress towards deleveraging; new annual regular dividend rate of $0.08 per share First quarter 2025 revenue of $1.513 billion, down 7% as-reported and down 4% at constant currency, consistent with company’s expectations First quarter 2025 diluted earnings per share of $0.33 and non-GAAP Adjusted diluted earnings per share of $1.02 First quarter 2025 net income of $87 million and Adjusted EBITDA (non-GAAP) of $484 million, representing an Adjusted EBITDA margin of 32.0% JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2025. “We have reset our capital allocation priorities to accelerate progress towards deleveraging, enabling a path to achieve a net leverage ratio of below 4.0x by year-end. Over the last year, we have established a leaner, more fit-for-purpose cost structure while increasing revenue contribution from our core growth drivers. By deleveraging more rapidly, we will continue to strengthen the future prospects of the company. Over time, this will position us to execute more of the compelling business development we’ve done to date, bringing in additional growth drivers to our portfolio, while maintaining lower leverage,” said Kevin Ali, Organon’s CEO. “With key growth drivers, Nexplanon and Vtama, on track to achieve their revenue objectives for the year, we are affirming our full year revenue and Adjusted EBITDA margin guidance, as well as our target of generating over $900 million of free cash flow before one-time costs.” First Quarter 2025 Revenue in $ millions Q1 2025 Q1 2024 VPY VPY ex-FX Women’s Health $ 463 $ 422 10 % 12 % Biosimilars 141 170 (17 )% (15 )% Established Brands 887 1,001 (11 )% (8 )% Other (1) 22 29 (23 )% (19 )% Revenue $ 1,513 $ 1,622 (7 )% (4 )% Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to third parties. For the first quarter of 2025, total revenue was $1.513 billion, down 7% on an as-reported basis and down 4% year-over-year excluding the impact of foreign currency (ex-FX). Women’s Health revenue increased 10% as-reported and 12% ex-FX in the first quarter of 2025, compared with the first quarter of 2024. Nexplanon® (etonogestrel implant) growth of 14% ex-FX, as well as a favorable year-over-year comparison in Follistim AQ® (follitropin beta injection) related to the exit of a spin-related interim operating model agreement in the United States, together more than offset a 41% ex-FX decline in NuvaRing® (etonogestrel / ethinyl estradiol vaginal ring) attributable to ongoing generic competition. Biosimilars revenue declined 17% as-reported and 15% ex-FX in the first quarter of 2025, compared with the first quarter of 2024, primarily due to the return to normalized levels of the contracted volume of Ontruzant® (trastuzumab-dttb) in Brazil, a 17% ex-FX decline in Renflexis® (infliximab-abda) attributable to competitive pricing pressure in the U.S. associated with the maturity of the product, and the timing of international tenders for Brenzys™ (etanercept). Performance was partially offset by sales of Hadlima® (adalimumab-bwwd) that have continued to ramp up since its July 2023 launch in the U.S. Established Brands revenue declined 11% as-reported and 8% ex-FX in the first quarter of 2025. Revenue contribution of Emgality®(1) (galcanezumab-gnlm) and Vtama®(2) (tapinarof), partially offset the impact of the loss of exclusivity (“LOE”) of Atozet™ (ezetimibe and atorvastatin) in key markets in Europe and lower sales of Singulair® (montelukast), particularly in China and Japan. (1) Organon acquired certain European licensing and distribution rights to Emgality and Rayvow from Eli Lilly beginning in early 2024. Emgality and Rayvow are registered trademarks of Eli Lilly in the European Union and other countries (used under license). (2) Vtama was acquired as part of Organon's acquisition of Dermavant Sciences Ltd. (“Dermavant”) which closed on October 28, 2024. First Quarter 2025 Profitability in $ millions, except per share amounts Q1 2025 Q1 2024 VPY Revenues $ 1,513 $ 1,622 (7 )% Cost of sales 672 665 1 % Gross profit 841 957 (12 )% Non-GAAP Adjusted gross profit (1) 934 1,007 (7 )% Net income 87 201 (57 )% Non-GAAP Adjusted net income (1) 265 315 (16 )% Diluted Earnings per Share (EPS) 0.33 0.78 (58 )% Non-GAAP Adjusted diluted EPS (1) 1.02 1.22 (16 )% Acquired in-process research & development (IPR&D) and milestones 6 15 — % Adjusted EBITDA (Non-GAAP) (1, 2) 484 538 (10 )% Q1 2025 Q1 2024 Gross margin 55.6 % 59.0 % Non-GAAP Adjusted gross margin (1) 61.7 % 62.1 % Adjusted EBITDA margin (Non-GAAP) (1, 2) 32.0 % 33.2 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. (2) Adjusted EBITDA and Adjusted EBITDA margin for 2025 and 2024 include $6 million and $15 million, respectively, related to acquired IPR&D and milestones. Gross margin was 55.6% as-reported and 61.7% on a non-GAAP adjusted basis in the first quarter of 2025, compared with 59.0% as-reported and 62.1% on a non-GAAP adjusted basis in the first quarter of 2024. Lower reported gross margin in the first quarter was due to higher year-over-year amortization expense related to the acquisition of intangibles in the prior year. The year-over-year decline in non-GAAP Adjusted gross margin was primarily due to unfavorable price. Net income for the first quarter of 2025 was $87 million, or $0.33 per diluted share, compared with $201 million, or $0.78 per diluted share, in the first quarter of 2024. For the first quarter of 2025, non-GAAP Adjusted net income was $265 million, or $1.02 per diluted share, compared with $315 million, or $1.22 per diluted share, in 2024. Non-GAAP Adjusted EBITDA margin was 32.0% in the first quarter of 2025 compared with 33.2% in the first quarter of 2024. The lower Adjusted EBITDA margin was primarily driven by the decline in Adjusted gross profit; non-GAAP operating expenses were down 1% year-over-year. Capital Allocation Today, Organon’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. This is a revision from the company's prior quarterly dividend rate of $0.28 per share. The dividend is payable on June 12, 2025, to stockholders of record at the close of business on May 12, 2025. As of March 31, 2025, cash and cash equivalents were $547 million, and debt was $8.96 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 2025 financial guidance is presented below on a non-GAAP basis, except revenue. Previous Guidance as of February 13, 2025 Current Guidance Revenue $6.125B-$6.325B Unchanged FX translation headwind ~$200M Unchanged, but with potential upside at current rates Adjusted gross margin 60.0%-61.0% Unchanged SG&A Mid 20% range Unchanged R&D Upper single-digit Unchanged IPR&D* - $6 million Adjusted EBITDA margin (Non-GAAP) 31.0%-32.0% Unchanged Interest ~$510M Unchanged Depreciation ~$135M Unchanged Effective non-GAAP tax rate 22.5%-24.5% Unchanged Fully diluted weighted average shares outstanding ~263M Unchanged *The company does not provide guidance for forward-looking IPR&D and milestone expense. The $6 million of IPR&D expense in current guidance reflects IPR&D expense recorded through March 31, 2025. Webcast Information Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its first quarter financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at https://www.organon.com/investor-relations/events-and-presentations/. 