KORU Medical Systems(KRMD)
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KORU Medical Systems(KRMD) - 2020 Q1 - Earnings Call Transcript
2020-05-10 08:19
Financial Data and Key Metrics Changes - Net sales increased by 27% to $6.3 million in Q1 2020 from $5 million in Q1 2019, driven by higher utilization of products by PIDD patients and expansion of HIZENTRA into CIDP [25] - Gross profit rose by 24% to $3.8 million in Q1 2020 from $3.1 million in Q1 2019, primarily due to increased sales volume [26] - Net income for Q1 2020 was $449,000, a turnaround of over $500,000 from a net loss of $85,000 in Q1 2019 [28] - Adjusted EBITDA improved by 38% to $1.3 million in Q1 2020 from $900,000 in Q1 2019 [28] Business Line Data and Key Metrics Changes - The increase in net sales for Q1 2020 reflected growth across infusion product lines and increased clinical trial sales compared to Q1 2019 [25][26] - The decline in gross margin was attributed to a noncash $100,000 charge related to the discontinuation of the Rescue VAC product line [26][18] Market Data and Key Metrics Changes - The company experienced higher demand for its products due to reactive purchasing associated with COVID-19, with minimal impact on production, inventory, supply chain, or distribution [11][12] - Plasma collection efforts are continuing despite COVID-19, with expectations of a ramp-up in collection activities as guidelines permit [15] Company Strategy and Development Direction - The company aims for a $50 million run rate by year-end 2022, improving operating efficiencies to achieve a gross margin of over 70% and generating over 20% organic revenue growth annually [20] - The focus remains on penetrating primary end markets, increasing clinical trial revenue, and solidifying contractual positions with key customers [20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the economic uncertainty due to COVID-19 but expressed confidence in the strong underlying demand for products [50] - The company believes that COVID-19 has highlighted the benefits of home healthcare, which may lead to increased conversations surrounding at-home infusion therapies [16] Other Important Information - The company ended Q1 2020 with $7.4 million in cash, a $1.6 million increase from the previous quarter, primarily due to a drawdown on the line of credit [29] - The company has not experienced significant slowdowns in customer payments to date, maintaining good liquidity and financial flexibility [31] Q&A Session Summary Question: Is the shift from IV to subcutaneous therapy a temporary benefit due to COVID-19 or a longer-term trend? - Management confirmed that the movement from IV to subcutaneous therapy is real, active, and sustainable, with COVID-19 amplifying this trend [37] Question: How did the business perform in April and what are the expectations for Q2? - Management noted increased demand in April attributed to COVID-19 and anticipated a strong tailwind from the shift to subcutaneous therapy [40] Question: How is the launch of Xembify progressing compared to HIZENTRA? - Management indicated that the launch of Xembify has been relatively slow but is starting to gain momentum [42] Question: Should there be more announcements or data releases from pharma companies throughout 2020? - Management expects commercialization of a successful hematology trial within the next 12 months and will share updates as they become available [44] Question: What is driving the decline in gross margins and when should this pressure moderate? - Management attributed the decline to increased production pressures and investments in manufacturing efficiency, with a focus on cost reduction going forward [45]
KORU Medical Systems(KRMD) - 2020 Q1 - Quarterly Report
2020-05-06 20:32
PART I [PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported strong Q1 2020 financial performance with increased net sales, a shift from net loss to net income, and positive operating cash flow, supported by asset growth [Balance Sheets](index=3&type=section&id=Balance%20Sheets) Total assets increased to **$16.6 million** as of March 31, 2020, driven by higher cash and inventory, while liabilities rose due to a new line of credit Balance Sheet Summary (Unaudited) | Account | March 31, 2020 ($) | December 31, 2019 ($) | | :--- | :--- | :--- | | **Total Current Assets** | $14,479,830 | $11,881,323 | | Cash and cash equivalents | $7,427,679 | $5,870,929 | | **Total Assets** | **$16,603,099** | **$13,881,861** | | **Total Current Liabilities** | $4,267,683 | $2,406,289 | | Line of credit payable | $1,500,000 | $0 | | **Total Liabilities** | **$4,471,123** | **$2,645,781** | | **Total Stockholders' Equity** | **$12,131,976** | **$11,236,080** | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) Net sales increased by **27.3%** to **$6.3 million** in Q1 2020, leading to a net income of **$449,428**, a significant improvement from a prior-year net loss Statement of Operations Highlights (Unaudited) | Metric | Three Months Ended Mar 31, 2020 ($) | Three Months Ended Mar 31, 2019 ($) | | :--- | :--- | :--- | | **Net Sales** | **$6,330,009** | **$4,974,278** | | Gross Profit | $3,788,210 | $3,047,954 | | Total Operating Expenses | $3,205,387 | $3,162,993 | | Net Operating Profit/(Loss) | $582,823 | ($115,039) | | **Net Income/(Loss)** | **$449,428** | **($85,390)** | | Diluted EPS | $0.01 | $0.00 | [Statements of Cash Flows](index=5&type=section&id=Statements%20of%20Cash%20Flows) Operating activities generated **$153,236** in cash for Q1 2020, a significant improvement, with overall cash and cash equivalents increasing to **$7.4 million** primarily due to financing activities Cash Flow Summary (Unaudited) | Activity | Three Months Ended Mar 31, 2020 ($) | Three Months Ended Mar 31, 2019 ($) | | :--- | :--- | :--- | | Net Cash Provided By/(Used In) Operating Activities | $153,236 | ($1,045,233) | | Net Cash Used In Investing Activities | ($180,138) | ($96,833) | | Net Cash Provided By/(Used In) Financing Activities | $1,583,652 | ($3,848) | | **Net Increase/(Decrease) in Cash** | **$1,556,750** | **($1,145,914)** | | **Cash and Cash Equivalents, End of Period** | **$7,427,679** | **$2,592,889** | [Notes to Financial Statements](index=6&type=section&id=Notes%20to%20Financial%20Statements) Notes to financial statements detail accounting policies, ongoing litigation, and significant post-quarter financing activities, including an expanded credit line and a favorable legal ruling - The company designs, manufactures, and markets proprietary portable medical devices for the ambulatory infusion market under FDA and international quality standards[14](index=14&type=chunk) - The company is involved in several ongoing lawsuits with its principal competitor, EMED Technologies Corporation, concerning patent infringement and other claims. The company believes it has meritorious defenses but notes that a negative outcome could have a material adverse effect[41](index=41&type=chunk)[51](index=51&type=chunk) - Subsequent to the quarter end, the company secured additional liquidity by extending its line of credit to **$3.5 million**, obtaining a **$1.48 million** PPP loan, and entering a **$2.5 million** equipment financing agreement[69](index=69&type=chunk)[71](index=71&type=chunk)[73](index=73&type=chunk) - On April 9, 2020, the U.S. Court of Appeals affirmed a summary judgment of non-infringement in favor of KORU Medical in a patent case brought by EMED[74](index=74&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the **27.3%** Q1 2020 revenue growth driven by market expansion, improved net income, and strategic liquidity actions taken in response to COVID-19 uncertainty [Overview and Recent Developments](index=16&type=section&id=Overview%20and%20Recent%20Developments) Q1 2020 net sales grew **27.3%** to **$6.3 million** driven by core market expansion, with the company proactively securing additional liquidity in response to COVID-19 - Q1 2020 net sales grew **27.3%** to **$6.3 million**, driven by higher sales volume in needle sets, tubing, and pumps, linked to growth in PIDD diagnosis and expansion into the neurology (CIDP) market[82](index=82&type=chunk) - In response to COVID-19 uncertainty, the company drew **$1.5 million** from its line of credit in March 2020[81](index=81&type=chunk) - Post-quarter, the company extended its line of credit to **$3.5 million** and secured a **$1.5 million** PPP loan under the CARES Act[86](index=86&type=chunk)[87](index=87&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Q1 2020 net sales increased **27.3%** to **$6.3 million**, driven by strong domestic growth, while a reduction in litigation expenses contributed to a net income of **$0.4 million** Net Sales Breakdown (Q1 2020 vs Q1 2019) | Region | Q1 2020 Sales ($) | Q1 2019 Sales ($) | Change (%) | | :--- | :--- | :--- | :--- | | Domestic | $5,340,866 | $3,883,565 | +37.5% | | International | $989,143 | $1,090,713 | -9.3% | | **Total** | **$6,330,009** | **$4,974,278** | **+27.3%** | - Gross margin declined from **61.3%** to **59.9%** YoY, primarily due to an obsolescence reserve for a discontinued product line and increased overtime, partially offset by price increases[89](index=89&type=chunk) - Litigation fees decreased by **$0.4 million** (**-79.9%**) YoY, while R&D expenses increased by **$0.2 million** (**+151.1%**) due to higher headcount for development initiatives[92](index=92&type=chunk)[93](index=93&type=chunk) - Net income for Q1 2020 was **$449,428**, compared to a net loss of **$85,390** in Q1 2019[95](index=95&type=chunk) [Liquidity and Capital Resources](index=18&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintained **$7.4 million** in cash as of March 31, 2020, with management confident in sufficient liquidity for the next 12 months, supported by positive operating cash flow - The company's principal source of liquidity is **$7.4 million** cash on hand as of March 31, 2020, which includes a **$1.5 million** draw against its line of credit[96](index=96&type=chunk) - Management believes current cash and expected cash from operations are sufficient to