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Westrock fee pany(WEST) - 2025 Q3 - Quarterly Report
2025-11-06 22:01
Financial Performance - Net sales for the three months ended September 30, 2025, increased to $354.8 million, up 60.5% from $220.9 million in the same period of 2024[13] - Gross profit for the three months ended September 30, 2025, was $41.4 million, compared to $37.1 million in 2024, reflecting a gross margin of 11.7%[13] - The company reported a net loss of $19.1 million for the three months ended September 30, 2025, compared to a net loss of $14.3 million in the same period of 2024[14] - Net loss for the nine months ended September 30, 2025, was $67.884 million, compared to a net loss of $55.691 million for the same period in 2024, representing an increase in losses of approximately 21.5%[18] - For the three months ended September 30, 2025, the company recognized $354.8 million in net sales, a 60.5% increase from $220.9 million in the same period of 2024[69] - Revenue from coffee and tea for the three months ended September 30, 2025, was $186.4 million, up 61.5% from $115.5 million in 2024[69] - For the nine months ended September 30, 2025, net sales totaled $849.480 million, compared to $621.749 million for the same period in 2024, marking an increase of about 36.5%[157][158] Assets and Liabilities - Total current assets increased to $393.6 million as of September 30, 2025, from $333.6 million at December 31, 2024, representing an increase of 17.9%[12] - Total liabilities rose to $893.0 million as of September 30, 2025, compared to $730.4 million at December 31, 2024, indicating an increase of 22.2%[12] - The company’s total assets reached $1.18 billion as of September 30, 2025, compared to $1.10 billion at December 31, 2024[12] - The company’s total shareholders' equity decreased to $11.4 million as of September 30, 2025, from $97.5 million at December 31, 2024[12] - Total debt increased to $538.13 million as of September 30, 2025, up from $447.73 million on December 31, 2024, marking a 20.2% increase[82] Cash Flow and Expenses - Cash and cash equivalents at the end of the period on September 30, 2025, were $33.971 million, up from $22.359 million at the end of September 30, 2024, indicating a year-over-year increase of approximately 52.5%[18] - Cash flows from operating activities resulted in a net cash used of $55.703 million for the nine months ended September 30, 2025, compared to $16.023 million for the same period in 2024, indicating a significant increase in cash outflow[18] - Selling, general and administrative expenses were $47.0 million for the three months ended September 30, 2025, slightly up from $46.1 million in 2024[13] - Interest expense for the three months ended September 30, 2025, was $14.0 million, significantly higher than $6.9 million in the same period of 2024[13] - The company incurred interest expenses of $39.741 million for the nine months ended September 30, 2025, compared to $21.921 million for the same period in 2024, representing an increase of approximately 81%[157][158] Equity and Investments - The company recognized a $2.3 million gain from the de-consolidation of Rwanda Trading Company during the three months ended June 30, 2025[23] - The company holds a 49.9% equity method investment in a joint venture with a balance of $7.5 million as of September 30, 2025[44] - The company had an equity investment with a carrying value of approximately $1.0 million as of September 30, 2025, with no adjustments made to its carrying value[139] Legal Matters - The company is currently involved in legal proceedings with Dairy Farmers of America, Inc., alleging trade secret misappropriation, which may impact its financial position[167][168] - The company intends to vigorously defend against the legal claims and has not yet determined the potential financial impact of the lawsuit[168][169] Future Obligations and Financing - Future purchase obligations amount to $218.5 million as of September 30, 2025, primarily for inventory purchases over the next 12 months[170] - The company issued $30.0 million in 5.00% convertible senior notes due 2031 on November 4, 2025, with an initial conversion price of $5.25[176][177] - The company modified its Credit Agreement on November 4, 2025, extending the Covenant Relief Period until October 1, 2026[180] Segment Performance - Segment Adjusted EBITDA for the Beverage Solutions segment was $20.422 million for Q3 2025, up from $11.752 million in