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Trinity Capital (TRIN) - 2025 Q3 - Quarterly Report
2025-11-05 13:04
Investment Strategy - Trinity Capital Inc. targets investments in growth-oriented companies with expected annual revenues of up to $100 million[389]. - The company aims to generate current income and capital appreciation primarily through term loans, equipment financings, and asset-based lending[388]. - Investments typically have initial interest-only periods of up to 24 months and total terms of up to 60 months[390]. - The company is required to invest at least 70% of total assets in qualifying assets under the 1940 Act[388]. - As of the latest report, substantially all of the company's investments are considered Level 3 assets due to the nature of lending to venture capital-backed companies[405]. Financial Performance - As of September 30, 2025, the company's investment portfolio had an aggregate fair value of approximately $2,192.4 million, up from $1,725.6 million as of December 31, 2024, representing a growth of 27.2%[412]. - The company recorded $1.4 million and $2.7 million in dividend income for the three and nine months ended September 30, 2025, respectively, compared to $0.5 million and $1.0 million for the same periods in 2024, indicating a significant increase of 180% and 170%[410]. - Total investment income for the three months ended September 30, 2025, was approximately $75.6 million, an increase of 22.3% from $61.8 million in the same period of 2024, with an effective yield of 15.0%[432]. - Net investment income for the three months ended September 30, 2025, was approximately $37.0 million, compared to $29.4 million for the same period in 2024, representing a 25.8% increase[440]. - The net realized losses on investments for the three months ended September 30, 2025, were approximately $(20.0) million, compared to $(13.9) million for the same period in 2024[443]. Portfolio Management - The company has engaged independent valuation firms to assist in valuing its investments, particularly those with potential for material fluctuations[401]. - The company's ten largest portfolio companies represented approximately 24.6% of the total fair value of investments as of September 30, 2025, down from 26.7% as of December 31, 2024[417]. - The weighted average time to maturity of the debt in the portfolio was approximately 3.3 years as of September 30, 2025, compared to 3.2 years as of December 31, 2024[415]. - The company’s portfolio management team utilizes an ongoing investment risk rating system to monitor outstanding loans and equipment financings, ensuring proactive risk management[421]. - As of September 30, 2025, loans to three portfolio companies and equipment financings to one portfolio company on non-accrual status totaled approximately $56.2 million, with a fair value of approximately $20.7 million, representing 1.0% of the Company's debt investment portfolio[430]. Capital Structure and Financing - The company completed its initial public offering on February 2, 2021, raising capital through the sale of 8,006,291 shares at $14.00 per share[393]. - The company received an aggregate of $607.8 million in proceeds from repayments and sales of investments during the nine months ended September 30, 2025, including $224.3 million from early repayments on debt investments[418]. - The asset coverage ratio as of September 30, 2025, was approximately 184.2%, allowing the company to potentially borrow $2 for every $1 of investor equity[459]. - Total contractual obligations as of September 30, 2025, amounted to $1,191.758 million, with $125.354 million due within one year[465]. - The company intends to pay quarterly distributions to stockholders, with the most recent distribution of $0.51 per share declared for September 30, 2025[466][467]. Market and Risk Factors - The company is subject to financial market risks, including valuation risk and interest rate risk, which could materially impact its market risks[479]. - The company may hedge against interest rate and currency exchange rate fluctuations using standard hedging instruments, which could limit its ability to benefit from lower interest rates[486]. - The company’s net income could be impacted by hypothetical changes in interest rates, with a 300 basis points increase in the Prime Rate potentially resulting in a net income increase of $34.931 million[484]. - The company has minimal exposure to currency risk as payments from foreign domiciled portfolio companies are primarily received in U.S. dollars[485]. Stock Performance - As of November 3, 2025, the last reported closing sales price of the common stock was $15.12 per share, representing a premium of approximately 13.6% to the net asset value per share of $13.31[470]. - The net asset value per share is determined at the end of each quarter and may not reflect the value on the date of high and low closing sales prices[471]. - The company’s shares may trade at a market price that is less than the net asset value per share, with potential for trading at unsustainable premiums or discounts[472]. Corporate Governance - The company formed a wholly-owned subsidiary, Trinity Capital Adviser LLC, to provide investment advisory services[394]. - The company has entered into indemnification agreements with its directors and executive officers to provide maximum indemnification permitted under Maryland law[474].
