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INVESTOR PRESENTATION / 投资者报告 OCTOBER 2017 / 201710MILESTONE SCIENTIFIC, INC. © 2017, Milestone Scientific, Inc. All Rights Reserved

INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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Page 1: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

INVESTOR PRESENTATION / 投资者报告 OCTOBER 2017 / 2017年10月

MILESTONE SCIENTIFIC, INC.

© 2017, Milestone Scientific, Inc. All Rights Reserved

Page 2: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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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Page 3: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

NYSE: MLSS

ABOUT MILESTONE SCIENTIFIC

MILESTONE SCIENTIFIC简介

3

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

Page 4: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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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Page 5: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

NYSE: MLSS

REDEFINING INJECTION TECHNOLOGY

重新定义注射科技

5

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

Page 6: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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

6

Page 7: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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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Page 8: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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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Page 9: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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%

9

第一/二季度销售额 年销售额 毛利率

Page 10: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

THE FUTURE

未来

10

Page 11: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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

11

Epidural / 硬膜外麻醉

Intra-Articular / 关节内

Peripheral Nerve Block / 外周神

经阻滞

Cosmetic / 美容

Page 12: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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

12

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

Page 13: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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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Page 14: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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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Page 15: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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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Page 16: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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

16

Page 17: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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

17

Page 18: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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

18

Page 19: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

THANK YOU

谢谢

The Wand, STA Single Tooth Anesthesia System, and DPS Dynamic Pressure Sensing Technology are registered trademarks of Milestone Scientific, Inc.

Page 20: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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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Page 21: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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

Page 22: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

NYSE: MLSS

CAP TABLE AS OF AUGUST 2017

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Page 23: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

NYSE: MLSS

股权结构表(截至2017年8月)

23

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

Page 24: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

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%

24

Page 25: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

NYSE: MLSS

RECENT PUBLICATIONS

近期发表的文章

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NYSE: MLSS

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Page 27: INVESTOR PRESENTATION / 投资者报告 - NAI 500...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

NYSE: MLSS

RECENT PUBLICATIONS

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