BioStem Technologies Reports Third Quarter 2025 Financial Results

Rhea-AI Summary

BioStem Technologies (OTC: BSEM) reported third quarter 2025 results on November 13, 2025, including net revenue of $10.5 million and GAAP net income of $0.8 million (earnings per share $0.05). The company reported adjusted EBITDA of $2.7 million and cash and cash equivalents of $27.2 million as of September 30, 2025.

Operational highlights included a 40% quarter-over-quarter product volume increase, positive randomized controlled trial results for BioREtain submitted to CMS, remediation of prior FDA inspection issues with a clean 361 inspection, appointment of KPMG, a land purchase for a new headquarters site, and a VA partnership to launch American Amnion in Q4.

Positive

• Gross margin improved to 88.5% of net revenue in Q3 2025
• Achieved 40% quarter-over-quarter product volume growth
• Positive RCT results for BioREtain submitted to CMS
• Remediated FDA issues; new 361 inspection had no observations
• Cash and cash equivalents of $27.2 million at 9/30/2025

Negative

• Net revenue declined 43% versus Q3 2024 to $10.5 million
• Adjusted EBITDA fell to $2.7 million from $10.4 million in Q3 2024
• Operating expenses increased to $7.8 million from $4.9 million
• GAAP net income declined to $0.8 million from $6.8 million year‑ago

POMPANO BEACH, Fla., Nov. 13, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today reported financial results for the third quarter ended September 30, 2025.

Recent Business Highlights

• Achieved 40% growth in product volume quarter-over-quarter
• Reported positive top-line randomized controlled trial results demonstrating superior outcomes with BioREtain^® Allografts in diabetic foot ulcers as published in the International Journal of Tissue Repair and submitted to CMS for consideration for inclusion in local coverage determinations (LCDs)
• Continued enrollment of subjects in the BioREtain® venous leg ulcer randomized controlled trial ahead of schedule, supporting progress toward top line read out in Q1 2026
• Established a partnership with a Service-Disabled Veteran-Owned Small Business (SDVOSB) to serve the Department of Veterans Affairs (VA) through the launch of our American Amnion product in Q4
• Secured land purchase at the Research Park at Florida Atlantic University in Boca Raton for future headquarters
• Remediated all concerns noted from FDA’s prior 2023 inspection and the associated Form 483. The FDA conducted a new 361 inspection this quarter, which was completed with no nonconformances, comments or observations
• Appointed KPMG LLP (“KPMG”) as the Company's independent registered public accounting firm
  
  

Financial Highlights

• Reported restated financials in accordance with US GAAP accounting standards that reflect adjustments to the accounting treatment for the Company’s bona fide services fees paid to its commercial partner, Venture Medical
• Generated net revenue of $10.5 million for the third quarter 2025; revenue is now reported inclusive of the contra revenue, or net of the Bonafide Services Fees paid to Venture Medical
• Reported $0.8 million net income for the third quarter 2025, and achieved seventh consecutive quarter of positive adjusted EBITDA
  
  

“This quarter underscored the resilience of our business model, the discipline of our operations, and the strength of our team as we continued to execute through an evolving reimbursement landscape. BioStem remains well positioned financially, operationally, and clinically to lead through this transition and emerge even stronger,” said Jason Matuszewski, CEO and Chairman of the Board of BioStem. “We have taken important steps to position the company for the future, including advancing our BioREtain clinical program, expanding access through new payers and sites of care, completing our restated financial statements, and continuing to evaluate strategic acquisitions that would diversify our product portfolio and commercial channels. We continue to establish a foundation that we believe will drive market share gains and ongoing success in any future market environment.”

Third Quarter 2025 Financial Results

The following financial results are unaudited and may change pending the completion of our financial statement independent audit, including an audit of our restated financial statements which were released earlier today.

Net revenue was $10.5 million, a 43% decrease compared to Q3 2024. The decrease was primarily driven by lower volume in our wound care portfolio as a result of reimbursement uncertainty and increased competition.

Gross profit was $9.3 million, or 88.5% of net revenue, compared to $14.2 million or 77.0% of net revenue in Q3 2024. The increase reflects a product mix shift towards our products that do not carry a licensing fee in the third quarter of this year.

