Investor Presentation NASDAQ:BLFS

Transcription

1 Investor Presentation NASDAQ:BLFS

2 Safe Harbor Statement This presentation contains forward-looking statements, including, but not limited to, statements concerning the company s anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, new products, and third party projections regarding the future market for regenerative medicine and cold chain packaging and instrumentation services. 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, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; 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 and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law. 2

3 BIOPRESERVATION TOOLS FOR CELLS, TISSUES AND ORGANS

4 Preservation of Biologic Material Drug Discovery Solid Organs Tissue Biopsies Tumor Regenerative Medicine Blood Bone Marrow Allogeneic Transplant Autologous Transplant Biobanking 4

5 Biopreservation Challenges Removed from the body - cells, tissues and organs enter a continuum of degradation a race against time! Survival - Quantity Viability - Quality Function Survival Viability Function Ex Vivo Time Ex Vivo Time Ex Vivo Time Hypothermia (cold chain management) is used to preserve biologic integrity and functional performance. Traditional methods and tools are not optimized and offer limited protection from preservation-induced stress, injury, and death. 5

6 Biopreservation Tools Media and other tools designed to preserve biologics during ex vivo storage Shipping products designed to maintain stability of cells and tissues during transportation from patient to lab and back to patient Goal: maximize effectiveness of biologic based medicine 6

7 BIOPRESERVATION MEDIA

8 Our Biopreservation Media Clinical grade preservation media made per GMP facility and QMS certified to ISO13485 Formulated to mitigate molecular cell stress during refrigeration and freeze/thaw process Serum-free, protein-free, AOF; USP ingredients; US FDA Master Files Patented technology; performance superior to commercial and homemade alternatives; also protected by trade secrets 8

9 Cell Yield Comparison Preserved in traditional home brew Cells are mostly dead Preserved in BioLife HypoThermosol Cells are vital, thriving Human mesenchymal stem cells isolated from bone marrow; condition of cells after 5 days of cold storage, then returned to culture conditions and assayed 24 hours later 9

10 Better Cell Yield = Cost Reductions Source Material Manufactured Cell Products Yield LESS Required = MORE Doses Yield LESS Required to Achieve Desired Therapeutic Effect Cost Cost 10

11 Limited Shelf Life = Cost Adder If distribution range is limited by short shelf-life - multiple production facilities required Increased CAPEX requirements Cell Factory Cell Factory Cell Factory Cell Factory Cell Factory 11

12 Longer Shelf Life = Lower Costs Our products extend shelf life to support worldwide distribution of cellular therapeutics Reduced CAPEX requirements Cell Factory 12

13 biologistex Intelligent, Informed, Precise Biologic Materials Management

14 Cold Chain Biologistics Source Material Preservation Media Temperature Controlled Container Patient Cell Factory Temperature Controlled Container Preservation Media Manufactured Cell Product 14

15 Current Biologistics Reality TIME All vaccines and 70% of biologics are temperature sensitive Regenerative medicine therapies require precise thermal protection during shipment Limited temp stability of traditional shipping containers; cell viability declines; lost and unusable doses Limited use of real-time temperature monitoring and reporting during shipment 15

16 Biologistics Risks Rx Clinical $ Economic Administering a thermally sensitive biologic dose that was exposed to unknown temperature excursions, packout errors or has exceeded it stability period Cost of scrapping biologic source material or manufactured cell products Clinical trial impact from poor biologistics management; lost dose, poor shipping container performance, temperature excursions 16

17 Breakthrough Disruptive Technology Simple, reusable, super insulating shipping container Smart box integrated cellular modem and payload monitoring electronics Cloud-hosted biologistics management app Easy packout process evo Smart Shipper 17

18 Current Solutions Inadequate Foam Coolers Limited performance Technology essentially unchanged for over 25 years Single use Environmental impact Vacuum Panel Shipper Very large footprint; heavy Expensive to ship Complicated assembly Refrigerants must be preconditioned to multiple temperature ranges before use 18

19 Biologistex CCMSM Cloud App Actionable Alerts LIMS/API EVO # Alert: Delivered to St. Luke s Medical Center on 5/5/2015 at 20:08 PST 19

20 Web App SaaS Business Model Real-time Location Biologistex CCM SM EVO # Alert: Package is within 5 miles of destination as of 5/5/2015 at 21:19PST Multiparameter Monitoring Configurable Alerts 20

21 SaaS Business Model Potential to build a base of thousands of shippers deployed throughout the world each generating subscription revenue for rental use and data access 21

22 OTHER SERVICES

23 Contract Manufacturing Services Utilizing excess production capacity Niche provider of aseptic media formulation, fill, and finish services Highly selective opportunities with strong alignment with our capabilities 23

24 OUR MARKETS

25 3 Strategic Markets BIOBANKING DRUG DISCOVERY REGENERATIVE MEDICINE Umbilical cord blood banks Adult stem cell banks Tissue banks Biorepositories Hair transplant physicians Pharmaceutical companies Cell suppliers Toxicity testing labs Commercial cell therapy and tissue engineering companies Hospital-based stem cell transplant centers University-based clinical research labs 25

26 Products Used in 185 Clinical Trials Each successful trial = $0.5-2M/year in revenue Pre-Clinical Phase I Phase II Phase III Solid Tumors Hematologic Malignancies Heart Disease Stroke Joint Disease Vision Loss Immune Disorders All Others

27 Biologistics Addressable Market $500 Million Estimated Addressable Market for Shipping Containers Specialized Packaging $2.6 Billion $4.9 Billion $3.2 Billion $5.1 Billion Transportation Source: IMS Health, Evaluate Pharma Source: imarc Group, December

28 Growing Demand for Biopreservation Media $345 Million $820 Million Major growth expected from Regenerative Medicine segment Source: Biopreservation Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, (Transparency Market Research, April, 2014) 28

29 INVESTMENT OPPORTUNITY

30 NASDAQ: BLFS Complementary tools extend shelf life and increase survival of cells and tissues IP embedded in more than 185 clinical trials 25% annual core products revenue growth $8.5M cash and no debt at end of Q1 30

31 Significant Long-Term Growth Drivers $ Biopreservation unmet needs Increased regulatory scrutiny Increased commercial risk; trial failure Smart, high performance containers The Internet of Things; SaaS Model Regen Med Franchise Building the Pipeline Capturing Value Revenue and Profit Growth; Enterprise Value 31

32 500+ existing customers Products used in rapid growth biobanking and drug discovery markets >185 Regenerative medicine clinical projects and trials using BioLife products New SaaS offering will revolutionize biologistics management $100M Current production revenue capacity Significant Growth Potential 32

33 Investment Fundamentals March 31, 2015 Cash and Investments $8.6M Total Debt $0.00 Total Stockholder Equity $12.7M Shares Outstanding 3/25/14 issued 3.6M shares at $4.30 Options most in the money Warrants most at $4.75 debt conversion/equity raise 12M 1.4M 7.4M Average Volume ~100,000 shares Market Cap ~$25M Public Float 52% 33

34 NASDAQ:BLFS BioLife Solu5ons, Inc Monte Villa Parkway, Suite 310 Bothell, WA For addi(onal ques(ons or comments, please contact: Michael Rice President and CEO (425) Daphne Taylor CFO, VP - Finance & AdministraHon dtaylor@biolifesoluhons.com (425)