– Company Achieves Record-Breaking First Quarter Results for 2024, Marking the Launch of BioStem 2.0 –
– Company Reports First Quarter EBITDA of $4.9 Million –
– Project Continued Growth from Sales of AmnioWrap2 ® –
– Financial Results Conference Call and Webcast on Tuesday May 14, 2024 at 4:30 pm EDT –
POMPANO BEACH, Fla., May 14, 2024 (GLOBE NEWSWIRE) — BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived biologics, today reported financial results for the first quarter ended March 31, 2024.
Jason Matuszewski, CEO of BioStem, commented, “BioStem had an outstanding first quarter. Revenue reached $41.9 million, nearly 71 times higher than revenue of roughly $0.6 million for last year’s comparable quarter. This growth was driven by the continued successful commercial acceptance into the private office setting of AmnioWrap2, our innovative placental-derived allograft product designed to address a broad spectrum of wound applications. Gross margin reached 95% of revenue compared to 82% in the first quarter of 2023, reflecting the increase in sales and the ongoing benefit from our distribution agreement with Venture Medical. On a US GAAP basis, we are also pleased to report being net income positive for the first time in the history of the Company as well as converting from a net shareholders’ deficit position into a net positive equity position.
“An exciting recent development is the USPTO’s prioritized examination of our patent for BioREtain ® processing technology, essential for BioStem’s product differentiation and advanced wound care support. We’ve also advanced our clinical capabilities by engaging McCoy Clinical Consulting to lead our Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) trials, to accelerate trial processes and demonstrate the real-world benefits of our BioREtain products. Additionally, completing our strategic two-year audit strengthens our financial transparency and governance. These advancements in operations, governance, clinical trials, and sales strategies have launched BioStem 2.0, marking a new phase in our evolution as a global MedTech leader, focused on driving revenue growth and expanding our operational scale.”
Recent Highlights:
- Engaged McCoy Clinical Consulting to spearhead pivotal clinical trials for Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) treatments, enhancing the company’s clinical capabilities.
- Advanced intellectual property portfolio with the prioritized examination of a critical patent by the USPTO.
First Quarter 2024 Financial Highlights
- Net revenue grew to $41.9 million in the first quarter of 2024 compared to $0.6 million in the first quarter of 2023.
- Gross profit was $39.7 million, or 95% of revenue, in the first quarter of 2024.
- Adjusted EBITDA income was $7.9 million in the first quarter of 2024 compared to an Adjusted EBITDA loss of ($1.0) million in the first quarter of 2023.
- First quarter in the history of the Company with positive GAAP income.
First Quarter 2024 Operational Highlights
- Completed two years of audited financial statements in continued preparation for moving the Company to a national exchange.
- Completed construction and provisioned equipment for expansion of processing capacity.
- Expanded the Quality, Operational, Sales and Marketing teams to support increased capacity and drive growth.
First Quarter–Financial Results:
The following table represents net revenue, gross margin, operating expenses, and other expenses for the first quarter March 31, 2024, and March 31, 2023, respectively:
| Three months ended March 31, | ||||||||||||||
| 2024 | 2023 | $ Change | % Change | |||||||||||
| Net revenue | $ | 41,904,213 | $ | 576,103 | $ | 41,328,110 | 7174% | |||||||
| Gross profit | $ | 39,679,509 | $ | 474,954 | $ | 39,204,556 | 8254% | |||||||
| Gross profit % | 95% | 82% | 12% | |||||||||||
| Operating expenses | $ | (35,071,396) | $ | (3,938,106) | $ | (31,133,289) | 791% | |||||||
| Other expense, net | $ | (165,513) | $ | (116,935) | $ | (48,578) | -42% | |||||||
Financial Results for Three Months Ended March 31, 2023
Net revenue for the three months ended March 31, 2024, was $41.9 million compared to $0.6 million for the three months ended March 31, 2023, an increase of $41.3 million, or 7,174%. 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 March 31, 2024, was $39.7 million, or 95% of revenue, compared to $0.5 million, or 82% of net revenue, for the three months ended March 31, 2023, an increase of $39.2 million. The increase in gross profit resulted primarily from the acceleration of sales volume of the Company’s higher margin AmnioWrap2 products and no sales of higher cost flowable products in the first quarter of 2024.
Operating expenses for the three-months ended March 31, 2024, were $35.1 million, compared to $3.9 million for the three-months ended March 31, 2023, an increase of $31.1 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 Details
Date: Tuesday, May 14, 2024
Time: 4:30 pm EDT
Webcast Link: https://events.q4inc.com/attendee/274186276
Participant Toll-Free Dial-In Number : 1 (888) 596-4144
Participant Toll Dial-In Number : 1 (646) 968-2525
To submit questions, participants must have Internet connectivity as questions will only be addressed via the webcast. The conference call line will be in listen-only mode.
