Iovance Biotherapeutics(IOVA) - 2025 Q4 - Annual Report
2026-02-24 14:35
Product Development and Approvals - Amtagvi® has the potential to address over 30,000 previously treated advanced melanoma patients annually, with approvals in the U.S. and Canada, and pending approvals in the UK and Australia by 2026[538]. - The U.S. accelerated approval of Amtagvi® is based on safety and efficacy results from the C-144-01 global, multicenter clinical trial, with a Phase 3 confirmatory trial ongoing[544]. - The company is conducting two ongoing registrational trials in frontline advanced melanoma and previously treated advanced non-small cell lung cancer (NSCLC)[539]. - Iovance acquired worldwide rights to Proleukin® in May 2023, enhancing its commercial strategy and revenue channels[546]. - The company plans to resubmit a centralized marketing authorization application in the EU in 2026 after withdrawing its initial application in July 2025[538]. Financial Performance - Revenue for the year ended December 31, 2025, is primarily driven by product sales of Amtagvi® and Proleukin®, with Amtagvi® revenue recognized upon patient infusion and Proleukin® revenue upon shipment[558][559]. - Amtagvi® revenue for the year ended December 31, 2025, was $220.0 million, a 112% increase from $103.6 million in 2024[574]. - Total product revenue increased by $99.4 million, or 61%, to $263.5 million in 2025 compared to $164.1 million in 2024[574]. - Total product revenue for the year ended December 31, 2024 increased by $162.9 million, or 13,698%, compared to 2023, due to the acquisition of Proleukin® and the launch of Amtagvi®[592]. Costs and Expenses - Cost of sales increased by $79.9 million, or 86%, to $173.2 million in 2025, driven by higher sales of Amtagvi® and related manufacturing costs[576][577]. - Research and development expenses rose by $24.0 million, or 9%, to $300.3 million in 2025, primarily due to increased clinical trial costs and payroll[578][583]. - Selling, general, and administrative expenses remained flat at $152.3 million in 2025 compared to $152.3 million in 2024[584]. - Research and development expense for the year ended December 31, 2024 decreased by $57.0 million, or 17%, compared to 2023, primarily due to a decrease in clinical manufacturing costs[599]. - Selling, general, and administrative expense for the year ended December 31, 2024 increased by $46.2 million, or 44%, compared to 2023, mainly due to increased payroll and related expenses[603]. Cash Flow and Financing - As of December 31, 2025, the company had $303.0 million in cash, cash equivalents, short-term investments, and restricted cash, with $163.1 million in cash and cash equivalents[611]. - Net cash used in operating activities for the year ended December 31, 2025, was $302.4 million, a decrease from $353.0 million in 2024, driven by increased sales of Amtagvi®[620]. - Net cash provided by investing activities for the year ended December 31, 2025, was $47.5 million, a significant improvement from net cash used of $96.4 million in 2024[625]. - Net cash provided by financing activities for the year ended December 31, 2025, was $300.8 million, a decrease from $390.7 million in 2024, primarily due to lower net proceeds from common stock sales[628]. - During the year ended December 31, 2025, the company received $306.3 million in net proceeds from the sale of common stock[616]. Strategic Initiatives - A strategic restructuring plan was approved in August 2025, resulting in a workforce reduction of approximately 19% to optimize business performance and extend cash runway[613]. - The company anticipates continued increases in selling, general, and administrative expenses as it expands the use of Amtagvi® and Proleukin®[568]. - The company expects to continue incurring significant expenses to support commercial activities for Amtagvi® and ongoing clinical programs, indicating a focus on research and development[612]. Market and Operational Risks - The company anticipates that revenues from Amtagvi® and Proleukin® may not be sufficient to generate positive operational cash flows within the next 12 months[611]. - The company's operating results could be significantly affected by changes in foreign currency exchange rates, particularly with the pound sterling[660]. - Foreign currency transaction gains and losses were immaterial for the years ended December 31, 2025, and 2024, indicating no significant foreign currency exchange risk[661]. Research and Development Focus - Research and development activities are central to the business model, with a focus on late-stage clinical development candidates[581]. - The company expects to continue incurring research and development expenses for ongoing clinical trials and product candidates[566]. - The company recognizes accrued research and development costs as expenses incurred, with significant costs related to clinical trials[651]. Compliance and Regulatory Matters - The company reviews intangible assets for impairment at least annually, with no indicators of impairment noted as of December 31, 2025[644]. - Revenue recognition follows ASC 606, with revenue recognized when control of goods is transferred to customers[646]. - The company has no off-balance sheet arrangements as of December 31, 2025[633].
