KORU Medical Systems, Inc. (KRMD) FY 2024 MD&A
This page reproduces the company's own Item 7 MD&A text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and
results of operations should be read together with our consolidated financial statements and related notes included under ITEM 8 of this
Annual Report on Form 10-K. This discussion contains forward-looking statements about our business and operations. Our actual
results may differ materially from those we currently anticipate as a result of many factors, including those described under Part I –
FORWARD LOOKING STATEMENTS and elsewhere in this Annual Report.
OVERVIEW
The Company develops, manufactures and commercializes innovative patient-centric
large volume subcutaneous solutions primarily for the subcutaneous drug delivery market as governed by the United States Food and Drug
Administration (the “FDA”) quality and regulatory system and international standards for quality system management.
Our revenues derive from three business sources: (i) domestic core (which
consists of US and Canada), (ii) international core, and (iii) novel therapies. Our domestic core and international core revenues
consist of sales of our products for the delivery of subcutaneous drugs that are FDA cleared for use with the FREEDOM Infusion System,
with the primary delivery for immunoglobulin to treat Primary Immunodeficiency Diseases (“PIDD”) and Chronic Inflammatory
Demyelinating Polyneuropathy (“CIDP”). Novel therapies revenues consist of product revenues from our infusion system (syringe
drivers, tubing and needles) for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical
companies in the drug development process as well as non-recurring engineering services revenues (“NRE”) received from biopharmaceutical
companies to ready or customize the FREEDOM System for clinical and commercial use.
The Company ended the 2024 fiscal year with $33.6 million in net revenues,
an 18.0% increase compared with $28.5 million in the same period last year driven by growth in our core domestic and international business
of 12.3% and 31.5% respectively, and further driven by a 61.9% increase in our novel therapies business.
Gross profit, for the year ended December 31, 2024, was $21.3 million,
an increase of 27.7% or $4.6 million from the same period last year. Gross margin was 63.4% for the year ended December 31, 2024, an increase
from 58.6% from the prior year. We define gross margin as gross profit stated as a percentage of net revenues.
Operating expenses for the year ended December 31, 2024, were $27.8 million,
up from $27.0 million for the same period last year.
RESULTS OF OPERATIONS
Year Ended December 31, 2024 compared to Year Ended December 31, 2023
Net Revenues
The following table summarizes our net revenues for the years ended December
31, 2024 and 2023:
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| Years Ended December 31, | Change from Prior Year | % of Net Revenues | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | $ | % | 2024 | 2023 | ||||||||||
| Net Revenues | |||||||||||||||
| Domestic Core | $ | 25,214,613 | $ | 22,446,519 | $ | 2,768,094 | 12.3% | 74.9% | 78.7% | ||||||
| International Core | 6,043,979 | 4,596,097 | 1,447,882 | 31.5% | 18.0% | 16.1% | |||||||||
| Total Core | 31,258,592 | 27,042,616 | 4,215,976 | 15.6% | 92.9% | 94.8% | |||||||||
| Novel Therapies | 2,387,871 | 1,475,050 | 912,821 | 61.9% | 7.1% | 5.2% | |||||||||
| Total | $ | 33,646,463 | $ | 28,517,666 | $ | 5,128,797 | 18.0% | 100% | 100% |
Total net revenues increased $5.1 million, or 18.0%, to $33.6 million,
for the year ended December 31, 2024, as compared with the same period last year. Domestic core growth of 12.3% was primarily driven by
volume growth in pumps and consumables attributed to overall SCIg market growth and new account share gains. International core growth
of 31.5% was driven by overall SCIg market growth, increased penetration in several established EU markets, and the entry into multiple
new geographic markets. Novel therapies net revenues increased $0.9 million, or 61.9%, driven primarily by an increase in NRE collaborations
and an increase in clinical trial supply shipments when compared to the prior year.
