Company reports record preliminary fourth quarter net revenue of $102.9 Million, contributing to a total of $301.8 Million in revenue for 2024
Achieves preliminary GAAP net income of $15.5 million, or $0.94 per share, marking the fourth consecutive quarter of profitability
Preliminary Q4 2024 Adjusted EBITDA of $11.1 Million
Financial Results Conference Call and Webcast to be held on April 14, 2025 at 4:30 pm ET
POMPANO BEACH, Fla., April 14, 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 fourth quarter and full year ended December 31, 2024. The Company will host a webcast and conference call today, April 14, 2025, at 4:30 pm ET. These results are unaudited, have been prepared consistent with the Company’s current accounting policies and are subject to resolution of all SEC comments on the Company’s pending Form 10 related to its planned uplisting to Nasdaq as discussed below.
Jason Matuszewski, CEO of BioStem, commented: “2024 was a transformative year for BioStem, with our fourth consecutive quarter of record revenue growth, preliminarily reporting $102.9 million in the fourth quarter and $301.8 million for the full year. These results reflect the sustained demand for our products and emphasize the strength of our portfolio of skin substitutes powered by BioREtain. The ongoing success of AmnioWrap2™ continues to drive growth, and we are also encouraged by the strong first-quarter revenue from Vendaje AC®. I would like to recognize our dedicated team at BioStem and our commercial partners at Venture Medical for their outstanding performance in the fourth quarter and throughout the year.”
Mr. Matuszewski continued: "BioStem remains committed to demonstrating the clinical effectiveness of our BioREtain® technology. Since the fourth quarter, we have initiated three clinical trials evaluating the efficacy of BioREtain-powered products against the standard of care in patients with diabetic foot ulcers or venous leg ulcers. Separately, we were pleased to announce groundbreaking results in the fourth quarter from a retrospective study on DFU wound closure, which was published in the peer-reviewed International Wound Journal. These trials are aimed at demonstrating clinical superiority for healthcare professionals and payers, which will support ongoing market expansion.”
Fourth Quarter 2024 and Recent Corporate Highlights:
Over the past several months, BioStem has achieved a series of clinical, regulatory, and financial milestones that reflect the Company’s ongoing growth and innovation in regenerative medicine. In October 2024, BioStem initiated the BR-AC-DFU-101 clinical trial to study the therapeutic effects of its BioREtain® technology in treating diabetic foot ulcers. Shortly thereafter, the Company secured national pricing for Vendaje AC® from the Centers for Medicare & Medicaid Services (CMS), enabling reimbursement in all Medicare Administrative Contractor (MAC) regions. With reimbursement established, BioStem proceeded with the nationwide launch of Vendaje AC® in collaboration with Venture Medical.
Strengthening its clinical evidence base, BioStem reported breakthrough results from a diabetic foot ulcer wound closure study in October, showing BioREtain® outperformed standard of care treatments. These findings reinforced the value of the company’s technology in advanced wound care.
In November 2024, BioStem reported record third quarter revenue of $82.6 million, continuing its trend of strong financial performance. That same month, the Company received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application related to its sterile human placental allografts—expanding its intellectual property portfolio.
Entering 2025, BioStem launched a new clinical trial in January to evaluate the efficacy of BioREtain® in treating diabetic foot ulcers using Vendaje®. Most recently, in February 2025, BioStem received Institutional Review Board (IRB) approval to advance a new clinical trial aimed at demonstrating the therapeutic benefits of BioREtain® in treating venous leg ulcers—broadening the platform’s clinical reach.
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 December 31, 2024, and December 31, 2023, respectively:
Year ended December 31,
Three months ended December 31,
2024
2023
$ Change
% Change
2024
2023
$ Change
Net revenue
$
301,827,302
$
16,685,405
$
285,141,897
1709
%
$
102,874,353
$
11,541,146
$
91,333,207
Gross profit
$
288,081,477
$
15,424,847
$
272,656,630
1768
%
$
99,339,786
$
10,912,917
$
88,426,869
Gross profit %
95
%
92
%
3
%
97
%
95
%
Operating expenses
$
256,880,836
$
23,203,816
$
233,677,020
1007
%
$
90,858,208
$
11,177,634
$
79,680,574
Operating income (loss)
$
31,200,641
$
(7,778,969
)
$
38,979,610
501
%
$
8,481,578
$
(264,717
)
$
8,746,295
Other expense, net
$
683,680
$
(704,015
)
$
1,387,695
197
%
$
7,038,920
$
(244,999
)
$
7,283,919
Net income (loss)
$
31,884,321
$
(8,482,984
)
$
40,367,305
476
%
$
15,520,498
$
(509,716
)
$
16,030,214
_______________ 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.
Fourth Quarter 2024 Financial Highlights:
Net revenue was $102.9 million in Q4 2024, compared to $11.5 million in Q4 2023, which is an increase of $91.3 million, or $791%
Gross profit was $99.3 million in Q4 2024, or 97% of net revenue, compared to $10.9 million in Q4 2023, or 95%
Adjusted EBITDA was $11.1 million in Q4 2024, compared to adjusted EBITDA of $1.3 million in Q4 2023. (See the non-GAAP financial measures table below)
GAAP Net income was $15.5 million or $0.94 per share in Q4 2024, compared to a net loss of $510 thousand or ($0.04) per share in Q4 2023
Financial Results for the Three-Months Ended December 31, 2024:
Net revenue for the three months ended December 31, 2024, was $102.9 million, compared to $11.5 million for the same period in 2023, reflecting an increase of $91.3 million for the quarter. This increase was driven primarily by the nationwide launch of Vendaje AC® and continued market demand for AmnioWrap2®.
Gross profit for the three months ended December 31, 2024, was $99.3 million, or 97% of net revenue, compared to $10.9 million, or 95% of net revenue for the same period in 2023, reflecting an increase of $88.4 million. This improvement was largely due to nationwide launch of Vendaje AC® in Q4 2024, which has no licensing fee and continued market demand for AmnioWrap2®.
Operating expenses for the fourth quarter of 2024 were $90.9 million, compared to $11.2 million for the fourth quarter of 2023, an increase of $79.7 million. The increase in operating expenses is primarily due to increased headcount, higher Bona Fide Service Fees associated with the distributor agreement for AmnioWrap2® and increases in share-based compensation.
Full Year 2024 Financial Highlights:
Net revenue for fiscal 2024 was $301.8 million, compared to $16.7 million reported for fiscal 2023, which is an increase of $285.1 million, or $1,709%
Gross profit was $288.1 million for fiscal 2023, or 95% of net revenue, compared to $15.4 million for fiscal year 2023, representing a 1,768 % increase
Adjusted EBITDA was $39.4 million for fiscal 2024, compared to an adjusted EBITDA loss of $$892 thousand for the same period in 2023. (See the non-GAAP financial measures table below)
Net income was $31.9 million, or $1.95 per share, compared to a net loss of $8.5 million, or $0.62 per share for the same period last year
Financial Results for 12-Month Period Ended December 31, 2024:
Net revenue for the 12-month period ended December 31, 2024, was $301.8 million, compared to $16.7 million for the same period in 2023, an increase of $285.1 million. This increase was driven primarily by the nationwide launch of Vendaje AC® and continued market demand for AmnioWrap2®.
Gross profit for the 12-months ended December 31, 2024, was $288.1 million, or 95% of net revenue, compared to $15.4 million, or 92% of net revenue for the same period in 2023, an increase of $272.7 million. This growth was primarily attributable to new sales volumes from the launch of Vendaje AC® and the continued growth of AmnioWrap2®.
Operating expenses for the 12-months of 2024 were $256.9 million, compared to $23.2 million for the same period in 2023, an increase of $233.7 million. The increase was due to higher costs related to scaling our operations, including workforce expansion, higher Bona Fide Service Fees associated with the Venture Medical distributor agreements and increases in share-based compensation.
The live and archived webcast of the call will also be available on the BioStem Technologies website under the Investor Relations section HERE.
