Financial Performance - Comparable store sales growth of 9.9% and total year-over-year sales growth of 8.3%, or $15.4 million, to $201.7 million[1][6] - Adjusted EBITDA of $5.4 million, an increase of $6.2 million compared to the prior year, with a flowthrough of 40%[1][10] - Net income of $0.9 million, compared to a net loss of $3.4 million in Q1 2024, with diluted earnings per share of $0.11[6][10] - Adjusted operating income for Q1 2025 was $1,036 million, compared to a loss of $5,589 million in Q1 2024[22] - Adjusted net income for Q1 2025 was $1,418 million, improving from a loss of $2,663 million in Q1 2024[22] - Adjusted diluted earnings per share (EPS) for Q1 2025 was $0.17, compared to a loss of $0.32 in Q1 2024[22] - Adjusted EBITDA for Q1 2025 was $5,406 million, a significant increase from a loss of $796 million in Q1 2024[23] Inventory and Expenses - Merchandise inventory decreased by 7.6% to $109.9 million, with a 45% reduction in aged product compared to Q1 2024[10] - SG&A expenses leveraged 270 basis points compared to Q1 2024, reflecting disciplined cost controls amid increased sales[6][10] - Adjusted SG&A expenses for Q1 2025 were $74,404 million, compared to $72,831 million in Q1 2024[22] - The company incurred $402 million in cyber incident expenses during Q1 2025[22] - Other non-recurring expenses amounted to $885 million in Q1 2025, down from $1,380 million in Q1 2024[22] - The company reported an asset impairment of $64 million in Q1 2025, while there was no such expense in Q1 2024[22] Future Outlook - The company expects full-year comparable store sales growth in the mid-single digits, and EBITDA to be in the range of $6 million to $10 million, a significant improvement from 2024[11] - Plans to open up to 5 new stores and remodel approximately 50 stores during fiscal 2025[11] - Total liquidity at the end of Q1 2025 was approximately $117.0 million, with no debt and $41.6 million in cash[10][11] Operational Focus - The company continues to focus on enhancing customer experience and operational improvements to drive future growth[4][5] Interest and Tax - Interest income for Q1 2025 was $458 million, down from $849 million in Q1 2024[22] - The company did not report any income tax benefit in Q1 2025, compared to a benefit of $2,773 million in Q1 2024[22] Gross Margin - Gross margin improved to 39.6%, up 90 basis points from 38.7% in Q1 2024, driven by higher initial markup and lower shrink[6][10]

Financial Performance - Third quarter fiscal 2025 net earnings were $57.8 million, down 49.1% from $113.5 million a year ago, with diluted EPS of $0.48 compared to $0.92 in 2024[1][23] - Net earnings for the nine months ended April 30, 2025, were $252.7 million, a decrease from $304.3 million in the same period of 2024[28] - The diluted EPS for the nine months ended April 30, 2025, was $2.09, down from $2.48 in the previous year[44] - Adjusted net earnings for the nine months ended April 30, 2025, were $321.4 million, compared to $304.3 million in the prior year[44] Sales and Revenue - Total sales for the third quarter reached $940.1 million, a 1.3% increase compared to $927.9 million in the same period last year, driven by pricing benefits and volume growth[3][23] - Total net sales for the company increased by 1.3% to $940.1 million in the three months ended April 30, 2025, compared to $927.9 million in the same period of 2024[33] - Life Sciences sales are projected to grow high-single digits versus 2024, driven by strong demand in Disk Drive and Food & Beverage replacement parts[17] - The Mobile Solutions segment reported a decline in net sales by 0.4% to $582.6 million, with the Off-Road and On-Road categories decreasing by 8.3% and 24.5% respectively[33] - The Industrial Solutions segment saw an increase in net sales by 5.3% to $283.3 million, driven by a 27.1% increase in the Aerospace and Defense category[33] - Life Sciences segment net sales increased by 0.7% to $74.2 million, reflecting a growth of 8.3% for the nine months ended April 30, 2025[33] - Total company revenue increased by 2.2% for the nine months ended April 30, 2025, with a notable growth of 5.4% in the APAC region[37] - The Aerospace and Defense segment saw a significant revenue increase of 24.2% for the nine months ended April 30, 2025, driven by strong demand[40] - The Industrial Solutions segment experienced a total revenue increase of 2.1% for the nine months ended April 30, 2025, despite a decline in EMEA[40] Margins and Expenses - Gross