Centuri Holdings, Inc.(CTRI) - 2025 Q3 - Quarterly Results
2025-11-05 13:04
Financial Performance - Achieved record quarterly revenue of $850.0 million, an 18.1% increase from $720.1 million in Q3 2024[4] - Base Revenue and Base Gross Profit were $848.6 million and $77.6 million, representing increases of 25% and 28% year-over-year, respectively[6] - Adjusted EBITDA for Q3 2025 was $75.2 million, compared to $78.8 million in Q3 2024[4] - Net income attributable to common stock was $2.1 million, compared to a net loss of $(3.7) million in Q3 2024[4] - Total revenue for the fiscal three months ended September 28, 2025, was $850,044,000, a 18.1% increase from $720,053,000 for the same period in 2024[35] - Adjusted Net Income for the fiscal nine months ended September 28, 2025, was $23,066, compared to $7,859 for the same period in 2024[29] - Adjusted Diluted Earnings per Share for the fiscal three months ended September 28, 2025, was $0.19, compared to $0.06 in the same period last year[31] - Net income for the fiscal three months ended September 28, 2025, was $2,114, compared to a loss of $3,617 for the same period in 2024[29] Bookings and Backlog - Secured bookings of $815 million in Q3 2025, resulting in a book-to-bill ratio of 1.8x for the first three quarters of 2025[7] - Reached a record high backlog of $5.9 billion, a 59% increase from year-end 2024[4] Guidance and Projections - Updated 2025 revenue guidance to $2.8 to $2.9 billion, up from previous guidance of $2.70 to $2.85 billion[11] Segment Performance - Canadian Gas segment revenue grew by 38.7%, leading all segments in growth for Q3 2025[12] Debt and Liabilities - Net Debt to Adjusted EBITDA Ratio was 3.8x as of September 28, 2025, slightly up from 3.7x as of June 29, 2025[8] - Total debt as of September 28, 2025, was $944,612, with net debt amounting to $928,479 after accounting for cash and cash equivalents[32] - The Net Debt to Adjusted EBITDA Ratio as of September 28, 2025, was 3.8, slightly up from 3.7 in the previous quarter[32] - Total liabilities rose to $1,587,273,000 as of September 28, 2025, from $1,514,169,000 at December 29, 2024[39] Cash Flow and Expenditures - Cash and cash equivalents decreased to $16,133,000 as of September 28, 2025, from $49,019,000 at the beginning of the period[39] - Net cash used in operating activities for the fiscal nine months ended September 28, 2025, was $(5,769,000), a significant decrease from $97,232,000 in the prior year[41] - Capital expenditures for the fiscal nine months ended September 28, 2025, were $(68,738,000), compared to $(66,093,000) in the same period of 2024[41] Company Developments - The company completed its separation from Southwest Gas Holdings, becoming a fully independent public company[9] - Separation-related costs for the fiscal three months ended September 28, 2025, were $2,343, reflecting expenses incurred post-IPO[29] Profitability Metrics - Adjusted EBITDA for the fiscal three months ended September 28, 2025, was $75,213, with an Adjusted EBITDA Margin of 8.8%, down from 10.9% in the prior year[29] - Base gross profit for the fiscal nine months ended September 28, 2025, was $154,744,000, up 29.0% from $119,936,000 in the prior year[35] - Base gross profit margin improved to 9.1% for the fiscal three months ended September 28, 2025, compared to 8.9% in the same period last year[35] - Operating income for the fiscal nine months ended September 28, 2025, was $55,761,000, an increase from $53,124,000 in the prior year[37] Non-Cash Items - Non-cash stock-based compensation for the fiscal three months ended September 28, 2025, was $2,143, compared to $1,318 in the same period in 2024[29] - The company incurred $8,240 in loss on debt modification and extinguishment during the fiscal three months ended September 28, 2025[31] Revenue Adjustments - Revenue derived from storm restoration services is excluded from Base Revenue, which is adjusted to provide a clearer view of ongoing operations[24]
MannKind(MNKD) - 2025 Q3 - Quarterly Results
2025-11-05 13:03