About BioStem Technologies, Inc.:
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, please visit: www.biostemtechnologies.com.
Preliminary Results
BioStem’s financial results for the fourth quarter and full year 2024 included in this press release are preliminary, unaudited and subject to finalization of year-end financial and accounting procedures and resolution of all SEC comments on the Form 10 BioStem filed with the SEC in connection with its planned uplist to Nasdaq. These financial results should not be viewed as a substitute for audited 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 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:
Except for statements of historical fact, this release also contains forward-looking statements within the meaning of applicable securities laws. These forward-looking statements 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 matters. Forward-looking statements in this release include statements regarding the Company’s plans and expectations for future performance, including: (i) the preliminary financial results for the fourth quarter and full year ended December 31, 2024; (ii) the impact of Vendaje AC® on revenue growth and SG&A expenses; (iii) the Company’s clinical strategy and the impact of breakthrough data; (iv) the anticipated timing for future clinical trials as well as the expectation that such trials will demonstrate the clinical superiority of the Company’s products; (v) the Company’s expectations regarding its ability to uplist to Nasdaq; (vi) the SEC’s comments to the Company’s Form 10 and its ability to resolve such comments; (vii) potential changes to the Company’s financial reporting as a result of the SEC review process, including any resulting impacts to the Company’s revenue, net income, Adjusted EBITDA or EPS; (viii) the Company’s strategic initiatives and the Company’s ability to accelerate growth, innovate and compete in 2025 and beyond; (ix) first quarter revenue; (x) demand for its products; (xi) the outcome of the proposed Local Coverage Determination adjustments; and (xii) continued financial growth, further clinical validation, expanded payer coverage, and ongoing market penetration of our 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. The following is a list of factors, among others, that could cause actual results to differ materially from those contemplated by the forward-looking statements: the impact of any changes to the reimbursement levels for the Company’s products; market demand and acceptance of the Company’s products; ability to sustain revenue growth; ability to effectively compete with its competitors; 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; ability to raise funds to expand its business; changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; ability to maintain production of its products in sufficient quantities to meet demand; ability to conduct clinical studies to demonstrate the efficacy of the Company’s products and the risks described in our registration statement on Form 10 filed with the Securities and Exchange Commission (the “SEC”) on January 23, 2025, and as may be identified in subsequent reports filed with the SEC. 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 commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
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.
16,662
16,215
Additional paid-in capital
54,642,012
44,306,872
Treasury stock, 18,000 shares at cost
(43,346
)
(43,346
)
Accumulated deficit
(13,739,796
)
(45,624,117
)
Total stockholders' equity (deficit)
40,875,532
(1,344,376
)
Total liabilities and stockholders' equity
$
140,375,727
$
14,560,291
BioStem Technologies, Inc. and Subsidiaries
Consolidated Statements of Operations
Years Ended
December 31, 2024
December 31, 2023
Revenue, net
$
301,827,302
$
16,685,405
Cost of goods sold
13,745,825
1,260,558
Gross profit
288,081,477
15,424,847
Operating Expenses:
95.4
%
92.4
%
Sales and marketing expenses
236,058,090
11,986,385
General and administrative expenses
18,690,414
10,646,421
Research and development expenses
1,911,031
341,996
Depreciation and amortization expense
221,301
229,014
Total operating expenses
256,880,836
23,203,816
Income (loss) from operations
31,200,641
(7,778,969
)
Other income (expense):
Interest expense, net
(587,222
)
(700,326
)
Other expense
-
(3,689
)
Other income (expense), net
(587,222
)
(704,015
)
Total Income (loss) from operations before income taxes
30,613,419
(8,482,984
)
Income tax benefit
1,270,902
-
Net Income (loss)
$
31,884,321
$
(8,482,984
)
Basic net income (loss) per share attributable to common stockholders
$
1.95
$
(0.62
)
Diluted net income (loss) per share attributable to common stockholders
$
1.47
$
(0.62
)
Basic weighted average common shares outstanding
16,368,429
13,748,035
Diluted weighted average common shares outstanding
21,698,384
13,748,035
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:
