Investor Presentation Q Results NASDAQ: BLFS

Transcription

1 Investor Presentation Q Results NASDAQ: BLFS 1

2 Sole source supplier of critical, proprietary cell & gene therapy manufacturing reagents to the regenerative medicine industry 2

3 Disclaimer Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of These forward-looking statements include, but are not limited to, statements concerning the company's anticipated business and operations, guidance for financial results in 2018, including achieving GAAP operating profit, GAAP net income, EBITDA, adjusted EBITDA and cash flow from operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, regulatory approvals and/or commercial manufacturing of our customers' products, and potential customer revenue. 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. Discussion of Non-GAAP Financial Measures BioLife Solutions management believes that the non-gaap measure of EBITDA and Adjusted EBITDA enhances an investor s understanding of the Company s financial and operating performance and its future prospects by being more reflective of core operating performance. BioLife Solutions management uses this financial metric for strategic decision making, forecasting future financial results, and evaluating current period financial and operating performance. The presentation of non-gaap financial information is not intended to be reviewed in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP. A reconciliation of GAAP to non-gaap results is included in the financial tables in the press release issued on November 8, Adjusted EBITDA Definition: EBITDA is a non-gaap measure defined by BioLife Solutions, Inc., as net income/(loss) excluding interest expense/(income), income tax expense, depreciation expense, and amortization expense. Adjusted EBITDA is a non-gaap measure defined by BioLife Solutions, Inc., as net income/(loss) excluding interest expense/(income), income tax expense, depreciation expense, amortization expense, stock-based compensation expense and the loss/(gain) on equity method investments. 3

4 Investment Thesis NASDAQ: BLFS Delivering rapid, profitable growth; Two consecutive quarters with >$1 million net income month revenue up 81% over same period in 2017 Enabling scalable manufacturing of cell and gene therapies; potential cures for cancer and other leading causes of death Proprietary IP and sticky customer relationships sole source supplier; embedded in customers manufacturing and distribution processes Main competition is the use of traditional, non-optimized home-brew media Embedded in more than 300 customer clinical applications 44% ownership in SAVSU Technologies; next generation cell and gene therapy cold chain tools supplier Pursuing M&A strategy to accelerate revenue growth 4

5 Marquee Customer Base CELL & GENE THERAPY COMPANIES 5

6 Survival Viability Function Biopreservation Challenges CAR T and other cell therapies MUST be kept alive during manufacturing and shipping to maintain therapeutic potency Survival How Long Viability How Many Function How Well Ex Vivo Time Ex Vivo Time Ex Vivo Time Cold storage is used to preserve biologic integrity and function by lowering metabolism. Traditional methods and tools are not optimized and offer limited protection from preservation-induced stress, injury, and death. 6

7 Extending Biologic Shelf-Life Cells Preserved in traditional home brew Cells Preserved in HypoThermosol Dead cells Healthy cells Human mesenchymal stem cells isolated from bone marrow; condition of cells after 5 days of cold storage, then returned to culture and assayed 24 hours later 7

8 Biopreservation Yield: COGS and Efficacy Source Material Manufactured Cell Products Cost LESS Required = MORE Doses Cost LESS Required to Achieve Desired Therapeutic Effect Yield Yield 8

9 CryoStor Freeze Media Serum-free, protein-free, animal-origin free; high quality ingredients; US FDA Master File Formulated to mitigate molecular cell stress during freeze/thaw process in cord blood stem cells, T cells, others Improved cell viability and functional recovery compared to commercial and home-brew alternatives in numerous cell types 9

10 HypoThermosol Storage Media Serum-free, protein-free, animal-origin free; high quality ingredients; US FDA Master File Optimized for hypothermic (2-8 C) storage and shipping of cells and tissues Enables multiple days of cell and tissue storage for transport of source material and manufactured cell products throughout the world 10

11 Customer Engagement - Product Integration TIME & TEMP SENSITIVE Source Material Preservation Media Cell Therapy Manufacturing Workflow Patient Biopreservation Media for Source Material and Manufactured Dose Cell Manufacturing Preservation Media Final Manufactured Product TIME & TEMP SENSITIVE 11

12 Q Regenerative Medicine Funding 12

13 Kite Pharma (Gilead) YESCARTA CAR T Cell Therapy US FDA approval in October 2017 for adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy Our CryoStor freeze media is embedded in each dose of YESCARTA and other clinical trials in USA, China, Japan, EU 13

14 Influential Customers Leveraging Awareness CLINICAL CENTERS CMO & CDMO 14

15 Distributor Channel: ~ 30% of Total Revenue Private: Vancouver, BC : shipped to > 700 different end customers Part of Merck Group : 2017 shipped to > 600 different end customers Internal product use : drop ship distribution customer >10 year relationship : drop ship distribution customer 15

16 Q1-Q Revenue up 81% Y/Y - Key Segments 2017 vs 2018 Segment Revenue $9,000,000 REGENERATIVE MEDICINE Cell therapy companies Hospital-based stem cell transplant centers University-based clinical research labs Cell therapy CDMO, CRO 56% OF % Y/Y Growth $8,000,000 $7,000,000 $6,000,000 $5,000,000 $4,000,000 $3,000,000 $2,000,000 $1,000,000 $0 Regen Med Distributors Q1-Q Q1-Q DISTRIBUTORS Worldwide distribution network Includes regenerative medicine, drug discovery and biobanking end users 32% OF % Y/Y Growth 16