Revenue Performance - Q3 2025 revenues reached $82.1 million, a 17% increase compared to Q3 2024[4] - Year-to-date 2025 revenues totaled $237.0 million, reflecting a 14% increase versus the same period in 2024[10] - Afrezza's revenue for Q3 2025 was $18.5 million, up 23% from $15.0 million in Q3 2024[9] - Total revenues for the three months ended September 30, 2025, were $82.13 million, a 17.2% increase from $70.08 million in the same period of 2024[23] - Commercial product sales reached $22.31 million for the three months ended September 30, 2025, compared to $19.73 million in 2024, reflecting a 13.1% growth[23] Expenses - Research and development expenses increased by $1.1 million, or 9%, in Q3 2025 compared to the prior year[8] - Selling, general and administrative expenses rose by $5.2 million, or 22%, in Q3 2025 due to higher headcount and acquisition-related costs[12] - Research and development expenses for the three months ended September 30, 2025, were $14.06 million, an increase from $12.93 million in 2024, reflecting a 8.8% rise[23] - The company incurred acquisition-related expenses of $3.67 million during the three months ended September 30, 2025, associated with the acquisition of scPharma[29] Net Income - Net income for Q3 2025 was $8.0 million, down from $11.6 million in Q3 2024[12] - Non-GAAP net income for Q3 2025 increased by 45% to $22.4 million compared to $15.4 million in Q3 2024[12] - Net income for the three months ended September 30, 2025, was $7.99 million, down from $11.55 million in 2024, representing a 30.5% decrease[23] - Non-GAAP net income for the three months ended September 30, 2025, was $22.45 million, compared to $15.35 million in 2024, a 46.5% increase[28] - The company reported a basic net income per share of $0.03 for the three months ended September 30, 2025, down from $0.04 in 2024[23] Assets and Liabilities - Cash, cash equivalents, and investments totaled $286.3 million as of September 30, 2025[9] - Cash and cash equivalents increased to $127.39 million as of September 30, 2025, from $46.34 million at the end of 2024[25] - Total assets rose to $494.64 million as of September 30, 2025, compared to $393.84 million at the end of 2024, marking a 25.6% increase[25] - Total liabilities increased to $539.19 million as of September 30, 2025, up from $472.66 million at the end of 2024, indicating a 14.0% rise[25] Acquisition - The acquisition of scPharmaceuticals was completed on October 7, 2025, expected to diversify and accelerate revenue growth[5] Regulatory Updates - The FDA accepted the sBLA for Afrezza in the pediatric population, with a PDUFA date set for May 29, 2026[3]
Praxis(PRAX) - 2025 Q3 - Quarterly Results
2025-11-05 13:03
Financial Performance - Praxis reported a net loss of $73.9 million for Q3 2025, compared to a net loss of $51.9 million in Q3 2024, reflecting an increase in operating expenses[13] - Net loss for the three months ended September 30, 2025, was $73,934,000, compared to a net loss of $51,910,000 for the same period in 2024, reflecting a 42% increase in losses[29] - The net loss per share attributable to common stockholders increased from $2.75 in Q3 2024 to $3.36 in Q3 2025[29] - The accumulated deficit increased from $836,740,000 on December 31, 2024, to $1,051,097,000 on September 30, 2025, indicating a rise of approximately 25%[27] - The company reported no collaboration revenue for the three months ended September 30, 2025, compared to $302,000 in Q3 2024[29] - Other income for the three months ended September 30, 2025, was $4,425,000, slightly down from $4,925,000 in Q3 2024[29] Research and Development - Research and development expenses increased to $65.8 million in Q3 2025 from $41.9 million in Q3 2024, primarily due to a $21.7 million increase in the Cerebrum™ platform[11] - Research and development expenses increased by 57% from $41,881,000 in Q3 2024 to $65,797,000 in Q3 2025[29] - The company has four clinical-stage product candidates in its diversified CNS portfolio[21] Cash and Assets - As of September 30, 2025, Praxis had $389.2 million in cash, cash equivalents, and marketable securities, down from $469.5 million at the end of 2024[8] - Total assets decreased from $483,110,000 on December 31, 2024, to $396,388,000 on September 30, 2025, representing a decline of approximately 18%[27] Clinical Trials and Programs - Ulixacaltamide demonstrated a mean improvement of 4.3 points in the modified Activities of Daily Living 11 (mADL11) at Week 8 in the Essential3 program, with statistical significance (p<0.0001)[3] - In the second pivotal study of ulixacaltamide, 55% of patients maintained their response compared to 33% in the placebo group (p=0.037)[4] - The POWER1 study for vormatrigine has completed recruitment, with topline results expected in the first half of 2026, while POWER2 is expected to be fully enrolled in the second half of 2026[2] - Praxis plans to conduct an interim analysis