Transcript American Jianye Greentech Holdings

The New Standard of Care for
Drug Delivery Injection Technology
Investor Presentation – February 2014
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, 2012. 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.
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Investment Highlights

For the first three quarters in 2013 the company is cash flow positive and profitable

In November Milestone Medical raised $3M at a post money valuation of $33M and listed on the
Warsaw Stock Exchange under the ticker MMD

Two medical products are now commercialized and are waiting regulatory approval

Conventional needle syringes present significant challenges for patients, doctors and the medical
industry – including safety, cost, and malpractice insurance

Over 24 patents surrounding injection/drug delivery system

Patented and FDA approved painless injection/drug delivery system

Opportunity to expand into new drug delivery applications

Recent partnership with Tri-anim provides expansive distribution for the epidural instrument

Disposables create high-margin recurring-revenue model

Highly scalable business utilizing outsourced production model
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Hypodermic Needle Syringes
• An efficient means of drug delivery, but with weaknesses that have not
been addressed since its invention almost 150 years ago
• Drawbacks:
–
–
–
–
–
Pain and the fear of pain
Tissue damage caused by uncontrolled flow rates of medication into tissue
Transient or permanent paralysis
Post-operative complications
Risk of medical emergencies including patient fatality
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CompuFlo®/DPS® 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 precisely the
location needed, eliminating guesswork
– Minimizes tissue damage and eliminates the pain of the
injection because the flow rate and pressure
of the injection are controlled
• Disposable injection handpiece allows
precise tactile control during the injection
• Demonstrated success in dentistry,
dermatology, rhinoplasty, podiatry and other uses
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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
• Over 50 million injections successfully
delivered to date
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Proprietary Advantages
• 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
Patient
• Eliminates
pain
• Reduces
needle
anxiety
• No collateral
numbing
Doctor
• Site specific
targeting
• Precision fluid
metering
• Eliminates
needle
deflection
• Safe, disposable
handpiece
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• Rapid onset
anesthesia/
reduced
waiting time
• Better
ergonomics
• New injection
techniques
• No missed
blocks
Industry Recognition
• Favorably evaluated in more than 50 peer reviewed and
independent clinical research reports
“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
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Aseptico Partnership
•
Formed strategic alliance with Aseptico
–
–
•
Aseptico will take over responsibility for marketing directly to individual dentists and small
offices
–
–
–
–
•
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
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
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
–
Anticipated revenue growth should drive profitability and cash flow
on the dental business alone
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Intellectual Property
Computer Controlled Drug Delivery Systems
Dental Anesthetic and Delivery Injection Unit
Design for a Dental Anesthetic Delivery System Holder
Design for a Dental Anesthetic Delivery System Housing
Design for a Dental Anesthetic Delivery System Handle
Cartridge Holder for Injection Device
Dental Anesthetic Delivery Injection Unit
Microprocessor-controlled Fluid Dispensing Apparatus
Pressure/Force Computer Controlled Drug Delivery System
Dental Anesthetic and Delivery Injection Unit with Automated Rate Control
Pressure/Force Computer Controlled Drug Delivery System with Exit Pressure
Pressure/Force Computer Controlled Drug Delivery System with Automated Charging
Drug Delivery System with Profiles
Cartridge Holder for Anesthetic and Delivery Injection Device
Design for Drive Unit for Anesthetic
Design for Drive Unit for Anesthetic
Drug Infusion Device with Tissue Identification Using Pressure Sensing
Computer Controlled Drug Delivery Systems with Pressure Sensing
Hand Piece for Fluid Administration
Self-Administration Injection System
Engineered Sharps Injury Protection Devices
Handpiece for Injection Device with a Retractable and Rotating Needle
Safety IV Catheter Device
Safety IV Catheter Infusion Device
Handpiece for Injection Device with a Retractable and Rotating Needle
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PATENT
DATE
6,022,337
D422,361
D423,665
D427,314
6,132,414
6,152,734
6,159,161
6,200,289
6,652,482
6,786,885
6,887,216
6,945,954
D558,340
D566,265
D579,540
7,449,008
7,618,409
7,625,354
7,740,612
2/8/2000
4/4/2000
4/25/2000
6/27/2000
10/17/2000
11/28/2000
12/12/2000
3/13/2001
11/25/2003
9/14/2004
5/3/2005
9/20/2005
12/25/2007
4/8/2008
10/28/2008
11/11/2008
11/17/2009
12/1/2009
6/22/2010
6,428,517
6,726,658
6,905,482
6,966,899
8/6/2002
4/27/2004
6/14/2005
11/22/2005
Breakthrough Medical Applications
•
Unique ability to identify the tissue in which the needle tip is imbedded
–
•
•
Management believes our products will improve safety, reduce costs including malpractice and
broaden the market
due to reduced risk factors
Over 700 potential discrete injection applications according to an independent
analysis
–
Clinical evidence demonstrating benefits in epidurals, intra-articular injections, colorectal surgery,
podiatry, dermatology, nasal/sinus surgery, hair transplant and cosmetic surgery
–
Other applications include: neurosurgical injections/aspirations, ophthalmic surgery, cosmetic
surgery, botox, dermatology, etc.
New products subject to 510(k) submission, reducing cost and time to market
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Market Overview: Epidural
•
Epidural market is estimated over $1 billion annually per year in the U.S. alone
– 2.4 million women receive epidurals while in labor each year in the U.S.
– More than 8.9 million epidurals administered for other purposes each year
•
Doctors using conventional syringes identify the epidural space by relying on
subjective perception
– 1 in 30 women suffer complications with conventional standard of care – ranging from