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: https://registrations.events/direct/Q4I585113 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 an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit https://www.organon.com 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 2025 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 expectations regarding regulatory approvals (including the timing and outcome thereof) and product launch dates, potential benefits of Organon’s non-U.S. manufacturing locations, full-year 2025 guidance estimates and predictions regarding other financial information and metrics, expectations regarding Organon’s collaborations with third parties, and franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as “guidance,” potential,” “should,” “continue,” “will,” “continue,” “expects,” “intends,” “plans,” “believes,” “future,” “estimates,” “opportunity,” “path,” 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, expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon’s customers and business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; market volatility, downgrades to the U.S. government’s sovereign credit rating or its perceived creditworthiness, changing political or geopolitical conditions, market contraction, boycotts, and sanctions, as well as Organon’s ability to successfully manage uncertainties related to the foregoing; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as Organon’s products lose patent protection; any failure by Organon to retain market exclusivity for Nexplanon or to obtain an additional period of exclusivity in the United States for Nexplanon subsequent to the expiration of the rod patents in 2027; the continued impact of the September 2024 LOE for Atozet; restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the U.S. Securities and Exchange Commission (“SEC”) and other U.S. and comparable government agencies; difficulties and uncertainties inherent in the implementation of Organon’s acquisition strategy or failure to recognize the benefits of such acquisitions; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon’s business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals or declining sales; delays or failures to demonstrate adequate efficacy and safety of Organon’s product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of Organon’s product candidates; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care insurance coverage; legal factors, including product liability claims, antitrust litigation and governmental investigations, including tax disputes, environmental claims and patent disputes with branded and generic competitors, any of which could preclude commercialization of products or negatively affect the profitability of existing products; lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the FDA and other regulatory authorities; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of Organon’s products; cyberattacks on, or other failures, accidents, or security breaches of, Organon’s or third-party providers’ information technology systems, which could disrupt Organon’s operations and those of third parties upon which it relies; increased focus on privacy issues in countries around the world, including the United States, the European Union, and China, and a more difficult legislative and regulatory landscape for privacy and data protection that continues to evolve with the potential to directly affect Organon’s business, including recently enacted laws in a majority of states in the United States requiring security breach notification; changes in tax laws including changes related to the taxation of foreign earnings; the impact of any future pandemic, epidemic, or similar public health threat on Organon’s business, operations and financial performance; loss of key employees or inability to identify and recruit new employees; changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to Organon; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon’s products. 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 SEC, including the company’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). 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, 2025 2024 Revenues $ 1,513 $ 1,622 Cost of sales 672 665 Gross Profit 841 957 Selling, general and administrative 420 431 Research and development 96 112 Acquired in-process research and development and milestones 6 15 Restructuring costs 86 23 Interest expense 124 131 Exchange (gains) losses (4 ) 6 Other expense, net 12 3 Income before income taxes 101 236 Income tax expense 14 35 Net income $ 87 $ 201 Earnings per share: Basic $ 0.34 $ 0.78 Diluted $ 0.33 $ 0.78 Weighted average shares outstanding: Basic 257,862 255,695 Diluted 261,001 258,362 TABLE 2 Sales by top products (Unaudited, $ in millions) Three Months Ended March 31, 2025 2024 ($ in millions) U.S. Int’l Total U.S. Int’l Total Women’s Health Nexplanon/Implanon NXT $ 176 $ 72 $ 248 $ 153 $ 67 $ 220 Follistim AQ 35 34 69 11 35 46 NuvaRing 6 16 22 16 22 38 Ganirelix Acetate Injection 5 23 27 6 23 29 Marvelon/Mercilon — 39 39 — 33 33 Jada 15 — 15 13 — 13 Other Women’s Health (1) 15 27 43 15 28 43 Biosimilars Renflexis 44 12 57 55 14 69 Hadlima 33 14 47 22 8 30 Ontruzant 4 14 18 8 31 39 Brenzys — 14 14 — 24 24 Aybintio — 5 5 — 8 8 Established Brands Cardiovascular Atozet — 77 77 — 132 132 Zetia 1 84 85 2 82 84 Cozaar/Hyzaar 2 53 55 3 65 67 Vytorin 1 22 23 1 27 28 Rosuzet — 4 4 — 16 16 Other Cardiovascular (1) — 30 30 — 37 38 Respiratory Singulair 2 72 74 2 95 98 Nasonex — 71 72 — 77 77 Dulera 34 10 43 43 13 56 Clarinex — 34 34 1 36 37 Other Respiratory (1) 10 3 13 7 3 9 Non-Opioid Pain, Bone and Dermatology Arcoxia — 62 62 — 75 75 Fosamax 1 32 33 1 38 40 Diprospan — 30 30 — 29 29 Vtama 20 4 24 — — — Other Non-Opioid Pain, Bone and Dermatology (1) 4 65 68 5 68 72 Other Propecia 1 24 26 2 21 23 Emgality/Rayvow — 32 32 — 10 10 Proscar — 24 24 — 26 26 Other (1) 3 76 78 5 79 84 Other (2) — 22 22 — 29 29 Revenues $ 412 $ 1,101 $ 1,513 $ 371 $ 1,251 $ 1,622 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. (2) Other includes manufacturing sales to third parties. TABLE 3 Organon & Co. Sales by geographic area (Unaudited, $ in millions) Three Months Ended March 31, 2025 2024 Europe and Canada $ 376 $ 450 United States 412 371 Asia Pacific and Japan 251 287 China 204 206 Latin America, Middle East, Russia, and Africa 240 274 Other (1) 30 34 Revenues $ 1,513 $ 1,622 (1) Other includes manufacturing sales to third parties. Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Unaudited, $ in millions) Three Months Ended March 31, 2025 2024 GAAP Gross Profit $ 841 $ 957 Adjusted for: Spin-related costs (1) — 3 Manufacturing network costs (2) 29 10 Stock-based compensation 4 4 Amortization 50 33 Acquisition-related costs (3) 9 — Other 1 — Adjusted Non-GAAP Gross Profit $ 934 $ 1,007 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. (3) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5. Three Months Ended March 31, 2025 2024 GAAP Gross Margin 55.6 % 59.0 % Total impact of Non-GAAP adjustments 6.1 % 3.1 % Adjusted Non-GAAP Gross Margin 61.7 % 62.1 % Three Months Ended March 31, 2025 2024 GAAP Selling, general and administrative expenses $ 420 $ 431 Adjusted for: Spin-related costs (1) — (40 ) Stock-based compensation (16 ) (18 ) Restructuring related charges (6 ) — Other (3 ) — Adjusted Non-GAAP Selling, general and administrative expenses $ 395 $ 373 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) (Unaudited, $ in millions except per share amounts) Three Months Ended March 31, 2025 2024 GAAP Research and development expenses $ 96 $ 112 Adjusted for: Spin-related costs (1) — (2 ) Manufacturing network costs (2) (3 ) — Stock-based compensation (4 ) (4 ) Other (1 ) — Adjusted Non-GAAP Research and development expenses $ 88 $ 106 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. Three Months Ended March 31, 2025 2024 GAAP Reported Net Income $ 87 $ 201 Adjusted for: Cost of sales adjustments 93 50 Selling, general and administrative adjustments 25 58 Research and development adjustments 8 6 Restructuring 86 23 Change in fair value of contingent consideration 11 — Other expense, net 4 4 Tax impact on adjustments above(1) (49 ) (27 ) Non-GAAP Adjusted Net Income $ 265 $ 315 (1) For the three months ended March 31, 2025 and 2024, the GAAP income tax rates were 13.4% and 14.7%, respectively, and the non-GAAP income tax rates were 19.2% and 16.4%, respectively. These adjustments represent 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, 2025 2024 GAAP Diluted Earnings per Share $ 0.33 $ 0.78 Total impact of Non-GAAP adjustments 0.69 0.44 Non-GAAP Diluted Earnings per Share $ 1.02 $ 1.22 Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended March 31, 2025 2024 GAAP Reported Net Income $ 87 $ 201 Depreciation (1) 32 30 Amortization 50 33 Interest expense 124 131 Income tax expense 14 35 EBITDA (Non-GAAP) $ 307 $ 430 Restructuring and related charges 92 23 Spin-related costs (2) — 49 Manufacturing network related (3) 36 10 Acquisition-related costs (4) 9 — Change in contingent consideration 11 — Other costs 5 — Stock-based compensation 24 26 Adjusted EBITDA (Non-GAAP) $ 484 $ 538 Adjusted EBITDA margin (Non-GAAP) 32.0 % 33.2 % (1) Excludes accelerated depreciation included in one-time costs. (2) 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 for the three months ended March 31, 2024, 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 for the three months ended March 31, 2024, associated with temporary transition service agreements with Merck & Co., Inc., Rahway, NJ, US. (3) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs. (4) Acquisition related costs for the three months ended March 31, 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. As the costs described in (1) through (4) above are directly related to the separation of Organon and acquisition related activities and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provides meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance.

In February 2025, the global pharmaceutical industry witnessed a series of milestone post-marketing collaboration deals, highlighting a deep integration of pharmaceutical innovation and market expansion that transcends geographical boundaries. From treatments for rare diseases to cancer management, and from improving sleep quality to alleviating chronic pain, drug development and distribution partnerships are advancing at an unprecedented pace. In February, Eisai joined forces with SciClone Pharmaceuticals to advance the application of tasurgratinib in the Greater China region, offering new hope to patients with cholangiocarcinoma. Meanwhile, Nxera Pharma’s partnership with Holling Bio-Pharma Corp. aims to introduce daridorexant to the Taiwanese market, providing a novel treatment option for insomnia sufferers. In another example of global collaboration, Bavarian Nordic and Biological E Limited announced a partnership to expand global supply of the chikungunya vaccine, underscoring the cooperative spirit of multinational companies in addressing public health challenges. 1. Eisai and SciClone Partner to Advance the Development and Distribution of Tasurgratinib in Greater China On February 28, 2025, Eisai announced a significant licensing agreement with a subsidiary of SciClone Pharmaceuticals. The agreement grants SciClone exclusive rights to develop and commercialize tasurgratinib in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan. Tasurgratinib is a novel tyrosine kinase inhibitor that selectively inhibits FGFR1, FGFR2, and FGFR3. It has already been approved in Japan for the treatment of unresectable cholangiocarcinoma with FGFR2 gene fusions or rearrangements that have progressed after chemotherapy, and it was successfully launched in November 2024. Through this collaboration, Eisai aims to leverage SciClone’s strong market presence and commercialization capabilities in the region to accelerate the local deployment of tasurgratinib, bringing hope to more patients. Under the terms of the agreement, Eisai will receive an upfront payment in recognition of the licensing rights. In addition, milestone payments will be made as the drug progresses through development stages and secures regulatory approvals. Following product launch, Eisai will also receive royalties based on net sales, providing a return on its R&D investment and reflecting confidence in the drug’s market performance. This financial structure is designed to promote close collaboration between both parties and maximize the value of tasurgratinib. Tasurgratinib, as an orally bioavailable tyrosine kinase inhibitor, exerts its effects through selective inhibition of FGFR1, FGFR2, and FGFR3. This selectivity allows tasurgratinib to target specific types of cancer cells effectively without interfering with other essential physiological processes. In particular, tumors associated with FGFR abnormalities—such as cholangiocarcinoma and certain breast cancers—present promising therapeutic targets. In addition to its approved use in cholangiocarcinoma in Japan, tasurgratinib is currently undergoing a Phase I clinical trial in Japan for patients with estrogen receptor-positive, HER2-negative breast cancer, further exploring its potential in broader oncology indications. 