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: [email protected]
Twitter: @BSEM_Tech
Facebook: BioStem Technologies
Investor Relations:
Jeff Ramson
New York, NY 10001
T: 646-863-6893
[email protected]
-Tables Follow-
| BioStem Technologies, Inc. and Subsidiaries | |||||||
| Consolidated Balance Sheets | |||||||
| (Unaudited) | |||||||
| March 31, 2024 | December 31, 2023 | ||||||
| Current Assets | |||||||
| Cash | $ | 643,241 | $ | 239,406 | |||
| Accounts receivable, net | 41,622,643 | 11,371,730 | |||||
| Inventory, net | 882,763 | 658,678 | |||||
| Prepaid expenses and other assets | 585,489 | 329,239 | |||||
| Total current assets | 43,734,136 | 12,599,053 | |||||
| Long-Term Assets | |||||||
| Property and equipment, net | 1,133,865 | 1,154,856 | |||||
| Construction-in-process | 215,081 | 202,700 | |||||
| Right-of-use asset, net | 9,636 | 11,443 | |||||
| Intangible assets, net | 316,737 | 347,604 | |||||
| Goodwill | 244,635 | 244,635 | |||||
| Other assets | 20,000 | – | |||||
| Total assets | $ | 45,674,089 | $ | 14,560,291 | |||
| Current Liabilities | |||||||
| Accounts payable and accrued expenses | $ | 2,818,370 | $ | 1,391,711 | |||
| Bona fide services fee payable (Note 4) | 29,839,849 | 7,787,211 | |||||
| Accrued interest | 1,762,824 | 1,697,787 | |||||
| Short-term finance lease | 8,988 | 8,988 | |||||
| Notes payable | 4,125,902 | 4,445,782 | |||||
| Other current liabilities | 251,060 | 289,409 | |||||
| Total current liabilities | 38,806,994 | 15,620,888 | |||||
| Long-Term Liabilities | |||||||
| Finance lease, less current portion | 1,397 | 3,294 | |||||
| Notes payable, less current portion | 216,263 | 265,635 | |||||
| Other long-term liabilities, less current portion | 7,425 | 14,850 | |||||
| Total long-term liabilities | 225,085 | 283,779 | |||||
| Total liabilities | 39,032,078 | 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 March 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 March 31, 2024 and December 31, 2023. | – | – | |||||
| Common stock, $0.001 par value authorized, 975,000,000 shares issued and outstanding 16,343,762 and 16,214,390 shares as of March 31, 2024 and December 31, 2023. | 16,354 | 16,215 | |||||
| Additional paid-in capital | 47,851,046 | 44,306,872 | |||||
| Treasury stock, 18,000 shares at cost | (43,346 | ) | (43,346 | ) | |||
| Accumulated deficit | (41,182,043 | ) | (45,624,643 | ) | |||
| Total stockholders’ equity (deficit) | 6,642,011 | (1,344,376 | ) | ||||
| Total liabilities and stockholders’ equity (deficit) | $ | 45,674,089 | $ | 14,560,291 | |||
| BioStem Technologies, Inc. and Subsidiaries | |||||||
| Consolidated Statements of Operations | |||||||
| (Unaudited) | |||||||
| Three-months ended, | |||||||
| March 31, 2024 | March 31, 2023 | ||||||
| Revenue, net | $ | 41,904,213 | $ | 576,103 | |||
| Cost of goods sold | 2,224,704 | 101,149 | |||||
| Gross profit | 39,679,509 | 474,954 | |||||
| Operating Expenses: | |||||||
| Sales and marketing expenses | 30,547,721 | 133,257 | |||||
| General and administrative expenses | 4,399,262 | 3,746,505 | |||||
| Research and development expenses | 70,748 | – | |||||
| Depreciation and amortization expense | 53,665 | 58,345 | |||||
| Total operating expenses | 35,071,396 | 3,938,106 | |||||
| Income/(loss) from operations | 4,608,114 | (3,463,153 | ) | ||||
| Other Income (Expense): | |||||||
| Interest expense | 163,942 | 120,426 | |||||
| Other income (expense) | (1,571 | ) | 3,491 | ||||
| Other income (expense), net | 165,513 | 116,935 | |||||
| Total Income (loss) from operations before income taxes | 4,442,601 | (3,580,088 | ) | ||||
| Income taxes | – | – | |||||
| Net Income (loss) | $ | 4,442,075 | $ | (3,580,088 | ) | ||
| Basic net income (loss) per share attributable to common stockholders | $ | 0.27 | $ | (0.28 | ) | ||
| Diluted net income (loss) per share attributable to common stockholders | $ | 0.20 | $ | (0.28 | ) | ||
| Basic weighted average common shares outstanding | 16,316,178 | 12,564,950 | |||||
| Diluted weighted average common shares outstanding | 22,383,275 | 12,564,950 | |||||
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 March 31, | |||||||||||||||
| 2024 | 2023 | $ Change | % Change | ||||||||||||
| Net income (loss) | $ | 4,442,075 | $ | (3,580,088 | ) | $ | 8,022,162 | 224 | % | ||||||
| Interest expense | 163,942 | 120,426 | 43,517 | -36 | % | ||||||||||
| Depreciation and amortization | 53,665 | 58,345 | (4,680 | ) | -8 | % | |||||||||
| EBITDA | $ | 4,659,682 | $ | (3,401,317 | ) | $ | 8,060,999 | 237 | % | ||||||
| Share-based compensation | 3,279,098 | 2,428,546 | 850,552 | ||||||||||||
| Adjusted EBITDA | $ | 7,938,780 | $ | (972,771 | ) | $ | 8,911,551 | 916 | % | ||||||
| Adjusted EBITDA / Revenue | 1378 | % | -35 | % | 1413 | % | |||||||||
