Drug Approvals and Designations - ARIKAYCE received accelerated approval in the US in September 2018 for MAC lung disease, with subsequent approvals in Europe and Japan in October 2020 and March 2021 respectively[21]. - BRINSUPRI was approved in the US in August 2025 and in Europe in November 2025 for non-cystic fibrosis bronchiectasis, with regulatory submissions accepted in the UK and Japan[37]. - The FDA granted orphan drug designation to TPIP for pulmonary arterial hypertension in January 2026, with a Phase 3 study planned for H1 2026[27]. - The FDA granted orphan drug designation for INS1201 in August 2025 for the treatment of DMD, and treprostinil palmitil received the same designation in January 2026 for PAH[135]. - Orphan drug designation provides a seven-year exclusive marketing period in the US upon FDA approval for drugs targeting rare diseases[136]. - The European Commission grants a 10-year orphan exclusivity period for drugs with orphan drug marketing authorization, extendable by two years with an agreed pediatric investigation plan[140]. Clinical Trials and Studies - The Phase 2b CEDAR study of brensocatib for hidradenitis suppurativa completed enrollment in October 2025, with topline data expected in Q2 2026[30]. - The ENCORE trial for ARIKAYCE completed enrollment with 425 patients in Q4 2024, and topline data is anticipated by April 2026[28]. - The ASPEN study of brensocatib demonstrated a 21.1% reduction in the annualized rate of pulmonary exacerbations compared to placebo[44]. - The Phase 2b study of brensocatib in chronic rhinosinusitis was discontinued as it did not meet primary or secondary efficacy endpoints[82]. - The Phase 1 study of TPIP was generally well tolerated, with 88.4% of patients experiencing treatment-emergent adverse events (TEAEs) compared to 75.8% in the placebo group[77]. - The Phase 2a study showed that 79.3% of TPIP patients reached the maximum dose of 640 µg by Week 5, with serious adverse events reported in 20.7% of TPIP patients versus 40.0% in the placebo group[70]. - The Phase 2b study demonstrated a 35% placebo-adjusted reduction in pulmonary vascular resistance (PVR) and a 60% reduction in NT-proBNP concentrations, both statistically significant[75]. Market Potential and Commercialization - The potential addressable market for bronchiectasis is estimated at 500,000 patients in the US, 600,000 in the European 5, and 150,000 in Japan[45]. - The estimated addressable market for TPIP at launch includes approximately 50,000 diagnosed patients with PH-ILD and 35,000 with PAH in the United States[81]. - The company aims to ensure a successful US commercial launch of BRINSUPRI and expand the label for ARIKAYCE[36]. - The company is exploring lifecycle management programs for ARIKAYCE to reach more patients beyond refractory MAC lung disease[63]. Intellectual Property and Patents - The company owns or licenses over 1,400 patents, including more than 400 related to ARIKAYCE, to maintain proprietary protection for its product candidates[93]. - The company has 13 in-force US patents related to ARIKAYCE, with expiration dates ranging from 2026 to 2035, ensuring patent coverage through at least May 15, 2035[97][98]. - The company owns 10 in-force European patents for ARIKAYCE, with expiration dates also extending to 2035, which supports its market position in Europe[99]. - There are 13 in-force US patents for BRINSUPRI, with expiration dates primarily in 2035, which secures the company's intellectual property for this drug[102][103]. Financial and Investment Activities - The company made an upfront payment of $30 million to AstraZeneca for exclusive global rights to develop and commercialize brensocatib, with additional milestone payments totaling up to $42.5 million for further indications[113]. - An asset purchase agreement with Opsidio in December 2025 included an upfront payment of $40.0 million and contingent payments up to $382 million based on development and sales milestones[127]. - The aggregate investment to increase long-term production capacity for ARIKAYCE, including agreements with Patheon, is estimated to be approximately $127.7 million[125]. - The company is focused on controlling spending and prudently deploying capital to support the best return-generating opportunities[36]. Regulatory and Compliance - The FDA's approval process includes extensive regulation and compliance checks, ensuring safety and efficacy before marketing[146]. - The FDA may require substantial post-approval testing, known as Phase 4 studies, to gather additional information on a drug's effects and side effects[157]. - The FDA typically requires post-marketing clinical studies to verify clinical benefits for drugs granted accelerated approval, with the possibility of withdrawal if studies fail[159]. - The FDA's enforcement of promotional regulations includes strict penalties for off-label marketing, which can lead to significant liabilities for companies[189]. Pediatric Considerations - Pediatric assessments are required under the PREA for certain NDAs, BLAs, and supplements to ensure safety and effectiveness in pediatric populations[216]. - The BPCA incentivizes pediatric research with the possibility of six months of pediatric exclusivity for drugs that meet specific criteria[217]. - In the EU, new drugs must undergo mandatory pediatric testing through a pediatric investigation plan (PIP) approved by the EMA[218]. - The MHLW in Japan recommends adequate post-marketing surveillance for pediatric drugs to collect information for proper use[219].

