KORU Medical Systems, Inc. Announces 2024 First Quarter Financial Results Delivering Double-Digit Revenue Growth

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KORU Medical Systems, Inc. (NASDAQ: KRMD) reported Q1 2024 financial results with net revenues of $8.2 million, an 11% increase YoY. Gross profit increased by 23% to $5.1 million. The company reaffirmed its full year 2024 revenue guidance of $31.2-$32.2 million, reflecting growth of 10-13% YoY. KORU Medical continues to expand its Core business and Novel Therapies collaborations, aiming for increased value for customers, patients, and shareholders.

Positive

• First quarter 2024 net revenues of $8.2 million, an 11% increase YoY and record high quarterly revenues.

• Core business (U.S. and International) experienced 14% growth YoY, driven by SCIg market growth, share gains, and geographic expansion.

• Entered a Novel Therapies collaboration with an oncology drug therapy, bringing total collaborations to 16.

• Gross profit increased by 23% to $5.1 million, with a gross margin of 62% showing improvement YoY.

• Ending cash balance of $10.8 million and quarterly cash usage of $0.7 million, reflecting increased operating leverage and working capital improvements.

• Reaffirmed full year 2024 revenue guidance of $31.2-$32.2 million, representing growth of 10-13% YoY.

Negative

• Novel Therapies net revenues declined by 21.3% primarily due to a milestone completion for a collaboration agreement in the prior year period.

• Net loss for Q1 2024 was $1.9 million, compared to a net loss of $2.4 million for the same period in 2023.

• Adjusted EBITDA for Q1 2024 was ($0.9) million, compared to adjusted EBITDA of ($2.0) million for the same period in 2023.

• Cash flow breakeven expected in Q4 2024 and cash flow positive for full year 2025.

Financial Analyst

Observing KORU Medical Systems' recent performance, the 11% year-over-year increase in net revenues to $8.2 million is a solid indicator of the company's growth trajectory. In particular, the substantial 63.1% increase in International Core revenues showcases the company's effective market expansion strategy. However, it's worth noting the slight $0.26 million revenue brought forward to March, a one-off which could slightly distort the perceived growth rate.

Impressively, the gross profit margin expansion to 62% from 56.1% reflects significant operational efficiencies. This improvement could be a result of the company's strategic consolidation of manufacturing sites and indicates robust cost management that if sustained, can enhance profitability. Potential investors should watch for consistency in this trend as it could be a strong driver of future earnings.

The guidance reaffirmation suggests a stable outlook, but investors should remain cognizant that the projected net revenue growth rates of 10% to 13% may already be priced into the stock. The anticipated cash flow breakeven in Q4 2024 and positive cash flow in 2025 can also be seen as a pivotal target for assessing the company's fiscal discipline and long-term viability.

Medical Technology Expert

The growth in the subcutaneous immunoglobulin (SCIg) market and the prefill adoption rates are significant for KORU Medical's core business, as these factors suggest a larger addressable market and potential for increased market share. The novel therapies collaboration in oncology also indicates strategic diversification which could reduce dependency on core SCIg products and open up new revenue streams.

Moreover, the collaboration count at 16, with 3 signed in the current year, reflects an active pipeline that may catalyze future growth. For investors, the key to evaluating KORU's long-term potential lies in monitoring the success rate of these collaborations converting into tangible products and revenue contributions.

Market Research Analyst

From a market perspective, KORU's focus on patient-centric infusion solutions positions the company in a high-demand area of medical technology, which is expected to grow due to aging populations and increased prevalence of chronic diseases. The narrative of expanding geographical footprint also aligns with broader trends in healthcare globalisation, tapping into emerging markets' potential.

Nonetheless, the decrease in Novel Therapies revenues by 21.3% warrants a closer look, as it may indicate challenges in sustaining growth in this segment or could merely reflect the milestone-based nature of such revenues. Investors should follow subsequent quarters to discern whether this is a temporary setback or indicative of a trend.