Q3 2024, indicating a year-over-year increase of about 74%[159][161] - Employee-related costs for the Beverage Solutions segment were $42.326 million for the nine months ended September 30, 2025, up from $35.017 million in the same period of 2024, reflecting an increase of about 20%[163][165] Inventory and Cost of Sales - Total inventories increased to $212.97 million as of September 30, 2025, up from $163.32 million on December 31, 2024, representing a 30.3% increase[70] - The company reported total costs of sales of $509.311 million for the nine months ended September 30, 2025, compared to $369.282 million for the same period in 2024, indicating an increase of approximately 38%[163][165]
Supernus Pharmaceuticals(SUPN) - 2025 Q3 - Quarterly Report
2025-11-06 22:01
Financial Performance - ONAPGO generated net product sales of $6.8 million in its first full quarter following the U.S. commercial launch in April 2025, with over 1,300 enrollment forms submitted by more than 450 prescribers[216]. - Collaboration revenue from ZURZUVAE was $20.2 million in Q3 2025, representing approximately two months of collaboration revenue since the Sage Acquisition, with U.S. sales increasing approximately 150% compared to the same period in 2024[216]. - Net sales of Qelbree increased 31% to $81.4 million in Q3 2025, with total IQVIA prescriptions reaching 238,770, a 23% increase year-over-year[216]. - Net sales of GOCOVRI increased 15% to $40.8 million in Q3 2025, driven by growth in prescriptions and the number of prescribers[216]. - Total revenues for Q3 2025 were $192.1 million, a 9% increase from $175.7 million in Q3 2024, while total revenues for the nine months ended September 30, 2025, were $507.4 million, up 4% from $487.7 million in the same period of 2024[235]. - Net product sales decreased by 1% to $168.5 million in Q3 2025 compared to $170.3 million in Q3 2024, and also decreased by 1% to $468.5 million for the nine months ended September 30, 2025, from $471.3 million in the prior year[236]. - The decline in net product sales was primarily due to lower sales of APOKYN (down 48% in Q3 2025) and Oxtellar XR (down 60% in Q3 2025) due to generic erosion, partially offset by increases in sales from Qelbree and GOCOVRI[236]. Acquisitions and Collaborations - The Company completed the acquisition of Sage Therapeutics, Inc. on July 31, 2025, integrating its established commercial product ZURZUVAE into its portfolio[203]. - Collaboration revenue (ZURZUVAE) was $20.2 million for the three and nine months ended September 30, 2025, attributed to the Sage Acquisition in July 2025[248]. - The company has contingent consideration milestones related to the Sage Acquisition, with potential payments totaling up to $234 million based on future sales of ZURZUVAE[272]. - The company incurred $70.9 million in acquisition-related costs associated with the Sage Acquisition in July 2025, contributing to the decline in earnings[266]. Product Development - SPN-817, a novel anticonvulsant for epilepsy, is currently in a Phase 2b study with a targeted enrollment of approximately 258 adult patients[213]. - SPN-820, a novel treatment for depression, plans to initiate a follow-on Phase 2b trial in approximately 200 adults with major depressive disorder by the end of 2025[214]. - SPN-443, a novel stimulant for ADHD, completed a Phase 1 study in 2024 and is expected to initiate a Phase 1 single-ascending/multiple ascending dose study in 2026[215]. - The FDA approved an expanded label update for Qelbree in January 2025, including new data on pharmacodynamics and use in breastfeeding mothers[205]. Inventory and Supply Chain - The Company is facing supply constraints for ONAPGO due to stronger than expected demand, prioritizing care for existing patients while working to build adequate inventory[216]. - The accrued product returns balance decreased to $43.3 million as of September 30, 2025, from $57.4 million as of September 30, 2024, primarily due to a $16.3 million estimated provision for product returns related to prior year sales[244]. - The accrued product rebates balance increased to $141.2 million as of September 30, 2025, from $111.7 million as of September 30, 2024, primarily due to the timing of payments associated with government programs[245]. Expenses and Financial Management - Selling and marketing expenses increased by 42% to $54.3 million for the three months ended September 30, 2025, and by 19% to $205.5 million for the nine months ended