of the EMBOLD study for relutrigine in Q4 2025, which may support an NDA submission in early 2026 if successful[2] - Approximately 20,000 patients have been attracted to the ENERGY program recruitment initiative for epilepsy studies, supporting patient identification[4] Regulatory Designations - The company has received Orphan Drug Designation and Breakthrough Therapy Designation for relutrigine and elsunersen from the FDA, indicating significant potential in treating rare diseases[18][19] Operating Expenses - Total operating expenses rose from $57,137,000 in Q3 2024 to $78,359,000 in Q3 2025, marking an increase of about 37%[29] - The weighted average common shares outstanding increased from 18,884,562 in Q3 2024 to 21,977,268 in Q3 2025, a rise of approximately 16%[29]
GCM Grosvenor(GCMG) - 2025 Q3 - Quarterly Results
2025-11-05 13:03
GCM GROSVENOR 2025 Third Quarter Results. Earnings Presentation 2 0 2 5 T h i r d Q u a r t e r R e s u l t s E a rn i n g s P r e s e n t a t i o n GCM Grosvenor Reports Q3 2025 Results CHICAGO, November 5, 2025 - GCM Grosvenor (Nasdag: GCMG), a leading global alternative asset management solutions provider, today reported results for the third fiscal quarter ended September 30, 2025. Dividend GCM Grosvenor's Board of Directors approved a $0.12 per share dividend payable on December 15, 2025 to shareholder ...
Establishment Labs(ESTA) - 2025 Q3 - Quarterly Results
2025-11-05 13:02
Revenue Performance - Total revenue for Q3 2025 was $53.8 million, a 33.8% increase from $40.2 million in Q3 2024[4] - US Motiva sales contributed $11.9 million to the total revenue in Q3 2025[5] - The company expects 2025 revenue to exceed $210 million, up from previous guidance of $208 million to $212 million[5] Profitability Metrics - Gross margin for Q3 2025 was 70.1%, compared to 63.9% in Q3 2024[6] - Adjusted EBITDA for Q3 2025 was positive $1.2 million, a significant improvement from a loss of $7.0 million in Q3 2024[5] - The net loss for Q3 2025 was $11.1 million, reduced from a net loss of $16.7 million in the same period last year[8] Cash Flow and Liquidity - Cash balance as of September 30, 2025, was $70.6 million, a decrease of $19.7 million from December 31, 2024[9] - The company aims to achieve cash flow positive status in 2026, with an expected 20% share of the US breast augmentation market[3] - Cash and cash equivalents decreased from $90,347 million as of December 31, 2024, to $70,624 million as of September 30, 2025, a decline of about 21.8%[23] Expenses - SG&A expenses increased to $37.2 million in Q3 2025, up from $34.1 million in Q3 2024, primarily due to increased investment in the US[7] - R&D expenses decreased slightly to $4.6 million in Q3 2025 from $4.8 million in Q3 2024[8] Balance Sheet Changes - Total assets decreased from $346,831 million as of December 31, 2024, to $338,895 million as of September 30, 2025, representing a decline of approximately 2.7%[23] - Total current liabilities increased from $68,278 million as of December 31, 2024, to $71,981 million as of September 30, 2025, reflecting a rise of approximately 5.0%[23] - Inventory increased from $78,766 million as of December 31, 2024, to $88,158 million as of September 30, 2025, representing a growth of approximately 11.0%[23] - Total shareholders' equity decreased significantly from $53,095 million as of December 31, 2024, to $16,363 million as of September 30, 2025, a decline of approximately 69.1%[23] - Long-term liabilities increased from $219,577 million as of December 31, 2024, to $246,458 million as of September 30, 2025, reflecting an increase of about 12.2%[23] Interest and EBITDA - Interest expense for the three months ended September 30, 2025, was $6,203 million, compared to $5,313 million for the same period in 2024, indicating an increase of about 16.7%[25] - EBITDA for the three months ended September 30, 2025, was a loss of $2,179 million, compared to a loss of $9,103 million for the same period in 2024, showing a significant improvement[25] - Adjusted EBITDA for the nine months ended September 30, 2025, was a loss of $19,454 million, compared to a loss of $15,116 million for the same period in 2024, indicating a worsening performance[25]
Burford Capital(BUR) - 2025 Q3 - Quarterly Report
2025-11-05 13:01
