- Preliminary net revenue increased 73% to $72.5 million for Q1 2025, compared to $41.9 million in Q1 2024
- Achieved preliminary GAAP net income of $4.5 million, or $0.27 per share
- Reported preliminary Q1 2025 Adjusted EBITDA of $7.8 million
- Quarter-end cash balance of $26.7 million, up from $22.8 million as of December 31, 2024
- Financial results conference call and webcast to be held on May 12, 2025 at 4:30 pm ET
POMPANO BEACH, Fla., May 12, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM) (the “Company” or “BioStem”), a leading MedTech company focused on the development, manufacture, and commercialization of placental-derived biologics, today reported preliminary financial results for the first quarter ended March 31, 2025. The Company will host a webcast and conference call today at 4:30 pm ET. These results are unaudited, have been prepared in accordance with current accounting policies, and remain subject to SEC review related to the Company’s pending Form 10 filing in connection with its planned uplisting to Nasdaq.
Jason Matuszewski, CEO of BioStem, commented: “I am pleased to report the strongest first quarter in BioStem’s history, with Q1 2025 revenue increasing 73% compared to the first quarter of 2024. With the launch of Vendaje AC® in Q4 2024, we have seen rapid adoption of that product through our commercial partnership with Venture Medical. Furthermore, we are encouraged by the LCD implementation date being extended from April 2025 to January 2026, as the uncertainty throughout this quarter had created temporary headwinds that impacted our operations and sequential growth trajectory.”
Mr. Matuszewski added: “As we progress through Q2 and the rest of the year, we remain focused on continued growth and further strengthening our position in the chronic wound care market. Strategically, we are prioritizing the transition of more customers to Vendaje AC to drive brand consistency within the Vendaje family, while also reducing SG&A by phasing out licensing fees associated with AmnioWrap2. On the capital markets front, we remain in active review with the SEC regarding our Form 10 registration and uplisting process, and we look forward to completing this milestone and becoming listed on Nasdaq. We want to thank our shareholders for their continued support.”
First Quarter 2025 and Recent Corporate Highlights:
In Q1 2025, BioStem announced key milestones that further solidify its leadership in placental-derived products for wound care. The Company has received Institutional Review Board (IRB) approval to initiate a new clinical trial evaluating BioREtain® Amnion Chorion (BR-AC) for the treatment of venous leg ulcers (VLUs). This study is BioStem’s third prospective clinical trial and reflects its ongoing commitment to building a robust body of clinical evidence that demonstrates superior patient outcomes and supports wider adoption of its advanced wound care solutions.
BioStem also launched its BR-AM-DFU clinical trial to evaluate Vendaje®, the Company’s proprietary amniotic membrane product, in the treatment of non-healing diabetic foot ulcers. This trial will evaluate Vendaje against the current standard of care, offering an opportunity to further validate the clinical efficacy of the BioREtain technology platform and accelerate commercial growth in the diabetic wound care segment.
Additionally, BioStem has expanded its intellectual property portfolio with the U.S. Patent and Trademark Office. With a total of 55 patents that have been issued and 52 pending patents, the Company continues to reinforce its innovation leadership and lay the groundwork for the development of next-generation products in regenerative medicine and wound care.
Summary Financial Information1:
The following table represents preliminary net revenue, gross margin, operating expenses, and other expenses for the fourth quarter and year-to-date periods ended March 31, 2025, and March 31, 2024, respectively:
| Three months ended, | |||||||||||||||
| March 31, 2025 | March 31, 2024 | $ Change | % Change | ||||||||||||
| Net revenue | $ | 72,528,112 | $ | 41,904,213 | $ | 30,623,899 | 73 | % | |||||||
| Gross profit | $ | 71,674,674 | $ | 39,679,509 | $ | 31,995,165 | 81 | % | |||||||
| Gross profit % | 99 | % | 95 | % | 4 | % | |||||||||
| Operating expenses | $ | 66,425,350 | $ | 35,071,396 | $ | 31,353,953 | 89 | % | |||||||
| Operating income (loss) | $ | 5,249,325 | $ | 4,608,114 | $ | 641,211 | 14 | % | |||||||
| Other expense, net | $ | (766,229 | ) | $ | (1,350,200 | ) | $ | 583,971 | -43 | % | |||||
| Net income (loss) | $ | 4,483,096 | $ | 3,257,914 | $ | 1,225,182 | 38 | % | |||||||
________________________
1 As will be discussed in more detail on the BioStem conference call, BioStem is currently going through an SEC review process in connection with its planned uplist to Nasdaq. The ongoing discussions with the SEC relate to the accounting treatment of the Bona Fide Service Fees (BFSF) paid to Venture, and the related impact to reported revenue, gross margin and operating expenses. All of the financial information provided herein, including in this Summary Financial Information, are unaudited, has been prepared consistent with the Company’s current accounting policies and is subject to resolution of all SEC comments and completion of all closing and audit procedures which may cause actual results to differ materially from those presented in this press release.
