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BioStem Technologies Reports Record Second Quarter 2024 Revenue of $74.5 Million

  • Company reports transformative second-quarter revenue, contributing to a record total of $116.4 million in revenue for the first half of 2024
  • AmnioWrap2 continues to be a major growth driver achieving an impressive 56.5% sequential revenue increase compared to Q1 2024
  • Achieves second consecutive quarter of positive net income with $6.3 million
  • Generated Adjusted Q2 2024 EBITDA of $10.0 million
  • Financial Results Conference Call and Webcast on Monday, August 12, 2024, at 4:30 pm EDT

POMPANO BEACH, Fla., Aug. 12, 2024 (GLOBE NEWSWIRE) — BioStem Technologies Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacture, and commercialization of placental-derived biologics, reports financial results for the second quarter ended June 30, 2024. The Company will host a webcast and conference call on Monday, August 12, 2024, at 4:30 pm EDT.

Jason Matuszewski, CEO of BioStem, stated: “I am pleased to report that BioStem has achieved its second consecutive quarter of net revenue growth and profitability, with $74.5 million generated in this quarter alone. The first half of 2024 has demonstrated significant revenue growth for our products, totaling $116.4 million, a considerable increase from the $1.6 million reported for the same period last year. Moreover, our gross margin remains robust in the mid 90 percent range. This substantial growth has also bolstered our cash position, increasing to $6.6 million for the quarter, a $6 million increase from Q1. Our solid financial performance underscores the positive momentum we’ve built across the company, largely attributable to the stellar success of AmnioWrap2 since its commercial launch in the fourth quarter of 2023.”

Mr. Matuszewski continued: “2024 has been a breakout year for BioStem and the Company is well-positioned to capitalize on the opportunities within the wound care market. We remain focused on advancing our innovative products and driving our strategic initiatives forward. On the clinical trial front, we received Institutional Review Board (IRB) approval for a study evaluating AmnioWrap2® in diabetic foot ulcers (DFU). We are confident that positive data from our ongoing trials will not only propel commercial advancements but also expand payer insurance coverage in the advanced wound care market. BioStem is committed to accelerating revenue growth, enhancing profitability, and delivering substantial value to our shareholders, and we look forward to sharing further updates in the quarters ahead.”

Second Quarter 2024 and Recent Operational Highlights:

  • July: Received Institutional Review Board (IRB) approval to initiate a clinical study evaluating AmnioWrap2(TM) (AW2) in diabetic foot ulcers to demonstrate the efficacy of the product to advance expanded payer insurance coverage.
  • June: Reported breakthrough results with AmnioWrap2® in a retrospective wound care study that was published in Health Science Reports, a peer-reviewed journal, finding superior results for BioStem’s products offering better treatment efficiency in general wound closure.
  • April: Retained clinical research industry veteran Nick McCoy to lead DFU and VLU trials for BioREtain allografts to support BioStem’s clinical focus on completing studies that proactively address the continually changing reimbursement landscape.
  • May: Advanced intellectual property portfolio with the prioritized examination of a critical patent by the USPTO.

Summary Financial Information

The following table represents net revenue, gross margin, operating expenses, and other expenses for the second quarter and year-to-date periods ended June 30, 2024, and June 30, 2023, respectively:

  Three months ended June 30,             Six months ended June 30,        
    2024       2023     $ Change   % Change       2024       2023     $ Change   % Change
                                 
Net revenue $ 74,491,996     $ 1,068,400     $ 73,423,596   6872 %     $ 116,396,284     $ 1,644,503     $ 114,751,781     6978 %
Gross profit $ 70,744,100     $ 862,295     $ 69,881,805   8104 %     $ 110,422,079     $ 1,337,249     $ 109,084,831     8157 %
Gross profit %   95 %     81 %       14 %       95 %     82 %       12 %
Operating expenses $ 61,924,969     $ 3,575,684     $ 58,349,285   1632 %     $ 35,071,396     $ 3,938,106     $ 31,133,289     791 %
Other expense, net $ 142,837     $ 141,638     $ 1,199   -1 %     $ 308,350     $ 898,073     $ (589,723 )   -66 %
                                                           

Second Quarter 2024 Financial Highlights:

  • Net revenue grew to $74.5 million in the second quarter of 2024 compared to $1.0 million in the second quarter of 2023
  • Gross profit was $70.7 million, or 95% of net revenue, in the second quarter of 2024
  • Adjusted EBITDA income was $10.0 million in the second quarter of 2024 compared to an adjusted EBITDA loss of ($1.3) million in the second quarter of 2023

Financial Results for Three-Months Ended June 30, 2024:
Net revenue for the three-months ended June 30, 2024, was $74.5 million compared to $1.0 million for the three-months ended June 30, 2023, an increase of $73.5. The increase in net revenue was driven primarily by the continued market demand of AmnioWrap2 which launched in the 4th quarter of 2023.