MAHWAH, N.J.--(BUSINESS WIRE)-- 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

• First quarter 2024 net revenues of $8.2 million, an 11% increase over the prior year and record high quarterly revenues
• Core business (U.S. and International) growth of 14% over the prior year, driven by overall SCIg market growth, share gains, and geographic expansion
• Entered a Novel Therapies collaboration with an oncology drug therapy, bringing total collaborations to 16, with 3 signed year-to-date
• Gross profit of $5.1 million, a 23% increase over the prior year, and gross margin of 62%, reflecting year-over-year improvement of 620 basis points
• Ending cash balance of $10.8 million and quarterly cash usage of $0.7 million driven by increased operating leverage and working capital improvements
• Reaffirmed full year 2024 revenue guidance of $31.2 million to $32.2 million, representing growth of 10% to 13% over the prior year.

“We are excited by a strong start to the year, with double-digit record revenue growth in our Core business and the addition of a new oncology collaboration in our Novel Therapies business,” said Linda Tharby, KORU Medical’s President and CEO. “The Core business saw another quarter of sequential growth in the subcutaneous immunoglobulin market, increasing prefill adoption rates, and further geographic expansion. As a part of our Novel Therapies strategy to expand the Freedom subcutaneous infusion system to new drug therapies, we are proud of the progress we’ve made in diversifying our drug pipeline and signing three new collaborations year-to-date. We also continued to drive operating leverage evidenced this quarter by gross margin expansion and a significant reduction in cash usage over the prior year. We are committed to our strategic growth agenda and providing increased value to our customers, patients, and shareholders.”

2024 First Quarter Financial Results

		Three Months Ended March 31,						Change from Prior Year							% of Net Revenues
		2024			2023			$				%			2024			2023
Net Revenues
Domestic Core		$	5,953,865		$	5,719,135		$	234,730			4.1	%		72.7	%		77.4	%
International Core			1,790,483			1,097,490			692,993			63.1	%		21.8	%		14.8	%
Total Core			7,744,348			6,816,625			927,723			13.6	%		94.5	%		92.2	%
Novel Therapies			453,450			575,980			(122,530	)		(21.3	%)		5.5	%		7.8	%
Total		$	8,197,798		$	7,392,605		$	805,193			10.9	%		100	%		100	%

Total net revenues increased $0.8 million, or 10.9%, to $8.2 million for the three months ended March 31, 2024, as compared with the same period in 2023. Domestic Core revenues increased by 4.1% from higher consumable volumes driven by new patients starts and share gains. International Core revenues increased by 63.1%, from higher consumable and pump volumes driven largely by increased Ig supply, increased penetration within approved indications, and geographic expansion. International orders were expedited for certain distribution partners of $0.26 million in March 2024 to ensure adequate inventory to fulfill patient needs in the event of a supply disruption related to the BSI regulatory review process. Novel Therapies net revenues declined by 21.3% primarily driven by a milestone completion for a collaboration agreement in the prior year period.

Gross profit increased $1.0 million, or 23%, to $5.1 million in the three months ended March 31, 2024, compared to $4.1 million in the same period in 2023. Gross margin increased to 62.3% compared to 56.1% in the first quarter of 2023. The increase in gross margin was primarily driven by production efficiencies from outsourced manufacturing and consolidation of US manufacturing sites.

Total operating expenses for the first quarter of 2024 were $7.1 million, a decrease of $0.1 million, or 1.9%, compared to $7.2 million in the prior year period.

Net loss for the first quarter of 2024 was $1.9 million, or $(0.04) per diluted share, compared to a net loss of $2.4 million, or ($0.05) per diluted share, for the same period of 2023. Adjusted EBITDA for the first quarter of 2024 was ($0.9) million, or ($0.02) per diluted share, compared to adjusted EBITDA of ($2.0) million, or ($0.04) per diluted share, for the same period of 2023. A reconciliation of adjusted EBITDA and adjusted diluted EPS is provided at the end of this press release.

Cash and cash equivalents were $10.8 million as of March 31, 2024, reflecting cash usage of $0.7 million in the first quarter of 2024.

