Financial Results Announcement - Arcellx, Inc. announced its financial results for the fiscal quarter ended September 30, 2025[6] - The press release detailing the financial results was issued on November 5, 2025[6] Company Information - The company is listed on The Nasdaq Stock Market under the symbol ACLX[5]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _______________________________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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 num ...

Financial Performance - Net sales for Q3 2025 reached $110,252,000, a 10.4% increase from $99,873,000 in Q3 2024[22] - The company reported a net loss of $672,000 for Q3 2025, compared to a net loss of $1,075,000 in Q3 2024[22] - For the nine months ended September 30, 2025, the company reported a net loss of $5,052,000 compared to a net income of $1,367,000 for the same period in 2024[29] - The net loss attributable to Brilliant Earth Group, Inc. for the three months ended September 30, 2025, was $(528) thousand, compared to a net loss of $(836) thousand in 2024[49] - Net loss for the three months ended September 30, 2025, was $0.7 million, a decrease of 37.5% compared to a net loss of $1.1 million for the same period in 2024[114] - Adjusted EBITDA for the three months ended September 30, 2025, was $3.6 million, unchanged from the same period in 2024[114] - Adjusted EBITDA for the nine months ended September 30, 2025, was $7.821 million, with an Adjusted EBITDA margin of 2.5%[141] Revenue and Sales - Net sales for the three months ended September 30, 2025, were $110.3 million, an increase of 10.4% compared to $99.9 million for the same period in 2024[114] - Net sales for the nine months ended September 30, 2025, increased by $10.4 million, or 3.4%, compared to the same period in 2024, driven by a 15.9% increase in order volumes[126] - The increase in net sales was driven by a 16.8% rise in order volumes, partially offset by a 5.5% decrease in average order value (AOV)[115] - The average order value (AOV) decreased by 10.7% to $2,116 for the nine months ended September 30, 2025, primarily due to a higher mix of lower price point products[136] Expenses and Liabilities - Operating expenses for the nine months ended September 30, 2025, totaled $187,353,000, up from $182,213,000 in the same period of 2024[22] - Operating expenses for the three months ended September 30, 2025, increased by $2.2 million, or 3.6%, compared to the same period in 2024[120] - Interest expense decreased by $1.0 million, or 79.4%, for the three months ended September 30, 2025, primarily due to the prepayment of $34.8 million under the SVB Term Loan[122] - Interest expense decreased by $1.5 million, or 40.4%, for the nine months ended September 30, 2025, due to principal payments made on the SVB Term Loan[132] - The total accrued expenses and other current liabilities as of September 30, 2025, were $29.3 million, a decrease from $31.7 million at the end of 2024[60] Assets and Equity - Total current assets decreased to $135,651,000 as of September 30, 2025, from $211,413,000 at December 31, 2024, representing a decline of 35.8%[20] - Cash and cash equivalents decreased to $73,429,000 as of September 30, 2025, from $161,925,000 at December 31, 2024, a decline of 54.7%[20] - Stockholders' equity attributable to Brilliant Earth Group, Inc. decreased to $11,979,000 as of September 30, 2025, from $15,329,000 at December 31, 2024[20] - As of September 30, 2025, Brilliant Earth Group, Inc. reported total stockholders' equity of $67,075,000[24] - The company had $15.2 million in consigned inventory held on behalf of suppliers as of September 30, 2025[59] Shareholder Activities - The company repurchased common stock amounting to $58,112,000 during the period[24] - The Board of Directors declared a one-time cash dividend of $0.25 per share, totaling approximately $25.0 million, with $3.8 million paid to Class A common stockholders[145] - The Company repurchased a total of 41,112 shares of Class A common stock in July 2025 at an average price of $1.53 per share, and 17,000 shares in August 2025 at an average price of $1.76 per share[178] - The total value of shares that may yet be purchased under the repurchase program is approximately $18.9 million as of September 30, 2025[178] Market and Strategic Initiatives - The company operates in one segment, focusing on the retail sale of ethically sourced diamonds, gemstones, and jewelry[42] - The company is evaluating the impact of new accounting standards issued by FASB, which may affect future disclosures but not the consolidated financial statements[46][47] - The company plans to continue expanding its showroom presence and enhancing its omnichannel strategy to drive growth[99] - The company is focused on cost-effective customer acquisition and retention strategies to support future growth[98] - The company is in the early stages of international expansion, with plans to localize its website and open new showrooms in overseas markets[102] Tax and Compliance - The Company has recorded a corresponding estimated liability of $7.8 million representing 85% of the projected tax benefits to the Continuing Equity Owners[82] - The Company