Company Overview - The company is the world's largest dedicated provider of capital for litigation and legal assets, focusing on large, complex disputes [240]. - The company maintains access to corporate debt capital markets, supported by credit rating upgrades from Moody's and S&P, and successfully completed a debt offering in July 2025 [241]. Financial Performance - Total revenues decreased by 72% to $69.8 million for the three months ended September 30, 2025, compared to $249.1 million in the same period of 2024 [274]. - Operating income fell by 88% to $24.8 million for the three months ended September 30, 2025, down from $202.2 million in 2024 [274]. - Net loss attributable to Burford Capital Limited shareholders was $19.2 million for the three months ended September 30, 2025, compared to net income of $135.6 million in 2024 [275]. - Total revenues decreased by 16% to $379.9 million for the nine months ended September 30, 2025, compared to $453.1 million in 2024 [276]. - Net income attributable to Burford Capital Limited shareholders was $100.1 million for the nine months ended September 30, 2025, down from $159.5 million in 2024 [276]. - Total revenues decreased by 33% for the nine months ended September 30, 2025, primarily due to lower asset management income, reflecting a decrease in capital provision income earned by BOF-C [413]. Capital Provision and Asset Management - Capital provision income decreased by 70% to $80.1 million for the three months ended September 30, 2025, from $271.0 million in 2024 [279]. - The company reported a higher incidence of pre-adjudication settlements since June 2021 compared to earlier periods, though the long-term trend remains uncertain [246]. - The company’s asset management business reports assets under management (AUM) based on the fair value of capital invested in private funds and vehicles [258]. - The total AUM was $3.2 billion as of September 30, 2025, down from $3.5 billion as of December 31, 2024 [429]. Cash Flow and Receivables - Cash receipts are considered an important measure of operating performance, reflecting cash generated from capital provision and other assets [268]. - Cash and cash equivalents increased by 44% to $677.7 million as of September 30, 2025, compared to $469.9 million as of December 31, 2024 [314]. - Due from settlement of capital provision assets decreased by 47% to $96.8 million as of September 30, 2025, primarily due to cash received from realizations [318]. - Cash received from realizations during 2025 accounted for 68% of the $183.9 million due from settlement receivables collected [318]. Operating Expenses - Total operating expenses increased by 17% for the nine months ended September 30, 2025, reaching $135.2 million, compared to $115.2 million in 2024 [297]. - Total operating expenses increased by 24% for the nine months ended September 30, 2025, primarily due to an increase in compensation and benefits costs [414]. - The increase in operating expenses was primarily due to higher share-based and deferred compensation costs, which were partially offset by lower fair value driven compensation-related accruals [345]. Market Conditions and Economic Impact - Court systems have returned to functionality post-Covid-19, but some backlogs remain, affecting cash realizations [245]. - Inflation impacts revenues positively by increasing legal case fees and expenses, which can lead to higher returns on successful cases [248]. - The company has not seen any discontinuance of matters despite ongoing court backlogs and economic uncertainties [245]. Asset Valuation and Performance Metrics - The internal rate of return (IRR) is calculated on concluded legal finance assets, excluding unrealized gains or losses [262]. - Return on invested capital (ROIC) measures the absolute realizations from concluded assets in excess of financing expenditure, expressed as a percentage [263]. - The weighted average life (WAL) of legal finance assets indicates the average time until cash realizations are received [264]. - The cumulative realizations increased to $3.6 billion as of September 30, 2025, from $3.3 billion as of December 31, 2024 [396]. Debt and Leverage - The company plans to continue being an opportunistic issuer of debt securities to fund growth or refinance future debt maturities [435]. - The company had five series of debt securities outstanding as of September 30, 2025, with one series listed on the London Stock Exchange [433]. - The leverage ratio requirement mandates that Group Net Debt must be less than 50% of Group Total Assets [436]. - The company is in compliance with all covenants under the trust deeds and indentures as of September 30, 2025 [437].
