B&G Foods(BGS) - 2025 Q3 - Quarterly Results
2025-11-05 21:06
Financial Performance - Net sales for Q3 2025 decreased by $21.8 million, or 4.7%, to $439.3 million compared to Q3 2024[4] - Base business net sales for Q3 2025 decreased by $11.9 million, or 2.7%, to $437.0 million, driven by a volume decrease of $12.9 million, or 2.9%[5] - The company had a net loss of $19.1 million, or $0.24 per diluted share, for Q3 2025, compared to net income of $7.5 million, or $0.09 per diluted share, for Q3 2024[12] - For the first three quarters of 2025, net sales decreased by $91.8 million, or 6.6%, to $1,289.1 million compared to the same period in 2024[14] - Adjusted net income for the first three quarters of 2025 was $18.1 million, or $0.23 per adjusted diluted share, down from $31.1 million, or $0.39 per adjusted diluted share, in the same period of 2024[23] - Net sales for the third quarter ended September 27, 2025, were $439.3 million, a decrease of 4.7% compared to $461.1 million for the same period in 2024[51] - The company reported a net loss of $19.1 million for the third quarter, compared to a net income of $7.5 million in the same quarter of the previous year[51] - Net sales for the third quarter of 2025 were $439.3 million, a decrease from $461.1 million in the same period of 2024, while net sales for the first three quarters of 2025 totaled $1.29 billion compared to $1.38 billion in 2024[63] Segment Performance - Specialty segment net sales for Q3 2025 were $150,526, a decrease of $10,465 or 6.5% compared to Q3 2024[28] - Meals segment net sales for Q3 2025 were $109,966, down $1,616 or 1.4% from Q3 2024, with adjusted EBITDA increasing by 2.7% to $23,879[29] - Frozen & Vegetables segment net sales for Q3 2025 were $77,398, a decline of $11,783 or 13.2% compared to Q3 2024, while adjusted EBITDA increased by 260.2% to $4,175[30] - Spices & Flavor Solutions segment net sales for Q3 2025 were $101,414, an increase of $2,095 or 2.1% from Q3 2024, but adjusted EBITDA decreased by 7.4% to $26,399[32] - Specialty segment net sales decreased to $150.5 million in Q3 2025 from $161.0 million in Q3 2024, a decline of 8.9%[52] - Frozen & Vegetables segment net sales fell to $77.4 million in Q3 2025, down 13.2% from $89.2 million in Q3 2024[52] Expenses and Costs - Selling, general and administrative expenses for the first three quarters of 2025 increased by $3.2 million, or 2.3%, to $140.9 million[17] - Total segment adjusted expenses for Q3 2025 were $347.1 million, down from $366.8 million in Q3 2024, a reduction of 5.4%[52] - The increase in Frozen & Vegetables segment adjusted EBITDA for Q3 2025 was primarily due to a decrease in raw material and manufacturing costs[31] - The decrease in Spices & Flavor Solutions segment adjusted EBITDA was attributed to increased raw material costs, particularly for garlic and black pepper[32] Impairments and Charges - The company recorded pre-tax, non-cash impairment charges of $26.0 million related to indefinite-lived intangible trademark assets during Q3 2025[9] - The company incurred an impairment of intangible assets amounting to $26.0 million during the third quarter[51] - The company recognized pre-tax, non-cash goodwill impairment charges of $70.6 million within its Frozen & Vegetables reporting unit during the first quarter of 2024[61] Guidance and Outlook - The company narrowed its full-year fiscal 2025 guidance for net sales to a range of $1.82 billion to $1.84 billion[7] - For fiscal 2025, the company narrowed its net sales guidance to a range of $1.82 billion to $1.84 billion and adjusted EBITDA guidance to $273.0 million to $280.0 million[33] - The company’s guidance does not fully reflect potential impacts from recently imposed tariffs and retaliatory actions by other countries[34] - Future outlook includes expectations for net sales and adjusted EBITDA to stabilize as divestitures are completed, although risks remain due to market conditions and competition[46] Cash and Assets - Total current assets increased to $816.9 million as of September 27, 2025, compared to $781.4 million at the end of 2024[49] - Cash and cash equivalents increased to $60.9 million from $50.6 million at the end of 2024[49] - Long-term debt remained stable at approximately $2.02 billion, with total liabilities at $2.47 billion as of September 27, 2025[49] Conference Call - The company will hold a conference call on November 5, 2025, to discuss Q3 2025 financial results[36]