expects significant cash payments under the Tax Receivable Agreement (TRA), which will reduce overall cash flow available[149] - The total amount of tax distributions to members was $50 million during the third quarter of 2024, indicating ongoing compliance with tax obligations[27] Legal and Risk Factors - The Company intends to vigorously defend against the claims made in the lawsuit filed by a former employee, with any liability currently not probable or reasonably estimable[176] - There have been no material changes to the Company's risk factors as previously disclosed in the 2024 Form 10-K[177] - The Company has stipulated to the filing of an amended complaint in the ongoing lawsuit, which may include class claims[176] Internal Controls and Governance - A material weakness in internal control over financial reporting was identified, related to ineffective IT general controls[168] - The Company plans to raise additional funds if current liquidity is insufficient, which may involve issuing equity securities or debt financing[150]

Financial Performance - Q4'25 reported ARR of $2,478 million, a 10% increase year-over-year, with constant currency ARR growth of 8.5%[5] - FY'25 total revenue reached $2,739 million, representing a 19% year-over-year growth, with Q4'25 revenue at $894 million, a 43% increase year-over-year[10] - Non-GAAP earnings per share for Q4'25 was $3.47, a 126% increase compared to $1.54 in Q4'24, with FY'25 non-GAAP EPS at $8.00, up 57% year-over-year[10] - Recurring revenue for the three months ended September 30, 2025, was $861,071,000, a 47.8% increase from $582,430,000 for the same period in 2024[38] - Total revenue for the twelve months ended September 30, 2025, reached $2,739,226,000, up 19.2% from $2,298,472,000 in 2024[38] - Net income for the three months ended September 30, 2025, was $354,828,000, compared to $126,523,000 for the same period in 2024, representing a 180.5% increase[38] - Earnings per share for the twelve months ended September 30, 2025, was $6.18, up from $3.14 in 2024, reflecting a 96.2% increase[38] - Non-GAAP net income for the twelve months ended September 30, 2025, was $965.8 million, compared to $613.4 million for the same period in 2024, reflecting a 57.5% growth[42] Cash Flow and Expenses - Operating cash flow for Q4'25 was $104 million, up 6% from $98 million in Q4'24, while free cash flow increased by 7% to $100 million[5] - The company expects FY'26 constant currency ARR growth of 7% to 9%, with operating cash flow projected at approximately $1.03 billion[9] - Total operating expenses for the twelve months ended September 30, 2025, were $1,311,858,000, an increase from $1,265,594,000 in 2024[38] - Free cash flow for the twelve months ended September 30, 2025, was $856.7 million, compared to $735.6 million in 2024, reflecting a 16.5% increase[48] Stock and Shareholder Actions - PTC plans to repurchase approximately $200 million of its common stock in Q1'26 as part of a $2 billion share repurchase authorization[9] - The company anticipates a decrease in Q1'26 fully diluted share count to approximately 120 million shares from 121 million shares in Q1'25[21] Profitability and Margins - The company reported a gross margin of $776,896,000 for the three months ended September 30, 2025, compared to $513,722,000 in 2024, indicating a significant improvement in profitability[38] - GAAP gross margin for Q3 2025 was $776.9 million, up from $513.7 million in Q3 2024, representing a 51.3% increase[42] - GAAP operating income for Q3 2025 was $433.6 million, significantly higher than $194.0 million in Q3 2024, representing a 123.8% increase[42] Revenue Streams - License revenue for the three months ended September 30, 2025, was $484,081,000, a substantial increase from $239,448,000 in 2024[40] - Support and cloud services revenue for the twelve months ended September 30, 2025, was $1,469,180,000, compared to $1,359,355,000 in 2024, marking a growth of 8.1%[40] Company Strategy and Market Position - The divestiture of Kepware and ThingWorx is expected to enhance the company's focus on CAD, PLM, ALM, and SLM solutions[3] - PTC employs over 7,000 people and supports more than 30,000 customers globally, indicating a strong market presence[35] Future Outlook and Risks - The company anticipates potential risks affecting future performance, including macroeconomic conditions and customer adoption of new software solutions[34] - FY'26 guidance includes an expected increase in GAAP and non-GAAP operating expenses by approximately 4% due to growth investments[21] Assets and Equity - Total assets as of September 30, 2025, were $6.62 billion, compared to $6.38 billion a year earlier, showing a 3.8% increase[45] - Stockholders' equity increased to $3.83 billion as of September 30, 2025, from $3.21 billion in 2024, a growth of 19.2%[45]

Ongoing enrollment of patients in Phase 1 study with LN, SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) Adicet Bio Reports Third Quarter 2025 Financial Results and Provides Business Updates Announced positive preliminary safety and efficacy data from Phase 1 clinical trial of ADI-001 in patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE); data highlighted rapid a ...

