Latest news with #Emgality
Canada News.Net
4 days ago
- Health
- Canada News.Net
Ajovy becomes the first FDA-approved migraine prevention for kids
SILVER SPRING, Maryland: The U.S. Food and Drug Administration has approved Teva Pharmaceuticals' Ajovy for use in children, marking the first time a migraine prevention drug has been cleared for pediatric patients. Ajovy, an injectable treatment already approved for adults, can now be used in children aged six and older who weigh at least 45 kilograms (about 99 pounds), the FDA said this week. The medication is administered once a month. This expanded approval offers a new option for families of children suffering from episodic migraines—severe, recurring headaches that occur frequently enough to disrupt daily life but not on a daily basis. In children, these headaches are often accompanied by nausea, fatigue, and sensitivity to light and sound. Ajovy belongs to a class of medications known as CGRP (calcitonin gene-related peptide) inhibitors, which work by blocking a protein associated with triggering migraines. The drug was first approved in 2018 for adult use and now joins its rivals, Amgen's Aimovig and Eli Lilly's Emgality, in the pediatric space. However, Ajovy is the first among them to secure FDA approval for migraine prevention in children. In clinical trials, the most common side effects in children were pain and redness at the injection site. The FDA noted that the overall safety profile in pediatric patients was similar to that seen in adult studies. More serious but less common side effects include rash, itchiness, and hypersensitivity to the drug. Migraine is one of the most common neurological conditions in children and adolescents, and options for prevention have long been limited. Pediatric neurologists have often relied on off-label prescriptions of adult medications or lifestyle adjustments to manage the condition. The FDA's approval of Ajovy for children could help shift that treatment landscape. Ajovy's pediatric approval also strengthens Teva's position in the competitive CGRP inhibitor market. While Amgen's Aimovig and Lilly's Emgality have gained traction among adult patients.
Yahoo
4 days ago
- Health
- Yahoo
Teva's Ajovy becomes first migraine prevention drug approved for children
The US Food and Drug Administration (FDA) has approved a label expansion to Teva's Ajovy in certain children and adolescents, making it the first migraine prevention drug of its kind in the age group. Single-dose injectable Ajovy (fremanezumab-vfrm) is now approved for the preventive treatment of episodic migraine in children and adolescent patients aged between six and 17 years who weigh 45kg or more. Ajovy is part of a class of drugs called calcitonin gene-related peptide (CGRP) inhibitors, which block a protein involved in triggering migraines. The FDA approved Ajovy for adults in 2018. Israel-based Teva narrowly missed having the first CGRP-targeting drug approved for migraines at the time, following Novartis and Amgen's Aimovig (erenumab) approval earlier in the year. However, the therapy is not approved for children or adolescents, meaning its patient reach is now not as wide as Ajovy. One in ten children and adolescents in the US suffers from migraines, one of the most common neurological conditions. Paediatric migraine is often underrecognised and undertreated, disrupting lifestyle such as school attendance and social interactions. Episodic migraine refers to recurring severe headaches in children that do not occur daily but are frequent enough to interfere with daily activities. Ajovy is administered once a month and available for in-office or at-home use, offering an accessible treatment option for patients and their caregivers, such as parents. A higher-dose version, given every three months as three injections, is also available for adults. Teva's Phase III SPACE trial (NCT03539393) with the drug demonstrated statistically significant superior efficacy compared to placebo over three months in the paediatric population. The safety profile was consistent with that in the adult population – the most common side effects being itchiness, rash and drug hypersensitivity. Teva's global marketing business head Chris Fox said: 'Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood. 'With this FDA approval, Ajovy now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.' The label expansion in children and adolescents gives Teva an edge over Novartis/Amgen, as well as Eli Lilly, whose Emgality (galcanezumab) – also a CGRP inhibitor – is also approved and on the market. Last year, Teva's migraine treatment Ajovy generated $507m in global sales, an 18% increase compared to the previous year. Analysis by GlobalData forecasts sales of $885m by 2031. Neither Amgen nor Lilly disclosed specific sales for their two products in 2024. GlobalData is the parent company of Pharmaceutical Technology. "Teva's Ajovy becomes first migraine prevention drug approved for children" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Business Wire
5 days ago
- Business
- Business Wire
Organon Reports Results for the Second Quarter Ended June 30, 2025
JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the second quarter ended June 30, 2025. 'During the quarter we paid down principal on our long-term debt and began implementing meaningful cost savings, which together set us on a path to achieve net leverage below 4.0x by the end of this year. We will aim to drive further improvement, with the goal of achieving net leverage of 3.5x or below by the end of 2026,' said Kevin Ali, Organon's Chief Executive Officer. 'We are right where we want to be with VTAMA, making significant progress on our access objectives, with the overall portfolio compensating well for the loss of exclusivity of Atozet in Europe.' Second Quarter 2025 Revenue For the second quarter of 2025, total revenue was $1.594 billion, down 1% on both an as-reported basis as well as excluding the impact of foreign currency (ex-FX). Women's Health revenue increased 3% as-reported and increased 2% ex-FX in the second quarter of 2025, compared with the second quarter of 2024. The company's fertility business grew 15% ex-FX in the second quarter driven by a favorable year-over-year comparison in Follistim AQ® (follitropin beta injection) related to the 2023 exit of a spin-related interim operating model agreement in the U.S., increased demand and favorable rate in the U.S., and geographic footprint expansion. Sales of Nexplanon® (etonogestrel implant) declined 1% ex-FX in the second quarter. Outside the U.S., Nexplanon grew 10% ex-FX in the period largely offsetting a 5% decline in the U.S. In the U.S., customers relying on federal and state subsidized programs are facing potentially constrained funding, which factored into their purchasing decisions for contraceptive products during the second quarter. Biosimilars revenue increased 5% as-reported and increased 6% ex-FX in the second quarter of 2025, compared with the second quarter of 2024, primarily due to strong performance of Hadlima ® (adalimumab-bwwd), which more than offset expected declines in Ontruzant® (trastuzumab-dttb) and Renflexis® (infliximab-abda) associated with the maturity of those products. Established Brands revenue declined 3% as-reported and declined 4% ex-FX in the second 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 sodium), particularly in China and Japan. (1) Organon acquired certain European licensing and distribution rights to Emgality and Rayvow from Eli Lilly and Company ('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. Second Quarter 2025 Profitability Gross margin was 54.8% as-reported and 61.7% on a non-GAAP adjusted basis in the second quarter of 2025, compared with 58.4% as-reported and 62.0% on a non-GAAP adjusted basis in the second quarter of 2024. Lower reported gross margin in the second quarter was due to higher year-over-year amortization expense related to the acquisition of intangibles in the prior year, as well as amortization associated with the inventory fair value adjustment related to the Dermavant acquisition. Non-GAAP Adjusted gross margin was consistent with the prior year period. Net income for the second quarter of 2025 was $145 million, or $0.56 per diluted share, compared with $195 million, or $0.75 per diluted share, in the second quarter of 2024. Second quarter 2025 GAAP diluted earnings per share includes a $46 million gain, or $0.14 per share, for early extinguishment of debt. For the second quarter of 2025, non-GAAP Adjusted net income was $261 million, or $1.00 per diluted share, compared with $289 million, or $1.12 per diluted share, in 2024. Non-GAAP Adjusted EBITDA margin was 32.7% in the second quarter of 2025 compared with 31.9% in the second quarter of 2024. The year-over-year improvement in Adjusted EBITDA margin was primarily driven by a 3% reduction in operating expenses. 