Forward Looking Statements

Forward Looking Statements

This document includes statements concerning our operating results (including product sales), financial condition and product development milestones, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements herein that are not clearly historical in nature are forward-looking, and the words “anticipate,” “assume,” “believe,” “expect,” “estimate,” “plan,” “will,” “may,” and the negative of these and similar expressions generally identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond Flamel’s control and could cause actual results to differ materially from the results contemplated in such forward-looking statements. These risks, uncertainties and contingencies include the risks relating to: our dependence on a small number of products and customers for the majority of our revenues; the possibility that our Bloxiverz® and Vazculep® products, which are not patent protected, could face substantial competition resulting in a loss of market share or forcing us to reduce the prices we charge for those products; the possibility that we could fail to successfully complete the research and development for the two pipeline products we are evaluating for potential application to the FDA pursuant to our “unapproved-to-approved” strategy, or that competitors could complete the development of such products and apply for FDA approval of such products before us; our dependence on the performance of third parties in partnerships or strategic alliances for the commercialization of some of our products; the possibility that our products may not reach the commercial market or gain market acceptance; our need to invest substantial sums in research and development in order to remain competitive; our dependence on certain single providers for development of several of our drug delivery platforms and products; our dependence on a limited number of suppliers to manufacture our products and to deliver certain raw materials used in our products; the possibility that our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do; the challenges in protecting the intellectual property underlying our drug delivery platforms and other products; our dependence on key personnel to execute our business plan; the possibility that we may cease to qualify as a foreign private issuer, which would increase the costs and expenses we incur to comply with U.S. securities laws; and the other risks, uncertainties and contingencies described in the Company’s filings with the U.S. Securities and Exchange Commission, including our annual report on Form 20-F for the year ended December 31, 2014, all of which filings are also available on the Company’s website. Flamel undertakes no obligation to update its forward-looking statements as a result of new information, future events or otherwise, except as required by law.

Flamel Technologies Transformed

• Fully integrated global specialty pharmaceutical company with FDA approved

products and a broad pipeline using Flamel’s proprietary drug delivery platforms

• Two FDA approved products marketed by Flamel in the United States on track

to drive significant cash flow in 2016

• Incremental clinical data expected from several of Flamel’s pipeline products

over the next 12-18 months

• Anticipated positive cash flow in 2015 and 2016

• Net cash position of over $128 million on September 30, 2015

Key Milestones Achieved

2014

 Launch of Bloxiverz® and Vazculep® in the United States

 Completed an equity raise of $113 million (net proceeds)

 Divested contract manufacturing facility

 Implemented corporate reorganization

• Shifted all intellectual property from France to Ireland

 Presented positive clinical and preclinical data • Micropump® sodium oxybate: eliminated middle of

the night dose

• LiquiTime® ibuprofen: twice-daily dosing confirmed

• Medusa™ exenatide: PK* profile compatible with release over one week in humans

*PK = pharmacokinetics

2015

 Generated over $170M of revenues

• Profitable, and cash flow positive for first time in company's history

 Presented positive clinical and preclinical data • LiquiTime® guaifenesin: twice-daily dosing

confirmed

• Trigger Lock™ hydromorphone: bioequivalence criteria met (under fasted conditions)

• Medusa™ exenatide: positive interim results from a Phase 1a clinical trial

 Licensed exclusive U.S. rights to the LiquiTime® drug delivery platform to Perrigo for the

2016 Expectations

• Achieve total product sales of $100-120 million

• Launch UMD#3

• Start patient registration for pivotal study of Micropump® sodium oxybate

• Begin licensing discussions for Trigger Lock™ platform

• Complete and report data from Phase 1b study with Medusa™ exenatide in patients

• Commence development of additional projects, including UMD#4

Flamel’s Goals

•

Upcoming Milestones

Upcoming Milestones

Technology 1H 2016 2H 2016

UMD Product #3* Launch in the USA

Micropump® Submit SPA/IND/CTA; Initiate sodium

oxybate pivotal trial Pivotal trial ongoing

LiquiTime® Confirmatory PK study for guaifenesin IND/CTA filing for Phase 3 efficacy studies for ibuprofen

