KORU Medical Systems(KRMD)
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KORU Medical Systems(KRMD) - 2024 Q1 - Quarterly Results
2024-05-01 20:01
EXHIBIT 99.1 KORU MEDICAL SYSTEMS, INC. ANNOUNCES 2024 FIRST QUARTER FINANCIAL RESULTS DELIVERING DOUBLE-DIGIT REVENUE GROWTH MAHWAH, NJ – May 1, 2024 – KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient- centric large volume subcutaneous infusion solutions, today reported financial results for the first quarter ended March 31, 2024. Recent Highlights "We are ...
KORU Medical Systems(KRMD) - 2023 Q4 - Earnings Call Transcript
2024-03-14 00:27
Financial Data and Key Metrics Changes - The company reported total net revenues of $28.5 million for the full year 2023, reflecting a 2% increase year-over-year [19][43] - The net loss for Q4 2023 was $7.5 million, compared to a net loss of $2 million in Q4 2022, while the full year net loss was $13.7 million, up from $8.7 million in 2022 [62] - The company anticipates 2024 net revenues to range between $31.2 million and $32.2 million, representing a growth of 10% to 13% [49][57] Business Line Data and Key Metrics Changes - Domestic core revenues for Q4 2023 were $5.6 million, reflecting a 5% year-over-year growth, driven by share gains and double-digit growth in infusion pump sales [41] - International core revenues increased by 8% year-over-year to $1.3 million, supported by improved Ig supply and expansion into new geographies [42] - Novel therapies revenues decreased by 62% in Q4 2023 to $200,000, primarily due to a large revenue milestone recognized in 2022 [42] Market Data and Key Metrics Changes - The overall SCIg market ended 2023 with mid- to high single-digit growth, with the company achieving approximately 6% year-over-year revenue growth [33] - Prefilled syringe penetration grew to 14% in Q4 2023, with a 2.5% increase in patients using prefilled syringes [35] - The company expects international business growth to be in the range of 15% to 20% for 2024 [58] Company Strategy and Development Direction - The company is focused on increasing domestic SCIg penetration, broadening its novel therapies pipeline, and expanding geographically as part of its Vision 26 initiative [50] - The launch of the 50 ML Hizentra prefilled syringe is expected to be a critical growth driver, with plans to increase penetration among CIDP patients [31][24] - The company aims to achieve breakeven cash flows in Q4 2024 and be cash flow positive for the full year 2025 [10][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in returning to double-digit net revenue growth in 2024, driven by increased market penetration and share gains [6][39] - The company is encouraged by the strong momentum in its core business and the novel therapies pipeline, anticipating significant growth opportunities [32][39] - Management highlighted the importance of patient preference for prefilled syringes, with 78% of patients preferring this method over traditional vial therapy [24] Other Important Information - The company closed 2023 with a cash balance of $11.5 million, representing a $700,000 cash gain for Q4 [46] - A new $10 million credit facility has been established to support strategic growth capital opportunities [11] - The company plans to present new data on patient adherence to the FREEDOM system at the upcoming NHIA conference [53] Q&A Session Summary Question: Guidance for 2024 and growth profile - Management provided insights on expected growth in domestic, international, and novel therapies, emphasizing the contribution from the Hizentra 50 ML [13][14] Question: Uptake in CIDP market - Management noted that CIDP currently accounts for about 10% of the user base and sees significant growth potential due to the convenience of prefilled syringes [69] Question: Impact of new collaborations - Management confirmed three new collaborations for 2024, with expectations for continued progress in the novel therapies pipeline [66][67] Question: Quarterly revenue and gross margin cadence - Management indicated that revenues would follow prior year patterns, with expectations for increasing revenues throughout the year [78][79] Question: Supply chain inflationary pressures - Management acknowledged ongoing inflationary pressures and anticipated some pricing increases from vendor contracts [80]
KORU Medical Systems(KRMD) - 2023 Q4 - Annual Results
2024-03-13 20:19
Exhibit 10.1 LOAN AND SECURITY AGREEMENT dated as of March 8, 2024 between KORU MEDICAL SYSTEMS, INC., as Borrower and HSBC VENTURES USA INC., as Bank This LOAN AND SECURITY AGREEMENT (this "Agreement") is dated as of March 8, 2024 (the "Effective Date") by and between KORU MEDICAL SYSTEMS, INC., a Delaware corporation ("Borrower") and HSBC VENTURES USA INC. ("Bank"), and provides the terms on which Bank shall lend to Borrower and Borrower shall repay Bank. The parties agree as follows: Section 1 Definition ...