17 Q3 Financial Results Leveraged Growth (In Thousands) Q3 18 Q3 17 Change % Change Revenue $5,293 $2,963 $2,330 79% Gross Margin % 70% 63% 700 bps N/A OPEX $2,492 $1,900 $592 31% Operating Profit/(Loss) $1,195 ($32) $1,227 N/A Net Income/Loss $1,151 ($425) $1,576 N/A Adjusted EBITDA $1,662 $298 $1,364 N/A Cash Provided/(Used) by Operating Activities $809 $74 $735 N/A Cash Balance $32,381 $2,831 $29,550 N/A 17

18 9 Months 2018 Financial Results (In Thousands) Q1-Q3 18 Q1-Q3 17 Change % Change Revenue $14,286 $7,887 $6,399 81% Gross Margin % 68% 62% 600 bps N/A OPEX $7,159 $5,744 $1,415 25% Operating Profit/(Loss) $2,619 ($838) $3,457 N/A Net Income/Loss $2,094 ($2,063) $4,157 N/A Adjusted EBITDA $3,995 $312 $3,683 N/A Cash Provided/(Used) by Operating Activities $1,762 ($198) $1,960 N/A Cash Balance $32,381 $2,831 $29,550 N/A 18

19 2018 Guidance Update FY2018 est Change Revenue $19.0mm - $20.0mm $11.0mm 72% - 82% Growth Gross margin % 68% - 70% 61% 7 9 pts OPEX $9.5mm - $10mm $7.8mm 15% - 22% Operating Profit / (Loss) Full Year Positive ($1.1mm) N/A Net income to common shareholders Full Year Positive ($2.7mm) N/A Adjusted EBITDA Proportionate increases $0.4mm N/A 19

20 M&A Growth Strategy Acquire complementary companies with technologies used in cell and gene therapy manufacturing to increase our share of the spend for these tools Supplier base is fragmented; consolidation opportunity Acquisitions could: Leverage sales and marketing resources Increase enterprise revenue and profit Unlock benefits of larger scale enterprise $20 million investment by Casdin Capital to seed the program 20

21 SAVSU Technologies Private: based in Albuquerque, NM BioLife owns 44% with two board seats A leading developer and supplier of next generation cold chain management tools for cell and gene therapies evo brand precision, cloud-connected shipping containers evo.is cloud SAAS track/trace live cell visibility platform Partnered with leading specialty couriers to leverage their sales and marketing teams and worldwide support infrastructure Product evaluations and validations underway at 30 cell and gene therapy companies 21

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23 SAVSU Technologies - Entire Temp Range Covered with Smart, Cloud-Connected Shippers 23

24 SAVSU Technologies evo.is Cold Chain SAAS 24

25 Experienced Executive Team Mike Rice Chief Executive Officer BS Bus Admin; 10 years as BLFS CEO; chief visionary of BLFS market opportunities, branding, marketing strategies; 18 years medical device sales, sales management, marketing; patient monitoring, defibrillators, implantable CRM, hearing devices, LAN/WAN; 5 issued and 13 pending patents Karen Foster Vice President, Operations BS Biological Sciences, MS Zoology, MBA; 25 year career in quality and manufacturing operations including 13 years VP Manufacturing Operations and Site Leader at ViaCord, 2 positions leading 80 member teams; certified Six Sigma Green Belt Roderick de Greef Chief Financial Officer BA Economics, MBA; 25 years CFO experience for 5 public companies; Serves/served on 5 US public company boards; Raised >$200mm from US, EU and AP private and institutional investors; Structured, negotiated and closed $400mm of public company mergers and acquisition transactions in the US and Europe Jim Mathers Vice President, Global Sales BA, Biology, MBA; 35 years sales and sales and marketing management; repeated achievement in driving early adoption of new medical device technologies for Stryker, MAKO Surgical, BrainLab, AccuRay, Cardiac Science, JNJ Aby J. Mathew, PhD CTO, Senior Vice President BS Microbiology, PhD, Cell & Molecular Biology; co-developer of platform HypoThermosol media; in demand industry thought leader in biopreservation of cells and tissues for clinical applications; catalyst responsible for driving regen med market to adopt BLFS clinical grade biopreservation media; 6 issued and 6 pending patents; numerous journal articles Todd Berard Vice President, Marketing BS, Biochemistry, MBA; 16 years marketing including leadership of marcom, corporate branding, product marketing, and positioning for Verathon, Physio Control (MDT), tech startups 25

26 Cap Table 26.0mm Fully Diluted Shares* Shares 18.5mm Options/RSUs 3.3mm Warrants 4.1mm Directors & Officers Affiliates Other Increasing institutional holders ~27% held by two long term shareholders Directors & Officers Affiliates Other Management and employee incentives 2.1mm vested $1.82 wt. avg exercise price Directors & Officers Affiliates Other $ mm held by two affiliates $ * As of

27 Investment Thesis NASDAQ: BLFS Delivering rapid, profitable growth; Two consecutive quarters with >$1 million net income month revenue up 81% over same period in 2017 Enabling scalable manufacturing of cell and gene therapies; potential cures for cancer and other leading causes of death Proprietary IP and sticky customer relationships sole source supplier; embedded in customers manufacturing and distribution processes Main competition is the use of traditional, non-optimized home-brew media Embedded in more than 300 customer clinical applications 44% ownership in SAVSU Technologies; next generation cell and gene therapy cold chain tools supplier Pursuing M&A strategy to accelerate revenue growth 27

28 NASDAQ: BLFS For additional questions or comments, please contact: BioLife Solutions, Inc Monte Villa Parkway, Suite 310 Bothell, WA Mike Rice President and CEO (425) Roderick de Greef CFO (425)