Specialty Pharmaceutical Company Focused on PainEgalet+Presentat… · and OXAYDO®; our ability to execute on our sales and marketing strategy, ... Secured Notes and non-cash amortization

© Copyright 2017. Egalet Corporation

Specialty Pharmaceutical Company Focused on Pain

Egalet Corporate Presentation

NASDAQ: EGLT1


Forward-Looking Statements

2

Statements included in this presentation that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities

Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations, and are subject to known and

unknown uncertainties, risks and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be

materially different from those anticipated by such statements. You can identify forward-looking statements by terminology such as “may,” “could,”

“plans,” “future,” “expects,” “goal,” “intends,” “assess,” “continue to,” “potential,” “anticipates,” “believes,” “estimates,” or “predicts,” or the negative of

these terms or other comparable terminology. Forward‐looking statements contained in this presentation include, but are not limited to, (i) our

expectations regarding when our product candidates could be launched or on the market and key factors with regard to such launch, (ii) statements

regarding the potential market size for our products, (iii) the timing or likelihood of regulatory filings and approvals for our product candidates; (iv) our

expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (v) the impact of our existing commercial presence on the

launch of our new products; (vi) the impact of the addition of our new products and product candidates on our market presence; (vii) statements

regarding the expansion of new prescribers and prescriptions for our products; (viii) the timing of the expansion of dosage levels for our products; (ix)

our expectations regarding our path to sustainability and growth; (x) the eventual outcome of the FDA’s actions relating to abuse-deterrent products; and

(xi) our expectations regarding our finances, our funding sources, our use of funds and potential payments under our notes and our royalty rights

agreements. In addition, we, through our senior management, from time to time make forward-looking public statements concerning our expected future

operations and performance and other developments. Actual results could differ materially from those discussed due to a number of factors, including,

but not limited to: our ability to obtain regulatory approval of our product candidates; our ability to successfully commercialize SPRIX®, ARYMO™ ER

and OXAYDO®; our ability to execute on our sales and marketing strategy, including developing relationships with customers, physicians, payors and

other constituencies; the accuracy of our estimates of the size and characteristics of the potential markets for our product candidates and our ability to

serve those markets; unexpected safety or efficacy data; competitive factors; changes in the regulatory environment for our products; any further FDA

action relating to abuse-deterrent products; general market conditions; our need for future capital; our estimates regarding expenses, future revenues,

capital requirements and needs for additional financing; and other risk factors described in our filings with the United States Securities and Exchange

Commission. Egalet assumes no obligation to update or revise any forward-looking statements contained in this presentation whether as a result of new

information or future events, except as may be required by law.


Egalet’s Path to Sustainability

3

• Licensed/Acquired products

• Established commercial

• Generated revenue

• Progressed pipeline

• Raised capital

• Drive revenue growth

• Commercial focus

• LCM/acquisitions

• Specialty focus:

CNS, orphan

• Aggressive M&A

• Add late-stage or

commercial products

• Invest in key business

areas

• Establish competitive

advantage

2014 - 2016 2017 2019

• Established technology

• Filed patents

• Secured capital

• Signed BD deal

2013

Build R&D

Foundation

Fuel GrowthEnsure

Sustainability

Establish

Commercial

Presence

© Copyright 2017. Egalet Corporation.

Focusing on Large Markets & Addressing FDA Priority

4 4

✓ Rapidly growing specialty pharmaceutical company

✓ Products and pipeline target large markets and designed to address top FDA priority

✓ Ability to use business development to bring in complementary innovative products

✓ Organic growth leveraging proprietary Guardian™ Technology

✓ Strong cash position


Balancing the Need for Pain Products with New Solutions

5

100 MILLION

People living with pain in US

Abuse-deterrent opioids

Novel pain targets

Non-narcotic treatments


Focused Commercial Strategy

6


Field Structure to Maximize Commercial Opportunities

7

32 Territory

Managers

~4,500 HCPs• High prescriber pain physicians

• High prescribers of IM Toradol®

50 Territory

Managers

~6K HCPs• High LAO decile

• Embeda prescribers

• High low dose oxycodone prescribers

• OXAYDO prescribers


SPRIX® Nasal Spray

8

• Non-opioid for pain relief at the opioid level

• Potent non-steroidal anti-inflamatory drug (NSAID) with rapid

absorption

• Convenient dosing of well known pain medicine, ketorolac

• Targeting high prescriber pain physicians and high prescribers of

IM Toradol®

Indicated in adult patients for the short-term (up to 5 days) management of

moderate to moderately severe pain that requires analgesia at the opioid level.