KORU Medical Systems(KRMD) - 2023 Q4 - Annual Report
2024-03-13 20:18
PART I [Business](index=3&type=section&id=Item%201.%20Business) The company develops, manufactures, and commercializes subcutaneous infusion solutions with revenue from domestic, international, and novel therapy segments - The company's revenue is primarily derived from its mechanical infusion products, the FREEDOM Infusion Systems, used for subcutaneous drug delivery[17](index=17&type=chunk)[19](index=19&type=chunk) - A significant portion of sales is concentrated through a small number of distributors, with **five distributors accounting for approximately 74% of net revenues**[30](index=30&type=chunk) - The company relies heavily on single-source suppliers and a contract manufacturer for **approximately 80% of its consumables**[32](index=32&type=chunk)[33](index=33&type=chunk) - As of December 31, 2023, the company's intellectual property portfolio includes **15 U.S. patents and 60 foreign patents**[58](index=58&type=chunk) Research and Development Expenditure | Year | R&D Expense (USD) | | :--- | :--- | | 2023 | $5.7 million | | 2022 | $5.0 million | [Risk Factors](index=10&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant business risks from supplier and customer concentration, regulatory challenges, and stock ownership concentration [Risks Related to Our Business](index=10&type=section&id=Risks%20Related%20to%20Our%20Business) - The company's **EU device approval is at risk** following a negative recommendation from its notified body, which could materially affect revenues[96](index=96&type=chunk) - A high concentration of customers exists, with **five distributors comprising approximately 74% of net revenues** as of December 31, 2023[111](index=111&type=chunk) - The company is dependent on **single-source suppliers** for a majority of its raw materials and components, posing supply chain disruption risks[124](index=124&type=chunk) - **Compliance with the new EU Medical Device Regulation (MDR) by December 2028** is required to continue selling products in the EU[72](index=72&type=chunk)[74](index=74&type=chunk) [Risks Related to Ownership of Our Common Stock](index=23&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) - There is a significant concentration of stock ownership, with **three stockholders beneficially owning approximately 17%, 11%, and 7%**[154](index=154&type=chunk) - The company has **never paid dividends** and does not intend to in the foreseeable future[155](index=155&type=chunk) - The common stock price has been volatile, trading between **$1.82 and $12.84 per share** since its Nasdaq listing in October 2019[158](index=158&type=chunk) [Unresolved Staff Comments](index=24&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - Not applicable[166](index=166&type=chunk) [Properties](index=25&type=section&id=Item%202.%20Properties) The company's principal facility is a 43,975 square foot leased space in Mahwah, New Jersey - The company leases a 43,975 square foot facility in Mahwah, New Jersey for its headquarters and manufacturing[171](index=171&type=chunk) [Legal Proceedings](index=25&type=section&id=Item%203.%20Legal%20Proceedings) The company reports no material legal proceedings as of the filing date - None[172](index=172&type=chunk) [Mine Safety Disclosures](index=25&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations - Not applicable[173](index=173&type=chunk) PART II [Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=25&type=section&id=Item%205.%20Market%20for%20the%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "KRMD," and no cash dividends are planned - Common stock trades on the Nasdaq Capital Market under the symbol "KRMD"[175](index=175&type=chunk) - The company does not plan to pay cash dividends in the foreseeable future[175](index=175&type=chunk) [Selected Financial Data](index=25&type=section&id=Item%206.