Investor Presentation

Transcription

1 Investor Presentation December 2013

2 Safe Harbor Statement This presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning a potential reverse stock split, a potential uplisting or conversion of debt into equity. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, the risk that the Reverse Stock Split will not be effected, the risk that the NASDAQ listing or debt conversion will not be completed, and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. We undertake no obligation to update the forwardlooking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law. 2 DECEMBER 2013 INVESTOR PRESENTATION

3 Corporate Developments December 2013 Applied to uplist on NASDAQ Reverse split approved Milestones & Value Drivers S-1 filed for proposed $10MM equity raise Entire $14MM debt load will convert to common upon close of funding Products embedded in >100 regenerative medicine applications & clinical trials > $500 million addressable market 3 DECEMBER 2013 INVESTOR PRESENTATION

4 Life Sciences Tools Provider Serving $500M+ Market NEXTGENERATION PRODUCTS SCALABLE PRODUCTION FACILITY LARGE, GROWING CUSTOMER BASE Proprietary, best in class biopreserveration media products for cells, tissues and organs Two cgmp clean room suites; 150,000 liter annual production 500+ customers and key distributors in strategic market segments: Regenerative Medicine Biobanking Drug Discovery 4 DECEMBER 2013 INVESTOR PRESENTATION

5 Industry Leading Customers Drug Discovery Regenerative Medicine Biobanking Distributors 5 DECEMBER 2013 INVESTOR PRESENTATION

6 Products and Services HypoThermosol CryoStor BloodStor Hypothermic storage & shipping media Cryopreservation freeze media Cord blood stem cell freeze media cgmp, Serum free, protein free biopreservation media products for cells, tissues, and organs SAVSU Precision Thermal Shippers Contract aseptic media formulation, fill and finish services 6 DECEMBER 2013 INVESTOR PRESENTATION

7 Revenue Growth 2013 Guidance: $6.5 - $7.0 Million $7 $6 $5 $4 $3 $2 $1 $ months DECEMBER 2013 INVESTOR PRESENTATION

8 Target Markets Regenerative Medicine Commercial cell therapy and tissue engineering companies, hospital based stem cell transplant centers, university based research labs A Biobanking Umbilical cord blood banks, adult stem cell banks, tissue banks, biorepositories, hair transplant physicians Drug Discovery Pharmaceutical companies, cell suppliers, toxicity testing labs 8 DECEMBER 2013 INVESTOR PRESENTATION

9 Regenerative Medicine Opportunity Fragile, live cells from source materials such as blood, tissue, and organs are enabling the development of biologic based therapies and treatments for the leading causes of death and disability. These must be transported from the processing lab to the bedside in a refrigerated or frozen state to preserve viability, quality, and potency. This is Biopreservation! Use of traditional, archaic home brew cocktail results in yield loss and limited shelf life of precious cells intended for clinical applications. Developers face increasing quality and regulatory pressure to switch to pre formulated, engineered media and reagents. 9 DECEMBER 2013 INVESTOR PRESENTATION

10 BioLife Products Meet The Opportunity Pre formulated cgmp Serum free Protein free Enable 2x to 3x longer shelf life of cell and tissue based clinical therapies several days! Increase the yield and viability of cells in the clinical dose 10 DECEMBER 2013 INVESTOR PRESENTATION

11 BioLife Products Embedded in Regenerative Medicine Stroke ALD & MS ALS UTD* AMD AMI CHF & DCM Liver Disorders GVHD Spinal Disorders HIV Lymphoma Melanoma AML Autoimmune Dis. Incontinence UTD* Various Cancers Wound healing Joint Repair CLI Myeloma * UNABLE TO DISCLOSE 11 DECEMBER 2013 INVESTOR PRESENTATION

12 Value Proposition Outperform all other biopreservation media BioLife Preserved Cells Highest quality cgmp Customer service Competitive Products 12 DECEMBER 2013 INVESTOR PRESENTATION

13 Competition Home Brew Biopreservation Media Traditional, culture media based formulas Limited biopreservation efficacy Components sourced from multiple vendors Mixing required for each daily/weekly batch Lower quality ingredients Limited release criteria Typically non GMP process 13 DECEMBER 2013 INVESTOR PRESENTATION

14 BioLife Products Embedded in Drug Discovery 50 Cell Products from Peripheral and Cord Blood StemPro Cells Gibco Hepatocytes Several icell ipsc Types Hepatocytes MNC from Bone Marrow Tumor Cells, Chondrocytes 14 DECEMBER 2013 INVESTOR PRESENTATION

15 Proprietary, High-Value Technology INTELLECTUAL PROPERTY 5 issued patents Several submitted applications ~ 300 third party issued and pending patents citing use of BioLife products EMBEDDED TECHNOLOGY Critical supplier status with leading companies: Regenerative medicine Cord blood banks Suppliers of cells used in drug screening 15 DECEMBER 2013 INVESTOR PRESENTATION

16 Rapidly Expanding Market Regenerative Medicine Market Growth (Billions) Demand for Biopreservation Media (Millions) $12 $10 $8 $6 $4 $2 $0 $10.0 $32B $1.4 $7B $550 $500 $450 $400 $350 $300 $250 $200 $150 $100 $50 $150 M $150 $500 $500M Source: visiongain October 2012 Source: Management estimates, Axis Research Mind 16 DECEMBER 2013 INVESTOR PRESENTATION

17 BioLife Production Environment Approximately 16,000 square feet Two independent, multi grade cgmp suites EU grades A D (ISO classes ,000) Very well characterized, monitored, and controlled processes Facilities re qualified via media fill validation and inspections every six months Quality environment built and managed to device and limited drug standards 17 DECEMBER 2013 INVESTOR PRESENTATION

18 BioLife Quality Environment ISO13485 certification management system for the design and manufacturing of medical devices 21 CFR Part 820 Quality System Regulation for Good Manufacturing Practices (GMP) of medical devices 21 CFR Parts 210 and 211 covering GMP for Aseptic Production Volume 4, EU Guidelines, Annex 1 for the Manufacture of Sterile Medicinal Products ISO for Aseptic Processing of Healthcare Products ISO for Clean Rooms and Associated Controlled Environments Internal audits of all critical functions 3 rd party auditor of our internal audits 18 DECEMBER 2013 INVESTOR PRESENTATION

19 Investment Summary Innovative Leader Positioned for Growth Operational Excellence Corporate Objectives Best in class, proprietary products, firstchoice market position Leading supplier of clinical grade biopreservation media products BioLife technology is embedded in >100 clinical trial stage cell therapies Significant revenue upside upon regulatory approval of customer products High quality, scalable GMP manufacturing facility; two independent clean room suites ISO certified FDA Master Files Uplist to NASDAQ Elimination of debt 2014 equity raise Acquiring/licensing synergistic products 19 DECEMBER 2013 INVESTOR PRESENTATION