Allison(ALSN) - 2025 Q4 - Annual Report
2026-02-24 14:28
Financial Performance - In 2025, total net sales decreased by 7% to $3,010 million compared to $3,225 million in 2024[209] - North America On-Highway net sales fell by 12% to $1,540 million in 2025, primarily due to lower demand for medium-duty and class 8 vocational trucks[209] - Defense end market net sales increased by 26% to $267 million in 2025, driven by higher demand for tracked vehicle applications[212] - Adjusted EBITDA for 2025 was $1,130 million, representing 37.5% of net sales, compared to 36.1% in 2024[221] - Gross profit for 2025 was $1,463 million, down 4% from $1,529 million in 2024, with gross profit as a percentage of net sales increasing by 120 basis points[226] - Operating income for 2025 was $880 million, representing 29% of net sales, compared to $992 million or 31% in 2024[223] - Net income for 2025 was $623 million, accounting for 21% of net sales, compared to $731 million or 23% in 2024[223] - Adjusted free cash flow for 2025 was $661 million, slightly up from $658 million in 2024[221] Cash Flow and Liquidity - The company generated $836 million in net cash provided by operating activities for the year ended December 31, 2025[221] - Total available cash and cash equivalents increased to $1,495 million in 2025 from $781 million in 2024[233] - Cash flows from operating activities for the year ended December 31, 2025, were $836 million, an increase of 4.4% from $801 million in 2024[250] - Cash used for investing activities increased to $184 million in 2025 from $147 million in 2024, primarily due to a $32 million rise in capital expenditures[251] - Financing activities provided $57 million in cash in 2025, a significant recovery from a cash usage of $427 million in 2024, driven by $500 million from the issuance of Senior Notes[252] - As of December 31, 2025, the company had $1,495 million in cash and cash equivalents and $745 million available under the Revolving Credit Facility[1] Expenses and Costs - The cost of sales for 2025 consisted of approximately 66% direct material costs, 26% overhead costs, and 8% direct labor costs[215] - Selling, general and administrative expenses increased by 13% to $380 million in 2025, driven by $64 million related to the Acquisition[227] - Engineering expenses decreased by 13% to $174 million in 2025, reflecting reduced spending on product initiatives[228] - Interest expense for 2025 was $92 million, an increase of 3% from $89 million in 2024[230] Debt and Financing - As of December 31, 2025, total indebtedness included $509 million from ATI's Term Loan and $1,000 million from 3.75% Senior Notes due January 2031[236] - The company authorized an additional $1,000 million for its stock repurchase program, totaling $5,000 million, with $328 million repurchased in 2025[246] - The company made $5 million and $104 million of principal payments on the Term Loan during the years ended December 31, 2025 and 2024, respectively[239] - On January 2, 2026, the company entered into an amendment to increase the Revolving Credit Facility commitments by $250 million to a total of $1,000 million[241] - The company had no amounts outstanding under the Revolving Credit Facility as of December 31, 2025[240] Impairment and Valuation - An impairment analysis in Q4 2025 resulted in an $8 million loss for tangible assets and a $21 million loss for intangible assets due to deteriorating market conditions[268] - The company performed a quantitative impairment analysis of goodwill in 2025, indicating no impairment as the fair value exceeded carrying value[262] - The company recorded $29 million in losses associated with the impairment of long-lived assets in 2025[229] - The company evaluates the carrying value of long-lived assets whenever events indicate that the carrying value may not be recoverable, with impairment recognized when future cash flows are less than carrying value[266] - The company utilizes a market approach for impairment analysis, reflecting the complexity of determining fair values[268] Future Outlook and Assumptions - The company believes that cash provided by operating activities and available liquidity will meet cash requirements for the next twelve months[248] - The company anticipates increased capital expenditures and cash income taxes in 2026 compared to 2025[245] - A 10% change in sales incentives could impact earnings by approximately $8 million, highlighting the sensitivity of revenue recognition estimates[254] - Assumptions and estimates regarding future cash flows and market conditions are complex and subjective, potentially impacting reported financial results[267] Other Considerations - Provisions for estimated warranty expenses are made at the time of product sale, with adjustments based on historical claims and repair costs[269] - The company assesses the need for a valuation allowance against deferred tax assets quarterly, considering various factors including recent losses and forecasts of future profitability[274] - A one percentage point decrease in the assumed discount rate would increase the defined benefit pension plans obligation by approximately $13 million and the OPEB obligation by approximately $6 million as of December 31, 2025[271][272] - The acquisition method is used for business combinations, with assets and liabilities recorded at estimated fair value at acquisition date, and excess purchase price recorded as goodwill[276] - The company reviews the useful lives of intangible assets periodically to determine if revisions are warranted based on events or circumstances[264] - Warranty costs may differ from estimates if actual claim rates are higher or lower than historical rates[269]
Elanco(ELAN) - 2025 Q4 - Annual Report
2026-02-24 14:19
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 Commission file number 001-38661 Elanco Animal Health Incorporated (Exact name of Registrant as specified in its charter) INDIANA 82-5497352 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 450 ELANCO CIRCLE, INDIANAPOLIS, INDIANA 46221 (Address an ...
