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All Time Record Sales Growth for Unmatched 'Evacuated Cell' Insulation From Very Small Share Structure Company With Only 38 Million OS / 16 Million Float: Innovative Designs, Inc. Stock Symbol: IVDN

All Time Record Sales Growth for Unmatched 'Evacuated Cell' Insulation From Very Small Share Structure Company With Only 38 Million OS / 16 Million Float: Innovative Designs, Inc. Stock Symbol: IVDN

Experienced New Board Member Just Added with Ties to Multi-Billion Dollar Homebuilding Industry Including D.R. Horton ($DHI), Ryan Homes ($NVR) and More
Sole Maker of Patented Insultex® Insulation Delivering Construction Cost and Energy Saving Performance Superior to All Competition.
Unique Evacuated Cell House Wrap Material Provides an Unmatched R-6 Rating, Water Vapor, Air & Wind Barrier and Other Important Advantages.
New Board Member is Experienced Real Estate Developer with Relations to Top Homebuilding Names Including D.R. Horton, NVR / Ryan Homes and More.
New Government Building Codes Require Continuous Insulation with Higher Performance and IVDN Meets or Exceeds These Standards Where Many Competitors Now Do Not.
Increased Order Fulfilment Capabilities Recently Added with Plans for Further Enhancement to Handle Increasing Demand.
Sales for the Current 2025 1st Quarter, Still in Progress, Show a Comp Increase in Excess of 7 Times Sales Over the 1st Quarter of 2024.
Over a Quarter of a Million Dollars in Purchase Orders are Currently in the Queue to be Filled.
2024 Fiscal Third Quarter Revenues More Than Doubled Same Period in 2023.
First Nine Months of Fiscal 2024 Delivered a 285% Increase Over 2023.
Accelerating Order Flow and Record Backlog in 2024 vs. No Backlog in 2023.
Innovative Designs, Inc. (Symbol: IVDN), manufactures and markets its unique, patented Insultex® material, a quantum leap forward in insulation as the thinnest, lightest and warmest insulator on the market today. IVDN products deliver optimum warmth and comfort via insulating, windproof and waterproof protection with no animal materials. IVDN holds issued US patents on both the evacuated cell material and its manufacturing process.
For home building, home remodeling and other construction, significant improvements in energy efficiency measures, such as IVDN Insultex House Wrap® can provide, have never been more important. Superior insulation, for heating or cooling, is fast becoming a primary factor in the multi-billion dollar construction and remodeling industry today. In addition to lowering construction costs because additional insulation boards or supports are not needed, Insultex® use results in high energy efficiency and a reduction of greenhouse gas emissions that contribute to the global climate change crisis.
IVDN Insultex House Wrap® delivers an unmatched R-6 rating because of its unique and patented evacuated or vacuum cell structure design. The dedicated IVDN Insultex House Wrap® website explains the scientific principles in detail along with visual aids. Insultex® also provides a moisture barrier and other key benefits that make it simply the best insulation choice available today.
The IVDN Insultex House Wrap ® website may be visited at http://www.insultexhousewrap.com.
Homeowners who upgrade to superior IVDN Insultex House Wrap® insulation may also qualify for substantial tax credits under The Inflation Reduction Act, in addition to enjoying the lower energy bills that result.
As building codes and exterior R-Value requirements are quickly evolving across the country, IVDN distributor Built Link Solutions has proven highly proactive in contacting prospective accounts, notifying them of the cost-effective solution that Insultex House Wrap® provides.
Randy Kimbler, Director of Business Development for Built Link Solutions, stated: 'Insultex House Wrap® is gaining traction in the market as it provides a timely and effective solution. Its cost-effectiveness, innovation, and ability to address today's building challenges are driving positive feedback nationwide.'
For investors, IVDN has a very small share structure with only about 38 million shares outstanding and a public float of about 16 million shares. Also, according to the latest 10-K filing, IVDN Management and Directors are holding over 8 million of these shares making IVDN avery lean stock.
IVDN Welcomes Experienced Real Estate Developer with Relations to Top Homebuilding Names Including D.R. Horton, NVR / Ryan Homes and More
On January 23rd IVDN announced a new addition to the Company's Board of Directors, Mr. John Spagnolo Jr., an accomplished real estate investor and developer. For over 20 years Mr. Spagnolo, Jr. has been successful in building high end homes, residential and commercial properties and other development projects. Most notably, over the course of his career, Mr. Spagnolo, Jr., has nurtured relationships with key contacts at some of the most important companies in the multi-billion-dollar homebuilding and construction industry. These include D.R. Horton, NVR [Ryan Homes], Maronda Homes, Rockford Homes, Fischer Homes, Infinity Custom Homes and more. Regarding his new role on the IVDN Board of Directors, John Spagnolo Jr. stated: 'I am strongly enthusiastic about the sales growth potential of the unique Insultex House Wrap® product in the building and remodeling environment that we see before us today. This is the primary reason I have accepted the offer to join the Innovative Designs team at this time. With its patented evacuated cell design, Insultex House Wrap® is catching on at the go-to solution for all the most important standards of thermal insulation that builders and remodelers must now meet to stay competitive and in compliance with new government building codes. In 2025 and beyond, I believe we can introduce the unmatched advantages of Insultex House Wrap® to building professionals on every level of the industry and I expect that they will want to use this superior insulation solution in significantly increasing quantities.' IVDN sales for the current 2025 1st quarter, which is still in progress, show a comp increase in excess of 7 times sales over the 1st quarter of 2024. In addition, over a quarter of a million dollars in purchase orders are in the queue to be filled.
Innovative Designs Inc. Reports Record Sales Results to Shareholders
On December 30th IVDN reported the following milestones for its fiscal third quarter:
2024 Fiscal Third Quarter Revenues More Than Doubled Same Period in 2023.
First Nine Months of Fiscal 2024 Delivered Over a 285% Increase Over 2023.
Accelerating Order Flow and Record Backlog in 2024 vs. No Backlog in 2023.
Increasing Production Capabilities to Meet Rising Demand.
Plans for Investor Conference Call / Shareholders Meeting in the Company's 2nd Quarter.
Media Contact
Company Name: INNOVATIVE DESIGNS, INC.
Contact Person: Joseph Riccelli, CEO
Email: Send Email
Phone: 412-799-0350
Address:124 Cherry St
City: Pittsburgh
State: Pennsylvania
Country: United States
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Organon Reports Results for the Second Quarter Ended June 30, 2025
Organon Reports Results for the Second Quarter Ended June 30, 2025

Business Wire

time10 minutes ago

  • 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

Polpharma Biologics and Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar PB016
Polpharma Biologics and Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar PB016

Business Upturn

time13 minutes ago

  • Business Upturn

Polpharma Biologics and Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar PB016

Business Wire India Polpharma Biologics S.A. ('Polpharma Biologics') announces a global (except for Middle East & North Africa) licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab, an integrin receptor antagonist, (reference product: Entyvio®*), a biologic therapy indicated for moderate to severe ulcerative colitis and Crohn's disease. Under the terms of the agreement, Polpharma Biologics will lead development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialization rights worldwide, excluding Middle East & North Africa. 'This partnership reinforces our mission to broaden access to high-quality biologics that improve patient outcomes globally,' said Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group. 'Fresenius Kabi's deep commercialization experience and commitment to biosimilars make them an ideal partner for bringing PB016 to patients worldwide. Together, we are taking an important step toward addressing the rising burden of chronic inflammatory diseases.' The agreement builds on Polpharma Biologics' growing biosimilar portfolio and proven development capabilities. The company has previously brought forward multiple biosimilars — including ranibizumab and natalizumab — across global markets in partnership with leading pharmaceutical companies. This strategic collaboration strengthens both companies' commitments to expanding global access to affordable biologic medicines while supporting healthcare system sustainability. *Entyvio® is a registered trademark of Takeda. About Polpharma Biologics: Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical organizations. The expertise of Polpharma Biologics lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists. Learn more at About Fresenius Kabi: As part of the global healthcare company Fresenius, Fresenius Kabi specializes in (bio)pharmaceuticals, medical technologies and nutrition products for critical and chronic conditions. The company's products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. For more information, please visit Important Note This press release is for informational purposes only and does not constitute promotional material for PB016 in Poland or any other jurisdiction. The commercialization of proposed vedolizumab biosimilar PB016 is solely the responsibility of Fresenius Kabi, the marketing authorization holder, in accordance with all applicable laws and regulations. Disclaimer This press release is issued from Polpharma Biologics Group and is intended to provide worldwide information to healthcare professionals, media and (potential) investors about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either express or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy. Disclaimer: The above press release comes to you under an arrangement with Business Wire India. Business Upturn take no editorial responsibility for the same. Ahmedabad Plane Crash