2. Nxera Pharma and Holling Collaborate to Commercialize Daridorexant in Taiwan On February 28, 2025, Tokyo- and Cambridge-based Nxera Pharma announced it had signed a licensing, supply, and commercialization agreement with Holling Bio-Pharma Corp., Taiwan’s largest pharmaceutical distributor, to bring daridorexant to the Taiwanese market. The collaboration seeks to address the growing demand for effective insomnia treatments in the region. Daridorexant is a new oral dual orexin receptor antagonist (DORA) that helps regulate overactive wakefulness signals by selectively binding to and inhibiting orexin receptors OX1R and OX2R, thereby promoting better sleep onset and maintenance. Under the agreement, Nxera will supply the drug product, while Holling will handle regulatory approval, commercialization, and distribution activities, retaining all regulatory rights. Holling is expected to submit a New Chemical Entity (NCE) application to the Taiwan Food and Drug Administration by mid-2025. If approved, daridorexant could be launched in Taiwan by mid-2026. Nxera will receive an upfront payment upon signing, along with additional milestone payments based on regulatory progress and sales performance. Nxera is also entitled to royalties on net sales from product supply, reflecting the mutual confidence in daridorexant’s market potential and supporting further development efforts. Daridorexant works by blocking the binding and activity of orexins—neuropeptides that promote wakefulness—through dual inhibition of their receptors. The drug has already been launched in Japan under the brand name QUVIVIQ™ following approval in September 2024 and a subsequent market launch in December 2024 by Nxera Pharma Japan in collaboration with Shionogi. Nxera is also conducting a Phase III clinical trial in South Korea to evaluate daridorexant’s efficacy and safety in adults with insomnia. Notably, QUVIVIQ™ has also received regulatory approval in the United States, Europe, and several other countries, where Idorsia Pharmaceuticals Ltd. is responsible for marketing activities. This broad international recognition further supports daridorexant’s status as a best-in-class treatment option. The development of daridorexant continues to progress positively. In addition to its successful launch in Japan, the Phase III trial in South Korea is ongoing, aiming to confirm the drug’s safety and efficacy in improving insomnia symptoms in adults. Given the significant number of insomnia patients in Taiwan, the introduction of daridorexant is expected to have a meaningful impact on clinical practice in the region. Furthermore, this collaboration is part of Nxera’s broader strategy to enhance access to innovative medicines across Japan and the wider Asia-Pacific region by partnering with leading regional commercial players, thus reaching a larger patient population while leveraging the company’s internal expertise in specialty and rare disease medicines. 3. Bavarian Nordic Partners with Biological E Limited to Expand Global Access to Chikungunya Vaccine On February 28, 2025, Bavarian Nordic announced a strategic partnership with Indian biopharmaceutical company Biological E Limited to enhance the global supply of its Chikungunya vaccine. This collaboration underscores both companies’ commitment to improving access to this important vaccine in developing countries. Through this partnership, Bavarian Nordic and Biological E Limited plan to co-invest in the further development of the vaccine and ensure its availability across more countries and regions. The product at the center of this agreement is a vaccine specifically designed to prevent Chikungunya virus infection. This innovative vaccine mimics the structural features of the virus—particularly its surface proteins—to induce a specific antibody response from the human immune system. These antibodies can recognize and neutralize the actual Chikungunya virus during infection, thereby preventing disease onset. Utilizing virus-like particle (VLP) technology, the vaccine delivers robust immune protection without containing live virus, significantly enhancing its safety profile. This Chikungunya VLP vaccine has already received its first regulatory approval in the United States for the prevention of Chikungunya fever. It has also been granted multiple special regulatory designations in both the U.S. and the European Union, including Accelerated Approval, Breakthrough Therapy Designation, Fast Track, and Priority Review—highlighting the recognized public health value of the vaccine. Beyond U.S. approval, additional clinical trials and regulatory submissions are underway in various other countries and regions to expand its global reach. Originally developed by PaxVax Holding Co., Ltd., the vaccine has achieved several critical development milestones. After Bavarian Nordic acquired the program, it advanced the clinical research and secured the initial U.S. approval. Through its new collaboration with Biological E Limited, the vaccine is expected to gain more rapid market access in Asia and other developing regions. Biological E Limited's deep market knowledge and extensive distribution network in these areas make it a key partner in achieving this objective. Moreover, early-stage development efforts were supported by Emergent BioSolutions, Inc. and the U.S. National Institute of Allergy and Infectious Diseases (NIAID), laying a solid foundation for the vaccine’s success. This partnership marks a significant step toward broader protection against Chikungunya fever worldwide. 4. RedHill and Hyloris Sign Global (Excluding North America) Commercialization Agreement for RHB-102 to Improve Quality of Life for Cancer and Gastrointestinal Patients On February 25, 2025, RedHill Biopharma Ltd. announced the signing of an exclusive development and commercialization licensing agreement with Hyloris Pharmaceuticals SA for RHB-102 (Bekinda®). Under this agreement, Hyloris gains the rights to develop and commercialize RHB-102 in all global markets except the United States, Canada, and Mexico. This collaboration reflects the shared commitment of both companies to provide effective treatment options to more patients worldwide, particularly those suffering from chemotherapy/radiation-induced nausea and vomiting (CINV/RINV), acute gastroenteritis, gastritis, and diarrhea-predominant irritable bowel syndrome (IBS-D). As part of the agreement, Hyloris will pay RedHill an upfront fee and milestone payments of up to $60 million based on the achievement of specific commercial targets. Additionally, Hyloris will pay mid-to-high double-digit percentage royalties on net sales, subject to certain cost deductions and inclusive of minimum annual payments. This financial structure not only provides RedHill with necessary funding support but also incentivizes Hyloris to actively promote RHB-102 and ensure its success in global markets. RHB-102 is a once-daily, dual-release, proprietary oral tablet formulation of ondansetron, a 5-HT3 receptor antagonist used to treat nausea and vomiting. It is available in two dosage strengths: 12 mg and 24 mg, aimed respectively at IBS-D and other indications such as acute gastroenteritis and gastritis. The extended-release profile allows for 24-hour symptom control, representing a significant therapeutic advancement for cancer patients undergoing chemotherapy or radiotherapy, as well as for those with gastrointestinal disorders. RHB-102 has completed multiple key clinical trials, including a Phase III study in the United States for acute gastroenteritis and gastritis (24 mg dose) and a Phase II study for IBS-D (12 mg dose), both of which met their primary endpoints. Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a positive opinion, paving the way for a Marketing Authorization Application (MAA) in the UK. If approved, RHB-102 would become the first 24-hour extended-release oral ondansetron formulation indicated for CINV/RINV. RedHill also plans to continue pursuing FDA approval for RHB-102 in the United States. 