Trigger Lock™ Pre-IND meeting with FDA

Supplemental alcohol

interaction study / partnership discussions

Medusa™ Complete Phase 1b study Assess future development plans / partnership

Drug/ Technology Indication _ClinicalPre- Proof of _{Concept Ranging}Dose _{Pivotal Review}Under Approved Marketed _ForceSales

Bloxiverz®/UMD1 _{Anesthesia Flamel}

Vazculep®/UMD1 _{Anesthesia Flamel}

UD/UMD1_{#3 Undisclosed Flamel}

UD/UMD1_{#4 Undisclosed Flamel}

Sodium oxybate/

Micropump® Narcolepsy TBD

Ibuprofen/LiquiTime® Pain, fever Perrigo

Guaifenesin/LiquiTime® Respiratory Perrigo

Hydromorphone/

Trigger Lock™ Pain TBD

Exenatide/Medusa™ Diabetes TBD

Flamel’s Pipeline (1H 2016)

1_{UMD is Flamel’s Unapproved Marketed Drugs Strategy that does not involve patented technology} 2_{Dose ranging not required by the FDA}

UD = undisclosed TBD= To Be Determined

Flamel’s Pipeline Looking Ahead (

2H 2016

)

Drug/ Technology Indication _ClinicalPre- Proof of _{Concept Ranging}Dose _{Pivotal Review}Under Approved Marketed Sales Force

Bloxiverz®/UMD1 _{Anesthesia Flamel}

Vazculep®/UMD1 _{Anesthesia Flamel}

Disclosed/UMD1_{#3 Disclosed Flamel}

Disclosed/UMD1_{#4 Disclosed Flamel}

Sodium oxybate/

Micropump® Narcolepsy TBD

Ibuprofen/LiquiTime® Pain, fever Perrigo

Guaifenesin/LiquiTime® Respiratory Perrigo

Hydromorphone/

Trigger Lock™ Pain TBD

Exenatide/Medusa™ Diabetes TBD

2

1_{UMD is Flamel’s Unapproved Marketed Drugs Strategy that does not involve patented technology} 2_{Dose ranging not required by the FDA}

UD = undisclosed TBD= To Be Determined

Flamel’s Marketed Products

•

Bloxiverz®

Marketed Product – BLOXIVERZ®

• FDA approval on May 31, 2013; currently 1 of 3 approved versions of neostigmine methylsulfate injection

• Owns 50% of the market at end 2015

• Approximately 4 million vials sold annually in the United States*

• More details can be found at www.bloxiverz.com

Marketed Product – VAZCULEP®

• FDA approval on June 30, 2014

(only FDA-approved phenylephrine injection available in three vial sizes)

• Form: 1 mL single use vials, 5 mL and 10 mL

pharmacy bulk package vials for intravenous injection (bolus or infusion) (strength: 10 mg/mL)

• Indication: Treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia

• Market potential at end 2015* (estimates based on January to November data)

• 1mL vial – 5.7 million 5mL vial – 1.2 million 10mL vial – 0.2 million

• More details can be found at www.vazculep.com

Flamel’s R&D Pipeline

•

Micropump® sodium oxybate

•

LiquiTime® ibuprofen

•

LiquiTime® guaifenesin

•

Trigger Lock™ hydromorphone

Micropump® Sodium Oxybate for Narcolepsy

• FT218 is an extended release oral solid formulation of sodium oxybate using

Micropump® technology

• Studied in 40 healthy volunteers across 2 studies, up to 7.5g dose

• No safety or tolerability issues

• PK results at 4.5g dose in comparison to Xyrem® :

Onset of action similar to Xyrem®

Cmax lower than Xyrem®

Total drug exposure similar to Xyrem ®

Sodium oxybate mean blood concentration at 7 and 8 hours after administration similar to Xyrem®

• PK results at 6g and 7.5g doses in line with expectation relative to lower dose of

FT218

• Profile is consistent with the target of only one single dose before bedtime

Current dosing regimen for Xyrem® : two equal divided doses, first at bedtime and second 2,5 to 4 hours later

• Flamel met with FDA mid 2015

• Next step: regulatory submission of Phase III clinical trial application and

• First nine months of 2015 sales for Jazz’s Xyrem® were $703 million; FY2015 sales could exceed $900 million

