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The New Standard of Care for Drug Delivery Injection Technology Investor Presentation – June 2013.

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Presentation on theme: "The New Standard of Care for Drug Delivery Injection Technology Investor Presentation – June 2013."— Presentation transcript:

1 The New Standard of Care for Drug Delivery Injection Technology Investor Presentation – June 2013

2 Safe Harbor This presentation contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, The forward-looking statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason. 2

3 Investment Highlights Two medical instruments in the development stage Conventional needle syringes present significant challenges for patients, doctors and the medical industry Patented and FDA approved painless injection/drug delivery system Sales and marketing strategy targeting large dental groups High margin recurring revenue model from disposable handpieces Opportunity to expand into new drug delivery applications Highly scalable business utilizing outsourced production model Achieved profitability in the first quarter of

4 Hypodermic Needle Syringes Pain and tissue damage are a direct result of uncontrolled flow rates and pressure during the administration of drug solutions into human tissue Side effects include – Transient or permanent paralysis – Post-operative complications – Pain and the fear of pain – Risk of medical emergencies including patient fatality – Tissue damage 4

5 About Milestone Scientific Proprietary computer-controlled injection technologies targeting the medical and dental markets First major breakthrough in injection technology since the invention of the hypodermic syringe Precision, painless injections for all dental treatments – Root canals, crowns, fillings, cleanings, etc. – Over 50 million injections administered to date Award-winning products Global distribution network – North and South America, Asia, Africa and Europe – IP portfolio consists of 24 issued patents 5

6 Core CompuFlo® Technology Regulates and controls flow rate of fluid Dynamic Pressure Sensing® capability provides visual and audible in-tissue pressure feedback – Ability to identify tissue types and inject drugs at the precise location – Minimizes tissue damage and eliminates the pain of the injection because the flow rate and pressure of the injection are controlled Disposable injection handpiece that provides for precise tactile control during the injection Ability to record data from the injection event 6

7 Single-Tooth Anesthesia (STA) System Allows dentists to administer injections accurately and painlessly into the periodontal ligament space, effectively anesthetizing a single tooth Anesthetizes the tooth within one or two minutes versus 8-18 minutes for a block injection – No pain or collateral anesthesia in the cheek, lips or tongue Capable of performing all injections done with a conventional syringe 7

8 Proprietary Advantages 8 Eliminates pain Reduces needle anxiety No collateral numbing Site specific targeting Precision fluid metering Eliminates needle deflection Safe, disposable handpiece Rapid onset anesthesia/ reduced waiting time Better ergonomics New injection techniques No missed blocks PatientDoctor There are approximately 40 million dental phobics—people afraid to visit a dentist, in the United States – Causing over 25% of appointments to be canceled

9 Intellectual Property 9

10 Industry Recognition Favorably evaluated in more than 50 peer reviewed and independent clinical research reports 10 “Many doctors have found that as a result of the unique characteristics of Computer-Controlled Local Anesthesia Delivery (C-CLAD™), most traditional dental injection techniques can be performed with greater predictability and with less discomfort.” - Dr. Stanley F. Malamed, Professor of Anesthesia and Medicine at the University of Southern California School of Dentistry

11 Established Distribution Channels AsepticoUSA & Canada Henry ScheinUSA Patterson Dental SupplyUSA Benco DentalUSA Milestone DeutschlandGermany FM ProduktyPoland Executive DentalPuerto Rico/US Virgin Islands MedentaRussia Nabd Al HayatSaudi Arabia Karr DentalSwitzerland Dental Practice SystemsUnited Kingdom China National Medicines CorporationChina Istrodent Pty Ltd ABSouth Africa Unident ABScandinavia 11 Over 47 distributors worldwide in over 60 countries