severe pain to wet tap to paraplegia and even death
– Average cost per epidural malpractice settlement: $362,000
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Epidural Instrument
•
•
•
In clinical studies, Milestone’s epidural instrument is able to reliably identify
pressure characteristics of the different tissues, including the decrease in pressure
in the epidural space
Within seconds, the location of the needle can easily be determined, with higher
pressures indicating the needle is in the ligamentum flavum
Practitioners using Milestone’s instrument correctly identified the epidural space
with a success rate of 100% (Gelber, Gebhard, et al. Regional Anesthesia and Pain
Medicine, 33:4; 2008)
•
Milestone partnership with Tri-anim speeds distribution
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Tri-anim Health Services Partnership
•
•
Three-year agreement announced in July 2013; begins after FDA marketing
clearance
Tri-anim to be distributor of Milestone’s epidural injection technology for
childbirth and other pain management needs in the pain management/hospital
sector
– Nation’s largest provider of specialty sales and distribution solutions for healthcare, and
largest distributor to birthing pain management centers
– Tri-Anim is a division of Sarnova, which offers healthcare products to thousands of
customers across the U.S.
– Partnership gives Milestone’s products national reach
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Osteoarthritis
• Intra-articular market expected to reach $7 billion by 2015
– Osteoarthritis affects 33 million patients in U.S. alone
– 21 million in U.S. receive intra-articular injections
• Conventional injections less efficacious, as doctors often fail to locate
intra-articular space or use inappropriate volumes of hyaluronic acid
• DPS® has been successful in identifying the intra-articular space for the
administration of medications to treat a variety of joint pathologies in an
independent study (In-vivo animal study; White paper on file, 2008 )
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Milestone Medical
• In November Milestone Medical raised $3M, 50% of the funding was
provided by the third largest open pension fund in Poland, at a post
money valuation of $33M and listed on the Warsaw Stock Exchange under
the ticker MMD
• The two products developed are epidural and intra-articular drug delivery
instruments utilizing DPS® technology
• Milestone provides exclusive worldwide royalty-free license for use of its
patents as they relate to these 2 instruments
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9 mo. Highlights
• Revenue for the nine months ended September 30, 2013 was $7.2 million
versus $6.4 million for same period in 2012
– Total domestic sales increased 20% to $3.9 million
– Achieved a 52.0% increase in domestic instrument sales
– International sales increased to $3.3 million versus $3.1 million
• Gross profit increased 17.5% to $5.0 million versus the same period in
2012
–
Gross margin increased 260 basis points to 69.0%
• Third consecutive quarter of profitability
• At the end of the third quarter the company remains cash flow positive for
the year
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Income Statement Highlights
Quarter Ended
Nine Months Ended
September 30,
September 30,
2013
Revenue
Gross Profit
Gross Margin
Operating Income (Loss)
Net Income (Loss)
2012
$2,444,195 $2,129,241
2013
2012
$7,211,973
$6,377,574
1,766,403
1,503,531
4,978,029
4,234,913
72%
71%
69%
66%
436,272
51,647
755,145
(235,110)
$218,523
$15,150
443,277
(504,571)
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Balance Sheet Highlights
30-Sep-13
31-Dec-12
Cash and cash equivalents
Total current assets
Total assets
$ 401,836
3,597,904
6,347,527
$ 165,249
2,498,822
5,661,103
Total current liabilities
Total long-term liabilities
Total liabilities
2,553,700
2,553,700
3,274,564
450,000
3,724,564
Total stockholders equity
$3,793,827
$1,936,539
Clean capital structure with no warrants, convertible debt
or preferred shares outstanding
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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.
Mark Hochman, D.D.S., Director of Clinical Affairs. Dr. Hochman has served as Director of Clinical Affairs and Director of R&D since 1999. 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 1984. 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
Stephen Solomon, Director of Engineering and Regulatory Affairs. Mr. Solomon has served as Milestone’s Director of Engineering and
Regulatory Affairs since March 2011 and of Milestone Scientific since 2007. Previously he was Manager of Engineering Services of RFL Electronics
from 1998 to 2007, Director of Technology Transfer at Medjet from 1996 to 1998 and Manager of Engineering Services from 1991 to 1996.
Previously he held managerial and staff engineering positions at Unisys Burroughs Corporation and Perkin-Elmer Interdata. He holds a Master of
Science degree in mechanical engineering from Loyola University, a Master of Business Administration from Rutgers and a Bachelor of Science in
engineering and applied sciences from the University of California.
Joe Bjorklund, Director of Sales and Business Development. Prior to joining Milestone, Mr. Bjorklund was Vice President of Business
Development, Vice President Sales-North America and Business Manager, Emerging Markets of Ultrsonix, Inc., a manufacturer of diagnostic
ultrasound systems from 2006 to 2011. Before that he was National Sales Director-Hospital Business for RF Technologies and a regional sales
manager for SonoSite Inc. from 2001 to 2003. Earlier in his career he was a Research and Laboratory Coordinator – ARIC (Arthrosclerosis Risk in
Communities) at the University of Minnesota Division of Epidemiology from 1995 to 1999. He holds a Bachelor of Arts degree from St. John’s
University, Minnesota.
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Management Team (cont’d)
Dale Johnson, Director of International Distribution. Mr. Johnson joined Milestone in 2010. 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.
Joseph D’Agostino, CPA, COO & CFO. Mr. D’Agostino became CFO in October 2008. 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).
Renee Cultrara, Director of Education. Ms. Cultrara joined Milestone Scientific in 2008. 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.
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.
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Investment Highlights