5. Pharmanovia and Er-Kim Reach Exclusive Distribution Agreement for Sunosi® in Eastern Europe In February 2025, Pharmanovia announced that it had entered into an exclusive distribution agreement with Er-Kim, a leading Turkish pharmaceutical company, for Sunosi® (solriamfetol) in Eastern Europe. This collaboration brings Sunosi® to the Eastern European market to meet the treatment needs of patients suffering from narcolepsy and obstructive sleep apnea (OSA). Although specific financial details have not been fully disclosed, it can be inferred that the agreement involves an upfront payment, milestone payments, and a royalty structure based on sales performance. This arrangement not only supports further development and marketing efforts for the product but also reflects both parties' confidence in the commercial potential of Sunosi®. Sunosi® is a medication indicated for the treatment of excessive daytime sleepiness associated with narcolepsy and OSA. Its active ingredient, solriamfetol, is a selective dopamine and norepinephrine reuptake inhibitor (DNRI). By increasing the concentrations of these neurotransmitters in the brain, Sunosi® effectively enhances wakefulness and alertness, helping patients regain a normal daily rhythm. This mechanism of action makes it an important treatment option, particularly for patients who do not respond well to or cannot tolerate traditional therapies. Sunosi® has been approved and is commercially available in several countries and regions. Originally developed by Jazz Pharmaceuticals, it received FDA approval in the United States in 2019 for the treatment of excessive daytime sleepiness in adults with narcolepsy or OSA. Since then, Sunosi® has gradually expanded its market presence globally. The partnership between Pharmanovia and Er-Kim marks a significant step toward deeper penetration into the Eastern European market, allowing more patients to benefit from the treatment. Ongoing monitoring of Sunosi®'s long-term safety and efficacy continues to ensure the provision of optimal treatment options for patients. Beyond its current indications, Sunosi® may also demonstrate potential efficacy in treating other types of excessive daytime sleepiness disorders, providing new directions for future research. Pharmanovia will continue to monitor the accumulation of clinical data for Sunosi® and explore broader application possibilities. Through its collaboration with Er-Kim, Pharmanovia aims to establish a strong market position in Eastern Europe while raising awareness of the disease and available treatment options. Furthermore, as the understanding of the pathophysiology of excessive daytime sleepiness deepens, Sunosi® is expected to introduce new research findings in the coming years, offering a stronger scientific foundation for its use. This partnership between Pharmanovia and Er-Kim not only enhances the accessibility of Sunosi® in Eastern Europe but also highlights both companies' shared commitment to improving public health. Leveraging Er-Kim's strong local presence and extensive distribution network will be key to achieving this goal. Such cross-border collaborations accelerate the entry of innovative therapies into emerging markets, offering patients more treatment choices. With increasing recognition and support for Sunosi® across more countries and regions, the medication is expected to significantly improve the quality of life for patients with excessive daytime sleepiness worldwide in the coming years. 6. Apotex Partners with Grünenthal to Bring Qutenza® to the Canadian Market On February 24, 2025, Apotex Inc., Canada’s largest pharmaceutical company, and Grünenthal, a global leader in pain management and related diseases, announced a strategic licensing agreement. Under the agreement, Apotex will obtain exclusive rights to Qutenza® in Canada. This partnership aims to introduce Qutenza® as an innovative treatment option for patients suffering from neuropathic pain in Canada. Although specific financial terms have not been fully disclosed, it can be inferred that Grünenthal will receive an upfront payment, additional milestone payments upon achieving specific regulatory milestones, and royalties based on sales. This financial arrangement not only supports further development and commercialization of the product but also reflects both parties’ confidence in the commercial potential of Qutenza®. Qutenza® is a topical, non-systemic, non-opioid pain treatment patch indicated for the management of neuropathic pain. Its active ingredient is high-concentration capsaicin (8%), a naturally occurring compound that is applied directly to the skin to alleviate pain. Capsaicin works by activating and subsequently desensitizing the TRPV1 receptors in sensory nerves, which play a key role in the transmission of pain signals. Through this mechanism, Qutenza® provides effective relief from chronic pain caused by nerve damage without causing systemic side effects or the risk of addiction. This treatment is particularly beneficial for patients who do not respond well to or cannot tolerate traditional therapies. Since acquiring global rights to Qutenza® in 2018, Grünenthal has continued to invest resources in the product’s development and expansion. Qutenza® has been commercialized in the European Union and the United States, with its indication broadened through relaunch and label expansion efforts. In the U.S. market, Qutenza® has experienced a significant brand resurgence, laying a strong foundation for its further promotion worldwide. Apotex’s subsidiary, Searchlight Pharma, will be responsible for seeking marketing authorization for Qutenza® in Canada and for its subsequent commercialization and distribution upon regulatory approval. This partnership is expected to further enhance the global availability and impact of Qutenza®. Since 2017, Grünenthal has invested over €2 billion in successful mergers and acquisitions, continually creating synergies across manufacturing, logistics, and commercial activities by integrating acquired brands into its infrastructure. For Apotex, this partnership not only strengthens its ability to meet patient needs but also expands its global portfolio, which includes more than 550 branded, generic, and biosimilar products. With the launch of Qutenza® in the Canadian market, an effective new treatment option will soon be available for many patients suffering from neuropathic pain. 7. Daré Bioscience Partners with Theramex to Develop the First Biodegradable Long-Acting Contraceptive Implant, Casea S On February 20, 2025, Daré Bioscience, a company focused on innovation in women’s health, announced a co-development and licensing agreement with Theramex, a global specialty pharmaceutical company dedicated to women’s health. This collaboration aims to advance the development of a first-in-class, biodegradable, long-acting contraceptive implant based on etonogestrel. The agreement marks a significant partnership in promoting women’s health management. Etonogestrel is a small-molecule drug used for contraception. It was first approved on July 17, 2006, in the United States for contraceptive use. As the current Phase 1 study is foundation-funded, there are no direct development costs for either Daré or Theramex at this stage. Under the agreement, Daré receives a royalty-free, exclusive, fully paid-up, and sublicensable license to the U.S. patent