Financial Results for the Three Months Ended March 31, 2025:
- Net revenue for Q1 2025 was $72.5 million, a 73% increase compared to Q1 2024. The increase was driven by strong performance across the Company’s wound care portfolio, led by VendajeAC, supported by expanded commercial coverage and sales force expansion.
- Gross profit was $71.7 million, or 99% of net revenue, compared to $39.7 million or 95% of net revenue in Q1 2024. The improvement reflects product mix benefits, scale efficiencies, and increased contributions from Vendaje AC, which does not incur licensing fees.
- Operating expenses totaled $66.4 million, up from $35.1 million in Q1 2024, primarily driven by increased sales and marketing costs associated with the Venture Medical distribution agreement.
- Adjusted EBITDA for the first quarter was $7.8 million, compared to $7.9 million in Q1 2024. The slight decline reflects higher gross profit being offset by increased operating expenses, including sales and marketing costs—primarily Bona Fide Service Fees tied to elevated sales volume—along with higher research and development expenses related to three active clinical trials, and increased general and administrative costs driven by expanded headcount as the company scales.
- GAAP net income was $4.5 million or $0.27 per share, compared to $3.3 million or $0.20 per share in Q1 2024. This marks BioStem’s fifth consecutive quarter with positive GAAP net income.
- Quarter-end cash balance of $26.7 million, up from $22.8 million as of December 31, 2024.
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/970503834
The live and archived webcast will be available on the BioStem Technologies website under the Investor Relations section, HERE.
Join BioStem’s Distribution List & Social Media:
To follow the latest developments at BioStem, sign-up to the Company’s email distribution list HERE, and follow us on X and LinkedIn.
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 ® , and VENDAJE OPTIC ® . 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 X and LinkedIn.
Preliminary Results:
BioStem’s financial results for the first quarter 2024 and 2025 included in this press release are preliminary, unaudited and subject to finalization of BioStem’s audited financial statements for the year ended December 31, 2024 and resolution of all SEC comments on the Form 10 registration statement BioStem filed with the SEC in connection with its planned uplist to Nasdaq. These financial results should not be viewed as a substitute for final reviewed results prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preliminary financial results represent management estimates that constitute forward-looking statements subject to risks and uncertainties. As a result, the preliminary financial results and other information provided herein may materially differ from the actual results that will be reflected in the consolidated audited financial statements for the year ended December 31, 2024 and unaudited financial statements for the first quarter ended March 31, 2025 and 2024 when they are completed and publicly disclosed. BioStem undertakes no obligation to update or supplement the information provided herein until it reports its final audited financial results for the year ended December 31, 2024.
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. 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 preliminary financial results for the first quarter 2025; the anticipated timing of current and planned clinical trials; the expectation that such trials will demonstrate the clinical superiority of the Company’s products; the Company’s expectations regarding its ability to uplist to Nasdaq; the Company’s ability to resolve the SEC’s comments to the Company’s Form 10 registration statement; the Company’s strategic initiatives; second 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 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; changes in applicable laws or regulations; the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and the effects of global and regional economic, political, social and health crises;. There may be additional risks about which the Company is presently unaware 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.
BioStem Technologies, Inc.:
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
X: @BSEM_Tech
Facebook: BioStemTechnologies
Investor Relations:
Adam Holdsworth
E-Mail: adam@biostemtech.com
Phone: 917-497-9287
| BioStem Technologies, Inc. and Subsidiaries | ||||||||
| Consolidated Balance Sheets | ||||||||
| March 31, 2025 (Unaudited) | December 31, 2024 (Unaudited) | |||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 26,673,455 | $ | 22,832,706 | ||||
| Accounts receivable, net | 109,657,309 | 104,980,085 | ||||||
| Inventory | 1,972,637 | 1,824,001 | ||||||