Gross Profit
Our gross profit for the years ended December 31, 2024, and 2023 is as
follows:
| Years Ended December 31, | Change from Prior Year | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | $ | % | ||||||||
| Gross Profit | $ | 21,331,858 | $ | 16,708,282 | $ | 4,623,576 | 27.7% | ||||
| Gross Margin | 63.4% | 58.6% |
Gross profit increased $4.6 million, or 27.7%, to $21.3 million, in the
year ended December 31, 2024, compared to the same period in 2023 driven by the increase in net revenues of $5.1 million coupled with
significant gross margin improvement. Gross margin increased to 63.4% in the year ended 2024 compared to 58.6% for the year ended 2023,
primarily driven by increased manufacturing productivity, improved margin on product revenue mix, and increases in average selling prices
versus the prior year.
Operating Expenses
Our selling, general and administrative, research and development and depreciation
and amortization expenses for the years ended December 31, 2024, and 2023 are as follows:
| Years Ended December 31, | Change from Prior Year | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | $ | % | ||||||||
| Selling, general and administrative | $ | 21,631,674 | $ | 20,365,617 | $ | 1,266,057 | 6.2% | ||||
| Research and development | 5,257,942 | 5,742,254 | (484,312 | ) | (8.4)% | ||||||
| Depreciation and amortization | 888,473 | 870,390 | 18,083 | 2.1% | |||||||
| Total Operating Expense | $ | 27,778,089 | $ | 26,978,261 | $ | 799,828 | 3.0% |
Selling, general and administrative expenses increased $1.3 million, or
6.2%, to $21.6 million, during the year ended December 31, 2024 compared with the same period last year, primarily due to a $1.7 million
increase in compensation and benefits-related bonus accrual and sales commission related to year over year company performance, partially
offset by lower recruiting expenses and liability insurance costs.
Research and development expenses decreased $0.5 million, or 8.4%, to $5.3
million, during the year ended December 31, 2024 compared with the same period last year, primarily due to lower overall project spend
driven by timing, partially offset by CTO severance costs and an increase in compensation and benefits-related bonus accrual related to
year over year company performance.
Depreciation and amortization expense remained flat at $0.9 million during
the year ended December 31, 2024, as compared to $0.9 million during the same period in 2023, primarily driven by capital spending related
to projects.
Net Loss
| Years Ended December 31, | Change from Prior Year | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | $ | % | ||||||||
| Net Loss | $ | (6,066,633 | ) | $ | (13,741,062 | ) | $ | 7,674,429 | 55.9% |
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Our net loss decreased $7.7 million in the year ended December 31, 2024
compared with the same period last year, mostly driven by lower net operating losses of $3.8 million as a result of our gross profit improvement
of 27.7%, and an operating expense increase of 3%. In the prior year we established an allowance for the non-realization of deferred tax
assets which reversed a tax benefit of $4.0 million, partially offsetting in the current year was lower interest income of $0.1 million
driven by a lower cash balance coupled with lower yields.
LIQUIDITY AND CAPITAL RESOURCES
Our principal source of liquidity is our cash on hand of $9.6 million as
of December 31, 2024. Our principal source of operating cash inflows is from sales of our products in our core business, NRE services,
and clinical trial products to our customers. Our principal cash outflows relate to the purchase and production of inventory, funding
of research and development, and selling, general and administrative expenses. To develop new products, support future growth, achieve
operating efficiencies, and maintain product quality, we are continuing to invest in research and development, innovation, and equipment.
Operating expenses for the 2024 fiscal year were $27.8 million.
Our inventory position was $2.8 million at December 31, 2024, which reflects
a decrease of $0.7 million from December 31, 2023.
We expect that our cash on hand and cash flows from operations will
be sufficient to meet our requirements at least through the next twelve months. Continued execution on our longer-term strategic
plan may require the Company to draw on our credit facility, take on additional debt, raise capital through issuance of equity, or a
combination. Our future capital requirements may vary from those currently planned and will depend on many factors, including our
rate of sales growth, the timing and extent of spending on various strategic initiatives including research and development, our
international expansion, the timing of new product introductions, market acceptance of our solutions, and overall economic
conditions including inflation and the potential impact of global supply imbalances on the global financial markets. To the extent
that current and anticipated future sources of liquidity are or are expected to be insufficient to fund our future business
activities and requirements, we may be required to draw on our new credit facility or seek additional equity or debt financing
sooner. There can be no assurance the Company will be able to obtain the financing or raise the capital required to fund its
operations or planned expansion.