Gross profit for the three-months ended June 30, 2024, was $70.7 million, or 95% of net revenue, compared to $0.8 million, or 81% of net revenue, for the three-months ended June 30, 2023, an increase of $69.9 million. The increase in gross profit was primarily driven from the accelerated sales volume and strong margins from the Company’s AmnioWrap2 product.

Operating expenses for the three-months ended June 30, 2024, were $61.9million, compared to $3.6 million for the three-months ended June 30, 2023, an increase of $58.3 million. The increase in operating expenses is primarily due to additional headcount, service fees owed to BioStem’s distributor for AmnioWrap2, and increases in share-based compensation.

Net income for the three months ended June 30, 2024 was $6.4 million or $0.39 per share versus a net loss of ($2.8) million in the three months ended June 30, 2023.

First Half 2024 Financial Highlights

  • Net revenue grew to $116.4 million in the six-month period of 2024 compared to $1.6 million for the same period in 2023
  • Gross profit was $110.4 million, or 95% of net revenue, for the first half of 2024
  • Adjusted EBITDA income was $17.9 million in the first half of 2024 compared to an Adjusted EBITDA loss of ($2.1) million in the first half of 2023

Financial Results for Six-Month Period Ended June 30, 2024
Net revenue for the six-month period ended June 30, 2024, was $116.4 million compared to $1.6 million for the six months ended June 30, 2023, an increase of $114.8 million. The increase in net revenue was driven primarily by the continued market demand of AmnioWrap2 which launched in the 4th quarter of 2023.

Gross profit for the six-months ended June 30, 2024, was $110.4 million, or 95% of net revenue, compared to $1.3 million, or 82% of net revenue, for the six months ended June 30, 2023, an increase of $109.1 million. The increase in gross profit was primarily driven from the accelerated sales volume and strong margins from the Company’s AmnioWrap2 product.

Operating expenses for the six-months ended June 30, 2024, were $35.1 million, compared to $3.9 million for the six-months ended June 30, 2024, an increase of $31.2 million. The increase in operating expenses is primarily due to additional headcount, service fees owed to BioStem’s distributor for AmnioWrap2, and increases in share-based compensation.

  • Conference Call & Webcast Information:
    • Date: Monday, August 12, 2024
    • Time: 4:30 pm EDT
    • Webcast Link: https://events.q4inc.com/attendee/133546543
    • Conference ID: 1391783
    • USA / International Toll: +1 (646) 307-1963
    • USA – Toll-Free: (800) 715-9871
    • Canada – Toronto: (647) 932-3411
    • Canada – Toll-Free: (800) 715-9871

The live and archived webcast of the call will also be available on the BioStem Technologies website under the Investors section or by clicking 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: http://www.biostemtechnologies.com

Forward-Looking Statements 
Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 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: (1) the impact of any changes to the reimbursement levels for the Company’s products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, 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.

Contacts:
BioStem Technologies, Inc.
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
Email: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStem Technologies

Investor Relations:
Jeff Ramson
New York, NY 10001
T: 646-863-6893
jramson@pcgadvisory.com

-Tables Follow-

BioStem Technologies, Inc. and Subsidiaries
Consolidated Balance Sheets
 
         
    June 30, 2024   December 31, 2023
    (unaudited)    
Current Assets        
Cash   $ 6,572,126     $ 239,406  
Accounts receivable, net     78,190,570       11,371,730  
Inventory, net     1,370,749       658,678  
Prepaid expenses and other assets     1,939,187       329,239  
Total current assets     88,072,632       12,599,053  
Long-Term Assets        
Property and equipment, net     1,443,677       1,154,856  
Construction-in-process     43,423       202,700  
Right-of-use asset, net     318,334       11,443  
Intangible assets, net     285,870       347,604  
Goodwill     244,635       244,635  
Other assets     50,009        
Total assets   $ 90,458,580     $ 14,560,291  
         