Financial Performance - Total operating revenues for Q3 2025 were $886 million, a decrease of 5.2% compared to $935 million in Q3 2024[16] - Passenger revenue for Q3 2025 was $854 million, down 6.2% from $910 million in Q3 2024[16] - Operating expenses increased to $963 million in Q3 2025, up 5.1% from $916 million in Q3 2024[16] - Net loss for Q3 2025 was $77 million, compared to a net income of $26 million in Q3 2024[16] - Operating income for the nine months ended September 30, 2025, was a loss of $198 million, compared to a gain of $13 million for the same period in 2024[16] - Basic earnings per share for Q3 2025 was $(0.34), compared to $0.11 in Q3 2024[16] - The company reported a net loss of $190 million for the nine months ended September 30, 2025, compared to a net income of $31 million for the same period in 2024[117] - The company reported a loss before income taxes of $76 million for Q3 2025, compared to a profit of $27 million in Q3 2024[107] Cash and Liquidity - Cash and cash equivalents decreased to $566 million as of September 30, 2025, from $740 million at the end of 2024[12] - As of September 30, 2025, total available liquidity was $691 million, consisting of $561 million in unrestricted cash and cash equivalents[119] - The company reported a net cash used in operating activities of $434 million for the nine months ended September 30, 2025, compared to $169 million in the same period of 2024[169] - Net cash provided by financing activities was $418 million for the nine months ended September 30, 2025, compared to $182 million in 2024[169] Assets and Liabilities - Total assets increased to $6,701 million as of September 30, 2025, compared to $6,153 million at the end of 2024[12] - Total liabilities rose to $6,267 million as of September 30, 2025, up from $5,549 million at the end of 2024[12] - Total debt rose to $673 million as of September 30, 2025, compared to $507 million as of December 31, 2024, marking a 32.7% increase[41] - Long-term debt, net, increased to $305 million as of September 30, 2025, from $241 million as of December 31, 2024, reflecting a 26.6% increase[41] - The debt to capital ratio increased to 61% as of September 30, 2025, compared to 45% at the end of 2024[162] Revenue Breakdown - Operating revenues from domestic flights were $841 million for the three months ended September 30, 2025, compared to $890 million in 2024[37] - Passenger revenues totaled $854 million, down from $910 million year-over-year, with fare revenues at $330 million compared to $342 million in 2024[37] - Non-fare passenger revenues decreased to $524 million from $568 million, with service fees at $234 million and baggage fees at $178 million, both lower than the previous year[37] - Total operating revenues decreased by $49 million, or 5%, during the three months ended September 30, 2025, primarily due to a 4% lower capacity measured by ASMs[120] Operating Costs - Total operating expenses for Q3 2025 increased to $963 million, resulting in a cost per available seat mile (CASM) of 9.95¢, a 9% increase compared to Q3 2024[110] - Non-fuel expenses increased by 11% in Q3 2025 compared to the same period in 2024, driven by higher employee benefit costs and increased station costs[111] - Total operating expenses for the nine months ended September 30, 2025, increased to $2,925 million, resulting in a CASM of 9.77¢, a 6% increase compared to the prior year[113] - Aircraft rent expense for the nine months ended September 30, 2025, was $536 million, up from $483 million for the same period in 2024, representing an 11% increase[52] Capacity and Utilization - Available seat miles (ASMs) for Q3 2025 were 9,689 million, down from 10,075 million in Q3 2024, indicating a disciplined capacity deployment strategy[108] - The average daily aircraft utilization decreased by 15% to 8.7 hours in Q3 2025, down from 10.2 hours in Q3 2024[156] - The load factor increased by 2.7 percentage points to 80.7% for the three months ended September 30, 2025, compared to 78.0% in the prior year[120] Tax and Regulatory Matters - The effective tax rate for Q3 2025 was an expense of 1.3% on pre-tax losses, significantly lower than the 3.7% expense on pre-tax income in Q3 2024[86] - The effective tax rate for the nine months ended September 30, 2025, was 2.2%, down from 11.4% in 2024, influenced by an increase in valuation allowance for net operating losses[144] - The company is subject to a revised preliminary assessment of $133 million related to federal excise tax from the IRS[70] Employee and Labor Relations - As of September 30, 2025, approximately 86% of the company's employees were represented by unions, with various collective bargaining agreements in place[73] - The company is currently negotiating new labor contracts with unions representing its pilots and flight attendants[105] Future Commitments and Investments - As of September 30, 2025, the company had total purchase commitments for aircraft and engines amounting to $11.436 billion[68] - The company has a firm obligation to purchase 178 A320neo family aircraft and 31 additional spare engines to be delivered by 2031[166]