Operating expenses totaled $7.8 million, up from $4.9 million in Q3 2024, primarily driven by increased clinical trials activities and investments in infrastructure as the Company scales for future growth.

GAAP net income was $0.8M or $0.05 per share, compared to net income of $6.8 million or $0.42 per share in Q3 2024. 

Adjusted EBITDA for the third quarter was $2.7 million, compared to $10.4 million in Q3 2024. The decline reflects lower revenue and  gross profit, and higher operating expenses.

As of September 30, 2025, cash and cash equivalents totaled $27.2 million.

Conference Call & Webcast Information:

• Conference ID: 9695874
• North America Toll-Free: (800) 715-9871
• International Toll: +1 (646) 307-1963
• Webcast Link: https://events.q4inc.com/attendee/951812886

The live and archived webcast will be available on the BioStem Technologies website under the Investor Relations section, HERE.

About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain^® processing method. BioREtain^® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE^®, VENDAJE AC^®, VENDAJE OPTIC^®, American Amnion, and American AC. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and LinkedIn.

Join BioStem’s Distribution List & Social Media:
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Forward-Looking Statements:

Certain statements in this press release may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to expectations or forecasts of future events including with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate”, “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical fact. Forward-looking statements in this release include, among other things, statements regarding: the financial results for the third quarter 2025; the Company’s expectations regarding clinical trial results, including the anticipated timing of current and planned clinical trials; the timing of enrollment and publication of data from such trials; the anticipated commercial benefits from such clinical trials; the expectation that such trials will demonstrate the clinical superiority of the Company’s products, and the estimated addressable market growth for the Company’s products; the Company’s expectations regarding its ability to uplist to Nasdaq; the Company’s strategic initiatives; third quarter and full year 2025 projections; continued financial growth; and the market penetration of the Company’s core products.

Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: the impact of any changes to the reimbursement levels for the Company’s products; significant and continuing competition, which could adversely affect the Company’s business, results of operations and financial condition; rapid technological change, which could cause the Company’s products to become outdated or obsolete, harming the Company’s ability to effectively compete; the Company’s ability to convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; the risk that the Company may be unable to successfully market is products to the end users of such products; the Company’s ability to obtain coverage of its products when, or if, the LCDs are implemented; the risk that the Company may be unable to raise capital on terms acceptable to it, or at all, which could have a material adverse impact of the Company’s business, financial condition, and prospects; the audit of the Company’s restated financial statements and the impact of any changes to the accounting treatment of the Company’s revenue and expenses; the Company’s ability to obtain financing to expand its business; the Company has incurred significant losses since inception and may incur losses in the future; the impact of any changes in applicable laws or regulations; the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and the possibility that the Company may be adversely affected by other general economic, business, and/or competitive factors. There may be additional risks about which the Company is presently unaware of or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company undertakes no duty to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contact BioStem Technologies, Inc.:
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStemTechnologies
Phone: 954-380-8342

Investor Relations:
Philip Trip Taylor, Gilmartin Group
ir@biostemtech.com

BioStem Technologies, Inc. and Subsidiaries
Consolidated Balance Sheets
	As of				As of
	September 30, 2025				December 31, 2024 (Restated)
Current Assets
Cash and cash equivalents	$	27,158,117			$	22,832,706
Accounts receivable, net		20,104,929				23,107,027
Inventory		2,728,981				1,824,001
Short-term loan receivable		-				1,250,000
Prepaid expenses and other assets		2,699,667				2,874,317
Total current assets		52,691,694				51,888,051
Long-Term Assets
Property and equipment, net		1,702,568				1,504,577
Construction-in-process		2,822,661				190,422
Right-of-use asset, net		374,790				271,214
Intangible assets, net		136,310				224,137
Goodwill		244,635				244,635
Deferred tax assets		4,420,185				4,179,632
Total assets	$	62,392,843			$	58,502,668
Current Liabilities
Accounts payable and accrued expenses	$	4,586,098			$	5,289,786
License fees payable		907,839				2,359,575
Income tax payable		-				2,908,730
Accrued interest		2,160,000				1,962,983
Operating lease liabilities		228,759				106,723
Notes payable, net of discount		3,000,000				3,957,744
Other current liabilities		1,335,341				711,360
Total current liabilities		12,218,037				17,296,901
Long-Term Liabilities
Operating lease liabilities, less current portion		158,397				180,235
Notes payable, less current portion		-				150,000
Total long-term liabilities		158,397				330,235
Total liabilities		12,376,434				17,627,136
Commitments and contingencies (Note 11)
Stockholders' Equity
Series A-1 convertible preferred stock, $0.001 par value authorized, 300 shares; issued and outstanding, 300 shares as of September 30, 2025 and December 31, 2024		-				-
Series B-1 convertible preferred stock, $0.001 par value authorized, 500,000 shares; issued and outstanding 5 shares as of September 30, 2025 and December 31, 2024.		-				-
Common stock, $0.001 par value authorized, 975,000,000 shares issued and outstanding 16,783,341and 16,661,482 shares as of September 30, 2025 and December 31, 2024, respectively.		16,784				16,662
Additional paid-in capital		59,102,980				54,642,012
Treasury stock, 18,000 shares at cost		(43,346	)			(43,346	)
Accumulated deficit		(9,060,009	)			(13,739,796	)
Total stockholders' equity		50,016,409				40,875,532
Total liabilities and stockholders' equity	$	62,392,843			$	58,502,668