For the first three quarters in 2013 the company is cash flow positive and profitable

In November Milestone Medical raised $3M at a post money valuation of $33M and listed on the
Warsaw Stock Exchange under the ticker MMD

Two medical products are now commercialized and are waiting regulatory approval

Conventional needle syringes present significant challenges for patients, doctors and the medical
industry – including safety, cost, and malpractice insurance

Over 24 patents surrounding injection/drug delivery system

Patented and FDA approved painless injection/drug delivery system

Opportunity to expand into new drug delivery applications

Recent partnership with Tri-anim provides expansive distribution for the epidural instrument

Disposables create high-margin recurring-revenue model

Highly scalable business utilizing outsourced production model
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Appendix: Key Statistics
Ticker:
MLSS
Exchange:
OTCQB
Share price (as of 2/03/2014):
$1.40
Common shares outstanding:
17.6 M
Market capitalization:
$24.7 M
Total shareholder’s equity (9/30/2013):
$3.8 M
9 mo. revenue
$7.2 M
9 mo. net income
$443,277
9 mo. EPS
$0.03
Fiscal year-end:
December 31
Security Ownership of Management:
23.2%
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Appendix: Board of Directors
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.
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 2003. 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 1997. Mr. Schiller has been a partner in the Chicago
law firm of Schiller, Klein & McElroy, P.C. since 1977. He has also been President of The Dearborn Group, a residential property management
and real estate acquisition company since 1980. Mr. Schiller became a Director of the Gravitas Cayman Corporation in February 2010.
Gravitas Cayman Corporation is an Investment Fund.
Pablo Felipe Serna Cardenas, Director. Mr. Serna Cardenas has been a director of Milestone since June 2006. 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 1999-2001, 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 2008.
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The New Standard of Care for
Drug Delivery Injection Technology
Thank you.