- 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. ( 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: [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 | ||||||||
| 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 | % | |||||||||||||