BioStem Technologies, Inc. and Subsidiaries
Consolidated Statements of Operations
	Three-months ended,
	September 30, 2025				September 30, 2024
					Restated
Revenue, net	$	10,473,402			$	18,412,816
Cost of goods sold		1,204,794				4,238,658
Gross profit		9,268,608				14,174,158
Operating Expenses
Sales and marketing expenses		1,305,957				1,027,764
General and administrative expenses		4,498,341				3,311,659
Research and development expenses		1,957,876				488,859
Depreciation and amortization expense		57,644				54,038
Total operating expenses		7,819,818				4,882,320
Income from operations		1,448,790				9,291,838
Other income (expense):
Interest income (expense), net		143,284				(139,288	)
Other expense		(123,345	)			-
Other income (expense), net		19,939				(139,288	)
Total income from operations before income taxes		1,468,729				9,152,550
Income tax expense		(707,677	)			(2,332,648	)
Net income	$	761,052			$	6,819,902
Basic net income per share attributable to common stockholders	$	0.05			$	0.42
Diluted net income per share attributable to common stockholders	$	0.03			$	0.32
Basic weighted average common shares outstanding		16,749,593				16,324,482
Diluted weighted average common shares outstanding		23,235,347				21,129,197

Non-GAAP Financial Measures:

Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA, which we calculate as net income less interest, taxes, depreciation and amortization and share-based compensation expense, to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA helps identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA provides useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making.

The following is a reconciliation of GAAP net income (loss) to non-GAAP EBITDA and non-GAAP Adjusted EBITDA for each of the periods presented:

	Three months ended,
	September 30, 2025				September 30, 2024
Net income	$	761,052			$	6,819,902
Interest expense/(income)		(143,284	)			139,288
Depreciation and amortization		57,644				54,038
Income taxes		707,677				2,332,648
EBITDA		1,383,089				9,345,876
Share-based compensation		1,151,988				1,007,465
Legal settlement		125,000				-
Adjusted EBITDA	$	2,660,077			$	10,353,341

FAQ

What were BioStem (BSEM) reported Q3 2025 revenues and net income on Nov 13, 2025?

BioStem reported net revenue of $10.5 million and GAAP net income of $0.8 million for Q3 2025.

How did BioStem's margins change in Q3 2025 for BSEM?

Gross profit was $9.3 million, representing 88.5% of net revenue in Q3 2025, up from 77.0% a year earlier.

What clinical progress did BioStem (BSEM) announce on Nov 13, 2025?

BioStem reported positive randomized controlled trial results for BioREtain in diabetic foot ulcers and ongoing enrollment in a venous leg ulcer RCT ahead of schedule.

Did BioStem resolve prior FDA inspection findings before Q3 2025?

Yes. The company remediated prior Form 483 concerns and a new 361 inspection completed this quarter with no nonconformances, comments, or observations.

How much cash did BioStem (BSEM) hold at September 30, 2025?

BioStem reported $27.2 million in cash and cash equivalents as of September 30, 2025.

What strategic actions did BioStem announce alongside Q3 2025 results?

The company appointed KPMG as auditor, purchased land for a Boca Raton headquarters, and established a VA partnership to launch American Amnion in Q4.