Fiscal Year and Demand Projections - The company operates on a 52-53 week fiscal year, with fiscal years 2023 and 2025 consisting of 52 weeks, and 2024 consisting of 53 weeks[17]. - The company estimates consumer demand for smartphones will remain approximately flat for calendar year 2025 compared to 2024, with expected mid single-digit percentage growth in 5G handsets[29]. Automotive and IoT Trends - By 2030, 68% of new vehicles produced are projected to have embedded cellular connectivity, with 48% featuring 5G connectivity, up from 21% in 2025[31]. - The share of new light-duty vehicles sold globally with Level 2 or higher autonomy is expected to grow from 24% in 2025 to 52% in 2030[31]. - Industry demand for IoT devices is expected to remain strong across consumer, edge networking, and industrial applications, driven by 5G and AI technologies[32]. - The company’s Snapdragon Digital Chassis platforms are enabling advanced driver assistance and automated driving solutions in the automotive sector[18]. Technology Development and Innovation - The company anticipates continued advancements in generative AI capabilities of edge devices and increased adoption of generative AI technologies in handsets and other edge devices[25]. - The company has developed Qualcomm Oryon CPU core technology aimed at enhancing performance and efficiency across a wide portfolio of Snapdragon powered products[37]. - The Qualcomm AI Engine includes dedicated hardware for high-performance, low-power AI use cases on-device, enhancing privacy and security[38]. - The company continues to invest heavily in research and development to drive the evolution of mobile, automotive, and IoT technologies[36]. 5G and Telecommunications - 5G technology is designed to support diverse services, including enhanced mobile broadband, massive IoT, and mission-critical communications, utilizing various spectrum types and deployment scenarios[40]. - The company continues to contribute to 3GPP standardization activities, defining the evolution of 5G and establishing requirements for 6G[41]. - The QCT segment focuses on integrated circuit products and system software for mobile devices, automotive systems, and IoT products, with a technology roadmap that maintains backward compatibility with existing standards[44]. Licensing and Intellectual Property - QTL segment generates significant licensing revenues from cellular standard-essential patents, which are essential for the manufacture and sale of wireless products[54]. - The company has a leading intellectual property portfolio with extensive patents related to wireless communication technologies, essential for the commercial implementation of LTE and 5G products[55]. - The company has licensed its patents to hundreds of companies, contributing to industry growth and reducing device pricing[56]. - QTL licensing revenues are primarily generated through per-unit royalties based on a percentage of the wholesale selling price of licensed products[58]. Competition and Market Position - The company faces intense competition in the semiconductor industry, with competitors focusing on performance, integration, quality, and innovation[53]. - The QCT segment's marketing strategy promotes Qualcomm as a leader in intelligent computing and aims to expand the reach of Snapdragon and Dragonwing brands[51]. - Qualcomm's semiconductor business may suffer due to customers vertically integrating and developing their own integrated circuit products, notably from major clients like Apple, Samsung, and Xiaomi[108]. Customer Concentration and Revenue Risks - A significant portion of Qualcomm's revenues is derived from a small number of customers and licensees, particularly from premium-tier handset devices, which is expected to continue in the foreseeable future[102]. - The company anticipates that Apple will increasingly utilize its own modem products in future devices, which will negatively impact Qualcomm's QCT revenues and cash flows[103]. - Qualcomm's licensing revenues are significantly impacted by a limited