margin decreased to 34.2% from 35.6% in 2024, attributed to higher manufacturing costs[7] - Operating expenses as a percentage of sales rose to 24.9%, up from 20.1% in the prior year, driven by impairment charges and restructuring costs[8] - Operating margin fell to 9.3% for the three months ended April 30, 2025, compared to 15.5% in the prior year[30] - The company reported a gross profit of $947.4 million for the nine months ended April 30, 2025, compared to $939.6 million in the prior year[43] - The adjusted EBITDA for the nine months ended April 30, 2025, was $510.3 million, an increase from $485.5 million in the previous year[43] Cash Flow and Capital Expenditures - Free cash flow for the nine months ended April 30, 2025, was $192.4 million, down from $300.7 million in the same period last year[43] - Capital expenditures for fiscal 2025 are forecasted to be between $75 million and $90 million, with adjusted free cash flow conversion expected to be between 80% and 90%[18] - The company reported a cash conversion ratio of 126.2% for the three months ended April 30, 2025, up from 105.9% in the prior year[30] Shareholder Actions and Debt - The company repurchased 2.4% of its outstanding shares for $192.4 million during the third quarter, with a year-to-date total of 3.3% repurchased for $273.8 million[11] - Long-term debt increased to $638.8 million as of April 30, 2025, compared to $483.4 million as of July 31, 2024[26] Guidance and Future Outlook - Adjusted full-year EPS guidance for fiscal 2025 is narrowed to between $3.64 and $3.70, reflecting an increase from prior guidance[13] - The company anticipates continued growth in adjusted EPS for fiscal 2025, although specific guidance is not provided due to variable factors[45] - The effective tax rate for the nine months ended April 30, 2025, was 26.2%, an increase from 23.1% in the same period of 2024[30]

NUCANA PLC UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | | For the Three Months Ended | | | --- | --- | --- | | | March 31, | | | | 2025 | 2024 | | | (in thousands) | | | | £ | £ | | Loss for the period | (2,473) | (6,838) | | Other comprehensive (expense) income: | | | | Items that may be reclassified subsequently to profit or loss: | | | | Exchange differences on translation of foreign operations | (27) | 7 | | Other comprehensive (expense) income for the period | (27) | 7 | | Total ...

Financial Position - Cash and cash equivalents totaled $2,277 as of April 18, 2025, down from $10,230 as of November 1, 2024[26] - Total assets as of April 18, 2025, amounted to $152,443 million, compared to $164,393 million as of April 19, 2024, indicating a decrease of 7.2%[62] - As of April 18, 2025, total debt is $2,340, with long-term debt amounting to $1,702 after reclassification of $1,239 of equipment note payable to current notes payable[77] Inventory and Sales - Total inventories increased to $40,055 as of April 18, 2025, compared to $33,338 as of November 1, 2024, with finished goods rising to $23,010 from $20,391[47] - The reserve for slow-moving and obsolete inventory was $1,201 as of April 18, 2025, up from $1,115 as of November 1, 2024[47] - The Company reported total sales of $50,639 million for the twelve weeks ended April 18, 2025, compared to $47,314 million for the same period in 2024, representing a year-over-year increase of 4.9%[62] - For the twenty-four weeks ended April 18, 2025, total sales reached $103,184 million, an increase from $102,156 million in the prior year, reflecting a growth of 1%[68] - The Company’s segment for Frozen Food Products generated sales of $27,842 million for the twenty-four weeks ended April 18, 2025, compared to $27,304 million in the same period of 2024, marking a growth of 2%[63] Expenses and Income - Promotional allowances deducted from sales for the twelve weeks ended April 18, 2025, were $4,219, compared to $3,871 for the same period in 2024, reflecting a 9% increase[34] - The gross margin for the twelve weeks ended April 18, 2025, was $11,071 million, up from $10,726 million in the prior year, indicating an increase of 3.2%[62] - Operating income for the twelve weeks ended April 18, 2025, was a loss of $3,187 million, compared to a loss of $3,246 million in the same period of 2024, showing a slight improvement[62] - A price increase on products is planned to offset higher costs for meat commodities, alongside efforts to reduce selling, general, and administrative expenses[80] Tax and Liabilities - The Company’s effective tax