fund operations, R&D, and capital expenditures for the next 12 months[98](index=98&type=chunk) Cash Flow Summary (Q1 2020 vs Q1 2019) | Cash Flow Activity | Three Months Ended Mar 31, 2020 ($) | Three Months Ended Mar 31, 2019 ($) | | :--- | :--- | :--- | | Net cash provided by/(used in) operating activities | $153,236 | ($1,045,233) | | Net cash used in by investing activities | ($180,138) | ($96,833) | | Net cash provided by/(used in) financing activities | $1,583,652 | ($3,848) | [Non-GAAP Financial Measures](index=20&type=section&id=Non-GAAP%20Financial%20Measures) The company utilizes Adjusted EBITDA as a non-GAAP measure, which increased to **$1.3 million** in Q1 2020, reflecting adjustments for various non-operating expenses Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA | Reconciliation Item | Three Months Ended Mar 31, 2020 ($) | Three Months Ended Mar 31, 2019 ($) | | :--- | :--- | :--- | | GAAP Net Income/(Loss) | $449,428 | ($85,390) | | Tax Expense/(Benefit) | $141,928 | ($22,099) | | Depreciation/Amortization | $87,224 | $83,651 | | Litigation Expenses | $99,158 | $492,515 | | Stock Compensation Expense | $300,966 | $121,875 | | Other Adjustments | $190,331 | $337,446 | | **Non-GAAP Adjusted EBITDA** | **$1,279,035** | **$927,998** | - Management uses Adjusted EBITDA as a supplemental measure for internal planning, forecasting, and evaluating performance for incentive compensation[110](index=110&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has indicated that disclosures regarding quantitative and qualitative market risk are not applicable - The company has indicated that Quantitative and Qualitative Disclosures About Market Risk are not applicable[117](index=117&type=chunk) [Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2020, with no material changes to internal control over financial reporting - Management concluded that as of the end of the reporting period, the Company's disclosure controls and procedures were effective[118](index=118&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2020, that have materially affected, or are reasonably likely to materially affect, these controls[119](index=119&type=chunk) PART II [PART II – OTHER INFORMATION](index=22&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in complex, ongoing legal proceedings with its main competitor, EMED, concerning patent infringement and other claims, with uncertain outcomes despite some favorable rulings - The company is involved in several lawsuits with its principal competitor, EMED Technologies Corporation, concerning patent infringement, antitrust violations, and other business tort claims[120](index=120&type=chunk) - The company is vigorously defending against all claims and believes it has meritorious defenses, but the outcomes cannot be predicted with certainty and could have a material adverse effect on the business[131](index=131&type=chunk) - A recent development includes a unanimous decision on April 9, 2020, by the Court of Appeals for the Federal Circuit (CAFC) affirming a district court's judgment of non-infringement in favor of KORU Medical[128](index=128&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) A material new risk factor is the uncertainty related to the COVID-19 pandemic, which could severely impact future operations and financial condition through various disruptions - A material new risk factor is the uncertainty related to the COVID-19 pandemic[132](index=132&type=chunk)[133](index=133&type=chunk) - Potential impacts from COVID-19 include disruptions to employees, suppliers, business operations, and the availability of drugs administered by the company's products, which could severely impact financial results[133](index=133&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q1 2020, the company issued common stock to non-employee directors and facilitated the exercise of options by its COO, all under registration exemptions - The company issued **9,189 shares** of common stock to non-employee directors as compensation during the three-month period ended March 31, 2020[134](index=134&type=chunk) - On January 7, 2020, the company's COO, Manuel Marques, exercised options for **175,000 shares** of common stock for an aggregate exercise price of **$85,500**[135](index=135&type=chunk) [Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including required certifications by executive officers and Interactive Data Files for financial statements - Exhibits filed include CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[138](index=138&type=chunk) - Exhibit 101 contains the Interactive Data Files (XBRL) for the financial statements and notes[137](index=137&type=chunk)[138](index=138&type=chunk)
KORU Medical Systems(KRMD) - 2020 Q1 - Earnings Call Presentation
2020-05-05 21:55
Q1 2020 Financial Results May 5, 2020 Nasdaq: KRMD DISCLAIMER / NON-GAAP MEASURES This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "expect", "plan," "goal," "seek," "vision, "confident," "future," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make rega ...
