BioStem Technologies Reports Record Preliminary Fourth-Quarter Net Revenue of $102.9 Million and Preliminary Full-Year 2024 Revenue of $301.8 Million

   -- 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 $301.8 million for the full year. These results reflect the sustained demand for our products and emphasize the strength of our portfolio of skin substitutes powered by BioREtain. The ongoing success of AmnioWrap2$(TM)$ continues to drive growth, and we are also encouraged by the strong first-quarter revenue from Vendaje AC$(R)$. 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(R) 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(R) technology in treating diabetic foot ulcers. Shortly thereafter, the Company secured national pricing for Vendaje AC(R) 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(R) 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(R) 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(R) in treating diabetic foot ulcers using Vendaje(R). 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(R) in treating venous leg ulcers--broadening the platform's clinical reach.

Summary Financial Information(1) :

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(R) and continued market demand for AmnioWrap2(R).

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(R) in Q4 2024, which has no licensing fee and continued market demand for AmnioWrap2(R).

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(R) 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(R) and continued market demand for AmnioWrap2(R).

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