for Casea S, recently acquired by Theramex. If Phase 1 results are positive, Daré will take responsibility for conducting Phase 2 studies in the U.S., and funding for future Phase 3 trials in the U.S. will be negotiated between Daré and Theramex based on market opportunity. Etonogestrel is a synthetic progestin that primarily works by inhibiting ovulation to prevent pregnancy. It also thickens cervical mucus, making it harder for sperm to reach the egg, and alters the endometrium to reduce the likelihood of implantation. As a long-acting reversible contraceptive (LARC), etonogestrel is typically delivered via a subdermal implant that can continuously release the hormone for up to three years, offering extended contraceptive protection. Due to its high efficacy and convenience, etonogestrel has become one of the preferred contraceptive options for many women. Since its initial approval, etonogestrel has been authorized for contraceptive use in multiple countries and regions worldwide. It has also been studied for other indications such as dysmenorrhea, bleeding disorders, lower urinary tract symptoms, and benign prostatic hyperplasia. Although some indications are no longer under investigation, the use of etonogestrel in contraception continues to evolve. Companies such as Organon NV are actively working to expand its applications and improve efficacy through ongoing research. 8. SK Chemicals Partners with Jeil Health Science to Boost Pharmacy Sales of Ginexin and Trast On March 17, 2025, SK Chemicals announced a co-marketing agreement with Jeil Health Science, a leading South Korean manufacturer of over-the-counter (OTC) pharmaceuticals. The partnership is aimed at increasing pharmacy sales of two SK Chemicals products—Ginexin-F Soft Cap 120mg and Trast Patch 30—by leveraging Jeil Health Science’s extensive distribution network. Previously, these products were distributed through general pharmaceutical wholesalers. Ginexin-F Soft Cap 120mg: This product is a circulation enhancer formulated with ginkgo biloba extract and comes in a soft capsule format, sold exclusively through pharmacies. Ginkgo biloba extract is renowned for its antioxidant properties and is widely used to improve blood circulation and alleviate symptoms related to poor circulation. Trast Patch 30: This is a pain relief patch available in packs of 7, 10, and 30 units, with the 30-pack being particularly suited for patients requiring repeated use. The patch is applied directly to the skin and delivers active ingredients to relieve localized pain, making it suitable for conditions such as muscle aches and arthritis. Both products are already on the market and have established brand recognition and customer bases. Ginexin enjoys a strong reputation as a natural-origin blood circulation booster, while Trast is favored by consumers for its convenient application and effective pain relief. The goal of the partnership is to further expand the market share of these two products in the pharmacy channel and to enhance consumer awareness and trust through more targeted marketing strategies. Through this collaboration, SK Chemicals aims to take advantage of Jeil Health Science’s powerful sales network—serving over 12,000 pharmacies directly—and its proven track record in promoting OTC products, especially in pain management with successful brands like Kefentech and Jeil Cool Pap. Han Sang-chul, CEO of Jeil Health Science, expressed his enthusiasm for the partnership, stating that they are honored to work with SK Chemicals to promote products that have earned long-term trust in the fields of blood circulation and pain relief. Together, the two companies hope to strengthen Ginexin and Trast’s positions as leading brands in their respective markets and to provide more therapeutic options for patients. This partnership not only aims to enhance the market standing of both companies but also to deliver higher-quality products and services to a broader consumer base. 9. X4 Pharmaceuticals and Taiba Rare Enter Exclusive Agreement to Advance Distribution and Commercialization of XOLREMDI® (Mavorixafor) in Select Middle Eastern Countries On February 19, 2025, X4 Pharmaceuticals, a company committed to improving the lives of patients with rare immunodeficiency diseases, announced an exclusive agreement with Taiba Rare, a division of Taiba Healthcare. The agreement grants Taiba Rare exclusive rights to distribute and commercialize XOLREMDI® (mavorixafor) in Saudi Arabia, the United Arab Emirates, Qatar, Oman, Kuwait, Bahrain, and Egypt, contingent upon obtaining local regulatory approvals. Although specific financial terms have not been disclosed, agreements of this nature typically include upfront payments, sales-based milestone payments, and royalties. These arrangements align the interests of both parties and incentivize Taiba Rare to actively promote XOLREMDI®. Given that XOLREMDI® is the first and only treatment approved for WHIM syndrome (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis), the therapy holds significant market potential, making the partnership attractive to both companies. XOLREMDI® (mavorixafor) is an oral, once-daily treatment approved by the U.S. Food and Drug Administration (FDA) in April 2024 for patients aged 12 and older with WHIM syndrome. It works by increasing the number of circulating mature neutrophils and lymphocytes, thereby enhancing the body's ability to fight infections. Mavorixafor functions by inhibiting the CXCR4 receptor, promoting the release of white blood cells from the bone marrow into the bloodstream. While XOLREMDI® has already received FDA approval in the U.S., its Marketing Authorization Application (MAA) is currently under review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The collaboration with Taiba Rare will accelerate the product's introduction into Middle Eastern markets, offering new treatment options for patients with WHIM syndrome. Under the agreement, Taiba Rare will be responsible for XOLREMDI®’s distribution, promotion, marketing, and sales in the designated region and will jointly develop key strategic decisions with X4 Pharmaceuticals. 10. Beihai Biotechnology Partners with Zydus Lifesciences to Commercialize BEIZRAY® (BH009) in the U.S. On February 18, 2025, Beihai Biotechnology announced a strategic partnership with Zydus Lifesciences. Under the agreement, Beihai grants Zydus exclusive commercialization rights for its novel oncology drug BEIZRAY® in the United States. Following the agreement, Beihai will receive an upfront payment of USD 15 million, with an additional USD 10 million upon the first product delivery—amounting to nearly RMB 200 million in total. Beihai will also benefit from future sales-based milestone payments and a high double-digit percentage share of profits. This payment structure not only provides Beihai with early financial support but also motivates both parties to ensure the commercial success of the product. BEIZRAY® (BH009) is a proprietary, improved formulation of docetaxel developed by Beihai Biotechnology for the treatment of various solid tumors, including breast cancer, non-small cell lung cancer, prostate cancer, gastric cancer, and head and neck squamous cell carcinoma. It acts by stabilizing microtubules and preventing their depolymerization, arresting the cell cycle in the mitotic phase and thereby inhibiting tumor cell proliferation. BEIZRAY® is distinguished by its use of targeted molecular delivery technology that eliminates the use of polysorbate 80—a common component in traditional docetaxel formulations—significantly reducing adverse reactions and improving patient safety. BEIZRAY® received FDA approval in October 2024, making it the first clinically validated and demonstrably superior docetaxel reformulation approved in nearly 30 years. Clinical trials have shown that BEIZRAY® reduces the risk of hematologic toxicity and severe allergic reactions, thereby enhancing the benefit-risk profile for patients. This partnership will leverage Zydus Lifesciences’ robust sales infrastructure in the U.S. to expedite market access and deliver this innovative treatment to a broader patient population. 