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. The dividend is payable on September 11, 2025, to stockholders of record at the close of business on August 15, 2025. As of June 30, 2025, cash and cash equivalents were $599 million, and debt was $8.90 billion. During the second quarter of 2025, the company made principal repayments on long-term debt totaling $345 million; the company repurchased and cancelled $242 million of its 5.125% notes due in 2031 prior to maturity (the '2031 Notes') which resulted in a pre-tax gain on extinguishment of debt of $42 million; and the company paid and terminated a legacy funding agreement of Dermavant valued at $103 million, which resulted in a pre-tax gain on extinguishment of debt of $4 million. 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. Webcast Information Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its second quarter 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 may join by dialing (888) 596-4144 (U.S. and Canada Toll-Free) or (646) 968-2525 and using the access code Conference ID: 1036555#. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. 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 full-year 2025 guidance estimates and predictions regarding other financial information and metrics, as well as expectations regarding Organon's franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as 'goals,' 'guidance,' potential,' 'should,' 'will,' 'continue,' 'expects,' 'believes,' 'future,' 'estimates,' 'opportunity,' 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® (etonogestrel implant) 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™ (ezetimibe and atorvastatin); the success of our efforts to adapt our business and sales strategies to address the changing market and regulatory landscape in order to achieve our business objectives and remain competitive, which may include implementing or continuing to assess product discount programs and wholesaler inventory levels under the relevant agreements for certain products such as Nexplanon; 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 ( TABLE 2 Organon & Co. Sales by top products (Unaudited, $ in millions) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 ($ in millions) U.S. Int'l Total U.S. Int'l Total U.S. Int'l Total U.S. Int'l Total Women's Health Nexplanon/Implanon NXT $ 163 $ 77 $ 240 $ 171 $ 70 $ 242 $ 339 $ 148 $ 488 $ 324 $ 137 $ 462 Follistim AQ 30 43 74 22 40 62 65 77 142 33 75 108 NuvaRing 7 21 28 10 19 29 13 37 50 26 41 67 Ganirelix Acetate Injection 3 25 27 5 22 27 7 47 54 11 45 56 Marvelon/Mercilon — 33 33 — 41 41 — 72 72 — 73 73 Jada 18 — 18 14 — 14 33 — 33 27 — 27 Other Women's Health (1) 14 27 42 13 23 34 30 57 86 27 52 79 General Medicines Biosimilars Renflexis 46 17 63 56 13 69 90 30 120 111 27 138 Hadlima 36 14 50 20 8 28 69 27 96 42 16 58 Ontruzant 5 26 31 10 38 48 8 41 49 18 69 87 Brenzys — 22 22 — 12 12 — 36 36 — 36 36 Aybintio — 4 4 — 7 7 — 10 10 — 15 15 Tofidence 3 — 3 — — — 3 — 3 — — — Cardiovascular Atozet — 86 86 — 140 140 — 162 162 — 271 271 Zetia 1 72 74 2 73 75 3 156 159 4 155 159 Cozaar/Hyzaar 2 54 56 2 58 60 4 107 111 5 122 127 Vytorin 1 26 27 2 26 28 2 48 50 3 52 56 Rosuzet — 6 6 — 9 9 — 10 10 — 25 25 Other Cardiovascular (1) 1 33 34 1 31 32 1 64 65 1 71 71 Respiratory Singulair 2 64 66 2 90 93 4 136 140 5 186 190 Nasonex — 66 66 — 60 60 — 137 137 — 137 137 Dulera 32 9 41 39 8 47 66 19 84 82 21 103 Clarinex 1 33 34 1 35 35 1 67 68 2 71 73 Other Respiratory (1) 11 3 14 8 4 13 21 6 27 15 6 22 Non-Opioid Pain, Bone and Dermatology Arcoxia — 63 63 — 68 68 — 124 124 — 143 143 Fosamax — 34 34 1 34 35 2 65 67 3 72 74 Diprospan — 41 41 — 37 37 — 71 71 — 66 66 Vtama 29 2 31 — — — 49 6 54 — — — Other Non-Opioid Pain, Bone and Dermatology (1) 4 76 80 5 73 78 7 143 151 9 141 151 Other Propecia 1 30 32 2 27 28 3 55 58 3 47 51 Emgality/Rayvow — 42 42 — 30 30 — 74 74 — 40 40 Proscar — 22 22 — 23 23 — 46 46 1 49 50 Other (1) 3 85 87 2 69 72 5 159 164 7 149 155 Other (2) 1 24 23 — 31 31 1 44 46 (1 ) 61 59 Revenues $ 414 $ 1,180 $ 1,594 $ 388 $ 1,219 $ 1,607 $ 826 $ 2,281 $ 3,107 $ 758 $ 2,471 $ 3,229 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. Expand TABLE 3 Organon & Co. Sales by geographic area (Unaudited, $ in millions) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Europe and Canada $ 419 $ 457 $ 795 $ 907 United States 414 388 826 758 Asia Pacific and Japan 250 260 502 546 China 204 216 409 421 Latin America, Middle East, Russia, and Africa 285 251 524 525 Other (1) 22 35 51 72 (1) Other includes manufacturing sales to third parties. Expand TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Unaudited, $ in millions) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP Gross Profit $ 874 $ 939 $ 1,715 $ 1,896 Adjusted for: Spin-related costs (1) — 3 — 6 Manufacturing network costs (2) 33 15 62 25 Stock-based compensation 4 5 8 9 Amortization 53 34 103 67 Acquisition-related costs (3) 10 — 19 — Other 9 — 10 — Adjusted Non-GAAP Gross Profit $ 983 $ 996 $ 1,917 $ 2,003 (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 June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP Gross Margin 54.8 % 58.4 % 55.2 % 58.7 % Total impact of Non-GAAP adjustments 6.9 % 3.6 % 6.5 % 3.3 % Adjusted Non-GAAP Gross Margin 61.7 % 62.0 % 61.7 % 62.0 % Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP Selling, general and administrative expenses $ 453 $ 437 $ 873 $ 868 Adjusted for: Spin-related costs (1) — (29 ) — (69 ) Stock-based compensation (14 ) (18 ) (30 ) (36 ) Restructuring related charges (4 ) — (10 ) — Other (26 ) — (29 ) — Adjusted Non-GAAP Selling, general and administrative expenses $ 409 $ 390 $ 804 $ 763 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. Expand TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) (Unaudited, $ in millions except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP Research and development expenses $ 95 $ 116 $ 191 $ 228 Adjusted for: Spin-related costs (1) — (1 ) — (3 ) Manufacturing network costs (2) (3 ) — (6 ) — Stock-based compensation (4 ) (5 ) (8 ) (9 ) Other — — (1 ) — Adjusted Non-GAAP Research and development expenses $ 88 $ 110 $ 176 $ 216 (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 June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP Reported Net Income $ 145 $ 195 $ 232 $ 396 Adjusted for: Cost of sales adjustments 109 57 202 107 Selling, general and administrative adjustments 44 47 69 105 Research and development adjustments 7 6 15 12 Restructuring 2 — 88 23 Change in fair value of contingent consideration 12 — 23 — Other (gain) expense, net (45 ) 6 (41 ) 10 Tax impact on adjustments above (1) (13 ) (22 ) (62 ) (49 ) Non-GAAP Adjusted Net Income $ 261 $ 289 $ 526 $ 604 (1) For the three months ended June 30, 2025 and 2024, the GAAP income tax rates were 37.0% and 17.3%, respectively, and the non-GAAP income tax rates were 27.2% and 17.8%, respectively. For the six months ended June 30, 2025 and 2024, the GAAP income tax rates were 29.8% and 16.0%, respectively, and the non-GAAP income tax rates were 23.4% and 17.1%, 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 June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP Diluted Earnings per Share $ 0.56 $ 0.75 $ 0.89 $ 1.53 Total impact of Non-GAAP adjustments 0.44 0.37 1.13 0.81 Non-GAAP Adjusted Diluted Earnings per Share $ 1.00 $ 1.12 $ 2.02 $ 2.34 Expand TABLE 5 Organon & Co. Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP Reported Net Income $ 145 $ 195 $ 232 $ 396 Depreciation (1) 33 31 65 61 Amortization 53 34 103 67 Interest expense 131 131 255 262 Income tax expense 84 40 98 75 EBITDA (Non-GAAP) $ 446 $ 431 $ 753 $ 861 Restructuring and related charges 6 — 98 23 Spin-related costs (2) — 39 — 88 Manufacturing network related (3) 36 15 72 25 Acquisition-related costs (4) 10 — 19 — Change in contingent consideration 12 — 23 — Other (income) costs (5) (10 ) — (5 ) — Stock-based compensation 22 28 46 54 Adjusted EBITDA (Non-GAAP) $ 522 $ 513 $ 1,006 $ 1,051 Adjusted EBITDA margin (Non-GAAP) 32.7 % 31.9 % 32.4 % 32.5 % (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, $19 million and $40 million for the three and six months ended June 30, 2024, 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 $6 million and $20 million for the three and six months ended June 30, 2024, respectively, 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 and six months ended June 30, 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. (5) Other (income) costs for the three and six months ended June 30, 2025 include $46 million pre-tax gain related to the repurchase and cancellation of approximately $242 million of the 2031 Notes and the repayment and termination of the funding agreement with NovaQuest Co-Investment Fund VIII, L.P. and legal settlement reserves. As the costs described in (1) through (5) 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. Expand
NZ Herald
22-07-2025
- Health
- NZ Herald
Migraine: West Auckland sisters share reality of managing ‘invisible disease'
When Barden fell pregnant with her daughter, now 10, her attacks stopped temporarily. However, they continued throughout her pregnancy with her son. Since having children, the pill has 'made a huge difference' in helping prevent her migraine attacks, she says. 'I've looked at whether it's worthwhile going off it, we tried that for a while and they came back with a vengeance.' The migraine-specific preventive medication Emgality has been 'super effective'. 'Now I would maybe get one a month that I can push through. It's been maybe 5 months since I've had one that put me to bed, and that was a real rarity... the impact on my day-to-day life is extraordinarily different to what it was.' But it comes at a cost - usually around $350 a month, though she's found one pharmacy selling Emgality for $279. For Barden, that cost is well worth being able to work and earn, and be present in her family life. 'I'm so grateful that I'm in a financial position that I can afford it, that I found a cheaper option and I can drive to it, but there are so many people where it is just out of reach.' Sisters Katie Barden and Robin Wilson-Whiting have tried multiple different treatments for migraine. Photo / Supplied Migraine may be genetic, but her sister Robin Wilson-Whiting is proof that not everyone gets the same symptoms - or finds the same treatments helpful. Wilson-Whiting, 37, who works as a union organiser, started getting migraine attacks around the age of 24, and recognised the signs thanks to her sister. 'It wasn't directly correlated, but I think they started sometime after I'd had a pretty gnarly bike accident, which involved a concussion,' she says. 'I guess I had a shortcut because Katie had already been dealing with them for a while.' 'What a cute thing to share,' Barden jokes, while her sister adds, 'It's a blessing and a curse. Not that I'm glad that either one of us deals with migraines, but the fact that we can share tips.' Wilson-Whiting gets different types of attacks, from those with an aura - a 'flickering visual disturbance' - to brain fog that she likens to 'wading through sludge'. 'There's pain that is strong and definitely exhausting and uncomfortable, but you're able to get through your day, so you end up just working through. The other type that I struggle with is a kind of brain fog [where] I feel like I could stare at the wall all day.' The treatments that work for her older sister haven't worked for her. 'I've given all of the non-funded ones a pretty good go, and sometimes it's a relief that it doesn't work because of the eye-watering [cost],' she admits. One of the few remaining treatment options available in the country has helped reduce her headache days from 4 to 5 a week at the very worst to 'maybe 2″. Most people with migraine rely on a combination of medical and non-medical treatments and lifestyle changes to help prevent attacks. 'As a migraine sufferer, you just learn certain things,' Barden explains. 'I know that I can't get too tired, I can't go too long without food, I drink lots of water. I don't really do perfume because it's too strong. Sleep hygiene is such an important one.' Neither of them drinks alcohol, because as Barden puts it, 'a hangover would feel just like a migraine'. Wilson-Whiting, meanwhile, avoids certain things in her diet, such as cured meats, MSG and Diet Coke, which can all be triggers. 'I pretty much won't go away from home for a night or weekend without my wheat bag and my ice pack. Heat on my neck and ice on my forehead.' Cold water makes a big difference - she'll often pop round to her sister's place to use their swimming pool. 'It's given me immense relief, probably another 4 hours of energy that I wouldn't have had otherwise.' The sisters' individual journeys show just how migraine 'affects everyone in different ways', Barden says. 'We have tried the same medications and responded differently to them, or not at all. 'Because it is a relatively invisible disease, you do unfortunately get really good at just pushing through. If I just curled up in a ball in a dark corner every time I had [an attack], I wouldn't partake in my own life.' When it comes to well-meaning but misguided advice, they've heard it all. Wilson-Whiting lists a few things not to say to migraine sufferers: 'Have you tried Paracetamol? Do you drink enough water? Have you tried meditation? 