Updated Campaign to Speak to Target Audience

9


Quarterly SPRIX® Rx Continue to Increase

➢ Revenue: Q4: $4.6 MM; YTD: $13.3 MM

➢ Prescription Growth: 22% over Q3

➢ New Prescribers: Q4 + >440

10


OXAYDO®, Only IR Oxycodone Designed to Discourage Nasal Abuse

11

• Immediate-release oxycodone with aversion technology

• Designed to discourage abuse via most common non-oral route of

abuse for oxycodone—snorting

• Approved in 5 mg and 7.5 mg doses

• Demonstrated BE at 15 mg

• Abuse-deterrent Category 1 data showed resists syringeability and

sNDA under review at FDA

For the management of acute and chronic moderate to severe pain where the use

of an opioid analgesic is appropriate.

Goal: 10 and 15 mg dosage strengths in 2H 2017


Rolling Out a New Campaign to Improve HCP Conversation

12


Quarterly OXAYDO® Rx Continue to Increase

➢ Revenue: Q4: $1.5 MM; YTD: $3.6 MM

➢ Prescription Growth: 22% over Q3

➢ New Prescribers: Q4 + >440

13


ARYMO™ ER, An Abuse-Deterrent Morphine

14


FDA Moving Toward All Abuse-Deterrent Formulations

2/16 FDA Opioid Action Plan

3/16 FDA Draft Generic Guidance

4/15 FDA ADF Guidance

1/13 FDA Draft ADF Guidance

GOAL: Remove Non-ADFs from Market

+ 4/16/13 OxyContin Approved

+ 7/23/14 Targiniq ER Approved

+ 11/20/14 Hysingla ER Approved

+ 11/17/14 Embeda Approved

+ 10/2/15 MorphaBond Approved

+ 08/19/16 Troxyca ER Approved

+ 04/26/16 Xtampza ER Approved

+ 1/9/17 ARYMO ER Approved

+ 01/18/17 Vantrela ER Approved

- 9/26/16 Remoxy Rejected

- 6/15/16 Apadaz Rejected

2017

2013

2014

2016

2015

15


Guardian™ Technology Confers Physical and Chemical Barriers to Abuse

16

Polyethylene oxide (PEO)+

Chemical

(polymer matrix)

Injection molding machine

Physical

(hardness)

Well-characterized process,

differentiated by heat & pressure

Viscous hydrogel on

contact with liquid

Extended-release profile with

physical and chemical

abuse-deterrent properties


Inject

ADFs May Intervene at Several Points in Progression of Substance Abuse

Exposed to Opioid

Snort

Susceptible to Addiction

Chew/Crush

ADF

(Manipulated Oral)

ADF

(Nasal)

ADF

(IV)

Inject

Snort

Susceptible to Addiction

Chew/Crush/Swallow

Exposed to Opioid

17

© Copyright 2017. Egalet Corporation.1

818

Morphine - Most Commonly Prescribed ER Opioid in U.S.

98.4%are non abuse-deterrent

1.6%

ADFs

ER Morphine PrescriptionsJanuary-November 2016

IMS (National Prescription Audit) Database

IMS (National Prescription Audit) Database

0.0M

1.0M

2.0M

3.0M

4.0M

5.0M

6.0M

7.0M

8.0M

TR

x V

olu

me

Morphine

Fentanyl

Oxycodone

Methadone

Oxymorphone

Other Moieties


ARYMO™ ER (morphine sulfate) extended-release tablets C-II

• FDA approved for the management of pain severe enough

to require daily, around-the-clock, long-term opioid

treatment and for which alternative treatment options are

inadequate

• First abuse-deterrent, extended-release morphine

developed with Guardian™ Technology

• Available in 15, 30 and 60 mg doses

19

NOW AVAILABLE


ARYMO™ ER is Now Available

20

Abuse of ARYMO ER by injection, as well as by the oral and nasal routes, is still possible.