Zimmer Biomet(ZBH) - 2025 Q3 - Quarterly Report
2025-11-05 21:06
Financial Performance - Net sales increased by 9.7% to $2,001.4 million in Q3 2025 compared to $1,824.2 million in Q3 2024, and by 5.9% to $5,987.7 million in the nine-month period compared to $5,655.4 million in the prior year [120][125]. - Net earnings decreased to $230.9 million in Q3 2025 from $249.1 million in Q3 2024, and to $565.8 million in the nine-month period from $664.3 million in the prior year, primarily due to acquisition costs and higher interest expenses [121]. - The company anticipates a full-year revenue growth of 6.7% to 7.7% for 2025, driven by market growth and new product introductions [122]. - Tariffs are expected to add approximately $40 million in expenses for the full year 2025, impacting overall net earnings [123]. Sales Growth - The Paragon 28 acquisition contributed 3.6% to net sales growth in Q3 2025 and 2.1% in the nine-month period, with a total impact of 2.7% expected for the full year 2025 [120][122]. - The U.S. net sales growth was 10.6% in Q3 2025 and 5.9% in the nine-month period, driven by the Paragon 28 acquisition and market growth in key product categories [131]. - International net sales increased by 8.5% in Q3 2025 and 5.8% in the nine-month period, with foreign currency exchange rates contributing positively [131]. - The S.E.T. product category saw a significant increase of 19.2% in Q3 2025, largely attributed to the Paragon 28 acquisition [126][132]. Expenses and Costs - Cost of products sold, excluding intangible asset amortization, decreased as a percentage of net sales to 27.9% in Q3 2025 from 29.5% in Q3 2024, despite increased costs in absolute terms [133]. - Intangible asset amortization expense rose to 8.8% of net sales in Q3 2025, reflecting the impact of the Paragon 28 acquisition and other technology-based asset purchases [134]. - R&D expenses increased in amount but decreased as a percentage of net sales, driven by Paragon 28-related expenses and technology projects, with a total of $21.4 million and $74.9 million recognized in the three and nine-month periods ended September 30, 2025, respectively [135][137]. - SG&A expenses increased in both amount and percentage of net sales, attributed to higher net sales, Paragon 28 expenses, and investments in marketing and IT [136]. Cash Flow and Financing - Cash flows from operating activities were $1,179.7 million in the nine-month period ended September 30, 2025, compared to $993.1 million in the same prior year period [149]. - Cash flows used in investing activities were $1,653.7 million in the nine-month period ended September 30, 2025, including $1,226.3 million for the acquisition of Paragon 28 [150]. - Cash flows provided by financing activities were $1,223.0 million in the nine-month period ended September 30, 2025, with proceeds from senior notes totaling $2,492.1 million [151]. - As of September 30, 2025, the company had $1,292.7 million in cash and cash equivalents, with $1.0 billion available to borrow under the 2025 364-Day Credit Agreement [147][148]. Tax and Debt - The effective tax rate for the three and nine-month periods ended September 30, 2025, was 17.2% and 22.6%, respectively, compared to negative 8.2% and positive 11.0% in the same prior year periods [142]. - As of September 30, 2025, the company had outstanding debt of $8,112.6 million, with $600.0 million classified as current debt [155]. Restructuring Plans - The company initiated global restructuring programs in February 2025, with expenses recognized of $21.4 million and $74.9 million in the three and nine-month periods ended September 30, 2025 [137]. - The 2025 Restructuring Plan is expected to incur total pre-tax charges of approximately $85 million by the end of 2027, with $43 million incurred through September 30, 2025 [159]. - The 2023 Restructuring Plan resulted in total pre-tax charges of approximately $117 