rate was 27.2% for the second quarter of fiscal year 2025, down from 28.5% in 2024, reflecting a tax benefit of $1,301 million[71] - The estimated liabilities for self-insured workers' compensation and employee healthcare are subject to inherent uncertainties, which may lead to significant changes in future periods[24] - The company has retained a valuation allowance of $99 million against certain California net operating losses, with state loss carryforwards of approximately $5,000 million expiring through 2040[72] Credit and Compliance - The company has a line of credit with Wells Fargo Bank, N.A. allowing borrowing up to $7,500, with $2,000 borrowed on May 20, 2025[39] - The company has a revolving line of credit facility allowing borrowing up to $7,500 until November 30, 2025, with an interest rate of the daily simple secured overnight financing rate plus 2.0%[74] - The company was in violation of the Fixed Charge Coverage Ratio covenant as of April 18, 2025, which was waived for that fiscal quarter[78] - The company does not anticipate compliance with the Fixed Charge Coverage Ratio covenant during the third and fourth fiscal quarters of 2025, potentially impacting liquidity[80] - The company is discussing potential solutions with Wells Fargo Bank regarding the amendment or renewal of the revolving line of credit[80] Regulatory and Accounting - The company adopted ASU No. 2016-13 on November 4, 2023, which did not have a material impact on the financial statements[42] - The company has been subject to audits for federal income tax returns for fiscal years 2021 through 2023 and state income tax returns for 2020 through 2023[73] - Walmart accounted for 29.7% of sales and 25.2% of accounts receivable as of April 18, 2025, compared to 28.4% and 25.1% respectively in 2024[29] - Dollar General represented 14.1% of sales and 24.2% of accounts receivable as of April 18, 2025, compared to 14.5% and 22.1% in 2024[29]

Financial Performance - Credo reported a record revenue of $436.8 million for fiscal year 2025, representing a 126% increase year over year[2]. - In Q4 2025, revenue reached $170.0 million, growing by 25.9% quarter over quarter and 179.7% year over year[4]. - GAAP net income for Q4 2025 was $36.6 million, with a GAAP diluted net income per share of $0.20[4]. - For Q1 2026, revenue is expected to be between $185.0 million and $195.0 million[5]. - Non-GAAP net income for the year ended May 3, 2025, reached $129,926 thousand, significantly higher than $14,570 thousand in the previous year[21]. - GAAP gross profit for the three months ended May 3, 2025, was $114,188 thousand, compared to $39,966 thousand for the same period last year, reflecting a 185.5% increase[21]. - Non-GAAP operating income for the three months ended May 3, 2025, was $62,523 thousand, compared to $7,462 thousand in the same period last year, a 737.5% increase[21]. Expenses and Margins - Research and development expenses for Q4 2025 were $47.6 million, up from $36.3 million in the previous quarter[17]. - Total operating expenses for Q4 2025 were $80.4 million, compared to $59.7 million in Q3 2025[17]. - GAAP gross margin for Q1 2026 is projected to be between 63.4% and 65.4%[5]. - Non-GAAP gross margin is projected to be between 64.0% and 66.0% for the three months ending August 2, 2025[22]. - Total GAAP operating expenses for the year ended May 3, 2025, were $245,785 thousand, up from $156,489 thousand, indicating a 57.0% increase[21]. - GAAP operating income margin improved to 19.9% for the three months ended May 3, 2025, compared to a loss margin of (13.0)% in the same period last year[21]. Assets and Liabilities - The company ended Q4 2025 with a cash and short-term investment balance of $431.3 million[4]. - Total assets increased to $809,257 thousand, up from $601,932 thousand, representing a 34.4% growth year-over-year[19]. - Total current assets rose to $713,534 thousand, an increase of 34.5% from $530,265 thousand year-over-year[19]. - Cash and cash equivalents increased to $236,328 thousand, compared to $66,942 thousand, marking a 253.5% rise year-over-year[19]. - Total liabilities decreased to $127,675 thousand from $61,734 thousand, a reduction of 51.5% year-over-year[19]. Market Outlook - The company anticipates continued demand for its high-performance connectivity solutions, particularly from hyperscaler customers[2]. - Credo's innovative solutions are aimed at supporting the growing needs of AI, cloud computing, and hyperscale networks[14].