%20Selected%20Financial%20Data) This section is not applicable as the company is a smaller reporting company - Not applicable[177](index=177&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Fiscal year 2023 saw a 2.2% revenue increase to $28.5 million, an improved gross margin, but a widened net loss to $13.7 million [Results of Operations](index=26&type=section&id=Results%20of%20Operations) - The increase in net loss was primarily driven by the establishment of a **$6.0 million valuation allowance** for the non-realization of deferred tax assets[193](index=193&type=chunk) Net Revenues by Segment (FY 2023 vs. FY 2022) | Segment | 2023 (USD) | 2022 (USD) | Change (%) | | :--- | :--- | :--- | :--- | | Domestic Core | $22,446,519 | $21,205,204 | +5.9% | | International Core | $4,596,097 | $4,164,714 | +10.4% | | Novel Therapies | $1,475,050 | $2,526,119 | -41.6% | | **Total** | **$28,517,666** | **$27,896,037** | **+2.2%** | Profitability Metrics (FY 2023 vs. FY 2022) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Gross Profit | $16.7 million | $15.4 million | | Gross Margin | 58.6% | 55.1% | | Net Loss | ($13.7 million) | ($8.7 million) | [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) - The company's principal source of liquidity is cash on hand, which was **$11.5 million** as of December 31, 2023[195](index=195&type=chunk) - Management expects that cash on hand and cash flows from operations will be sufficient to meet requirements for at least the next twelve months[197](index=197&type=chunk) - Subsequent to year-end, on March 8, 2024, the company entered into a new loan and security agreement providing for a **$5 million revolving credit facility and a $5 million term loan facility**[312](index=312&type=chunk) Cash Flow Summary (FY 2023 vs. FY 2022) | Activity | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,892,553) | ($5,404,549) | | Net cash used in investing activities | ($814,597) | ($2,801,568) | | Net cash (used in)/provided by financing activities | ($218,867) | $279,485 | [Quantitative and Qualitative Disclosures about Market Risk](index=30&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable as the company is a smaller reporting company - Not applicable[221](index=221&type=chunk) [Financial Statements and Supplementary Data](index=30&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section includes audited financial statements for 2023 and 2022, with an unqualified opinion from the independent auditor - The independent auditor identified the **deferred tax valuation allowance** as a critical audit matter, noting the high degree of management judgment required in its estimation[231](index=231&type=chunk)[232](index=232&type=chunk) Key Balance Sheet Data (As of Dec 31) | Account | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $11,482,240 | $17,408,257 | | Total Current Assets | $20,255,929 | $29,801,636 | | Total Assets | $28,460,972 | $42,332,443 | | Total Current Liabilities | $4,454,278 | $6,958,940 | | Total Liabilities | $8,107,201 | $11,006,480 | | Total Stockholders' Equity | $20,353,771 | $31,325,963 | Key Statement of Operations Data (Year Ended Dec 31) | Account | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Net Revenues | $28,517,666 | $27,896,037 | | Gross Profit | $16,708,282 | $15,368,986 | | Net Operating Loss | ($10,269,979) | ($10,780,873) | | Net Loss | ($13,741,062) | ($8,661,142) | | Net Loss Per Share (Basic & Diluted) | ($0.30) | ($0.19) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosures](index=45&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosures) The company reports no changes in or disagreements with its accountants - None[316](index=316&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls, procedures, and internal control over financial reporting were effective as of December 31, 2023 - Management concluded that as of December 31, 2023, the company's **disclosure controls and procedures were