• Company reports third sequential quarter of record growth, contributing to a record total of $199.0 million in revenue for the first nine-months of 2024

• Achieves third consecutive quarter of positive GAAP net income of $6.8 million or $0.42 per share.

• Generated Q3 2024 Adjusted EBITDA of $9.9 million

• Financial Results Conference Call and Webcast on Tuesday, November 12, 2024, at 4:30 pm ET

POMPANO BEACH, FL, November 12, 2024 – PRISM MediaWire – 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 financial results for the third quarter ended September 30, 2024. The Company will host a webcast and conference call on Tuesday, November 12, 2024 at 4:30 pm ET.

“I’m pleased to report that BioStem has achieved another major milestone with our third consecutive quarter of record growth. In Q3 2024, we posted revenue of $82.6 million for the quarter, totaling $199 million for the first nine-months of 2024. Our strong financial performance is a direct result of the continued success of our AmnioWrap2® allografts using our patented BioREtain® technology, which is driving increased commercial acceptance across a wide range of non-acute sites of service. I’d like to acknowledge both the BioStem and Venture team for their exceptional dedication and effort in achieving these impressive results.”

“In October, we initiated the nationwide launch of Vendaje AC® in partnership with Venture Medical, following National Average Sale Price (ASP) approval across all Medicare Administrative Contractor (MAC) regions. We are well-positioned to see revenue contributions from this product, which will be included in the results for the fourth quarter of 2024. We continue to execute on our clinical strategy and recently announced breakthrough data for a diabetic foot ulcer study in a peer-reviewed journal, demonstrating the clinical efficacy of BioREtain compared to the standard of care. BioStem also launched the BR-AC-DFU-101 diabetic foot ulcer clinical trial in 60 patients at 10 sites across the U.S., and we are expecting to launch a similarly designed trial for venous leg ulcers, BR-AC-VLU-101. These studies are critical to demonstrating the clinical superiority of BioStem’s products over existing treatments and will be instrumental in expanding payer coverage across commercial plans, Medicare Advantage, and Medicaid.”

“We continue to make advancements in our capital markets strategy. We filed our Registration Statement on Form 10 with the Securities and Exchange Commission and submitted an application for Nasdaq uplisting, signaling our readiness to obtain a national listing. We are confident that the strategic initiatives we’ve implemented will position BioStem for continued success, further accelerating our growth and creating even more value for our shareholders as we look ahead to the remainder of 2024 and beyond.”

Jason Matuszewski, CEO of BioStem

Third Quarter 2024 and Recent Operational Highlights:

• October 29, 2024: BioStem Technologies Initiates Nationwide Launch of Vendaje AC® through Venture Medical Following Established Reimbursement in All Medicare Administrative Contractor (MAC) Regions

• October 17, 2024: BioStem Technologies Reports Breakthrough Results in a Diabetic Foot Ulcer Wound Closure Study Comparing BioREtain® to Standard of Care Treatment

• October 15, 2024: BioStem Technologies Establishes National Pricing for Vendaje AC® from the Center for Medicare Services and Provides Reimbursement in All MAC Regions

• October 2, 2024: BioStem Technologies Initiates BR-AC-DFU-101 Clinical Trial to Study BioREtain® in Diabetic Foot Ulcers

• September 30, 2024: BioStem Technologies, Inc. Files Form 10 with the Securities and Exchange Commission and Submits Nasdaq Application for Uplisting

• August 21, 2024: BioStem Receives Institutional Review Board (IRB) Approval to Advance Clinical Study Evaluating the Value of Vendaje® Compared to the Standard of Care for Non-Healing Diabetic Foot Ulcers

• July 10, 2024: BioStem Receives Institutional Review Board (IRB) Approval to Advance a Clinical Study Evaluating AmnioWrap2® in Diabetic Foot Ulcers

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 September 30, 2024, and September 30, 2023, respectively:

Third Quarter 2024 Financial Highlights:

• Net revenue grew to $82.6 million in Q3 2024, compared to $3.5 million in Q3 2023.

• Gross profit was $78.3 million, or 94.9% of net revenue, in Q3 2024.

• Adjusted EBITDA was $9.9 million in Q3 2024, compared to an adjusted EBITDA loss of $0.1 million in Q3 2023.

• Net income was $6.8 million or $0.42 per share in Q3 2024, compared to a net loss of ($1.5) million or ($0.11) per share in Q3 2023.

Financial Results for the Three-Months Ended September 30, 2024:

Net revenue for the three months ended September 30, 2024, was $82.6 million, compared to $3.5 million for the same period in 2023, reflecting an increase of $79.1 million. This increase was driven primarily by the continued market demand for AmnioWrap2®.

Gross profit for the three months ended September 30, 2024, was $78.3 million, or 94.9% of net revenue, compared to $3.5 million, or 90.7% of net revenue, for the same period in 2023, an increase of $74.8 million. This improvement was largely due to strong sales growth of AmnioWrap2®, which continues to perform well across a range of patient applications.

Operating expenses for the third quarter of 2024 were $69.0 million, compared to $4.5 million for the third quarter of 2023, an increase of $64.5 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.

Year-to-Date Financial Highlights:

• Net revenue for the first nine-months of 2024 grew to $199.0 million, compared to $5.1 million for the same period in 2023.

• Gross profit was $188.7 million, or 94.9% of net revenue, for the nine months ended September 30, 2024.

• Adjusted EBITDA was $27.3 million in the nine-month period of 2024, compared to an adjusted EBITDA loss of $2.7 million for the same period in 2023.

• Net income was $16.3 million or $1.00 per share, compared to a net loss of ($8.0) million or ($0.61) per share for the same period last year.

Financial Results for Nine-Month Period Ended September 30, 2024:

Net revenue for the nine-month period ended September 30, 2024, was $199.0 million, compared to $5.1 million for the same period in 2023, an increase of $193.9 million. This revenue growth is primarily driven by sales of AmnioWrap2®, which has seen continued strong market demand.

Gross profit for the nine-months ended September 30, 2024, was $188.7 million, or 94.9% of net revenue, compared to $4.5 million, or 87.7% of net revenue, for the same period in 2023, an increase of $184.2 million. This growth was primarily attributable to higher sales volumes and improved margins on AmnioWrap2® products.

Operating expenses for the first nine months of 2024 were $166.0 million, compared to $12.0 million for the same period in 2023, an increase of $154 million, due to higher costs related to scaling our operations, including workforce expansion, higher Bona Fide Service Fees associated with the distributor agreements for AmnioWrap2® and increases in share-based compensation.

Conference Call & Webcast Information:

• Conference ID: 9695874
• USA / International Toll: +1 (646) 307-1963
• USA – Toll-Free: (800) 715-9871
• Canada – Toronto: (647) 932-3411
• Canada – Toll-Free: (800) 715-9871
• Webcast Link: https://events.q4inc.com/attendee/565640065

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

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

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:

Source: BioStem Technologies