million, with expected annual pre-tax operating expense reductions of $175 million to $200 million by the end of 2025 [159]. - The 2019 Restructuring Plan is projected to incur total pre-tax restructuring charges of approximately $400 million by the end of 2025, with $388 million incurred through September 30, 2025 [159]. - The company expects to reduce gross annual pre-tax operating expenses by approximately $95 million relative to 2024 baseline expenses by the end of 2027 as benefits from the 2025 Restructuring Plan are realized [159]. - The company is executing multiple restructuring plans aimed at improving operational efficiency and reducing costs [159]. Litigation and Tax Matters - Total liabilities for litigation matters were estimated at $146.6 million as of September 30, 2025, with potential future payments ranging from $0 to approximately $325 million [161]. - The company is involved in various litigation matters, which may result in charges exceeding current estimates upon resolution [161]. - Future payments related to development and distribution contracts may be significant but are not recognized on the balance sheet due to uncertainty [161]. - The IRS has proposed adjustments for tax years 2013-2015 and 2016-2019, which the company disputes, potentially impacting future cash flows [160]. Acquisitions - The company completed the acquisition of Monogram for approximately $180 million, with potential additional consideration of up to $570 million based on future milestones [162].
STAAR Surgical(STAA) - 2025 Q3 - Quarterly Report
2025-11-05 21:06
Financial Performance - For the nine months ended September 26, 2025, net sales were $181.6 million, a decrease of 31% compared to $265.0 million for the same period in 2024[89] - Net sales for the nine months ended September 26, 2025 decreased by 31% compared to the same period in 2024, primarily due to decreased sales in China, with APAC region sales down 42% and ICL unit sales down 43%[99] - For the three months ended September 26, 2025, net sales increased by 6.9% to $94.7 million compared to $88.6 million for the same period in 2024[97] - The company reported a net loss of $62.1 million for the nine months ended September 26, 2025[115] Sales by Region - Net sales to distributors in China for the nine months ended September 26, 2025, were $60.3 million, down from $154.5 million in the prior year[89] - The Americas region sales increased by 20% with ICL unit growth of 15%, driven by sales growth in Canada and the U.S.[98] - The EMEA region sales increased by 8% with ICL unit growth of 23%, primarily due to sales growth in distributor markets[98] Gross Profit and Margins - The gross profit margin for the three months ended September 26, 2025, was 82.2%, up from 77.3% in the same period of 2024[96] - Gross profit for the three months ended September 26, 2025 increased by 13.7% year-over-year, with a gross margin of 82.2%, up from 77.3% in the same period of 2024[100] - Gross profit for the nine months ended September 26, 2025 decreased by 33.3% year-over-year, with a gross margin of 76.3%, down from 78.5% in the same period of 2024[101] Expenses - General and administrative expenses for the three months ended September 26, 2025 decreased by 4.3% year-over-year, representing 21.9% of sales, down from 24.5%[102] - Selling and marketing expenses for the three months ended September 26, 2025 decreased by 18.7% year-over-year, accounting for 24.8% of sales, down from 32.6%[103] - Research and development expenses for the three months ended September 26, 2025 decreased by 24.8% year-over-year, representing 9.7% of sales, down from 13.8%[104] - Merger transaction and related costs amounted to $5.9 million for the three months ended September 26, 2025, representing 6.3% of sales[105] - Restructuring, impairment, and related charges totaled $27.9 million for the nine months ended September 26, 2025, representing 15.3% of sales[107] Cash Flow and Assets - Cash and cash equivalents increased by $31.996 million from $144.159 million in December 27, 2024 to $176.155 million in September 26, 2025[114] - Total current assets decreased by $46.731 million from $367.940 million in December 27, 