| Short-term loan receivable | 1,250,000 | 1,250,000 | ||||||
| Prepaid expenses and other assets | 2,479,457 | 2,874,317 | ||||||
| Total current assets | 142,032,858 | 133,761,109 | ||||||
| Long-Term Assets | ||||||||
| Property and equipment, net | 1,488,128 | 1,504,578 | ||||||
| Construction-in-process | 348,503 | 190,422 | ||||||
| Right-of-use asset, net | 247,104 | 271,214 | ||||||
| Intangible assets, net | 193,270 | 224,137 | ||||||
| Goodwill | 244,635 | 244,635 | ||||||
| Deferred tax assets | 4,759,016 | 4,179,632 | ||||||
| Total assets | $ | 149,313,514 | $ | 140,375,727 | ||||
| Current Liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 4,048,467 | $ | 5,289,787 | ||||
| License fees payable | 443,850 | 2,359,575 | ||||||
| Bona fide services fee payable | 85,525,228 | 81,873,058 | ||||||
| Income tax payable | 4,285,551 | 2,908,730 | ||||||
| Accrued interest | 2,029,677 | 1,962,983 | ||||||
| Operating lease liabilities | 110,653 | 106,722 | ||||||
| Notes payable, net of discount | 3,894,122 | 3,957,744 | ||||||
| Other current liabilities | 1,155,591 | 711,361 | ||||||
| Total current liabilities | 101,493,139 | 99,169,960 | ||||||
| Long-Term Liabilities | ||||||||
| Operating lease liabilities, less current portion | 151,280 | 180,235 | ||||||
| Notes payable, less current portion | 150,000 | 150,000 | ||||||
| Total long-term liabilities | 301,280 | 330,235 | ||||||
| Total liabilities | 101,794,420 | 99,500,195 | ||||||
| Commitments and contingencies (Note 8) | ||||||||
| Stockholders' Equity (Deficit) | ||||||||
| Series A-1 convertible preferred stock, $0.001 par value authorized, 300 shares; issued and outstanding, 300 shares as of December 31, 2024 and December 31, 2023. | - | - | ||||||
| Series B-1 convertible preferred stock, $0.001 par value authorized, 500,000 shares; issued and outstanding 5 shares as of December 31, 2024 and December 31, 2023. | - | - | ||||||
| Common stock, $0.001 par value authorized, 975,000,000 shares issued and outstanding 16,661,482 and 16,214,390 shares as of December 31, 2024 and December 31, 2023, respectively. | 16,602 | 16,662 | ||||||
| Additional paid-in capital | 56,803,063 | 54,642,012 | ||||||
| Treasury stock, 18,000 shares at cost | (43,346 | ) | (43,346 | ) | ||||
| Accumulated deficit | (9,257,226 | ) | (13,739,796 | ) | ||||
| Total stockholders' equity (deficit) | 47,519,094 | 40,875,532 | ||||||
| Total liabilities and stockholders' equity | $ | 149,313,514 | $ | 140,375,727 | ||||
| BioStem Technologies, Inc. and Subsidiaries | ||||||||
| Consolidated Statements of Operations | ||||||||
| Three-months ended, | ||||||||
| March 31, 2025 | March 31, 2024 | |||||||
| Revenue, net | $ | 72,528,112 | $ | 41,904,213 | ||||
| Cost of goods sold | 853,438 | 2,224,704 | ||||||
| Gross profit | 71,674,674 | 39,679,509 | ||||||
| Gross Margin % | 98.8 | % | 94.7 | % | ||||
| Operating Expenses | ||||||||
| Sales and marketing expenses | 57,684,468 | 30,547,721 | ||||||
| General and administrative expenses | 6,994,004 | 4,399,262 | ||||||
| Research and development expenses | 1,690,154 | 70,748 | ||||||
| Depreciation and amortization expense | 56,723 | 53,665 | ||||||
| Total operating expenses | 66,425,350 | 35,071,396 | ||||||
| Income (loss) from operations | 5,249,325 | 4,608,114 | ||||||
| Other income (expense): | ||||||||
| Interest expense, net | 31,617 | (163,942 | ) | |||||
| Other expense | (409 | ) | 1,571 | |||||
| Other income (expense), net | 31,208 | (165,513 | ) | |||||
| Total Income (loss) from operations before income taxes | 5,280,533 | 4,442,601 | ||||||
| Income tax expense | (797,437 | ) | (1,184,687 | ) | ||||
| Net Income (loss) | $ | 4,483,096 | $ | 3,257,914 | ||||
| Basic net income (loss) per share attributable to common stockholders | $ | 0.27 | $ | 0.20 | ||||
| Diluted net income (loss) per share attributable to common stockholders | $ | 0.17 | $ | 0.15 | ||||
| Basic weighted average common shares outstanding | 16,673,875 | 16,316,178 | ||||||
| Diluted weighted average common shares outstanding | 26,257,562 | 22,383,275 | ||||||
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, | ||||||||||||||||
| March 31, 2025 | March 31, 2024 | $ Change | % Change | |||||||||||||
| Net income | $ | 4,483,096 | $ | 3,257,914 | $ | 1,225,182 | 38 | % | ||||||||
| Interest expense | (31,617 | ) | 163,942 | 195,559 | -119 | % | ||||||||||
| Depreciation and amortization | 56,723 | 53,665 | 3,058 | 6 | % | |||||||||||
| Income Taxes | 797,437 | 1,184,687 | (387,250 | ) | -33 | % | ||||||||||
| EBITDA | 5,305,639 | 4,660,208 | 645,431 | 14 | % | |||||||||||
| Share-based compensation | 2,536,933 | 3,279,117 | (742,184 | ) | -23 | % | ||||||||||
| Adjusted EBITDA | $ | 7,842,572 | $ | 7,939,325 | $ | (96,753 | ) | -1 | % | |||||||