number of licensees, including several Chinese OEMs, and any failure to meet obligations could adversely affect financial performance[107]. Supply Chain and Manufacturing Risks - The company faces risks related to supply and manufacturing, relying on a limited number of third-party suppliers, which could negatively impact its results of operations if supply strategies fail[92]. - The company is subject to order and shipment uncertainties that could further impact its results of operations[128]. - The reliance on a limited number of third-party suppliers for manufacturing could negatively impact the company's ability to meet customer demand and affect profitability[128]. Cybersecurity and Operational Risks - The company may incur significant costs related to product liability claims, which could divert management attention and negatively impact financial results[179]. - The company has encountered cybersecurity threats and intrusions, which may affect its IT systems and proprietary information[143]. - The company expects to continue investing in the security of its IT systems and proprietary information to mitigate risks associated with cybersecurity[146]. Global Market and Regulatory Environment - Qualcomm's revenues are significantly concentrated in China, and the risks associated with this concentration are heightened by U.S./China trade tensions[109]. - The company derives a significant portion of its revenues from Chinese OEMs and non-Chinese OEMs that utilize its products in devices sold into China, which has the largest number of smartphone users in the world[199]. - The company is subject to various global regulations, including those related to cybersecurity, privacy, and data protection, which could adversely affect its business and results of operations[200].

Financial Performance - Net income for Q3 2025 was $36.5 million, or $0.42 per diluted share, a 19% increase compared to Q3 2024[113] - Adjusted net income for Q3 2025 rose 48% year-over-year to $45.2 million, or $0.52 per share[113] - For the nine months ended September 30, 2025, net income totaled $110.6 million, a 27% increase compared to the same period in 2024[114] - Net income for Q3 2025 was $36,467,000, a decrease of 14.3% from Q2 2025's $42,687,000 and an increase of 19.0% from Q3 2024's $30,651,000[146] - Adjusted net income for Q3 2025 reached $45,164,000, compared to $44,466,000 in Q2 2025 and $30,511,000 in Q3 2024, reflecting a year-over-year increase of 47.9%[146] - Earnings per diluted share for Q3 2025 was $0.42, down from $0.50 in Q2 2025 but up from $0.36 in Q3 2024[146] - Adjusted earnings per diluted share for Q3 2025 was $0.52, consistent with Q2 2025 and up from $0.36 in Q3 2024[146] Acquisitions - The acquisition of Heartland Bancshares, completed on July 11, 2025, added approximately $153.3 million in loans and $705.2 million in deposits[107] - The acquisition of Villages Bancorporation, completed on October 1, 2025, expanded the company's presence with 19 new branches[108] - Seacoast expects the Heartland acquisition to be accretive to earnings in 2026, with tangible book value dilution earned back in approximately two years[107] - Total assets increased by $1.5 billion, or 10%, to $16.7 billion as of September 30, 2025, including the acquisition of Heartland which added $823.5 million in assets[149] Asset and Loan Growth - Organic deposit growth was 7% annualized, while organic loan growth was 8% annualized[113] - Average loans increased by $246.1 million (2%) in Q3 2025 compared to Q2 2025, and by $676.3 million (7%) compared to Q3 2024[117] - Loans, net of unearned income, totaled $11.0 billion at September 30, 2025, a $664.2 million, or 6.4%, increase from December 31, 2024[158] - CRE owner-occupied loans increased by $212.1 million, or 13%, totaling $1.9 billion at September 30, 2025[163] - Residential real estate loans rose by $78.0 million to $2.7 billion at September 30, 2025, with $1.0 billion in fixed-rate mortgages and $1.0 billion in adjustable-rate mortgages[165] - Commercial and financial loans increased by $156.6 million, or 9%, totaling $1.8 billion at September 30, 2025[166] Interest Income and Margin - Net interest income for Q3 2025 was $133.5 million, a 5% increase from Q2 2025[113] - Net interest income for Q3 2025 was $133,468,000, an increase of 5.0% from $126,864,000 in Q2 2025 and up 25.1% from $106,665,000 in Q3 2024[146] - The yield on securities was 3.89% for the nine months ended September 30, 2025, compared to 3.65% for the same period in 2024[117] - Net interest margin decreased one basis point to 3.57% in