- 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, Fla., Nov. 12, 2024 (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 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.
Jason Matuszewski, CEO of BioStem, commented: “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.”
Mr. Matuszewski continued: “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.”
Mr. Matuszewski concluded: “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.”
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:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||
| 2024 | 2023 | $ Change | % Change | 2024 | 2023 | $ Change | % Change | ||||||||||||||||||||||||
| Net revenue | $ | 82,556,740 | $ | 3,499,756 | $ | 79,056,984 | 2259 | % | $ | 198,952,949 | $ | 5,144,259 | $ | 193,808,690 | 3767 | % | |||||||||||||||
| Gross profit | $ | 78,318,082 | $ | 3,174,680 | $ | 75,143,402 | 2367 | % | $ | 188,741,691 | $ | 4,511,930 | $ | 184,229,761 | 4083 | % | |||||||||||||||
| Gross profit % | 95 | % | 91 | % | 4 | % | 95 | % | 88 | % | 7 | % | |||||||||||||||||||
| Operating expenses | $ | 69,025,742 | $ | 4,512,391 | $ | 64,513,351 | 1430 | % | $ | 166,022,628 | $ | 12,026,182 | $ | 153,996,446 | 1281 | % | |||||||||||||||
| Operating income (loss) | $ | 9,292,340 | $ | (1,337,711 | ) | $ | 10,630,051 | 795 | % | $ | 22,719,063 | $ | (7,514,252 | ) | $ | 30,233,315 | 402 | % | |||||||||||||
| Other expense, net | $ | 139,289 | $ | 200,443 | $ | (61,154 | ) | 31 | % | $ | 523,968 | $ | 459,016 | $ | 64,952 | 14 | % | ||||||||||||||
| Net income (loss) | $ | 6,820,403 | $ | (1,538,154 | ) | $ | 8,358,557 | 543 | % | $ | 16,363,823 | $ | (7,973,268 | ) | $ | 24,337,091 | 305 | % | |||||||||||||
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 applicable securities laws. 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 in this release include statements regarding the Company’s plans and expectations for future performance, including: (i) the Company’s expectations about the impact of Vendaje AC® on revenue growth; (ii) the Company’s clinical strategy and the impact of breakthrough data; (iii) the anticipated timing for future clinical trials as well as the expectation that such trials will demonstrate the clinical superiority of the Company’s products; (iv) the Company’s expectations regarding its ability to uplist to Nasdaq; (v) the Company’s strategic initiatives and the Company’s ability to accelerate growth in 2024 and beyond and (vi) the Company’s expectations regarding the demand for its products.
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. The following is a list of factors, among others, that could cause actual results to differ materially from those contemplated by the forward-looking statements: the impact of any changes to the reimbursement levels for the Company’s products; market demand and acceptance of the Company’s products; ability to sustain revenue growth; ability to effectively compete with its competitors; ability to convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; ability to raise funds to expand its business; changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; ability to maintain production of its products in sufficient quantities to meet demand; ability to conduct clinical studies to demonstrate the efficacy of the Company’s products and the risks described in our registration statement on Form 10 filed with the Securities and Exchange Commission (the “SEC”) on September 27, 2024, and as may be identified in subsequent reports filed with the SEC. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. 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
| BioStem Technologies, Inc. and Subsidiaries | ||||||||
| Consolidated Balance Sheets | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| Current Assets | (Unaudited) | |||||||
| Cash | $ | 14,613,488 | $ | 239,406 | ||||
| Accounts receivable, net | 81,072,073 | 11,371,730 | ||||||
| Inventory | 2,073,248 | 658,678 | ||||||
| Short-term loan receivable | 1,250,000 | - | ||||||
| Prepaid expenses and other assets | 2,374,643 | 329,239 | ||||||
| Total current assets | 101,383,452 | 12,599,053 | ||||||
| Long-Term Assets | ||||||||
| Property and equipment, net | 1,420,506 | 1,154,856 | ||||||
| Construction-in-process | 166,257 | 202,700 | ||||||
| Right-of-use asset, net | 295,101 | 11,443 | ||||||
| Intangible assets, net | 255,003 | 347,604 | ||||||
| Goodwill | 244,635 | 244,635 | ||||||
| Other assets | 435,510 | - | ||||||
| Total assets | $ | 104,200,464 | $ | 14,560,291 | ||||
| Current Liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 2,074,129 | $ | 870,236 | ||||
| License fee payable (Note 5) | 3,209,325 | 521,475 | ||||||
| Bona fide services fee payable (Note 5) | 62,993,743 | 7,787,211 | ||||||
| Income tax payable | 5,831,272 | - | ||||||
| Accrued interest | 1,896,258 | 1,697,787 | ||||||