Financial Performance - Total revenues for the three months ended April 30, 2025, were $759,043,000, representing a 16.7% increase from $650,345,000 in the same period of 2024[18]. - Subscription services revenue increased to $634,768,000, up 18.9% from $533,955,000 year-over-year[18]. - Net income for the quarter was $228,190,000, a 41.1% increase compared to $161,664,000 in the prior year[18]. - Operating income rose to $233,732,000, reflecting a 50.5% increase from $155,172,000 in the same quarter of 2024[18]. - The company reported a gross profit of $585,219,000, which is a 22.8% increase from $476,461,000 in the same quarter last year[18]. - Net cash provided by operating activities was $877,158,000, compared to $763,516,000 for the same period in 2024, marking a 14.9% increase[24]. - The company generated net income of $714 million for the fiscal year ended January 31, 2025, representing a 35.7% increase from $526 million in 2024[80]. Assets and Equity - Cash and cash equivalents at the end of the period were $1,964,982,000, up from $1,118,785,000 at the beginning of the year[15]. - Total assets increased to $7,765,077,000, compared to $7,339,756,000 as of January 31, 2025[15]. - Stockholders' equity grew to $6,211,098,000, up from $5,832,373,000 at the end of the previous quarter[15]. - Veeva's total available-for-sale securities amounted to $4,103,435 thousand as of April 30, 2025, with a gross unrealized gain of $31,083 thousand and unrealized losses of $2,050 thousand[32]. Expenses - Research and development expenses were $184,033,000, an increase of 13.1% from $162,711,000 in the prior year[18]. - Sales and marketing expenses increased slightly to $98,628 thousand, a 1% rise from $97,301 thousand, driven by higher employee compensation costs[107]. - General and administrative expenses increased by 12% to $68,826 thousand, primarily due to a $10 million rise in employee compensation-related costs[109]. Tax and Income Per Share - The effective tax rate for the three months ended April 30, 2025, was 23.6%, up from 21.9% in the prior year, primarily due to reduced future benefits from non-deductible compensation[44]. - Basic net income per share increased to $1.40 for the three months ended April 30, 2025, up from $1.00 in the same period of 2024, a 40% increase[60]. Customer and Market Insights - North America generated $459,467 thousand in revenues for the three months ended April 30, 2025, a 20.4% increase from $381,599 thousand in 2024[71]. - R&D Solutions accounted for 54% of total revenues for the three months ended April 30, 2025, while Commercial Solutions accounted for 46%[79]. - The company served 1,477 customers as of January 31, 2025, an increase from 1,432 customers in 2024[81]. Risks and Challenges - The company faces risks related to cybersecurity, including potential breaches that could harm customer trust and lead to significant liabilities[153]. - The markets for the company's solutions are highly competitive, with significant competition from firms like Salesforce and IQVIA[160]. - The company is subject to changing laws and regulations, which may impose additional compliance costs and liabilities[158]. - The company faces risks related to international operations, including regulatory, economic, and political challenges[171]. Compliance and Regulatory Environment - Compliance with complex regulations in the life sciences industry is essential; failure to comply could lessen demand for solutions and expose the company to significant claims[193]. - Increasingly complex data protection regulations, such as the EU GDPR, impose significant obligations and potential penalties for non-compliance, affecting operational costs[199]. - The company anticipates ongoing evolution of privacy and data protection laws, which will require continuous compliance efforts and could lead to increased operational complexity[201]. Strategic Initiatives - The company announced the launch of Veeva AI, integrating AI across major application areas, which may introduce new risks and challenges affecting adoption[207]. - The company expects R&D Solutions revenues to increase as a percentage of total revenues in the future[79].