Q3 2025, but increased 40 basis points from 3.17% in Q3 2024, driven by lower deposit costs[116] Deposits and Funding - Total deposits increased by $847.9 million, or 7%, to $13.1 billion at September 30, 2025, driven by customer growth and the Heartland acquisition[193] - The cost of average total deposits was 1.81% in Q3 2025, down from 2.34% in Q3 2024[120] - Noninterest demand deposits represented 28% of total deposits at September 30, 2025, compared to 27% at December 31, 2024[194] - The cost of funds was 1.96% in Q3 2025, down from 2.43% in Q3 2024[116] Noninterest Income and Expenses - Noninterest income for Q3 2025 totaled $23.8 million, a decrease of $0.7 million, or 3%, from Q2 2025, but an increase of $0.1 million, or 1%, from Q3 2024[128] - Noninterest expense for Q3 2025 was $102.0 million, an increase of $10.3 million, or 11%, from Q2 2025, and an increase of $17.2 million, or 20%, from Q3 2024[135] - Wealth management income reached $4.6 million in Q3 2025, up $0.4 million, or 9%, from Q2 2025, and up $0.7 million, or 19%, from Q3 2024, with assets under management increasing by $414.1 million, or 20%[129] Credit Quality - The allowance for credit losses was $141,285 thousand as of September 30, 2025, slightly improved from $145,579 thousand in the previous year[127] - Nonperforming assets (NPAs) decreased to $65.6 million, down 34% from $98.9 million at the end of 2024[177] - The ratio of allowance for credit losses to total loans was 1.34% at September 30, 2025, unchanged from December 31, 2024[184] - The Company recorded a provision expense of $8.4 million for Q3 2025, compared to $6.3 million in Q3 2024[183] Capital and Ratios - The company maintains a strong capital position with a Tier 1 capital ratio of 14.5% and a tangible common equity to tangible assets ratio of 9.8%[113] - Shareholders' equity increased to $2,345,233 thousand in Q3 2025, up from $2,252,208 thousand in Q2 2024, reflecting a growth of 4.13%[126] - The total risk-based capital ratio was 15.90% at September 30, 2025, well above the regulatory minimum of 10.00%[208] Interest Rate Sensitivity - The projected impact of a +3.00% change in interest rates on net interest income for the 1-12 months is a decrease of 5.2%[215] - The Economic Value of Equity (EVE) is sensitive to interest rate changes, with a projected decrease of 18.3% for a +3.00% rate change and an increase of 9.4% for a -2.00% rate change[225] - A gradual shift in interest rates would have a more modest impact on EVE compared to an instantaneous shift[225]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 ☐ 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 001-35292 LCNB Corp. (Exact name of registrant as specified in its charter) Ohio 31-1626393 (State or other juris ...

Product Overview - The company currently markets three drug products: FIRDAPSE®, AGAMREE®, and FYCOMPA®[168] - FIRDAPSE® received FDA approval in November 2018 and was launched in the U.S. in January 2019, with a recent sNDA approval increasing the maximum daily dosage from 80 mg to 100 mg[171] - The FDA approved AGAMREE® for treating Duchenne muscular dystrophy (DMD) in patients aged two years and older on October 26, 2023[192] - AGAMREE® received marketing authorization from the European Commission on December 18, 2023, for DMD patients aged four and older[199] - AGAMREE® was launched for the treatment of DMD in the U.S. on March 13, 2024, with significant commercialization expenses incurred during the first quarter of 2024[193] Financial Performance - Total revenues for the three and nine months ended September 30, 2025, were approximately $148.4 million and $436.4 million, respectively, compared to $128.7 million and $349.9 million for the same periods in 2024, representing an increase of 15.5% and 24.7%[233][234] - FIRDAPSE® net product revenue increased to approximately $92.2 million and $260.8 million for the three and nine months ended September 30, 2025, up from approximately $79.3 million and $223.5 million in 2024, reflecting a growth of 16.2% and 16.7%[235] - AGAMREE® net product revenue was approximately $32.4 million and $81.8 million for the three and nine months ended September 30, 2025, compared to approximately $15.0 million and $25.0 million in 2024, indicating significant growth following its commercial launch in March 2024[236] - FYCOMPA® net product revenue decreased by approximately $8.3 million or 25.8% for the three months and $5.3 million or 5.3% for the nine months ended September 30, 2025, due to generic competition following patent expiration[239] - Net income for Q3 