| Short-term finance lease | - | 8,988 | ||||||
| Operating lease liabilities | 103,083 | - | ||||||
| Notes payable, net of discount | 4,018,373 | 4,445,782 | ||||||
| Other current liabilities | 884,732 | 289,409 | ||||||
| Total current liabilities | 81,010,915 | 15,620,888 | ||||||
| Long-Term Liabilities | ||||||||
| Operating lease liabilities, less current portion | 208,338 | - | ||||||
| Finance lease liabilities, less current portion | - | 3,294 | ||||||
| Notes payable, less current portion | 150,000 | 265,635 | ||||||
| Other long-term liabilities, less current portion | - | 14,850 | ||||||
| Total long-term liabilities | 358,338 | 283,779 | ||||||
| Total liabilities | 81,369,253 | 15,904,667 | ||||||
| Commitments and Contingencies (Note 11) | ||||||||
| Stockholders' Equity (Deficit) | ||||||||
| Series A-1 convertible preferred stock, $0.001 par value authorized, 300 shares; issued and outstanding, 300 shares as of September 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 September 30, 2024 and December 31, 2023. | - | - | ||||||
| Common stock, $0.001 par value authorized, 975,000,000 shares issued and outstanding 16,338,436 and 16,214,390 shares as of September 30, 2024 and December 31, 2023. | 16,339 | 16,215 | ||||||
| Additional paid-in capital | 52,118,512 | 44,306,872 | ||||||
| Treasury stock, 18,000 shares at cost | (43,346 | ) | (43,346 | ) | ||||
| Accumulated deficit | (29,260,294 | ) | (45,624,117 | ) | ||||
| Total stockholders' equity (deficit) | 22,831,211 | (1,344,376 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 104,200,464 | $ | 14,560,291 | ||||
| BioStem Technologies, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30, 2024 | September 30, 2023 | September 30, 2024 | September 30, 2023 | ||||||||||||
| Revenue, net | $ | 82,556,740 | $ | 3,499,756 | $ | 198,952,949 | $ | 5,144,259 | |||||||
| Cost of goods sold | 4,238,658 | 325,076 | 10,211,258 | 632,329 | |||||||||||
| Gross profit | $ | 78,318,082 | $ | 3,174,680 | $ | 188,741,691 | $ | 4,511,930 | |||||||
| Operating Expenses: | |||||||||||||||
| Sales and marketing expenses | 65,187,066 | 2,307,209 | 154,736,499 | 3,402,582 | |||||||||||
| General and administrative expenses | 3,299,381 | 2,111,625 | 10,483,155 | 8,281,048 | |||||||||||
| Research and development expenses | 482,495 | 37,512 | 638,396 | 168,144 | |||||||||||
| Depreciation and amortization expense | 56,800 | 56,045 | 164,578 | 174,408 | |||||||||||
| Total operating expenses | 69,025,742 | 4,512,391 | 166,022,628 | 12,026,182 | |||||||||||
| Income/(loss) from operations | 9,292,340 | (1,337,711 | ) | 22,719,063 | (7,514,252 | ) | |||||||||
| Other Income (Expense): | |||||||||||||||
| Interest expense | (138,478 | ) | (199,776 | ) | (521,471 | ) | (463,242 | ) | |||||||
| Other (expense) income | (811 | ) | (667 | ) | (2,497 | ) | 4,226 | ||||||||
| Other expense, net | (139,289 | ) | (200,443 | ) | (523,968 | ) | (459,016 | ) | |||||||
| Total Income (loss) from operations before income taxes | 9,153,051 | (1,538,154 | ) | 22,195,095 | (7,973,268 | ) | |||||||||
| Income taxes | 2,332,648 | - | 5,831,272 | - | |||||||||||
| Net Income (loss) | $ | 6,820,403 | $ | (1,538,154 | ) | $ | 16,363,823 | $ | (7,973,268 | ) | |||||
| Basic net income (loss) per share attributable to common stockholders | $ | 0.42 | $ | (0.11 | ) | $ | 1.00 | $ | (0.61 | ) | |||||
| Diluted net income (loss) per share attributable to common stockholders | $ | 0.32 | $ | (0.11 | ) | $ | 0.79 | $ | (0.61 | ) | |||||
| Basic weighted average common shares outstanding | 16,324,482 | 13,497,502 | 16,312,517 | 13,112,918 | |||||||||||
| Diluted weighted average common shares outstanding | 21,129,197 | 13,497,502 | 20,771,288 | 13,112,918 | |||||||||||
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:
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||
| 2024 | 2023 | $ Change | % Change | 2024 | 2023 | $ Change | % Change | ||||||||||||||||||||||
| Net income (loss) | $ | 6,820,403 | $ | (1,538,154 | ) | $ | 8,358,557 | 543 | % | $ | 16,363,823 | $ | (7,973,268 | ) | $ | 24,337,091 | 305 | % | |||||||||||
| Interest expense | 138,478 | 199,776 | 61,298 | 31 | % | 521,471 | 463,242 | (58,229 | ) | -13 | % | ||||||||||||||||||
| Depreciation and amortization | 56,800 | 56,045 | 755 | 1 | % | 164,578 | 174,408 | (9,830 | ) | -6 | % | ||||||||||||||||||
| Income Tax | 2,332,648 | - | 2,332,648 | 100 | % | 5,831,272 | - | 5,831,272 | 100 | % | |||||||||||||||||||
| EBITDA | $ | 9,348,329 | $ | (1,282,333 | ) | $ | 10,630,662 | 829 | % | $ | 22,881,144 | $ | (7,335,618 | ) | $ | 30,216,762 | 412 | % | |||||||||||
| Share-based compensation | 528,000 | 1,185,800 | (657,800 | ) | -55 | % | 4,458,557 | 4,649,461 | (190,904 | ) | -4 | % | |||||||||||||||||
| Adjusted EBITDA | $ | 9,876,329 | $ | (96,533 | ) | $ | 9,972,862 | 10331 | % | $ | 27,339,701 | $ | (2,686,157 | ) | $ | 30,025,858 | 1118 | % | |||||||||||