• >45% CAGR for Xyrem from 2010-2015

• ~178,000 narcoleptic patients in the U.S.*

• Jazz reports less than 13,000 patients currently on treatment

• May benefit from the significant number of untreated patients • Limited competition to date

• Xyrem expected to maintain dominant position in the narcolepsy market

• Micropump® sodium oxybate anticipated to benefit from improved profile

Micropump® Sodium Oxybate – Market Opportunity

LiquiTime® Ibuprofen

• Extended release liquid oral suspension for treatment of pain and fever

• Ibuprofen oral suspension twice-daily dosing confirmed

• First-in-Man (FIM) clinical study in healthy volunteers (15 subjects)

• Trial design: open-label, randomized, 3-way crossover with an immediate-release ibuprofen control and 2 formulations of LiquiTime® ibuprofen

• PK results announced in September 2014 demonstrated:

 Bioequivalence to immediate-release ibuprofen

 Similar onset versus immediate-release ibuprofen

 Similar blood levels at 12 hours versus immediate-release ibuprofen

 No safety or tolerability issues

• Exclusive U.S. rights licensed to Perrigo for the OTC drug market

LiquiTime® Guaifenesin

• Extended release liquid oral suspension for treatment of cough and cold

• Guaifenesin oral suspension twice-daily dosing confirmed

• First-In-Man (FIM) clinical study in healthy volunteers (16 subjects)

• Trial design: open label, randomized, 4-way crossover with an immediate release guaifenesin control dosed three times over 12 hours and three formulations of LiquiTime® guaifenesin

• PK results announced in March 2015 demonstrated:

 A profile that is highly likely to succeed in a pivotal bioequivalence study

 Similar blood levels at 12 hours versus immediate-release guaifenesin

 No safety or tolerability issues

• Exclusive U.S. rights licensed to Perrigo for the OTC drug market

• Cough and cold U.S. market is estimated at $6.5b annually1

• OTC ibuprofen-containing products recorded over $490 million2_{of sales}

• OTC guaifenesin-containing products recorded over $440 million2 _{of sales}

• Cough/cold market dominated by OTC drugs, many of which are combinations:

• Ibuprofen or Acetaminophen/paracetamol (analgesic and antipyretic)

• Chlorpheniramine or Diphenhydramine (antihistamine)

• Pseudoephedrine or Phenylephrine (decongestant)

• Dextromethorphan (antitussive)

• Guaifenesin (expectorant)

• LiquiTime® allows for combination of active ingredients with potential to

tailor release profile for each

• Exclusive U.S. rights to LiquiTime® licensed to Perrigo for OTC market in October 2015

LiquiTime® OTC – Market Opportunity

1_{Deutsche Bank} 2 _{IMS – U.S. sales}

• FT227, an abuse-deterrent, extended-release, oral hydromorphone product

for treatment of pain

• Positive results from two pilot PK studies in healthy volunteers announced in June 2015

 Bioequivalence criteria for area under the curve (AUC) and the peak plasma concentration

(Cmax) met under fasted conditions

 No notable difference in either AUC or Cmax in fed and fasted conditions (comparing the effect of food on the PK parameters)

• Independent research by CRO further validates in-house data on abuse deterrent properties and robust technology

 FT227 demonstrated better resistance in extraction/recovery studies in different media and under several different conditions than both Exalgo and Oxycontin

 Shown to resist both chemical and physical manipulation

• Next steps: Flamel will meet with the FDA in 1H 2016; partnering discussions

begun

• Trigger Lock™ technology is applicable to all opioids

• Abuse of painkillers is a major public health concern in the USA

• ~2.1 million in US in 2012 suffered from substance use disorders related to prescription

opioid pain relievers

• U.S. market for prescription painkillers (all forms) in 2015 (Jan.-Nov.):$6.5b1

• OxyContin® (extended-release oxycodone, Purdue): $2.1b1

• ER hydromorphone (Exalgo® & generics) $138m1

• Number of prescriptions for opioids (like hydrocodone and oxycodone products) escalated from ~76 million in 1991 to ~207 million in 20132

