POMPANO BEACH, FLORIDA., November 13, 2022 – 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 quarter ended September 30, 2023.
Jason Matuszewski, Chief Executive Officer of BioStem Technologies Inc. said, “2023 has been a remarkable year of growth and milestones for our organization, we are excited to share our latest achievements, innovations, and strategic partnerships that continue to drive our mission of advancing the development, manufacture, and commercialization of cutting-edge placental-derived allografts for advanced wound care. In this earnings call, we will delve into the recent significant milestones that have shaped our journey, including securing a CMS Q code for VENDAJE AC®, a successful capital raise, the initiation of a crucial clinical trial for diabetic foot ulcers, and game-changing partnerships with NovaBay Pharmaceuticals and Venture Medical. These accomplishments reflect our dedication to transforming the field of regenerative medicine and improving the lives of patients worldwide.”
Three-months Ending September 30, 2023 – Financial Results Summary
Quarter and Year-to Date ending September 30, 2023 – Results:
The following table represents net revenue, gross margin, operating expenses, and other income (loss) for the three and Nine-months ended September 30, 2023, and September 30, 2022, respectively:
Statement of Operations Highlights –Year to Date September 30,2023:
Net revenue for the Nine-months ended September 30, 2023, was $5.24 million, compared to $6.082 million for the Nine-months ended September 30, 2022, a decrease of ($0.839) million, or (14%). The decrease in sales was driven primarily by a shift in business development strategy in the first and second quarters of 2023 away from direct sales to private offices of our Vendaje product to a strategic distributor of our recently announced Amniowrap2 product. This strategic partnership began in the third quarter of 2023.
Gross profit for the Nine-months ended September 30, 2023, was $4.629 million, or 88% of revenue, compared to $5.325 million, or 88% of net revenue, for the Nine-months ended September 30, 2022, a decrease of ($0.696) million, or (13%). Despite the decrease in sales, gross profit remained consistent year over year due to continued movement in our product sales mix shift from higher cost flowable products into membrane products.
Operating expenses for the Nine-months ended September 30, 2023, were $9.582 million, compared to $6.362 million for the Nine-months ended September 30, 2022, an increase of $3.219 million or 51%. The increase in operating expenses is primarily driven by a $2.525 million increase in share-based compensation offset by a reduction in spending on other operating expenses, in particular, sales and marketing.
Total other expense, net, for the Nine-months ended September 30, 2023, was ($0.789) million, compared to ($2.450) million for the Nine-months ended September 30, 2022, a decrease in expense of $1.661 million or 67%. The Nine-months ended September 30, 2022, contained a one-time charge of $2.083 million on a debt restructuring.
Net loss for the Nine-months ended September 30, 2023, was ($5.0) million, or ($0.43) per share, compared to a net loss of ($3.461) million, or ($0.32) per share, for the Nine-months ended September 30, 2022, an increase to net loss of ($2.167) million, or ($0.10) per share.
Statement of Cashflows and Balance Sheet Highlights:
Cashflows (used in) operations was ($2.088) million for the nine-months ended September 30, 2023, compared to cashflows provided by operations of $0.746million for the nine-months ended September 30, 2022. The decrease in cash provided by operations is due to an increase in net loss, an increase in accounts receivable in Q3 to a customer with extended terms offset by other non-cash, GAAP charges included in net loss such as debt restructuring charges and share-based compensation.
Cashflows used in investing activities were ($0.210) million for the nine-months ended September 30, 2023, compared to cashflows used in investing activities of ($0.400) for the nine months ended September 30, 2022.
Cashflows provided by financing activities were $1.636 million and $0.354 million for the Nine-months ended September 30, 2023, and 2022, respectively. The increase in cashflows from financing activities was due to the issuance of common stock for cash of $0.444 million and net new borrowings on debt of $1.191 million.
The Company maintained cash on hand as of September 30, 2023, of $0.110 million compared to $1.042 million as of September 30, 2022.
The Company continues to strengthen its balance sheet. The Company converted $0.378 million of liabilities to common stock during the Nine-months ended September 30, 2023.
Also, as disclosed in the footnotes to the financial statements, the Company completed its private placement in October 2023. An additional $2.0 million cashflows from this financing activity will be reflected in the fourth quarter financial statements.
BIOSTEM TECHNOLOGIRES INC.
CONSOLIDATED BALANCE SHEETS
BIOSTEM TECHNOLOGIES INC.
CONSOLIDATED STATEMENTS OF
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:
Conference Call Details
Date: Tuesday, November 14, 2023
Time: 10:30 am EDT
Conference ID: 4373739
Participant Toll-Free Dial-In Number: 1 (888) 880-2204
Participant Toll Dial-In Number: 1 (646) 960-0414
In order 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 Advanced Chronic Wounds
Advanced wounds represent a significant healthcare concern, characterized by a prolonged healing process and the potential for severe complications. These wounds may encounter healing delays at any stage of the healing cascade due to a variety of factors, including irritation from friction or pressure, poor circulation, persistent inflammation, oxidative stress, and infection. Wound types that are particularly problematic include diabetic foot ulcers, venous leg ulcers, and pressure ulcers. The complexity of treating advanced wounds has a considerable impact on patient well-being and on healthcare systems, highlighted by the need for specialized care. The global advanced wound care market size was valued at $7.0 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.5% from 2023 to 2030
About BioStem’s Product Portfolio
BioStem's structural tissue allograft product portfolio includes VENDAJE®, VENDAJE AC®, VENDAJE OPTIC® and AmnioWrap2®. The company’s VENDAJE® products are placental-derived, minimally manipulated dehydrated tissue allografts that serve as a protective covering for soft tissue wounds. They are comprised of extracellular matrix scaffolding which provides the wound bed with mechanical protection and functional support for cell migration, growth factors that help modulate proliferation and angiogenesis, and anti-inflammatory cytokines that inhibit inflammatory effects, to support the body's natural healing cascade.
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). Its 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, Fla. More information about BioStem Technologies is available here.
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.