Financial Performance - Insmed reported total revenues of $606.4 million for the full year 2025, with BRINSUPRI revenues of $172.7 million and ARIKAYCE revenues of $433.8 million, reflecting a 19% annual growth for ARIKAYCE[1]. - The company expects full-year 2026 BRINSUPRI revenues to be at least $1 billion and maintains ARIKAYCE revenue guidance of $450 million to $470 million[1]. - ARIKAYCE global revenue grew 19% in 2025 compared to 2024, exceeding the upper end of the 2025 guidance of $420 million to $430 million[7]. - Product revenues for the three months ended December 31, 2025, were $263.843 million, a significant increase from $104.442 million in the same period of 2024, representing a growth of 152%[21]. - Total operating expenses for the twelve months ended December 31, 2025, were $1.853 billion, up from $1.242 billion in 2024, reflecting an increase of 49.1%[21]. - The net loss for the three months ended December 31, 2025, was $328.485 million, compared to a net loss of $235.548 million for the same period in 2024, indicating a 39.3% increase in losses[21]. - The company reported a net loss of $328.5 million, or $1.54 per share, for the fourth quarter of 2025, compared to a net loss of $235.5 million, or $1.32 per share, for the same period in 2024[16]. - Cash and cash equivalents as of December 31, 2025, were $510.445 million, down from $555.030 million as of December 31, 2024, a decrease of 8%[23]. - Total assets increased to $2.265 billion as of December 31, 2025, from $2.025 billion in 2024, marking an increase of 11.8%[23]. - The total liabilities decreased to $1.526 billion as of December 31, 2025, from $1.740 billion in 2024, a reduction of 12.3%[23]. Research and Development - Research and development expenses for the full year 2025 were $771.1 million, up from $598.4 million in 2024, primarily due to increased compensation and the acquisition of INS1148[16]. - Research and development expenses for the twelve months ended December 31, 2025, were $771.093 million, up from $598.367 million in 2024, an increase of 28.9%[21]. - Insmed plans to advance Phase 3 studies for TPIP in patients with pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) in 2026[19]. - The company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs[19]. - Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS) and expects to report topline data in the second quarter of 2026[9]. - Insmed's early-stage programs include technologies such as gene therapy and AI-driven protein engineering[59]. Product Portfolio and Market Focus - The company is focused on expanding its product portfolio with innovative therapies such as ARIKAYCE and BRINSUPRI, which are already approved for specific indications[24][26]. - ARIKAYCE is indicated for adults with limited or no alternative treatment options for Mycobacterium avium complex (MAC) lung disease, requiring a minimum of 6 consecutive months of multidrug therapy[45]. - The company has developed several investigational products, including INS1201 and INS1202, targeting significant unmet medical needs in respiratory and neurological diseases[30][31]. - Insmed is advancing a diverse portfolio of approved and investigational medicines, focusing on pulmonary and inflammatory conditions[59]. Adverse Reactions and Safety - The most common adverse reactions in patients using ARIKAYCE included dysphonia (47%), cough (39%), and bronchospasm (29%), with significant differences compared to the background regimen alone[42]. - In the ASPEN trial, the incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9% for placebo and BRINSUPRI 10 mg and 25 mg, respectively[53]. - The incidence of skin cancers in patients treated with BRINSUPRI was 0.5% and 1.9% for 10 mg and 25 mg doses, compared to 1.1% in placebo-treated patients[54]. - The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease[46]. Company Recognition and Forward-Looking Statements - The company has been recognized as one of the best employers in the biopharmaceutical industry, including five consecutive years as the No. 1 Science Top Employer[60]. - Forward-looking statements indicate potential risks, including failure to successfully commercialize ARIKAYCE and BRINSUPRI in key markets[61]. - The company cautions that actual results may differ materially from forward-looking statements due to various risks and uncertainties[63].

