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Jefferies Healthcare Conference June 6, 2017

Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

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Page 1: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

Jefferies Healthcare ConferenceJune 6, 2017

Page 2: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

Disclaimer

This presentation contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 andother federal securities laws, including, but not limited to, statements concerning: the Prescription Drug User Fee Act (PDUFA) dates forCotempla XR-ODT™; Neos Therapeutics, Inc.’s ability to successfully commercialize Adzenys XR-ODT™ and, if approved, Cotempla XR-ODT™ and its other product candidates in the United States and the timing thereof; its ability to successfully advance its pipeline ofproduct candidates; its ability to maintain and protect its intellectual property; the outcome or success of its clinical trials; the rate anddegree of market acceptance of its products; and its ability to develop sales and marketing capabilities. In some cases, you can identifyforward looking statements by terms such as “may,” ”will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,”“project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similarexpressions. The forward looking statements of this presentation are only predictions and are subject to a number of risks, uncertaintiesand assumptions, including, without limitation, our commercialization strategy for Adzenys XR-ODT™ and other products that may beapproved, our ability to successfully address the deficiencies identified by the FDA or which may be identified by the FDA which precludeapproval of the NDA for our Cotempla XR-ODT™ product candidate, including that we demonstrate bioequivalence between the clinicaltrial material and to-be-marketed drug product and that we assess the food effect on the to-be-marketed drug product; the receipt ofregulatory approval for Cotempla XR-ODT™ and NT-0201; the timing of such approval; Neos Therapeutics’ ability to market and sellAdzenys XR-ODT™ and any other products that may be approved; Neos Therapeutics’ ability to successfully compete in the market formedications indicated for ADHD; the manufacture of Adzenys XR-ODT™ and, if approved, Cotempla XR-ODT™ or Neos Therapeutics’other product candidates; and other risks set forth under the caption “Risk Factors” in Neos Therapeutics’ most recent Annual Report onForm 10-K and its other SEC filings. Moreover, Neos Therapeutics operates in a very competitive and rapidly changing environment. Newrisks emerge from time to time. It is not possible for Neos Therapeutics’ management to predict all risks, nor can Neos Therapeuticsassess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results todiffer materially from those contained in any forward looking statements it may make. In light of these risks, uncertainties andassumptions, the forward looking events and circumstances discussed in this presentation may not occur and actual results could differmaterially and adversely from those anticipated or implied in the forward looking statements. You should not rely upon forward lookingstatements as predictions of future events. Although Neos Therapeutics believes that the expectations reflected in the forward lookingstatements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstancesreflected in the forward looking statements will be achieved or occur. Moreover, except as required by law, neither Neos Therapeuticsnor any other person assumes responsibility for the accuracy and completeness of the forward looking statements. Forward lookingstatements in this presentation represent Neos Therapeutics’ views only as of the date of this presentation. Neos Therapeuticsundertakes no obligation to update or review any forward looking statement, whether as a result of new information, futuredevelopments or otherwise, except as required by law.

This presentation may contain trade names, trademarks or service marks of other companies. Neos Therapeutics does not intend theuse or display of other parties’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of,these other parties. Solely for convenience, the trade names, trademarks or service marks in this presentation are referred to withoutthe symbols ® and ™, but such references should not be construed as any indicator that their respective owners will not assert, to thefullest extent under applicable law, their rights thereto.

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Page 3: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

Investment Highlights

First and only FDA-approved extended

release orally disintegrating tablet for

the treatment of ADHD in patients 6

years and older

Robust prescription growth since

launch in May 2016

Number of prescribers and new to

brand (NBRx) market share growing

rapidly

Composition of matter patent through

2032

3

• Two additional ADHD product

candidates under FDA review with

PDUFA dates Jun 19, 2017 and Sept

15, 2017

• Launches anticipated in the fall of

2017 and Jan 2018

• Experienced commercial team with

50+ years of track record in ADHD

• Expanded ADHD product portfolio

would offer both amphetamine and

methylphenidate options

• Proprietary platform technology for

additional product candidates

Extended-Release

Orally Disintegrating Tablets

Page 4: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

ADHD is a $10.4B Market

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• Estimated to affect 11.0% of children between the ages

of 4 and 171 and 4.4% of adults in the U.S.2

• ADHD prescriptions grew by 5.6% during 20163

• Prescriptions for stimulant medications account for ~92% of the market4

Drug Type12 Months4 of

Prescriptions (Million)