'Maybe think a little bit before you offer simple solutions to something people have been really battling with for decades.' What is migraine disease? Epidemiologist Dr Fiona Imlach is a senior research fellow at the University of Otago in Wellington's public health department, and has suffered from chronic migraines herself. Her experience led her to co-found the Migraine Foundation Aotearoa New Zealand (MFANZ) in 2022, to raise awareness and help get funding for new migraine medications. As Imlach explains, there are two ways of talking about migraines - the attacks themselves, and as a neurological disease. 'The typical episode is a moderate-severe headache associated with nausea or vomiting, also associated with some sort of sensitivity to light and sound, also smells,' she says. 'You can have migraine without a headache, and you can have other symptoms even before you get the headache and after the headache.' Beforehand, symptoms commonly include visual aura, fatigue, brain fog, mood swings, nausea and neck pain. After the headache, there's what Imlach describes as a 'hangover period'. 'You often feel a bit rotten for a day or two afterwards.' A migraine headache usually starts on one side of the head, though it can spread, and can last at least four hours or up to 3 days. It will also worsen if you try to do regular activities like exercise. 'People think it's just a headache - it's not just a headache. If you get regular tension headaches, [that's] quite a different experience than if you've got migraine,' Imlach says. Then there's migraine as a neurological disease. 'That means that I've got this neurological condition where I have a brain that has a tendency to send me on these attacks.' It's not clear what exactly causes the disease, but it's known to be genetic and to have certain triggers. 'We can see from scans that there are things happening in the brain, and we know that there are some neurotransmitters involved in pain and sensory processing and all these things which are involved in migraine. 'That's where new drugs are targeting these things, but we don't understand why we get it or why some people only have one or two attacks ever or in a year, and some people have them almost every day.' To be diagnosed with migraine disease, you need to have had at least five separate attacks. 'If you get 15 or more days a month of a migraine-type headache, you'd be classified as [having] chronic migraine. Even less than that can be really destructive for people because of those other symptoms.' Only two migraine-specific painkillers, called triptans, are available in New Zealand - though there are seven available worldwide. Dr Fiona Imlach, a Senior Research Fellow at Otago University's Department of Public Health in Wellington. Photo / Otago University 'Internationally, the guidance around triptans is if you fail one, try another because they're all a bit different. You have to try three before you can say that you've failed this treatment,' Imlach explains. 'Nobody in New Zealand can say they've failed the treatment because they actually don't have enough to try.' New medications developed specifically for migraine prevention include one targeting a neurotransmitter in the brain that has been shown to cause migraine attacks, which Imlach says has 'changed my life'. 'I had tried just about everything... but this new medication, which I fund myself because it's not funded yet, has been the only thing that's worked and it's knocked back my 14 days of headache to about four, which has made a huge difference.' Imlach recently published a study showing about half of Kiwis with migraine use non-medical treatments such as supplements, and that access to more treatments is needed as well as further research into migraine. 'You just have to try to find something that works for you, and everybody's journey is different, so that explains why people have tried so many different things, because they're really just trying to find an answer,' she says. Several of those newer migraine medications are on Pharmac's waiting list for funding, as well as a third triptan, which it had previously proposed to decline but is now back on the options list. MFANZ are surveying migraine sufferers about their use of triptans to help make a case for funding it. One reason more migraine medications should be funded, Imlach says, is that migraine affects people's ability to work. 'If you're trying to stimulate the economy and get productivity and growth, you'd want people to be working optimally,' she says. 'I couldn't work full-time when I had chronic migraine. '[These are] treatments that could benefit not only people's quality of life, minimise suffering and improve family lives, but actually improve society.'