ZETA(ZETA) - 2025 Q3 - Quarterly Report
2025-11-05 13:01
Financial Performance - Total revenues for Q3 2025 reached $337,169,000, a 25.7% increase from $268,295,000 in Q3 2024[21] - Operating expenses for Q3 2025 totaled $328,417,000, compared to $280,674,000 in Q3 2024, reflecting an increase of 17.0%[21] - The net loss for Q3 2025 was $3,634,000, significantly improved from a net loss of $17,375,000 in Q3 2024[21] - The company reported a basic loss per share of $0.02 for Q3 2025, an improvement from a loss of $0.09 per share in Q3 2024[21] - For the nine months ended September 30, 2025, the net loss was $38,048, compared to a net loss of $85,007 for the same period in 2024, representing a 55.3% improvement[30] - The net loss for the three months ended September 30, 2025, was $3.6 million, compared to a net loss of $17.4 million for the same period in 2024[154] Cash and Assets - Cash and cash equivalents increased to $385,184,000 as of September 30, 2025, up from $366,157,000 at the end of 2024[20] - Total current assets rose to $689,061,000, a 11.7% increase from $616,540,000 as of December 31, 2024[20] - The company’s total assets reached $1,150,767,000 as of September 30, 2025, compared to $1,111,373,000 at the end of 2024, reflecting a growth of 3.5%[20] - Stockholders' equity increased to $689,206,000 as of September 30, 2025, up from $676,801,000 at the end of 2024, representing a growth of 1.9%[20] - Cash and cash equivalents at the end of the period were $385,184, a decrease from $418,538 at the end of 2024[30] Liabilities and Equity - Total liabilities increased to $461,561,000, compared to $434,572,000 at the end of 2024, marking a rise of 6.2%[20] - The total accumulated deficit increased to $1,066,350,000, reflecting ongoing financial challenges[22] - As of September 30, 2025, the Company had long-term borrowings of $196,884, slightly up from $196,288 as of December 31, 2024[75] Revenue Sources - Total revenues for the nine months ended September 30, 2025, were $910,030, a 31.7% increase from $691,081 in 2024[51] - Direct platform revenue accounted for 75% of total revenue for the nine months ended September 30, 2025, compared to 68% in 2024, indicating a shift towards more direct revenue generation[45] - The increase in revenue was driven by $63.0 million from new customers, including approximately $20.6 million from the acquisition of LiveIntent, and $5.9 million from existing customers[155] Expenses - Research and development expenses for the nine months ended September 30, 2025, were $87,203,000, up from $66,407,000 in the same period of 2024, indicating a 31.2% increase[21] - General and administrative expenses increased by $5.9 million, or 11.7%, for the three months ended September 30, 2025, compared to the same period in 2024[157] - Selling and marketing expenses rose by $0.8 million, or 0.9%, for the three months ended September 30, 2025, driven by higher employee-related costs[158] - Research and development expenses increased by $7.0 million, or 30.7%, for the three months ended September 30, 2025, primarily due to higher employee-related costs[159] Acquisitions and Investments - The Company finalized the acquisition of LiveIntent for a total consideration of $276,976, which included $176,456 recognized as goodwill[69] - The proposed acquisition of Marigold enterprise software business is valued at up to $325,000, consisting of $100,000 in cash and $100,000 in Class A Common Stock[73] - The company incurred capital expenditures of $10,558 for the nine months ended September 30, 2025, down from $17,458 in 2024, reflecting a 39.5% reduction[30] Stock and Shareholder Actions - The company repurchased shares totaling 2,673,451, reflecting a strategy to manage equity and enhance shareholder value[22] - The Company authorized a stock repurchase plan (2025 SRP) of up to $200,000 for Class A Common Stock through December 31, 2027, supplementing the previous plan (2024 SRP) of $100,000[105] - During the nine months ended September 30, 2025, the Company repurchased 5,958,584 shares of Class A Common Stock for a total value of $85,092, with $198,944 remaining available for future purchases[106] Tax and Compliance - The company recorded an income tax provision of $3,676 for the nine months ended September 30, 2025, with an effective tax rate of negative 10.7% on a pre-tax loss of $34,372[117] - The income tax provision increased by $2.6 million, or 239.7%, for the nine months ended September 30, 2025, yielding an effective tax rate of negative 10.7%[176] Operational Insights - The company experienced a foreign currency translation adjustment loss of $112,000 during the quarter[22] - The company recognized $20,930 in revenues from deferred revenues during the nine months ended September 30, 2025, compared to $18,819 in 2024, a 11.2% increase[40] - The company is not currently involved in any litigation that would materially adversely affect its business, operating results, cash flows, or financial condition[214] Risk Factors - There have been no material changes to the risk factors previously disclosed in the 2024 Annual Report, except for new risks related to technology operations in India[215] - The reliance on technology and development resources in India may expose the company to unanticipated costs and liabilities, potentially affecting cost savings[216] - Enforcement of intellectual property rights in India may be less effective than in the U.S., leading to potential litigation and significant cash expenditures[217]