Financial Performance - Revenues for the three months ended May 2, 2025, increased by $30 million to $1,877 million, a 2% rise compared to the same period in the prior year[110] - Operating income decreased by 8% to $121 million, with operating income as a percentage of revenues falling to 6.4% from 7.1% in the prior year[110] - Net income for the three months ended May 2, 2025, was $68 million, down 12% from $77 million in the prior year[110] - Revenues for the Defense and Intelligence segment decreased by $3 million to $1,433 million for the three months ended May 2, 2025, compared to $1,436 million in the prior year[116] - Civilian segment revenues increased by $33 million to $444 million for the three months ended May 2, 2025, compared to $411 million in the prior year, primarily due to ramp-up in volume on existing and new contracts[118] - Total revenues for the company were $1,877 million for the three months ended May 2, 2025, compared to $1,847 million in the prior year, reflecting an overall increase[126] Taxation - The effective income tax rate for the three months ended May 2, 2025, was 20.6%, up from 19.0% in the prior year, primarily due to lower tax benefits from employee share-based compensation[112] - The effective income tax rate increased to 20.6% for the three months ended May 2, 2025, compared to 19.0% in the prior year[112] - The company does not anticipate the OECD's 15% global minimum tax framework to have a significant impact on its effective tax rate or financial results[115] Backlog and Bookings - Net bookings for the three months ended May 2, 2025, were estimated at $2.4 billion, contributing to a total backlog of $22,343 million[133] - Funded backlog as of May 2, 2025, was $3,265 million, down from $3,444 million as of January 31, 2025[133] - Total backlog included $19,078 million in negotiated unfunded backlog, up from $18,413 million[133] - The total backlog as of May 2, 2025, was $22,343 million, consisting of $3,265 million in funded backlog and $19,078 million in negotiated unfunded backlog[133] Operating Income and EBITDA - Operating income increased by 18% to $40 million, with operating income as a percentage of revenues rising to 9.0% from 8.3%[118] - Adjusted operating income rose by 13% to $52 million, with adjusted operating income as a percentage of revenues increasing to 11.7%[118] - EBITDA for the three months ended May 2, 2025, was $156 million, representing 8.3% of revenues, down from 9.0% in the prior year[126] - Adjusted EBITDA was $157 million, accounting for 8.4% of revenues, a decrease from 9.0% in the prior year[126] - Operating loss in the corporate segment increased to $17 million, a 70% decline compared to the prior year[121] - Adjusted operating income for the Defense and Intelligence segment decreased by 7% to $115 million, representing 8.0% of revenues, down from 8.6% in the prior year[116] - Adjusted EBITDA for the three months ended May 2, 2025, was $157 million, a decrease from $166 million in the prior year, with adjusted EBITDA as a percentage of revenues at 8.4%[126] Cash Flow and Liquidity - The company expects to fund future cash needs through cash on hand, operating cash flows, and access to a $1.0 billion Revolving Credit Facility[136] - Net cash provided by operating activities increased by $2 million to $100 million for the three months ended May 2, 2025, compared to $98 million in the prior year[139] - Cash used in investing activities increased by $8 million to $15 million, primarily due to higher contributions to investments[140] - Cash used in financing activities decreased by $42 million to $94 million, mainly due to higher proceeds from borrowings[141] - The company expects to fund ongoing working capital and discretionary investments with cash on hand and future operating cash flows, supported by a $1.0 billion Revolving Credit Facility and a $300 million MARPA Facility[136] - The total cash decrease for the three months ended May 2, 2025, was $9 million, compared to a decrease of $45 million in the prior year[139] - Future cash needs will focus on working capital, capital expenditures, and contractual commitments, with a strategy based on cash provided by operating activities and free cash flow[137] - The company believes existing cash, future operating cash flows, and access to financing will meet short-term liquidity and long-term capital needs[138] Competition and Market Position - Approximately 98% of revenues were generated from contracts with the U.S. government, highlighting the company's reliance on government spending[98] - The company is positioned to benefit from new defense and border defense spending as Congress works on a budget reconciliation package[99] - The company anticipates that spending packages like the infrastructure bill and CHIPS and Science Act may provide additional opportunities in digital modernization and climate resiliency[103] - The company faces increased competition due to the U.S. government's reliance on competitive bidding processes, which may pressure pricing[104] - The company is implementing strategic sourcing and developing repeatable offerings to maintain competitiveness in pricing and service delivery[106] - The company has approximately 1,700 active contracts and employs around 24,000 individuals, indicating a strong operational capacity[91] Cost Structure - Labor-related cost of revenues accounted for 59% in both Defense and Intelligence and Total SAIC segments for the three months ended May 2, 2025[135] - The proportion of subcontractor-related cost of revenues was 29% for the Defense and Intelligence segment for the three months ended May 2, 2025[135] Accounting Policies - There have been no changes to critical accounting policies and estimates during the three months ended May 2, 2025[142]

