Pompano Beach, FL, December 7, 2018 -- BioStem Technologies, Inc. (OTC PINK: BSEM) (“BioStem Technologies” or the “Company”), a global life sciences corporation providing innovative technologies with a concentration in Pharmaceuticals and Regenerative Medicine, today released a third quarter 2018 shareholder letter to update shareholders on its recent accomplishments and upcoming milestones.
“2018 has been a year of tremendous growth and transition for BioStem Technologies, exemplified notably by the launch of four placental-derived tissue allografts that have been developed for the Regenerative Medicine Market,” said Henry Van Vurst, BioStem Technologies’ Chief Executive Officer. “As we prepare to launch with RHEO™ and Vendaje™ in the U.S. market, we are advancing our pharmaceutical active ingredient repacking business, Qualified Pharma Ingredients Inc., the majority owned subsidiary (“QPI”), and making pre-clinical progress with our drug development in Nesvik Pharmaceuticals, Inc., our wholly owned subsidiary (“Nesvik”). We are pleased to share our third quarter successes across our total company portfolio - a breadth of progress that is a testament to the tireless work of the BioStem Technologies team.”
BioStem Life Sciences
BioStem Life Sciences, Inc., a wholly owned subsidiary of BioStem Technologies, launched in Q3 with four placental-derived tissue allografts under the brand names RHEO™, Vendaje™ and Vendaje AC™ with initial sales being encouraging as the rollout continues. RHEO™, a connective tissue allograft flowable matrix derived from human amnion fluid, preserved to maintain the structural properties of the attractive, biologically active elements present in tissue regeneration. Vendaje AC™, is a matrix allograft composed of dehydrated human amnion/chorion membrane that contains multiple extracellular matrix proteins, growth factors, cytokines, and other specialty proteins, preserved to maintain the structural properties of the attractive, biologically active elements present in tissue regeneration. RHEO™ and Vendaje™ sales made up a large part of our total revenue in Q3. We expect this trend to continue into Q4 2018 and in 2019
Qualified Pharma Ingredients
It is our expectation that Qualified Pharma Ingredients will launch six new products in the fourth fiscal quarter of 2018. QPI is a premier supplier of high-quality active pharmaceutical ingredients and other pharmaceutical compounding supplies, and the addition of recent certification from the DEA to handle controlled substances now expands our deliverable product line. We expect that QPI will continue to broaden its interstate market through the acquisition of additional out-of-state licenses, premising the expansion of our business throughout the U.S. in Q4 and 2019.
Nesvik’s drug development of oral solutions is underway. Nesvik, our wholly owned subsidiary, identifies traditional solid dosage drugs and formulates them into easier-to-ingest liquid delivery methods for niche patient groups using the FDA’s 502(b)(2) accelerated pathway. The first four drugs are focused on the pediatric and geriatric patient population, of which approximately 20% of the targeted patient population has trouble ingesting solid dosage medications. The four products will be called BSEM120, 125, 130, and 135 through the development phases and all have received PRE-IND numbers from the FDA. The Gnomon Group, engaged by Nesvik earlier in the Quarter, currently provides senior regulatory strategy and submission management support for the New Drug Application communications with the FDA. Working with these partners, we hope to advance the process expediently and efficiently.
During Q3 2018, we announced that we’ve embarked on an expanded shareholder communications initiative as part of our plan to build trust and credibility with our stakeholders. As part of that initiative, BioStem is in the process of developing mission and vision statements for the Company in order to more clearly communicate to our shareholders, and potential new investors, our path for growth and profitability. These efforts will include new branding and an enhanced website, as well. We’re committed to transparency and we’ve partnered with outside professionals to ensure we get it right.
Upcoming Anticipated Milestones
Key milestones we expect to achieve in the fourth quarter of 2018 include the QPI sales launch and moving BioStem Life Sciences from its current headquarters to our state of the art lab in Pompano Beach, Florida.
Third Quarter 2018 Financial Results
• Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2018 and December 31, 2017 were $413.2 thousand and $51.5 thousand, respectively. The increase in cash, cash equivalents and marketable securities is primarily related to the completion of a debt offering of $1 million on July, 27 2018.
• Revenues: Total revenues were $376.8 thousand for the three months ended September 30, 2018 compared to $55.2 thousand for the three months ended September 30, 2017. Total revenues were $476.1 thousand for the nine months ended September 30, 2018 compared to $254.9 thousand for the nine months ended September 30, 2017. The increase in both periods was primarily attributable to initial sales of our four placenta derived tissue products.
• G&A Expenses: General and administrative expenses were $1.9 million for the three months ended September 30, 2018 compared to $1.6 million for the three months ended September 30, 2017. General and administrative expenses were $4.1 million for the nine months ended September 30, 2018 compared to $4.6 million for the nine months ended September 30, 2017. The increase in 2018 was attributable to increases in employee-related costs due to increased headcount to support overall growth, commercial-readiness activities, and professional and consulting fees.
• Net Loss: Net loss was $1.6 million, or $0.20 per diluted share, for the three months ended September 30, 2018 compared to $1.5 million, or $0.29 per diluted share, for the three months ended September 30, 2017. Net loss was $3.8 million, or $0.49 per diluted share, for the nine months ended September 30, 2018 compared to $4.4 million, or $1.12 per diluted share, for the nine months ended September 30, 2017.
About BioStem Technologies, Inc.
BioStem Technologies, Inc. is a global life sciences corporation, providing innovative technologies with a concentration in Pharmaceuticals and Regenerative Medicine. The Company’s mission is to discover, develop and produce the most effective Pharmaceutical and Regenerative Medicine products in the world. The Company is comprised of a diverse group of scientists, physicians, and entrepreneurs who collaborate to create innovative products. These technologies improve the Quality of Life for our patients and, as a result, drive shareholder value. For more information, go to: www.biostemtechnologies.com. Information on the foregoing website is not incorporated into this release.
Except for statements of historical fact, the matters discussed in this press release are forward-looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "future," "plan" or "planned," "expects," believe" or "projected." These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and additional risks factors as discussed in reports filed by the Company with OTC Markets.
Andrew Van Vurst
Chief Operating Officer
Chuck Harbey, Managing Director
PCG Advisory Group