Cash Flows
The following table summarizes our cash flows:
| Year Ended December 31, 2024 | Year Ended December 31, 2023 | ||||||
|---|---|---|---|---|---|---|---|
| Net cash used in operating activities | $ | (319,718 | ) | $ | (4,892,553 | ) | |
| Net cash used in investing activities | $ | (1,333,042 | ) | $ | (814,597 | ) | |
| Net cash used in financing activities | $ | (248,533 | ) | $ | (218,867 | ) |
Operating Activities
Net cash used in operating activities was $0.3 million for the year ended
December 31, 2024. This net cash usage was primarily due to the net loss of $6.1 million, offset by a $2.6 million increase in accrued
expenses for 2024 bonuses and payroll, $0.7 million in lower inventories, and $0.7 million in increased accounts payable, partially offset
by a higher accounts receivable balance of $1.7 million, and $0.2 million of changes in other liabilities, prepaids, and other assets.
Further contributing to this change were non-cash items of $3.8 million
including stock-based compensation expense of $2.6 million, depreciation and amortization expense of $0.9 million, and $0.3 million for
non-cash leasing charges and losses on disposals of fixed assets.
Net cash used in operating activities of $4.9 million for the year ended
December 31, 2023 was primarily due to the net loss of $13.7 million, plus cash flows used to reduce accrued expenses of $1.2 million
primarily from the payment of 2023 employee bonuses, and a decrease in accounts payable of $1.4 million. Partially offsetting these increases
were cash flows generated from a decrease in inventory of $2.9 million, a decrease in accounts receivable of $0.5 million, and other changes
in working capital of $0.4 million.
Further contributing to this change were the establishment of an allowance
for non-realization of deferred tax assets of $4.0 million, stock-based compensation of $2.8 million, depreciation and amortization of
$0.9 million, and a loss on disposal of fixed assets of $0.1 million.
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Investing Activities
Net cash used in investing activities of $1.3 million for the year ended
December 31, 2024, was driven by capital expenditures for manufacturing equipment related to our production line for our next generation
consumables.
Net cash used in investing activities of $0.8 million for the year ended
December 31, 2023, was for capital expenditures for research and development and manufacturing equipment
Financing Activities
Net cash used in financing activities of $0.2 million for the year ended
December 31, 2024 was primarily due to payments on our note payable for insurance premium financing, partially offset by new borrowings
for a subsequent insurance premium financing agreement. In addition, we had payments for taxes related to net share settlement of equity
awards of $0.1 million.
Net cash used in financings activities of $0.2 million for the year ended
December 31, 2023, due to payments on our note payable for insurance premium financings, partially offset by the borrowings for the insurance
premium financing, and $0.1 million for payments on our finance leases.
Debt and Borrowing Capacity
Refer to “NOTE 5 — DEBT OBLIGATIONS” in the accompanying
“Notes to Financial Statements” appearing in this Annual Report on Form 10-K for further details regarding debt and borrowing
capacity.
Lease Commitments
We have finance and operating leases for our corporate office and certain
office and computer equipment. Our three operating leases have remaining lease terms of 7.7 years, 4.1 years, and 3.4 years, respectively.
Our three finance leases have remaining lease terms of 2.4 years, 2.0 years, and 3.8 years, respectively.
Refer to “NOTE 6 — LEASES” in the accompanying “Notes
to Financial Statements” appearing in this Annual Report on Form 10-K for further details regarding our operating and finance leases.