Trigger Lock™ – Market Opportunity

• FT228 is a subcutaneous injection formulation of exenatide, a GLP-1

(glucagon-like peptide – 1) for treatment of Type 2 diabetes

• Interim phase I human clinical data reported on December 22, 2015

 All safety and pharmacokinetic (PK) assessment objectives throughout ascending single

dose administrations of FT228

 Safety profile of FT228 was favorable in healthy volunteers up to a dose of 140 mcg

 Extremely low incidence of the gastrointestinal side effects commonly related to twice daily subcutaneous administration of exenatide (nausea, vomiting, abdominal discomfort, loss of appetite)

 Low incidence of mild injection site reactions

• PK profile compatible with a release over one week in humans

• Market opportunity: GLP-1 products recorded over $3.2 billion*:

• $2.1b for Victoza® (once a day liraglutide, Novo Nordisk)

• $600m for Bydureon® (once-a-week exenatide, AstraZeneca)

• $266m for Byetta® (twice-a-day exenatide, AstraZeneca)

• Next steps: completion of Phase 1b study in 1H 2016; seek partnership

Medusa™ Exenatide

Flamel’s Strengths

•

Diversified and proven drug delivery platforms

•

Strong intellectual property

•

Seasoned senior management

Diversified and Proven Drug Delivery Platforms

• Outstanding drug delivery platforms to tackle key challenges in the formulation, in various

dosage forms (e.g. capsules, tablets, sachets or oral liquid suspensions; or injectable for

subcutaneous administration) of a broad range of drugs (already-marketed, off-patent or novel)

Micropump, LiquiTime, Trigger Lock and Medusa are trademarks of Flamel Ireland Ltd.

Modified/Controlled Release of Solid Oral Drugs

Modified/Controlled Release of Liquid Oral Drugs

Abuse-Resistant Modified/Controlled Release

Narcotics/Opioid Analgesics

Modified/Controlled Release of Injectable Drugs

Strong Intellectual Property

Broad portfolio of patents*

• New patents may be issued targeting each individual product in development where a Flamel drug delivery platform is applied to a specific molecule

Date of expiration of granted patents

Platform US Europe

Micropump® July 2027 July 2023

LiquiTime® September 2025 April 2023

Trigger Lock™ April 2027 May 2026 (pending)

Medusa™ June 2031 June 2027 (pending)

Seasoned Senior Management

Name Title Appointed Experience

Michael S. Anderson Chief Executive Officer 2012 40+ years Pharma Sandy Hatten Senior Vice President, Quality and Regulatory Affairs 2015 30+ years Pharma Phillandas T.

Thompson, J.D., M.B.A. Senior Vice President, General Counsel 2013 16+ years Legal Mike Kanan Senior Vice President and Chief Financial Officer 2015 30+ years Financial Gregory J. Davis Vice President, Corporate and Business Development 2015 20+ years Pharma David Monteith, Ph.D. Vice President, Research and Development 2014 25+ years Pharma Dhiren D’Silva Vice President of Irish and European

Condensed Consolidated Statement of Operations

(Unaudited)

In USD million,

except EPS (USD) and shares data (million)

Nine months ended September30,

2014

September 30, 2015

Total Revenue $ 11.8 $129.8

Total Costs and Expenses (72.2) (135.3)

Profit (loss) from continuing

operations (60.4) (5.4)

Net income (loss) from continuing

operations (57.0) (35.4)

Net income (loss) (57.8) (35.4)

Diluted EPS from continuing

operations (1.62) (0.88)

Adjusted Diluted EPS (non-GAAP) (0.44) 0.72

Condensed Balance Sheet

(Unaudited)

securities $92.8 $113.2 $116.1

LT debt1 _{118.5 123.2 149.7}

Other LT liabilities2 _{2.3 2.1 2.2}

1 _{Includes government loans for R&D projects, acquisition liability contingent consideration, warrant}

consideration, and royalty agreements concluded in February 2013 and December 2013

Flamel Technologies Transformed

• Fully integrated global specialty pharmaceutical company with FDA

approved products and a broad pipeline using Flamel’s proprietary drug delivery platforms