September 30, 2025, primarily due to higher professional and consulting expenses[252]. - General and administrative expenses surged by 565% to $15.4 million for the three months ended September 30, 2025, and by 127% to $157.7 million for the nine months ended September 30, 2025, mainly due to acquisition-related costs from the Sage acquisition[253]. - Research and Development (R&D) expenses were $29.4 million for the three months ended September 30, 2025, compared to $29.0 million in 2024, with a total of $78.4 million for the nine months ended September 30, 2025, down from $80.1 million in 2024[251]. - The provision for product rebates increased to $295.1 million for the nine months ended September 30, 2025, from $293.6 million in the same period of 2024, primarily due to higher Qelbree sales[247]. Cash Flow and Liquidity - Cash and cash equivalents increased to $151.4 million as of September 30, 2025, from $69.3 million as of December 31, 2024, representing a 118% increase[261]. - Total cash, cash equivalents, and unrestricted marketable securities amounted to $281.2 million as of September 30, 2025, which the company believes will be sufficient to meet cash requirements over the next 12 months[262]. - Net cash provided by operating activities decreased to $27.5 million in 2025 from $127.5 million in 2024, primarily due to a net loss of $34.4 million compared to net earnings of $58.5 million in the prior year[266]. - Net cash provided by investing activities was $55.4 million in 2025, a significant improvement from net cash used of $177.2 million in 2024, primarily due to higher inflows from marketable securities[267]. - Cash and cash equivalents at the end of the period increased to $152.8 million in 2025 from $31.7 million in 2024, reflecting a net change of $126.9 million[265]. Risk Management and External Factors - The company does not hedge foreign currency exchange rate risk, and all liabilities were substantially denominated in U.S. dollars as of September 30, 2025[281]. - Inflation has not significantly impacted the company's consolidated results, although there are expectations of variability in labor and vendor service costs due to uncontrollable factors[282].
Tucows(TCX) - 2025 Q3 - Quarterly Report
2025-11-06 22:01
Revenue Performance - For the three months ended September 30, 2025, the company reported net revenue of $98.6 million, a 7.0% increase from $92.3 million in the same period of 2024[207]. - For the nine months ended September 30, 2025, net revenue reached $291.6 million, up 8.9% from $269.2 million in the prior year[207]. - Total net revenues for the three months ended September 30, 2025 increased by $6.3 million, or 7%, to $98.6 million compared to the same period in 2024, driven by growth in Tucows Domains, Wavelo, and Ting[254]. - For the nine months ended September 30, 2025, total net revenues increased by $22.4 million, or 8%, to $291.6 million compared to the same period in 2024, with significant contributions from Tucows Domains, Wavelo, and Ting[255]. - Ting generated $17.0 million in net revenue during the three months ended September 30, 2025, up $1.7 million, or 11%, driven by subscriber growth on the Fiber network[258]. - Wavelo Platform Services net revenues for the three months ended September 30, 2025 increased by $1.8 million, or 18%, to $11.9 million, supported by incremental revenues from existing and new customers[261]. - Wholesale domain services net revenue increased by $2.0 million, or 4%, to $51.9 million during the three months ended September 30, 2025, due to passthrough price increases and recognition of previously deferred revenue[265]. - Value-added services net revenue increased by $0.9 million, or 17%, to $6.1 million during the three months ended September 30, 2025, driven by strong expiry auction sales[268]. Subscriber and Infrastructure Metrics - As of September 30, 2025, Ting Internet had 52,000 active subscribers, an increase from 50,000 active subscribers as of September 30, 2024[209]. - Ting Internet had access to 126,000 owned infrastructure serviceable addresses as of September 30, 2025, down from 132,000 in the previous year[209]. - Contract liabilities increased by $1.9 million to $158.7 million as of September 30, 2025, primarily due to Ting construction mobilization in a new partner market[256]. - As of September 30, 2025, EchoStar accounted for 12% of total net revenues and represented 51% of total accounts receivable[257]. - Ting Internet had access to 126,000 owned infrastructure serviceable addresses and 52,000 active subscribers as of September 30, 2025, compared to 132,000 and 50,000 respectively in the prior year[260]. Cost and Expense Management - Total cost of revenues for the three months ended September 30, 2025, was $74.4 million, reflecting a $4.3 million increase from $70.1 million in the same period in 2024[285]. - Cost of revenues for Ting's Fiber Internet Services increased by $2.2 million, or 51%, to $6.5 million for the three months ended September 30, 2025, compared to the same period in 2024[288]. - Total cost of revenues for the nine months ended September 30, 2025, increased by $13.9 million, or 7%, to $221.8 million from $207.9 million in the same period in 2024[286]. - Costs for Wholesale domain services for the nine months ended September 30, 2025 increased by $5.6 million, or 5%, to $123.4 million compared to $117.8 million for the same period in 2024[295]. - Costs for retail domain services for the nine months ended September 30, 2025 increased by $0.6 million, or 5%, to $13.0 million compared to $12.4 million for the same period in 2024[299]. - Cost of revenues from Mobile Services and Eliminations for the nine months ended September 30, 2025 increased by $4.2 million or 48%, to $13.0 million compared to $8.8 million for the same period in 2024[302]. - Sales and marketing expenses for the nine months ended September 30, 2025 decreased by $13.7 million, or 28%, to $34.8 million compared to $48.5 million for the same period in 2024[307]. - General and administrative expenses for the nine months ended September 30, 2025 decreased by $1.9 million or 6%, to $28.6 million compared to $30.5 million for the same period in 2024[314]. - Technical operations and development expenses for the nine months ended September 30, 2025 decreased by $0.7 million, or 5%, to $13.4 million compared to $14.1 million for the same period in 2024[311]. - Network expenses for the nine months ended September 30, 2025 decreased by $2.4 million or 5%, to $49.7 million compared to $52.1 million for the same period in 2024[304]. Strategic Initiatives and Future Outlook - The company is reviewing strategic alternatives for the Ting business due to ongoing capital needs[214]. - The company continues to invest in fiber to the home (FTTH) deployments, reflecting ongoing efforts to build networks in areas with strong demand, despite the risks associated with upfront investments[230]. - Wavelo's software solutions are being utilized by EchoStar and Ting to enhance subscriber growth and operational efficiency[216]. - The company continues to evaluate the potential impact of the One Big Beautiful Bill Act on future periods and related disclosures[325]. - The Company plans to fund cash requirements for Tucows businesses excluding Ting solely through operating income for Fiscal 2025[352]. - The company has commenced a process to review strategic alternatives for the Ting business due to ongoing capital needs and potential inability to meet financial obligations[350]. Financial Position and Risks - As of September 30, 2025, cash and cash equivalents decreased by $2.8 million, primarily due to $3.2 million used in operating activities and $12.8 million for additions to property and equipment[332]. - As of September 30, 2025, Ting had $33.7 million in unrestricted cash and cash equivalents, down from $45.4 million as of December 31, 2024[349]. - The Company had $40.1 million in outstanding foreign exchange forward contracts to trade U.S. dollars for Canadian dollars[358]. - A sensitivity analysis indicated that a hypothetical 10% adverse movement in foreign currency exchange rates would decrease net income by approximately $4.0 million for the nine months ended September 30, 2025[360]. - The company evaluates credit risk concentrations primarily related to cash equivalents, marketable securities, foreign exchange contracts, and accounts receivable[361]. - Interest rate risk exposure is primarily related to the 2023 Credit Agreement[362]. - The company will continue to monitor foreign exchange exposure risks and may take additional actions to hedge or mitigate these risks in the future[360].
Wintrust Financial Corp Series F Pfd(WTFCN) - 2025 Q3 - Quarterly Report
2025-11-06 22:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________ FORM 10-Q _________________________________________ ☑ 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 001-35077 ___________________________ ...
Wintrust Financial Corporation(WTFCM) - 2025 Q3 - Quarterly Report
2025-11-06 22:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________ FORM 10-Q _________________________________________ ☑ 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 001-35077 ___________________________ ...
Wintrust(WTFC) - 2025 Q3 - Quarterly Report
2025-11-06 22:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________ FORM 10-Q _________________________________________ ☑ 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 9700 W. Higgins Road, Suite 800 Rosemont, Illinois 60018 (Ad ...
WINTRUST FINL(WTFCP) - 2025 Q3 - Quarterly Report
2025-11-06 22:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________ FORM 10-Q _________________________________________ ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State of incorporation or organization) (I.R.S. Employer Identification No.) Illinois 36-3873352 For the quarterly period ended September 30, 2025 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 193 ...
ePlus(PLUS) - 2026 Q2 - Quarterly Report
2025-11-06 22:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from____ to ____. Commission file number: 1-34167 ePlus inc. (Exact name of registrant as specified in its charter) Delaware 54-1817218 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSU ...
Aspen Aerogels(ASPN) - 2025 Q3 - Quarterly Report
2025-11-06 22:01
Financial Performance - Revenue for the nine months ended September 30, 2025, was $229.8 million, a decrease of $99.8 million, or 30%, from $329.6 million for the same period in 2024[137]. - Net loss for the nine months ended September 30, 2025, was $316.6 million, with a net loss per share of $3.85, compared to a net income of $2.0 million and earnings per share of $0.03 for the same period in 2024[138]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $20.9 million, down from $67.2 million for the same period in 2024[147]. - Total revenue decreased by $44.3 million, or 38%, to $73.0 million for the three months ended September 30, 2025, from $117.3 million in the comparable period in 2024[167]. - Total revenue decreased by $99.8 million, or 30%, to $229.8 million for the nine months ended September 30, 2025, from $329.6 million in the comparable period in 2024[188]. - Gross profit decreased by $66.9 million, or 49%, to $68.9 million for the nine months ended September 30, 2025, from $135.8 million in the comparable period in 2024[198]. Revenue Breakdown - Sales of PyroThin thermal barriers were $306.8 million, $110.1 million, and $55.6 million for the fiscal years 2024, 2023, and 2022, respectively, indicating a decline in thermal barrier revenues in 2025 compared to the prior year[130]. - Thermal barrier revenue decreased by $84.0 million, or 35%, to $152.8 million for the nine months ended September 30, 2025, from $236.8 million in the comparable period in 2024[194]. - Thermal barrier revenue decreased by $41.9 million, or 46%, to $48.7 million for the three months ended September 30, 2025, compared to $90.6 million in the same period in 2024[172]. - Energy industrial revenue decreased by $15.9 million, or 17%, to $76.9 million for the nine months ended September 30, 2025, from $92.8 million in the comparable period in 2024[189]. - Energy industrial revenue decreased by $2.4 million, or 9%, to $24.3 million for the three months ended September 30, 2025, from $26.7 million in the same period in 2024[168]. Cost and Expenses - Total cost of revenue decreased by $33.0 million, or 17%, to $160.8 million for the nine months ended September 30, 2025, from $193.8 million in the comparable period in 2024[195]. - Gross profit decreased by $28.2 million, or 58%, to $20.8 million for the three months ended September 30, 2025, from $49.0 million in the comparable period in 2024[177]. - Manufacturing costs for thermal barriers decreased by $7.0 million due to lower volumes and cost-cutting efforts in 2025[176]. - Research and development expenses decreased by $3.0 million, or 22%, to $10.6 million for the nine months ended September 30, 2025, from $13.6 million in the comparable period in 2024[199]. - Sales and marketing expenses decreased by $5.2 million, or 19%, to $21.9 million for the nine months ended September 30, 2025, from $27.1 million in the comparable period in 2024[201]. - General and administrative expenses decreased by $12.1 million, or 23%, to $40.4 million for the nine months ended September 30, 2025, from $52.5 million in the comparable period in 2024[203]. Cash Flow and Financing - Net cash provided by operating activities increased by $6.8 million to $16.7 million for the nine months ended September 30, 2025, compared to $9.9 million in the comparable period in 2024[220]. - Net cash