effective**[317](index=317&type=chunk) - Based on the COSO framework, management determined that the company maintained **effective internal control over financial reporting** as of December 31, 2023[321](index=321&type=chunk) [Other Information](index=46&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[323](index=323&type=chunk) PART III [Directors, Executive Officers, Corporate Governance, Executive Compensation, and Other Matters](index=46&type=section&id=Items%2010-14) Required information for Items 10-14 is incorporated by reference from the company's 2024 proxy statement - Information regarding Directors, Executive Officers, Corporate Governance (Item 10), Executive Compensation (Item 11), Security Ownership (Item 12), Certain Relationships and Related Transactions (Item 13), and Principal Accountant Fees and Services (Item 14) is incorporated by reference from the registrant's 2024 proxy statement[326](index=326&type=chunk)[327](index=327&type=chunk)[328](index=328&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=46&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the Form 10-K, including material contracts and certifications - All financial statement schedules have been omitted as they are not required or applicable[332](index=332&type=chunk) - The report includes a list of filed exhibits, including corporate governance documents, material agreements, and Sarbanes-Oxley certifications[334](index=334&type=chunk)[335](index=335&type=chunk)[336](index=336&type=chunk) [Form 10-K Summary](index=48&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for Form 10-K - None[338](index=338&type=chunk)
KORU Medical Systems(KRMD) - 2023 Q3 - Earnings Call Transcript
2023-11-09 01:12
KORU Medical Systems, Inc. (NASDAQ:KRMD) Q3 2023 Earnings Conference Call November 8, 2023 4:30 PM ET Company Participants Linda Tharby - Chief Executive Officer and President, Director Tom Adams - Chief Medical Officer Conference Call Participants Caitlin Cronin - Canaccord Genuity Joseph Downing - Piper Sandler Frank Takkinen - Lake Street Capital Operator Good day. And welcome to the KORU Medical Systems Third Quarter 2023 Earnings Call. All participants will be in listen-only mode. [Operator Instruction ...
KORU Medical Systems(KRMD) - 2023 Q3 - Earnings Call Presentation
2023-11-08 22:30
6 • Freedom60 with PFS is preferred by 78% of patients • 70% of patients are on >50 mL 15 Total Collaborations | +1/-1 in Q3 2023 $2.5B TAM(1) | 2M(2) Global Patient Population 2025 7 8 9 Submitted for regulatory approval 10 Back Order $0.3 $7.8 $7.0 (10%) $5.9 $5.8 $1.1 $1.1 $0.2 $0.8 Q3 2022 Q3 2023 Novel Therapies International Core • Decreased 2% y/y, +6% YTD • Lower consumable volumes as compared to prior year when a $0.3M backorder was cleared. • Outpaced U.S. Rx script declines driven by increased vo ...
KORU Medical Systems(KRMD) - 2023 Q3 - Quarterly Report
2023-11-08 21:06
FORM 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 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: 0-12305 KORU MEDICAL SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 13-30 ...
KORU Medical Systems(KRMD) - 2023 Q2 - Quarterly Report
2023-08-09 20:20
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 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: 0-12305 KORU MEDICAL SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 13-3044880 ...
KORU Medical Systems(KRMD) - 2023 Q1 - Earnings Call Transcript
2023-05-07 11:42
KORU Medical Systems, Inc. (NASDAQ:KRMD) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants Gregory Chodaczek - Gilmartin Group Linda Tharby - President, CEO & Director Thomas Adams - Interim CFO, Secretary & Treasurer Conference Call Participants Jason Bednar - Piper Sandler & Co. Alexander Nowak - Craig-Hallum Operator Greetings, and welcome to the KORU Medical Systems First Quarter 2023 Earnings Call. During the presentation, all participants will be in a listen-only mode. After ...