2025 was $52.8 million ($0.43 per basic share), compared to $43.9 million ($0.37 per basic share) in Q3 2024, reflecting a 20.3% increase[255] - For the nine months ended September 30, 2025, net income was $161.6 million ($1.32 per basic share), compared to $108.0 million ($0.92 per basic share) in the same period of 2024, representing a 49.7% increase[255] Research and Development - A Phase 1 study is currently underway to evaluate the immunosuppressive effects of AGAMREE® for future indications, with results expected by the end of Q1 2026[200] - The company expects future research and development activities to become more significant as it seeks to expand its portfolio and develop additional indications for FIRDAPSE® and AGAMREE®[246] Expenses and Costs - Research and development expenses for the three months ended September 30, 2025, were approximately $2.7 million, a decrease of 19.1% from $3.3 million in 2024, while for the nine months, expenses increased to approximately $10.9 million from $8.9 million, a rise of 23.2%[245] - Cost of sales for the three and nine months ended September 30, 2025, were approximately $22.7 million and $61.2 million, respectively, compared to $19.3 million and $47.2 million in 2024, reflecting an increase of 17.6% and 29.7%[241] - Selling, general and administrative expenses for Q3 2025 were approximately $47.5 million, a 3.5% increase from $45.9 million in Q3 2024, representing 58% and 59% of total operating costs, respectively[247] - For the nine months ended September 30, 2025, selling, general and administrative expenses totaled approximately $140.3 million, up 5.1% from $133.5 million in the same period of 2024[248] Cash and Investments - The company had cash and investments of approximately $689.9 million as of September 30, 2025, sufficient to support operations for at least the next 12 months[214] - Cash and cash equivalents as of September 30, 2025, were $689.9 million, up from $517.6 million at December 31, 2024[256] - Net cash provided by operating activities for the nine months ended September 30, 2025, was $163.8 million, compared to $168.9 million for the same period in 2024[263] Agreements and Collaborations - The company entered into a License and Collaboration Agreement with Santhera Pharmaceuticals for AGAMREE® and made a $75 million payment for exclusive North American rights[190] - The company is obligated to make a milestone payment of $36 million to Santhera following the NDA approval for AGAMREE®[192] - The company agreed to pay Jacobus a total of $30 million in cash related to a settlement, with $10 million paid at closing, $10 million on the first anniversary, and $10 million on the second anniversary[270] - The annual royalty on Catalyst's net sales of amifampridine products in the U.S. is set at 1.5% for 2022-2025 (minimum $3 million per year) and 2.5% for 2026 until patent expiration (minimum $5 million per year)[271] Market and Competition - The estimated number of DMD patients in the U.S. is between 11,000 and 13,000, with approximately 70% currently receiving corticosteroid treatment[197] - The company faces uncertainties regarding the successful commercialization of FIRDAPSE®, AGAMREE®, and FYCOMPA®, including market size estimates and competition from generics[275] Stock and Share Repurchase - A new share repurchase program was authorized on October 1, 2025, allowing for the repurchase of up to $200 million in common stock[215] - As of November 3, 2025, the company repurchased 405,092 shares for an aggregate purchase price of approximately $8.4 million, averaging $20.74 per share[216] Other Financial Metrics - License and other revenue for the three and nine months ended September 30, 2025, was $27 thousand and $71 thousand, respectively, compared to $2.3 million and $2.4 million in 2024, indicating a significant decline due to the absence of milestone payments[240] - Other income, net for Q3 2025 was $4.8 million, down from $6.3 million in Q3 2024, primarily due to a decrease in the share price of investments[251] - The effective income tax rate for the nine months ended September 30, 2025, was approximately 23.6%, slightly lower than 24.0% for the same period in 2024[253] - Total stock-based compensation for Q3 2025 was $5.7 million, an increase from $4.4 million in Q3 2024, and for the nine months, it was $19.1 million compared to $17.1 million in the same period of 2024[250] Marketing and Awareness - The company has expanded its digital and social media activities to increase awareness of its products among potential patients and healthcare providers[176]