2024 to $321.209 million in September 26, 2025[114] - Net cash used in operating activities for the nine months ended September 26, 2025 was $(30.316) million, compared to $15.083 million for the same period in 2024[115] - Net cash provided by investing activities was $65.754 million for the nine months ended September 26, 2025, compared to $(39.722) million for the same period in 2024[115] - Net cash used in financing activities was $(4.505) million for the nine months ended September 26, 2025, compared to $5.834 million for the same period in 2024[118] - The company’s working capital decreased by $38.062 million from $297.634 million in December 27, 2024 to $259.572 million in September 26, 2025[114] Tax and Other Income - The effective tax rate for the three months ended September 26, 2025 was 52.7%, compared to 24.2% for the same period in 2024[112] - Other income, net for the three months ended September 26, 2025 decreased by 96.0% year-over-year, amounting to $300, while for the nine months it increased by 21.4% to $7.3 million[109] Strategic Initiatives - The company entered into a Merger Agreement with Alcon Research, LLC on August 4, 2025, with STAAR becoming a wholly owned subsidiary of Alcon[88] - The company has implemented consignment agreements with distributors in China to mitigate financial exposure from tariffs[91] - The company expects distributors to make more frequent purchases of ICLs in smaller quantities, reducing the risk of inventory buildup[92] Market Risk - There have been no material changes in the company's qualitative and quantitative market risk since the last annual report[120]
Forward Air(FWRD) - 2025 Q3 - Quarterly Report
2025-11-05 21:06
Business Operations - The company operates as a leading asset-light freight provider, focusing on transportation services including LTL, truckload, and intermodal drayage across the U.S., Canada, and Mexico [92]. - The company monitors key operating statistics such as tonnage, weight per shipment, revenue per hundredweight, and average length of haul to evaluate performance in its Expedited Freight and Intermodal segments [99][105]. - The company is actively monitoring macroeconomic conditions, including proposed tariffs on imported goods, which may impact freight demand and overall business performance [108]. - The company continues to focus on creating synergies across its services, particularly within the Expedited Freight segment, to enhance operational efficiency [96]. - The company is implementing a transformation of the combined business post-acquisition to maximize revenues and efficiencies while retaining existing customers [110]. Financial Performance - Estimated revenue for key product groups for the period ended December 31, 2024, approximated 70% for ground transportation, 12% for air & ocean forwarding, 9% for intermodal drayage, and 9% for warehousing/value-added services [98]. - Operating revenues decreased by $24,174, or 3.7%, to $631,763 for the three months ended September 30, 2025, compared to $655,937 for the same period in 2024 [115]. - Income from continuing operations decreased by $7,690, or 33.9%, to $15,007 for the three months ended September 30, 2025, attributed to lower operating revenues and increased acquisition expenses [117]. - Net loss decreased by $11,578, to $23,757 for the three months ended September 30, 2025, compared to a net loss of $35,335 for the same period in 2024 [120]. - Operating revenues increased by $22,472, or 1.2%, to $1,863,888 for the nine months ended September 30, 2025, compared to $1,841,416 for the same period in 2024 [146]. - Net loss decreased by $990,164, or 90.4%, to $105,312 for the nine months ended September 30, 2025, compared to a net loss of $1,095,476 for the same period in 2024 [151]. Expenses and Cost Management - Operating expenses decreased by $16,484, or 2.6%, to $616,756 for the three months ended September 30, 2025, mainly due to lower shipment volumes and a prior year goodwill impairment charge of $14,751 [116]. - Total other expenses decreased by $17,214, or 31.0%, to $38,379 for the three months ended September 30, 2025, due to lower net interest expenses and adjustments to tax