Financial Performance - As of December 31, 2024, the company reported a working capital deficit of approximately $17.3 million and an accumulated deficit of approximately $113.0 million[28]. - The company has incurred net losses since inception and expects to continue doing so, with significant fluctuations in losses depending on various operational activities[28]. - The company incurred a net loss of $58.7 million and $37.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $115.7 million as of December 31, 2024[198]. - The company generated negative operating cash flows of $10.5 million for the year ended December 31, 2024[198]. - The company has cash of only $0.6 million, which raises concerns about its ability to meet current liabilities[208]. Product Development and Commercialization - The company has generated revenue only from Proclarix since its acquisition, while ENTADFI has not generated any revenue and commercialization activities have been abandoned[27]. - The company is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets, with no current plans to resume its commercialization[25]. - The company has abandoned the commercialization of ENTADFI due to cash runway and indebtedness, and the assets were fully impaired as of June 30, 2024[73]. - Proclarix is an in vitro diagnostic test for prostate cancer, approved for sale in the European Union, and aims to reduce unnecessary biopsies by providing a risk score for patients with elevated PSA levels[48]. - Proclarix is designed to aggregate multimodal information to develop a patient-centric diagnostic approach, with plans to enhance the risk score with additional biomarkers in the future[48]. Acquisitions and Partnerships - The acquisition of Proteomedix was completed on December 15, 2023, providing Proteomedix shareholders with an initial 16.4% ownership stake in the company[45]. - The acquisition of Proteomedix by Onconetix was valued at approximately $75 million, with 91,885 shares of Common Stock and 2,696,729 shares of Series B Preferred Stock issued as consideration[52]. - The Company purchased assets related to Veru's ENTADFI business for a total possible consideration of $100 million, with an initial payment of $20 million[68]. - The Company entered into a Subscription Agreement for a private placement of $5 million, with each unit consisting of one share of Common Stock and a warrant to purchase additional shares[61]. - Proteomedix entered an exclusive partnership with LabCorp in 2023 for the development and commercialization of Proclarix in the United States, receiving an upfront license fee and future royalty payments[109]. Regulatory and Compliance - The company has received multiple deficiency notices from Nasdaq regarding compliance with listing standards, including failure to maintain a minimum bid price and timely filing of reports[38][40]. - The maximum timeframe for the evaluation of a Marketing Authorization Application (MAA) by the EMA is 210 days, with potential accelerated reviews in urgent cases[147]. - The EMA requires a risk management plan (RMP) for all new MAAs, detailing measures to minimize risks associated with the product[153]. - Compliance with the General Data Protection Regulation (GDPR) is mandatory for processing personal health data in the EU, imposing significant obligations on pharmaceutical companies[137]. - Proteomedix has CE marked Proclarix IVDs under IVDD in 2019 and is now in compliance with IVDR, which includes performance and safety testing[161]. Market and Competitive Landscape - The global market for in vitro diagnostic (IVD) products is projected to reach $101 billion in 2024, with Europe and North America being the largest markets[116]. - In 2022, there were 1,467,854 new cases of prostate cancer and 397,430 related deaths worldwide, highlighting the significant market need for improved diagnostic tools[114]. - The molecular diagnostics field is highly competitive, with many companies developing tests that could pose technological and market access advantages over Proclarix[120]. - Proclarix aims to address the diagnostic "grey zone" where approximately 10% of men have elevated PSA levels, with only 20-40% presenting clinically with cancer[115]. - The use of MRI for prostate cancer diagnosis has increased, but costs range from $415 to $900, indicating a need for more accessible non-invasive diagnostic tests like Proclarix[119]. Operational Challenges - The company has significant debt obligations to Veru, including $10 million due, with forbearance agreements in place until June 30, 2025[204]. - The marketing approval process for Proclarix is lengthy and unpredictable, which may harm the company's business if approval is not obtained[209]. - The company may face significant delays and costs in obtaining foreign regulatory approvals for its products[217]. - Coverage and adequate reimbursement for the product may not be available, impacting its commercial success[219]. - The company has no manufacturing facilities and outsources the production of its IVD kits to a CMO in Germany[186].