12 Non-Dental/Medical Applications Over 700 discrete injection applications according to an independent analysis – Vast opportunity for different instruments and disposables in various areas of medicine Unique ability to identify the tissue in which the needle tip is imbedded – Epidural, intra-articular, organ, subcutaneous and intramuscular injections Medical procedures requiring intravenous sedation can be performed with local anesthesia – Use of local anesthetic minimizes side effects, accelerating recovery times, lowering costs and eliminating potential complications Clinical evidence demonstrating benefits in epidurals, intra-articular injections, colorectal surgery, podiatry, dermatology, nasal/sinus surgery, hair transplant and cosmetic surgery New products subject to 510(k) submission, reducing cost and time to market 12

13 Near-Term Application: Epidural 2.5 million U.S. women who give birth each year receive epidurals – Represents approximate $1 billion annual U.S. market – Doctors using conventional syringes identify the epidural space by relying on subjective perception Potential complications with conventional standard of care – Wet Tap (1 in 30) – Dural Puncture (1 in 100) – Catheter Misplaced into Vein (1 in 300) – Neurological Injury > one year (1 in 6,700) – Neurological Injury < one year (1 in 240,000) – Epidural Abscess or Hematoma (1 in 150,000) – Paraplegia (1 in 250,000) – Death (less than 1 in 100,000) CompuFlo® consistently and accurately identifies the epidural space – Detects the difference in pressure between the ligamentum flavum and the extraligamentary tissue – In studies, epidural space has been correctly identified 100% of the time 13

14 Other Near-Term Applications Osteoarthritis – Affects 33 million in U.S. alone; 21M in US receive intra-articular injections – IA market expected to reach $7B by 2015 – Conventional injections less efficacious, as doctor often fails to locate intra-articular space or use inappropriate volume of hyaluronic acid – CompuFlo® successful in independent study administering hyaluronic acid and other medicaments into the intra-articular space Self Administered – Injectable drugs self-administered by patients with long term chronic conditions such as Multiple Sclerosis and Rheumatoid Arthritis – CompuFlo® provides painless subcutaneous injection method – A significant reduction in pain will have a positive impact on compliance Other near-term applications include: neurosurgical injections/aspirations, ophthalmic surgery, cosmetic surgery, botox, podiatry, colorectal anesthesia, dermatology, etc. 14

15 Beijing 3H Joint Venture Formed medical joint venture with Beijing 3H (Heart-Help-Health) Scientific Technology in July 2011 First two products under development are epidural and intra-articular drug delivery instruments utilizing CompuFlo technology 50/50 arrangement between Beijing 3H and Milestone Scientific Milestone to provide exclusive worldwide royalty-free license for use of its patents as they relate to these 2 instruments only Beijing 3H contributed $1.5 million to the medical joint venture Epidural Intra-articular 15

16 New Sales & Marketing Strategy Refocused sales strategy – Reduced reliance on third party distributors – Marketing directly to group practices Expanded customer support & education – Hired director of international sales and director of domestic sales – Utilizing independent hygienists to train and support group dental practices Signed on first group dental practice in 2011—Towncare Dental – 27 offices throughout central and south Florida – The STA Instrument will replace the syringe in these practices 16

17 17 TodayNear- Term (1) Medium- Term Total # Dentists150 (2) Hand Piece Price$1.39$1.70$3.00 Gross Margin65%70+% Annualized Gross Profit (3) $0.2M$2.4M+$12.6M+ 1.Anticipate closing groups representing 1000 dentists; however actual rollout is dictated by group scheduling 2.Includes dentists in practices under contract, training to follow (2 months training per 100 dentists) 3.Assumes industry average 2,000 procedures per dentist (per work day, per year) Target Dental Group Practice Model

18 Recent Developments Milestone's STA Single Tooth Anesthesia System® computer (STA System) was approved by the People's Republic of China State Food and Drug Administration (SFDA) – The SFDA has bifurcated approval of STA System computer from The Wand® handpiece – Upon approval of The Wand handpiece, Milestone's exclusive Chinese distributor, China National Medicines Corporation (CNMC) will be able to commence sales of the STA System across China Signed on 2 additional group practices – Dental American Partners: 5 offices, 20 dentists, 7 hygienists in the Southern Florida region – Christie Dental: 17 locations and 35 dentists throughout Central Florida Educational partnership with the University of Florida College of Dentistry and Valencia College – Milestone will supply university faculty with its STA Single Tooth Anesthesia System® to train students 18

