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.
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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 | |||