NewAmsterdam Pharma pany N.V.(NAMS) - 2025 Q3 - Quarterly Report
2025-11-05 13:00
Revenue and Financial Performance - The company has not generated significant revenue from pharmaceutical product sales, primarily relying on a non-refundable upfront amount of $120.9 million (€115.0 million) from the Menarini License[78]. - Revenue for the three months ended September 30, 2025 was $0.3 million, a decrease of $28.8 million or 99% compared to $29.1 million for the same period in 2024, primarily due to the absence of clinical milestones earned in 2025[94]. - For the nine months ended September 30, 2025, revenue was $22.5 million, a decrease of $10.3 million or 31% compared to $32.8 million for the same period in 2024[106]. - The company recognizes revenue from the sale of obicetrapib tablets and active pharmaceutical ingredients, with revenue recognized upon the transfer of control to Menarini[82]. - The December 2024 Offering generated net proceeds of $453.4 million after deducting underwriting discounts and commissions, enhancing the company's capital resources[118]. - The company completed a public offering of 5,871,909 Ordinary Shares at a price of $19.00 per share, generating net proceeds of $190.0 million after expenses[119]. - The company entered into a sales agreement allowing for the issuance of up to $250 million of Ordinary Shares, with no sales made under this agreement during the nine months ended September 30, 2025[120]. Expenses and Losses - Research and development expenses are expected to be significant as the company advances product candidates through clinical trials and pursues regulatory approval[86]. - Research and development expenses decreased by $4.7 million or 13% to $31.0 million for the three months ended September 30, 2025, driven by a $6.6 million decrease in clinical expenses due to the completion of several Phase 3 trials[95][97]. - Selling, general and administrative expenses increased by $6.1 million or 33% to $24.5 million for the three months ended September 30, 2025, primarily due to a $6.3 million increase in personnel expenses[98]. - Loss for the period was $72.0 million for the three months ended September 30, 2025, an increase of $55.4 million compared to a loss of $16.6 million for the same period in 2024[103]. - Total operating expenses for the nine months ended September 30, 2025 were $182.2 million, an increase of $16.3 million compared to $165.9 million for the same period in 2024[105]. - The company incurred an accumulated loss of $687.5 million as of September 30, 2025, and expects to continue incurring significant losses in the foreseeable future[116]. Cash and Liquidity - Cash, cash equivalents, and marketable securities as of September 30, 2025 totaled $756.0 million, providing liquidity for ongoing operations[117]. - The company had cash and cash equivalents of $538.4 million as of September 30, 2025, sufficient to meet estimated obligations of $27.9 million due within one year[130]. - Net cash used in operating activities decreased to $106.9 million for the nine months ended September 30, 2025, from $121.1 million in the same period of 2024[126]. - Net cash used in investing activities increased significantly to $153.8 million in the nine months ended September 30, 2025, primarily due to investments in marketable securities[128]. - Net cash provided by financing activities decreased to $15.8 million for the nine months ended September 30, 2025, compared to $202.9 million in the same period of 2024[129]. Clinical Trials and Product Development - The Phase 3 BROADWAY trial showed a 21% reduction in major adverse cardiovascular events (MACE) endpoint, with ongoing Phase 3 cardiovascular outcomes trial (PREVAIL) expected to conclude by the end of 2026[68]. - Obicetrapib demonstrated statistically significant LDL-C reductions in multiple Phase 3 trials, meeting primary and secondary endpoints[67]. - Approximately 30 million patients in the U.S. do not achieve risk-based LDL-C goals despite lipid-lowering therapy, highlighting a significant market opportunity[72]. - The company aims to develop an LDL-C lowering monotherapy and a fixed-dose combination therapy to address unmet needs in patients with elevated LDL-C[73]. - The company has observed obicetrapib to be well tolerated in over 3,500 patients, with side effects similar in frequency and severity to placebo[67]. Partnerships and Agreements - The company has partnered with Menarini for the commercialization of obicetrapib in Europe, with marketing authorization applications validated by the European Medicines Agency[75]. - The Menarini Supply Agreement includes provisions for the transfer of manufacturing and establishes the company as Menarini's exclusive supplier of obicetrapib products[76]. - Under the Menarini License, the company received a non-refundable upfront payment of €115 million and is eligible for up to €863 million in milestone payments[121][122]. - As of September 30, 2025, the company received €30.0 million in milestone payments and €13.8 million in R&D reimbursements from Menarini[123]. Financial Instruments and Risks - The fair value of derivative warrant liabilities was $44.4 million as of September 30, 2025, with a 1% change in market price affecting the liability by $0.4 million[141]. - The company's exposure to foreign currency risk was $112.8 million as of September 30, 2025, with a potential earnings impact of approximately $1.1 million from a hypothetical 1% change in exchange rates[139].