KORU Medical Systems(KRMD) - 2023 Q1 - Quarterly Report
2023-05-04 20:15
PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=2&type=section&id=ITEM%201.%20Financial%20Statements%20(Unaudited)) KORU Medical Systems reported Q1 2023 revenue of $7.4 million, a net loss of $2.4 million, decreased total assets, and increased cash used in operations [Balance Sheets](index=2&type=section&id=Balance%20Sheets) Total assets decreased to $38.3 million as of March 31, 2023, driven by reduced cash, with corresponding declines in liabilities and equity Balance Sheet Summary (Unaudited) | Balance Sheet Items | March 31, 2023 (USD) | December 31, 2022 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $12,224,865 | $17,408,257 | | Total Current Assets | $25,214,658 | $29,801,636 | | Total Assets | $38,253,980 | $42,332,443 | | **Liabilities & Equity** | | | | Total Current Liabilities | $4,524,217 | $6,958,940 | | Total Liabilities | $8,457,680 | $11,006,480 | | Total Stockholders' Equity | $29,796,300 | $31,325,963 | [Statements of Operations](index=3&type=section&id=Statements%20of%20Operations) Q1 2023 net sales grew 18.4% to $7.4 million, gross profit increased, but gross margin slightly declined, resulting in a narrowed net loss of $2.4 million Statements of Operations Summary (Unaudited) | Metric | Three Months Ended March 31, 2023 (USD) | Three Months Ended March 31, 2022 (USD) | | :--- | :--- | :--- | | Net Sales | $7,392,605 | $6,244,330 | | Gross Profit | $4,147,035 | $3,622,305 | | Total Operating Expenses | $7,203,863 | $6,748,820 | | Net Operating Loss | ($3,056,828) | ($3,126,515) | | Net Loss | ($2,410,885) | ($2,537,514) | | Net Loss Per Share (Basic & Diluted) | ($0.05) | ($0.06) | [Statements of Cash Flows](index=4&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $4.7 million in Q1 2023, leading to a $5.2 million net decrease in cash and equivalents Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2023 (USD) | Three Months Ended March 31, 2022 (USD) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($4,660,583) | ($1,752,072) | | Net Cash Used in Investing Activities | ($283,837) | ($752,602) | | Net Cash Used in Financing Activities | ($238,972) | ($252,968) | | Net Decrease in Cash | ($5,183,392) | ($2,757,642) | | Cash and Cash Equivalents, End of Period | $12,224,865 | $22,577,247 | [Statements of Stockholders' Equity](index=5&type=section&id=Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased to $29.8 million by March 31, 2023, primarily due to the net loss, partially offset by stock-based compensation - Stockholders' equity decreased by approximately **$1.5 million** during the quarter, from **$31,325,963** to **$29,796,300**[17](index=17&type=chunk) - The primary reason for the decrease in equity was the net loss of **$2,410,885**[17](index=17&type=chunk) [Notes to Financial Statements](index=6&type=section&id=Notes%20to%20Financial%20Statements) The notes detail accounting policies, revenue recognition, stock-based compensation, debt obligations, and comprehensive lease liabilities - The company's revenues are derived from three sources: domestic core, international core, and novel therapies. For Q1 2023, domestic sales constituted **85% of total revenues**, consistent with Q1 2022[36](index=36&type=chunk)[41](index=41&type=chunk) - As of March 31, 2023, the company had **$3.9 million** in total unrecognized compensation cost related to its 2015 stock option plan, expected to be recognized over a weighted-average period of **45 months**[59](index=59&type=chunk) - The company has a **$3.5 million** revolving line of credit with Keybank, with no amount outstanding as of March 31, 2023. The maturity date is **June 1, 2023**[67](index=67&type=chunk) Lease Liabilities as of March 31, 2023 | Lease Type | Total Lease Liabilities (USD) | Weighted Avg. Remaining Term | | :--- | :--- | :--- | | Operating Leases | $3,913,923 | 9.4 Years | | Finance Leases | $468,538 | 4.3 Years | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reported an 18.4% revenue increase to $7.4 million, with slight gross margin decline, increased R&D, and sufficient liquidity for the next 12 months [Overview](index=16&type=section&id=Overview) The company develops medical devices for subcutaneous drug delivery, reporting 18.4% net revenue growth in Q1 2023 and completing key manufacturing and facility transitions - Q1 2023 net