SIGNIFICANT ACCOUNTING POLICIES AND CRITICAL ACCOUNTING ESTIMATES
The preparation of financial statements in conformity with generally accepted
accounting principles of the United States (“GAAP”) requires estimates and assumptions that affect the reported amounts of
assets and liabilities, revenues and expenses, and related disclosures of contingent liabilities in the financial statements and accompanying
notes. The SEC has defined a company’s critical accounting policies as the ones that are most important to the portrayal of
the company’s financial condition and results of operations, and which require the company to make its most difficult and subjective
judgments, often as a result of the need to make estimates of matters that are inherently uncertain. Based on this definition, we
have identified some of our more critical accounting estimates below. We also have other key accounting policies, which involve
the use of estimates, judgments, and assumptions that are significant to understanding our results. For additional information,
see “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in the accompanying “Notes
to Financial Statements” appearing in this Annual Report on Form 10-K. Although we believe that our estimates, assumptions,
and judgments are reasonable, they are based upon information presently available. Actual results may differ significantly from
these estimates under different assumptions, judgments, or conditions.
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Revenue Recognition
Our revenues are derived from three business sources: (i) domestic core
(which consists of US and Canada), (ii) international core, and (iii) novel therapies. Our core domestic and international revenues
consist of sales of our syringe drivers, tubing and needles (“Product Revenue”) for the delivery of subcutaneous drugs that
are FDA cleared for use with the KORU Medical infusion system, with the primary delivery for immunoglobulin to treat Primary Immunodeficiency
Diseases (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”). Novel therapies consist of Product
Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug
development process as well as non-recurring engineering services (“NRE”) revenues (including testing and registration services)
received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use across multiple drug
categories.
For Product Revenue, we recognize revenues when shipment occurs, and at
which point the customer obtains control and ownership of the goods. Shipping costs generally are billed to customers and are included
in Product Revenue.
The Company generally does not accept return of goods shipped unless it
is a Company error. The only credits provided to customers are for defective merchandise. The Company warrants the syringe
driver from defects in materials and workmanship under normal use and the warranty does not include a performance obligation. The
costs under the warranty are expensed as incurred.
Rebates are provided to distributors for the difference in selling price
to distributor and pricing specified to select customers. In addition, rebates are provided to customers for meeting growth targets.
Provisions for both distributor pricing and customer growth rebates are variable consideration and are recorded as a reduction of
revenue in the same period the related sales are recorded or when it is probable the growth target will be achieved.
We recognize NRE revenue under an input method, which recognizes revenue
on the basis of our efforts or inputs (for example, resources consumed, labor hours expended, costs incurred, or time elapsed) to the
satisfaction of a performance obligation relative to the total expected inputs to the satisfaction of that performance obligation (i.e.
completion milestone). The input method that we use is based on costs incurred.
Contracts are often modified to account for changes in contract specifications
and requirements. Contract modifications exist when the modification either creates new, or changes existing, enforceable rights and obligations.
Generally, when contract modifications create new performance obligations, the modification is considered to be a separate contract and
revenue is recognized prospectively. When contract modifications change existing performance obligations, the impact on the existing transaction
price and measure of progress for the performance obligation to which it relates is generally recognized as an adjustment to revenue (either
as an increase in or a reduction of revenue) on a cumulative catch-up basis. Contract assets primarily represent revenue earnings over
time that are not yet billable based on the terms of the contracts. Contract liabilities (i.e., deferred revenue) consist of fees invoiced
or paid by the Company’s customers for which the associated performance obligations have not been satisfied and revenue has not
been recognized based on the Company’s revenue recognition criteria described above. As of December 31, 2023, the Company has recognized
a contract asset of zero which is included in other accounts receivable in the accompanying balance sheet.
Inventory
Inventories of raw materials are stated at the lower of standard cost,
which approximates average cost, or market value including allocable overhead. Work-in-process and finished goods are stated at
the lower of standard cost or market value and include direct labor and allocable overhead.
We maintain reserves for excess and obsolete inventory resulting from the
potential inability to sell certain products at prices in excess of current carrying costs. We make estimates regarding the future recoverability
of the costs of these products and record provisions based on historical experience, expiration of sterilization dates and expected future
trends. If actual product life cycles, product demand or acceptance of new product introductions are less favorable than projected by
management, additional inventory write downs may be required, which could unfavorably affect future operating results.
ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED
Refer to “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES” in the accompanying “Notes to Financial Statements” appearing in this Annual Report on Form 10-K.
ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED
Refer to “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES” in the accompanying “Notes to Financial Statements” appearing in this Annual Report on Form 10-K.
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