liabilities [118]. - Purchased transportation costs decreased by $14,770, or 10.5%, to $125,265 for the three months ended September 30, 2025, representing 48.4% of Expedited Freight operating revenues [126]. - Salaries, wages, and employee benefits decreased by $5,023, or 8.5%, to $54,403 for the three months ended September 30, 2025, accounting for 21.0% of Expedited Freight operating revenues [127]. - Other operating expenses decreased by $5,241, or 20.0%, to $20,914 for the three months ended September 30, 2025, reflecting acquisition integration synergies and reduced shipments [128]. - Operating expenses decreased by $1,155,611, or 38.8%, to $1,824,596 for the nine months ended September 30, 2025, primarily due to a prior year goodwill impairment charge of $1,107,465 [147]. Acquisition and Integration - The company completed the acquisition of Omni Newco, LLC on January 25, 2024, and has exceeded initial expectations regarding cost synergies from this integration [110]. - The Omni Logistics segment contributed to the revenue increase due to an extra twenty-four days included in 2025 following the Omni Acquisition in January 2024 [146]. - Corporate operating loss increased to $18,289 for the three months ended September 30, 2025, compared to $1,799 in the same period in 2024, primarily due to acquisition and integration expenses [144]. - The company incurred significant indebtedness related to the Omni Acquisition, which could have important consequences for its business operations [183]. Market Conditions and Strategic Alternatives - The company has experienced a decrease in industry freight volumes, as measured by the Cass Freight Index, in each of the first three quarters of 2025 compared to the same periods in 2024 [107]. - The company has initiated a comprehensive review of strategic alternatives to maximize shareholder value, including potential sale or merger options [109]. - The company’s earnings depend significantly on increasing freight volume and revenue per shipment, particularly in a challenging freight environment [96]. Tax and Compliance - The effective tax rate for the three months ended September 30, 2025 was (1.6)%, compared to (4.0)% for the same period in 2024, influenced by interest expense disallowances and other factors [119]. - The effective tax rate for the nine months ended September 30, 2025 was (3.2)%, compared to 15.0% for the same period in 2024, primarily due to interest expense disallowances [150]. - The company expects to maintain compliance with its leverage ratio covenant over the next year, which is critical to avoid default under the Credit Agreement [183]. Cash Flow and Capital Expenditures - Net cash provided by operating activities increased to $67,112 for the nine months ended September 30, 2025, compared to a net cash used of $45,770 for the same period in 2024, primarily due to increased income from continuing operations [184]. - Net cash used in investing activities significantly decreased to $18,976 for the nine months ended September 30, 2025, from $1,592,878 in the same period of 2024, largely due to the absence of the Omni Acquisition in 2025 [185]. - Capital expenditures for the first nine months of 2025 were $20,765, down from $29,810 in 2024, primarily related to technology and operating equipment purchases [185].
Sabra(SBRA) - 2025 Q3 - Quarterly Results
2025-11-05 21:06
Financial Performance - The company reported a net income attributable to Sabra Health Care REIT, Inc. of $22.538 million for the three months ended September 30, 2025, compared to $29.788 million in the same period of 2024[7]. - Net income for the three months ended September 30, 2025, was $22,517, a decrease from $65,542 in the previous quarter, reflecting a decline of 65.6%[14]. - Net income for the nine months ended September 30, 2025, was $128.363 million, with a loss of $109.972 million attributed to corporate expenses[20]. - Net income for the nine months ended September 30, 2025, was $128.363 million, with a loss of $109.972 million in corporate adjustments[25]. Cash Flow and Income Metrics - FFO attributable to Sabra Health Care REIT, Inc. for the nine months ended September 30, 2025, was $271.010 