revenues increased by **18.4%** to **$7.4 million** compared to **$6.2 million** in Q1 2022, with growth in all three business sources[79](index=79&type=chunk) - Completed the transition of finished goods manufacturing of needle and tubing sets to Command Medical Products, a third-party contract manufacturer[77](index=77&type=chunk) - Completed the move of its corporate headquarters and manufacturing facility to Mahwah, NJ during the first quarter of 2023[78](index=78&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Total net revenues increased by 18.4% in Q1 2023 across all segments, but gross margin declined to 56.1% due to higher costs, leading to a narrowed net loss of $2.4 million Net Revenues Breakdown (Q1 2023 vs Q1 2022) | Revenue Source | Q1 2023 (USD) | Q1 2022 (USD) | Change (%) | | :--- | :--- | :--- | :--- | | Domestic Core | $5,719,135 | $4,993,536 | +14.5% | | International Core | $1,097,490 | $894,942 | +22.6% | | Novel Therapies | $575,980 | $355,852 | +61.9% | | **Total** | **$7,392,605** | **$6,244,330** | **+18.4%** | - Gross profit as a percentage of revenues decreased to **56.1%** in Q1 2023 from **58.0%** in Q1 2022, primarily due to higher manufacturing costs for labor and materials[83](index=83&type=chunk) - Research and development expenses increased by **36.3%** (**$0.4 million**) due to new hires to support innovation efforts[84](index=84&type=chunk)[86](index=86&type=chunk) [Liquidity and Capital Resources](index=18&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is primarily cash on hand, totaling $12.2 million, with management expecting sufficient resources for at least the next 12 months - The company's cash on hand was **$12.2 million** as of March 31, 2023[89](index=89&type=chunk) - Inventory increased by **$0.2 million** to **$6.6 million** at March 31, 2023, with an expectation to significantly reduce this position during the remainder of 2023[90](index=90&type=chunk) - Management expects that current cash, cash flows from operations, and available financing will be sufficient to meet requirements at least through **March 31, 2024**[92](index=92&type=chunk) [Cash Flows](index=19&type=section&id=Cash%20Flows) Net cash used in operating activities was $4.7 million in Q1 2023, primarily due to net loss and unfavorable working capital changes, with investing and financing also using cash Cash Flow Summary (Three Months Ended March 31) | Cash Flow Activity | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,660,583) | ($1,752,072) | | Net cash used in investing activities | ($283,837) | ($752,602) | | Net cash used in financing activities | ($238,972) | ($252,968) | - The **$4.7 million** use of cash in operations in Q1 2023 was primarily due to the **$2.4 million** net loss and working capital changes, including a **$1.3 million** decrease in accrued expenses and a **$0.9 million** decrease in accounts payable[95](index=95&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=20&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has indicated that this section is not applicable for the reporting period - The company stated that there are no applicable quantitative and qualitative disclosures about market risk for this period[100](index=100&type=chunk) [Controls and Procedures](index=20&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of **March 31, 2023**[101](index=101&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the first quarter of 2023[102](index=102&type=chunk) PART II. OTHER INFORMATION [Risk Factors](index=21&type=section&id=ITEM%201A.%20Risk%20Factors) The company highlights a risk related to bank failures and financial institution instability, as its cash deposits exceed FDIC insurance limits - A key risk factor is the potential impact of bank failures, as the company's cash deposits exceed FDIC insurance limits[105](index=105&type=chunk) - A failure of a financial institution holding the company's funds could disrupt access to cash, adversely impact liquidity, and limit the ability to pay vendors[105](index=105&type=chunk) [Exhibits](index=21&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO/CFO certifications and Inline XBRL documents - The report includes CEO and CFO certifications as required by the Sarbanes-Oxley Act[106](index=106&type=chunk) - Interactive data files (Inline XBRL documents) are also included as exhibits[106](index=106&type=chunk)