Cipher Mining (CIFR) - 2025 Q4 - Annual Report
2026-02-24 14:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________ FORM 10-K __________________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to ________. Commission File Number: 001-39625 ______ ...
Mohawk(MHK) - 2025 Q4 - Annual Report
2026-02-24 13:46
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [Mark One] ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 01-13697 (Commission File Number) MOHAWK INDUSTRIES, INC. (Exact name of registrant as specified in its charter) | Delaware | 52-1604305 | | --- | --- | | (Stat ...
PLBY (PLBY) - 2025 Q4 - Annual Results
2026-02-24 13:35
Exhibit 99.1 Playboy Reports Preliminary Fourth Quarter 2025 Financial Results Q4 2025 Revenues Expected to Increase to Between $34.0 Million and $35.0 Million Net Income Between $2.5 Million and $3.5 Million, as Compared to a Net Loss of $12.5 Million in Q4 2024 Adjusted EBITDA Expected to Grow to Between $6.6 Million and $7.0 Million, as Compared to Loss of $0.1 Million in Q4 2024 LOS ANGELES, February 24, 2026 - Playboy, Inc. (Nasdaq: PLBY) ("Playboy" or the "Company"), a global pleasure and leisure comp ...
NexPoint Residential Trust(NXRT) - 2025 Q4 - Annual Results
2026-02-24 13:16
EARNINGS SUPPLEMENT: FOURTH QUARTER & FULL YEAR 2025 NEXPOINT RESIDENTIAL TRUST, INC. 300 CRESCENT COURT, SUITE 700 DALLAS, TX 75201 INVESTOR RELATIONS: KRISTEN GRIFFITH NXRT.NEXPOINT.COM NEXPOINT RESIDENTIAL TRUST, INC. [NYSE:NXRT] TABLE OF CONTENTS Exhibit 99.1 24 February 2026 | NYSE: NXRT FOR IMMEDIATE RELEASE Contact: Investor Relations Kristen Griffith IR@nexpoint.com (214) 276-6300 Media inquiries: Pro-Nexpoint@prosek.com NEXPOINT RESIDENTIAL TRUST, INC. REPORTS FOURTH QUARTER AND FULL YEAR 2025 RESU ...