11. Baheal Pharmaceutical Partners with Roche to Advance Commercialization of Rituximab in China On February 13, 2025, Baheal Pharmaceutical announced that it had entered into a collaboration agreement with Roche. Under this agreement, Baheal has obtained the exclusive rights to promote Roche’s well-known oncology-targeted therapy Rituximab in mainland China. According to the agreement, Roche will pay Baheal a quarterly service fee for its promotional efforts. This arrangement ensures that while Baheal bears the promotional costs, it also receives a corresponding economic return based on sales performance. Additionally, the agreement stipulates that Roche may not appoint any third party to promote the product in the region without prior notice to Baheal, ensuring Baheal’s exclusivity in the market. Rituximab is the world’s first monoclonal antibody specifically targeting the CD20 antigen and marked the beginning of a new era in targeted cancer therapy. It is primarily used for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and other related diseases. Rituximab binds to the CD20 antigen on the surface of B lymphocytes, inducing immune responses against the cancer cells and promoting their apoptosis, thereby inhibiting tumor growth. Since its initial approval in the U.S. in 1997, Rituximab has accumulated over two decades of clinical use and has benefited more than 6.8 million patients worldwide. In China, Rituximab was approved in April 2000, and with approvals for multiple indications—including maintenance therapy for treatment-naïve follicular lymphoma and combination chemotherapy for chronic lymphocytic leukemia—its market potential continues to grow. 12. Chong Kun Dang Secures Exclusive Distribution and Sales Rights for Bayer’s Nexavar and Stivarga in South Korea Chong Kun Dang Pharmaceutical has announced that it has reached an agreement with German pharmaceutical giant Bayer to exclusively distribute and sell two of Bayer’s key oncology drugs—Nexavar and Stivarga—in the South Korean market. This partnership aims to leverage Chong Kun Dang’s robust market network and sales capabilities to expand the local market share of both therapies. Although the specific financial terms have not been disclosed, such agreements typically involve an upfront payment, milestone payments based on sales performance, and profit-sharing arrangements. These structures align the interests of both parties and incentivize Chong Kun Dang to actively promote the products and expand their market presence. Nexavar: A multi-kinase inhibitor indicated for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, and radioactive iodine-refractory differentiated thyroid cancer. It works by inhibiting several intracellular protein kinases involved in tumor growth and angiogenesis. Stivarga: Also a multi-kinase inhibitor, Stivarga is indicated for metastatic colorectal cancer, gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma. It shares a similar mechanism of action with Nexavar but is approved for different indications and is sometimes used as a follow-up treatment after Nexavar. Both Nexavar and Stivarga are globally approved and have been widely used in clinical practice across many countries and regions. They have demonstrated significant efficacy in treating specific types of cancer and have accumulated extensive real-world usage data. With Chong Kun Dang now taking over the distribution and sales of these two drugs in South Korea, the accessibility of these innovative therapies for local patients is expected to increase substantially. For Chong Kun Dang, this partnership strengthens its presence in the oncology sector by adding two well-recognized therapeutic options to its portfolio, potentially creating new growth drivers for the company. For Bayer, choosing Chong Kun Dang as its local partner reflects confidence in the latter’s commercial capabilities and market expertise in South Korea. This strategic alliance is expected to accelerate market penetration of Nexavar and Stivarga in South Korea, ultimately benefiting more patients with access to advanced cancer treatments. Furthermore, it highlights the growing trend of multinational pharmaceutical companies partnering with strong local firms to optimize resource allocation and achieve mutually beneficial outcomes in global market expansion. 13. Lotus Pharmaceutical Partners with Formycon to Advance Commercialization of FYB203/AHZANTIVE® in the Asia-Pacific Region On February 5, 2025, Klinge Biopharma GmbH, the exclusive global commercialization rights holder of FYB203/AHZANTIVE® (Aflibercept), announced an exclusive licensing agreement with multinational pharmaceutical company Lotus Pharmaceutical. Under the terms of the agreement, Lotus will be responsible for the commercialization of FYB203/AHZANTIVE® in the Asia-Pacific region, including Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, Vietnam, and the Hong Kong Special Administrative Region. Concurrently, Formycon also signed a finished product supply agreement with Lotus. According to the agreement, Klinge will receive an upfront payment from Lotus and is eligible for additional milestone payments tied to product launch and sales achievements. Furthermore, Klinge will receive royalties based on Lotus’ net sales, with Formycon sharing in Klinge’s revenues at a rate ranging from mid-single to low-double-digit percentages. This payment structure not only provides Klinge with initial financial support but also incentivizes all parties to collaborate closely toward the successful commercialization of the product. FYB203/AHZANTIVE® is a biosimilar to Eylea® (Aflibercept), used for the treatment of neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The drug works by inhibiting vascular endothelial growth factor (VEGF), thereby reducing the formation of abnormal blood vessels in the retina. VEGF is a protein that promotes the formation of new blood vessels, but its overexpression in certain eye diseases can lead to vision loss or even blindness. By blocking the action of VEGF, FYB203/AHZANTIVE® helps stabilize or improve patients’ vision. FYB203/AHZANTIVE® has achieved significant progress in development, receiving approval from the U.S. Food and Drug Administration (FDA) in June 2024, followed by European Commission approval in January 2025. Currently, Formycon and Lotus are working closely together to prepare submissions to regulatory authorities in the Asia-Pacific region, in accordance with local regulations, to facilitate the timely launch of FYB203/AHZANTIVE® in these markets. This process includes the consolidation of clinical data and adaptations to meet local market requirements. 