2024 Guidance

Reaffirming full year 2024 net revenue between $31.2 and $32.2 million, representing growth of 10% to 13%

• Gross margin between 59% and 61% for the full year 2024
• 2024 year-end cash balance greater than $8.0 million
• Cash flow breakeven in the fourth quarter of 2024 and cash flow positive for full year 2025

Conference Call and Webcast Details

The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Wednesday, May 1, 2024 at 4:30 PM ET.

To participate in the call, please dial (877) 407-0784 (domestic) or (201) 689-8560 (international). The live webcast will be available on the IR Calendar on the News/Events page of the Investors section of KORU Medical's website.

Non-GAAP Measures

This press release includes the non-GAAP financial measures “adjusted EPS”, "adjusted diluted EPS" and “adjusted EBITDA” that are not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges that have a material effect on KORU Medical's reported results and, therefore, should not be relied upon as the sole financial measures to evaluate the Company's financial results. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. Reconciliations of the Company's non-GAAP measures are included at the end of this press release.

About KORU Medical Systems

KORU Medical develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System (“the FREEDOM System”) currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. These devices are used for infusions administered in the home and alternate care settings. For more information, please visit www.korumedical.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact are forward-looking statements, including, but not limited to, financial guidance and expected operating performance for fiscal 2024. Forward-looking statements discuss the Company's current expectations and projections relating to its financial position, results of operations, plans, objectives, future performance, and business. Forward-looking statements can be identified by words such as "guidance", "expect", "plan", "believe" and "will". Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, uncertainties associated with SCIg market growth, prefilled syringe penetration, plasma supply, clinical trial activity and success, the Company’s EU certification, the shift to increased healthcare delivery in the home, new patient diagnoses, customer ordering patterns, global health crises, innovation and competition, labor and supply price increases, inflationary impacts, labor supply, and those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024 , which is on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of May 1, 2024. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

KORU MEDICAL SYSTEMS, INC. BALANCE SHEETS (UNAUDITED)
		March 31,				December 31,
		2024				2023
ASSETS
CURRENT ASSETS
Cash and cash equivalents		$	10,820,317			$	11,482,240
Accounts receivable less allowance for doubtful accounts of $24,777 as of March 31, 2024 and $24,777 as of December 31, 2023			4,392,511				4,045,211
Inventory			3,147,312				3,481,301
Other receivables			288,714				28,889
Prepaid expenses			830,408				1,218,288
TOTAL CURRENT ASSETS			19,479,262				20,255,929
Property and equipment, net			3,755,530				3,837,657
Intangible assets, net of accumulated amortization of $406,801 and $390,341 as of March 31, 2024 and December 31, 2023, respectively			737,901				754,361
Operating lease right-of-use assets			3,428,885				3,514,055
Deferred income tax assets, net of allowance for non-realization of deferred tax assets of $6,391,452 and $6,002,777 for March 31, 2024 and December 31, 2023, respectively			—				—
Other assets			98,970				98,970
TOTAL ASSETS		$	27,500,548			$	28,460,972
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable		$	1,774,185			$	975,193
Accrued expenses			1,459,405				1,711,427
Note payable			159,031				314,344
Other liabilities			457,653				512,520
Accrued payroll and related taxes			519,441				462,941
Financing lease liability – current			111,103				109,540
Operating lease liability – current			372,109				368,313
TOTAL CURRENT LIABILITIES			4,852,927				4,454,278
Financing lease liability, net of current portion			288,253				316,623
Operating lease liability, net of current portion			3,241,837				3,336,300
TOTAL LIABILITIES			8,383,017				8,107,201
STOCKHOLDERS’ EQUITY
Common stock, $0.01 par value, 75,000,000 shares authorized, 49,143,589 and 49,089,864 shares issued 45,723,087 and 45,669,362 shares outstanding as of March 31, 2024, and December 31, 2023, respectively			491,436				490,899
Additional paid-in capital			47,717,888				47,018,707
Treasury stock, 3,420,502 shares as of March 31, 2024 and December 31, 2023, at cost			(3,843,562	)			(3,843,562	)
Accumulated deficit			(25,248,231	)			(23,312,273	)
TOTAL STOCKHOLDERS’ EQUITY			19,117,531				20,353,771
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	27,500,548			$	28,460,972