million, an increase from $236.453 million in the same period of 2024[7]. - Cash rental income for the three months ended September 30, 2025, was $88.946 million, a decrease from $91.829 million in the same period of 2024[12]. - Cash Net Operating Income - pro rata for the three months ended September 30, 2025, was $22,271, a decrease from $22,806 in the previous quarter, showing a decline of 2.3%[14]. - Cash Net Operating Income - pro rata reached $383.709 million, reflecting adjustments for non-cash revenue and expenses[22]. - Cash Net Operating Income (Cash NOI) for the nine months was $383.709 million, reflecting a pro rata Cash NOI of $229.601 million[25]. - Annualized Cash Net Operating Income (Annualized Cash NOI) reached $521.999 million, with annualizing adjustments totaling $138.290 million[25]. Operational Metrics - The company’s Adjusted EBITDA for the three months ended September 30, 2025, was $121.672 million, with an annualized figure of $486.688 million[9]. - Total Net Operating Income (NOI) consolidated was $382.990 million, with $154.444 million from private payors and $195.479 million from non-private payors[22]. - Net Operating Income - consolidated for the three months ended September 30, 2025, was $30,105, an increase from $25,294 in the previous quarter, representing a growth of 19.0%[14]. - Total Net Operating Income (NOI) for the period was $382.990 million, with a pro rata NOI of $382.951 million[25]. Expenses and Costs - The company anticipates general and administrative expenses of approximately $50 million for 2025, which includes $11 million of stock-based compensation expense[5]. - Depreciation and amortization for the three months ended September 30, 2025, was $19,989, an increase from $14,372 in the previous quarter, representing a growth of 39.4%[14]. - Depreciation and amortization expenses totaled $135.591 million, impacting overall net income[20]. - Interest expenses totaled $83.549 million, contributing to the overall financial burden[20]. - General and administrative expenses were reported at $37.802 million, highlighting operational costs[20]. Future Projections - The company expects 2025 net income per diluted common share to be between $0.655 and $0.665, with normalized FFO attributable to common stockholders projected between $1.455 and $1.465[3]. - The company anticipates full-year average same-store Cash NOI growth in the mid-teens percentage range for the Senior Housing - Managed portfolio[5]. - The weighted average share count for Normalized FFO is expected to be approximately 244.7 million shares[5]. Joint Ventures and Other Income - Income from unconsolidated joint ventures for the three months ended September 30, 2025, was $4,034, an increase from $3,713 in the previous quarter, reflecting a growth of 8.6%[17]. - The company’s share of unconsolidated joint ventures' net operating income was $10.949 million, contributing to overall performance metrics[20]. - The company’s share of unconsolidated joint ventures' Net Operating Income was $10.949 million, contributing to overall performance[25]. Real Estate and Market Challenges - The company recorded a net gain on sales of real estate amounting to $(5.544) million, reflecting challenges in the real estate market[20]. - Impairment of real estate was noted at $6.674 million, indicating potential asset value concerns[20]. - Adjustments for net income not related to Senior Housing - Managed for the three months ended September 30, 2025, totaled $(14,590), a decrease from $(56,463) in the previous quarter, indicating an improvement of 74.1%[14].
Adicet Bio(ACET) - 2025 Q3 - Quarterly Report
2025-11-05 21:06
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 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38359 Adicet Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 81-3305277 (State or other jurisdict ...
Vera Therapeutics(VERA) - 2025 Q3 - Quarterly Report
2025-11-05 21:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Vera Therapeutics, Inc. 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 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40407 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorp ...