19 Aseptico Partnership Formed strategic alliance with Aseptico – Aseptico will serve as the exclusive distributor of STA Systems and related disposable items – Aseptico has served the dental market for over 38 years and markets their products to over 150,000 dentists across the U.S. and Canada Aseptico will take over responsibility for marketing directly to individual dentists and small offices – Expected to significantly reduce sales and marketing expenses – Aseptico participates in over 70 dental shows annually – Will attend pediatric dental shows in the U.S. and Canada – Aseptico has committed to an active advertising initiative targeting major dental publications, as well as direct mailing campaigns 19

20 Scalable Business Model Aseptico will handle all sales & marketing to individual dentists and single office practices – Year 1: Milestone’s sales and marketing expenses will be reduced over $200K Cost-effective strategy targeting group dental practices Anticipated revenue growth should drive profitability and cash flow 20

21 Q Highlights Revenue increased 30% to $2.5 million versus $1.9 million for the first quarter of 2012 – Domestic sales increased 49% to $1.3 million – Achieved a 33% increase in domestic instrument sales – International sales increased 13%, with international handpiece sales increasing 39% Gross profit increased to $1.7 million versus $1.3 million in the first quarter of 2012 – Gross margin increased 189 basis points Achieved profitability for the first quarter of

22 Income Statement Highlights 22 Quarter Ended March 31, Revenue $2,489,542$1,921,358 Gross Profit 1,677,4991,258,412 Gross Margin67%65% Operating Income (Loss)167,761(233,151) Net Income (Loss)$150,746($355,181)

23 Balance Sheet Highlights 23 Clean capital structure with no warrants, convertible debt or preferred shares outstanding

24 Management Team Leonard Osser, CEO & Director. Mr. Osser served as the Company’s Chairman from 1991 until September of 2009, and since 2007, was Chief Executive Officer of the Company. From 1980 until the consummation of Milestone’s public offering in November 1995, Mr. Osser was primarily engaged as the principal owner and Chief Executive Officer of U.S. Asian Consulting Group, Inc., a New Jersey-based provider of consulting services specializing in distressed or turnaround situations in both the public and private markets. Joseph D’Agostino, CPA, COO & CFO. Mr. D’Agostino became CFO in October Prior to joining Milestone, Mr. D’Agostino served as Senior VP and Treasurer of Summit Global Logistics, a publicly traded, full service international freight forwarder and customs broker with operations in the United States and China. Previous executive posts also included EVP and CFO of Haynes Security, Inc., EVP of Finance and Administration for Casio, Inc., the U.S. subsidiary of Casio Computer Co., Ltd.; and Manager of Accounting and Auditing for Main Hurdman’s National Office in New York City (merged into KPMG). Mark Hochman, D.D.S., Director of Clinical Affairs. Dr. Hochman has served as Director of Clinical Affairs and Director of R&D since He has a Doctorate of Dental Surgery with advanced training in the specialties of Periodontics and Orthodontics from New York University of Dentistry and has been practicing dentistry since He holds a faculty appointment as a clinical associate professor at NYU School of Dental Surgery. Recognized as a world authority on Advanced Drug Delivery Instruments, Dr. Hochman has published numerous articles in this area, and shares in the responsibility for inventing much of the technology Dr. Eugene Casagrande, Director of Int’l & Professional Relations. Dr. Casagrande joined the company in 1998 and is charged with pursuing a broad range of clinical and industry-related strategic business opportunities for the Company. He has also lectured both nationally and internationally at over 35 dental schools and in over 22 countries on Computer-Controlled Local Anesthesia Delivery. Dr. Casagrande is past president of the California State Board of Dentistry and the Los Angeles Dental Society and is a Fellow of the American and International Colleges of Dentists and has served on the faculty of the University of Southern California, School of Dentistry. 24