Harmony Biosciences(HRMY) - 2025 Q4 - Annual Report
2026-02-24 13:16
Financial Performance - WAKIX (pitolisant) generated net product revenue of $868.5 million for the year ended December 31, 2025, with an average of approximately 8,500 patients on the treatment in Q4 2025[25]. - Three customers accounted for 100% of gross product revenue for the year ended December 31, 2025, with Caremark LLC at 38%, Accredo Health Group, Inc. at 36%, and PANTHERx Specialty Pharmacy LLC at 26%[54]. - The company is substantially dependent on the commercial success of its only approved product, WAKIX, which was approved for treating excessive daytime sleepiness (EDS) in adult patients with narcolepsy in August 2019 and for cataplexy in October 2020[145]. - The company's revenue from WAKIX is influenced by market size, competition, pricing acceptance, and reimbursement capabilities[147]. - The company expects WAKIX sales to generate substantially all revenue for the foreseeable future, making its market acceptance critical for profitability[151]. - The potential market opportunity for WAKIX may be smaller than estimated, with assumptions based on current market data that could prove incorrect[153]. Product Development and Pipeline - The company has exclusive rights to develop and commercialize next-generation pitolisant products, including pitolisant Gastro-Resistant and pitolisant High-Dose, currently in clinical development[18]. - The FDA granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi Syndrome (PWS) in February 2024, with a Phase 3 TEMPO study initiated in Q1 2024[33]. - The company expanded its portfolio by acquiring Epygenix Therapeutics, adding global rights to develop EPX-100 and EPX-200 for rare epilepsy, with EPX-100 in Phase 3 trials[19]. - A Phase 2 proof-of-concept trial for pitolisant in Myotonic Dystrophy Type 1 (DM1) showed clinically meaningful improvements in excessive daytime sleepiness and fatigue, with topline data released in December 2023[35]. - The company is pursuing label expansion for WAKIX in idiopathic hypersomnia, with a focus on a new formulation, pitolisant High-Dose, after receiving a refusal-to-file letter in February 2025[30]. - The company is exploring a new formulation of pitolisant for fatigue in multiple sclerosis as the lead indication, with plans for a Phase 1 PK study[38]. - Pitolisant GR and Pitolisant HD formulations entered clinical studies in Q4 2023, with a pivotal bioequivalence study for Pitolisant GR expected to submit a New Drug Application in early 2026 and a target PDUFA date in Q1 2027[37]. - The pivotal bioequivalence study confirmed that 17.8mg of Pitolisant GR is bioequivalent to existing 17.8mg WAKIX tablets, with area under the curve and Cmax ratios of 108.46% and 99.65% respectively[37]. - The total addressable market for EPX-100 among patients with Dravet Syndrome (DS) is approximately 5,000 people, and for Lennox-Gastaut Syndrome (LGS) is approximately 35,000 people[41]. - EPX-100 has been granted orphan drug designation and rare pediatric disease designation by the FDA for treatment of both DS and LGS, currently in two Phase 3 registrational clinical trials[41]. Regulatory Environment - The FDA imposes substantial regulatory requirements on the company, affecting the drug development and approval process, which requires significant time and financial resources[75]. - The FDA requires the completion of preclinical studies, including laboratory tests and animal studies, before an IND can be submitted[76]. - An IND must become effective within 30 days of submission unless the FDA raises concerns, which can delay clinical trials[76]. - Clinical trials must adhere to Good Clinical Practice (GCP) regulations, and progress reports must be submitted annually to the FDA[78]. - The FDA aims to review standard NDAs within ten months from the filing date, with a preliminary review occurring within the first 60 days[83]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug outweigh its risks[84]. - The FDA inspects manufacturing facilities and clinical trial sites to ensure compliance with current Good Manufacturing Practices (cGMP) before approving an NDA[86]. - Post-approval, drugs are subject to ongoing FDA regulation, including requirements for recordkeeping and reporting adverse experiences[95]. - The FDA may withdraw approval if compliance with regulatory requirements is not maintained or if new safety issues arise post-marketing[98]. - Orphan Drug Designation allows for a seven-year marketing exclusivity period for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[106]. Intellectual Property and Licensing - The company relies on license agreements with Bioprojet for core intellectual property related to pitolisant, and any loss of these rights would adversely affect its business[154]. - The company has exclusive rights to develop, manufacture, and commercialize BP1.15205 in the U.S. and Latin America, with positive pre-clinical data announced in June 2025[39]. - The company has exclusive rights to develop and commercialize BP1.15205 for narcolepsy, with an upfront license fee of $25.5 million and potential milestone payments totaling up to $363.2 million[62]. - The WAKIX patent portfolio includes four U.S. patents, with expiration dates ranging from March 2030 to March 2044, ensuring protection for the product[64]. - Utility patents have been filed for Pitolisant GR and Pitolisant HD, with potential patent protection extending to the mid-2040s[37]. - The 2017 License Agreement (LCA) includes tiered royalty rates of 13% to 24% on net sales of WAKIX, with additional royalties of 3% for trademark licensing[58]. - In July 2022, the company entered into a new License Agreement (2022 LCA) with Bioprojet, paying an initial fee of $30.0 million and potential additional payments of up to $155.0 million based on milestones[60]. Market and Competitive Landscape - The