Dyne Therapeutics(DYN) - 2025 Q3 - Quarterly Report
2025-11-05 21:05
Financial Performance - For the nine months ended September 30, 2025, the company reported net losses of $334.3 million, compared to $227.9 million for the same period in 2024, with an accumulated deficit of $1.3 billion as of September 30, 2025[107]. - The net loss for Q3 2025 was $108.0 million, compared to a net loss of $97.1 million in Q3 2024, reflecting an increase of $10.9 million[129]. - The net loss for the nine months ended September 30, 2025, was $334.3 million, compared to a net loss of $227.9 million in 2024, reflecting an increase of $106.4 million (approximately 46.7%)[137]. - Total operating expenses for the nine months ended September 30, 2025, were $352.1 million, an increase of $105.3 million (approximately 42.7%) compared to $246.8 million in 2024[137]. - Research and development expenses rose to $302.9 million in 2025, up $103.3 million (approximately 51.8%) from $199.6 million in 2024, driven by increased clinical trial activities[138]. - The company has not generated any revenue from product sales and has incurred significant operating losses since its inception, with expectations of continued losses as it advances its product candidates[105][106]. - The company has not generated any revenue since inception and does not expect to do so until at least 2027[115]. - Interest income decreased to $8.5 million in Q3 2025 from $9.3 million in Q3 2024 due to lower overall interest rates[134]. - Interest income increased to $22.2 million in 2025 from $19.3 million in 2024, a rise of $2.9 million (approximately 15.0%) due to higher invested cash balances[141]. - Net cash used in operating activities was $291.4 million for the nine months ended September 30, 2025, compared to $208.0 million in 2024, indicating a rise of $83.4 million (approximately 40.1%)[152]. Clinical Development - The company is developing z-basivarsen (DYNE-101) for myotonic dystrophy type 1 (DM1), with a registrational expansion cohort expected to enroll 60 patients at a dose of 6.8 mg/kg every eight weeks, aiming for full enrollment by early Q2 2026[90]. - In the MAD portion of the ACHIEVE trial, z-basivarsen demonstrated a 3.3 seconds improvement in video hand opening time (vHOT) compared to placebo at 6 months, with a 10% improvement in muscle strength at 6 months increasing to 20% at 12 months[93]. - The company plans to initiate a Phase 3 clinical trial of z-basivarsen in Q1 2026 and anticipates a potential launch in Q1 2028, assuming favorable data and FDA approval[91]. - The FDA granted Breakthrough Therapy Designation to z-basivarsen for DM1 in June 2025, supporting its expedited development[92]. - The DELIVER trial for z-rostudirsen (DYNE-251) is ongoing, with a registrational expansion cohort of 32 participants completed in March 2025, and data expected in December 2025[101]. - In March 2025, z-rostudirsen demonstrated dose-dependent exon skipping and dystrophin expression, with best-in-class levels of dystrophin expression reported in the 20 mg/kg cohort[99]. - The FDA granted Breakthrough Therapy Designation to z-rostudirsen for DMD in August 2025, and it received Orphan Drug designation in Japan in September 2025[102]. Funding and Financial Strategy - The company anticipates that existing cash and marketable securities will fund operations into Q3 2027, assuming positive clinical trial results[111]. - The company may need substantial additional funding to support operations and growth strategy, relying on equity offerings, debt financings, and collaborations[109]. - The company expects to finance cash needs through equity offerings, debt financings, collaborations, and licensing arrangements, which may dilute stockholder ownership[157]. - The company raised $140.6 million from the sale of 10,660,159 shares of common stock under its at-the-market offering program during the nine months ended September 30, 2025[148]. - The company entered into a Loan Agreement with Hercules in June 2025, providing for term loans up to $275.0 million, with an initial tranche of $100.0 million funded[149]. - The company expects to incur significant expenses and operating losses for the foreseeable future, with no revenue expected from product candidates until at least 2027[145]. Operational Expenses - Research and development expenses for Q3 2025 were $97.2 million, an increase of $4.4 million from $92.8 million in Q3 2024[130]. - General and administrative expenses for Q3 2025 were $16.7 million, up $3.8 million from $12.9 million in Q3 2024[133]. - The company expects general and administrative expenses to rise as headcount increases to support growth strategy[123]. - The company has committed to pay an additional $65.6 million in fees through September 2027 under a master manufacturing services agreement with a CMO[162]. - A second master manufacturing services agreement obligates the company to compensate the CMO at least $25.5 million in fees through March 2027[163]. - The company has a lease obligation of $0.4 million per month, increasing to $0.5 million per month during the lease term, which lasts 8.5 years[161]. - The company has incurred $31.2 million towards non-current assets under the manufacturing services agreement as of September 30, 2025[162]. Risks and Accounting Policies - The company faces risks related to the costs and timing of regulatory reviews and clinical trials for product candidates[159]. - The company has not experienced significant changes in market risk management as of September 30, 2025[168]. - The company’s critical accounting policies include accrued research and development expenses and stock-based compensation, which may significantly impact financial results[165]. - There have been no significant changes to critical accounting policies since the last Annual Report filed on February 27, 2025[166].