12 Months5 of $

(Billion)

Amphetamine 44.1 $5.7

Methylphenidate 20.6 $3.4

Non-Stimulants 5.7 $1.3

1. 2011-2012 National Survey of Children’s Health (US-DHHS) http://www.cdc.gov/nchs/slaits/nsch.htm. Accessed March 19, 2015.

2. Brus ML, et al. J. Psychiatr Pract. 2014; (6):428-37.

3. QuintilesIMS: National Prescription Audit – trailing 12 month data as of December 2016

4. QuintilesIMS; National Prescription Audit – trailing 12 month data as of December 2016

5. QuintilesIMS; National Sales Perspective – trailing 12 month data as of November 2016

Page 5: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

Patient-Friendly Features of Adzenys XR-ODTAttractive to Both Pediatric & Adult Patient Populations

Portable,

child-resistant

blister pack

• Available in

6 dosage strengths

• Therapeutically

Equivalent to

Adderall XR

• Disintegrates in the mouth

• Orange Flavor

Can be taken without water

Once-daily

Administration

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Page 6: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

• Team of 125 sales

professionals calling on

12,500 physicians

• Focused on high volume

prescribers

• Programs and strategies

to provide accessibility

and affordability

Adzenys XR-ODT: Commercial Overview

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Page 7: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

196870

1520

3088

4335

5535

71197676

8870

10201

1322512942

0

2000

4000

6000

8000

10000

12000

14000

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Jan

Feb

Mar

Apr

Adzenys XR-ODT TRx

• Average 14% monthly

prescription growth in 2017

• 88,704 total TRx through May

26th

• Utilization across both

pediatric and adult patient

populations

Adzenys XR-ODT: Robust Prescription Growth Since Launch

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Source: QuintilesIMS Health National Prescription Audit

Page 8: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

68253

550912

13421617

18942167

23862780

2965

106362

486

684

782

660

640

548

476

577

665538

0

500

1000

1500

2000

2500

3000

3500

4000

May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr

Pre

scri

bers

6,524 Adzenys XR-ODT PrescribersThrough April 2017

Repeat New

Source: QuintilesIMS Xponent Weekly

Adzenys XR-ODT: New and Repeat Prescribers Continue to Grow

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Page 9: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

Patient Switching Accounts for Majority of New to Brand Business (NBRx)

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61%Pediatric NBRx

39%Adult NBRx

Switches, 72%

New Therapy Starts, 28%

Switches, 77%

New Therapy Starts, 23%

Source: QuintilesIMS Health New To Brand NPA; Launch to date through May 19 2017

Page 10: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

Patients are Switching to Adzenys XR-ODT from Multiple Products

Source: QuintilesIMS Health New To Brand NPA Data; Launch through Mar 2017

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Switches to Adzenys XR-ODT

Vyvanse26%

Adderall XR 17%

Adderall IR19%

Dyanavel XR1%

Quillivant XR6%

Concerta9%

Daytrana1%

Other Methylphenidates

16%

Non-Stimulants6%

Page 11: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

0

2000

4000

6000

8000

10000

12000

14000

Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr

TRx V

olu

me

TRx Uptake Curves – Through Apr 2017

ADZENYS XR-ODT 05-2016 DYANAVEL XR 04-2016 QUILLICHEW ER 04-2016

2016 2017

Source: QuintilesIMS Health National Prescription Audit

Adzenys XR-ODT: Tracking Well Against Recent ADHD Launches

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Page 12: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