used in investing activities was $35.0 million for the nine months ended September 30, 2025, compared to $71.5 million in the comparable period in 2024[221]. - Net cash used in financing activities totaled $50.6 million for the nine months ended September 30, 2025, primarily for the repayment of the Revolving Facility and Term Loan Facility[222]. - The cash and cash equivalents balance as of September 30, 2025, was $150.7 million, sufficient to support current operating requirements for at least the next twelve months[216]. - As of September 30, 2025, the company had unrestricted cash and cash equivalents of $150.7 million, primarily for working capital and capital expansion purposes[233]. Restructuring and Costs - Restructuring and demobilization costs amounted to $1.6 million for the three months ended September 30, 2025, due to a restructuring plan initiated in February 2025[184]. - Restructuring and demobilization costs for the nine months ended September 30, 2025, included severance and other personnel costs of $7.3 million[205]. - Impairment of property, plant, and equipment costs increased by $284.9 million, to $287.6 million for the nine months ended September 30, 2025, from $2.7 million in the comparable period in 2024[207]. Market and Strategic Initiatives - The company has entered into multi-year production contracts with several automotive EV OEM customers, including General Motors and Toyota, to supply thermal barriers for their EV battery systems[129]. - The company’s thermal barrier technology aims to enhance battery performance and safety in EVs by impeding thermal runaway in lithium-ion battery systems[128]. - The company is focused on expanding its market presence in the EV sector and believes in the commercial potential of its technology[228]. - The company anticipates future revenues and profit margins from its supply relationships with automotive OEMs in the EV market[228]. - The East Providence facility was converted in 2024 to support the growth of the thermal barrier program, with a flexible supply strategy in place to meet demand[135]. Tax and Regulatory - The company incurred $2.5 million in income tax expense for the nine months ended September 30, 2025, related to its maquiladora operations in Mexico[211]. - Income tax expense increased by $0.3 million, or 122%, to $0.6 million for the three months ended September 30, 2025, from $0.3 million in the comparable period in 2024[187]. Other Financial Considerations - The company does not believe inflation has had a material effect on its results of operations during the periods presented, but acknowledges potential future impacts[236]. - The company is exposed to interest rate fluctuations, but a hypothetical 100 basis point change would not have a material effect on operations[234]. - The company has $1.7 million of restricted cash to support outstanding letters of credit for commercial contracts[235]. - The company evaluates its critical accounting policies and estimates on an ongoing basis, which may impact reported financial results[226]. - Foreign currency transaction losses were $0.2 million for the nine months ended September 30, 2025, compared to $2.3 million for the same period in 2024[237].
Cerus(CERS) - 2025 Q3 - Quarterly Report
2025-11-06 22:01
Regulatory Approvals and Product Development - The INTERCEPT Blood System is intended for use with blood components and has received regulatory approvals in multiple regions, including the U.S. and Europe [123]. - The platelet system is FDA approved for ex vivo preparation of pathogen-reduced apheresis platelet components, reducing the risk of transfusion-transmitted infection [124]. - The red blood cell system is currently in development, with a CE application resubmitted in July 2025 after previous data was deemed insufficient [127]. - The ReCePI study, assessing INTERCEPT-treated red blood cells, met its primary efficacy endpoint, demonstrating non-inferiority compared to conventional red blood cells [127]. - FDA approval for the INTERCEPT Blood System for Cryoprecipitation was received in November 2020, with ongoing efforts to support blood centers in obtaining necessary licenses [129]. - The company anticipates that additional clinical trial data will be required for the red blood cell system's potential approval, delaying the planned PMA submission [127]. - The company is required to obtain new PMAs for its INTERCEPT Blood System with a new LED-based illuminator, which may limit U.S. usage if data requirements are not met [134]. Financial Performance - Product revenue for the three months ended September 30, 2025, was $52,698, a 15% increase from $46,017 in 2024, and for the nine months, it was $148,382, also a 15% increase from $129,461 in 2024 [151]. - Government contract revenue increased by 63% to $7,539 for the three months ended September 30, 2025, and by 38% to $20,837 for the nine months compared to the same periods in 2024 [152]. - Total revenue for the three months ended September 30, 2025, was $60,237, a 19% increase from $50,656 in 2024, and for the nine months, it was $169,219, a 17% increase from $144,570 in 2024 [151]. - Cost of product revenue increased by 24% to $24,558 for the three months ended September 30, 2025, and by 15% to $65,843 for the nine months compared to the same periods in 2024 [154]. - Gross margin on product sales was 53% for the three months ended September 30, 2025, down from 57% in 2024, while it remained at 56% for the nine months in both years [155]. - Research and development expenses increased by 13% to $15,825 for the three months ended September 30, 2025, and by 18% to $51,330 for the nine months compared to the same periods in 2024 [158]. - Selling, general and administrative expenses rose by 5% to $18,618 for the three months ended September 30, 2025, and by 6% to $60,086 for the nine months compared to the same periods in 2024 [161]. Funding and Capital Management - The company has two agreements with BARDA for funding, with the 2016 agreement expiring in September 2026 and the 2024 agreement expiring in September 2030 [128]. - The company has entered into agreements with blood center manufacturing partners for the sale of INTERCEPT Blood System for Cryoprecipitation kits, but sales are limited until sufficient quantities are produced [130]. - The company may borrow additional capital under existing credit agreements, which could include restrictive covenants and high effective interest rates, potentially impacting working capital [131]. - Economic uncertainty and inflationary pressures may limit the company's ability to access additional capital, negatively affecting liquidity and planned development activities [132]. - The company has entered into government contracts, including the 2016 BARDA Agreement, with a total funding commitment of up to $185.5 million for the development of the red blood cell system [144]. - The 2024 BARDA Agreement aims to advance the red blood cell system's development with committed funding of up to $32.1 million, potentially increasing to $188.4 million [145]. - The company has a five-year agreement with the FDA for the development of next-generation compounds, with a total contract value of $11.1 million [146]. - The company has an agreement with the U.S. Department of Defense, with a total contract value increased to $25.0 million for the development of pathogen-reduced, lyophilized cryoprecipitate [147]. - The company expects to continue seeking access to equity capital markets to support development efforts, which may lead to substantial dilution for existing shareholders [178]. - The company anticipates that available cash and cash equivalents will be sufficient to meet capital requirements for at least the next 12 months [176]. - The company has not sold any shares under the amended Sales Agreement allowing for the issuance of up to $96.8 million of common stock [179]. Risks and Challenges - The company faces risks related to regulatory approvals, market acceptance, and the ability to secure adequate clinical supplies for the INTERCEPT Blood System [121]. - The company faces risks related to government funding cuts and potential delays in obtaining expected funding from BARDA, which could significantly impact revenues and cash flows [180]. - The company does not currently engage in hedging contracts to mitigate foreign exchange fluctuations, which could materially affect future results [183]. Cash Flow and Working Capital - Cash and cash equivalents as of September 30, 2025, were $15,670, down from $20,266 as of December 31, 2024, while total cash, short-term investments, and restricted cash amounted to $79,651 [169]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $(1.36) million, compared to $6.43 million provided in the same period in 2024 [171]. - Net cash used in investing activities increased to $(4.79) million for the nine months ended September 30, 2025, from $(0.84) million in the same period in 2024 [172]. - Net cash provided by financing activities decreased to $1.26 million for the nine months ended September 30, 2025, down from $4.22 million in the same period in 2024 [173]. - Working capital decreased to $80.03 million as of September 30, 2025, from $88.89 million as of December 31, 2024, primarily due to increases in accounts payable and accrued liabilities [174]. - Total debt as of September 30, 2025, is $84.9 million, a slight increase from $84.2 million as of December 31, 2024 [171].