14. Daewon Pharmaceutical Partners with AstraZeneca Korea to Promote Asthma Treatment Products In early February 2025, Daewon Pharmaceutical announced a collaboration agreement with AstraZeneca Korea to take on the distribution responsibilities for AstraZeneca’s asthma treatment products in the South Korean market. This partnership aims to leverage Daewon’s robust sales network and market expertise to broaden the reach of these essential medications, ensuring that more patients have access to effective treatment options. The agreement includes an upfront payment, sales-based milestone payments, and royalties calculated based on net sales. This structure ensures mutual benefit: AstraZeneca Korea can rapidly expand market share for its products through Daewon’s extensive distribution channels, while Daewon Pharmaceutical gains financial returns from successful product promotion and strengthens its presence in the respiratory disease market. Budesonide/Formoterol (Symbicort) is one such combination product included in this partnership. It consists of a long-acting β2-agonist (LABA) and an inhaled corticosteroid (ICS), designed for long-term control of asthma symptoms. Budesonide helps reduce airway inflammation, while Formoterol relaxes the airway smooth muscles, making breathing easier. This combination therapy effectively alleviates asthma symptoms and reduces the risk of acute exacerbations. These asthma treatment products have been approved globally and have been marketed in numerous countries for years, backed by extensive clinical experience and safety data. For certain products within this collaboration, additional registration steps or labeling adjustments may be required to comply with Korean regulatory standards. However, given their proven efficacy and safety profiles in other markets, it is expected that they will quickly gain recognition and be widely adopted in South Korea. 15. MITEM Pharma Acquires FLISINT® from Sanofi, Committed to Safeguarding the Interests of Patients with Rare and Life-Threatening Diseases In February 2025, MITEM Pharma announced the successful acquisition of the specialty drug FLISINT® from Sanofi. This acquisition underscores MITEM Pharma’s ongoing mission to improve the quality of life for patients suffering from rare and life-threatening diseases. Through this collaboration with Sanofi, MITEM Pharma not only expands its product portfolio but also strengthens its expertise in targeted therapeutic areas. FLISINT® is a specialty medication designed for the treatment of specific rare diseases. Although its exact indication was not disclosed, the name suggests that it may be intended for the treatment of a genetic disorder or metabolic condition requiring specialized attention. The mechanism of action of FLISINT® likely involves addressing enzyme deficiencies or abnormal protein expression caused by genetic mutations, thereby alleviating symptoms and slowing disease progression. For example, it may function through enzyme replacement therapy or by modulating intracellular signaling pathways to restore normal physiological functions. FLISINT® has successfully completed multiple phases of clinical trials and has been approved by regulatory authorities in several countries and regions. This confirms the drug's safety and efficacy, offering an effective treatment option for patients with specific rare conditions. However, with ongoing scientific advancements and the accumulation of new data, further studies may be necessary to explore broader applications or to optimize the formulation for enhanced efficacy and reduced side effects. Conclusion The series of partnership agreements and acquisitions in February 2025 reveals an overarching trend: globalization, specialization, and technological advancement are reshaping the pharmaceutical industry. Whether it's deepening market penetration through local collaboration (such as the partnership between Daewon Pharmaceutical and AstraZeneca Korea) or entering emerging markets (such as X4 Pharmaceuticals' agreement with Taiba Rare for the Middle East), these partnerships demonstrate how pharmaceutical companies are leveraging each other's strengths for mutual benefit. More importantly, they share a common goal—to enhance healthcare access and outcomes for patients worldwide. It is noteworthy that these collaborations go beyond traditional sales and distribution agreements and extend into R&D partnerships. For instance, MITEM Pharma’s acquisition of FLISINT® from Sanofi, as well as Daré Bioscience’s co-development of the biodegradable long-acting contraceptive implant Casea S with Theramex, highlight the growing importance of long-term strategic alliances in driving innovation and accelerating product development in today's rapidly evolving healthcare environment. In summary, the pharmaceutical collaborations of February 2025 mark the dawn of a new era—one characterized by cooperation, resource sharing, and a focus on addressing complex health challenges. As technology continues to evolve and societal awareness of health deepens, we can expect to see more such partnerships emerge, further advancing the frontier of medicine and delivering new therapeutic possibilities to patients around the globe. How to get the latest progress on drug deals? If you would like to access the latest transaction event information, you can click on the 'Deal' module from the homepage of the Synapse database. Within the Deal module, you can search for global pharmaceutical transaction information using labels such as Drugs, Organization, Target, Drug Type, Deal Date.  Furthermore, you can obtain the original link to the transaction coverage by clicking on the "Deal Name." In the analysis view, you can see the most active assignors, assignees, popular targets, and other dimensions of analysis, as well as the distribution of research and development statuses at the time of the transaction, to help you better understand the search results. The Synapse database also supports the ability to view current transactions from the dimension of "drugs" (by selecting "drugs" from the "Adjust Dimension" dropdown menu above). Targeting transactions involving renowned pharmaceutical companies that are of interest to the industry, such as Merck, Roche, etc., Synapse has identified a group of "leading companies" through drugs that have achieved global sales exceeding 1 billion US dollars in 2022. Transactions involving drugs from these leading companies can be filtered by clicking on the "Leading Company" tag on the left-hand side. In addition to the drug transaction module, you can also view related transaction history on the drug detail page and the institution detail page. Click on the image below to explore new pharmaceutical funding transactions!