New to Brand Market Share of Adzenys XR-ODT is Growing Rapidly

12

3.4%

10.5% 11.7% 11.9%

62.5%

8.3%

12.6%10.4%

23.3%

45.4%

12.4% 11.7%

7.8%

28.0%

40.2%

0%

10%

20%

30%

40%

50%

60%

70%

DYANAVEL XR QUILLICHEW ER DAYTRANA ADZENYS XR-ODT QUILLIVANT XR

NB

Rx

Sh

are

Alternative Dosage Form - New to Brand (NBRx) Market Share

Jun 16 Jan 17 Apr 17

Source: Quintiles IMS Health National Prescription Audit

Page 13: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

• New-to-market blocks have been lifted by all of the major

commercial accounts

Managed Care Coverage With Over 80% of Lives Covered by Commercial Payers

Ensure Adzenys

XR-ODT is

Accessible &

Affordable to

Patients

Minimize the Impact of Prior Authorizations (PA)

Obtain Open Access with Government & Commercial Payers

Ensure Out-of-Pocket Expenses are not a Barrier to Use

1

2

3

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Page 14: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

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• Cotempla XR-ODT™ (Methylphenidate) – PDUFA Date

June 19, 2017

• Amphetamine XR-Liquid Suspension – PDUFA Date

September 15, 2017

Two Additional ADHD Product Candidates Under FDA Review

Page 15: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

• If approved, Cotempla XR-ODT™ is positioned

to be the first methylphenidate XR-ODT for

once-a-day treatment of ADHD

• Composition-of-matter patent scheduled to

expire in 2032

• Compelling Phase 3 efficacy data in children

with ADHD

• NDA resubmitted Dec 19, 2016 (responded to

CRL)

• PDUFA date: June 19, 2017

• Expected to launch in the fall of 2017

Cotempla XR-ODT

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Page 16: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

• NDA resubmitted Dec 19, 2016 (Responded to CRL)

• Conducted a bridging study demonstrating bioequivalence between the clinical

trial (Pilot Scale) and to-be-marketed (Commercial Scale) material

• Completed three-month stability and process validation studies

• Compelling Phase 3 efficacy data in children with ADHD

Cotempla XR-ODT Regulatory and Clinical Update

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• Statistically significant

effects of Cotempla vs.

placebo across all endpoints

• Time to onset: within 1 hour

• Duration of effect: 12 hours

SKAMP: Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale

Page 17: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

• Amphetamine XR-liquid suspension for

once-a-day treatment of ADHD

• Composition-of-matter patents

scheduled to expire in 2032

• Completed human bioequivalence trial

vs. Adderall XR capsules

• Completed bridging study with

commercial scale material

• PDUFA date: September 15, 2017

• Expected to launch in Jan 2018

Amphetamine XR-Liquid Suspension (NT-0201)

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Page 18: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

Adzenys XR-ODT®(Amphetamine)

ADHD

Cotempla XR-ODT®(Methylphenidate)

ADHD

AMPH XR-Liquid (NT-0201)

ADHD

Tussionex®1 Generic(Liquid Suspension)

Cough/Cold

NT-0400 CNS/GI

NT-0500 CNS/GI

Growing Product Portfolio

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Launched May 2016

PDUFA Date June 19, 2017

PDUFA Date Sept 15, 2017

Launched Sept 2014

1 Tussionex® is a registered trademark of the UCB Group of Companies

Page 19: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

Financial Overview

Three Months Ended March 31, 2017 (in 000s)

Net Product Sales $5,627

Gross Profit $1,012

Operating Loss $(14,957)

Net Loss $(17,090)

Weighted Average Shares 19,625

Cash, Cash Equivalents & ST Investments $54,232

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• Adzenys XR-ODT three month net revenues of $3.1 million • Tussionex three month net revenues of $2.5 million

Page 20: Jefferies Healthcare Conference Therapeutics... · statements in this presentation represent Neos Therapeutics’views only as of the date of this presentation. Neos Therapeutics

• Adzenys XR-ODT launched May 2016

• Robust prescription growth since launch

• Number of prescribers and NBRx market share growing

rapidly

• 88,704 total TRx through May 26th, 2017

• Two additional ADHD product candidates under FDA review,

with launches anticipated in the fall of 2017 and Jan 2018

• Protection against generic competition through long-term

composition-of-matter patents

• Platform technology for additional branded product

candidates in multiple therapeutic areas

Summary

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