The accompanying notes are an integral part of these financial statements.
KORU MEDICAL SYSTEMS, INC. STATEMENTS OF OPERATIONS (UNAUDITED)
		Three Months Ended
		March 31,
		2024				2023
NET REVENUES		$	8,197,798			$	7,392,605
Cost of goods sold			3,094,500				3,245,570
Gross Profit			5,103,298				4,147,035
OPERATING EXPENSES
Selling, general and administrative			5,357,620				5,425,877
Research and development			1,475,674				1,564,869
Depreciation and amortization			231,370				213,117
Total Operating Expenses			7,064,664				7,203,863
Net Operating Loss			(1,961,366	)			(3,056,828	)
Non-Operating Income/(Expense)
Loss on currency exchange			(11,479	)			(680	)
Loss on disposal of fixed assets, net			(300	)			(56,279	)
Interest income, net			37,187				125,502
TOTAL OTHER INCOME			25,408				68,543
LOSS BEFORE INCOME TAXES			(1,935,958	)			(2,988,285	)
Income Tax Benefit			—				577,400
NET LOSS		$	(1,935,958	)		$	(2,410,885	)
NET LOSS PER SHARE
Basic		$	(0.04	)		$	(0.05	)
Diluted		$	(0.04	)		$	(0.05	)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
Basic			45,712,224				45,487,593
Diluted			45,712,224				45,487,593

The accompanying notes are an integral part of these financial statements.
KORU MEDICAL SYSTEMS, INC. STATEMENTS OF CASH FLOWS (UNAUDITED)
		For the Three Months Ended
		March 31,
		2024				2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net Loss		$	(1,935,958	)		$	(2,410,885	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense and warrant expense			699,718				881,222
Depreciation and amortization			231,370				213,117
Deferred income taxes			—				(577,400	)
Loss on disposal of fixed assets			300				56,279
ROU landlord credit			(5,497	)			(5,497	)
Changes in operating assets and liabilities:
Increase in Accounts receivable			(607,125	)			(647,994	)
Decrease / (Increase) in Inventory			333,989				(233,551	)
Decrease in Prepaid expenses and other assets			387,880				288,786
(Decrease) / Increase in Other liabilities			(54,867	)			4,207
Increase / (Decrease) in Accounts payable			798,992				(888,679	)
Increase / (Decrease) in Accrued payroll and related taxes			56,500				(41,984	)
Decrease in Accrued expenses			(252,022	)			(1,298,204	)
NET CASH USED IN OPERATING ACTIVITIES			(346,720	)			(4,660,583	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment			(133,083	)			(272,605	)
Purchases of intangible assets			(0	)			(11,232	)
NET CASH USED IN INVESTING ACTIVITIES			(133,083	)			(283,837	)
CASH FLOWS FROM FINANCING ACTIVITIES
Payments on indebtedness			(155,313	)			(214,892	)
Payments on finance lease liability			(26,807	)			(24,080	)
NET CASH (USED IN) FINANCING ACTIVITIES			(182,120	)			(238,972	)
NET DECREASE IN CASH AND CASH EQUIVALENTS			(661,923	)			(5,183,392	)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD			11,482,240				17,408,257
CASH AND CASH EQUIVALENTS, END OF PERIOD		$	10,820,317			$	12,224,865
Supplemental Information
Cash paid during the periods for:
Interest		$	12,296			$	12,326
Income taxes		$	—			$	—
Schedule of Non-Cash Operating, Investing and Financing Activities:
Issuance of common stock as compensation		$	123,804			$	175,776