• Two FDA approved products marketed by Flamel in the United States on

track to drive significant cash flow in 2016

• Incremental clinical data expected from several of Flamel’s pipeline products

over the next 12-18 months

• Anticipated positive cash flow in 2015 and 2016

• Net cash position of over $128 million on September 30, 2015

Micropump® Platform at a Glance

• Extended/delayed-release of drugs in the GI tract

• Precise pharmacokinetics of single or combination of drugs in various formats

• Numerous Micropump®-based products successfully tested in human clinical trials

Various dosage forms (tablet, capsule, sachet, liquid)

Commercial stage

platform approved in the USA and EU

Widely used and accepted excipients

Rapid development time Combination of

multiple release profiles and/or multiple active ingredients

Taste-masking properties

Easy to scale-up

• Microparticles are dispersed in the stomach and pass into the small intestine, after which each microparticle releases the drug at an adjustable rate and over an extended period of time (up to 24 hours)

• Drug released at an adjustable rate controlled and/or delayed

• Micropump® microparticles can be used separately or together to provide highly specialized delivery profiles

Micropump Microparticles for Controlled/Modified Release

Granules

drug granulate or layered neutral core

LiquiTime® Platform at a Glance

LiquiTime® is a novel, proprietary and innovative delivery platform allowing the stable

Liquid and controlled release formulation of one or several combined drugs overTime

LiquiTime® meets challenges faced in the treatment of pediatric and geriatric patients and patient populations who have difficulty swallowing tablets or capsules, and may provide better patient compliance

LiquiTime’s versatility allows once- or twice-daily liquid formulationsof a wide variety of drugs

This graph illustrates the different near zero-order release profiles which can be tailored for the same drug

Each microparticle is individually coated and behaves as an

independent micro reservoir

Coating

• controls diffusion

•keeps its integrity

•offers good resistance to stress

LiquiTime® for Extended-Release Liquid Suspension

Liquid suspension contains small coated drug microparticles A dose typically contains 5,000 to 50,000 particles

ER microparticles are suspended in the liquid medium

Granules

drug granulate or layered neutral core

Trigger Lock™ is a proprietary and innovative delivery platform that enables the controlled release of narcotic and opioid analgesics while deterring their abuse

Trigger Lock™ successfully addresses the issues of narcotic/opioid analgesics tampering:

 The sustained release Micropump®-based microparticles are resistant to crushing: each microparticle retains its polymer coating which is virtually impervious to further crushing

 Trigger Lock™ resists extraction attempts (even in boiling liquids) with beverages (alcoholic or not) preventing injection

 Trigger Lock™ preserves the bioavailability of the narcotic/opioid analgesics

 Trigger Lock™ is compatible with different dosage forms (capsules, tablets)

Trigger Lock™ Platform at a Glance

1. Drug loaded Micropump® microparticles

Sustained Release (SR) microparticles which are resistant to crushing

2. Viscosifying ingredient(s)

To prevent abuse by injection after extraction in a small volume of solvent

3. Quenching ingredient(s)

To prevent extraction in large volumes of liquid

 Each microparticle retains its polymer coating which is virtually impervious to further crushing

Medusa

Depot

Solubilization and stabilization of drugs

Applicable to a wide range of small molecules, peptide

and protein drugs

Safe, non-immunogenic and fully biodegradable

Sustained delivery from 1 to 7 days in human Combination of several

different drugs in the same formulation

Bio-friendly, water-based, solvent-free

formulation process

Strong IP position

Medusa™ Depot for Injection

Formulation by simple mixing in water Non-covalent association

(reversible hydrophobic and/or electrostatic interaction)

of the drug with Medusa™ nanoparticles

Injection

In vivo depot formation

1 2 3

Sustained release of the unmodified drug

over 1 to 7 days

*

* *

Water clear liquid Solution Or Freeze-dried

In Vitro In Vivo

• Made of polyglutamic acid and Vitamin E

• Amphiphilic and spontaneously forms stable nanoparticles in water

Headquarters

33 avenue du Dr. Georges Levy 69200 Vénissieux (Lyon) France Corporate Contact Phone: +33 472 783 434 Fax: +33 472 783 435 E-mail: [email protected]

Specialty Pharmaceutical Company with Proprietary Drug Delivery Platforms Focused on