Financial Performance - As of December 31, 2024, the company reported a working capital deficit of approximately $17.3 million and an accumulated deficit of approximately $113.0 million[28]. - The company has incurred net losses since inception and expects to continue doing so, with significant fluctuations in losses anticipated based on various operational activities[28]. - The company generated negative operating cash flows of $10.5 million for the year ended December 31, 2024[198]. - The company incurred a net loss of $58.7 million and $37.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $115.7 million as of December 31, 2024[198]. - The company has no assurance of generating sufficient revenue to support self-sustaining cash flows, raising substantial doubt about its ability to continue as a going concern[30]. - The company has abandoned the commercialization of ENTADFI due to cash constraints and is seeking to sell or transact the ENTADFI assets[205]. - The company plans to seek funding through a combination of equity offerings, debt financing, or other capital sources, which may not be available on favorable terms[207]. Product Development and Commercialization - Proclarix is an in vitro diagnostic test for prostate cancer, approved for sale in the European Union, and is expected to be marketed in the U.S. as a lab-developed test[23]. - Proclarix aims to address the issue of overdiagnosis in prostate cancer, which can lead to unnecessary biopsies and increased healthcare costs[48]. - Proclarix generated revenues of $86,957 in 2024, while prior to its acquisition by Onconetix, Proteomedix had revenues of $67,380 from Proclarix sales[49]. - The marketing approval process for Proclarix is lengthy and unpredictable, and the company cannot commercialize Proclarix in the U.S. without obtaining approval from CMS and state agencies[210]. - The company’s ability to commercialize its product depends on obtaining adequate reimbursement from government health programs and private insurers[219]. - Coverage and reimbursement for newly approved products may be delayed and may not cover the costs of manufacture, sale, and distribution[220]. Regulatory Compliance - The company received multiple deficiency notices from Nasdaq regarding compliance with listing standards, including failure to maintain a minimum bid price and timely filing of reports[38][40][41]. - The EMA requires a risk management plan (RMP) for all new MAAs, detailing measures to minimize risks associated with the product[153]. - Compliance with the General Data Protection Regulation (GDPR) is mandatory for processing personal health data in the EU, imposing significant obligations on pharmaceutical companies[137]. - Regulatory approval processes vary significantly between countries, impacting the timeline and requirements for marketing products internationally[139]. - The IVDR introduces significant changes for IVD manufacturers, including a new risk-based classification system and stricter regulatory responsibilities throughout the supply chain[159]. Partnerships and Acquisitions - The company signed a Non-Binding Letter of Intent with Ocuvex Therapeutics for a potential business combination, where Ocuvex equity holders would own approximately 90% of the combined company[33]. - Proteomedix entered an exclusive partnership with LabCorp in 2023 for the commercialization of Proclarix in the United States, receiving an upfront license fee and future royalty payments[109]. - The company entered into an asset purchase agreement to acquire six FDA-approved pharmaceutical assets for a total of $8.5 million in cash and 1 million shares of common stock[74][75]. - The partnership with Immunovia AB aims to leverage Proteomedix's R&D capabilities to accelerate the roll-out of their proprietary IMMray PanCan-d test[179]. - Proteomedix has entered into a research and development partnership with New Horizon Health Limited to enhance cancer patient management[178]. Market Opportunity and Competitive Landscape - In 2022, there were 1,467,854 new cases of prostate cancer and 397,430 related deaths worldwide, highlighting the significant market opportunity for Proclarix[114]. - The worldwide market for in vitro diagnostic (IVD) products is projected to be valued at $101 billion in 2024, with Europe and North America being the largest markets[116]. - The molecular diagnostics field is highly competitive, with many companies developing tests for prostate cancer, but Proclarix offers advantages such as being blood-based and minimally invasive[120]. - Proclarix is positioned as a complementary tool to MRI-based diagnosis, supporting the decision-making process for patients undergoing MRI and targeted biopsy[127]. Product Features and Efficacy - Proclarix is designed to indicate the risk of clinically significant prostate cancer using a risk score derived from a clinical decision support system[86]. - Proclarix has demonstrated a 90% sensitivity and a 95% negative predictive value for clinically significant prostate cancer in clinical studies[95]. - The validation study showed that Proclarix could reduce unnecessary biopsies by approximately 43% compared to clinical comparators[95]. - EAU guidelines recommend using Proclarix as an additional biomarker test to reduce negative biopsies in men with PSA levels between 3–10 ng/mL[99]. - Proclarix was included in the 2023 AUA/SUO clinical practice guideline, emphasizing its role in the early detection of clinically significant prostate cancer (GG2+) and improving biopsy safety[100]. Financial Instruments and Debt - The Company issued a non-convertible debenture to the PMX Investor for $5 million, with an interest rate of 4% per annum[62]. - The Altos Debenture was amended to extend the maturity date to October 31, 2024, and the outstanding debt was settled through the issuance of units[64]. - Following the PMX Transaction, sellers owned approximately 87.2% of Onconetix's outstanding equity interests[55]. - The PMX Transaction involved Onconetix issuing shares valued at approximately $75 million as consideration for the acquisition of Proteomedix[52]. - The fair value of the shares issued in the PMX Transaction was approximately $65.1 million, based on the closing price of $9.528 per share[53].