• Physical/chemical barrier approach to abuse deterrence

• No clinically relevant food effect

• No alcohol dose dumping

• Increased resistance to cutting, crushing, grinding or breaking using a

variety of tools

• No objection from FDA re: communicating with HCPs about intranasal abuse

• Forms a viscous hydrogel (i.e., a gelatinous mass) on contact with liquid that

resists passage through a hypodermic needle

Expected to make abuse by injection difficult


Key Factors for Successful ARYMO™ ER Commercial Launch Planned for Q1 2017

Support wholesaler/retail pharmacy stocking and pull through

Convey value proposition, product positioning through personal

promotion

Launch non-personal support programs and tactics to accelerate brand

awareness

Ensure adequate product access/availability across commercial,

Medicare Part D and Medicaid segments

21


Development Pipeline

22


Robust Pipeline

23

Approved

Late-Stage

Early-Stage

SPRIX® (ketorolac tromethamine) Nasal Spray Short-term pain

Egalet-002, AD, ER oxycodoneChronic pain

Egalet-004, AD ER HydrocodoneChronic pain

OXAYDO® (oxycodone HCl, USP) Tablets for oral use only – CII Acute and chronic pain

Egalet-003, AD Stimulant

Ph 1 Ph 2 Pivotal NDA Filed Marketed

Guardian TechnologyCommercial Products

SPRIX® Nasal Spray for outside US Short-term pain

Preclinical

Partnered Products

ARYMO™ ER (morphine sulfate) extended-release tablets C-II Chronic pain


Financials and Conclusion

24


Selected Financial Data

25

Cash and marketable securities 86,826$ (1) Strong cash position

Working capital 68,276$ (1)

Total Debt 101,000$ (1)

Income Statement 2015 2016

Net product revenue 4,184$ 16,964$ Growth of SPRIX and OXAYDO

Operating expenses 75,046$ 97,988$ Expansion and growth of commercial organization

Interest expense 7,476$ 12,108$ Addition of senior secured debt

Net loss (57,932)$ (90,632)$

Cash Flow 2015 2016

Cash used in operations (39,735)$ (72,867)$

Purchase of SPRIX and License of OXAYDO (15,800)$ -$ Product acquisition and license

Cash used in investing activities (3,970)$ (7,237)$ Manufacturing capacity

Cash provided by financing activities 152,293$ 21,647$ Debt & equity financings

Net increase (decrease) in cash and

marketable securities 92,969$ (58,882)$

As of December 31, 2016

(1) Excludes net proceeds of $38 million of senior secured debt

proceeds received in Janaury 2017 due to ARYMO ER approval.

For the years ended December 31,

For the years ended December 31,


Financial Expectations for 2017

• Continue growth of SPRIX and OXAYDO revenue

• Introduce ARYMO™ ER

• Total operating expenses in 2017 to be approximately the same as 2016

– Lower R&D due to winding down of clinical trials

– Higher S&M due to sales force expansion and ARYMO ER launch

– Growing G&A to support larger commercial organization and impact of OPC costs

• OPC Costs will be approximately $6-8 million in the first half of 2017, which represent the requirements

for the class-wide extended-release/long-acting opioid analgesics as part of the Opioid Post-

Marketing Requirement Consortium or OPC

• Interest expense is a combination of cash interest on 5.5% Convertible Notes, 13.0% Senior

Secured Notes and non-cash amortization of debt discount

26


Sustainable Growth with Numerous Milestones

H2 2016 Egalet-002 Cat 3 IN HAP

ARYMO ER Approval

Q1 2017 ARYMO ER launch

H2 2017 New doses of OXAYDO available

Q4 2017 Complete Egalet-002 Phase 3 program

2019 submit Egalet-002 NDA

27


Thank You

@EgaletCorp

Egalet.com

28

Documents

Specialty Pharmaceutical Company Focused on PainEgalet+Presentat… · and OXAYDO®; our ability to execute on our sales and marketing strategy, ... Secured Notes and non-cash amortization