Revenue Performance - Revenue for Q4 2025 was $2.9 billion, an increase of 11% compared to Q4 2024, driven by services and gross contract reimbursable revenue growth of 8% and 16% respectively[5] - Full year revenue for 2025 reached $10.3 billion, reflecting a 9% increase from 2024[5] - Services revenue for Q4 2025 was $2.0 billion, up 9% from Q4 2024, with project management revenue in EMEA and APAC leading the growth[5] - Capital markets revenue increased by 17% in Q4 2025, particularly strong in office and retail transactions in the Americas[7] - Revenue for the year ended December 31, 2025, was $10.3 billion, an increase of $841.7 million or 9% compared to the previous year, driven by 19% growth in Capital markets and 8% growth in Leasing revenue[15] - Total revenue for the year 2025 reached $10,288.2 million, up 8.9% from $9,446.5 million in 2024[34] - Americas total revenue for Q4 2025 reached $2,095.5 million, a 10% increase compared to $1,912.9 million in Q4 2024[40] - EMEA total revenue for Q4 2025 was $340.7 million, reflecting an 18% increase from $289.2 million in Q4 2024[41] - APAC total revenue for Q4 2025 amounted to $477.6 million, a 12% increase from $427.4 million in Q4 2024[42] Profitability and Loss - Net loss for Q4 2025 was $22.4 million, compared to net income of $112.9 million in Q4 2024, primarily due to a one-time impairment loss of $177.0 million[5] - Net loss for the three months ended December 31, 2025, was $22.4 million, compared to net income of $112.9 million for the same period in 2024, reflecting a decline of $135.3 million[13] - Net income margin for the year ended December 31, 2025, was 0.9%, down from 1.4% in the prior year, primarily due to the impairment loss on the Greystone JV[24] - Americas net loss for Q4 2025 was $53.9 million, compared to a net income of $84.8 million in Q4 2024, representing a significant decline[40] Adjusted Metrics - Adjusted EBITDA for Q4 2025 was $238.7 million, a 7% increase from Q4 2024, with an adjusted EBITDA margin of 11.7%[5] - Adjusted EBITDA for the year ended December 31, 2025, was $656.2 million, an increase of $74.3 million or 13% compared to the previous year[25] - Adjusted net income for 2025 was $285.2 million, a 34% increase from 2024[5] - Adjusted EBITDA for the three months ended December 31, 2025, was $238.7 million, an increase from $222.3 million in the same period of 2024, reflecting a year-over-year growth of approximately 7.0%[59] - Adjusted net income for the year ended December 31, 2025, was $285.2 million, compared to $212.5 million in 2024, reflecting a year-over-year increase of approximately 34.2%[64] Cash Flow and Liquidity - Cash flow from operating activities for 2025 was $340.4 million, an increase of $132.4 million from 2024[5] - Liquidity as of December 31, 2025, was $1.8 billion, consisting of $1.0 billion in undrawn revolving credit and $0.8 billion in cash[5] - Cash flows from operating activities for 2025 were $340.4 million, compared to $208.0 million in 2024[38] - Free cash flow for the year ended December 31, 2025, was $293.0 million, compared to $167.0 million in 2024, indicating a significant increase of 75.5%[64] Costs and Expenses - Costs of services for the year ended December 31, 2025, were $8.4 billion, an increase of $688.0 million or 9% compared to the previous year, primarily due to a $398.0 million increase in employment costs[16] - Operating, administrative, and other expenses for the year ended December 31, 2025, were $1.3 billion, an increase of $93.1 million or 8% compared to the previous year[17] - Total costs and expenses for the year ended December 31, 2025, were $9,835.7 million, up from $9,107.6 million in 2024, representing an increase of about 8.0%[61] - The company’s fee-based operating expenses for the year ended December 31, 2025, were $6,460.7 million, compared to $6,051.8 million in 2024, marking an increase of approximately 6.8%[61] Impairment and Other Charges - The company reported a significant impairment charge of $177.0 million in 2025[38] - The company incurred $177.0 million in impairment of investments for the three months ended December 31, 2025, which was not present in the same period of 2024[59] - The company recognized $2.8 million in non-operating items related to the Greystone JV for the three months ended December 31, 2025, which were excluded from the calculation of Adjusted EBITDA[56] Shareholder Information - The weighted average shares outstanding for the year ended December 31, 2025, were 231.2 million, slightly up from 228.9 million in 2024[64]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the period from to Commission file number 001-12111 Pediatrix Medical Group, Inc. (Exact name of registrant as specified in its charter) FLORIDA 26-3667538 (State or other jurisdiction (I.R.S. Employer of ...

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