McKesson(MCK) - 2026 Q2 - Quarterly Results
2025-11-05 21:05
Exhibit 99.1 McKESSON CORPORATION REPORTS FISCAL 2026 SECOND QUARTER RESULTS AND RAISES FULL YEAR ADJUSTED EPS GUIDANCE IRVING, Texas, November 5, 2025 - McKesson Corporation (NYSE:MCK) today announced results for the second quarter ended September 30, 2025. Second quarter revenues were $103.2 billion, an increase of 10% from a year ago, driven by growth in the North American Pharmaceutical segment, due to increased prescription volumes from retail national account customers, and growth in the distribution ...
Hamilton Beach(HBB) - 2025 Q3 - Quarterly Results
2025-11-05 21:05
Revenue Performance - Revenue declined 15.2% to $132.8 million compared to $156.7 million in the same quarter last year[3] - Revenue decline was primarily driven by lower volumes in the U.S. Consumer business, with a delay in orders from a large retailer[4] Profitability Metrics - Gross margin decreased to 21.1% from 28.0%, impacted by a one-time 370 basis point effect from a temporary 125% tariff on Chinese imports[3][5] - Operating profit decreased to $2.9 million compared to $10.6 million in the prior year[6] - Net income was $1.7 million, or $0.12 per diluted share, compared to $1.9 million, or $0.14 per diluted share in the same quarter last year[7] - Net income for the nine months ended September 30, 2025, increased to $7.9 million, up from $6.8 million in the same period of 2024, reflecting a growth of 16.9%[20] Expenses and Cost Management - Selling, general and administrative expenses (SG&A) decreased to $25.1 million from $33.3 million, primarily due to lower personnel costs[6] Cash Flow and Liquidity - Net cash used for operating activities was $14.6 million for the nine months ended September 30, 2025, compared to $35.2 million cash provided in the same period last year[8] - Net cash provided by operating activities was $(14.6) million for the nine months ended September 30, 2025, compared to $35.2 million in 2024, indicating a significant decline[20] - Cash and cash equivalents dropped to $17.2 million from $45.6 million, a decrease of 62.3%[20] Debt and Liabilities - Net debt increased to $32.8 million from $22.5 million year-over-year[9] - Net (cash) debt stood at $32.8 million as of September 30, 2025, compared to $(0.6) million at December 31, 2024, indicating a shift to a net debt position[21] - Total liabilities decreased to $228.3 million as of September 30, 2025, down from $249.2 million at December 31, 2024, a reduction of 8.3%[18] Asset Management - Total assets decreased to $392.4 million as of September 30, 2025, from $415.1 million at December 31, 2024, representing a decline of 5.5%[18] - Inventory increased to $174.8 million as of September 30, 2025, from $124.9 million at December 31, 2024, an increase of 40%[18] - Total stockholders' equity slightly decreased to $164.0 million from $165.9 million, a decline of 1.1%[18] Dividends and Shareholder Returns - Cash dividends paid amounted to $4.8 million for the nine months ended September 30, 2025, compared to $4.7 million in 2024, reflecting a marginal increase[20] Business Outlook - The company did not provide specific guidance on its business outlook due to increased uncertainty from higher tariffs[10] - The company expects further top-line and margin recovery in the fourth quarter due to improved visibility and brand strength[2] Operational Challenges - The company reported a net change in operating assets and liabilities of $(27.8) million for the nine months ended September 30, 2025, compared to $(10.5) million in 2024, indicating increased operational challenges[20]