Current Liabilities        
Accounts payable and accrued expenses   $ 6,892,842     $ 1,391,711  
Bona fide services fee payable (Note 4)     60,792,973       7,787,211  
Accrued interest     1,829,534       1,697,787  
Short-term finance lease     99,567       8,988  
Notes payable     4,007,331       4,445,782  
Other current liabilities, net     587,054       289,409  
Total current liabilities     74,209,301       15,620,888  
Long-Term Liabilities        
Finance lease, less current portion     235,598       3,294  
Notes payable, less current portion     142,436       265,635  
Other long-term liabilities, less current portion           14,850  
Total long-term liabilities     378,034       283,779  
Total liabilities     74,587,335       15,904,667  
         
Commitments and contingencies (Note 10)        
         
Stockholders’ Equity (Deficit)        
Series A-1 convertible preferred stock, $0.001 par value authorized, 300 shares; issued and outstanding, 300 shares as of June 30, 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 June 30, 2024 and December 31, 2023.            
Common stock, $0.001 par value authorized, 975,000,000 shares issued and outstanding 16,287,342 and 16,214,390 shares as of June 30, 2024 and December 31, 2023.     16,418       16,215  
Additional paid-in capital     50,717,858       44,306,872  
Treasury stock, 18,000 shares at cost     (43,346 )     (43,346 )
Accumulated deficit     (34,819,685 )     (45,624,117 )
Total stockholders’ equity (deficit)     15,871,245       (1,344,376 )
Total liabilities and stockholders’ equity (deficit)   $ 90,458,580     $ 14,560,291  
                 

BioStem Technologies, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
               
  Three Months Ended   Six Months Ended
  June 30, 2024   June 30, 2023   June 30, 2024   June 30, 2023
Revenue, net $ 74,491,996     $ 1,068,400     $ 116,396,209     $ 1,644,503  
Cost of goods sold   3,747,896       206,104       5,972,600       307,253  
Gross profit   70,744,100       862,295     $ 110,423,609     $ 1,337,250  
Operating Expenses:              
Sales and marketing expenses   59,003,833       596,101       89,551,554       729,358  
General and administrative expenses   2,786,106       2,862,010       7,185,889       6,503,975  
Research and development expenses   80,917       57,555       151,665       96,421  
Depreciation and amortization expense   54,113       60,018       107,778       118,363  
Total operating expenses   61,924,969       3,575,684       96,996,886       7,448,117  
Income/(loss) from operations   8,819,131       (2,713,389 )     13,426,723       (6,110,867 )
Other Income (Expense):              
Interest expense   (142,722 )     (143,040 )     (306,664 )     (263,466 )
Other income (expense)   (115 )     1,402       (1,686 )     4,893  
Other income (expense), net   (142,837 )     (141,638 )     (308,350 )     (258,573 )
Total Income (loss) from operations before income taxes   8,676,294       (2,855,027 )     13,118,373       (6,369,440 )
Income taxes   (2,313,937 )           (3,498,624 )      
Net Income (loss) $ 6,362,357     $ (2,855,027 )   $ 9,619,749     $ (6,369,440 )
               
Basic net income (loss) per share attributable to common stockholders $ 0.39     $ (0.22 )   $ 0.59     $ (0.50 )
               
Diluted net income (loss) per share attributable to common stockholders $ 0.30     $ (0.22 )   $ 0.43     $ (0.48 )
               
Basic weighted average common shares outstanding   16,296,689       13,259,109       16,306,640       12,848,200  
               
Diluted weighted average common shares outstanding   21,350,511       13,259,109       22,383,275       13,259,109  
                               

NON-GAAP FINANCIALS 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 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 June 30,             Six months ended June 30,        
      2024       2023     $ Change   % Change       2024       2023     $ Change   % Change
                                   
Net income (loss)   $ 6,362,357     $ (2,855,027 )   $ 9,217,383     323 %     $ 9,619,749     $ (6,435,115 )   $ 16,054,863     -249 %
Interest expense     142,722       143,040       (318 )   0 %       306,664       263,474       43,190     16 %
Depreciation and amortization     54,113       60,018       (5,905 )   -10 %       107,778       118,363       (10,585 )   -9 %
Income Tax     2,313,937             2,313,937     0 %       3,498,624             3,498,624     0 %
EBITDA   $ 8,873,129     $ (2,651,969 )   $ 11,525,098     435 %     $ 13,532,815     $ (6,053,277 )   $ 19,586,092     -324 %
Share-based compensation     1,088,391       1,361,027       (272,636 )   -20 %       4,367,508       3,860,247       507,261     13 %
Adjusted EBITDA   $ 9,961,520     $ (1,290,942 )   $ 11,252,462     872 %     $ 17,900,323     $ (2,193,030 )   $ 20,093,353     -916 %
                                                               

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