NewAmsterdam Pharma pany N.V.(NAMS) - 2025 Q3 - Quarterly Results
2025-11-05 13:00
Financial Performance - Revenue for the quarter ended September 30, 2025, was $0.3 million, a significant decrease from $29.1 million in the same period in 2024, mainly due to the absence of clinical milestone revenue[8] - Revenue for Q3 2025 was $348,000, a significant decrease from $29,111,000 in Q3 2024, representing a decline of approximately 98.8%[23] - The net loss for the quarter ended September 30, 2025, was $72.0 million, compared to a net loss of $16.6 million for the same period in 2024[9] - The operating loss for Q3 2025 was $55,143,000, compared to an operating loss of $25,003,000 in Q3 2024, reflecting a deterioration of 120.5%[23] - The company reported a loss for the nine months ended September 30, 2025, of $128,896,000, an improvement compared to a loss of $149,421,000 for the same period in 2024, showing a reduction of approximately 13.7%[26] Cash and Assets - As of September 30, 2025, NewAmsterdam reported cash, cash equivalents, and marketable securities of $756.0 million, down from $834.2 million as of December 31, 2024, primarily due to ongoing operating expenditures[8] - Cash and cash equivalents as of September 30, 2025, were $538,407,000, down from $771,743,000 at the end of 2024, a decrease of approximately 30.1%[21] - Total assets decreased to $786,427,000 as of September 30, 2025, from $864,620,000 at the end of 2024, a decline of about 9.0%[21] - The company had a total shareholders' equity of $728,070,000 as of September 30, 2025, compared to $757,500,000 at the end of 2024, a decrease of approximately 3.9%[21] Expenses - Research and Development (R&D) expenses were $31.0 million for the quarter ended September 30, 2025, compared to $35.7 million for the same period in 2024, reflecting a decrease in clinical and manufacturing expenses[8] - Selling, General and Administrative (SG&A) expenses increased to $24.5 million in the quarter ended September 30, 2025, from $18.4 million in the same period in 2024, driven by higher personnel costs[8] - Total operating expenses for Q3 2025 were $55,491,000, slightly up from $54,114,000 in Q3 2024, indicating an increase of about 2.5%[23] - Research and development expenses for Q3 2025 were $30,971,000, down from $35,702,000 in Q3 2024, a decrease of about 13.5%[23] Clinical Development - The European Medicines Agency accepted for review marketing authorization applications for obicetrapib monotherapy and the fixed-dose combination with ezetimibe in August 2025, marking a significant regulatory milestone[5] - NewAmsterdam plans to initiate the RUBENS Phase 3 clinical trial in Q4 2025 to evaluate obicetrapib in combination with ezetimibe for patients with type 2 diabetes or metabolic syndrome[4] - In the BROADWAY trial, obicetrapib was shown to reduce p-tau217 levels by 20.5% over 12 months in ApoE4/E4 carriers, indicating potential benefits for Alzheimer's disease[3] - The company completed enrollment of over 9,500 patients in the PREVAIL Phase 3 cardiovascular outcomes trial in April 2024[7] - NewAmsterdam continues to advance its clinical development strategy, including ongoing trials such as PREVAIL and REMBRANDT, to support the potential launch of obicetrapib[2] Interest Income - Interest income for the nine months ended September 30, 2025, was $21,119,000, an increase from $12,396,000 in the same period of 2024, representing a growth of about 70.5%[23] Cash Flow - The company experienced a net cash used in operating activities of $106,908,000 for the nine months ended September 30, 2025, compared to $121,083,000 for the same period in 2024, indicating a decrease of approximately 11.7%[26]