ElephantSqlDB® Unveils First Quantum‑Powered Cloud Database, Delivering Enterprise‑Class Performance at Indie‑Friendly Prices
ElephantSqlDB® Unveils First Quantum‑Powered Cloud Database, Delivering Enterprise‑Class Performance at Indie‑Friendly Prices

Business Wire

time40 minutes ago

  • Business Wire

ElephantSqlDB® Unveils First Quantum‑Powered Cloud Database, Delivering Enterprise‑Class Performance at Indie‑Friendly Prices

AUSTIN, Texas--(BUSINESS WIRE)--ElephantSqlDB, Inc., together with its subsidiary Dataark Systems, LLC, today announced the general availability of ElephantSqlDB®, the industry's first software‑as‑a‑service (SaaS) database built on a quantum‑asymptotic architecture. By combining an enhanced implementation of Grover's algorithm with NVIDIA® GPU simulation technology, the platform maintains single digit‑millisecond search speeds—even as data volumes grow from terabytes to petabytes—while keeping pricing predictable and affordable. 'Alleviate watching database bills climb faster than user growth,' said Cedric Harris, Founder & CEO of ElephantSqlDB, Inc. 'ElephantSqlDB® gives hyperscale performance, and transparent pricing that works for solo creators and Fortune 500 teams alike.' Share 'As a developer, I've felt the pain of watching database bills climb faster than user growth,' said Cedric Harris, Founder & CEO of ElephantSqlDB, Inc. 'ElephantSqlDB® eliminates that trade‑off. You get hyperscale performance, end‑to‑end security, and transparent pricing that works for solo creators and Fortune 500 teams alike.' Why It Matters Quantum‑Asymptotic Core A proprietary variant of Grover's algorithm accelerates search by orders of magnitude without specialized quantum hardware. Built‑in AI Optimization Machine‑learning models auto‑tune indexes, predict workloads, and route queries to the fastest execution path. Zero‑Knowledge Blockchain Security Transaction‑level encryption and immutable audit trails protect data from ransomware and insider threats. Broad SQL Compatibility Out‑of‑the‑box support for 13+ dialects—including PostgreSQL, MySQL, and SQLite—simplifies migration and multi-cloud deployment. Predictable Pricing Flat‑rate plans start at 1 TB storage / 256 GB RAM and scale linearly, eliminating surprise overage charges. Empowering the Indie‑Developer Economy Independent developers represent one of the fastest‑growing segments in cloud services, yet they are often priced out of enterprise‑grade infrastructure. ElephantSqlDB® was architected from day one to give these creators—building the next GitHub®, Figma®, or Supabase®—access to the same performance and security large enterprises enjoy, without the enterprise price tag. Early Traction 2,000+ developers pre‑registered during the private beta 150 new sign‑ups every day ahead of launch Accepted into the NVIDIA Inception Program, gaining early access to cutting‑edge GPU acceleration and quantum‑simulation toolkits (ElephantSqlDB® is a completely new service and is not affiliated with the legacy 'ElephantSQL' add‑on.) About ElephantSqlDB, Inc. ElephantSqlDB, Inc. is redefining cloud‑database economics with a quantum‑enhanced, AI‑driven platform purpose‑built for modern AI, SQL, and NoSQL workloads. Headquartered in Austin, Texas, the company's mission is to make world‑class data infrastructure accessible to every developer on the planet. Learn more at

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