25 Management Team (cont’d) Renee Cultrara, Director of Education. Ms. Cultrara joined Milestone Scientific in She has been a practicing clinical hygienist for 23 years. Her responsibilities at Milestone include training and educating field reps, group accounts and our inside sales team. She is a Registered Dental Hygienist. Dale Johnson, Director of International Distribution. Mr. Johnson joined Milestone in His 25-year tenure in the pharmaceutical industry includes key marketing positions in the international arena, including Director of Marketing and then Vice President, International Business at Zila Pharmaceuticals, Inc., a leader in the prevention and treatment of oral diseases. Prior executive posts included Executive Vice President at MedLearning, a communications company serving the pharmaceutical and biotech industries and Group Vice President of Business Development at DOBI Medical Systems, a technology company engaged in the diagnosis of breast cancer. He also held key marketing positions at Apex Communications, Inc., a medical communications company and at Glaxo, Inc., where he spent eleven years and rose through the ranks to International Marketing Director for Dermatology Products. Marvin Terrell, Director of Domestic Distribution. Mr. Terrell joined Milestone in 2010 to oversee the company’s distribution network in the U.S. and Canada. Previously, he served as North American Director of Sales for OralCDx Laboratories where he conceptualized and implemented sales and marketing strategies for BrushTest®, a quick and painless method dentists use to detect oral cancer. Previously, he was Vice President of Sales and New Business Development for Professional Dental Technologies where he managed day-to-day sales and business development activities for the dental division representing over $40 million in annual sales. He also held the position of Manager, National Accounts, Medical Division at HPSC, Inc. 25

26 Board of Directors Leslie Bernhard, Chairman of the Board. Leslie Bernhard assumed the position of Chairman in October 2009 and previously served as an Independent Director since May She co-founded AdStar, Inc. and since 1986 has served as its President, Chief Executive Officer and Executive Director. AdStar is an application service provider for the newspaper classified advertising industry. She also serves on the Board of Directors of Universal Power Group (AMEX:UPG) of Dallas, Texas. Leonard M. Schiller, Director. Mr. Schiller has been a director of Milestone since April Mr. Schiller has been a partner in the Chicago law firm of Schiller, Klein & McElroy, P.C. since He has also been President of The Dearborn Group, a residential property management and real estate acquisition company since Mr. Schiller became a Director of the Gravitas Cayman Corporation in February Gravitas Cayman Corporation is an Investment Fund. Pablo Felipe Serna Cardenas, Director. Mr. Serna Cardenas has been a director of Milestone since June He is the founder of SPOT Investments, a European-based financial services firm. Previously, from 2001 to 2005, he was a director and Senior Manager at Dynamic Decisions Group Ltd, an equity research and valuation consulting firm. In that capacity, Mr. Serna Cardenas led the corporate finance team at Dynamic Decisions in investment banking and project valuation consulting. Prior to joining Dynamic Decisions, from , Mr. Serna Cardenas served as an associate with Real Options Group. Real Options Group is an international academic research center consulting to business entities. Before joining Real Options Group, Mr. Serna Cardenas was the general manager with Estudios, Consultorias y Asesorias Financieras, a Financial Consulting firm in Columbia. He has been a director of Pairstech Fund, a UK hedge Fund since

27 Key Statistics Ticker: MLSS Exchange: OTCQB Share price (as of 5/31/2013): $1.13 Common shares outstanding: 16.8 M Market capitalization: $19.0 M 2012 revenue $8.6 M 2012 net income($870,306) 2012 EPS($0.05) Total shareholder’s equity (3/31/2013): $2.4 M Fiscal year-end: December 31 Security Ownership of Management:23.2% 27

28 Investment Highlights Two medical instruments in the development stage Conventional needle syringes present significant challenges for patients and doctors and the medical industry Patented and FDA approved painless injection/drug delivery system Sales and marketing strategy targeting large dental groups High margin recurring revenue model from disposable handpieces Opportunity to expand into new drug delivery applications Highly scalable business utilizing outsourced production model Achieved profitability in the first quarter of

29 The New Standard of Care for Drug Delivery Injection Technology Thank you.


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