Financial Performance - Net sales for the three months ended April 27, 2025, were $2,475 million, an increase of 4.5% compared to $2,369 million for the same period in 2024[9]. - Net earnings attributable to The Campbell's Company for the three months ended April 27, 2025, were $66 million, a decrease of 50% from $133 million in the same period last year[9]. - Total costs and expenses for the three months ended April 27, 2025, were $2,314 million, up 9.1% from $2,121 million for the same period in 2024[9]. - The company reported a total comprehensive income of $67 million for the three months ended April 27, 2025, down from $141 million in the same period last year[10]. - Net earnings for the nine months ended April 27, 2025, were $457 million, a decrease of 19.74% compared to $570 million for the same period in 2024[16]. - Cash flows from operating activities provided $872 million, slightly down from $897 million in the prior year[16]. - The company reported accumulated other comprehensive loss of $15 million as of April 27, 2025[37]. - Net sales for the three months ended April 27, 2025, were $2.475 billion, an increase from $2.369 billion for the same period in 2024, representing a growth of approximately 4.5%[50]. - Total net sales for Q3 2025 were $2.475 billion, a 4% increase from $2.369 billion in Q3 2024, driven by a 15% increase in Meals & Beverages segment sales[139]. Costs and Expenses - Research and development expenses for the three months ended April 27, 2025, were $23 million, down from $27 million in the same period last year[9]. - The total cost of products sold was $1,747 million for the three months ended April 27, 2025, compared to $1,637 million for the same period in 2024[88]. - The total interest expense was $85 million for the three months ended April 27, 2025, up from $70 million for the same period in 2024[88]. - Other expenses increased to $160 million in 2025 from $30 million in 2024, primarily due to a $150 million impairment charge related to the Snyder's of Hanover trademark[145]. - Marketing and selling expenses increased by 5% in 2025, primarily due to the impact of the acquisition of Sovos Brands[143]. Assets and Liabilities - The company's total assets as of April 27, 2025, were $14,828 million, a decrease from $15,235 million as of July 28, 2024[13]. - Current liabilities decreased to $2,849 million as of April 27, 2025, from $3,576 million as of July 28, 2024[13]. - Long-term debt increased to $6,097 million as of April 27, 2025, compared to $5,761 million as of July 28, 2024[13]. - Total equity at April 27, 2025, was $3,872 million, reflecting a decrease from $3,915 million at April 28, 2024[18]. - As of April 27, 2025, the company had negative working capital of $623 million, with total debt maturing within one year at $799 million[182]. Acquisitions and Divestitures - The company completed the acquisition of Sovos Brands, Inc. for a total consideration of $2.899 billion, with cash paid to shareholders amounting to $2.339 billion[27]. - The acquisition contributed $166 million to net sales and resulted in a loss of $75 million to net earnings for the period from March 12, 2024, to April 28, 2024[31]. - The company sold its Pop Secret popcorn business for $70 million, recognizing a pre-tax loss of $25 million[33]. - The noosa yoghurt business, part of the Sovos Brands acquisition, was sold for $188 million, with an after-tax loss of $15 million recorded[35]. - The company sold its Pop Secret popcorn business for $70 million and the noosa yoghurt business for $188 million in early 2025[185]. Impairment and Restructuring - The company incurred impairment charges of $176 million during the nine months ended April 27, 2025, compared to no impairment charges in the same period last year[16]. - The company recognized an impairment charge of $150 million on the Snyder's of Hanover trademark in the third quarter of 2025, reducing its carrying value to $470 million[44]. - The total aggregate impact of impairment charges year-to-date in 2025 was $176 million ($131 million after tax, or $0.44 per share)[135]. - Total pre-tax charges related to restructuring and optimization initiatives amounted to $895 million, with approximately $720 million being cash expenditures[57]. Shareholder Returns - Dividends paid amounted to $343 million, compared to $334 million in the same period last year[16]. - The company has approximately $200 million remaining under its September 2024 share repurchase program and $301 million under the September 2021 program[188]. - The company repurchased 1.247 million shares at a cost of $60 million during the nine-month period ended April 27, 2025[101]. Future Outlook and Guidance - The company plans to adopt new accounting guidance regarding segment disclosures starting with the 2025 annual reporting[24]. - The fiscal year ends on August 3, 2025, with 53 weeks expected in 2025, compared to 52 weeks in 2024[22]. - The company expects amortization expense to be approximately $70 million in 2025 and $40 million per year for the following four years[41]. - The company anticipates continued supply chain productivity and benefits from cost savings initiatives to mitigate inflationary pressures in 2025[127]. - The company expects total estimated pre-tax costs for identified actions to be approximately $210 million, with 70% allocated to Meals & Beverages, 9% to Snacks, and 21% to Corporate[63].