KORU Medical Systems(KRMD) - 2019 Q4 - Annual Report
2020-03-04 21:57
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 0-12305 REPRO MED SYSTEMS, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (IRS Employer Identification No.) ...
KORU Medical Systems(KRMD) - 2019 Q4 - Earnings Call Transcript
2020-02-26 19:26
KORU Medical Systems (NASDAQ:KRMD) Q4 2019 Earnings Conference Call February 26, 2020 9:00 AM ET Company Participants Devin Sullivan - SVP, Equity Group Don Pettigrew - President and CEO Karen Fisher - CFO Conference Call Participants Alex Nowak - Craig-Hallum Capital Group Andrew DeSilva - B. Riley FBR Operator Greetings and welcome to the KORU Medical Systems Fourth Quarter and Full Year 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and- ...
KORU Medical Systems(KRMD) - 2019 Q4 - Earnings Call Presentation
2020-02-26 14:55
NOT CALS TEMS | TM Q4 and FY 2019 CONFERENCE CALL February 26, 2020 Nasdaq: KRMD DISCLAIMER / NON-GAAP MEASURES This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "plan," "goal," "seek," "vision, "confident," "future," "will" and similar references to future periods. Examples of forward-looking statements include, among others, sta ...
KORU Medical Systems(KRMD) - 2019 Q3 - Earnings Call Transcript
2019-11-11 01:43
KORU Medical Systems (NASDAQ:KRMD) Q3 2019 Earnings Conference Call November 6, 2019 9:00 AM ET CompanyParticipants Devin Sullivan - SVP, Equity Group Don Pettigrew - President & CEO Karen Fisher - CFO Conference Call Participants Alex Nowak - Craig-Hallum Operator Greetings and welcome to the KORU Medical Systems Reports Third Quarter 2019 Financial Results Conference Call. [Operator Instructions] It is now my pleasure to introduce your host, Devin Sullivan, Senior Vice President of The Equity Group. Thank ...
KORU Medical Systems(KRMD) - 2019 Q3 - Earnings Call Presentation
2019-11-07 17:18
Q3 2019 CONFERENCE CALL November 6, 2019 Nasdaq: KRMD DISCLAIMER / NON-GAAP MEASURES This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "plan," "goal," "seek," "vision, "confident," "future," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding o ...
KORU Medical Systems(KRMD) - 2019 Q3 - Quarterly Report
2019-11-06 21:22
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 September 30, 2019 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 REPRO MED SYSTEMS, INC. (Exact name of registrant as specified in its charter) New York 13-30448 ...
Repro Med Systems (REPR) Presents At 4th Annual Dougherty & Company Institutional Investor Conference - Slideshow
2019-09-11 17:02
HIgHoFlo Super26" Subcutaneous Safety Needle Sets INVESTOR PRESENTATION Dougherty & Co. Institutional Investor Conference September 2019 OTCQX: REPR INVESTOR PRESENTATION JUNE 26, 2019 Home and Specialty Infusion Products that Improve the Patient Experience DISCLAIMER & NON-GAAP MEASURES OTCQX: REPR This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified ...