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INVESTOR PRESENTATION / 投资者报告 OCTOBER 2017 / 2017年10月
MILESTONE SCIENTIFIC, INC.
© 2017, Milestone Scientific, Inc. All Rights Reserved
NYSE: MLSS
SAFE HARBOR
安全港声明
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, 2016. The forward-looking statements in this presentation 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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NYSE: MLSS
ABOUT MILESTONE SCIENTIFIC
MILESTONE SCIENTIFIC简介
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COMPANY
公司
NYSE MKT / 纽交所: MLSS
Founded / 创立: 1991
Employees / 员工: 16
Headquarters / 总部: NJ / 美国新泽西州
Milestone Scientific is a medical R&D company that designs, patents, incubates and
commercializes a growing portfolio of innovative injection technologies. / Milestone Scientific
是一家医疗研发公司,致力于不断壮大的创新技术的设计、专利获取、孵化以及商业化。
TECHNOLOGY
技术
Proprietary DPS
Dynamic Pressure Sensing
Technology® in multiple dental and
medical injection products for
painless and precise drug delivery /
多款牙科和医疗注射产品中用到的专有DPS ®动态压力感测技术 ,
用于无痛精准释放药物
PRODUCTS
产品
Commercial / 商业:
The Wand® STA
CompuFlo® Epidural / CompuFlo®
硬膜外麻醉
CompuFlo® Intra-articular /
CompuFlo®关节内
Pipeline / 管线:
Peripheral Nerve Block / 外周神经阻滞断
Cosmetic / 美容
NYSE: MLSS
INVESTMENT HIGHLIGHTS
投资亮点
Platform technology for computerized injections / 电脑注射的平台技术
Can be customized for a variety of verticals / 能够为各种垂直领域提供定制
Wand Dental subsidiary demonstrates profitable growth model / Wand Dental子公司展示了可盈利的增长模式
Exclusive distribution with Henry Schein in US & Canada / 在美国和加拿大与Henry Schein签订独家经销协议
FDA & CE approval of CompuFlo® Epidural / CompuFlo®硬膜外麻醉获得美国食品药品监督管理局批准和欧盟CE认证
COMPASS pivotal trial will be published / COMPASS关键性试验将发布结果
CE approval of intra-articular indication / 关节内适应症获得欧盟CE认证
Solid IP: 23 US patents, foreign counterparts / 强大的知识产权:美国23项专利,外国副本
Scalable recurring revenue business model can be extended to a variety of verticals / 可扩展的经常性收入商业模式,可延伸至多个垂直领域
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NYSE: MLSS
REDEFINING INJECTION TECHNOLOGY
重新定义注射科技
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THE PROBLEM / 问题
Pain / 疼痛
Discomfort / 不适
Anxiety / 焦虑
Post-Injection / 注射之后
Necrosis and Pain / 细胞坏死和疼痛
The hypodermic
syringe was invented
over 160 years ago /
160多年前发明了皮下注射器
THE SOLUTION / 解决方案
Painless Injection / 无痛注射
Comfort / 舒适
Precise Injection / 精准注射
Safety / 安全
Milestone’s Patented DPS®
Dynamic Pressure Sensing
Technology / Milestone的专利DPS ®动态压力感测技术
NYSE: MLSS
IT BEGAN WITH DENTAL - THE WAND®
始于牙科–THE WAND®
Anesthetize a single tooth / 麻醉单颗牙齿
Reduction in chair time / 缩短椅旁时间
Reduced quantity of anesthetic / 减少麻醉剂用量
Fewer complications /减少并发症
Ergonomic grip /符合人体工学的抓握设计
Reduced patient cancellations / 患者取消的情况减少
Avoid tachycardia / 避免心动过速
For Clinicians / 临床医生角度: For Patients / 患者角度:
Painless injection / 无痛注射
No collateral numbness / 无附带麻木感
Faster onset of anesthesia / 麻醉起效更快
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NYSE: MLSS
THE WAND® SINGLE TOOTH ANESTHESIA INSTRUMENT
THE WAND®单颗牙齿麻醉工具
FDA and CE marketing clearance / 获得美国食品药品监督管理局批准和欧洲CE认证
Over 70 MM injections delivered to date迄今为止,进行超过7000万次注射
Over $10.5M in sales in 2016 / 2016年销售额超过$1050万
Favorable evaluations in more than 50 peer reviewed and independent clinical research reports / 在超过50篇同行评审和独立临床研究报告中获得好评
21 patents around DPS® Dynamic Pressure Sensing technology / 围绕DPS ®动态压力感测技术的21项专利
Wand Dental subsidiary is cash flow positive on a standalone basis / 单独来看, Wand Dental子公司已经实现正向现金流。
Wand STA
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NYSE: MLSS
US DENTAL DISTRIBUTION - HENRY SCHEIN
美国牙科市场经销 - HENRY SCHEIN
Recently announced a 10-year exclusive agreement with Henry Schein, Inc. (NASDAQ: HSIC), the
world‘s largest provider of dental products / 近期与世界最大的牙科产品供应商——Henry Schein Inc
签订了十年独家协议
Henry Schein‘s Exclusive Products Sales Specialist Team will exclusively market and distribute The Wand®
STA® / Henry Schein专属产品销售专家团队将独家推广并分销The Wand® STA®
25 sales representatives supported by 900 field service representatives / 25名销售代表,并由900
名现场服务代表提供支持
Minimum purchase orders to maintain exclusivity in the third through tenth years / 最低采购量订单,以保持第三到第十年期间的独家经销权
Total Addressable Market: About 150,000 dentists in the USA will perform about 75,000,000 injections
this year alone / 总体目标市场:美国大约150,000名牙科医生单单今年就将进行75,000,000次注射
Plan to ship about 2,800,000 disposables in 2017, representing about 4% market penetration / 计划2017年一次性产品出货量2,800,000件,代表着大约4%的市场渗透率
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NYSE: MLSS
REVENUE GROWTH
收入增长
$4.5
$5.8 $6.2
$9.5 $10.5
68%
60%
65%
56%
58%
60%
62%
64%
66%
68%
70%
$0.0
$2.0
$4.0
$6.0
$8.0
$10.0
$12.0
2015 2016 2017
Revenue ($millions) & Gross Margin (%)
收入($百万)和毛利率(%)
Q1/Q2 Sales Annual Sales GM%
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第一/二季度销售额 年销售额 毛利率
THE FUTURE
未来
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NYSE: MLSS BEYOND DENTAL:
THE MEDICAL OPPORTUNITY /
不局限于牙科:医疗行业机会
TOTAL ADDRESSABLE MARKET > $1B in the US alone / 总体目标市场:单美国就超过$10亿
Unique ability to identify tissue type and control flow rate / 发现组织类型和控制流速的独特能力
Allows for wide array of medical instruments across disciplines / 可用作跨领域的一系列广泛医疗器械
Completed development on first 2 medical instruments / 已完成两款医疗器械的开发工作
Received CE Mark approval on epidural and intra-articular instruments / 硬膜外麻醉和关节内器械已经获得CE认证
Received FDA clearance for epidural / 硬膜外麻醉已获得美国FDA批准
Pursuing FDA clearance for Intra- Articular / 关节内产品正在寻求美国FDA批准
Other applications under review in attractive markets with favorable competitive landscape / 正在考察竞争形势良好的诱人市场的其他应用
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Epidural / 硬膜外麻醉
Intra-Articular / 关节内
Peripheral Nerve Block / 外周神
经阻滞
Cosmetic / 美容
NYSE: MLSS TOTAL ADDRESSABLE MARKET:
> $1B IN THE USA ALONE
目标市场:单美国就超过$10亿
Company estimates derived from CDC, CMS, NCHS, AHRQ, NVSS, ASPS, and ASDS data
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Procedure
手术
Application Area
应用领域
# Injections per Year
(millions)
每年注射量(百万)
Epidural
硬膜外麻醉
Labor & Delivery / 产科
Periop Pain Management
/围手术期疼痛管理
Chronic Pain / 慢性疼痛
1.8
3.0
8.0
Peripheral Nerve
Block / 外周神经阻滞
9.0
Intra-articular
关节内
Knees / 膝盖
Shoulders / 肩膀
Hips/Other / 臀部/其他
2.5
1.5
1.0
Cosmetic / 美容 Botox / 肉毒杆菌 8.4
TOTAL / 共计 35.3 million / 3530万
NYSE: MLSS
EPIDURAL ANESTHESIA APPLICATION
硬膜外麻醉
CompuFlo makes the procedure more
reliable for the clinician / CompuFlo使得这一手术对临床医生来说更加可靠
Reliably identify epidural space, reducing
the risk of human error / 可靠发现硬膜外腔,降低人为误差的风险
Objective confirmation that epidural space
is identified / 客观确认发现硬膜外腔
Precisely controls fluid flow rate / 精准控制液体流速
Precise pressure monitoring / 精准压力监测
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NYSE: MLSS
THE COMPUFLO® EPIDURAL INSTRUMENT
THE COMPUFLO®硬膜外麻醉器械
Patented DPS ® Technology / DPS ®专利技术:
Controls fluid flow rate / 控制液体流速
Monitors pressure / 监测压力
Portable with battery backup / 便携式设备,带有备用电池
510(k) #161883 Indication for Use: The CompuFlo Epidural Computer
Controlled Anesthesia System is intended for use with an epidural needle for
the real time verification of needle tip placement in the lumbar epidural
space…. / 510(k) #161883 所使用的适应症: CompuFlo硬膜外麻醉计算
机控制麻醉系统专门用于硬膜外注射针,实时确认针尖位于腰部硬膜外腔
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NYSE: MLSS
COMPUFLO® EPIDURAL – PIVOTAL STUDY
COMPUFLO®硬膜外麻醉 – 关键性试验
Completed COMPASS Study (CompuFlo® Assessment Study), a randomized, controlled, parallel group, multicenter, pivotal study / 已完成COMPASS 试验( Compuflo®评估试验),该试验为随机对照、平行分组、多中心关键性试验
Designed to assess the safety and effectiveness of the epidural space verification. / 试验目的是评估确认硬膜外腔的安全性和效果。
Reached enrollment of 400 patients consisting of two separate arms / 实现400名患者入组,包含两个单独的分支: (i) pain management / 疼痛管理; (ii) labor and delivery / 产房
Demonstrated the reliability of the CompuFlo technology in identifying and confirming the epidural space location / 显示了CompuFlo技术在发现和确认硬膜外腔位置时的可靠性
Success rates of 99% in labor/delivery and in the epidural management of pain / 产房和硬膜外疼痛管理时的成功率达到99%
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NYSE: MLSS
INTRA-ARTICULAR INJECTION APPLICATION
关节内注射应用
Reliably and precisely place the therapeutic
agent where the physician wants it / 将治疗药剂精确可靠地定位到医生想要的位置
Approved in the EU / 在欧盟获得批准
510(k) in process in the USA / 美国510(k)
申请正在进行中
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NYSE: MLSS
COSMETIC
美容
Under development for use
with aesthetic injections / 正在开发用于美容注射
Fast, precise, painless
injections / 快速精准无痛注射
Accurate & comfortable
stylus grip / 精确舒适的笔式抓握
Simple electronic records /
简单方便的电子记录
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NYSE: MLSS
INVESTMENT THESIS
投资理论
Wand Dental subsidiary is growing profitably - continuing to prove that the technology and business model works / Wand Dental子公司正在增长并盈利-继续证明公司技术和业务模式可行
Proprietary disposables provide recurring revenue with high margins / 专有的一次性产品提供高利润率的重复性收入模式
Entering medical markets with clinically proven indications for use / 进入医疗市场,所使用的适应症临床得到证明 Anesthesia is approved in the USA and EU / 麻醉应用在美国和欧盟获得批准
Intra-articular is approved in EU and in process in the USA / 关节内产品在欧盟获得批准,并且正在美国寻求批准
Cosmetic under development / 正在开发美容应用
Operating margins will expand with growing revenue / 随着收入增加,营业利润率将提高 Highly scalable business model / 高扩展性的业务模式
Value Drivers 2017/2018 / 2017/2018年价值驱动力:
Operating results / 运营结果
COMPASS study publications / COMPASS试验结果发布
Distribution contracts / 分销合同
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THANK YOU
谢谢
The Wand, STA Single Tooth Anesthesia System, and DPS Dynamic Pressure Sensing Technology are registered trademarks of Milestone Scientific, Inc.
NYSE: MLSS
TWELVE MONTHS 2016 (AUDITED)
Income Statement Balance Sheet
Twelve Months Ended
December 31,
2016 2015
Revenue $10,482,005 $9,491,569
Gross Profit $6,306,472 $6,443,309
Gross Margin 60% 68%
Operating Loss (6,513,960)
(3,056,748)
Net Loss $(5,946,507) $(5,467,522)
31/Dec/16 31/Dec/15
Cashandcashequivalents 3,602,229$ 4,194,384$
Totalcurrentassets 12,713,812$ 11,824,151$
Otherassets 17,355 17,355
Totalassets 13,550,650 12,809,327
Totalcurrentliabilities $5,014,321 $3,643,835
Totallong-termliabilities - -
Totalliabilities 5,014,321 3,643,835
WorkingCapital 7,699,491 8,180,316
Totalstockholders'equity $8,536,329 $9,165,492
Clean capital structure with no debt
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NYSE: MLSS
2016年12个月(调整后)
损益表 资产负债表
截至12月31日的
12个月
2016 2015
收入 $10,482,005 $9,491,569
毛利润 $6,306,472 $6,443,309
毛利率 60% 68%
营业损失 (6,513,960)
(3,056,748)
净亏损 $(5,946,507) $(5,467,522)
31/Dec/16 31/Dec/15
Cashandcashequivalents 3,602,229$ 4,194,384$
Totalcurrentassets 12,713,812$ 11,824,151$
Otherassets 17,355 17,355
Totalassets 13,550,650 12,809,327
Totalcurrentliabilities $5,014,321 $3,643,835
Totallong-termliabilities - -
Totalliabilities 5,014,321 3,643,835
WorkingCapital 7,699,491 8,180,316
Totalstockholders'equity $8,536,329 $9,165,492
Clean capital structure with no debt / 清晰的资本结构,零负债
21
2016年12月31日 2015年12月31日
总资产
流动资产总额
其他资产
现金和现金等价物 现金和现金等价物
流动负债合计
长期负债合计
总负债
营运资本
总股东权益
NYSE: MLSS
CAP TABLE AS OF AUGUST 2017
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NYSE: MLSS
股权结构表(截至2017年8月)
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已发行股票
全面摊薄后资本总额
期权,平均行权价$2.54
转股的优先股($7,000,000 / 每股$2.37)
权证,行权价$2.54
NYSE: MLSS
KEY STATISTICS & NUMBERS AS OF DEC 31, 2016
截至2016年12月31日的重要数据和数字
Ticker / 代码: MLSS
Exchange / 上市交易所: NYSE
Cash and Treasury Bills / 现金和短期国库券: $3.6 M / $360万
Working Capital / 营运资本: $7.7 M / $770万
Total Shareholder’s Equity / 总股东权益: $8.5 M / $850万
Security Ownership of Management / 管理层持股比例 : 32.8%
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NYSE: MLSS
RECENT PUBLICATIONS
近期发表的文章
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NYSE: MLSS
RECENT PUBLICATIONS
近期发表的文章
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NYSE: MLSS
RECENT PUBLICATIONS
近期发表的文章
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