U.S. narcolepsy market had an approximate net sales value of $3.1 billion in 2025, expected to grow due to new therapies and increased diagnosis rates[24]. - The company faces significant competition in securing suitable collaborators due to recent business combinations among large pharmaceutical companies, which has reduced the number of potential partners[163]. - The company competes with larger biotechnology and pharmaceutical companies that have greater resources, making it challenging to capture market share[177]. - Generic competition may lead to price decreases for branded products, impacting the commercial potential of current and future products[178]. - Negative publicity regarding pharmaceutical pricing could impact the company's reputation and market acceptance of its products, potentially affecting revenue and profitability[159]. Operational Risks - The company relies heavily on third-party collaborations for product development and commercialization, which poses risks such as limited control over resources and potential abandonment of projects by collaborators[161]. - If third-party agreements are terminated, the company may not receive expected funding, delaying the development of pitolisant and future product candidates[162]. - The company has limited manufacturing capabilities and relies on third-party manufacturers for the supply of WAKIX and product candidates, which could impact commercialization if relationships fail[172]. - The company maintains a 12-month supply of finished goods inventory to ensure product availability, but any interruption in supply could adversely affect its business[174]. - Regulatory compliance is critical, and failure by third-party manufacturers to adhere to cGMP requirements could delay the commercialization of products[176]. - Public health pandemics, such as COVID-19, have disrupted operations, affecting patient access and prescription writing[189]. - Supply chain disruptions could impact the manufacturing and shipment of WAKIX, potentially delaying clinical trials and meeting demand[189]. Human Resources and Corporate Responsibility - The company had 293 full-time employees as of December 31, 2025, with 135 in commercial functions and 103 in research and development[138]. - The company is committed to corporate social responsibility, focusing on safe working conditions and community support through monetary donations and resources[141]. - Recruiting and retaining qualified personnel in operations, finance, and clinical roles is critical, with competition from other pharmaceutical companies[185]. - The company is highly dependent on key executives and scientific teams, with potential risks if these individuals leave[183]. - Future financial performance will depend on effective management of growth activities and associated costs in hiring and training personnel[180]. Legal and Compliance Risks - Violations of healthcare laws can result in significant penalties, including fines, imprisonment, and exclusion from government healthcare programs[120]. - HIPAA imposes strict privacy and security obligations on covered entities regarding health information, with significant penalties for non-compliance[121]. - The federal Anti-Kickback Statute prohibits remuneration to induce purchases of items reimbursable under federal healthcare programs[113]. - The federal Physician Payments Sunshine Act requires manufacturers to report payments or transfers of value to physicians and teaching hospitals annually[118]. - The Prescription Drug Marketing Act regulates the distribution of prescription drugs and drug samples, ensuring accountability in distribution[100]. Data Privacy and Cybersecurity - The company faces cybersecurity risks due to increased reliance on information technology systems and remote work[194]. - The rapid evolution of artificial intelligence presents risks related to data privacy, cybersecurity, and regulatory compliance[197]. - The U.S. regulatory environment for artificial intelligence is complex, with state and federal laws creating a challenging landscape[200]. - The integration of AI systems may increase cybersecurity risks and create new vulnerabilities for the company and its vendors[201]. Financial Obligations and Credit Risks - The company faces significant payment obligations under licensing agreements, which could impact its ability to develop and market products if not met[209][210]. - The TLA Credit Agreement contains restrictive covenants that may limit the company's operational flexibility and ability to engage in certain transactions[211]. - Failure to comply with the TLA Credit Agreement could result in default, leading to accelerated repayment obligations that may adversely affect financial condition[212][213]. - The company's obligations under the TLA Credit Agreement are secured by all assets, which could impact the distribution of assets in a liquidation scenario[214]. - The company has never paid dividends on common stock and does not intend to do so in the foreseeable future, relying on stock price appreciation for investor returns[215].
enviri(NVRI) - 2025 Q4 - Annual Results
2026-02-24 13:09
Exhibit 99.1 Investor Contact Media Contact +1.267.946.1407 +1.717.480.6145 David Martin Karen Tognarelli dmartin@enviri.com ktognarelli@enviri.com FOR IMMEDIATE RELEASE Enviri Corporation Reports Fourth Quarter and Full Year 2025 Results PHILADELPHIA (Feb. 24, 2026) - Enviri Corporation (NYSE: NVRI) (the "Company") today reported fourth quarter and full year 2025 results. Revenues in the fourth quarter of 2025 totaled $556 million, and on a U.S. GAAP ("GAAP") basis, the consolidated loss from continuing op ...
Portillo’s(PTLO) - 2025 Q4 - Annual Report
2026-02-24 13:07
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 28, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER: 001-40951 PORTILLO'S INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I ...