The accompanying notes are an integral part of these financial statements.
KORU MEDICAL SYSTEMS, INC. SUPPLEMENTAL INFORMATION (UNAUDITED)
A reconciliation of our non-GAAP measures is below:
	Three Months Ended
Reconciliation of GAAP Net Loss		March 31,
to Non-GAAP Adjusted EBITDA:	2024				2023
GAAP Net Loss	$	(1,935,958	)		$	(2,410,885	)
Tax (Benefit)/Expense		(388,675	)			(577,400	)
Valuation Allowance for DTA		388,675				—
Depreciation and Amortization		231,369				213,117
Interest (Income), Net		(37,187	)			(125,502	)
Reorganization Charges		99,329				—
Manufacturing Initiative Expenses		—				49,053
Product Discontinuance		—				—
Stock-based Compensation Expense		699,718				881,222
Adjusted EBITDA	$	(942,729	)		$	(1,970,395	)
Weighted average number common shares		45,712,224				45,487,593

	Three Months Ended
Reconciliation of Reported Diluted EPS	March 31,
to Non-GAAP Adjusted Diluted EPS:	2024				2023
Reported Diluted Earnings Per Share	$	(0.04	)		$	(0.05	)
Tax (Benefit)/Expense		(0.01	)			(0.01	)
Valuation Allowance for DTA		0.01				—
Depreciation and Amortization		0.01				0.01
Interest (Income)/Expense, Net		—				—
Reorganization Charges		—				—
Manufacturing Initiative Expenses		—				—
Product Discontinuance		—				—
Stock-based Compensation Expense		0.02				0.02
Adjusted Diluted Earnings Per Share	$	(0.02	)		$	(0.04	)

*Numbers presented are rounded to the nearest whole cent and percentage

Reorganization Charges. We have excluded the effect of reorganization charges in calculating our non-GAAP measures. In 2023 and 2024 we incurred severance expenses related to the reorganization of the leadership team, which we would not have otherwise incurred in periods presented as part of continuing operations.

Manufacturing Initiative Expenses. We have excluded the effect of expenses related to creating manufacturing efficiencies in calculating our non-GAAP measures. We incurred expenses in connection with these initiatives which we would not have otherwise incurred in periods presented as part of our continuing operations.

Stock-based Compensation Expense. We have excluded the effect of stock-based compensation expense in calculating our non-GAAP measures. We record non-cash compensation expenses related to grants of options and restricted shares for executives, employees and consultants, and grants of shares to our board of directors. Depending upon the size, timing and the terms of the grants, the non-cash compensation expense may vary significantly but will recur in future periods.

Allowance for nonrealization of deferred tax assets (DTA). We have excluded the effect of recording a full valuation allowance on our deferred tax assets in the first quarter ended 2024 in the amount of $0.4 million. It was determined that no valuation allowance was necessary in the first quarter ended 2023.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240501464191/en/

Investor Contact:

Louisa Smith

investor@korumedical.com

Source: KORU Medical Systems, Inc.

FAQ

What were KORU Medical Systems, Inc.'s Q1 2024 net revenues?

KORU Medical reported Q1 2024 net revenues of $8.2 million, an 11% increase YoY.

What was the gross profit for KORU Medical Systems, Inc. in Q1 2024?

KORU Medical's gross profit increased by 23% to $5.1 million in Q1 2024.

What is KORU Medical Systems, Inc.'s full year 2024 revenue guidance range?

KORU Medical reaffirmed its full year 2024 revenue guidance of $31.2-$32.2 million, reflecting growth of 10-13% YoY.

How many collaborations has KORU Medical Systems, Inc. entered into as of Q1 2024?

KORU Medical has entered into 16 collaborations, with 3 signed year-to-date.

What was the change in KORU Medical Systems, Inc.'s Novel Therapies net revenues in Q1 2024?

Novel Therapies net revenues declined by 21.3% in Q1 2024 primarily due to a milestone completion for a collaboration agreement in the prior year period.

What was the net loss for KORU Medical Systems, Inc. in Q1 2024?

KORU Medical reported a net loss of $1.9 million in Q1 2024, compared to a net loss of $2.4 million in the same period in 2023.